Trial Outcomes & Findings for Regimen Switch to Dolutegravir + Rilpivirine From Current Antiretroviral Regimen in Human Immunodeficiency Virus Type 1 Infected and Virologically Suppressed Adults (SWORD-1) (NCT NCT02429791)
NCT ID: NCT02429791
Last Updated: 2024-09-03
Results Overview
Percentage of participants with plasma HIV 1 RNA \<50 c/mL at Week 48 using the Food and Drug Administration (FDA) snapshot algorithm was assessed to demonstrate the non-inferior antiviral activity of switching to DTG + RPV once daily compared to continuation of CAR over 48 weeks in HIV-1 infected antiretroviral therapy (ART)-experienced participants. Virologic success or failure was determined by the last available HIV-1 RNA assessment while the participant was on-treatment within the window of the visit of interest. Plasma samples were collected for quantitative analysis of HIV-1 RNA.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
510 participants
Primary outcome timeframe
Week 48
Results posted on
2024-09-03
Participant Flow
The study was conducted at 65 centers in 13 countries.
510 participants were randomized and 2 participants withdrew before being exposed to study drug. The study included an Early Switch Phase, a Late Switch Phase, and a Continuation Phase.
Participant milestones
| Measure |
DTG + RPV
Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
Participants continued to receive their CAR (two nucleoside reverse transcriptase inhibitors \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during the Early Switch Phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) less than (\<) 50 copies (c)/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Early Switch Phase (Up to Week 52)
STARTED
|
252
|
256
|
|
Early Switch Phase (Up to Week 52)
COMPLETED
|
239
|
238
|
|
Early Switch Phase (Up to Week 52)
NOT COMPLETED
|
13
|
18
|
|
Late Switch Phase (Week 52 to Week 148)
STARTED
|
239
|
238
|
|
Late Switch Phase (Week 52 to Week 148)
COMPLETED
|
214
|
210
|
|
Late Switch Phase (Week 52 to Week 148)
NOT COMPLETED
|
25
|
28
|
|
Continuation Phase(Week 148 to Week 411)
STARTED
|
186
|
183
|
|
Continuation Phase(Week 148 to Week 411)
COMPLETED
|
179
|
178
|
|
Continuation Phase(Week 148 to Week 411)
NOT COMPLETED
|
7
|
5
|
Reasons for withdrawal
| Measure |
DTG + RPV
Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
Participants continued to receive their CAR (two nucleoside reverse transcriptase inhibitors \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during the Early Switch Phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) less than (\<) 50 copies (c)/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Early Switch Phase (Up to Week 52)
Adverse Event
|
6
|
2
|
|
Early Switch Phase (Up to Week 52)
Physician Decision
|
0
|
2
|
|
Early Switch Phase (Up to Week 52)
Lack of Efficacy
|
2
|
1
|
|
Early Switch Phase (Up to Week 52)
Lost to Follow-up
|
1
|
2
|
|
Early Switch Phase (Up to Week 52)
Protocol Violation
|
1
|
4
|
|
Early Switch Phase (Up to Week 52)
Withdrawal by Subject
|
3
|
7
|
|
Late Switch Phase (Week 52 to Week 148)
Adverse Event
|
11
|
12
|
|
Late Switch Phase (Week 52 to Week 148)
Physician Decision
|
0
|
4
|
|
Late Switch Phase (Week 52 to Week 148)
Lack of Efficacy
|
4
|
3
|
|
Late Switch Phase (Week 52 to Week 148)
Lost to Follow-up
|
0
|
1
|
|
Late Switch Phase (Week 52 to Week 148)
Protocol Violation
|
3
|
3
|
|
Late Switch Phase (Week 52 to Week 148)
Withdrawal by Subject
|
7
|
5
|
|
Continuation Phase(Week 148 to Week 411)
Adverse Event
|
3
|
1
|
|
Continuation Phase(Week 148 to Week 411)
Lack of Efficacy
|
1
|
0
|
|
Continuation Phase(Week 148 to Week 411)
Protocol Violation
|
1
|
0
|
|
Continuation Phase(Week 148 to Week 411)
Withdrawal by Subject
|
1
|
1
|
|
Continuation Phase(Week 148 to Week 411)
Lost to Follow-up
|
1
|
1
|
|
Continuation Phase(Week 148 to Week 411)
Investigator discretion
|
0
|
2
|
Baseline Characteristics
Regimen Switch to Dolutegravir + Rilpivirine From Current Antiretroviral Regimen in Human Immunodeficiency Virus Type 1 Infected and Virologically Suppressed Adults (SWORD-1)
Baseline characteristics by cohort
| Measure |
DTG + RPV
n=252 Participants
Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
n=256 Participants
Participants continued to receive their CAR (two nucleoside reverse transcriptase inhibitors \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during the Early Switch Phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) less than (\<) 50 copies (c)/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
Total
n=508 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.6 Years
STANDARD_DEVIATION 10.93 • n=5 Participants
|
43.6 Years
STANDARD_DEVIATION 10.76 • n=7 Participants
|
43.6 Years
STANDARD_DEVIATION 10.84 • n=5 Participants
|
|
Sex: Female, Male
Female
|
58 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
194 Participants
n=5 Participants
|
205 Participants
n=7 Participants
|
399 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Japanese/East Asian (EA) Heritage (H.)/South EA H.
|
25 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
24 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
198 Participants
n=5 Participants
|
188 Participants
n=7 Participants
|
386 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native and white
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American/African H. and Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 48Population: The analysis was performed on the Intent-to-Treat Exposed (ITT-E) population which consisted of all randomly assigned participants who received at least one dose of study drug.
Percentage of participants with plasma HIV 1 RNA \<50 c/mL at Week 48 using the Food and Drug Administration (FDA) snapshot algorithm was assessed to demonstrate the non-inferior antiviral activity of switching to DTG + RPV once daily compared to continuation of CAR over 48 weeks in HIV-1 infected antiretroviral therapy (ART)-experienced participants. Virologic success or failure was determined by the last available HIV-1 RNA assessment while the participant was on-treatment within the window of the visit of interest. Plasma samples were collected for quantitative analysis of HIV-1 RNA.
Outcome measures
| Measure |
DTG + RPV
n=252 Participants
Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
n=256 Participants
Participants continued to receive their CAR (two nucleoside reverse transcriptase inhibitors \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during the Early Switch Phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) less than (\<) 50 copies (c)/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 48 Using Snapshot Algorithm
|
95 Percentage of participants
|
96 Percentage of participants
|
SECONDARY outcome
Timeframe: At Weeks 24 and 48Population: ITT-E Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected and CD4+ cell count assessment by flow cytometry was carried out to evaluate the immunological activity of DTG + RPV once daily compared to continuation of CAR. Value obtained at Day 1 was considered as Baseline value. Change from Baseline was calculated as value at indicated time point minus Baseline value.
Outcome measures
| Measure |
DTG + RPV
n=252 Participants
Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
n=256 Participants
Participants continued to receive their CAR (two nucleoside reverse transcriptase inhibitors \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during the Early Switch Phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) less than (\<) 50 copies (c)/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Changes From Baseline in Cluster Designation (CD)4+ Lymphocyte Count at Weeks 24 and 48
Week 24
|
16.2 Cells per millimeter cube (mm^3)
Standard Deviation 150.34
|
47.4 Cells per millimeter cube (mm^3)
Standard Deviation 179.68
|
|
Changes From Baseline in Cluster Designation (CD)4+ Lymphocyte Count at Weeks 24 and 48
Week 48
|
32.3 Cells per millimeter cube (mm^3)
Standard Deviation 149.52
|
41.8 Cells per millimeter cube (mm^3)
Standard Deviation 185.53
|
SECONDARY outcome
Timeframe: Week 24Population: ITT-E Population
Percentage of participants with plasma HIV 1 RNA \< 50 c/mL at Week 24 using the FDA snapshot algorithm was assessed to evaluate the antiviral activity of DTG + RPV once daily compared to continuation of CAR. Virologic success or failure was determined by the last available HIV-1 RNA assessment while the participant was on-treatment within the window of the visit of interest. Plasma samples were collected for quantitative analysis of HIV-1 RNA.
Outcome measures
| Measure |
DTG + RPV
n=252 Participants
Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
n=256 Participants
Participants continued to receive their CAR (two nucleoside reverse transcriptase inhibitors \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during the Early Switch Phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) less than (\<) 50 copies (c)/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Percentage of Participants With Plasma HIV 1 RNA <50 c/mL at Week 24 Using Snapshot Algorithm
|
98 Percentage of participants
|
96 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to Week 411 or study discontinuationPopulation: Safety Population included all randomized participants who have received at least one dose of study drug.
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize participant or may require medical or surgical intervention were categorized as SAE. AEs were graded as per Division of Acquired Immunodeficiency Syndrome (DAIDS) grading. Grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=potentially life-threatening. Common AEs were those with \>5% incidence for either treatment.
Outcome measures
| Measure |
DTG + RPV
n=252 Participants
Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
n=238 Participants
Participants continued to receive their CAR (two nucleoside reverse transcriptase inhibitors \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during the Early Switch Phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) less than (\<) 50 copies (c)/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Number of Participants With Common Non-serious Adverse Event (AE), Any Serious AE (SAE), AE of Maximum Toxicity Grade 1, 2, 3 or 4 and AE Leading to Discontinuation (AELD)
Common non-serious AE
|
158 Participants
|
126 Participants
|
|
Number of Participants With Common Non-serious Adverse Event (AE), Any Serious AE (SAE), AE of Maximum Toxicity Grade 1, 2, 3 or 4 and AE Leading to Discontinuation (AELD)
Any SAE
|
37 Participants
|
30 Participants
|
|
Number of Participants With Common Non-serious Adverse Event (AE), Any Serious AE (SAE), AE of Maximum Toxicity Grade 1, 2, 3 or 4 and AE Leading to Discontinuation (AELD)
Maximum toxicity Grade 1 AE
|
82 Participants
|
73 Participants
|
|
Number of Participants With Common Non-serious Adverse Event (AE), Any Serious AE (SAE), AE of Maximum Toxicity Grade 1, 2, 3 or 4 and AE Leading to Discontinuation (AELD)
Maximum toxicity Grade 2 AE
|
97 Participants
|
107 Participants
|
|
Number of Participants With Common Non-serious Adverse Event (AE), Any Serious AE (SAE), AE of Maximum Toxicity Grade 1, 2, 3 or 4 and AE Leading to Discontinuation (AELD)
Maximum toxicity Grade 3 AE
|
37 Participants
|
17 Participants
|
|
Number of Participants With Common Non-serious Adverse Event (AE), Any Serious AE (SAE), AE of Maximum Toxicity Grade 1, 2, 3 or 4 and AE Leading to Discontinuation (AELD)
Maximum toxicity Grade 4 AE
|
15 Participants
|
9 Participants
|
|
Number of Participants With Common Non-serious Adverse Event (AE), Any Serious AE (SAE), AE of Maximum Toxicity Grade 1, 2, 3 or 4 and AE Leading to Discontinuation (AELD)
AELD
|
22 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Up to 48 weeksPopulation: Safety Population
Blood samples were collected to evaluate alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), total bilirubin, chloride, creatinine, glucose, potassium, phosphate, sodium, blood urea nitrogen (BUN), total carbon dioxide, lipase, creatine phosphokinase and creatinine clearance. Value obtained at Day 1 was considered as Baseline value. Number of participants who experienced maximum grade toxicity post-Baseline in clinical chemistry over 48 weeks was summarized. Clinical chemistry toxicities were graded using DAIDS grading table for grading severity of adult and pediatric adverse events. Grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=potentially life-threatening. For all laboratory parameters, one assessment out of range was sufficient to be considered a chemistry toxicity.
Outcome measures
| Measure |
DTG + RPV
n=252 Participants
Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
n=256 Participants
Participants continued to receive their CAR (two nucleoside reverse transcriptase inhibitors \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during the Early Switch Phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) less than (\<) 50 copies (c)/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks
Grade 1
|
95 Participants
|
78 Participants
|
|
Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks
Grade 2
|
61 Participants
|
86 Participants
|
|
Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks
Grade 3
|
22 Participants
|
23 Participants
|
|
Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks
Grade 4
|
5 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Up to 48 weeksPopulation: Safety Population
Blood samples were collected to evaluate hemoglobin, hematocrit, basophils, eosinophils, lymphocytes, monocytes, neutrophils, mean corpuscular volume (MCV), red blood cell (RBC) count, white blood cell (WBC) count and platelet count. Value obtained at Day 1 was considered as Baseline value. Number of participants who experienced maximum grade toxicity post-Baseline in hematology over 48 weeks was summarized. Hematology toxicities were graded using DAIDS grading table for grading severity of adult and pediatric adverse events. Grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=potentially life-threatening. For all laboratory parameters, one assessment out of range was sufficient to be considered a hematology toxicity.
Outcome measures
| Measure |
DTG + RPV
n=252 Participants
Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
n=256 Participants
Participants continued to receive their CAR (two nucleoside reverse transcriptase inhibitors \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during the Early Switch Phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) less than (\<) 50 copies (c)/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities Over 48 Weeks
Grade 1
|
11 Participants
|
11 Participants
|
|
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities Over 48 Weeks
Grade 2
|
3 Participants
|
2 Participants
|
|
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities Over 48 Weeks
Grade 3
|
3 Participants
|
1 Participants
|
|
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities Over 48 Weeks
Grade 4
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: At Week 48Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess hs-CRP. Change from Baseline was calculated as value at indicated time point minus Baseline value.
Outcome measures
| Measure |
DTG + RPV
n=234 Participants
Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
n=243 Participants
Participants continued to receive their CAR (two nucleoside reverse transcriptase inhibitors \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during the Early Switch Phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) less than (\<) 50 copies (c)/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Mean Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) at Week 48
|
0.11 mg/ Liter (L)
Standard Deviation 5.379
|
0.15 mg/ Liter (L)
Standard Deviation 4.944
|
SECONDARY outcome
Timeframe: At Week 48Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess cystatin C. Change from Baseline was calculated as value at indicated time point minus Baseline value.
Outcome measures
| Measure |
DTG + RPV
n=237 Participants
Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
n=245 Participants
Participants continued to receive their CAR (two nucleoside reverse transcriptase inhibitors \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during the Early Switch Phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) less than (\<) 50 copies (c)/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Mean Change From Baseline in Cystatin C at Week 48
|
0.00 mg/L
Standard Deviation 0.113
|
-0.01 mg/L
Standard Deviation 0.106
|
SECONDARY outcome
Timeframe: At Week 48Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess D-Dimer. Change from Baseline was calculated as value at indicated time point minus Baseline value.
Outcome measures
| Measure |
DTG + RPV
n=224 Participants
Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
n=238 Participants
Participants continued to receive their CAR (two nucleoside reverse transcriptase inhibitors \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during the Early Switch Phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) less than (\<) 50 copies (c)/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Mean Change From Baseline in D-Dimer at Week 48
|
-0.02 Nanomole/L fibrinogen equivalent units
Standard Deviation 2.651
|
0.02 Nanomole/L fibrinogen equivalent units
Standard Deviation 2.501
|
SECONDARY outcome
Timeframe: At Week 48Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess FABP and soluble cluster designation (CD)14. Change from Baseline was calculated as value at indicated time point minus Baseline value.
Outcome measures
| Measure |
DTG + RPV
n=252 Participants
Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
n=256 Participants
Participants continued to receive their CAR (two nucleoside reverse transcriptase inhibitors \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during the Early Switch Phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) less than (\<) 50 copies (c)/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Mean Change From Baseline in Fatty Acid Binding Protein 2 (FABP) and Soluble Cluster Designation (CD)14 at Week 48
FABP
|
-2.79 Nanogram/milliliter
Standard Deviation 3.007
|
-1.93 Nanogram/milliliter
Standard Deviation 2.150
|
|
Mean Change From Baseline in Fatty Acid Binding Protein 2 (FABP) and Soluble Cluster Designation (CD)14 at Week 48
Soluble CD14
|
379.72 Nanogram/milliliter
Standard Deviation 634.053
|
754.54 Nanogram/milliliter
Standard Deviation 656.462
|
SECONDARY outcome
Timeframe: At Week 48Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess soluble CD163 and oxidized LDL. Change from Baseline was calculated as value at indicated time point minus Baseline value.
Outcome measures
| Measure |
DTG + RPV
n=252 Participants
Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
n=256 Participants
Participants continued to receive their CAR (two nucleoside reverse transcriptase inhibitors \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during the Early Switch Phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) less than (\<) 50 copies (c)/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Mean Change From Baseline in Soluble CD163 and Oxidized Low Density Lipoprotein (LDL) at Week 48
Soluble CD163
|
50.18 Microgram (µg)/Liter
Standard Deviation 188.772
|
54.26 Microgram (µg)/Liter
Standard Deviation 238.900
|
|
Mean Change From Baseline in Soluble CD163 and Oxidized Low Density Lipoprotein (LDL) at Week 48
Oxidized LDL
|
9.49 Microgram (µg)/Liter
Standard Deviation 745.962
|
-41.30 Microgram (µg)/Liter
Standard Deviation 726.014
|
SECONDARY outcome
Timeframe: At Week 48Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess RBP, serum creatinine and glucose. Change from Baseline was calculated as value at indicated time point minus Baseline value.
Outcome measures
| Measure |
DTG + RPV
n=252 Participants
Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
n=256 Participants
Participants continued to receive their CAR (two nucleoside reverse transcriptase inhibitors \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during the Early Switch Phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) less than (\<) 50 copies (c)/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Mean Change From Baseline in Retinol Binding Protein (RBP), Serum Creatinine and Glucose at Week 48
RBP
|
-0.13 mg/deciliter (dL)
Standard Deviation 1.023
|
0.03 mg/deciliter (dL)
Standard Deviation 0.974
|
|
Mean Change From Baseline in Retinol Binding Protein (RBP), Serum Creatinine and Glucose at Week 48
Serum creatinine
|
0.087 mg/deciliter (dL)
Standard Deviation 0.1074
|
0.011 mg/deciliter (dL)
Standard Deviation 0.0876
|
|
Mean Change From Baseline in Retinol Binding Protein (RBP), Serum Creatinine and Glucose at Week 48
Glucose
|
0.762 mg/deciliter (dL)
Standard Deviation 13.6194
|
2.492 mg/deciliter (dL)
Standard Deviation 12.1674
|
SECONDARY outcome
Timeframe: At Week 48Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Urine biomarker samples were collected at Baseline (Day 1) and Week 48 to assess urine phosphate. Change from Baseline was calculated as value at indicated time point minus Baseline value.
Outcome measures
| Measure |
DTG + RPV
n=218 Participants
Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
n=224 Participants
Participants continued to receive their CAR (two nucleoside reverse transcriptase inhibitors \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during the Early Switch Phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) less than (\<) 50 copies (c)/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Mean Change From Baseline in Urine Phosphate at Week 48
|
-1.079 Millimoles (mmol)/ L
Standard Deviation 16.9226
|
-1.511 Millimoles (mmol)/ L
Standard Deviation 15.8515
|
SECONDARY outcome
Timeframe: At Week 48Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess B2M and 25 hydroxy-vitamin D. Urine samples were collected to assess B2M and RBP. Change from Baseline was calculated as value at indicated time point minus Baseline value. For 25 hydroxy-vitamin D, analysis of changes from Baseline was performed on log-transformed data. Results were transformed back via exponential transformation such that treatment comparisons are assessed via odds ratios.
Outcome measures
| Measure |
DTG + RPV
n=252 Participants
Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
n=256 Participants
Participants continued to receive their CAR (two nucleoside reverse transcriptase inhibitors \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during the Early Switch Phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) less than (\<) 50 copies (c)/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Mean Change From Baseline in Beta-2-microglobulin (B2M) (Blood and Urine), Urine RBP and 25 Hydroxy-vitamin D (Blood) at Week 48
Blood B2M
|
-15.1452 Nanomoles/ L
Standard Deviation 44.55903
|
-4.5995 Nanomoles/ L
Standard Deviation 38.90474
|
|
Mean Change From Baseline in Beta-2-microglobulin (B2M) (Blood and Urine), Urine RBP and 25 Hydroxy-vitamin D (Blood) at Week 48
Blood 25 hydroxy-vitamin D
|
-13.9 Nanomoles/ L
Standard Deviation 22.76
|
-8.2 Nanomoles/ L
Standard Deviation 24.43
|
|
Mean Change From Baseline in Beta-2-microglobulin (B2M) (Blood and Urine), Urine RBP and 25 Hydroxy-vitamin D (Blood) at Week 48
Urine B2M
|
-128.2045 Nanomoles/ L
Standard Deviation 726.38825
|
39.8394 Nanomoles/ L
Standard Deviation 253.43025
|
|
Mean Change From Baseline in Beta-2-microglobulin (B2M) (Blood and Urine), Urine RBP and 25 Hydroxy-vitamin D (Blood) at Week 48
Urine RBP
|
-8.8395 Nanomoles/ L
Standard Deviation 28.83977
|
-0.5851 Nanomoles/ L
Standard Deviation 27.56405
|
SECONDARY outcome
Timeframe: At Week 48Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Urine biomarker samples were collected at Baseline (Day 1) and Week 48 to assess urine albumin/creatinine ratio and urine protein/creatinine ratio. Change from Baseline was calculated as value at indicated time point minus Baseline value.
Outcome measures
| Measure |
DTG + RPV
n=252 Participants
Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
n=256 Participants
Participants continued to receive their CAR (two nucleoside reverse transcriptase inhibitors \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during the Early Switch Phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) less than (\<) 50 copies (c)/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Mean Change From Baseline in Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio at Week 48
Urine albumin/creatinine ratio
|
-1.19 Grams (g)/ mol
Standard Deviation 3.916
|
-2.59 Grams (g)/ mol
Standard Deviation 28.878
|
|
Mean Change From Baseline in Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio at Week 48
Urine protein/creatinine ratio
|
-5.63 Grams (g)/ mol
Standard Deviation 17.219
|
-1.43 Grams (g)/ mol
Standard Deviation 42.832
|
SECONDARY outcome
Timeframe: At Week 48Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess bone-specific alkaline phosphatase, procollagen 1 N-terminal propeptide, osteocalcin, Type I Collagen C-Telopeptides and sVCAM. Change from Baseline was calculated as value at indicated time point minus Baseline value. For bone-specific alkaline phosphatase, procollagen 1-N-propeptide, osteocalcin and type 1 collagen C-telopeptide, analyses of changes from baseline were performed on log-transformed data. Results were transformed back via exponential transformation such that treatment comparisons are assessed via odds ratios.
Outcome measures
| Measure |
DTG + RPV
n=252 Participants
Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
n=256 Participants
Participants continued to receive their CAR (two nucleoside reverse transcriptase inhibitors \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during the Early Switch Phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) less than (\<) 50 copies (c)/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Mean Change From Baseline in Bone-specific Alkaline Phosphatase, Procollagen 1 N-terminal Propeptide, Osteocalcin, Type I Collagen C-Telopeptides and Soluble Vascular Cell Adhesion Molecule (sVCAM) at Week 48
Bone-specific alkaline phosphatase
|
-2.89 µg/ L
Standard Deviation 4.024
|
0.90 µg/ L
Standard Deviation 4.129
|
|
Mean Change From Baseline in Bone-specific Alkaline Phosphatase, Procollagen 1 N-terminal Propeptide, Osteocalcin, Type I Collagen C-Telopeptides and Soluble Vascular Cell Adhesion Molecule (sVCAM) at Week 48
Procollagen type 1 N-propeptide
|
-9.1 µg/ L
Standard Deviation 20.34
|
-1.4 µg/ L
Standard Deviation 18.95
|
|
Mean Change From Baseline in Bone-specific Alkaline Phosphatase, Procollagen 1 N-terminal Propeptide, Osteocalcin, Type I Collagen C-Telopeptides and Soluble Vascular Cell Adhesion Molecule (sVCAM) at Week 48
Osteocalcin
|
-4.40 µg/ L
Standard Deviation 7.605
|
-0.68 µg/ L
Standard Deviation 6.579
|
|
Mean Change From Baseline in Bone-specific Alkaline Phosphatase, Procollagen 1 N-terminal Propeptide, Osteocalcin, Type I Collagen C-Telopeptides and Soluble Vascular Cell Adhesion Molecule (sVCAM) at Week 48
Type I Collagen C-Telopeptides
|
-0.18 µg/ L
Standard Deviation 0.307
|
-0.04 µg/ L
Standard Deviation 1.160
|
|
Mean Change From Baseline in Bone-specific Alkaline Phosphatase, Procollagen 1 N-terminal Propeptide, Osteocalcin, Type I Collagen C-Telopeptides and Soluble Vascular Cell Adhesion Molecule (sVCAM) at Week 48
sVCAM
|
-2.21 µg/ L
Standard Deviation 1291.994
|
89.07 µg/ L
Standard Deviation 1239.465
|
SECONDARY outcome
Timeframe: At Week 48Population: Safety Population. Only those participants with data available at the specified time point were analyzed.
Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess IL-6. Change from Baseline was calculated as value at indicated time point minus Baseline value.
Outcome measures
| Measure |
DTG + RPV
n=233 Participants
Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
n=243 Participants
Participants continued to receive their CAR (two nucleoside reverse transcriptase inhibitors \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during the Early Switch Phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) less than (\<) 50 copies (c)/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Mean Change From Baseline in Interleukin 6 (IL-6) at Week 48
|
0.17 Nanograms (ng)/ L
Standard Deviation 2.736
|
-0.18 Nanograms (ng)/ L
Standard Deviation 2.944
|
SECONDARY outcome
Timeframe: At Week 48Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess insulin resistance. Change from Baseline was calculated as value at indicated time point minus Baseline value. The homeostatic model assessment (HOMA) of insulin resistance (HOMA-IR) index, the product of basal glucose and insulin levels divided by 22.5 (1,2), is regarded as a simple, inexpensive, and reliable surrogate measure of insulin resistance.
Outcome measures
| Measure |
DTG + RPV
n=229 Participants
Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
n=237 Participants
Participants continued to receive their CAR (two nucleoside reverse transcriptase inhibitors \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during the Early Switch Phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) less than (\<) 50 copies (c)/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Mean Change From Baseline in Insulin Resistance Based on Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) at Week 48
|
-0.30 HOMA-IR Score
Standard Deviation 5.740
|
0.51 HOMA-IR Score
Standard Deviation 3.530
|
SECONDARY outcome
Timeframe: At Week 24 and at Week 48Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at Baseline (Day 1), Week 24 and Week 48 to assess fasting lipids which included total cholesterol, low density lipoprotein (LDL) cholesterol, high density lipoprotein (HDL) cholesterol and triglycerides. Change from Baseline was calculated as value at indicated time point minus Baseline value.
Outcome measures
| Measure |
DTG + RPV
n=252 Participants
Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
n=256 Participants
Participants continued to receive their CAR (two nucleoside reverse transcriptase inhibitors \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during the Early Switch Phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) less than (\<) 50 copies (c)/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Mean Change From Baseline in Fasting Lipids at Weeks 24 and 48
Total cholesterol, Week 24
|
0.076 mmol/ L
Standard Deviation 0.8398
|
0.061 mmol/ L
Standard Deviation 0.7368
|
|
Mean Change From Baseline in Fasting Lipids at Weeks 24 and 48
Total cholesterol, Week 48
|
0.089 mmol/ L
Standard Deviation 0.8488
|
0.064 mmol/ L
Standard Deviation 0.7197
|
|
Mean Change From Baseline in Fasting Lipids at Weeks 24 and 48
LDL cholesterol calculation, Week 24
|
0.165 mmol/ L
Standard Deviation 0.7065
|
0.103 mmol/ L
Standard Deviation 0.6503
|
|
Mean Change From Baseline in Fasting Lipids at Weeks 24 and 48
LDL cholesterol calculation, Week 48
|
0.108 mmol/ L
Standard Deviation 0.7178
|
0.029 mmol/ L
Standard Deviation 0.6134
|
|
Mean Change From Baseline in Fasting Lipids at Weeks 24 and 48
HDL cholesterol direct, Week 24
|
-0.030 mmol/ L
Standard Deviation 0.2601
|
-0.044 mmol/ L
Standard Deviation 0.2394
|
|
Mean Change From Baseline in Fasting Lipids at Weeks 24 and 48
HDL cholesterol direct, Week 48
|
0.023 mmol/ L
Standard Deviation 0.2757
|
0.018 mmol/ L
Standard Deviation 0.2722
|
|
Mean Change From Baseline in Fasting Lipids at Weeks 24 and 48
Triglycerides, Week 24
|
-0.154 mmol/ L
Standard Deviation 0.7324
|
-0.001 mmol/ L
Standard Deviation 0.7712
|
|
Mean Change From Baseline in Fasting Lipids at Weeks 24 and 48
Triglycerides, Week 48
|
-0.093 mmol/ L
Standard Deviation 0.9767
|
0.046 mmol/ L
Standard Deviation 0.8274
|
SECONDARY outcome
Timeframe: Up to Week 52Population: The analysis was performed on the Confirmed Virologic Withdrawal (CVW) resistance population which was comprised of all participants in the ITT-E Population who met confirmed CVW through the end of visit window (Week 48, Week 100 or Week 148) and had available on-treatment genotypic resistance data at the time CVW criterion was met.
Plasma samples were collected for drug resistance testing. Genotypic Resistance data for the following drugs (Rilpivirine \[RPV\], Dolutegravir \[DTG\], Emtricitabine \[FTC\], Tenofovir \[TDF\], Darunavir/r \[DRV/r\]) in participants Meeting CVW Criteria has been presented.
Outcome measures
| Measure |
DTG + RPV
n=1 Participants
Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
n=1 Participants
Participants continued to receive their CAR (two nucleoside reverse transcriptase inhibitors \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during the Early Switch Phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) less than (\<) 50 copies (c)/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Number of Participants With Genotypic Resistance- Early Switch Phase
INI, DTG, Low-level resistance
|
0 Participants
|
NA Participants
NA indicates data was not applicable as the drugs were not received. Genotypic resistance data is only shown for drugs received for Participants Meeting Confirmed Virologic Withdrawal Criteria
|
|
Number of Participants With Genotypic Resistance- Early Switch Phase
INI, DTG, Intermediate resistance
|
0 Participants
|
NA Participants
NA indicates data was not applicable as the drugs were not received. Genotypic resistance data is only shown for drugs received for Participants Meeting Confirmed Virologic Withdrawal Criteria
|
|
Number of Participants With Genotypic Resistance- Early Switch Phase
INI, DTG, High-level resistance
|
0 Participants
|
NA Participants
NA indicates data was not applicable as the drugs were not received. Genotypic resistance data is only shown for drugs received for Participants Meeting Confirmed Virologic Withdrawal Criteria
|
|
Number of Participants With Genotypic Resistance- Early Switch Phase
NRTI, FTC, Susceptible
|
NA Participants
NA indicates data was not applicable as the drugs were not received. Genotypic resistance data is only shown for drugs received for Participants Meeting Confirmed Virologic Withdrawal Criteria
|
1 Participants
|
|
Number of Participants With Genotypic Resistance- Early Switch Phase
NRTI, FTC, Potential low-level resistance
|
NA Participants
NA indicates data was not applicable as the drugs were not received. Genotypic resistance data is only shown for drugs received for Participants Meeting Confirmed Virologic Withdrawal Criteria
|
0 Participants
|
|
Number of Participants With Genotypic Resistance- Early Switch Phase
NRTI, FTC, Low-level resistance
|
NA Participants
NA indicates data was not applicable as the drugs were not received. Genotypic resistance data is only shown for drugs received for Participants Meeting Confirmed Virologic Withdrawal Criteria
|
0 Participants
|
|
Number of Participants With Genotypic Resistance- Early Switch Phase
NRTI, FTC, Intermediate resistance
|
NA Participants
NA indicates data was not applicable as the drugs were not received. Genotypic resistance data is only shown for drugs received for Participants Meeting Confirmed Virologic Withdrawal Criteria
|
0 Participants
|
|
Number of Participants With Genotypic Resistance- Early Switch Phase
NRTI, FTC, High-level resistance
|
NA Participants
NA indicates data was not applicable as the drugs were not received. Genotypic resistance data is only shown for drugs received for Participants Meeting Confirmed Virologic Withdrawal Criteria
|
0 Participants
|
|
Number of Participants With Genotypic Resistance- Early Switch Phase
NRTI, TDF, Susceptible
|
NA Participants
NA indicates data was not applicable as the drugs were not received. Genotypic resistance data is only shown for drugs received for Participants Meeting Confirmed Virologic Withdrawal Criteria
|
1 Participants
|
|
Number of Participants With Genotypic Resistance- Early Switch Phase
NRTI, TDF, Potential low-level resistance
|
NA Participants
NA indicates data was not applicable as the drugs were not received. Genotypic resistance data is only shown for drugs received for Participants Meeting Confirmed Virologic Withdrawal Criteria
|
0 Participants
|
|
Number of Participants With Genotypic Resistance- Early Switch Phase
NRTI, TDF, Low-level resistance
|
NA Participants
NA indicates data was not applicable as the drugs were not received. Genotypic resistance data is only shown for drugs received for Participants Meeting Confirmed Virologic Withdrawal Criteria
|
0 Participants
|
|
Number of Participants With Genotypic Resistance- Early Switch Phase
NRTI, TDF, Intermediate resistance
|
NA Participants
NA indicates data was not applicable as the drugs were not received. Genotypic resistance data is only shown for drugs received for Participants Meeting Confirmed Virologic Withdrawal Criteria
|
0 Participants
|
|
Number of Participants With Genotypic Resistance- Early Switch Phase
NRTI, TDF, High-level resistance
|
NA Participants
NA indicates data was not applicable as the drugs were not received. Genotypic resistance data is only shown for drugs received for Participants Meeting Confirmed Virologic Withdrawal Criteria
|
0 Participants
|
|
Number of Participants With Genotypic Resistance- Early Switch Phase
PI, DRV/r, Susceptible
|
NA Participants
NA indicates data was not applicable as the drugs were not received. Genotypic resistance data is only shown for drugs received for Participants Meeting Confirmed Virologic Withdrawal Criteria
|
1 Participants
|
|
Number of Participants With Genotypic Resistance- Early Switch Phase
PI, DRV/r, Potential low-level resistance
|
NA Participants
NA indicates data was not applicable as the drugs were not received. Genotypic resistance data is only shown for drugs received for Participants Meeting Confirmed Virologic Withdrawal Criteria
|
0 Participants
|
|
Number of Participants With Genotypic Resistance- Early Switch Phase
PI, DRV/r, Low-level resistance
|
NA Participants
NA indicates data was not applicable as the drugs were not received. Genotypic resistance data is only shown for drugs received for Participants Meeting Confirmed Virologic Withdrawal Criteria
|
0 Participants
|
|
Number of Participants With Genotypic Resistance- Early Switch Phase
PI, DRV/r, Intermediate resistance
|
NA Participants
NA indicates data was not applicable as the drugs were not received. Genotypic resistance data is only shown for drugs received for Participants Meeting Confirmed Virologic Withdrawal Criteria
|
0 Participants
|
|
Number of Participants With Genotypic Resistance- Early Switch Phase
PI, DRV/r, High-level resistance
|
NA Participants
NA indicates data was not applicable as the drugs were not received. Genotypic resistance data is only shown for drugs received for Participants Meeting Confirmed Virologic Withdrawal Criteria
|
0 Participants
|
|
Number of Participants With Genotypic Resistance- Early Switch Phase
NNRTI, RPV, Susceptible
|
1 Participants
|
NA Participants
NA indicates data was not applicable as the drugs were not received. Genotypic resistance data is only shown for drugs received for Participants Meeting Confirmed Virologic Withdrawal Criteria
|
|
Number of Participants With Genotypic Resistance- Early Switch Phase
NNRTI, RPV, Potential low-level resistance
|
0 Participants
|
NA Participants
NA indicates data was not applicable as the drugs were not received. Genotypic resistance data is only shown for drugs received for Participants Meeting Confirmed Virologic Withdrawal Criteria
|
|
Number of Participants With Genotypic Resistance- Early Switch Phase
NNRTI, RPV, Low-level resistance
|
0 Participants
|
NA Participants
NA indicates data was not applicable as the drugs were not received. Genotypic resistance data is only shown for drugs received for Participants Meeting Confirmed Virologic Withdrawal Criteria
|
|
Number of Participants With Genotypic Resistance- Early Switch Phase
NNRTI, RPV, Intermediate resistance
|
0 Participants
|
NA Participants
NA indicates data was not applicable as the drugs were not received. Genotypic resistance data is only shown for drugs received for Participants Meeting Confirmed Virologic Withdrawal Criteria
|
|
Number of Participants With Genotypic Resistance- Early Switch Phase
NNRTI, RPV, High-level resistance
|
0 Participants
|
NA Participants
NA indicates data was not applicable as the drugs were not received. Genotypic resistance data is only shown for drugs received for Participants Meeting Confirmed Virologic Withdrawal Criteria
|
|
Number of Participants With Genotypic Resistance- Early Switch Phase
INI, DTG, Susceptible
|
1 Participants
|
NA Participants
NA indicates data was not applicable as the drugs were not received. Genotypic resistance data is only shown for drugs received for Participants Meeting Confirmed Virologic Withdrawal Criteria
|
|
Number of Participants With Genotypic Resistance- Early Switch Phase
INI, DTG, Potential low-level resistance
|
0 Participants
|
NA Participants
NA indicates data was not applicable as the drugs were not received. Genotypic resistance data is only shown for drugs received for Participants Meeting Confirmed Virologic Withdrawal Criteria
|
SECONDARY outcome
Timeframe: Up to Week 148Population: CVW resistance Population
Plasma samples were collected for drug resistance testing. Genotypic Resistance data for the following drugs (DTG, Elvitegravir \[EVG\], Raltegravir \[RAL\], Delavirdine \[DLV\], Efavirenz \[EFV\], Etravirine \[ETR\], Nevirapine \[NVP\], RPV, Lamivudine \[3TC\], Abacavir \[ABC\], FTC, TDF, Zidovudine \[ZDV\], Stavudine \[d4T\], Didanosine \[ddI\], Atazanavir/r \[ATV/r\], DRV/r, Fosamprenavir/r \[FPV/r\], Indinavir/r \[IDV/r\], Lopinavir/r \[LPV/r\], Nelfinavir \[NFV\], Ritonavir \[RTV\], Saquinavir/r \[SQV/r\], Tipranavir/r \[TPV/r\]) in participants Meeting CVW Criteria has been presented.
Outcome measures
| Measure |
DTG + RPV
n=5 Participants
Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
Participants continued to receive their CAR (two nucleoside reverse transcriptase inhibitors \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during the Early Switch Phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) less than (\<) 50 copies (c)/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
INI, RAL, Potential low-level resistance
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
INI, DTG, Susceptible
|
5 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
INI, RAL, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
INI, RAL, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
INI, DTG, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
INI, DTG, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
INI, DTG, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
INI, DTG, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
INI, EVG,Susceptible
|
4 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
INI, EVG, Potential low-level resistance
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
INI, EVG,Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
INI, EVG, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
INI, EVG, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
INI, RAL,Susceptible
|
4 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NNRTI, EFV, Intermediate resistance
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NNRTI, EFV, High-level resistance
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NNRTI, ETR, Susceptible
|
3 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, RTV, Susceptible
|
5 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NNRTI, DLV, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NNRTI, DLV, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NNRTI, EFV, Susceptible
|
3 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NNRTI, EFV, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NNRTI, EFV, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
INI, RAL, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NNRTI, DLV, Susceptible
|
5 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NNRTI, DLV, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NRTI, ABC, Susceptible
|
5 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NRTI, ABC, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NRTI, ABC, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NRTI, ABC, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NRTI, ABC, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NRTI, FTC, Susceptible
|
5 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NRTI, FTC, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NRTI, FTC, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NRTI, FTC, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NRTI, FTC, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NRTI, TDF, Susceptible
|
5 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NRTI, TDF, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NRTI, TDF, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NRTI, TDF, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NRTI, TDF, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NRTI, ZDV, Susceptible
|
4 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NRTI, ZDV, Potential low-level resistance
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NRTI, ZDV, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NRTI, ZDV, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NRTI, ZDV, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NRTI, d4T, Susceptible
|
4 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NRTI, d4T, Potential low-level resistance
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NRTI, d4T, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NRTI, d4T, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NRTI, d4T, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NRTI, ddI, Susceptible
|
5 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NRTI, ddI, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NRTI, ddI, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NRTI, ddI, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NRTI, ddI, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, ATV/r, Susceptible
|
5 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, ATV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, ATV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, ATV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, ATV/r, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, DRV/r, Susceptible
|
5 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, DRV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, DRV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, DRV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, DRV/r, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, FPV/r, Susceptible
|
5 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, FPV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, FPV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, FPV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, FPV/r, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, IDV/r, Susceptible
|
5 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, IDV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, IDV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, IDV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, IDV/r, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, LPV/r, Susceptible
|
5 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, LPV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, LPV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, LPV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, LPV/r,High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, NFV, Susceptible
|
5 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, NFV, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, NFV, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, NFV, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, NFV, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, RTV, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, RTV, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, RTV, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, RTV, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, SQV/r, Susceptible
|
5 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, SQV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, SQV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, SQV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, SQV/r, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, TPV/r, Susceptible
|
5 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, TPV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, TPV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, TPV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, TPV/r, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NNRTI, ETR, Potential low-level resistance
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NNRTI, ETR, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NNRTI, ETR, Intermediate resistance
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NNRTI, ETR, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NNRTI,NVP, Susceptible
|
3 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NNRTI,NVP, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NNRTI,NVP, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NNRTI,NVP, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NNRTI, NVP, High-level resistance
|
2 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NNRTI, RPV, Susceptible
|
3 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NNRTI, RPV, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NNRTI, RPV, Low-level resistance
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NNRTI, RPV, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NNRTI, RPV, High-level resistance
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NRTI, 3TC, Susceptible
|
5 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NRTI, 3TC, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NRTI, 3TC, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NRTI, 3TC, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NRTI, 3TC, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NNRTI,DLV, Low-level resistance
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Post-Late switch (LS) Baseline (Week 52) up to Week 148Population: The analysis was performed on the Late Switch (LS) CVW resistance Population which was comprised of all participants in the LS-ITT-E Population who met CVW through the end of visit window (Week 48, Week 100 or Week 148) and had available on-treatment genotypic resistance data at the time CVW criterion was met. Only those participants with data available at the specified time point were analyzed.
Plasma samples were collected for drug resistance testing. Genotypic Resistance data for the following drugs (DTG, EVG, RAL, DLV, EFV, ETR, NVP, RPV, 3TC, ABC, FTC, TDF, ZDV, d4T, ddI, ATV/r, DRV/r, FPV/r, IDV/r, LPV/r, NFV, RTV, SQV/r, TPV/r) in participants Meeting CVW Criteria has been presented.
Outcome measures
| Measure |
DTG + RPV
n=1 Participants
Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
Participants continued to receive their CAR (two nucleoside reverse transcriptase inhibitors \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during the Early Switch Phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) less than (\<) 50 copies (c)/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
INI, DTG, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
INI, DTG, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
INI, DTG, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
INI, DTG, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
INI, DTG, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
INI, EVG,Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
INI, EVG, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
INI, EVG,Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
INI, EVG, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
INI, EVG, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
INI, RAL,Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
INI, RAL, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
INI, RAL, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
INI, RAL, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
INI, RAL, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
NNRTI, DLV, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
NNRTI, DLV, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
NNRTI,DLV, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
NNRTI, DLV, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
NNRTI, DLV, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
NNRTI, EFV, Susceptible
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
NNRTI, EFV, Potential low-level resistance
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
NNRTI, EFV, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
NNRTI, EFV, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
NNRTI, EFV, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
NNRTI, ETR, Susceptible
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
NNRTI, ETR, Potential low-level resistance
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
NNRTI, ETR, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
NNRTI, ETR, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
NNRTI, ETR, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
NNRTI,NVP, Susceptible
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
NNRTI,NVP, Potential low-level resistance
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
NNRTI,NVP, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
NNRTI,NVP, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
NNRTI, NVP, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
NNRTI, RPV, Susceptible
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
NNRTI, RPV, Potential low-level resistance
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
NNRTI, RPV, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
NNRTI, RPV, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
NNRTI, RPV, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
NRTI, 3TC, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
NRTI, 3TC, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
NRTI, 3TC, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
NRTI, 3TC, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
NRTI, 3TC, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
NRTI, ABC, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
NRTI, ABC, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
NRTI, ABC, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
NRTI, ABC, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
NRTI, ABC, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
NRTI, FTC, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
NRTI, FTC, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
NRTI, FTC, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
NRTI, FTC, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
NRTI, FTC, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
NRTI, TDF, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
NRTI, TDF, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
NRTI, TDF, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
NRTI, TDF, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
NRTI, TDF, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
NRTI, ZDV, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
NRTI, ZDV, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
NRTI, ZDV, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
NRTI, ZDV, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
NRTI, ZDV, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
NRTI, d4T, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
NRTI, d4T, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
NRTI, d4T, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
NRTI, d4T, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
NRTI, d4T, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
NRTI, ddI, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
NRTI, ddI, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
NRTI, ddI, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
NRTI, ddI, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
NRTI, ddI, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
PI, ATV/r, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
PI, ATV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
PI, ATV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
PI, ATV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
PI, ATV/r, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
PI, DRV/r, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
PI, DRV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
PI, DRV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
PI, DRV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
PI, DRV/r, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
PI, FPV/r, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
PI, FPV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
PI, FPV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
PI, FPV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
PI, FPV/r, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
PI, IDV/r, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
PI, IDV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
PI, IDV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
PI, IDV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
PI, IDV/r, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
PI, LPV/r, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
PI, LPV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
PI, LPV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
PI, LPV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
PI, LPV/r,High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
PI, NFV, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
PI, NFV, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
PI, NFV, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
PI, NFV, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
PI, NFV, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
PI, RTV, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
PI, RTV, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
PI, RTV, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
PI, RTV, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
PI, RTV, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
PI, SQV/r, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
PI, SQV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
PI, SQV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
PI, SQV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
PI, SQV/r, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
PI, TPV/r, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
PI, TPV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
PI, TPV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
PI, TPV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase
PI, TPV/r, High-level resistance
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to Week 52Population: CVW resistance Population
Plasma samples were collected for drug resistance testing. Phenotypic Resistance data for the following drugs (DTG, RAL, EVG, RPV, ETR, 3TC, ABC, FTC, TDF, d4T, ddI, ATV/r, DRV/r, FPV/r, IDV/r, LPV/r, SQV/r, TPV/r) in participants Meeting CVW Criteria has been presented.
Outcome measures
| Measure |
DTG + RPV
n=1 Participants
Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
n=1 Participants
Participants continued to receive their CAR (two nucleoside reverse transcriptase inhibitors \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during the Early Switch Phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) less than (\<) 50 copies (c)/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
NNRTI, EFV, Resistant
|
0 Participants
|
0 Participants
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
NNRTI, EFV, Sensitive
|
1 Participants
|
1 Participants
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
NNRTI, ETR, Resistant
|
0 Participants
|
0 Participants
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
NNRTI, ETR, Partially Sensitive
|
0 Participants
|
0 Participants
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
NNRTI, ETR, Sensitive
|
1 Participants
|
1 Participants
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
NNRTI, NVP, Resistant
|
0 Participants
|
0 Participants
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
NNRTI, NVP, Sensitive
|
1 Participants
|
1 Participants
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
NNRTI, RPV, Resistant
|
0 Participants
|
0 Participants
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
NNRTI, RPV, Sensitive
|
1 Participants
|
1 Participants
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
NRTI, 3TC, Resistant
|
0 Participants
|
0 Participants
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
NRTI, 3TC, Sensitive
|
1 Participants
|
1 Participants
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
NRTI, ABC, Resistant
|
0 Participants
|
0 Participants
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
NRTI, ABC, Partially Sensitive
|
0 Participants
|
0 Participants
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
NRTI, ABC, Sensitive
|
1 Participants
|
1 Participants
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
NRTI,FTC, Resistant
|
0 Participants
|
0 Participants
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
NRTI, FTC, Sensitive
|
1 Participants
|
1 Participants
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
NRTI, TDF, Resistant
|
0 Participants
|
0 Participants
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
NRTI, TDF, Partially Sensitive
|
0 Participants
|
0 Participants
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
NRTI, TDF, Sensitive
|
1 Participants
|
1 Participants
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
NRTI, ZDV, Resistant
|
0 Participants
|
0 Participants
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
NRTI, ZDV, Sensitive
|
1 Participants
|
1 Participants
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
NRTI, d4T, Resistant
|
0 Participants
|
0 Participants
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
NRTI, d4T, Sensitive
|
1 Participants
|
1 Participants
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
NRTI, ddI, Resistant
|
0 Participants
|
0 Participants
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
NRTI, ddI, Partially Sensitive
|
0 Participants
|
0 Participants
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
NRTI, ddI, Sensitive
|
1 Participants
|
1 Participants
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
PI, ATV/r, Resistant
|
0 Participants
|
0 Participants
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
PI, ATV/r, Sensitive
|
1 Participants
|
1 Participants
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
PI, DRV/r, Resistant
|
0 Participants
|
0 Participants
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
PI, DRV/r, Partially Sensitive
|
0 Participants
|
0 Participants
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
PI, DRV/r, Sensitive
|
1 Participants
|
1 Participants
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
PI, FPV/r, Resistant
|
0 Participants
|
0 Participants
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
PI, FPV/r, Partially Sensitive
|
0 Participants
|
0 Participants
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
PI, FPV/r, Sensitive
|
1 Participants
|
1 Participants
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
PI, IDV/r, Resistant
|
0 Participants
|
0 Participants
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
PI, IDV/r, Sensitive
|
1 Participants
|
1 Participants
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
PI, LPV/r, Resistant
|
0 Participants
|
0 Participants
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
PI, LPV/r, Partially Sensitive
|
0 Participants
|
0 Participants
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
PI, LPV/r, Sensitive
|
1 Participants
|
1 Participants
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
PI, NFV, Resistant
|
0 Participants
|
0 Participants
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
PI, NFV, Sensitive
|
1 Participants
|
1 Participants
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
PI, RTV, Resistant
|
0 Participants
|
0 Participants
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
PI, RTV, Sensitive
|
1 Participants
|
1 Participants
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
PI, SQV/r, Resistant
|
0 Participants
|
0 Participants
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
PI, SQV/r, Partially Sensitive
|
0 Participants
|
0 Participants
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
PI, SQV/r, Sensitive
|
1 Participants
|
1 Participants
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
PI, TPV/r, Resistant
|
0 Participants
|
0 Participants
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
PI, TPV/r, Partially Sensitive
|
0 Participants
|
0 Participants
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
PI, TPV/r, Sensitive
|
1 Participants
|
1 Participants
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
INI, DTG, Resistant
|
0 Participants
|
0 Participants
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
INI, DTG, Partially Sensitive
|
0 Participants
|
0 Participants
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
INI, DTG, Sensitive
|
1 Participants
|
1 Participants
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
INI, EVG, Resistant
|
0 Participants
|
0 Participants
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
INI, EVG, Sensitive
|
1 Participants
|
1 Participants
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
INI, RAL, Resistant
|
0 Participants
|
0 Participants
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
INI, RAL, Sensitive
|
1 Participants
|
1 Participants
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
NNRTI, DLV, Resistant
|
0 Participants
|
0 Participants
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
NNRTI, DLV, Sensitive
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to Week 148Population: CVW resistance Population
Plasma samples were collected for drug resistance testing. Phenotypic Resistance data for the following drugs (DTG, EVG, RAL, DLV, EFV, ETR, NVP, RPV, 3TC, ABC, FTC, TDF, ZDV, d4T, ddI, ATV/r, DRV/r, FPV/r, IDV/r, LPV/r, NFV, RTV, SQV/r, TPV/r) in participants Meeting CVW Criteria has been presented.
Outcome measures
| Measure |
DTG + RPV
n=5 Participants
Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
Participants continued to receive their CAR (two nucleoside reverse transcriptase inhibitors \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during the Early Switch Phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) less than (\<) 50 copies (c)/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
INI, DTG, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
INI, DTG, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
INI, DTG, Sensitive
|
5 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
INI, EVG, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
INI, EVG, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
INI, EVG, Sensitive
|
5 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
INI, RAL, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
INI, RAL, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
INI, RAL, Sensitive
|
5 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NNRTI, DLV, Resistant
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NNRTI, DLV, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NNRTI, DLV, Sensitive
|
4 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NNRTI, EFV, Resistant
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NNRTI, EFV, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NNRTI, EFV, Sensitive
|
4 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NNRTI, ETR, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NNRTI, ETR, Partially Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NNRTI, ETR, Sensitive
|
4 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NNRTI, NVP, Resistant
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NNRTI, NVP, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NNRTI, NVP, Sensitive
|
4 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NNRTI, RPV, Resistant
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NNRTI, RPV, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NNRTI, RPV, Sensitive
|
4 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NRTI, 3TC, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NRTI, 3TC, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NRTI, 3TC, Sensitive
|
5 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NRTI, ABC, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NRTI, ABC, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NRTI, ABC, Sensitive
|
5 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NRTI, FTC, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NRTI, FTC, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NRTI, FTC, Sensitive
|
5 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NRTI, TDF, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NRTI, TDF, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NRTI, TDF, Sensitive
|
5 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NRTI, ZDV, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NRTI, ZDV, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NRTI, ZDV, Sensitive
|
5 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NRTI, d4T, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NRTI, d4T, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NRTI, d4T, Sensitive
|
5 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NRTI, ddI, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NRTI, ddI, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NRTI, ddI, Sensitive
|
5 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, ATV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, ATV/r, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, ATV/r, Sensitive
|
5 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, DRV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, DRV/r, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, DRV/r, Sensitive
|
5 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, FPV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, FPV/r, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, FPV/r, Sensitive
|
5 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, IDV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, IDV/r, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, IDV/r, Sensitive
|
5 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, LPV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, LPV/r, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, LPV/r, Sensitive
|
5 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, NFV, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, NFV, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, NFV, Sensitive
|
5 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, RTV, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, RTV, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, RTV, Sensitive
|
5 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, SQV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, SQV/r, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, SQV/r, Sensitive
|
5 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, TPV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, TPV/r, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, TPV/r, Sensitive
|
5 Participants
|
—
|
SECONDARY outcome
Timeframe: Post-LS Baseline (Week 52) up to Week 148Population: LS CVW resistance Population. Only those participants with data available at the specified time point were analyzed.
Plasma samples were collected for drug resistance testing. Phenotypic Resistance data for the following drugs (DLV, EFV, ETR, NVP, RPV, 3TC, ABC, FTC, TDF, ZDV, d4T, ddI, ATV/r, DRV/r, FPV/r, IDV/r, LPV/r, NFV, RTV, SQV/r, TPV/r) in participants Meeting CVW Criteria has been presented.
Outcome measures
| Measure |
DTG + RPV
n=1 Participants
Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
Participants continued to receive their CAR (two nucleoside reverse transcriptase inhibitors \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during the Early Switch Phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) less than (\<) 50 copies (c)/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
NRTI, ddI, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
NNRTI, DLV, Resistant
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
NNRTI, DLV, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
NNRTI, DLV, Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
NNRTI, EFV, Resistant
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
NNRTI, EFV, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
NNRTI, EFV, Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
NNRTI, ETR, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
NNRTI, ETR, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
NNRTI, ETR, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
NNRTI, NVP, Resistant
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
NNRTI, NVP, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
NNRTI, NVP, Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
NNRTI, RPV, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
NNRTI, RPV, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
NNRTI, RPV, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
NRTI, 3TC, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
NRTI, 3TC, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
NRTI, 3TC, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
NRTI, ABC, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
NRTI, ABC, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
NRTI, ABC, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
NRTI, FTC, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
NRTI, FTC, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
NRTI, FTC, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
NRTI, TDF, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
NRTI, TDF, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
NRTI, TDF, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
NRTI, ZDV, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
NRTI, ZDV, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
NRTI, ZDV, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
NRTI, d4T, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
NRTI, d4T, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
NRTI, d4T, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
NRTI, ddI, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
NRTI, ddI, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
PI, ATV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
PI, ATV/r, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
PI, ATV/r, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
PI, DRV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
PI, DRV/r, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
PI, DRV/r, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
PI, FPV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
PI, FPV/r, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
PI, FPV/r, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
PI, IDV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
PI, IDV/r, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
PI, IDV/r, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
PI, LPV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
PI, LPV/r, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
PI, LPV/r, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
PI, NFV, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
PI, NFV, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
PI, NFV, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
PI, RTV, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
PI, RTV, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
PI, RTV, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
PI, SQV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
PI, SQV/r, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
PI, SQV/r, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
PI, TPV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
PI, TPV/r, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
PI, TPV/r, Sensitive
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: Pre-dose at Week 4, 24, 48, 56, 76 and 100Population: The analysis was performed on the Pharmacokinetic (PK) Parameter Population which consisted of all participants who received DTG +RPV and provided at least one evaluable estimate of predose concentration (C0). Only those participants with data available at the specified time points were analyzed.
Two separate blood samples for DTG and RPV were collected pre-dose at Weeks 4, 24, 48, 56, 76, and 100. Pre-dose concentrations of DTG and RPV at Weeks 4, 24, 48, 56, 76 and 100 is summarized for the participants switching to DTG + RPV in the early + late switch phase.
Outcome measures
| Measure |
DTG + RPV
n=243 Participants
Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
n=243 Participants
Participants continued to receive their CAR (two nucleoside reverse transcriptase inhibitors \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during the Early Switch Phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) less than (\<) 50 copies (c)/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Pre-dose Concentrations of DTG and RPV at Weeks 4, 24, 48, 56, 76 and 100 in Participants Switching to DTG + RPV-DTG+RPV Group Through Early and Late Switch Phase
Week 4
|
1581.06 µg/L
Standard Deviation 1146.860
|
92.05 µg/L
Standard Deviation 138.288
|
|
Pre-dose Concentrations of DTG and RPV at Weeks 4, 24, 48, 56, 76 and 100 in Participants Switching to DTG + RPV-DTG+RPV Group Through Early and Late Switch Phase
Week 24
|
1835.68 µg/L
Standard Deviation 1120.539
|
87.88 µg/L
Standard Deviation 39.141
|
|
Pre-dose Concentrations of DTG and RPV at Weeks 4, 24, 48, 56, 76 and 100 in Participants Switching to DTG + RPV-DTG+RPV Group Through Early and Late Switch Phase
Week 48
|
1915.11 µg/L
Standard Deviation 1304.238
|
95.18 µg/L
Standard Deviation 48.228
|
|
Pre-dose Concentrations of DTG and RPV at Weeks 4, 24, 48, 56, 76 and 100 in Participants Switching to DTG + RPV-DTG+RPV Group Through Early and Late Switch Phase
Week 56
|
1872.65 µg/L
Standard Deviation 1173.815
|
95.38 µg/L
Standard Deviation 53.602
|
|
Pre-dose Concentrations of DTG and RPV at Weeks 4, 24, 48, 56, 76 and 100 in Participants Switching to DTG + RPV-DTG+RPV Group Through Early and Late Switch Phase
Week 76
|
1711.83 µg/L
Standard Deviation 1092.143
|
88.10 µg/L
Standard Deviation 42.250
|
|
Pre-dose Concentrations of DTG and RPV at Weeks 4, 24, 48, 56, 76 and 100 in Participants Switching to DTG + RPV-DTG+RPV Group Through Early and Late Switch Phase
Week 100
|
1854.17 µg/L
Standard Deviation 1197.958
|
92.38 µg/L
Standard Deviation 44.604
|
SECONDARY outcome
Timeframe: Pre-dose at Weeks 56, 76 and 100Population: The analysis was performed on the LS PK Parameter Population which was comprised of all participants who were randomized to CAR and received DTG + RPV in the Late Switch Phase and provided at least one evaluable estimate of Pre-dose concentration. Only those participants with data available at the specified time points were analyzed.
Two separate blood samples for DTG and RPV were collected pre-dose at Weeks 56, 76, and 100. Pre-dose concentrations of DTG and RPV at Weeks 56, 76 and 100 is summarized for the participants switching to DTG + RPV in the late switch phase.
Outcome measures
| Measure |
DTG + RPV
n=225 Participants
Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
n=225 Participants
Participants continued to receive their CAR (two nucleoside reverse transcriptase inhibitors \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during the Early Switch Phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) less than (\<) 50 copies (c)/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Pre-dose Concentrations of DTG and RPV at Weeks 56, 76 and 100 in Participants Switching to DTG+RPV-CAR Group Through Late Switch Phase
Week 56
|
1738.55 µg/L
Standard Deviation 1329.931
|
84.14 µg/L
Standard Deviation 47.290
|
|
Pre-dose Concentrations of DTG and RPV at Weeks 56, 76 and 100 in Participants Switching to DTG+RPV-CAR Group Through Late Switch Phase
Week 76
|
1800.39 µg/L
Standard Deviation 1162.370
|
97.79 µg/L
Standard Deviation 52.532
|
|
Pre-dose Concentrations of DTG and RPV at Weeks 56, 76 and 100 in Participants Switching to DTG+RPV-CAR Group Through Late Switch Phase
Week 100
|
1907.20 µg/L
Standard Deviation 1235.676
|
101.93 µg/L
Standard Deviation 63.296
|
SECONDARY outcome
Timeframe: Pre-dose at Week 2, 4 and 8Population: The analysis was performed on the PK Parameter NNRTI Subset Extra Sampling Population which consisted of the first approximately 20 participants in the PK Parameter NNRTI Subset population who have extra PK samples at weeks 2,4 and 8. Only those participants with data available at the specified time points were analyzed.
Two blood samples were collected pre-dose for DTG and RPV at Weeks 2,4 and 8 only for the first 20 participants who switch from EFV or NVP to DTG + RPV. One blood sample was collected pre-dose for EFV or NVP at Week 2 for the first 20 participants who switch from EFV or NVP to DTG + RPV.
Outcome measures
| Measure |
DTG + RPV
n=26 Participants
Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
n=26 Participants
Participants continued to receive their CAR (two nucleoside reverse transcriptase inhibitors \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during the Early Switch Phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) less than (\<) 50 copies (c)/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Pre-dose Concentrations of DTG and RPV at Weeks 2, 4 and 8 in the First 20 Participants Who Switch From Efavirenz (EFV) or Nevirapine (NVP) to DTG + RPV
Week 2
|
821.25 µg/L
Standard Deviation 574.607
|
65.360 µg/L
Standard Deviation 31.2965
|
|
Pre-dose Concentrations of DTG and RPV at Weeks 2, 4 and 8 in the First 20 Participants Who Switch From Efavirenz (EFV) or Nevirapine (NVP) to DTG + RPV
Week 4
|
994.00 µg/L
Standard Deviation 581.201
|
67.374 µg/L
Standard Deviation 27.5663
|
|
Pre-dose Concentrations of DTG and RPV at Weeks 2, 4 and 8 in the First 20 Participants Who Switch From Efavirenz (EFV) or Nevirapine (NVP) to DTG + RPV
Week 8
|
1561.34 µg/L
Standard Deviation 1096.381
|
77.416 µg/L
Standard Deviation 37.7129
|
SECONDARY outcome
Timeframe: Week 48Population: ITT-E Population. Only those participants with data available at the specified time points were analyzed.
Percentage of participants with plasma HIV 1 RNA \< 50 c/mL at Week 48 using the FDA snapshot algorithm was assessed by Baseline third agent class to assess the impact of Baseline third agent class (INI, NNRTI, or PI) on efficacy of DTG +RPV compared to continuation of CAR. Plasma samples were collected for quantitative analysis of HIV-1 RNA. The analysis was done using Cochran-Mantel Haenszel test stratified by current antiretroviral third-agent class and age group.
Outcome measures
| Measure |
DTG + RPV
n=252 Participants
Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
n=256 Participants
Participants continued to receive their CAR (two nucleoside reverse transcriptase inhibitors \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during the Early Switch Phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) less than (\<) 50 copies (c)/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Percentage of Participants With Plasma HIV 1 RNA <50 c/mL at Week 48 Using Snapshot Algorithm by Baseline Third Agent Treatment Class
NNRTI
|
95 Percentage of participants
|
98 Percentage of participants
|
|
Percentage of Participants With Plasma HIV 1 RNA <50 c/mL at Week 48 Using Snapshot Algorithm by Baseline Third Agent Treatment Class
INI
|
98 Percentage of participants
|
96 Percentage of participants
|
|
Percentage of Participants With Plasma HIV 1 RNA <50 c/mL at Week 48 Using Snapshot Algorithm by Baseline Third Agent Treatment Class
PI
|
95 Percentage of participants
|
92 Percentage of participants
|
SECONDARY outcome
Timeframe: At Week 48Population: ITT-E Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected for CD4 cell count assessment by flow cytometry was carried out to assess the impact of Baseline third agent class (INI, NNRTI, or PI) on efficacy, safety and tolerability of DTG +RPV compared to continuation of CAR. Value at Day 1 was considered as Baseline. Change from Baseline was calculated as value at indicated time point minus Baseline value.
Outcome measures
| Measure |
DTG + RPV
n=252 Participants
Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
n=256 Participants
Participants continued to receive their CAR (two nucleoside reverse transcriptase inhibitors \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during the Early Switch Phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) less than (\<) 50 copies (c)/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Changes From Baseline in Cluster Designation (CD)4+ Lymphocyte Count at Week 48 by Baseline Third Agent Treatment Class
NNRTI
|
47.9 Cells per mm^3
Standard Deviation 142.90
|
25.0 Cells per mm^3
Standard Deviation 151.27
|
|
Changes From Baseline in Cluster Designation (CD)4+ Lymphocyte Count at Week 48 by Baseline Third Agent Treatment Class
INI
|
19.9 Cells per mm^3
Standard Deviation 148.63
|
39.9 Cells per mm^3
Standard Deviation 200.38
|
|
Changes From Baseline in Cluster Designation (CD)4+ Lymphocyte Count at Week 48 by Baseline Third Agent Treatment Class
PI
|
12.5 Cells per mm^3
Standard Deviation 160.27
|
74.7 Cells per mm^3
Standard Deviation 227.78
|
SECONDARY outcome
Timeframe: Up to 48 weeksPopulation: Safety Population. Only those participants with data available at the specified time points were analyzed.
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants with any AE, AELD or AE with maximum grade toxicity experienced by any one participant over 48 weeks by Baseline third agent class (INI, NNRTI, or PI) was summarized. AEs were graded as per DAIDS grading. Grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=potentially life-threatening.
Outcome measures
| Measure |
DTG + RPV
n=252 Participants
Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
n=256 Participants
Participants continued to receive their CAR (two nucleoside reverse transcriptase inhibitors \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during the Early Switch Phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) less than (\<) 50 copies (c)/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Number of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment Class
Any AE, NNRTI
|
102 Participants
|
98 Participants
|
|
Number of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment Class
Any AE, INI
|
38 Participants
|
34 Participants
|
|
Number of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment Class
Any AE, PI
|
60 Participants
|
58 Participants
|
|
Number of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment Class
NNRTI, Maximum toxicity Grade 1 AE
|
69 Participants
|
72 Participants
|
|
Number of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment Class
NNRTI, Maximum toxicity Grade 2 AE
|
27 Participants
|
23 Participants
|
|
Number of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment Class
NNRTI, Maximum toxicity Grade 3 AE
|
5 Participants
|
2 Participants
|
|
Number of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment Class
NNRTI, Maximum toxicity Grade 4 AE
|
1 Participants
|
1 Participants
|
|
Number of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment Class
INI, Maximum toxicity Grade 1 AE
|
28 Participants
|
20 Participants
|
|
Number of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment Class
INI, Maximum toxicity Grade 2 AE
|
7 Participants
|
12 Participants
|
|
Number of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment Class
INI, Maximum toxicity Grade 3 AE
|
2 Participants
|
2 Participants
|
|
Number of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment Class
INI, Maximum toxicity Grade 4 AE
|
1 Participants
|
0 Participants
|
|
Number of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment Class
PI, Maximum toxicity Grade 1 AE
|
31 Participants
|
30 Participants
|
|
Number of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment Class
PI, Maximum toxicity Grade 2 AE
|
23 Participants
|
18 Participants
|
|
Number of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment Class
PI, Maximum toxicity Grade 3 AE
|
4 Participants
|
9 Participants
|
|
Number of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment Class
PI, Maximum toxicity Grade 4 AE
|
2 Participants
|
1 Participants
|
|
Number of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment Class
AELD, NNRTI
|
3 Participants
|
0 Participants
|
|
Number of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment Class
AELD, INI
|
2 Participants
|
0 Participants
|
|
Number of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment Class
AELD, PI
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 48 weeksPopulation: Safety Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected to evaluate ALT, albumin, ALP, AST, total bilirubin, chloride, creatinine, glucose, potassium, phosphate, sodium, BUN, total carbon dioxide, lipase, creatine phosphokinase and creatinine clearance. Value at Day 1 was considered as Baseline. Number of participants who experienced maximum toxicity grade post-Baseline in chemistry parameters over 48 weeks by Baseline third agent treatment class (INI, NNRTI, PI) was summarized. Clinical chemistry toxicities were graded using DAIDS grading table for grading severity of adult and pediatric adverse events. Grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=potentially life-threatening.
Outcome measures
| Measure |
DTG + RPV
n=252 Participants
Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
n=256 Participants
Participants continued to receive their CAR (two nucleoside reverse transcriptase inhibitors \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during the Early Switch Phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) less than (\<) 50 copies (c)/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class
NNRTI, Grade 1
|
47 Participants
|
42 Participants
|
|
Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class
NNRTI, Grade 2
|
32 Participants
|
48 Participants
|
|
Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class
NNRTI, Grade 3
|
13 Participants
|
13 Participants
|
|
Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class
NNRTI, Grade 4
|
2 Participants
|
3 Participants
|
|
Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class
INI, Grade 1
|
13 Participants
|
11 Participants
|
|
Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class
INI, Grade 2
|
19 Participants
|
15 Participants
|
|
Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class
INI, Grade 3
|
1 Participants
|
1 Participants
|
|
Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class
INI, Grade 4
|
3 Participants
|
2 Participants
|
|
Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class
PI, Grade 1
|
35 Participants
|
25 Participants
|
|
Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class
PI, Grade 2
|
10 Participants
|
23 Participants
|
|
Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class
PI, Grade 3
|
8 Participants
|
9 Participants
|
|
Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class
PI, Grade 4
|
0 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Up to 48 weeksPopulation: Safety Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected to evaluate hemoglobin, hematocrit, basophils, eosinophils, lymphocytes, monocytes, neutrophils, MCV, RBC count, WBC count and platelet count. Value at Day 1 was considered as Baseline. Number of participants who experienced maximum toxicity grade post-Baseline in hematology parameters over 48 weeks by Baseline third agent treatment class (INSTI, NNRTI, PI) was summarized. Hematology toxicities were graded using DAIDS grading table for grading severity of adult and pediatric adverse events. Grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=potentially life-threatening.
Outcome measures
| Measure |
DTG + RPV
n=252 Participants
Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
n=256 Participants
Participants continued to receive their CAR (two nucleoside reverse transcriptase inhibitors \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during the Early Switch Phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) less than (\<) 50 copies (c)/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class
NNRTI; Grade 1
|
5 Participants
|
3 Participants
|
|
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class
NNRTI; Grade 2
|
1 Participants
|
1 Participants
|
|
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class
NNRTI; Grade 3
|
1 Participants
|
1 Participants
|
|
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class
NNRTI; Grade 4
|
0 Participants
|
1 Participants
|
|
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class
INI; Grade 1
|
2 Participants
|
2 Participants
|
|
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class
INI; Grade 2
|
1 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class
INI; Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class
INI; Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class
PI; Grade 1
|
4 Participants
|
6 Participants
|
|
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class
PI; Grade 2
|
1 Participants
|
1 Participants
|
|
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class
PI; Grade 3
|
2 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class
PI; Grade 4
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Week 48Population: CVW resistance Population
For all participants who meet virologic withdrawal criteria, plasma samples with HIV-1 RNA level \>=200 c/mL were to be analyzed in an attempt to obtain genotype data on as many samples as possible. Samples for drug resistance testing (genotypic) were to be collected at Day 1. Number of participants with genotypic resistance to CAR and to DTG or RPV for those meeting virologic withdrawal criteria in subgroups stratified based on Baseline third agent treatment class (INSTI, NNRTI, PI) were to be summarized. This outcome has not been analyzed as the number of participants was low (1 CVW per arm) and summaries by Baseline third agent were not provided. Therefore, data are not available for this outcome measure due to the insufficient number of participants with events.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to Week 48Population: CVW resistance Population
For all participants who meet virologic withdrawal criteria, plasma samples with HIV-1 RNA level \>=200 c/mL were to be analyzed in an attempt to obtain phenotype data on as many samples as possible. Samples for drug resistance testing (phenotypic) were to be collected at Day 1. Number of participants with phenotypic resistance to CAR and to DTG or RPV for those meeting virologic withdrawal criteria in subgroups stratified based on Baseline third agent treatment class (INSTI, NNRTI, PI) were to be summarized. This outcome was not analyzed as the number of participants was low (1 CVW per arm) and summaries by Baseline third agent were not provided. Therefore, data are not available for this outcome measure due to the insufficient number of participants with events.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At Week 24 and at Week 48Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at Baseline (Day 1), Weeks 24 and 48 to assess fasting lipids which included total cholesterol (CHO), LDL cholesterol, HDL cholesterol and triglycerides. Change from Baseline was calculated as value at indicated time point minus Baseline value.
Outcome measures
| Measure |
DTG + RPV
n=252 Participants
Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
n=256 Participants
Participants continued to receive their CAR (two nucleoside reverse transcriptase inhibitors \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during the Early Switch Phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) less than (\<) 50 copies (c)/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class
Triglycerides, INI, Week 24
|
—
|
8.386 mmol/mL
Standard Deviation 54.1265
|
|
Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class
Triglycerides, INI, Week 48
|
—
|
4.644 mmol/mL
Standard Deviation 48.8708
|
|
Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class
CHO, Week 24, overall
|
3.239 mmol/mL
Standard Deviation 18.1556
|
2.375 mmol/mL
Standard Deviation 14.8357
|
|
Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class
CHO, Week 48, overall
|
3.596 mmol/mL
Standard Deviation 18.7072
|
2.472 mmol/mL
Standard Deviation 14.7202
|
|
Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class
CHO, Week 24, NNRTI
|
—
|
3.383 mmol/mL
Standard Deviation 13.3685
|
|
Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class
CHO, Week 48, NNRTI
|
—
|
4.099 mmol/mL
Standard Deviation 13.8992
|
|
Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class
CHO, Week 24, INI
|
—
|
1.288 mmol/mL
Standard Deviation 14.8933
|
|
Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class
CHO, Week 48, INI
|
—
|
0.524 mmol/mL
Standard Deviation 15.3143
|
|
Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class
CHO, Week 24, PI
|
—
|
1.211 mmol/mL
Standard Deviation 17.3972
|
|
Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class
CHO, Week 48, PI
|
—
|
0.575 mmol/mL
Standard Deviation 15.7475
|
|
Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class
HDL CHO direct, Overall, Week 24
|
0.017 mmol/mL
Standard Deviation 18.7575
|
-2.478 mmol/mL
Standard Deviation 16.6754
|
|
Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class
HDL CHO direct, Overall, Week 48
|
3.975 mmol/mL
Standard Deviation 21.1039
|
3.095 mmol/mL
Standard Deviation 18.8909
|
|
Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class
HDL CHO direct, NNRTI, Week 24
|
—
|
0.062 mmol/mL
Standard Deviation 15.9300
|
|
Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class
HDL CHO direct, NNRTI, Week 48
|
—
|
4.818 mmol/mL
Standard Deviation 16.2253
|
|
Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class
HDL CHO direct, INI, Week 24
|
—
|
-4.968 mmol/mL
Standard Deviation 16.2973
|
|
Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class
HDL CHO direct, INI, Week 48
|
—
|
0.539 mmol/mL
Standard Deviation 22.6496
|
|
Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class
HDL CHO direct, PI, Week 24
|
—
|
-5.594 mmol/mL
Standard Deviation 17.7923
|
|
Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class
HDL CHO direct, PI, Week 48
|
—
|
1.457 mmol/mL
Standard Deviation 20.8346
|
|
Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class
LDL CHO calculation, Overall, Week 24
|
11.504 mmol/mL
Standard Deviation 36.9087
|
6.196 mmol/mL
Standard Deviation 24.0104
|
|
Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class
LDL CHO calculation, Overall, Week 48
|
8.257 mmol/mL
Standard Deviation 33.0405
|
3.258 mmol/mL
Standard Deviation 22.3644
|
|
Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class
LDL CHO calculation, NNRTI, Week 24
|
—
|
6.816 mmol/mL
Standard Deviation 20.9081
|
|
Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class
LDL CHO calculation, NNRTI, Week 48
|
—
|
4.920 mmol/mL
Standard Deviation 20.9300
|
|
Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class
LDL CHO calculation, INI, Week 24
|
—
|
6.355 mmol/mL
Standard Deviation 24.1747
|
|
Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class
LDL CHO calculation, INI, Week 48
|
—
|
3.490 mmol/mL
Standard Deviation 23.3198
|
|
Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class
LDL CHO calculation, PI, Week 24
|
—
|
4.813 mmol/mL
Standard Deviation 29.5705
|
|
Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class
LDL CHO calculation, PI, Week 48
|
—
|
-0.434 mmol/mL
Standard Deviation 24.4332
|
|
Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class
Triglycerides, Overall, Week 24
|
0.096 mmol/mL
Standard Deviation 55.6357
|
8.649 mmol/mL
Standard Deviation 48.8249
|
|
Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class
Triglycerides, Overall, Week 48
|
3.605 mmol/mL
Standard Deviation 54.4914
|
11.068 mmol/mL
Standard Deviation 54.6321
|
|
Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class
Triglycerides, NNRTI, Week 24
|
—
|
6.867 mmol/mL
Standard Deviation 44.8605
|
|
Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class
Triglycerides, NNRTI, Week 48
|
—
|
10.215 mmol/mL
Standard Deviation 58.4055
|
|
Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class
Triglycerides, PI, Week 24
|
—
|
12.283 mmol/mL
Standard Deviation 52.6943
|
|
Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class
Triglycerides, PI, Week 48
|
—
|
17.681 mmol/mL
Standard Deviation 50.6912
|
SECONDARY outcome
Timeframe: At Week 4, Week 24 and Week 48Population: ITT-E Population. Only those participants with data available at the specified time points were analyzed.
Symptom Distress Module, also called the HIV Symptom Index or Symptoms Impact Questionnaire, is a 20-item self-reported measure that addresses presence and perceived distress linked to symptoms commonly associated with HIV or its treatment. Symptom count is based on which of the 20 symptoms were present in participant. Symptom count is the sum of number of symptoms present and ranges from 0 (none) to 20 (all). Symptom bother score is based on score for each symptom present ranging from 1 (it doesn't bother me) to 4 (it bothers me a lot). Symptom bother score is unweighted sum of the bother item scores for each symptom. Symptom bother score ranges from 0 (minimum bother score) to 80 (maximum bother score). Last observation carried forward (LOCF) was used as primary method of analysis. Change from Baseline was calculated as value at indicated time point minus Baseline value. Day 1 was considered as Baseline value.
Outcome measures
| Measure |
DTG + RPV
n=252 Participants
Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
n=256 Participants
Participants continued to receive their CAR (two nucleoside reverse transcriptase inhibitors \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during the Early Switch Phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) less than (\<) 50 copies (c)/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Change From Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 4, 24 and 48-Early Switch Phase
Symptom count, Week 4
|
-1.6 Scores on a scale
Standard Deviation 4.19
|
0.2 Scores on a scale
Standard Deviation 4.26
|
|
Change From Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 4, 24 and 48-Early Switch Phase
Symptom count, Week 24
|
-0.8 Scores on a scale
Standard Deviation 5.19
|
-0.2 Scores on a scale
Standard Deviation 4.06
|
|
Change From Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 4, 24 and 48-Early Switch Phase
Symptom count, Week 48
|
-0.4 Scores on a scale
Standard Deviation 5.52
|
0.0 Scores on a scale
Standard Deviation 4.49
|
|
Change From Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 4, 24 and 48-Early Switch Phase
Symptom Bother Score, Week 4
|
-3.0 Scores on a scale
Standard Deviation 7.25
|
-0.8 Scores on a scale
Standard Deviation 7.82
|
|
Change From Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 4, 24 and 48-Early Switch Phase
Symptom Bother Score, Week 24
|
-1.7 Scores on a scale
Standard Deviation 8.47
|
-1.3 Scores on a scale
Standard Deviation 8.53
|
|
Change From Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 4, 24 and 48-Early Switch Phase
Symptom Bother Score, Week 48
|
-1.4 Scores on a scale
Standard Deviation 8.32
|
-0.7 Scores on a scale
Standard Deviation 9.03
|
SECONDARY outcome
Timeframe: At Week 56, Week 76, Week 100 and Week 148Population: ITT-E Population. Only those participants with data available at the specified time points were analyzed.
Symptom Distress Module, also called the HIV Symptom Index or Symptoms Impact Questionnaire, is a 20-item self-reported measure that addresses presence and perceived distress linked to symptoms commonly associated with HIV or its treatment. Symptom count is based on which of the 20 symptoms were present in participant. Symptom count is the sum of number of symptoms present and ranges from 0 (none) to 20 (all). Symptom bother score is based on score for each symptom present ranging from 1 (it doesn't bother me) to 4 (it bothers me a lot). Symptom bother score is unweighted sum of the bother item scores for each symptom. Symptom bother score ranges from 0 (minimum bother score) to 80 (maximum bother score). LOCF was used as primary method of analysis. Change from Baseline was calculated as value at indicated time point minus Baseline value. Day 1 was considered as Baseline value.
Outcome measures
| Measure |
DTG + RPV
n=214 Participants
Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
Participants continued to receive their CAR (two nucleoside reverse transcriptase inhibitors \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during the Early Switch Phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) less than (\<) 50 copies (c)/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Change From Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 56, 76, 100 and 148-DTG+RPV Group Through Early and Late Switch Phase
Symptom count, Week 56
|
-0.9 Scores on a scale
Standard Deviation 4.99
|
—
|
|
Change From Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 56, 76, 100 and 148-DTG+RPV Group Through Early and Late Switch Phase
Symptom count, Week 76
|
-0.2 Scores on a scale
Standard Deviation 5.42
|
—
|
|
Change From Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 56, 76, 100 and 148-DTG+RPV Group Through Early and Late Switch Phase
Symptom count, Week 100
|
-0.4 Scores on a scale
Standard Deviation 5.08
|
—
|
|
Change From Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 56, 76, 100 and 148-DTG+RPV Group Through Early and Late Switch Phase
Symptom count, Week 148
|
-0.6 Scores on a scale
Standard Deviation 5.24
|
—
|
|
Change From Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 56, 76, 100 and 148-DTG+RPV Group Through Early and Late Switch Phase
Symptom Bother Score, Week 56
|
-1.6 Scores on a scale
Standard Deviation 8.52
|
—
|
|
Change From Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 56, 76, 100 and 148-DTG+RPV Group Through Early and Late Switch Phase
Symptom Bother Score, Week 76
|
-0.9 Scores on a scale
Standard Deviation 8.84
|
—
|
|
Change From Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 56, 76, 100 and 148-DTG+RPV Group Through Early and Late Switch Phase
Symptom Bother Score, Week 100
|
-0.8 Scores on a scale
Standard Deviation 8.71
|
—
|
|
Change From Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 56, 76, 100 and 148-DTG+RPV Group Through Early and Late Switch Phase
Symptom Bother Score, Week 148
|
-0.8 Scores on a scale
Standard Deviation 9.15
|
—
|
SECONDARY outcome
Timeframe: At Week 56, Week 76, Week 100 and Week 148Population: LS ITT-E Population comprised of all participants randomized to CAR who received at least one dose of study treatment at or after the Week 52 Switch visit. Only those participants with data available at the specified time points were analyzed.
Symptom Distress Module, also called the HIV Symptom Index or Symptoms Impact Questionnaire, is a 20-item self-reported measure that addresses presence and perceived distress linked to symptoms commonly associated with HIV or its treatment. Symptom count is based on which of the 20 symptoms were present in participant. Symptom count is the sum of number of symptoms present and ranges from 0 (none) to 20 (all). Symptom bother score is based on score for each symptom present ranging from 1 (it doesn't bother me) to 4 (it bothers me a lot). Symptom bother score is unweighted sum of the bother item scores for each symptom. Symptom bother score ranges from 0 (minimum bother score) to 80 (maximum bother score). LOCF was used as primary method of analysis. Change from LS Baseline was calculated as value at indicated time point minus LS Baseline value. Value at Week 48 was considered as LS Baseline value.
Outcome measures
| Measure |
DTG + RPV
n=238 Participants
Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
Participants continued to receive their CAR (two nucleoside reverse transcriptase inhibitors \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during the Early Switch Phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) less than (\<) 50 copies (c)/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Change From LS Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch Phase
Symptom count, Week 56
|
-0.7 Scores on a scale
Standard Deviation 4.38
|
—
|
|
Change From LS Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch Phase
Symptom count, Week 76
|
0.1 Scores on a scale
Standard Deviation 4.19
|
—
|
|
Change From LS Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch Phase
Symptom count, Week 100
|
0.0 Scores on a scale
Standard Deviation 4.35
|
—
|
|
Change From LS Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch Phase
Symptom count, Week 148
|
0.4 Scores on a scale
Standard Deviation 4.92
|
—
|
|
Change From LS Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch Phase
Symptom Bother Score, Week 56
|
-2.0 Scores on a scale
Standard Deviation 8.11
|
—
|
|
Change From LS Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch Phase
Symptom Bother Score, Week 76
|
-0.4 Scores on a scale
Standard Deviation 8.33
|
—
|
|
Change From LS Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch Phase
Symptom Bother Score, Week 100
|
-0.4 Scores on a scale
Standard Deviation 9.17
|
—
|
|
Change From LS Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch Phase
Symptom Bother Score, Week 148
|
0.7 Scores on a scale
Standard Deviation 9.57
|
—
|
SECONDARY outcome
Timeframe: At Week 4, Week 24 and Week 48Population: ITT-E Population. Only those participants with data available at the specified time points were analyzed.
HIV TSQ is a 10-item self-reported scale that measures overall satisfaction with treatment and by specific domains e.g., convenience, flexibility. Each item is scored 0 (very dissatisfied, inconvenient) to 6 (very satisfied, convenient). The items are summed up to produce a treatment satisfaction total score (0 to 60) and 2 subscale scores: general satisfaction/clinical and lifestyle/ease subscales (0 to 30). Higher scores indicated greater treatment satisfaction as compared to the past few weeks. The HIV TSQ was administered as a paper questionnaire. Total score, lifestyle/ease score and General satisfaction/CS have been summarized. LOCF was used as primary method of analysis. Value obtained at Day 1 was considered as Baseline value. Change from Baseline was calculated as value at indicated time point minus Baseline value.
Outcome measures
| Measure |
DTG + RPV
n=252 Participants
Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
n=256 Participants
Participants continued to receive their CAR (two nucleoside reverse transcriptase inhibitors \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during the Early Switch Phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) less than (\<) 50 copies (c)/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Change From Baseline Treatment Satisfaction Using the HIV Treatment Satisfaction Questionnaire (HIV TSQ) at Weeks 4, 24 and 48-Early Switch Phase
Total score, Week 4
|
0.0 Scores on a scale
Interval -16.0 to 33.0
|
0.0 Scores on a scale
Interval -25.0 to 21.0
|
|
Change From Baseline Treatment Satisfaction Using the HIV Treatment Satisfaction Questionnaire (HIV TSQ) at Weeks 4, 24 and 48-Early Switch Phase
Total score, Week 24
|
1.0 Scores on a scale
Interval -18.0 to 33.0
|
0.0 Scores on a scale
Interval -28.0 to 28.0
|
|
Change From Baseline Treatment Satisfaction Using the HIV Treatment Satisfaction Questionnaire (HIV TSQ) at Weeks 4, 24 and 48-Early Switch Phase
Total score, Week 48
|
0.5 Scores on a scale
Interval -24.0 to 33.0
|
0.0 Scores on a scale
Interval -28.0 to 20.0
|
|
Change From Baseline Treatment Satisfaction Using the HIV Treatment Satisfaction Questionnaire (HIV TSQ) at Weeks 4, 24 and 48-Early Switch Phase
lifestyle/ease Sub-score, Week 4
|
0.0 Scores on a scale
Interval -7.0 to 15.0
|
0.0 Scores on a scale
Interval -9.0 to 13.0
|
|
Change From Baseline Treatment Satisfaction Using the HIV Treatment Satisfaction Questionnaire (HIV TSQ) at Weeks 4, 24 and 48-Early Switch Phase
lifestyle/ease Sub-score, Week 24
|
0.0 Scores on a scale
Interval -11.0 to 15.0
|
0.0 Scores on a scale
Interval -14.0 to 12.0
|
|
Change From Baseline Treatment Satisfaction Using the HIV Treatment Satisfaction Questionnaire (HIV TSQ) at Weeks 4, 24 and 48-Early Switch Phase
lifestyle/ease Sub-score, Week 48
|
0.0 Scores on a scale
Interval -13.0 to 16.0
|
0.0 Scores on a scale
Interval -14.0 to 13.0
|
|
Change From Baseline Treatment Satisfaction Using the HIV Treatment Satisfaction Questionnaire (HIV TSQ) at Weeks 4, 24 and 48-Early Switch Phase
General Satisfaction/CS, Week 4
|
0.0 Scores on a scale
Interval -10.0 to 18.0
|
0.0 Scores on a scale
Interval -16.0 to 13.0
|
|
Change From Baseline Treatment Satisfaction Using the HIV Treatment Satisfaction Questionnaire (HIV TSQ) at Weeks 4, 24 and 48-Early Switch Phase
General Satisfaction/CS, Week 24
|
0.0 Scores on a scale
Interval -7.0 to 18.0
|
0.0 Scores on a scale
Interval -14.0 to 17.0
|
|
Change From Baseline Treatment Satisfaction Using the HIV Treatment Satisfaction Questionnaire (HIV TSQ) at Weeks 4, 24 and 48-Early Switch Phase
General Satisfaction/CS, Week 48
|
0.0 Scores on a scale
Interval -14.0 to 18.0
|
0.0 Scores on a scale
Interval -14.0 to 10.0
|
SECONDARY outcome
Timeframe: At Week 56, Week 76, Week 100 and Week 148Population: ITT-E Population
HIV TSQ is a 10-item self-reported scale that measures overall satisfaction with treatment and by specific domains e.g., convenience, flexibility. Each item is scored 0 (very dissatisfied, inconvenient) to 6 (very satisfied, convenient). The items are summed up to produce a treatment satisfaction total score (0 to 60) and 2 subscale scores: general satisfaction/clinical and lifestyle/ease subscales (0 to 30). Higher scores indicated greater treatment satisfaction as compared to the past few weeks. The HIV TSQ was administered as a paper questionnaire. Total score, lifestyle/ease score and General satisfaction/CS have been summarized. LOCF was used as primary method of analysis. Value obtained at Day 1 was considered as Baseline value. Change from Baseline was calculated as value at indicated time point minus Baseline value.
Outcome measures
| Measure |
DTG + RPV
n=252 Participants
Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
Participants continued to receive their CAR (two nucleoside reverse transcriptase inhibitors \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during the Early Switch Phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) less than (\<) 50 copies (c)/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Change From Baseline Treatment Satisfaction Using HIV TSQ at Weeks 56, 76, 100 and 148 - DTG+RPV Group Through Early and Late Switch Phase
Total score, Week 56
|
0.0 Scores on a scale
Interval -42.0 to 33.0
|
—
|
|
Change From Baseline Treatment Satisfaction Using HIV TSQ at Weeks 56, 76, 100 and 148 - DTG+RPV Group Through Early and Late Switch Phase
Total score, Week 76
|
0.5 Scores on a scale
Interval -35.0 to 33.0
|
—
|
|
Change From Baseline Treatment Satisfaction Using HIV TSQ at Weeks 56, 76, 100 and 148 - DTG+RPV Group Through Early and Late Switch Phase
Total score, Week 100
|
0.0 Scores on a scale
Interval -17.0 to 33.0
|
—
|
|
Change From Baseline Treatment Satisfaction Using HIV TSQ at Weeks 56, 76, 100 and 148 - DTG+RPV Group Through Early and Late Switch Phase
Total score, Week 148
|
1.0 Scores on a scale
Interval -23.0 to 32.0
|
—
|
|
Change From Baseline Treatment Satisfaction Using HIV TSQ at Weeks 56, 76, 100 and 148 - DTG+RPV Group Through Early and Late Switch Phase
Lifestyle/ease Sub-score, Week 56
|
0.0 Scores on a scale
Interval -23.0 to 16.0
|
—
|
|
Change From Baseline Treatment Satisfaction Using HIV TSQ at Weeks 56, 76, 100 and 148 - DTG+RPV Group Through Early and Late Switch Phase
Lifestyle/ease Sub-score, Week 76
|
0.0 Scores on a scale
Interval -19.0 to 16.0
|
—
|
|
Change From Baseline Treatment Satisfaction Using HIV TSQ at Weeks 56, 76, 100 and 148 - DTG+RPV Group Through Early and Late Switch Phase
Lifestyle/ease Sub-score, Week 100
|
0.0 Scores on a scale
Interval -13.0 to 16.0
|
—
|
|
Change From Baseline Treatment Satisfaction Using HIV TSQ at Weeks 56, 76, 100 and 148 - DTG+RPV Group Through Early and Late Switch Phase
Lifestyle/ease Sub-score, Week 148
|
0.0 Scores on a scale
Interval -13.0 to 15.0
|
—
|
|
Change From Baseline Treatment Satisfaction Using HIV TSQ at Weeks 56, 76, 100 and 148 - DTG+RPV Group Through Early and Late Switch Phase
General Satisfaction/CS, Week 56
|
0.0 Scores on a scale
Interval -19.0 to 18.0
|
—
|
|
Change From Baseline Treatment Satisfaction Using HIV TSQ at Weeks 56, 76, 100 and 148 - DTG+RPV Group Through Early and Late Switch Phase
General Satisfaction/CS, Week 76
|
0.0 Scores on a scale
Interval -16.0 to 17.0
|
—
|
|
Change From Baseline Treatment Satisfaction Using HIV TSQ at Weeks 56, 76, 100 and 148 - DTG+RPV Group Through Early and Late Switch Phase
General Satisfaction/CS, Week 100
|
0.0 Scores on a scale
Interval -13.0 to 17.0
|
—
|
|
Change From Baseline Treatment Satisfaction Using HIV TSQ at Weeks 56, 76, 100 and 148 - DTG+RPV Group Through Early and Late Switch Phase
General Satisfaction/CS, Week 148
|
0.0 Scores on a scale
Interval -12.0 to 17.0
|
—
|
SECONDARY outcome
Timeframe: At Week 56, Week 76, Week 100 and Week 148Population: LS ITT-E Population. Only those participants with data available at the specified time points were analyzed.
HIV TSQ is a 10-item self-reported scale that measures overall satisfaction with treatment and by specific domains e.g., convenience, flexibility. Each item is scored 0 (very dissatisfied, inconvenient) to 6 (very satisfied, convenient). The items are summed up to produce a treatment satisfaction total score (0 to 60) and 2 subscale scores: general satisfaction/clinical and lifestyle/ease subscales (0 to 30). Higher scores indicated greater treatment satisfaction as compared to the past few weeks. The HIV TSQ was administered as a paper questionnaire. Total score, lifestyle/ease score and General satisfaction/CS have been summarized. LOCF was used as primary method of analysis. Value obtained at Week 48 was considered as LS Baseline value. Change from LS Baseline was calculated as value at indicated time point minus LS Baseline value.
Outcome measures
| Measure |
DTG + RPV
n=236 Participants
Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
Participants continued to receive their CAR (two nucleoside reverse transcriptase inhibitors \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during the Early Switch Phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) less than (\<) 50 copies (c)/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Change From LS Baseline Treatment Satisfaction Using HIV TSQ at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch Phase
Total score, Week 56
|
0.0 Scores on a scale
Interval -31.0 to 31.0
|
—
|
|
Change From LS Baseline Treatment Satisfaction Using HIV TSQ at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch Phase
Total score, Week 76
|
0.0 Scores on a scale
Interval -37.0 to 31.0
|
—
|
|
Change From LS Baseline Treatment Satisfaction Using HIV TSQ at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch Phase
Total score, Week 100
|
0.0 Scores on a scale
Interval -37.0 to 26.0
|
—
|
|
Change From LS Baseline Treatment Satisfaction Using HIV TSQ at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch Phase
Total score, Week 148
|
0.0 Scores on a scale
Interval -37.0 to 26.0
|
—
|
|
Change From LS Baseline Treatment Satisfaction Using HIV TSQ at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch Phase
Lifestyle/ease Sub-score, Week 56
|
0.0 Scores on a scale
Interval -14.0 to 16.0
|
—
|
|
Change From LS Baseline Treatment Satisfaction Using HIV TSQ at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch Phase
Lifestyle/ease Sub-score, Week 76
|
0.0 Scores on a scale
Interval -21.0 to 16.0
|
—
|
|
Change From LS Baseline Treatment Satisfaction Using HIV TSQ at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch Phase
Lifestyle/ease Sub-score, Week 100
|
0.0 Scores on a scale
Interval -21.0 to 18.0
|
—
|
|
Change From LS Baseline Treatment Satisfaction Using HIV TSQ at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch Phase
Lifestyle/ease Sub-score, Week 148
|
0.0 Scores on a scale
Interval -21.0 to 16.0
|
—
|
|
Change From LS Baseline Treatment Satisfaction Using HIV TSQ at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch Phase
General Satisfaction/CS, Week 56
|
0.0 Scores on a scale
Interval -17.0 to 16.0
|
—
|
|
Change From LS Baseline Treatment Satisfaction Using HIV TSQ at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch Phase
General Satisfaction/CS, Week 76
|
0.0 Scores on a scale
Interval -17.0 to 16.0
|
—
|
|
Change From LS Baseline Treatment Satisfaction Using HIV TSQ at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch Phase
General Satisfaction/CS, Week 100
|
0.0 Scores on a scale
Interval -17.0 to 14.0
|
—
|
|
Change From LS Baseline Treatment Satisfaction Using HIV TSQ at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch Phase
General Satisfaction/CS, Week 148
|
0.0 Scores on a scale
Interval -17.0 to 13.0
|
—
|
SECONDARY outcome
Timeframe: Up to Week 411Population: The analysis was performed on the CVW Resistance population.
For all participants who met virologic withdrawal criteria, plasma samples with HIV-1 RNA level \>=200 c/mL were analyzed in an attempt to obtain genotype data on as many samples as possible. Samples for drug resistance testing (genotypic) were collected at Day 1. Number of participants with genotypic resistance to DTG or RPV for those meeting virologic withdrawal criteria in subgroups, stratified based on baseline third agent treatment class (NNRTI, INI, PI) were summarized.
Outcome measures
| Measure |
DTG + RPV
n=3 Participants
Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
Participants continued to receive their CAR (two nucleoside reverse transcriptase inhibitors \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during the Early Switch Phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) less than (\<) 50 copies (c)/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, ATV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, ATV/r, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, INI, DTG, Susceptible
|
3 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, INI, DTG, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, INI, DTG, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, INI, DTG, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, INI, DTG, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, INI, EVG, Susceptible
|
3 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, INI, EVG, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, INI, EVG, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, INI, EVG, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, INI, EVG, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, INI, RAL, Susceptible
|
3 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, INI, RAL, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, INI, RAL, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, INI, RAL, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, INI, RAL, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NNRTI, DLV, Susceptible
|
3 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NNRTI, DLV, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NNRTI, DLV, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, DRV/r, Susceptible
|
3 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NNRTI, DLV, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NNRTI, DLV, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NNRTI, EFV, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NNRTI, EFV, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NNRTI, EFV, Low-level resistance
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NNRTI, EFV, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NNRTI, EFV, High-level resistance
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NNRTI, ETR, Susceptible
|
2 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NNRTI, ETR, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NNRTI, ETR, Low-level resistance
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NNRTI, ETR, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NNRTI, ETR, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NNRTI, NVP, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NNRTI, NVP, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NNRTI, NVP, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NNRTI, NVP, Intermediate resistance
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NNRTI, NVP, High-level resistance
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NNRTI, RPV, Susceptible
|
2 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NNRTI, RPV, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NNRTI, RPV, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NNRTI, RPV, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NNRTI, RPV, High-level resistance
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, 3TC, Susceptible
|
2 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, 3TC, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, 3TC, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, 3TC, Intermediate resistance
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, 3TC, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, ABC, Susceptible
|
2 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, ABC, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, ABC, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, ABC, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, ABC, High-level resistance
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, FTC, Susceptible
|
2 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, FTC, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, FTC, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, FTC, Intermediate resistance
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, FTC, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, TDF, Susceptible
|
2 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, TDF, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, TDF, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, TDF, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, TDF, High-level resistance
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, ZDV, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, ZDV, Potential low-level resistance
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, ZDV, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, ZDV, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, ZDV, High-level resistance
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, d4T, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, d4T, Potential low-level resistance
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, d4T, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, d4T, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, d4T, High-level resistance
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, ddI, Susceptible
|
2 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, ddI, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, ddI, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, ddI, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, ddI, High-level resistance
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, ATV/r, Susceptible
|
3 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, ATV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, ATV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, DRV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, DRV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, DRV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, DRV/r, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, FPV/r, Susceptible
|
3 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, FPV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, FPV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, FPV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, FPV/r, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, IDV/r, Susceptible
|
3 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, IDV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, IDV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, IDV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, IDV/r, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, LPV/r, Susceptible
|
3 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, LPV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, LPV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, LPV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, LPV/r, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, NFV, Susceptible
|
3 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, NFV, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, NFV, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, NFV, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, NFV, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, RTV, Susceptible
|
3 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, RTV, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, RTV, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, RTV, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, RTV, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, SQV/r, Susceptible
|
3 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, SQV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, SQV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, SQV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, SQV/r, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, TPV/r, Susceptible
|
3 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, TPV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, TPV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, TPV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, TPV/r, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, INI, DTG, Susceptible
|
2 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, INI, DTG, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, INI, DTG, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, INI, DTG, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, INI, DTG, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, INI, EVG, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, INI, EVG, Potential low-level resistance
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, INI, EVG, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, INI, EVG, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, INI, EVG, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, INI, RAL, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, INI, RAL, Potential low-level resistance
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, INI, RAL, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, INI, RAL, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, INI, RAL, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NNRTI, DLV, Susceptible
|
2 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NNRTI, DLV, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NNRTI, DLV, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NNRTI, DLV, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NNRTI, DLV, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NNRTI, EFV, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NNRTI, EFV, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NNRTI, EFV, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NNRTI, EFV, Intermediate resistance
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NNRTI, EFV, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NNRTI, ETR, Susceptible
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NNRTI, ETR, Potential low-level resistance
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NNRTI, ETR, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NNRTI, ETR, Intermediate resistance
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NNRTI, ETR, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NNRTI, NVP, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NNRTI, NVP, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NNRTI, NVP, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NNRTI, NVP, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NNRTI, NVP, High-level resistance
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NNRTI, RPV, Susceptible
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NNRTI, RPV, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NNRTI, RPV, Low-level resistance
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NNRTI, RPV, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NNRTI, RPV, High-level resistance
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NRTI, 3TC, Susceptible
|
2 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NRTI, 3TC, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NRTI, 3TC, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NRTI, 3TC, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NRTI, 3TC, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NRTI, ABC, Susceptible
|
2 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NRTI, ABC, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NRTI, ABC, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NRTI, ABC, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NRTI, ABC, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NRTI, FTC, Susceptible
|
2 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NRTI, FTC, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NRTI, FTC, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NRTI, FTC, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NRTI, FTC, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NRTI, TDF, Susceptible
|
2 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NRTI, TDF, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NRTI, TDF, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NRTI, TDF, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NRTI, TDF, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NRTI, ZDV, Susceptible
|
2 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NRTI, ZDV, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NRTI, ZDV, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NRTI, ZDV, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NRTI, ZDV, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NRTI, d4T, Susceptible
|
2 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NRTI, d4T, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NRTI, d4T, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NRTI, d4T, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NRTI, d4T, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NRTI, ddI, Susceptible
|
2 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NRTI, ddI, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NRTI, ddI, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NRTI, ddI, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NRTI, ddI, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, PI, ATV/r, Susceptible
|
2 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, PI, ATV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, PI, ATV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, PI, ATV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, PI, ATV/r, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, PI, DRV/r, Susceptible
|
2 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, PI, DRV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, PI, DRV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, PI, DRV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, PI, DRV/r, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, PI, FPV/r, Susceptible
|
2 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, PI, FPV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, PI, FPV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, PI, FPV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, PI, FPV/r, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, PI, IDV/r, Susceptible
|
2 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, PI, IDV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, PI, IDV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, PI, IDV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, PI, IDV/r, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, PI, LPV/r, Susceptible
|
2 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, PI, LPV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, PI, LPV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, PI, LPV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, PI, LPV/r, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, PI, NFV, Susceptible
|
2 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, PI, NFV, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, PI, NFV, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, PI, NFV, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, PI, NFV, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, PI, RTV, Susceptible
|
2 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, PI, RTV, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, PI, RTV, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, PI, RTV, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, PI, RTV, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, PI, SQV/r, Susceptible
|
2 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, PI, SQV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, PI, SQV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, PI, SQV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, PI, SQV/r, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, PI, TPV/r, Susceptible
|
2 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, PI, TPV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, PI, TPV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, PI, TPV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, PI, TPV/r, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, INI, DTG, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, INI, DTG, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, INI, DTG, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, INI, DTG, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, INI, DTG, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, INI, EVG, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, INI, EVG, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, INI, EVG, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, INI, EVG, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, INI, EVG, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, INI, RAL, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, INI, RAL, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, INI, RAL, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, INI, RAL, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, INI, RAL, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NNRTI, DLV, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NNRTI, DLV, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NNRTI, DLV, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NNRTI, DLV, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NNRTI, DLV, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NNRTI, EFV, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NNRTI, EFV, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NNRTI, EFV, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NNRTI, EFV, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NNRTI, EFV, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NNRTI, ETR, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NNRTI, ETR, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NNRTI, ETR, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NNRTI, ETR, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NNRTI, ETR, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NNRTI, NVP, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NNRTI, NVP, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NNRTI, NVP, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NNRTI, NVP, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NNRTI, NVP, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NNRTI, RPV, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NNRTI, RPV, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NNRTI, RPV, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NNRTI, RPV, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NNRTI, RPV, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NRTI, 3TC, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NRTI, 3TC, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NRTI, 3TC, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NRTI, 3TC, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NRTI, 3TC, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NRTI, ABC, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NRTI, ABC, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NRTI, ABC, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NRTI, ABC, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NRTI, ABC, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NRTI, FTC, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NRTI, FTC, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NRTI, FTC, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NRTI, FTC, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NRTI, FTC, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NRTI, TDF, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NRTI, TDF, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NRTI, TDF, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NRTI, TDF, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NRTI, TDF, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NRTI, ZDV, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NRTI, ZDV, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NRTI, ZDV, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NRTI, ZDV, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NRTI, ZDV, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NRTI, d4T, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NRTI, d4T, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NRTI, d4T, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NRTI, d4T, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NRTI, d4T, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NRTI, ddI, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NRTI, ddI, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NRTI, ddI, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NRTI, ddI, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NRTI, ddI, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, PI, ATV/r, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, PI, ATV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, PI, ATV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, PI, ATV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, PI, ATV/r, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, PI, DRV/r, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, PI, DRV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, PI, DRV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, PI, DRV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, PI, DRV/r, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, PI, FPV/r, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, PI, FPV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, PI, FPV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, PI, FPV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, PI, FPV/r, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, PI, IDV/r, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, PI, IDV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, PI, IDV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, PI, IDV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, PI, IDV/r, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, PI, LPV/r, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, PI, LPV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, PI, LPV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, PI, LPV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, PI, LPV/r, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, PI, NFV, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, PI, NFV, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, PI, NFV, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, PI, NFV, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, PI, NFV, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, PI, RTV, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, PI, RTV, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, PI, RTV, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, PI, RTV, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, PI, RTV, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, PI, SQV/r, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, PI, SQV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, PI, SQV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, PI, SQV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, PI, SQV/r, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, PI, TPV/r, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, PI, TPV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, PI, TPV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, PI, TPV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, PI, TPV/r, High-level resistance
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to Week 411Population: The analysis was performed on the CVW Resistance population.
For all participants who met virologic withdrawal criteria, plasma samples with HIV-1 RNA level \>=200 c/mL were analyzed in an attempt to obtain phenotype data on as many samples as possible. Samples for drug resistance testing (phenotypic) were collected at Day 1. Number of participants with phenotypic resistance to DTG or RPV for those meeting virologic withdrawal criteria in subgroups, stratified based on baseline third agent treatment class (NNRTI, INI, PI) were summarized.
Outcome measures
| Measure |
DTG + RPV
n=3 Participants
Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
Participants continued to receive their CAR (two nucleoside reverse transcriptase inhibitors \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during the Early Switch Phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) less than (\<) 50 copies (c)/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, PI, DRV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, NFV, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, NFV, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, NFV, Sensitive
|
3 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, RTV, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, INI, DTG, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, INI, DTG, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, INI, DTG, Sensitive
|
2 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, INI, EVG, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, INI, EVG, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, INI, EVG, Sensitive
|
2 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, INI, RAL, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, INI, RAL, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, INI, RAL, Sensitive
|
2 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NNRTI, DLV, Resistant
|
1 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NNRTI, DLV, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NNRTI, DLV, Sensitive
|
2 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NNRTI, EFV, Resistant
|
1 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NNRTI, EFV, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NNRTI, EFV, Sensitive
|
2 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NNRTI, ETR, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NNRTI, ETR, Partially Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NNRTI, ETR, Sensitive
|
2 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NNRTI, NVP, Resistant
|
1 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NNRTI, NVP, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NNRTI, NVP, Sensitive
|
2 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NNRTI, RPV, Resistant
|
1 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NNRTI, RPV, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NNRTI, RPV, Sensitive
|
2 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, 3TC, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, 3TC, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, 3TC, Sensitive
|
3 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, ABC, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, ABC, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, ABC, Sensitive
|
3 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, FTC, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, FTC, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, FTC, Sensitive
|
3 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, TDF, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, TDF, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, TDF, Sensitive
|
3 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, ZDV, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, ZDV, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, ZDV, Sensitive
|
3 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, d4T, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, d4T, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, d4T, Sensitive
|
3 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, ddI, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, ddI, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, ddI, Sensitive
|
3 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, ATV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, ATV/r, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, ATV/r, Sensitive
|
3 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, DRV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, DRV/r, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, DRV/r, Sensitive
|
3 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, FPV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, FPV/r, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, FPV/r, Sensitive
|
3 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, IDV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, IDV/r, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, IDV/r, Sensitive
|
3 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, LPV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, LPV/r, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, LPV/r, Sensitive
|
3 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, RTV, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, RTV, Sensitive
|
3 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, SQV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, SQV/r, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, SQV/r, Sensitive
|
3 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, TPV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, TPV/r, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, TPV/r, Sensitive
|
3 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, INI, DTG, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, INI, DTG, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, INI, DTG, Sensitive
|
2 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, INI, EVG, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, INI, EVG, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, INI, EVG, Sensitive
|
2 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, INI, RAL, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, INI, RAL, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, INI, RAL, Sensitive
|
2 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NNRTI, DLV, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NNRTI, DLV, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NNRTI, DLV, Sensitive
|
2 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NNRTI, EFV, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NNRTI, EFV, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NNRTI, EFV, Sensitive
|
2 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NNRTI, ETR, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NNRTI, ETR, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NNRTI, ETR, Sensitive
|
2 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NNRTI, NVP, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NNRTI, NVP, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NNRTI, NVP, Sensitive
|
2 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NNRTI, RPV, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NNRTI, RPV, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NNRTI, RPV, Sensitive
|
2 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NRTI, 3TC, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NRTI, 3TC, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NRTI, 3TC, Sensitive
|
2 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NRTI, ABC, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NRTI, ABC, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NRTI, ABC, Sensitive
|
2 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NRTI, FTC, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NRTI, FTC, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NRTI, FTC, Sensitive
|
2 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NRTI, TDF, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NRTI, TDF, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NRTI, TDF, Sensitive
|
2 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NRTI, ZDV, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NRTI, ZDV, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NRTI, ZDV, Sensitive
|
2 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NRTI, d4T, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NRTI, d4T, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NRTI, d4T, Sensitive
|
2 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NRTI, ddI, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NRTI, ddI, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, NRTI, ddI, Sensitive
|
2 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, PI, ATV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, PI, ATV/r, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, PI, ATV/r, Sensitive
|
2 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, PI, DRV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, PI, DRV/r, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, PI, DRV/r, Sensitive
|
2 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, PI, FPV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, PI, FPV/r, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, PI, FPV/r, Sensitive
|
2 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, PI, IDV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, PI, IDV/r, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, PI, IDV/r, Sensitive
|
2 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, PI, LPV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, PI, LPV/r, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, PI, LPV/r, Sensitive
|
2 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, PI, NFV, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, PI, NFV, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, PI, NFV, Sensitive
|
2 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, PI, RTV, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, PI, RTV, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, PI, RTV, Sensitive
|
2 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, PI, SQV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, PI, SQV/r, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, PI, SQV/r, Sensitive
|
2 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, PI, TPV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, PI, TPV/r, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
INI, PI, TPV/r, Sensitive
|
2 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, INI, DTG, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, INI, DTG, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, INI, DTG, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, INI, EVG, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, INI, EVG, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, INI, EVG, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, INI, RAL, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, INI, RAL, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, INI, RAL, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NNRTI, DLV, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NNRTI, DLV, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NNRTI, DLV, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NNRTI, EFV, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NNRTI, EFV, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NNRTI, EFV, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NNRTI, ETR, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NNRTI, ETR, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NNRTI, ETR, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NNRTI, NVP, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NNRTI, NVP, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NNRTI, NVP, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NNRTI, RPV, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NNRTI, RPV, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NNRTI, RPV, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NRTI, 3TC, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NRTI, 3TC, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NRTI, 3TC, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NRTI, ABC, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NRTI, ABC, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NRTI, ABC, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NRTI, FTC, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NRTI, FTC, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NRTI, FTC, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NRTI, TDF, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NRTI, TDF, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NRTI, TDF, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NRTI, ZDV, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NRTI, ZDV, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NRTI, ZDV, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NRTI, d4T, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NRTI, d4T, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NRTI, d4T, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NRTI, ddI, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NRTI, ddI, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, NRTI, ddI, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, PI, ATV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, PI, ATV/r, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, PI, ATV/r, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, PI, DRV/r, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, PI, DRV/r, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, PI, FPV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, PI, FPV/r, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, PI, FPV/r, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, PI, IDV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, PI, IDV/r, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, PI, IDV/r, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, PI, LPV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, PI, LPV/r, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, PI, LPV/r, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, PI, NFV, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, PI, NFV, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, PI, NFV, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, PI, RTV, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, PI, RTV, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, PI, RTV, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, PI, SQV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, PI, SQV/r, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, PI, SQV/r, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, PI, TPV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, PI, TPV/r, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
PI, PI, TPV/r, Sensitive
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 52 to Week 411Population: The analysis was to be performed on the Late Switch CVW Resistance population.
For all participants who meet virologic withdrawal criteria, plasma samples with HIV-1 RNA level \>=200 c/mL were analyzed in an attempt to obtain genotype data on as many samples as possible. Number of participants with genotypic resistance to CAR for those meeting virologic withdrawal criteria in subgroups, stratified based on baseline third agent treatment class (INI) were summarized.
Outcome measures
| Measure |
DTG + RPV
n=1 Participants
Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
Participants continued to receive their CAR (two nucleoside reverse transcriptase inhibitors \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during the Early Switch Phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) less than (\<) 50 copies (c)/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, INI, DTG, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, INI, DTG, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, INI, DTG, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, INI, DTG, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, INI, DTG, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, INI, EVG, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, INI, EVG, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, INI, EVG, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, INI, EVG, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, INI, EVG, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, INI, RAL, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, INI, RAL, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, INI, RAL, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, INI, RAL, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, INI, RAL, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NNRTI, DLV, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NNRTI, DLV, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NNRTI, DLV, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NNRTI, DLV, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NNRTI, DLV, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NNRTI, EFV, Susceptible
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NNRTI, EFV, Potential low-level resistance
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NNRTI, EFV, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NNRTI, EFV, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NNRTI, EFV, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NNRTI, ETR, Susceptible
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NNRTI, ETR, Potential low-level resistance
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NNRTI, ETR, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NNRTI, ETR, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NNRTI, ETR, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NNRTI, NVP, Susceptible
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NNRTI, NVP, Potential low-level resistance
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NNRTI, NVP, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NNRTI, NVP, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NNRTI, NVP, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NNRTI, RPV, Susceptible
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NNRTI, RPV, Potential low-level resistance
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NNRTI, RPV, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NNRTI, RPV, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NNRTI, RPV, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NRTI, 3TC, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NRTI, 3TC, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NRTI, 3TC, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NRTI, 3TC, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NRTI, 3TC, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NRTI, ABC, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NRTI, ABC, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NRTI, ABC, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NRTI, ABC, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NRTI, ABC, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NRTI, FTC, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NRTI, FTC, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NRTI, FTC, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NRTI, FTC, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NRTI, FTC, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NRTI, TDF, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NRTI, TDF, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NRTI, TDF, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NRTI, TDF, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NRTI, TDF, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NRTI, ZDV, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NRTI, ZDV, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NRTI, ZDV, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NRTI, ZDV, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NRTI, ZDV, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NRTI, d4T, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NRTI, d4T, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NRTI, d4T, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NRTI, d4T, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NRTI, d4T, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NRTI, ddI, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NRTI, ddI, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NRTI, ddI, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NRTI, ddI, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NRTI, ddI, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, PI, ATV/r, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, PI, ATV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, PI, ATV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, PI, ATV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, PI, ATV/r, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, PI, DRV/r, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, PI, DRV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, PI, DRV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, PI, DRV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, PI, DRV/r, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, PI, FPV/r, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, PI, FPV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, PI, FPV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, PI, FPV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, PI, FPV/r, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, PI, IDV/r, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, PI, IDV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, PI, IDV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, PI, IDV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, PI, IDV/r, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, PI, LPV/r, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, PI, LPV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, PI, LPV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, PI, LPV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, PI, LPV/r, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, PI, NFV, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, PI, NFV, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, PI, NFV, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, PI, NFV, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, PI, NFV, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, PI, RTV, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, PI, RTV, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, PI, RTV, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, PI, RTV, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, PI, RTV, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, PI, SQV/r, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, PI, SQV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, PI, SQV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, PI, SQV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, PI, SQV/r, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, PI, TPV/r, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, PI, TPV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, PI, TPV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, PI, TPV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, PI, TPV/r, High-level resistance
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 52 to Week 411Population: The analysis was performed on the Late Switch CVW resistance population.
For all participants who meet virologic withdrawal criteria, plasma samples with HIV-1 RNA level \>=200 c/mL were analyzed in an attempt to obtain phenotype data on as many samples as possible. Number of participants with phenotypic resistance to CAR for those meeting virologic withdrawal criteria in subgroups, stratified based on baseline third agent treatment class (INI) were summarized.
Outcome measures
| Measure |
DTG + RPV
n=1 Participants
Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
Participants continued to receive their CAR (two nucleoside reverse transcriptase inhibitors \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during the Early Switch Phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) less than (\<) 50 copies (c)/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NNRTI, DLV, Resistant
|
1 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NNRTI, DLV, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NNRTI, DLV, Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NNRTI, EFV, Resistant
|
1 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NNRTI, EFV, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NNRTI, EFV, Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NNRTI, ETR, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NNRTI, ETR, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NNRTI, ETR, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NNRTI, NVP, Resistant
|
1 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NNRTI, NVP, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NNRTI, NVP, Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NNRTI, RPV, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NNRTI, RPV, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NNRTI, RPV, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NRTI, 3TC, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NRTI, 3TC, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NRTI, 3TC, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NRTI, ABC, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NRTI, ABC, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NRTI, ABC, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NRTI, FTC, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NRTI, FTC, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NRTI, FTC, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NRTI, TDF, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NRTI, TDF, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NRTI, TDF, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NRTI, ZDV, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NRTI, ZDV, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NRTI, ZDV, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NRTI, d4T, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NRTI, d4T, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NRTI, d4T, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NRTI, ddI, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NRTI, ddI, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, NRTI, ddI, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, PI, ATV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, PI, ATV/r, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, PI, ATV/r, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, PI, DRV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, PI, DRV/r, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, PI, DRV/r, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, PI, FPV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, PI, FPV/r, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, PI, FPV/r, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, PI, IDV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, PI, IDV/r, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, PI, IDV/r, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, PI, LPV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, PI, LPV/r, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, PI, LPV/r, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, PI, NFV, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, PI, NFV, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, PI, NFV, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, PI, RTV, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, PI, RTV, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, PI, RTV, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, PI, SQV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, PI, SQV/r, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, PI, SQV/r, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, PI, TPV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, PI, TPV/r, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
INI, PI, TPV/r, Sensitive
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to Week 411Population: The analysis was performed on the CVW Resistance population which included all participants from the Intent-to-Treat Exposed (ITT-E) population who met CVW through the end of the visit window and had available on-treatment genotypic resistance data at the time the CVW criterion was met.
Plasma samples were collected for participants meeting the CVW criteria (previous plasma HIV-1 RNA \>=50 c/mL and current plasma HIV-1 RNA \>= 200 c/mL) to evaluate any potential genotypic evolution of resistance. Genotypic resistance data for the following drugs was presented: DTG, EVG, RAL, DLV, EFV, ETR, NVP, RPV, 3TC, ABC, FTC, TDF, ZDV, d4T, ddI, ATV/r, DRV/r, FPV/r, IDV/r, LPV/r, NFV, RTV, SQV/r, TPV/r.
Outcome measures
| Measure |
DTG + RPV
n=6 Participants
Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
Participants continued to receive their CAR (two nucleoside reverse transcriptase inhibitors \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during the Early Switch Phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) less than (\<) 50 copies (c)/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, ATV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, ATV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, ATV/r, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, DRV/r, Susceptible
|
6 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, DRV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, DRV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, DRV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, DRV/r, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, FPV/r, Susceptible
|
6 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, FPV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, FPV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, FPV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, FPV/r, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, IDV/r, Susceptible
|
6 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, IDV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, IDV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, IDV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, IDV/r, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, LPV/r, Susceptible
|
6 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, LPV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, LPV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, LPV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, LPV/r, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, NFV, Susceptible
|
6 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, NFV, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, NFV, Low-level resistance
|
00 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, NFV, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, NFV, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, RTV, Susceptible
|
6 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, RTV, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, RTV, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, RTV, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, RTV, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, SQV/r, Susceptible
|
6 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, SQV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, SQV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, SQV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, SQV/r, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, TPV/r, Susceptible
|
6 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, TPV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, TPV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, TPV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, TPV/r, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
INI, DTG, Susceptible
|
6 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
INI, DTG, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
INI, DTG, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
INI, DTG, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
INI, DTG, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
INI, EVG, Susceptible
|
5 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
INI, EVG, Potential low-level resistance
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
INI, EVG, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
INI, EVG, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
INI, EVG, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
INI, RAL, Susceptible
|
5 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
INI, RAL, Potential low-level resistance
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
INI, RAL, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
INI, RAL, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
INI, RAL, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NNRTI, DLV, Susceptible
|
6 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NNRTI, DLV, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NNRTI, DLV, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NNRTI, DLV, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NNRTI, DLV, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NNRTI, EFV, Susceptible
|
3 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NNRTI, EFV, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NNRTI, EFV, Low-level resistance
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NNRTI, EFV, Intermediate resistance
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NNRTI, EFV, High-level resistance
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NNRTI, ETR, Susceptible
|
3 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NNRTI, ETR, Potential low-level resistance
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NNRTI, ETR, Low-level resistance
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NNRTI, ETR, Intermediate resistance
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NNRTI, ETR, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NNRTI, NVP, Susceptible
|
3 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NNRTI, NVP, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NNRTI, NVP, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NNRTI, NVP, Intermediate resistance
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NNRTI, NVP, High-level resistance
|
2 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NNRTI, RPV, Susceptible
|
3 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NNRTI, RPV, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NNRTI, RPV, Low-level resistance
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NNRTI, RPV, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NNRTI, RPV, High-level resistance
|
2 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, 3TC, Susceptible
|
5 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, 3TC, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, 3TC, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, 3TC, Intermediate resistance
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, 3TC, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, ABC, Susceptible
|
5 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, ABC, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, ABC, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, ABC, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, ABC, High-level resistance
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, FTC, Susceptible
|
5 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, FTC, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, FTC, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, FTC, Intermediate resistance
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, FTC, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, TDF, Susceptible
|
5 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, TDF, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, TDF, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, TDF, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, TDF, High-level resistance
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, ZDV, Susceptible
|
4 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, ZDV, Potential low-level resistance
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, ZDV, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, ZDV, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, ZDV, High-level resistance
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, d4T, Susceptible
|
4 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, d4T, Potential low-level resistance
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, d4T, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, d4T, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, d4T, High-level resistance
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, ddI, Susceptible
|
5 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, ddI, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, ddI, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, ddI, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, ddI, High-level resistance
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, ATV/r, Susceptible
|
6 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, ATV/r, Potential low-level resistance
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to Week 411Population: The analysis was performed on the CVW Resistance population which included all participants from the ITT-E population who met CVW through the end of the visit window and had available on-treatment phenotypic resistance data at the time the CVW criterion was met.
Plasma samples were collected for participants meeting the CVW criteria (previous plasma HIV-1 RNA \>=50 c/mL and current plasma HIV-1 RNA \>= 200 c/mL) to evaluate any potential phenotypic evolution of resistance. Phenotypic resistance data for the following drugs was presented: DTG, EVG, RAL, DLV, EFV, ETR, NVP, RPV, 3TC, ABC, FTC, TDF, ZDV, d4T, ddI, ATV/r, DRV/r, FPV/r, IDV/r, LPV/r, NFV, RTV, SQV/r, TPV/r.
Outcome measures
| Measure |
DTG + RPV
n=6 Participants
Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
Participants continued to receive their CAR (two nucleoside reverse transcriptase inhibitors \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during the Early Switch Phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) less than (\<) 50 copies (c)/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
INI, DTG, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
INI, DTG, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
INI, DTG, Sensitive
|
5 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
INI, EVG, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
INI, EVG, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
INI, EVG, Sensitive
|
5 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
INI, RAL, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
INI, RAL, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
INI, RAL, Sensitive
|
5 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
NNRTI, DLV, Resistant
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
NNRTI, DLV, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
NNRTI, DLV, Sensitive
|
5 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
NNRTI, EFV, Resistant
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
NNRTI, EFV, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
NNRTI, EFV, Sensitive
|
5 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
NNRTI, ETR, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
NNRTI, ETR, Partially Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
NNRTI, ETR, Sensitive
|
5 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
NNRTI, NVP, Resistant
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
NNRTI, NVP, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
NNRTI, NVP, Sensitive
|
5 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
NNRTI, RPV, Resistant
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
NNRTI, RPV, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
NNRTI, RPV, Sensitive
|
5 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, 3TC, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, 3TC, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, 3TC, Sensitive
|
6 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, ABC, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, ABC, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, ABC, Sensitive
|
6 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, FTC, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, FTC, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, FTC, Sensitive
|
6 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, TDF, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, TDF, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, TDF, Sensitive
|
6 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, ZDV, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, ZDV, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, ZDV, Sensitive
|
6 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, d4T, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, d4T, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, d4T, Sensitive
|
6 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, ddI, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, ddI, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, ddI, Sensitive
|
6 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, ATV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, ATV/r, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, ATV/r, Sensitive
|
6 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, DRV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, DRV/r, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, DRV/r, Sensitive
|
6 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, FPV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, FPV/r, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, FPV/r, Sensitive
|
6 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, IDV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, IDV/r, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, IDV/r, Sensitive
|
6 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, LPV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, LPV/r, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, LPV/r, Sensitive
|
6 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, NFV, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, NFV, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, NFV, Sensitive
|
6 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, RTV, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, RTV, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, RTV, Sensitive
|
6 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, SQV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, SQV/r, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, SQV/r, Sensitive
|
6 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, TPV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, TPV/r, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, TPV/r, Sensitive
|
6 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 52 to Week 411Population: The analysis was performed on the Late Switch CVW resistance population which included all participants from the Late Switch ITT-E population who met CVW through the end of visit window and had available on-treatment genotypic resistance data at the time the CVW criterion was met.
Plasma samples were collected for participants meeting the CVW criteria (previous plasma HIV-1 RNA \>=50 c/mL and current plasma HIV-1 RNA \>= 200 c/mL) to evaluate any potential genotypic evolution of resistance. Genotypic resistance data for the following drugs was presented: DTG, EVG, RAL, DLV, EFV, ETR, NVP, RPV, 3TC, ABC, FTC, TDF, ZDV, d4T, ddI, ATV/r, DRV/r, FPV/r, IDV/r, LPV/r, NFV, RTV, SQV/r, TPV/r.
Outcome measures
| Measure |
DTG + RPV
n=2 Participants
Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
Participants continued to receive their CAR (two nucleoside reverse transcriptase inhibitors \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during the Early Switch Phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) less than (\<) 50 copies (c)/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
INI, DTG, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
INI, DTG, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
INI, DTG, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
INI, DTG, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
INI, DTG, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
INI, EVG, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
INI, EVG, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
INI, EVG, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
INI, EVG, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
INI, EVG, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
INI, RAL, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
INI, RAL, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
INI, RAL, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
INI, RAL, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
INI, RAL, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NNRTI, DLV, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NNRTI, DLV, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NNRTI, DLV, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NNRTI, DLV, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NNRTI, DLV, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NNRTI, EFV, Susceptible
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NNRTI, EFV, Potential low-level resistance
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NNRTI, EFV, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NNRTI, EFV, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NNRTI, EFV, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NNRTI, ETR, Susceptible
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NNRTI, ETR, Potential low-level resistance
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NNRTI, ETR, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NNRTI, ETR, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NNRTI, ETR, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NNRTI, NVP, Susceptible
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NNRTI, NVP, Potential low-level resistance
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NNRTI, NVP, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NNRTI, NVP, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NNRTI, NVP, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NNRTI, RPV, Susceptible
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NNRTI, RPV, Potential low-level resistance
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NNRTI, RPV, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NNRTI, RPV, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NNRTI, RPV, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NRTI, 3TC, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NRTI, 3TC, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NRTI, 3TC, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NRTI, 3TC, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NRTI, 3TC, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NRTI, ABC, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NRTI, ABC, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NRTI, ABC, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NRTI, ABC, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NRTI, ABC, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NRTI, FTC, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NRTI, FTC, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NRTI, FTC, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NRTI, FTC, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NRTI, FTC, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NRTI, TDF, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NRTI, TDF, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NRTI, TDF, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NRTI, TDF, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NRTI, TDF, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NRTI, ZDV, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NRTI, ZDV, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NRTI, ZDV, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NRTI, ZDV, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NRTI, ZDV, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NRTI, d4T, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NRTI, d4T, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NRTI, d4T, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NRTI, d4T, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NRTI, d4T, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NRTI, ddI, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NRTI, ddI, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NRTI, ddI, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NRTI, ddI, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NRTI, ddI, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
PI, ATV/r, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
PI, ATV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
PI, ATV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
PI, ATV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
PI, ATV/r, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
PI, DRV/r, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
PI, DRV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
PI, DRV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
PI, DRV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
PI, DRV/r, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
PI, FPV/r, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
PI, FPV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
PI, FPV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
PI, FPV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
PI, FPV/r, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
PI, IDV/r, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
PI, IDV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
PI, IDV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
PI, IDV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
PI, IDV/r, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
PI, LPV/r, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
PI, LPV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
PI, LPV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
PI, LPV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
PI, LPV/r, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
PI, NFV, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
PI, NFV, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
PI, NFV, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
PI, NFV, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
PI, NFV, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
PI, RTV, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
PI, RTV, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
PI, RTV, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
PI, RTV, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
PI, RTV, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
PI, SQV/r, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
PI, SQV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
PI, SQV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
PI, SQV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
PI, SQV/r, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
PI, TPV/r, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
PI, TPV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
PI, TPV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
PI, TPV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
PI, TPV/r, High-level resistance
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 52 to Week 411Population: The analysis was performed on the Late Switch CVW Resistance population which included all participants from the Late Switch ITT-E population who met CVW through the end of visit window and had available on-treatment phenotypic resistance data at the time the CVW criterion was met.
Plasma samples were collected for participants meeting the CVW criteria (previous plasma HIV-1 RNA \>=50 c/mL and current plasma HIV-1 RNA \>= 200 c/mL) to evaluate any potential phenotypic evolution of resistance. Phenotypic resistance data for the following drugs was presented: DTG, EVG, RAL, DLV, EFV, ETR, NVP, RPV, 3TC, ABC, FTC, TDF, ZDV, d4T, ddI, ATV/r, DRV/r, FPV/r, IDV/r, LPV/r, NFV, RTV, SQV/r, TPV/r.
Outcome measures
| Measure |
DTG + RPV
n=2 Participants
Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
Participants continued to receive their CAR (two nucleoside reverse transcriptase inhibitors \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during the Early Switch Phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) less than (\<) 50 copies (c)/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
NNRTI, DLV, Resistant
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
NNRTI, DLV, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
NNRTI, DLV, Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
NNRTI, EFV, Resistant
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
NNRTI, EFV, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
NNRTI, EFV, Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
NNRTI, ETR, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
NNRTI, ETR, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
NNRTI, ETR, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
NNRTI, NVP, Resistant
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
NNRTI, NVP, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
NNRTI, NVP, Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
NNRTI, RPV, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
NNRTI, RPV, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
NNRTI, RPV, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
NRTI, 3TC, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
NRTI, 3TC, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
NRTI, 3TC, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
NRTI, ABC, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
NRTI, ABC, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
NRTI, ABC, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
NRTI, FTC, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
NRTI, FTC, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
NRTI, FTC, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
NRTI, TDF, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
NRTI, TDF, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
NRTI, TDF, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
NRTI, ZDV, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
NRTI, ZDV, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
NRTI, ZDV, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
NRTI, d4T, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
NRTI, d4T, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
NRTI, d4T, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
NRTI, ddI, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
NRTI, ddI, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
NRTI, ddI, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
PI, ATV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
PI, ATV/r, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
PI, ATV/r, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
PI, DRV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
PI, DRV/r, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
PI, DRV/r, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
PI, FPV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
PI, FPV/r, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
PI, FPV/r, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
PI, IDV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
PI, IDV/r, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
PI, IDV/r, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
PI, LPV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
PI, LPV/r, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
PI, LPV/r, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
PI, NFV, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
PI, NFV, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
PI, NFV, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
PI, RTV, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
PI, RTV, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
PI, RTV, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
PI, SQV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
PI, SQV/r, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
PI, SQV/r, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
PI, TPV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
PI, TPV/r, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
PI, TPV/r, Sensitive
|
1 Participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At Weeks 100 and 148Population: ITT-E Population
Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with plasma HIV 1 RNA \< 50 c/mL using the FDA snapshot algorithm was assessed. Virologic success or failure was determined by the last available HIV-1 RNA assessment while the participant was on-treatment within the window of the visit of interest.
Outcome measures
| Measure |
DTG + RPV
n=252 Participants
Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
Participants continued to receive their CAR (two nucleoside reverse transcriptase inhibitors \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during the Early Switch Phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) less than (\<) 50 copies (c)/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Weeks 100 and 148 Using the Snapshot Algorithm-DTG+RPV Group Through Early and Late Switch Phase
Week 100
|
88 Percentage of participants
|
—
|
|
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Weeks 100 and 148 Using the Snapshot Algorithm-DTG+RPV Group Through Early and Late Switch Phase
Week 148
|
85 Percentage of participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At Weeks 100 and 148Population: ITT-E Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected for CD4+ cell count assessment by flow cytometry. Change from Baseline was calculated as value at indicated time point minus Baseline value.
Outcome measures
| Measure |
DTG + RPV
n=252 Participants
Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
Participants continued to receive their CAR (two nucleoside reverse transcriptase inhibitors \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during the Early Switch Phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) less than (\<) 50 copies (c)/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Change From Baseline in CD4+ Lymphocyte Count at Weeks 100 and 148-DTG+RPV Group Through Early and Late Switch Phase
Week 100
|
25.1 Cells/mm^3
Standard Deviation 156.31
|
—
|
|
Change From Baseline in CD4+ Lymphocyte Count at Weeks 100 and 148-DTG+RPV Group Through Early and Late Switch Phase
Week 148
|
39.9 Cells/mm^3
Standard Deviation 174.40
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At Weeks 100 and 148Population: LS ITT-E Population
Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with plasma HIV 1 RNA \< 50 c/mL using the FDA snapshot algorithm was assessed. Virologic success or failure was determined by the last available HIV-1 RNA assessment while the participant was on-treatment within the window of the visit of interest.
Outcome measures
| Measure |
DTG + RPV
n=238 Participants
Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
Participants continued to receive their CAR (two nucleoside reverse transcriptase inhibitors \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during the Early Switch Phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) less than (\<) 50 copies (c)/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Weeks 100 and 148 Using the Snapshot Algorithm-CAR Group Through Late Switch Phase
Week 100
|
90 Percentage of participants
|
—
|
|
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Weeks 100 and 148 Using the Snapshot Algorithm-CAR Group Through Late Switch Phase
Week 148
|
87 Percentage of participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At Weeks 100 and 148Population: LS ITT-E Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected for CD4+ cell count assessment by flow cytometry. Change from LS Baseline was calculated as value at indicated time point minus LS Baseline value.
Outcome measures
| Measure |
DTG + RPV
n=238 Participants
Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
Participants continued to receive their CAR (two nucleoside reverse transcriptase inhibitors \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during the Early Switch Phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) less than (\<) 50 copies (c)/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Change From LS Baseline in CD4+ Lymphocyte Count at Weeks 100 and 148-CAR Group Through Late Switch Phase
Week 100
|
-3.3 Cells/mm^3
Standard Deviation 180.82
|
—
|
|
Change From LS Baseline in CD4+ Lymphocyte Count at Weeks 100 and 148-CAR Group Through Late Switch Phase
Week 148
|
3.7 Cells/mm^3
Standard Deviation 205.29
|
—
|
Adverse Events
DTG + RPV (Early Switch)
Serious events: 10 serious events
Other events: 107 other events
Deaths: 0 deaths
CAR (Early Switch)
Serious events: 13 serious events
Other events: 102 other events
Deaths: 1 deaths
DTG + RPV (Early + Late Switch)
Serious events: 34 serious events
Other events: 167 other events
Deaths: 1 deaths
CAR (Late Switch)
Serious events: 22 serious events
Other events: 134 other events
Deaths: 0 deaths
DTG + RPV (Continuation Phase)
Serious events: 6 serious events
Other events: 0 other events
Deaths: 0 deaths
CAR (Continuation Phase)
Serious events: 9 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DTG + RPV (Early Switch)
n=252 participants at risk
Participants received DTG 50 mg + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase.
|
CAR (Early Switch)
n=256 participants at risk
Participants continued to receive their current antiretroviral regimen (two NRTIs + a third agent). A third agent included either an: INSTI, NNRTI or a PI. CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase.
|
DTG + RPV (Early + Late Switch)
n=252 participants at risk
Participants received DTG 50 mg + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
|
CAR (Late Switch)
n=238 participants at risk
Participants continued to receive their current antiretroviral regimen (two NRTIs + a third agent). A third agent included either an: INSTI, NNRTI or a PI. CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase.
At Week 52, participants who received CAR during the early switch phase, with HIV-1 RNA \<50 c/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed until Week 148.
|
DTG + RPV (Continuation Phase)
n=186 participants at risk
Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
CAR (Continuation Phase)
n=183 participants at risk
Participants continued to receive their CAR (NRTIs + a third agent). A third agent included either an: INSTI, a NNRTI or a PI. CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during the Early Switch Phase. At Week 52, participants with HIV-1 RNA \<50 c/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Hepatitis A
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/256 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
1.2%
3/252 • Number of events 3 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
1.3%
3/238 • Number of events 3 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/186 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/183 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Psychiatric disorders
Suicide attempt
|
0.40%
1/252 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/256 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.40%
1/252 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.42%
1/238 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/186 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/183 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Infections and infestations
Bronchitis
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.39%
1/256 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.40%
1/252 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/238 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/186 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/183 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/256 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.40%
1/252 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.42%
1/238 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/186 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/183 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.40%
1/252 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/256 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.40%
1/252 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/238 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/186 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/183 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Infections and infestations
Gastroenteritis
|
0.40%
1/252 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/256 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.40%
1/252 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/238 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/186 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/183 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease mixed cellularity stage unspecified
|
0.40%
1/252 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/256 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.40%
1/252 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/238 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/186 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/183 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.40%
1/252 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/256 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.40%
1/252 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/238 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/186 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/183 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Psychiatric disorders
Panic attack
|
0.40%
1/252 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/256 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.40%
1/252 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/238 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/186 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/183 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasmablastic lymphoma
|
0.40%
1/252 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/256 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.40%
1/252 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/238 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/186 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/183 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Infections and infestations
Pneumonia
|
0.40%
1/252 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/256 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.40%
1/252 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/238 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.54%
1/186 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/183 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Nervous system disorders
Syncope
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/256 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.40%
1/252 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.42%
1/238 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/186 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/183 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Ear and labyrinth disorders
Vertigo
|
0.40%
1/252 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/256 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.40%
1/252 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/238 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/186 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/183 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.40%
1/252 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/256 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.40%
1/252 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/238 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/186 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/183 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/256 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.40%
1/252 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/238 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/186 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/183 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Infections and infestations
Acute hepatitis B
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/256 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.42%
1/238 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/186 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/183 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/256 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.40%
1/252 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/238 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/186 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/183 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/256 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.40%
1/252 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/238 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/186 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/183 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.39%
1/256 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/238 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/186 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/183 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anogenital warts
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/256 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.42%
1/238 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/186 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/183 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Infections and infestations
Appendicitis
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/256 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.40%
1/252 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/238 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/186 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.55%
1/183 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/256 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.42%
1/238 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/186 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/183 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.39%
1/256 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/238 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/186 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/183 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/256 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.40%
1/252 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/238 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/186 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/183 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Infections and infestations
Cellulitis
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/256 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.42%
1/238 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/186 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.55%
1/183 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
General disorders
Death
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/256 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.40%
1/252 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/238 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/186 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/183 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/256 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.42%
1/238 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/186 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/183 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/256 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.42%
1/238 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/186 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/183 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/256 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.42%
1/238 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/186 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/183 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/256 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.40%
1/252 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/238 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/186 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/183 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/256 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.40%
1/252 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/238 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/186 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/183 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/256 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.42%
1/238 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/186 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/183 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/256 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.40%
1/252 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/238 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/186 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/183 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Infections and infestations
Hepatitis C
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.39%
1/256 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/238 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/186 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/183 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Infections and infestations
Influenza
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.39%
1/256 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/238 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.54%
1/186 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/183 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.39%
1/256 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/238 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.54%
1/186 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/183 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/256 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.40%
1/252 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/238 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/186 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/183 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.39%
1/256 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/238 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/186 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/183 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/256 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.42%
1/238 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/186 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/183 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/256 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.40%
1/252 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/238 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/186 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/183 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine carcinoma
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/256 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.40%
1/252 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/238 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/186 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/183 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.39%
1/256 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/238 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/186 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/183 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/256 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.40%
1/252 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/238 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/186 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/183 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/256 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.42%
1/238 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/186 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/183 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oropharyngeal squamous cell carcinoma
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/256 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.42%
1/238 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/186 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/183 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/256 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.40%
1/252 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/238 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/186 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/183 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/256 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.42%
1/238 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/186 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/183 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/256 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.42%
1/238 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/186 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/183 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Vascular disorders
Peripheral artery stenosis
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/256 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.40%
1/252 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/238 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/186 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/183 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Infections and infestations
Peritonsillar abscess
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.39%
1/256 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/238 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/186 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/183 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pleural neoplasm
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/256 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.40%
1/252 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/238 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/186 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/183 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/256 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.40%
1/252 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/238 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/186 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/183 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Injury, poisoning and procedural complications
Procedural pneumothorax
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/256 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.40%
1/252 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/238 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/186 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/183 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.39%
1/256 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/238 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/186 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/183 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.39%
1/256 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/238 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/186 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/183 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Infections and infestations
Rectal abscess
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.39%
1/256 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/238 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/186 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/183 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/256 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.42%
1/238 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/186 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/183 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Infections and infestations
Shigella infection
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/256 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.42%
1/238 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/186 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/183 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Infections and infestations
Staphylococcal osteomyelitis
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/256 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.40%
1/252 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/238 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/186 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/183 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Testicular germ cell tumour mixed
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/256 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.40%
1/252 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/238 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/186 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/183 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Infections and infestations
Thyroglossal cyst infection
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.39%
1/256 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/238 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/186 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/183 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/256 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.42%
1/238 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/186 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/183 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Endocrine disorders
Thyroid mass
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/256 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.42%
1/238 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/186 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/183 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Nervous system disorders
Toxic encephalopathy
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.39%
1/256 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/238 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/186 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/183 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/256 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.40%
1/252 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/238 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/186 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/183 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Cardiac disorders
Wolff-Parkinson-White syndrome
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/256 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.42%
1/238 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/186 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/183 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Infections and infestations
COVID-19
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/256 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/238 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
1.1%
2/186 • Number of events 2 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.55%
1/183 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Infections and infestations
Septic shock
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/256 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/238 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/186 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.55%
1/183 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Infections and infestations
Wound infection staphylococcal
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/256 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/238 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/186 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.55%
1/183 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/256 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/238 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/186 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.55%
1/183 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/256 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/238 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/186 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.55%
1/183 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/256 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/238 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/186 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.55%
1/183 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/256 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/238 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/186 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.55%
1/183 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/256 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/238 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/186 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.55%
1/183 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Injury, poisoning and procedural complications
Penile contusion
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/256 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/238 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.54%
1/186 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/183 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Hepatobiliary disorders
Cholelithiasis obstructive
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/256 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/238 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/186 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.55%
1/183 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/256 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/238 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.54%
1/186 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/183 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/256 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/238 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.54%
1/186 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/183 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/256 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/238 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.54%
1/186 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/183 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/256 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/238 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.54%
1/186 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/183 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/256 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/252 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/238 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/186 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.55%
1/183 • Number of events 1 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
Other adverse events
| Measure |
DTG + RPV (Early Switch)
n=252 participants at risk
Participants received DTG 50 mg + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase.
|
CAR (Early Switch)
n=256 participants at risk
Participants continued to receive their current antiretroviral regimen (two NRTIs + a third agent). A third agent included either an: INSTI, NNRTI or a PI. CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase.
|
DTG + RPV (Early + Late Switch)
n=252 participants at risk
Participants received DTG 50 mg + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
|
CAR (Late Switch)
n=238 participants at risk
Participants continued to receive their current antiretroviral regimen (two NRTIs + a third agent). A third agent included either an: INSTI, NNRTI or a PI. CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase.
At Week 52, participants who received CAR during the early switch phase, with HIV-1 RNA \<50 c/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed until Week 148.
|
DTG + RPV (Continuation Phase)
n=186 participants at risk
Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
CAR (Continuation Phase)
n=183 participants at risk
Participants continued to receive their CAR (NRTIs + a third agent). A third agent included either an: INSTI, a NNRTI or a PI. CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during the Early Switch Phase. At Week 52, participants with HIV-1 RNA \<50 c/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
10.7%
27/252 • Number of events 33 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
12.1%
31/256 • Number of events 35 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
20.6%
52/252 • Number of events 84 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
16.4%
39/238 • Number of events 55 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/186 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/183 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Nervous system disorders
Headache
|
9.5%
24/252 • Number of events 25 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
6.6%
17/256 • Number of events 19 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
14.7%
37/252 • Number of events 43 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
9.7%
23/238 • Number of events 29 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/186 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/183 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Gastrointestinal disorders
Diarrhoea
|
8.7%
22/252 • Number of events 24 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
6.6%
17/256 • Number of events 18 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
13.9%
35/252 • Number of events 38 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
8.0%
19/238 • Number of events 20 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/186 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/183 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.2%
8/252 • Number of events 9 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
7.4%
19/256 • Number of events 20 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
9.9%
25/252 • Number of events 28 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
7.6%
18/238 • Number of events 19 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/186 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/183 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Infections and infestations
Syphilis
|
3.2%
8/252 • Number of events 10 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
2.7%
7/256 • Number of events 7 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
10.7%
27/252 • Number of events 39 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
8.4%
20/238 • Number of events 24 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/186 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/183 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Infections and infestations
Upper respiratory tract infection
|
2.8%
7/252 • Number of events 9 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
3.9%
10/256 • Number of events 11 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
10.3%
26/252 • Number of events 32 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
7.1%
17/238 • Number of events 25 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/186 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/183 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Psychiatric disorders
Insomnia
|
3.6%
9/252 • Number of events 10 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
2.3%
6/256 • Number of events 6 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
7.1%
18/252 • Number of events 20 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
7.6%
18/238 • Number of events 20 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/186 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/183 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.6%
9/252 • Number of events 9 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
2.0%
5/256 • Number of events 6 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
7.1%
18/252 • Number of events 19 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
5.0%
12/238 • Number of events 16 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/186 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/183 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.2%
8/252 • Number of events 10 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
1.6%
4/256 • Number of events 5 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
5.6%
14/252 • Number of events 17 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
7.1%
17/238 • Number of events 19 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/186 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/183 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Infections and infestations
Influenza
|
1.6%
4/252 • Number of events 4 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
4.7%
12/256 • Number of events 13 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
4.8%
12/252 • Number of events 12 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
5.5%
13/238 • Number of events 16 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/186 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/183 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Infections and infestations
Bronchitis
|
2.8%
7/252 • Number of events 7 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
1.6%
4/256 • Number of events 5 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
6.3%
16/252 • Number of events 19 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
4.6%
11/238 • Number of events 14 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/186 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/183 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.2%
3/252 • Number of events 3 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
3.5%
9/256 • Number of events 9 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
4.0%
10/252 • Number of events 10 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
5.5%
13/238 • Number of events 13 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/186 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/183 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Psychiatric disorders
Depression
|
4.0%
10/252 • Number of events 10 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.78%
2/256 • Number of events 2 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
6.7%
17/252 • Number of events 18 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
2.1%
5/238 • Number of events 6 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/186 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/183 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
General disorders
Fatigue
|
3.6%
9/252 • Number of events 9 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
1.2%
3/256 • Number of events 3 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
5.2%
13/252 • Number of events 14 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
2.5%
6/238 • Number of events 6 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/186 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/183 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Infections and infestations
Urinary tract infection
|
3.6%
9/252 • Number of events 9 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.78%
2/256 • Number of events 2 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
5.2%
13/252 • Number of events 13 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
1.3%
3/238 • Number of events 3 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/186 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/183 • SAEs and all non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected until Week 411.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). Late Switch Safety Population was used for CAR (Late Switch). Continuation Phase Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER