Trial Outcomes & Findings for Efficacy, Safety and Tolerability Study of Long-acting Cabotegravir Plus Long-acting Rilpivirine (CAB LA + RPV LA) in Human-immunodeficiency Virus-1 (HIV-1) Infected Adults (NCT NCT03299049)
NCT ID: NCT03299049
Last Updated: 2025-08-22
Results Overview
Percentage of participants with HIV-1 RNA \>=50 c/mL as per FDA snapshot algorithm at Week 48 was assessed to demonstrate the non-inferior antiviral activity of CAB LA+RPV LA Q8W compared to CAB LA + RPV LA Q4W regimen over 48 weeks in HIV-1 infected ART experienced participants. The HIV-1 RNA \>=50 c/mL per Snapshot algorithm was determined by the last on-treatment HIV-1 RNA measurement within the Week 48 analysis visit window. Intent-to-treat-Exposed (ITT-E) Population comprised of all randomized participants who received at least one dose of study treatment. Participants were assessed according to their randomized treatment, regardless of the treatment they received.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
1049 participants
Primary outcome timeframe
Week 48
Results posted on
2025-08-22
Participant Flow
This non-inferiority study evaluated antiviral activity of cabotegravir(CAB) long acting(LA) 600 milligrams(mg) + rilpivirine(RPV) LA 900 mg administered every 8 weeks(Q8W) compared with CAB LA 400 mg+RPV LA 600 mg administered every 4 weeks(Q4W) over a 48-week period in virologically suppressed human immunodeficiency type 1 infection participants.
A total of 1049 eligible participants were randomized in a ratio of 1:1 to 1 of the 2 treatment arms in Maintenance Phase, of which 4 participants did not receive study treatment and 1045 participants were included in Intent to treat-Exposed Population. Results presented are based on Week 48 primary analysis.
Participant milestones
| Measure |
CAB LA + RPV LA Q8W
Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
|
CAB LA + RPV LA Q4W
Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
|
|---|---|---|
|
Overall Study
STARTED
|
522
|
523
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
522
|
523
|
Reasons for withdrawal
| Measure |
CAB LA + RPV LA Q8W
Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
|
CAB LA + RPV LA Q4W
Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
|
|---|---|---|
|
Overall Study
On-going
|
486
|
481
|
|
Overall Study
Withdrawal by Subject
|
6
|
21
|
|
Overall Study
Physician Decision
|
5
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
|
Overall Study
Pregnancy
|
1
|
3
|
|
Overall Study
Protocol Violation
|
1
|
1
|
|
Overall Study
Lack of Efficacy
|
9
|
3
|
|
Overall Study
Adverse Event
|
12
|
13
|
Baseline Characteristics
Efficacy, Safety and Tolerability Study of Long-acting Cabotegravir Plus Long-acting Rilpivirine (CAB LA + RPV LA) in Human-immunodeficiency Virus-1 (HIV-1) Infected Adults
Baseline characteristics by cohort
| Measure |
CAB LA + RPV LA Q8W
n=522 Participants
Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
|
CAB LA + RPV LA Q4W
n=523 Participants
Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
|
Total
n=1045 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.7 Years
STANDARD_DEVIATION 11.16 • n=5 Participants
|
42.3 Years
STANDARD_DEVIATION 10.58 • n=7 Participants
|
42.5 Years
STANDARD_DEVIATION 10.87 • n=5 Participants
|
|
Sex/Gender, Customized
Sex at birth=Female
|
137 Participants
n=5 Participants
|
143 Participants
n=7 Participants
|
280 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Sex at birth=Male
|
385 Participants
n=5 Participants
|
380 Participants
n=7 Participants
|
765 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Reported gender=Female
|
142 Participants
n=5 Participants
|
146 Participants
n=7 Participants
|
288 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Reported gender=Male
|
380 Participants
n=5 Participants
|
377 Participants
n=7 Participants
|
757 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian (AI) or Alaska Native (AN)
|
17 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian-Central/South Asian Heritage (H)
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian-East Asian H
|
20 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian-Japanese H
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian-South East Asian (SEA) H
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American (AA)
|
101 Participants
n=5 Participants
|
90 Participants
n=7 Participants
|
191 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian (NH) or other Pacific Islander
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White-Arabic/North African H
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White-White/Caucasian/European (EU) H
|
368 Participants
n=5 Participants
|
388 Participants
n=7 Participants
|
756 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White-Mixed White Race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multiple-AI/AN and Black/AA/White/Caucasian/EU H
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multiple-AI/AN and NH/Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multiple-SEA H and White/Caucasian/ EU H
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multiple-Black/AA and White-Arabic/North African H
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multiple-Black/AA and White/Caucasian/EU H
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 48Population: ITT-E Population.
Percentage of participants with HIV-1 RNA \>=50 c/mL as per FDA snapshot algorithm at Week 48 was assessed to demonstrate the non-inferior antiviral activity of CAB LA+RPV LA Q8W compared to CAB LA + RPV LA Q4W regimen over 48 weeks in HIV-1 infected ART experienced participants. The HIV-1 RNA \>=50 c/mL per Snapshot algorithm was determined by the last on-treatment HIV-1 RNA measurement within the Week 48 analysis visit window. Intent-to-treat-Exposed (ITT-E) Population comprised of all randomized participants who received at least one dose of study treatment. Participants were assessed according to their randomized treatment, regardless of the treatment they received.
Outcome measures
| Measure |
CAB LA + RPV LA Q8W
n=522 Participants
Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
|
CAB LA + RPV LA Q4W
n=523 Participants
Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
|
|---|---|---|
|
Percentage of Participants With Plasma Human Immunodeficiency Virus-ribonucleic Acid (HIV-RNA) >=50 Copies Per Milliliter (c/mL) as Per Food and Drug Administration (FDA) Snapshot Algorithm at Week 48
|
1.7 Percentage of participants
|
1.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 48Population: ITT-E Population.
Percentage of participants with plasma HIV-1 RNA \<50 c/mL at Week 48 using FDA Snapshot algorithm was assessed to demonstrate antiviral activity of CAB LA+RPV LA Q8W compared to CAB LA+ RPV LA Q4W. The HIV-1 RNA \<50 c/mL per Snapshot algorithm was determined by last on-treatment HIV-1 RNA measurement within the analysis visit window. The 95% CIs were derived using normal approximation (Wald CI)
Outcome measures
| Measure |
CAB LA + RPV LA Q8W
n=522 Participants
Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
|
CAB LA + RPV LA Q4W
n=523 Participants
Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
|
|---|---|---|
|
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL Using FDA Snapshot Algorithm at Week 48
|
94 Percentage of participants
|
93 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 24Population: ITT-E Population.
Percentage of participants with plasma HIV-1 RNA \<50 c/mL at Week 48 using FDA Snapshot algorithm was assessed to demonstrate antiviral activity of CAB LA+RPV LA Q8W compared to CAB LA+ RPV LA Q4W. The HIV-1 RNA \<50 c/mL per Snapshot algorithm was determined by last on-treatment HIV-1 RNA measurement within the analysis visit window. The 95% CIs were derived using normal approximation (Wald CI)
Outcome measures
| Measure |
CAB LA + RPV LA Q8W
n=522 Participants
Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
|
CAB LA + RPV LA Q4W
n=523 Participants
Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
|
|---|---|---|
|
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL Using FDA Snapshot Algorithm at Week 24
|
95 Percentage of participants
Interval 93.0 to 97.0
|
95 Percentage of participants
Interval 94.0 to 97.0
|
SECONDARY outcome
Timeframe: Weeks 24 and 48Population: ITT-E Population.
CVF was defined as rebound as indicated by two consecutive plasma HIV-1-RNA levels \>=200 c/mL after prior suppression to \<200 c/mL. Cumulative percentage of participants with protocol defined CVF up to Weeks 24 and 48 has been presented.
Outcome measures
| Measure |
CAB LA + RPV LA Q8W
n=522 Participants
Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
|
CAB LA + RPV LA Q4W
n=523 Participants
Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
|
|---|---|---|
|
Percentage of Participants With Protocol Defined Confirmed Virologic Failure (CVF) Through Weeks 24 and 48
Week 24
|
1.3 Percentage of participants
|
0.2 Percentage of participants
|
|
Percentage of Participants With Protocol Defined Confirmed Virologic Failure (CVF) Through Weeks 24 and 48
Week 48
|
1.5 Percentage of participants
|
0.4 Percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 24Population: ITT-E Population.
Percentage of participants with plasma HIV-1 RNA \>=50 c/mL at Week 24 using FDA Snapshot algorithm was assessed to demonstrate antiviral activity of CAB LA+RPV LA Q8W compared to CAB LA+ RPV LA Q4W. The HIV-1 RNA \>=50 c/mL per Snapshot algorithm was determined by the last on-treatment HIV-1 RNA measurement within the analysis visit window. The 95% CIs were derived using normal approximation (Wald CI).
Outcome measures
| Measure |
CAB LA + RPV LA Q8W
n=522 Participants
Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
|
CAB LA + RPV LA Q4W
n=523 Participants
Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
|
|---|---|---|
|
Percentage of Participants With HIV-RNA >=50 c/mL as Per FDA Snapshot Algorithm at Week 24
|
2.1 Percentage of participants
Interval 0.9 to 3.3
|
1.5 Percentage of participants
Interval 0.5 to 2.6
|
SECONDARY outcome
Timeframe: Weeks 48Population: ITT-E Population. Only those participants with data available at the specified data points were analyzed.
Plasma samples were collected for quantitative analysis of HIV-1 RNA. Logarithm to base 10 (log10) values for plasma HIV-1 RNA has been presented.
Outcome measures
| Measure |
CAB LA + RPV LA Q8W
n=493 Participants
Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
|
CAB LA + RPV LA Q4W
n=487 Participants
Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
|
|---|---|---|
|
Absolute Values for HIV-1 RNA at Week 48
|
1.599 Log 10 c/mL
Standard Deviation 0.0870
|
1.593 Log 10 c/mL
Standard Deviation 0.0302
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 48Population: ITT-E Population. Only those participants with data available at the specified data points were analyzed.
Plasma samples were collected for quantitative analysis of HIV-1 RNA. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value. Logarithm to base 10 values for plasma HIV-1 RNA has been presented.
Outcome measures
| Measure |
CAB LA + RPV LA Q8W
n=493 Participants
Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
|
CAB LA + RPV LA Q4W
n=487 Participants
Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
|
|---|---|---|
|
Change From Baseline Values for HIV-1 RNA at Week 48
|
0.007 Log 10 c/mL
Standard Deviation 0.0888
|
-0.015 Log 10 c/mL
Standard Deviation 0.1673
|
SECONDARY outcome
Timeframe: Week 48Population: ITT-E Population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected and CD4+ cell count assessment by flow cytometry was carried out to evaluate the immunologic activity of CAB LA+RPV LA Q8W compared to CAB LA+RPV LA Q8W.
Outcome measures
| Measure |
CAB LA + RPV LA Q8W
n=493 Participants
Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
|
CAB LA + RPV LA Q4W
n=486 Participants
Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
|
|---|---|---|
|
Absolute Values for Cluster of Differentiation 4 Plus (CD4+) at Week 48
|
685.9 Cells per cubic millimeter
Standard Deviation 261.70
|
700.0 Cells per cubic millimeter
Standard Deviation 278.18
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 48Population: ITT-E Population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected and CD4+ cell count assessment by flow cytometry was carried out to evaluate the immunologic activity of CAB LA+RPV LA Q8W compared to CAB LA+RPV LA Q4W. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
CAB LA + RPV LA Q8W
n=493 Participants
Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
|
CAB LA + RPV LA Q4W
n=486 Participants
Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
|
|---|---|---|
|
Change From Baseline Values for CD4+ at Week 48
|
5.3 Cells per cubic millimeter
Standard Deviation 168.62
|
-24.6 Cells per cubic millimeter
Standard Deviation 199.02
|
SECONDARY outcome
Timeframe: Up to Week 48Population: Safety Population.
An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgement. Safety Population comprised of all randomized participants who received at least one dose of study treatment. Participants were assessed according to actual treatment received.
Outcome measures
| Measure |
CAB LA + RPV LA Q8W
n=522 Participants
Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
|
CAB LA + RPV LA Q4W
n=523 Participants
Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
|
|---|---|---|
|
Number of Participants With Non-serious Adverse Events (Non-SAEs >=5% Incidence) and Serious Adverse Events (SAEs)-Maintenance Phase
Any non-SAE (>=5%)
|
429 Participants
|
427 Participants
|
|
Number of Participants With Non-serious Adverse Events (Non-SAEs >=5% Incidence) and Serious Adverse Events (SAEs)-Maintenance Phase
Any SAE
|
27 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: Up to Week 48Population: Safety Population.
Severity of adverse events were defined as per The Division of Acquired Immunodeficiency Syndrome (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS adverse events Grading Table). Severity grades for adverse events were as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (Potentially life-threatening) and Grade 5 (all deaths related to an AE).
Outcome measures
| Measure |
CAB LA + RPV LA Q8W
n=522 Participants
Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
|
CAB LA + RPV LA Q4W
n=523 Participants
Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
|
|---|---|---|
|
Number of Participants With Severity of Adverse Events-Maintenance Phase
Grade 1
|
201 Participants
|
195 Participants
|
|
Number of Participants With Severity of Adverse Events-Maintenance Phase
Grade 2
|
231 Participants
|
238 Participants
|
|
Number of Participants With Severity of Adverse Events-Maintenance Phase
Grade 3
|
38 Participants
|
43 Participants
|
|
Number of Participants With Severity of Adverse Events-Maintenance Phase
Grade 4
|
2 Participants
|
6 Participants
|
|
Number of Participants With Severity of Adverse Events-Maintenance Phase
Grade 5
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Week 48Population: Safety Population.
Clinical chemistry toxicities were graded as per the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)Blood samples were collected for the analysis of following clinical chemistry parameters: alanine aminotransferase (ALT), albumin, alkaline phosphate (ALP), aspartate aminotranferase (AST), bilirubin, carbon dioxide (CO2), cholesterol, creatinine kinase, creatinine, glomerular filtration rate (GFR) from creatinine adjusted for bovine serum albumin (BSA), glucose, hyperglycemia, hyperkalemia, hypernatremia, hypoglycemia, hypokalemia, hyponatremia, low density lipoprotein (LDL) calculation, lipase, phosphate, potassium, sodium and triglycerides. Severity grades were: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening).
Outcome measures
| Measure |
CAB LA + RPV LA Q8W
n=522 Participants
Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
|
CAB LA + RPV LA Q4W
n=523 Participants
Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
|
|---|---|---|
|
Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
ALT, Grade 1
|
45 Participants
|
49 Participants
|
|
Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
ALT, Grade 2
|
10 Participants
|
13 Participants
|
|
Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
ALT, Grade 3
|
1 Participants
|
3 Participants
|
|
Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
ALT, Grade 4
|
1 Participants
|
2 Participants
|
|
Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
Albumin, Grade 1
|
1 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
Albumin, Grade 2
|
1 Participants
|
1 Participants
|
|
Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
Albumin, Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
Albumin, Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
ALP, Grade 1
|
1 Participants
|
5 Participants
|
|
Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
ALP, Grade 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
ALP, Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
ALP, Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
AST, Grade 1
|
32 Participants
|
44 Participants
|
|
Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
AST, Grade 2
|
10 Participants
|
13 Participants
|
|
Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
AST, Grade 3
|
2 Participants
|
4 Participants
|
|
Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
AST, Grade 4
|
1 Participants
|
2 Participants
|
|
Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
Bilirubin, Grade 1
|
27 Participants
|
25 Participants
|
|
Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
Bilirubin, Grade 2
|
7 Participants
|
5 Participants
|
|
Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
Bilirubin, Grade 3
|
1 Participants
|
1 Participants
|
|
Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
Bilirubin, Grade 4
|
1 Participants
|
1 Participants
|
|
Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
CO2, Grade 1
|
98 Participants
|
111 Participants
|
|
Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
CO2, Grade 2
|
2 Participants
|
1 Participants
|
|
Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
CO2, Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
CO2, Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
Cholesterol, Grade 1
|
50 Participants
|
52 Participants
|
|
Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
Cholesterol, Grade 2
|
31 Participants
|
30 Participants
|
|
Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
Cholesterol, Grade 3
|
2 Participants
|
3 Participants
|
|
Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
Cholesterol, Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
Creatinine Kinase, Grade 1
|
41 Participants
|
32 Participants
|
|
Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
Creatinine Kinase, Grade 2
|
22 Participants
|
19 Participants
|
|
Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
Creatinine Kinase, Grade 3
|
7 Participants
|
9 Participants
|
|
Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
Creatinine Kinase, Grade 4
|
9 Participants
|
14 Participants
|
|
Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
Creatinine, Grade 1
|
5 Participants
|
9 Participants
|
|
Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
Creatinine, Grade 2
|
2 Participants
|
1 Participants
|
|
Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
Creatinine, Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
Creatinine, Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
GFR from creatinine adjusted for BSA, Grade 1
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
GFR from creatinine adjusted for BSA, Grade 2
|
110 Participants
|
134 Participants
|
|
Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
GFR from creatinine adjusted for BSA, Grade 3
|
15 Participants
|
19 Participants
|
|
Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
GFR from creatinine adjusted for BSA, Grade 4
|
0 Participants
|
1 Participants
|
|
Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
Glucose, Grade 1
|
84 Participants
|
87 Participants
|
|
Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
Glucose, Grade 2
|
34 Participants
|
43 Participants
|
|
Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
Glucose, Grade 3
|
3 Participants
|
5 Participants
|
|
Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
Glucose, Grade 4
|
1 Participants
|
1 Participants
|
|
Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
Hyperglycemia, Grade 1
|
80 Participants
|
77 Participants
|
|
Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
Hyperglycemia, Grade 2
|
32 Participants
|
38 Participants
|
|
Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
Hyperglycemia, Grade 3
|
2 Participants
|
5 Participants
|
|
Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
Hyperglycemia, Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
Hyperkalemia, Grade 1
|
8 Participants
|
2 Participants
|
|
Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
Hyperkalemia, Grade 2
|
0 Participants
|
1 Participants
|
|
Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
Hyperkalemia, Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
Hyperkalemia, Grade 4
|
0 Participants
|
1 Participants
|
|
Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
Hypernatremia, Grade 1
|
6 Participants
|
2 Participants
|
|
Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
Hypernatremia, Grade 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
Hypernatremia, Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
Hypernatremia, Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
Hypoglycemia, Grade 1
|
11 Participants
|
13 Participants
|
|
Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
Hypoglycemia, Grade 2
|
2 Participants
|
5 Participants
|
|
Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
Hypoglycemia, Grade 3
|
1 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
Hypoglycemia, Grade 4
|
1 Participants
|
1 Participants
|
|
Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
Hypokalemia, Grade 1
|
10 Participants
|
8 Participants
|
|
Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
Hypokalemia, Grade 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
Hypokalemia, Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
Hypokalemia, Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
Hyponatremia, Grade 1
|
23 Participants
|
26 Participants
|
|
Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
Hyponatremia, Grade 2
|
0 Participants
|
1 Participants
|
|
Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
Hyponatremia, Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
Hyponatremia, Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
LDL Cholesterol calculation, Grade 1
|
40 Participants
|
41 Participants
|
|
Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
LDL Cholesterol calculation, Grade 2
|
20 Participants
|
26 Participants
|
|
Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
LDL Cholesterol calculation, Grade 3
|
9 Participants
|
4 Participants
|
|
Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
LDL Cholesterol calculation, Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
Lipase, Grade 1
|
40 Participants
|
44 Participants
|
|
Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
Lipase, Grade 2
|
31 Participants
|
44 Participants
|
|
Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
Lipase, Grade 3
|
13 Participants
|
4 Participants
|
|
Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
Lipase, Grade 4
|
3 Participants
|
6 Participants
|
|
Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
Phosphate, Grade 1
|
75 Participants
|
72 Participants
|
|
Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
Phosphate, Grade 2
|
20 Participants
|
1 Participants
|
|
Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
Phosphate, Grade 3
|
0 Participants
|
2 Participants
|
|
Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
Phosphate, Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
Potassium, Grade 1
|
18 Participants
|
10 Participants
|
|
Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
Potassium, Grade 2
|
0 Participants
|
1 Participants
|
|
Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
Potassium, Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
Potassium, Grade 4
|
0 Participants
|
1 Participants
|
|
Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
Sodium, Grade 1
|
29 Participants
|
28 Participants
|
|
Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
Sodium, Grade 2
|
0 Participants
|
1 Participants
|
|
Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
Sodium, Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
Sodium, Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
Triglycerides, Grade 1
|
51 Participants
|
42 Participants
|
|
Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
Triglycerides, Grade 2
|
11 Participants
|
3 Participants
|
|
Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
Triglycerides, Grade 3
|
4 Participants
|
2 Participants
|
|
Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
Triglycerides, Grade 4
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to Week 48Population: Safety Population.
The hematology toxicities were graded as per the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table). Blood samples were collected for the analysis of following hematology parameters: hemoglobin, leukocytes, neutrophils and platelets. Severity grades were as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening).
Outcome measures
| Measure |
CAB LA + RPV LA Q8W
n=522 Participants
Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
|
CAB LA + RPV LA Q4W
n=523 Participants
Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
|
|---|---|---|
|
Number of Participants With Maximum Post-Baseline Hematology Toxicities-Maintenance Phase
Hemoglobin, Grade 1
|
9 Participants
|
4 Participants
|
|
Number of Participants With Maximum Post-Baseline Hematology Toxicities-Maintenance Phase
Hemoglobin, Grade 2
|
1 Participants
|
3 Participants
|
|
Number of Participants With Maximum Post-Baseline Hematology Toxicities-Maintenance Phase
Hemoglobin, Grade 3
|
2 Participants
|
4 Participants
|
|
Number of Participants With Maximum Post-Baseline Hematology Toxicities-Maintenance Phase
Hemoglobin, Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Hematology Toxicities-Maintenance Phase
Leukocytes, Grade 1
|
12 Participants
|
5 Participants
|
|
Number of Participants With Maximum Post-Baseline Hematology Toxicities-Maintenance Phase
Leukocytes, Grade 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Hematology Toxicities-Maintenance Phase
Leukocytes, Grade 3
|
1 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Hematology Toxicities-Maintenance Phase
Leukocytes, Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Hematology Toxicities-Maintenance Phase
Neutrophils, Grade 1
|
7 Participants
|
6 Participants
|
|
Number of Participants With Maximum Post-Baseline Hematology Toxicities-Maintenance Phase
Neutrophils, Grade 2
|
8 Participants
|
5 Participants
|
|
Number of Participants With Maximum Post-Baseline Hematology Toxicities-Maintenance Phase
Neutrophils, Grade 3
|
1 Participants
|
2 Participants
|
|
Number of Participants With Maximum Post-Baseline Hematology Toxicities-Maintenance Phase
Neutrophils, Grade 4
|
2 Participants
|
1 Participants
|
|
Number of Participants With Maximum Post-Baseline Hematology Toxicities-Maintenance Phase
Platelets, Grade 1
|
8 Participants
|
8 Participants
|
|
Number of Participants With Maximum Post-Baseline Hematology Toxicities-Maintenance Phase
Platelets, Grade 2
|
1 Participants
|
1 Participants
|
|
Number of Participants With Maximum Post-Baseline Hematology Toxicities-Maintenance Phase
Platelets, Grade 3
|
1 Participants
|
1 Participants
|
|
Number of Participants With Maximum Post-Baseline Hematology Toxicities-Maintenance Phase
Platelets, Grade 4
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Week 48Population: Safety Population.
An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Percentage of participants with adverse events leading to withdrawal has been presented.
Outcome measures
| Measure |
CAB LA + RPV LA Q8W
n=522 Participants
Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
|
CAB LA + RPV LA Q4W
n=523 Participants
Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
|
|---|---|---|
|
Percentage of Participants Who Discontinued Treatment Due to Adverse Events-Maintenance Phase
|
2 Percentage of participants
|
2 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Weeks 4, 8, 16, 24, 32, 40 and 48Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Blood samples were collected for the analysis of clinical chemical parameters including ALT, ALP, AST and creatinine kinase. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
CAB LA + RPV LA Q8W
n=522 Participants
Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
|
CAB LA + RPV LA Q4W
n=523 Participants
Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
|
|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and Creatinine Kinase Over Time
ALT, Week 4, n=326, 520
|
-1.3 International units per liter
Standard Deviation 11.11
|
0.1 International units per liter
Standard Deviation 14.01
|
|
Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and Creatinine Kinase Over Time
ALT, Week 8, n=510, 515
|
0.8 International units per liter
Standard Deviation 21.28
|
0.3 International units per liter
Standard Deviation 15.65
|
|
Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and Creatinine Kinase Over Time
ALT, Week 16, n=515, 513
|
1.5 International units per liter
Standard Deviation 47.60
|
-0.7 International units per liter
Standard Deviation 12.29
|
|
Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and Creatinine Kinase Over Time
ALT, Week 24, n=505, 503
|
1.9 International units per liter
Standard Deviation 63.03
|
-0.3 International units per liter
Standard Deviation 13.39
|
|
Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and Creatinine Kinase Over Time
ALT, Week 32, n=499, 498
|
-0.4 International units per liter
Standard Deviation 12.60
|
2.4 International units per liter
Standard Deviation 33.72
|
|
Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and Creatinine Kinase Over Time
ALT, Week 40, n=495, 490
|
0.4 International units per liter
Standard Deviation 13.50
|
6.6 International units per liter
Standard Deviation 112.13
|
|
Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and Creatinine Kinase Over Time
ALT, Week 48, n=493, 486
|
1.1 International units per liter
Standard Deviation 16.39
|
1.6 International units per liter
Standard Deviation 18.61
|
|
Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and Creatinine Kinase Over Time
ALP, Week 4, n=326, 520
|
-5.5 International units per liter
Standard Deviation 12.09
|
-2.1 International units per liter
Standard Deviation 10.25
|
|
Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and Creatinine Kinase Over Time
ALP, Week 8, n=510, 515
|
-4.1 International units per liter
Standard Deviation 13.07
|
-3.3 International units per liter
Standard Deviation 11.31
|
|
Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and Creatinine Kinase Over Time
ALP, Week 16, n=515, 513
|
-4.8 International units per liter
Standard Deviation 14.65
|
-4.2 International units per liter
Standard Deviation 13.07
|
|
Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and Creatinine Kinase Over Time
ALP, Week 24, n=505, 503
|
-5.2 International units per liter
Standard Deviation 16.04
|
-4.0 International units per liter
Standard Deviation 13.42
|
|
Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and Creatinine Kinase Over Time
ALP, Week 32, n=499, 498
|
-5.7 International units per liter
Standard Deviation 17.14
|
-4.1 International units per liter
Standard Deviation 14.95
|
|
Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and Creatinine Kinase Over Time
ALP, Week 40, n=495, 490
|
-5.9 International units per liter
Standard Deviation 17.61
|
-3.9 International units per liter
Standard Deviation 16.09
|
|
Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and Creatinine Kinase Over Time
ALP, Week 48, n=493, 486
|
-6.6 International units per liter
Standard Deviation 17.18
|
-4.5 International units per liter
Standard Deviation 15.02
|
|
Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and Creatinine Kinase Over Time
AST, Week 4, n=326, 520
|
-0.6 International units per liter
Standard Deviation 13.25
|
-0.3 International units per liter
Standard Deviation 18.47
|
|
Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and Creatinine Kinase Over Time
AST, Week 8, n=510, 515
|
0.6 International units per liter
Standard Deviation 11.71
|
0.0 International units per liter
Standard Deviation 14.46
|
|
Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and Creatinine Kinase Over Time
AST, Week 16, n=515, 513
|
1.2 International units per liter
Standard Deviation 24.79
|
-0.3 International units per liter
Standard Deviation 16.58
|
|
Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and Creatinine Kinase Over Time
AST, Week 24, n=505, 503
|
1.6 International units per liter
Standard Deviation 53.81
|
-0.2 International units per liter
Standard Deviation 21.65
|
|
Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and Creatinine Kinase Over Time
AST, Week 32, n=499, 498
|
-1.6 International units per liter
Standard Deviation 8.84
|
0.8 International units per liter
Standard Deviation 34.81
|
|
Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and Creatinine Kinase Over Time
AST, Week 40, n=495, 490
|
-1.0 International units per liter
Standard Deviation 10.14
|
2.5 International units per liter
Standard Deviation 66.54
|
|
Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and Creatinine Kinase Over Time
AST, Week 48, n=493, 486
|
-0.2 International units per liter
Standard Deviation 12.48
|
-0.7 International units per liter
Standard Deviation 16.12
|
|
Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and Creatinine Kinase Over Time
Creatinine kinase, Week 4, n=326, 520
|
30.2 International units per liter
Standard Deviation 689.41
|
-29.3 International units per liter
Standard Deviation 717.51
|
|
Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and Creatinine Kinase Over Time
Creatinine kinase, Week 8, n=510, 515
|
24.1 International units per liter
Standard Deviation 479.84
|
-23.7 International units per liter
Standard Deviation 682.90
|
|
Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and Creatinine Kinase Over Time
Creatinine kinase, Week 16, n=515, 513
|
30.6 International units per liter
Standard Deviation 692.65
|
-4.7 International units per liter
Standard Deviation 856.65
|
|
Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and Creatinine Kinase Over Time
Creatinine kinase, Week 24, n=505, 503
|
-13.6 International units per liter
Standard Deviation 265.16
|
31.1 International units per liter
Standard Deviation 1198.22
|
|
Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and Creatinine Kinase Over Time
Creatinine kinase, Week 32, n=499, 498
|
-23.3 International units per liter
Standard Deviation 314.46
|
-5.8 International units per liter
Standard Deviation 787.02
|
|
Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and Creatinine Kinase Over Time
Creatinine kinase, Week 40, n=495, 490
|
-12.5 International units per liter
Standard Deviation 336.08
|
34.2 International units per liter
Standard Deviation 1288.66
|
|
Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and Creatinine Kinase Over Time
Creatinine kinase, Week 48, n=493, 486
|
17.9 International units per liter
Standard Deviation 411.70
|
-2.9 International units per liter
Standard Deviation 810.46
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Weeks 4, 8, 16, 24, 32, 40 and 48Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Blood samples were collected for the analysis of clinical chemistry parameter: albumin. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
CAB LA + RPV LA Q8W
n=522 Participants
Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
|
CAB LA + RPV LA Q4W
n=523 Participants
Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
|
|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameter: Albumin Over Time
Week 4, n=326, 520
|
-0.5 Grams per liter
Standard Deviation 2.32
|
-0.2 Grams per liter
Standard Deviation 2.45
|
|
Change From Baseline in Clinical Chemistry Parameter: Albumin Over Time
Week 8, n=510, 515
|
-0.3 Grams per liter
Standard Deviation 2.48
|
-0.1 Grams per liter
Standard Deviation 2.48
|
|
Change From Baseline in Clinical Chemistry Parameter: Albumin Over Time
Week 16, n=515, 513
|
-0.3 Grams per liter
Standard Deviation 2.56
|
-0.4 Grams per liter
Standard Deviation 2.51
|
|
Change From Baseline in Clinical Chemistry Parameter: Albumin Over Time
Week 24, n=505, 503
|
-0.0 Grams per liter
Standard Deviation 2.49
|
-0.2 Grams per liter
Standard Deviation 2.59
|
|
Change From Baseline in Clinical Chemistry Parameter: Albumin Over Time
Week 32, n=499, 498
|
-0.2 Grams per liter
Standard Deviation 2.63
|
-0.3 Grams per liter
Standard Deviation 2.68
|
|
Change From Baseline in Clinical Chemistry Parameter: Albumin Over Time
Week 40, n=495, 490
|
0.1 Grams per liter
Standard Deviation 2.68
|
-0.3 Grams per liter
Standard Deviation 2.54
|
|
Change From Baseline in Clinical Chemistry Parameter: Albumin Over Time
Week 48, n=493, 486
|
-0.2 Grams per liter
Standard Deviation 2.59
|
-0.2 Grams per liter
Standard Deviation 2.60
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Weeks 4, 8, 16, 24, 32, 40 and 48Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Blood samples were collected for the analysis of clinical chemistry parameters: bilirubin and creatinine. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
CAB LA + RPV LA Q8W
n=522 Participants
Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
|
CAB LA + RPV LA Q4W
n=523 Participants
Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
|
|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameters: Bilirubin and Creatinine Over Time
Bilirubin, Week 4, n=326, 520
|
0.4 Micromoles per liter
Standard Deviation 6.44
|
0.1 Micromoles per liter
Standard Deviation 5.70
|
|
Change From Baseline in Clinical Chemistry Parameters: Bilirubin and Creatinine Over Time
Bilirubin, Week 8, n=510, 515
|
0.4 Micromoles per liter
Standard Deviation 5.68
|
0.1 Micromoles per liter
Standard Deviation 5.39
|
|
Change From Baseline in Clinical Chemistry Parameters: Bilirubin and Creatinine Over Time
Bilirubin, Week 16, n=515, 513
|
0.5 Micromoles per liter
Standard Deviation 5.78
|
0.2 Micromoles per liter
Standard Deviation 5.69
|
|
Change From Baseline in Clinical Chemistry Parameters: Bilirubin and Creatinine Over Time
Bilirubin, Week 24, n=505, 503
|
0.8 Micromoles per liter
Standard Deviation 9.42
|
0.5 Micromoles per liter
Standard Deviation 5.23
|
|
Change From Baseline in Clinical Chemistry Parameters: Bilirubin and Creatinine Over Time
Bilirubin, Week 32, n=499, 498
|
0.5 Micromoles per liter
Standard Deviation 5.54
|
0.4 Micromoles per liter
Standard Deviation 5.46
|
|
Change From Baseline in Clinical Chemistry Parameters: Bilirubin and Creatinine Over Time
Bilirubin, Week 40, n=495, 490
|
0.7 Micromoles per liter
Standard Deviation 6.00
|
0.4 Micromoles per liter
Standard Deviation 5.77
|
|
Change From Baseline in Clinical Chemistry Parameters: Bilirubin and Creatinine Over Time
Bilirubin, Week 48, n=493, 486
|
0.4 Micromoles per liter
Standard Deviation 5.77
|
0.7 Micromoles per liter
Standard Deviation 4.93
|
|
Change From Baseline in Clinical Chemistry Parameters: Bilirubin and Creatinine Over Time
Creatinine, Week 4, n=326, 521
|
0.89 Micromoles per liter
Standard Deviation 8.768
|
-0.36 Micromoles per liter
Standard Deviation 7.215
|
|
Change From Baseline in Clinical Chemistry Parameters: Bilirubin and Creatinine Over Time
Creatinine, Week 8, n=510, 515
|
-0.94 Micromoles per liter
Standard Deviation 8.638
|
-0.39 Micromoles per liter
Standard Deviation 8.191
|
|
Change From Baseline in Clinical Chemistry Parameters: Bilirubin and Creatinine Over Time
Creatinine, Week 16, n=515, 513
|
-0.24 Micromoles per liter
Standard Deviation 8.973
|
-0.03 Micromoles per liter
Standard Deviation 8.516
|
|
Change From Baseline in Clinical Chemistry Parameters: Bilirubin and Creatinine Over Time
Creatinine, Week 24, n=505, 503
|
0.22 Micromoles per liter
Standard Deviation 9.085
|
0.94 Micromoles per liter
Standard Deviation 9.591
|
|
Change From Baseline in Clinical Chemistry Parameters: Bilirubin and Creatinine Over Time
Creatinine, Week 32, n=499, 498
|
1.01 Micromoles per liter
Standard Deviation 9.490
|
2.09 Micromoles per liter
Standard Deviation 9.313
|
|
Change From Baseline in Clinical Chemistry Parameters: Bilirubin and Creatinine Over Time
Creatinine, Week 40, n=495, 490
|
1.02 Micromoles per liter
Standard Deviation 9.604
|
2.05 Micromoles per liter
Standard Deviation 9.414
|
|
Change From Baseline in Clinical Chemistry Parameters: Bilirubin and Creatinine Over Time
Creatinine, Week 48, n=493, 486
|
1.30 Micromoles per liter
Standard Deviation 9.813
|
2.30 Micromoles per liter
Standard Deviation 8.678
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Weeks 4, 8, 16, 24, 32, 40 and 48Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Blood samples were collected for the analysis of clinical chemistry parameters: CO2, chloride, phosphate, potassium, sodium and urea. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
CAB LA + RPV LA Q8W
n=522 Participants
Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
|
CAB LA + RPV LA Q4W
n=523 Participants
Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
|
|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Phosphate, Potassium, Sodium and Urea Over Time
Urea, Week 32, n=499, 498
|
0.11 Millimoles per liter
Standard Deviation 1.297
|
0.16 Millimoles per liter
Standard Deviation 1.356
|
|
Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Phosphate, Potassium, Sodium and Urea Over Time
CO2, Week 4, n=326, 520
|
-0.5 Millimoles per liter
Standard Deviation 2.29
|
-0.7 Millimoles per liter
Standard Deviation 2.32
|
|
Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Phosphate, Potassium, Sodium and Urea Over Time
CO2, Week 8, n=510, 515
|
-0.8 Millimoles per liter
Standard Deviation 2.12
|
-0.8 Millimoles per liter
Standard Deviation 2.23
|
|
Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Phosphate, Potassium, Sodium and Urea Over Time
CO2, Week 16, n=515, 513
|
-1.0 Millimoles per liter
Standard Deviation 2.31
|
-0.9 Millimoles per liter
Standard Deviation 2.33
|
|
Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Phosphate, Potassium, Sodium and Urea Over Time
CO2, Week 24, n=505, 503
|
-0.7 Millimoles per liter
Standard Deviation 2.38
|
-0.7 Millimoles per liter
Standard Deviation 2.28
|
|
Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Phosphate, Potassium, Sodium and Urea Over Time
CO2, Week 32, n=499, 498
|
-0.9 Millimoles per liter
Standard Deviation 2.31
|
-0.8 Millimoles per liter
Standard Deviation 2.43
|
|
Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Phosphate, Potassium, Sodium and Urea Over Time
CO2, Week 40, n=495, 490
|
-0.6 Millimoles per liter
Standard Deviation 2.33
|
-0.7 Millimoles per liter
Standard Deviation 2.44
|
|
Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Phosphate, Potassium, Sodium and Urea Over Time
CO2, Week 48, n=493, 485
|
-0.4 Millimoles per liter
Standard Deviation 2.32
|
-0.4 Millimoles per liter
Standard Deviation 2.41
|
|
Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Phosphate, Potassium, Sodium and Urea Over Time
Chloride, Week 4, n=326, 520
|
0.6 Millimoles per liter
Standard Deviation 2.19
|
0.2 Millimoles per liter
Standard Deviation 2.35
|
|
Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Phosphate, Potassium, Sodium and Urea Over Time
Chloride, Week 8, n=510, 515
|
0.3 Millimoles per liter
Standard Deviation 2.24
|
0.2 Millimoles per liter
Standard Deviation 2.34
|
|
Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Phosphate, Potassium, Sodium and Urea Over Time
Chloride, Week 16, n=515, 513
|
0.4 Millimoles per liter
Standard Deviation 2.30
|
0.2 Millimoles per liter
Standard Deviation 2.40
|
|
Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Phosphate, Potassium, Sodium and Urea Over Time
Chloride, Week 24, n=505, 503
|
0.1 Millimoles per liter
Standard Deviation 2.36
|
-0.1 Millimoles per liter
Standard Deviation 2.59
|
|
Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Phosphate, Potassium, Sodium and Urea Over Time
Chloride, Week 32, n=499, 498
|
0.2 Millimoles per liter
Standard Deviation 2.34
|
0.1 Millimoles per liter
Standard Deviation 2.64
|
|
Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Phosphate, Potassium, Sodium and Urea Over Time
Chloride, Week 40, n=495, 490
|
-0.1 Millimoles per liter
Standard Deviation 2.46
|
0.0 Millimoles per liter
Standard Deviation 2.36
|
|
Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Phosphate, Potassium, Sodium and Urea Over Time
Chloride, Week 48, n=493, 486
|
-0.0 Millimoles per liter
Standard Deviation 2.25
|
-0.1 Millimoles per liter
Standard Deviation 2.46
|
|
Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Phosphate, Potassium, Sodium and Urea Over Time
Phosphate, Week 4, n=326, 520
|
0.054 Millimoles per liter
Standard Deviation 0.182
|
0.018 Millimoles per liter
Standard Deviation 0.167
|
|
Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Phosphate, Potassium, Sodium and Urea Over Time
Phosphate, Week 8, n=510, 515
|
0.025 Millimoles per liter
Standard Deviation 0.177
|
0.029 Millimoles per liter
Standard Deviation 0.160
|
|
Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Phosphate, Potassium, Sodium and Urea Over Time
Phosphate, Week 16, n=515, 513
|
0.017 Millimoles per liter
Standard Deviation 0.181
|
0.007 Millimoles per liter
Standard Deviation 0.172
|
|
Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Phosphate, Potassium, Sodium and Urea Over Time
Phosphate, Week 24, n=505, 502
|
0.016 Millimoles per liter
Standard Deviation 0.170
|
-0.004 Millimoles per liter
Standard Deviation 0.168
|
|
Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Phosphate, Potassium, Sodium and Urea Over Time
Phosphate, Week 32, n=499, 498
|
-0.001 Millimoles per liter
Standard Deviation 0.183
|
0.001 Millimoles per liter
Standard Deviation 0.172
|
|
Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Phosphate, Potassium, Sodium and Urea Over Time
Phosphate, Week 40, n=495, 490
|
0.014 Millimoles per liter
Standard Deviation 0.180
|
0.001 Millimoles per liter
Standard Deviation 0.170
|
|
Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Phosphate, Potassium, Sodium and Urea Over Time
Phosphate, Week 48, n=493, 486
|
0.007 Millimoles per liter
Standard Deviation 0.169
|
0.010 Millimoles per liter
Standard Deviation 0.157
|
|
Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Phosphate, Potassium, Sodium and Urea Over Time
Potassium, Week 4, n=326, 520
|
0.03 Millimoles per liter
Standard Deviation 0.337
|
0.03 Millimoles per liter
Standard Deviation 0.303
|
|
Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Phosphate, Potassium, Sodium and Urea Over Time
Potassium, Week 8, n=510, 515
|
0.04 Millimoles per liter
Standard Deviation 0.317
|
0.04 Millimoles per liter
Standard Deviation 0.331
|
|
Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Phosphate, Potassium, Sodium and Urea Over Time
Potassium, Week 16, n=515, 513
|
0.03 Millimoles per liter
Standard Deviation 0.328
|
0.03 Millimoles per liter
Standard Deviation 0.341
|
|
Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Phosphate, Potassium, Sodium and Urea Over Time
Potassium, Week 24, n=505, 503
|
0.04 Millimoles per liter
Standard Deviation 0.338
|
0.03 Millimoles per liter
Standard Deviation 0.321
|
|
Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Phosphate, Potassium, Sodium and Urea Over Time
Potassium, Week 32, n=499, 498
|
0.04 Millimoles per liter
Standard Deviation 0.364
|
0.00 Millimoles per liter
Standard Deviation 0.340
|
|
Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Phosphate, Potassium, Sodium and Urea Over Time
Potassium, Week 40, n=495, 490
|
0.04 Millimoles per liter
Standard Deviation 0.351
|
0.02 Millimoles per liter
Standard Deviation 0.334
|
|
Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Phosphate, Potassium, Sodium and Urea Over Time
Potassium, Week 48, n=493, 486
|
0.04 Millimoles per liter
Standard Deviation 0.315
|
0.03 Millimoles per liter
Standard Deviation 0.327
|
|
Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Phosphate, Potassium, Sodium and Urea Over Time
Sodium, Week 4, n=326, 520
|
0.4 Millimoles per liter
Standard Deviation 2.02
|
0.1 Millimoles per liter
Standard Deviation 2.11
|
|
Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Phosphate, Potassium, Sodium and Urea Over Time
Sodium, Week 8, n=510, 515
|
0.1 Millimoles per liter
Standard Deviation 2.14
|
0.2 Millimoles per liter
Standard Deviation 2.02
|
|
Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Phosphate, Potassium, Sodium and Urea Over Time
Sodium, Week 16, n=515, 513
|
0.0 Millimoles per liter
Standard Deviation 2.00
|
-0.1 Millimoles per liter
Standard Deviation 2.01
|
|
Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Phosphate, Potassium, Sodium and Urea Over Time
Sodium, Week 24, n=505, 503
|
-0.2 Millimoles per liter
Standard Deviation 2.07
|
-0.3 Millimoles per liter
Standard Deviation 2.20
|
|
Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Phosphate, Potassium, Sodium and Urea Over Time
Sodium, Week 32, n=499, 498
|
-0.1 Millimoles per liter
Standard Deviation 2.10
|
-0.1 Millimoles per liter
Standard Deviation 2.21
|
|
Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Phosphate, Potassium, Sodium and Urea Over Time
Sodium, Week 40, n=495, 490
|
-0.3 Millimoles per liter
Standard Deviation 2.09
|
-0.2 Millimoles per liter
Standard Deviation 2.13
|
|
Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Phosphate, Potassium, Sodium and Urea Over Time
Sodium, Week 48, n=493, 486
|
-0.4 Millimoles per liter
Standard Deviation 2.02
|
-0.3 Millimoles per liter
Standard Deviation 2.21
|
|
Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Phosphate, Potassium, Sodium and Urea Over Time
Urea, Week 4, n=326, 520
|
0.24 Millimoles per liter
Standard Deviation 1.251
|
0.19 Millimoles per liter
Standard Deviation 1.227
|
|
Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Phosphate, Potassium, Sodium and Urea Over Time
Urea, Week 8, n=510, 515
|
0.07 Millimoles per liter
Standard Deviation 1.306
|
0.19 Millimoles per liter
Standard Deviation 1.336
|
|
Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Phosphate, Potassium, Sodium and Urea Over Time
Urea, Week 16, n=515, 513
|
0.07 Millimoles per liter
Standard Deviation 1.372
|
0.15 Millimoles per liter
Standard Deviation 1.320
|
|
Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Phosphate, Potassium, Sodium and Urea Over Time
Urea, Week 24, n=505, 503
|
0.06 Millimoles per liter
Standard Deviation 1.298
|
0.15 Millimoles per liter
Standard Deviation 1.270
|
|
Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Phosphate, Potassium, Sodium and Urea Over Time
Urea, Week 40, n=495, 490
|
0.18 Millimoles per liter
Standard Deviation 1.345
|
0.21 Millimoles per liter
Standard Deviation 1.412
|
|
Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Phosphate, Potassium, Sodium and Urea Over Time
Urea, Week 48, n=493, 486
|
0.13 Millimoles per liter
Standard Deviation 1.350
|
0.14 Millimoles per liter
Standard Deviation 1.457
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 48Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Blood samples were collected for the analysis of clinical chemistry parameters: cholesterol, glucose, direct HDL cholesterol, LDL cholesterol calculation and triglycerides. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
CAB LA + RPV LA Q8W
n=522 Participants
Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
|
CAB LA + RPV LA Q4W
n=523 Participants
Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
|
|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameters: Cholesterol, Glucose, Direct High Density Lipoprotein (HDL) Cholesterol, LDL Cholesterol Calculation and Triglycerides at Week 48
Cholesterol, Week 48, n=423, 408
|
0.023 Millimoles per liter
Standard Deviation 0.742
|
0.075 Millimoles per liter
Standard Deviation 0.748
|
|
Change From Baseline in Clinical Chemistry Parameters: Cholesterol, Glucose, Direct High Density Lipoprotein (HDL) Cholesterol, LDL Cholesterol Calculation and Triglycerides at Week 48
Glucose, Week 48, n=478, 470
|
0.16 Millimoles per liter
Standard Deviation 0.907
|
0.12 Millimoles per liter
Standard Deviation 1.208
|
|
Change From Baseline in Clinical Chemistry Parameters: Cholesterol, Glucose, Direct High Density Lipoprotein (HDL) Cholesterol, LDL Cholesterol Calculation and Triglycerides at Week 48
Direct HDL cholesterol, Week 48, n=423, 408
|
0.011 Millimoles per liter
Standard Deviation 0.292
|
-0.000 Millimoles per liter
Standard Deviation 0.288
|
|
Change From Baseline in Clinical Chemistry Parameters: Cholesterol, Glucose, Direct High Density Lipoprotein (HDL) Cholesterol, LDL Cholesterol Calculation and Triglycerides at Week 48
LDL cholesterol calculation, Week 48, n=415, 398
|
0.026 Millimoles per liter
Standard Deviation 0.629
|
0.098 Millimoles per liter
Standard Deviation 0.585
|
|
Change From Baseline in Clinical Chemistry Parameters: Cholesterol, Glucose, Direct High Density Lipoprotein (HDL) Cholesterol, LDL Cholesterol Calculation and Triglycerides at Week 48
Triglycerides, Week 48, n=423, 408
|
-0.039 Millimoles per liter
Standard Deviation 0.790
|
-0.017 Millimoles per liter
Standard Deviation 0.880
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Weeks 4, 8, 16, 24, 32, 40 and 48Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Blood samples were collected for the analysis of clinical chemistry parameter: GFR from creatinine adjusted using CKD-EPI. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
CAB LA + RPV LA Q8W
n=522 Participants
Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
|
CAB LA + RPV LA Q4W
n=523 Participants
Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
|
|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted Using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Over Time
Week 4, n=326, 521
|
-0.8 milliliters/minute/1.73 square meter
Standard Deviation 9.05
|
0.4 milliliters/minute/1.73 square meter
Standard Deviation 7.91
|
|
Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted Using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Over Time
Week 8, n=508, 514
|
1.0 milliliters/minute/1.73 square meter
Standard Deviation 9.07
|
0.4 milliliters/minute/1.73 square meter
Standard Deviation 8.62
|
|
Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted Using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Over Time
Week 16, n=515, 513
|
-0.2 milliliters/minute/1.73 square meter
Standard Deviation 9.08
|
-0.4 milliliters/minute/1.73 square meter
Standard Deviation 9.01
|
|
Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted Using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Over Time
Week 24, n=503, 503
|
-0.7 milliliters/minute/1.73 square meter
Standard Deviation 9.67
|
-1.7 milliliters/minute/1.73 square meter
Standard Deviation 10.65
|
|
Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted Using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Over Time
Week 32, n=499, 498
|
-1.7 milliliters/minute/1.73 square meter
Standard Deviation 10.12
|
-3.0 milliliters/minute/1.73 square meter
Standard Deviation 10.19
|
|
Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted Using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Over Time
Week 40, n=494, 489
|
-1.7 milliliters/minute/1.73 square meter
Standard Deviation 9.92
|
-2.9 milliliters/minute/1.73 square meter
Standard Deviation 9.95
|
|
Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted Using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Over Time
Week 48, n=493, 486
|
-1.9 milliliters/minute/1.73 square meter
Standard Deviation 9.96
|
-3.3 milliliters/minute/1.73 square meter
Standard Deviation 9.79
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Weeks 4, 8, 16, 24, 32, 40 and 48Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Blood samples were collected for the analysis of clinical chemistry parameter: Lipase. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
CAB LA + RPV LA Q8W
n=522 Participants
Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
|
CAB LA + RPV LA Q4W
n=523 Participants
Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
|
|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameter: Lipase Over Time
Week 4, n=326, 521
|
1.7 Units per liter
Standard Deviation 28.76
|
1.1 Units per liter
Standard Deviation 22.67
|
|
Change From Baseline in Clinical Chemistry Parameter: Lipase Over Time
Week 8, n=510, 514
|
1.5 Units per liter
Standard Deviation 23.82
|
1.4 Units per liter
Standard Deviation 24.74
|
|
Change From Baseline in Clinical Chemistry Parameter: Lipase Over Time
Week 16, n=515, 513
|
2.7 Units per liter
Standard Deviation 33.41
|
0.7 Units per liter
Standard Deviation 18.82
|
|
Change From Baseline in Clinical Chemistry Parameter: Lipase Over Time
Week 24, n=503, 503
|
0.7 Units per liter
Standard Deviation 19.71
|
2.6 Units per liter
Standard Deviation 34.49
|
|
Change From Baseline in Clinical Chemistry Parameter: Lipase Over Time
Week 32, n=499, 498
|
3.1 Units per liter
Standard Deviation 35.20
|
-0.5 Units per liter
Standard Deviation 21.91
|
|
Change From Baseline in Clinical Chemistry Parameter: Lipase Over Time
Week 40, n=494, 486
|
1.3 Units per liter
Standard Deviation 23.35
|
2.7 Units per liter
Standard Deviation 30.95
|
|
Change From Baseline in Clinical Chemistry Parameter: Lipase Over Time
Week 48, n=493, 486
|
3.2 Units per liter
Standard Deviation 53.46
|
2.9 Units per liter
Standard Deviation 42.61
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Weeks 4, 8, 16, 24, 32, 40 and 48Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Blood samples were collected for the analysis of hematology parameters: basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
CAB LA + RPV LA Q8W
n=522 Participants
Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
|
CAB LA + RPV LA Q4W
n=523 Participants
Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
|
|---|---|---|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Over Time
Monocytes, Week 32, n=489, 486
|
0.048 10^9 cells per liter
Standard Deviation 0.13969
|
0.039 10^9 cells per liter
Standard Deviation 0.14531
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Over Time
Monocytes, Week 40, n=479, 472
|
0.060 10^9 cells per liter
Standard Deviation 0.13570
|
0.060 10^9 cells per liter
Standard Deviation 0.15692
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Over Time
Monocytes, Week 48, n=486, 478
|
0.030 10^9 cells per liter
Standard Deviation 0.13329
|
0.033 10^9 cells per liter
Standard Deviation 0.13116
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Over Time
Neutrophils, Week 4, n=330, 516
|
0.152 10^9 cells per liter
Standard Deviation 1.44916
|
0.228 10^9 cells per liter
Standard Deviation 1.48979
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Over Time
Neutrophils, Week 8, n=506, 505
|
0.035 10^9 cells per liter
Standard Deviation 1.49397
|
0.141 10^9 cells per liter
Standard Deviation 1.48054
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Over Time
Neutrophils, Week 16, n=508, 507
|
-0.018 10^9 cells per liter
Standard Deviation 1.34384
|
0.082 10^9 cells per liter
Standard Deviation 1.52187
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Over Time
Neutrophils, Week 24, n=497, 495
|
0.047 10^9 cells per liter
Standard Deviation 1.36697
|
0.027 10^9 cells per liter
Standard Deviation 1.46192
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Over Time
Neutrophils, Week 32, n=489, 486
|
0.001 10^9 cells per liter
Standard Deviation 1.43051
|
-0.054 10^9 cells per liter
Standard Deviation 1.53192
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Over Time
Neutrophils, Week 40, n=479, 472
|
-0.021 10^9 cells per liter
Standard Deviation 1.53092
|
-0.090 10^9 cells per liter
Standard Deviation 1.58850
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Over Time
Neutrophils, Week 48, n=486, 478
|
-0.108 10^9 cells per liter
Standard Deviation 1.39875
|
-0.118 10^9 cells per liter
Standard Deviation 1.37189
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Over Time
Platelets, Week 4, n=329, 518
|
2.09 10^9 cells per liter
Standard Deviation 32.330
|
5.91 10^9 cells per liter
Standard Deviation 39.613
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Over Time
Platelets, Week 8, n=506, 507
|
-0.62 10^9 cells per liter
Standard Deviation 35.873
|
0.27 10^9 cells per liter
Standard Deviation 34.345
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Over Time
Platelets, Week 16, n=498, 505
|
0.01 10^9 cells per liter
Standard Deviation 35.207
|
-1.70 10^9 cells per liter
Standard Deviation 34.072
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Over Time
Platelets, Week 24, n=496, 496
|
0.26 10^9 cells per liter
Standard Deviation 36.085
|
-2.53 10^9 cells per liter
Standard Deviation 35.214
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Over Time
Platelets, Week 32, n=487, 486
|
1.67 10^9 cells per liter
Standard Deviation 40.601
|
-1.76 10^9 cells per liter
Standard Deviation 37.490
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Over Time
Platelets, Week 40, n=478, 472
|
0.38 10^9 cells per liter
Standard Deviation 38.636
|
0.32 10^9 cells per liter
Standard Deviation 38.028
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Over Time
Platelets, Week 48, n=489, 474
|
0.06 10^9 cells per liter
Standard Deviation 39.549
|
-1.51 10^9 cells per liter
Standard Deviation 35.440
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Over Time
Basophils, Week 4, n=330, 516
|
0.006 10^9 cells per liter
Standard Deviation 0.02751
|
0.003 10^9 cells per liter
Standard Deviation 0.02811
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Over Time
Basophils, Week 8, n=506, 505
|
0.000 10^9 cells per liter
Standard Deviation 0.02682
|
0.002 10^9 cells per liter
Standard Deviation 0.02699
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Over Time
Basophils, Week 16, n=508, 507
|
-0.000 10^9 cells per liter
Standard Deviation 0.02651
|
0.001 10^9 cells per liter
Standard Deviation 0.02929
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Over Time
Basophils, Week 24, n=497, 495
|
0.002 10^9 cells per liter
Standard Deviation 0.02809
|
0.002 10^9 cells per liter
Standard Deviation 0.02803
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Over Time
Basophils, Week 32, n=489, 486
|
0.005 10^9 cells per liter
Standard Deviation 0.02708
|
0.003 10^9 cells per liter
Standard Deviation 0.02988
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Over Time
Basophils, Week 40, n=479, 472
|
0.004 10^9 cells per liter
Standard Deviation 0.02716
|
0.004 10^9 cells per liter
Standard Deviation 0.02772
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Over Time
Basophils, Week 48, n=486, 478
|
0.005 10^9 cells per liter
Standard Deviation 0.02730
|
0.003 10^9 cells per liter
Standard Deviation 0.02926
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Over Time
Eosinophils, Week 4, n=330, 516
|
0.031 10^9 cells per liter
Standard Deviation 0.13775
|
0.015 10^9 cells per liter
Standard Deviation 0.15112
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Over Time
Eosinophils, Week 8, n=506, 505
|
0.015 10^9 cells per liter
Standard Deviation 0.14391
|
0.012 10^9 cells per liter
Standard Deviation 0.13314
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Over Time
Eosinophils, Week 16, n=508, 507
|
0.001 10^9 cells per liter
Standard Deviation 0.13474
|
0.010 10^9 cells per liter
Standard Deviation 0.13012
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Over Time
Eosinophils, Week 24, n=497, 495
|
0.001 10^9 cells per liter
Standard Deviation 0.13607
|
0.009 10^9 cells per liter
Standard Deviation 0.12836
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Over Time
Eosinophils, Week 32, n=489, 486
|
0.005 10^9 cells per liter
Standard Deviation 0.12762
|
0.011 10^9 cells per liter
Standard Deviation 0.13810
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Over Time
Eosinophils, Week 40, n=479, 472
|
0.006 10^9 cells per liter
Standard Deviation 0.13578
|
0.009 10^9 cells per liter
Standard Deviation 0.12297
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Over Time
Eosinophils, Week 48, n=486, 478
|
0.001 10^9 cells per liter
Standard Deviation 0.12444
|
0.002 10^9 cells per liter
Standard Deviation 0.12646
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Over Time
Leukocytes, Week 4, n=331, 520
|
0.437 10^9 cells per liter
Standard Deviation 1.5653
|
0.335 10^9 cells per liter
Standard Deviation 1.6343
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Over Time
Leukocytes, Week 8, n=508, 507
|
0.110 10^9 cells per liter
Standard Deviation 1.5863
|
0.214 10^9 cells per liter
Standard Deviation 1.6109
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Over Time
Leukocytes, Week 16, n=509, 507
|
0.050 10^9 cells per liter
Standard Deviation 1.4281
|
0.139 10^9 cells per liter
Standard Deviation 1.6384
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Over Time
Leukocytes, Week 24, n=499, 497
|
0.148 10^9 cells per liter
Standard Deviation 1.5229
|
0.139 10^9 cells per liter
Standard Deviation 1.6301
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Over Time
Leukocytes, Week 32, n=491, 489
|
0.185 10^9 cells per liter
Standard Deviation 1.5455
|
0.111 10^9 cells per liter
Standard Deviation 1.6454
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Over Time
Leukocytes, Week 40, n=480, 476
|
0.177 10^9 cells per liter
Standard Deviation 1.6601
|
0.100 10^9 cells per liter
Standard Deviation 1.8042
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Over Time
Leukocytes, Week 48, n=488, 478
|
-0.007 10^9 cells per liter
Standard Deviation 1.5561
|
-0.012 10^9 cells per liter
Standard Deviation 1.6035
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Over Time
Lymphocytes, Week 4, n=330, 516
|
0.187 10^9 cells per liter
Standard Deviation 0.44013
|
0.063 10^9 cells per liter
Standard Deviation 0.42683
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Over Time
Lymphocytes, Week 8, n=506, 505
|
0.040 10^9 cells per liter
Standard Deviation 0.39452
|
0.039 10^9 cells per liter
Standard Deviation 0.44987
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Over Time
Lymphocytes, Week 16, n=508, 507
|
0.060 10^9 cells per liter
Standard Deviation 0.43470
|
0.033 10^9 cells per liter
Standard Deviation 0.44030
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Over Time
Lymphocytes, Week 24, n=497, 495
|
0.081 10^9 cells per liter
Standard Deviation 0.41863
|
0.061 10^9 cells per liter
Standard Deviation 0.46240
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Over Time
Lymphocytes, Week 32, n=489, 486
|
0.119 10^9 cells per liter
Standard Deviation 0.46387
|
0.096 10^9 cells per liter
Standard Deviation 0.45178
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Over Time
Lymphocytes, Week 40, n=479, 472
|
0.126 10^9 cells per liter
Standard Deviation 0.44614
|
0.107 10^9 cells per liter
Standard Deviation 0.50590
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Over Time
Lymphocytes, Week 48, n=486, 478
|
0.063 10^9 cells per liter
Standard Deviation 0.43255
|
0.049 10^9 cells per liter
Standard Deviation 0.48991
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Over Time
Monocytes, Week 4, n=330, 516
|
0.051 10^9 cells per liter
Standard Deviation 0.14208
|
0.021 10^9 cells per liter
Standard Deviation 0.13359
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Over Time
Monocytes, Week 8, n=506, 505
|
0.003 10^9 cells per liter
Standard Deviation 0.12080
|
0.003 10^9 cells per liter
Standard Deviation 0.14270
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Over Time
Monocytes, Week 16, n=508, 507
|
-0.002 10^9 cells per liter
Standard Deviation 0.12804
|
-0.007 10^9 cells per liter
Standard Deviation 0.14361
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Over Time
Monocytes, Week 24, n=497, 495
|
0.019 10^9 cells per liter
Standard Deviation 0.13460
|
0.020 10^9 cells per liter
Standard Deviation 0.14458
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Weeks 4, 8, 16, 24, 32, 40 and 48Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Blood samples were collected for the analysis of hematology parameter: erythrocyte MCV. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
CAB LA + RPV LA Q8W
n=522 Participants
Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
|
CAB LA + RPV LA Q4W
n=523 Participants
Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
|
|---|---|---|
|
Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume (MCV) Over Time
Week 4, n=331, 520
|
-0.32 Femtoliters
Standard Deviation 2.136
|
-0.13 Femtoliters
Standard Deviation 2.322
|
|
Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume (MCV) Over Time
Week 8, n=509, 510
|
-1.16 Femtoliters
Standard Deviation 3.270
|
-0.84 Femtoliters
Standard Deviation 3.132
|
|
Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume (MCV) Over Time
Week 16, n=509, 507
|
-1.99 Femtoliters
Standard Deviation 4.583
|
-1.84 Femtoliters
Standard Deviation 4.370
|
|
Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume (MCV) Over Time
Week 24, n=500, 498
|
-2.46 Femtoliters
Standard Deviation 5.085
|
-2.41 Femtoliters
Standard Deviation 4.777
|
|
Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume (MCV) Over Time
Week 32, n=491, 491
|
-3.17 Femtoliters
Standard Deviation 5.005
|
-2.75 Femtoliters
Standard Deviation 4.682
|
|
Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume (MCV) Over Time
Week 40, n=481, 476
|
-3.35 Femtoliters
Standard Deviation 4.740
|
-3.15 Femtoliters
Standard Deviation 4.578
|
|
Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume (MCV) Over Time
Week 48, n=489, 478
|
-3.28 Femtoliters
Standard Deviation 5.000
|
-3.08 Femtoliters
Standard Deviation 4.797
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Weeks 4, 8, 16, 24, 32, 40 and 48Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Blood samples were collected for the analysis of hematology parameter: erythrocytes. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
CAB LA + RPV LA Q8W
n=522 Participants
Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
|
CAB LA + RPV LA Q4W
n=523 Participants
Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
|
|---|---|---|
|
Change From Baseline in Hematology Parameter: Erythrocytes Over Time
Week 4, n=331, 520
|
0.033 10^12 cells per liter
Standard Deviation 0.2206
|
0.024 10^12 cells per liter
Standard Deviation 0.2211
|
|
Change From Baseline in Hematology Parameter: Erythrocytes Over Time
Week 8, n=509, 510
|
0.092 10^12 cells per liter
Standard Deviation 0.2669
|
0.083 10^12 cells per liter
Standard Deviation 0.2651
|
|
Change From Baseline in Hematology Parameter: Erythrocytes Over Time
Week 16, n=509, 507
|
0.182 10^12 cells per liter
Standard Deviation 0.3050
|
0.162 10^12 cells per liter
Standard Deviation 0.3222
|
|
Change From Baseline in Hematology Parameter: Erythrocytes Over Time
Week 24, n=500, 498
|
0.209 10^12 cells per liter
Standard Deviation 0.3071
|
0.170 10^12 cells per liter
Standard Deviation 0.3225
|
|
Change From Baseline in Hematology Parameter: Erythrocytes Over Time
Week 32, n=491, 491
|
0.189 10^12 cells per liter
Standard Deviation 0.3145
|
0.150 10^12 cells per liter
Standard Deviation 0.3337
|
|
Change From Baseline in Hematology Parameter: Erythrocytes Over Time
Week 40, n=481, 476
|
0.229 10^12 cells per liter
Standard Deviation 0.3217
|
0.157 10^12 cells per liter
Standard Deviation 0.3184
|
|
Change From Baseline in Hematology Parameter: Erythrocytes Over Time
Week 48, n=489, 478
|
0.188 10^12 cells per liter
Standard Deviation 0.3288
|
0.170 10^12 cells per liter
Standard Deviation 0.3329
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Weeks 4, 8, 16, 24, 32, 40 and 48Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Blood samples were collected for the analysis of hematology parameter: hematocrit. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
CAB LA + RPV LA Q8W
n=522 Participants
Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
|
CAB LA + RPV LA Q4W
n=523 Participants
Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
|
|---|---|---|
|
Change From Baseline in Hematology Parameter: Hematocrit Over Time
Week 4, n=331, 520
|
0.002 Proportion of red blood cells in blood
Standard Deviation 0.02088
|
0.002 Proportion of red blood cells in blood
Standard Deviation 0.02202
|
|
Change From Baseline in Hematology Parameter: Hematocrit Over Time
Week 8, n=509, 510
|
0.004 Proportion of red blood cells in blood
Standard Deviation 0.02274
|
0.004 Proportion of red blood cells in blood
Standard Deviation 0.02362
|
|
Change From Baseline in Hematology Parameter: Hematocrit Over Time
Week 16, n=509, 507
|
0.008 Proportion of red blood cells in blood
Standard Deviation 0.02290
|
0.007 Proportion of red blood cells in blood
Standard Deviation 0.02485
|
|
Change From Baseline in Hematology Parameter: Hematocrit Over Time
Week 24, n=500, 498
|
0.008 Proportion of red blood cells in blood
Standard Deviation 0.02219
|
0.004 Proportion of red blood cells in blood
Standard Deviation 0.02413
|
|
Change From Baseline in Hematology Parameter: Hematocrit Over Time
Week 32, n=491, 491
|
0.003 Proportion of red blood cells in blood
Standard Deviation 0.02352
|
0.001 Proportion of red blood cells in blood
Standard Deviation 0.02469
|
|
Change From Baseline in Hematology Parameter: Hematocrit Over Time
Week 40, n=481, 476
|
0.006 Proportion of red blood cells in blood
Standard Deviation 0.02323
|
0.000 Proportion of red blood cells in blood
Standard Deviation 0.02378
|
|
Change From Baseline in Hematology Parameter: Hematocrit Over Time
Week 48, n=489, 478
|
0.003 Proportion of red blood cells in blood
Standard Deviation 0.02414
|
0.001 Proportion of red blood cells in blood
Standard Deviation 0.02565
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Weeks 4, 8, 16, 24, 32, 40 and 48Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Blood samples were collected for the analysis of hematology parameter: hemoglobin. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
CAB LA + RPV LA Q8W
n=522 Participants
Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
|
CAB LA + RPV LA Q4W
n=523 Participants
Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
|
|---|---|---|
|
Change From Baseline in Hematology Parameter: Hemoglobin Over Time
Week 4, n=331, 520
|
0.08 Grams per liter
Standard Deviation 6.425
|
-0.16 Grams per liter
Standard Deviation 6.797
|
|
Change From Baseline in Hematology Parameter: Hemoglobin Over Time
Week 8, n=509, 510
|
0.28 Grams per liter
Standard Deviation 7.028
|
-0.05 Grams per liter
Standard Deviation 7.419
|
|
Change From Baseline in Hematology Parameter: Hemoglobin Over Time
Week 16, n=509, 507
|
0.44 Grams per liter
Standard Deviation 6.979
|
0.05 Grams per liter
Standard Deviation 7.531
|
|
Change From Baseline in Hematology Parameter: Hemoglobin Over Time
Week 24, n=501, 498
|
1.48 Grams per liter
Standard Deviation 7.013
|
0.45 Grams per liter
Standard Deviation 7.488
|
|
Change From Baseline in Hematology Parameter: Hemoglobin Over Time
Week 32, n=491, 491
|
1.11 Grams per liter
Standard Deviation 7.633
|
0.05 Grams per liter
Standard Deviation 8.041
|
|
Change From Baseline in Hematology Parameter: Hemoglobin Over Time
Week 40, n=481, 476
|
1.36 Grams per liter
Standard Deviation 7.503
|
-0.47 Grams per liter
Standard Deviation 7.788
|
|
Change From Baseline in Hematology Parameter: Hemoglobin Over Time
Week 48, n=489, 478
|
-0.13 Grams per liter
Standard Deviation 7.631
|
-0.80 Grams per liter
Standard Deviation 8.462
|
SECONDARY outcome
Timeframe: Up to Week 48 analysisPopulation: The CVF Population comprised of all participants in ITT-E population who met CVF criteria. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Phenotypic resistance (PR) was analyzed in participants who met CVF criteria. PR for following Baseline third agent drugs: Integrase inhibitors(INI): bictegravir (BIC), CAB, dolutegravir (DTG), elvitegravir (EVG), raltegravir(RAL); non-nucleoside reverse transcriptase inhibitors(NNRTI): delavirdine(DLV), efavirenz(EFV), etravirine(ETR), nevirapine(NVP), RPV; nucleoside reverse transcriptase inhibitor (NRTI): lamivudine(3TC), abacavir(ABC), emtricitabine(FTC), tenofovir(TDF), zidovudine(ZDV), stavudine(d4T), didanosine(ddI) and protease inhibitors(PI): atazanavir(ATV), darunavir(DRV), fosamprenavir(FPV), indinavir(IDV), lopinavir(LPV), nelfinavir(NFV), ritonavir(RTV), saquinavir(SQV) and tipranavir (TPV) is presented. Phenotypic susceptibility was defined based on the fold change (FC) value: resistant (FC\>clinical higher cutoff or biological cutoff), partially sensitive (FC\<=clinical higher cutoff and \> clinical lower cutoff), sensitive(FC\<=clinical lower cutoff or biological cutoff)
Outcome measures
| Measure |
CAB LA + RPV LA Q8W
n=8 Participants
Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
|
CAB LA + RPV LA Q4W
n=2 Participants
Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
|
|---|---|---|
|
Number of Participants With Phenotypic Resistance- Maintenance Phase
INI, BIC, resistant, n=6, 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Phenotypic Resistance- Maintenance Phase
INI, BIC, sensitive, n=6, 2
|
6 Participants
|
2 Participants
|
|
Number of Participants With Phenotypic Resistance- Maintenance Phase
INI, CAB, resistant, n=6, 2
|
3 Participants
|
1 Participants
|
|
Number of Participants With Phenotypic Resistance- Maintenance Phase
INI, CAB, sensitive, n=6, 2
|
3 Participants
|
1 Participants
|
|
Number of Participants With Phenotypic Resistance- Maintenance Phase
INI, DTG, resistant, n=6, 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Phenotypic Resistance- Maintenance Phase
INI, DTG, partially sensitive, n=6, 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Phenotypic Resistance- Maintenance Phase
INI, DTG, sensitive, n=6, 2
|
6 Participants
|
2 Participants
|
|
Number of Participants With Phenotypic Resistance- Maintenance Phase
INI, EVG, resistant, n=6, 2
|
4 Participants
|
2 Participants
|
|
Number of Participants With Phenotypic Resistance- Maintenance Phase
INI, EVG, sensitive, n=6, 2
|
2 Participants
|
0 Participants
|
|
Number of Participants With Phenotypic Resistance- Maintenance Phase
INI, RAL, resistant, n=6, 2
|
4 Participants
|
2 Participants
|
|
Number of Participants With Phenotypic Resistance- Maintenance Phase
INI, RAL, sensitive, n=6, 2
|
2 Participants
|
0 Participants
|
|
Number of Participants With Phenotypic Resistance- Maintenance Phase
NNRTI, DLV, resistant, n=7, 2
|
6 Participants
|
2 Participants
|
|
Number of Participants With Phenotypic Resistance- Maintenance Phase
NNRTI, DLV, sensitive, n=7, 2
|
1 Participants
|
0 Participants
|
|
Number of Participants With Phenotypic Resistance- Maintenance Phase
NNRTI, EFV, resistant, n=7, 2
|
5 Participants
|
2 Participants
|
|
Number of Participants With Phenotypic Resistance- Maintenance Phase
NNRTI, EFV, sensitive, n=7, 2
|
2 Participants
|
0 Participants
|
|
Number of Participants With Phenotypic Resistance- Maintenance Phase
NNRTI, ETR, resistant, n=7, 2
|
0 Participants
|
2 Participants
|
|
Number of Participants With Phenotypic Resistance- Maintenance Phase
NNRTI, ETR, partially sensitive, n=7, 2
|
4 Participants
|
0 Participants
|
|
Number of Participants With Phenotypic Resistance- Maintenance Phase
NNRTI, ETR, sensitive, n=7, 2
|
3 Participants
|
0 Participants
|
|
Number of Participants With Phenotypic Resistance- Maintenance Phase
NNRTI, NVP, resistant, n=7, 2
|
6 Participants
|
2 Participants
|
|
Number of Participants With Phenotypic Resistance- Maintenance Phase
NNRTI, NVP, sensitive, n=7, 2
|
1 Participants
|
0 Participants
|
|
Number of Participants With Phenotypic Resistance- Maintenance Phase
NNRTI, RPV, resistant, n=7, 2
|
6 Participants
|
2 Participants
|
|
Number of Participants With Phenotypic Resistance- Maintenance Phase
NNRTI, RPV, sensitive, n=7, 2
|
1 Participants
|
0 Participants
|
|
Number of Participants With Phenotypic Resistance- Maintenance Phase
NRTI, 3TC, resistant, n=7, 2
|
1 Participants
|
1 Participants
|
|
Number of Participants With Phenotypic Resistance- Maintenance Phase
NRTI, 3TC, sensitive, n=7, 2
|
6 Participants
|
1 Participants
|
|
Number of Participants With Phenotypic Resistance- Maintenance Phase
NRTI, ABC, resistant, n=7, 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Phenotypic Resistance- Maintenance Phase
NRTI, ABC, partially sensitive, n=7, 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Phenotypic Resistance- Maintenance Phase
NRTI, ABC, sensitive, n=7, 2
|
7 Participants
|
2 Participants
|
|
Number of Participants With Phenotypic Resistance- Maintenance Phase
NRTI, FTC, resistant, n=7, 2
|
1 Participants
|
1 Participants
|
|
Number of Participants With Phenotypic Resistance- Maintenance Phase
NRTI, FTC, sensitive, n=7, 2
|
6 Participants
|
1 Participants
|
|
Number of Participants With Phenotypic Resistance- Maintenance Phase
NRTI, TDF, resistant, n=7, 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Phenotypic Resistance- Maintenance Phase
NRTI, TDF, partially sensitive, n=7, 2
|
0 Participants
|
1 Participants
|
|
Number of Participants With Phenotypic Resistance- Maintenance Phase
NRTI, TDF, sensitive, n=7, 2
|
7 Participants
|
1 Participants
|
|
Number of Participants With Phenotypic Resistance- Maintenance Phase
NRTI, ZDV, resistant, n=7, 2
|
0 Participants
|
2 Participants
|
|
Number of Participants With Phenotypic Resistance- Maintenance Phase
NRTI, ZDV, sensitive, n=7, 2
|
7 Participants
|
0 Participants
|
|
Number of Participants With Phenotypic Resistance- Maintenance Phase
NRTI, d4T, resistant, n=7, 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Phenotypic Resistance- Maintenance Phase
NRTI, d4T, sensitive, n=7, 2
|
7 Participants
|
2 Participants
|
|
Number of Participants With Phenotypic Resistance- Maintenance Phase
NRTI, ddI, resistant, n=7, 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Phenotypic Resistance- Maintenance Phase
NRTI, ddI, partially sensitive, n=7, 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Phenotypic Resistance- Maintenance Phase
NRTI, ddI, sensitive, n=7, 2
|
7 Participants
|
2 Participants
|
|
Number of Participants With Phenotypic Resistance- Maintenance Phase
PI, ATV, resistant, n=7, 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Phenotypic Resistance- Maintenance Phase
PI, ATV, sensitive, n=7, 2
|
7 Participants
|
2 Participants
|
|
Number of Participants With Phenotypic Resistance- Maintenance Phase
PI, DRV, resistant, n=7, 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Phenotypic Resistance- Maintenance Phase
PI, DRV, partially sensitive, n=7, 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Phenotypic Resistance- Maintenance Phase
PI, DRV, sensitive, n=7, 2
|
7 Participants
|
2 Participants
|
|
Number of Participants With Phenotypic Resistance- Maintenance Phase
PI, FPV, resistant, n=7, 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Phenotypic Resistance- Maintenance Phase
PI, FPV, partially sensitive, n=7, 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Phenotypic Resistance- Maintenance Phase
PI, FPV, sensitive, n=7, 2
|
7 Participants
|
2 Participants
|
|
Number of Participants With Phenotypic Resistance- Maintenance Phase
PI, IDV, resistant, n=7, 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Phenotypic Resistance- Maintenance Phase
PI, IDV, sensitive, n=7, 2
|
7 Participants
|
2 Participants
|
|
Number of Participants With Phenotypic Resistance- Maintenance Phase
PI, LPV, resistant, n=7, 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Phenotypic Resistance- Maintenance Phase
PI, LPV, partially sensitive, n=7, 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Phenotypic Resistance- Maintenance Phase
PI, LPV, sensitive, n=7, 2
|
7 Participants
|
2 Participants
|
|
Number of Participants With Phenotypic Resistance- Maintenance Phase
PI, NFV, resistant, n=7, 2
|
0 Participants
|
1 Participants
|
|
Number of Participants With Phenotypic Resistance- Maintenance Phase
PI, NFV, sensitive, n=7, 2
|
7 Participants
|
1 Participants
|
|
Number of Participants With Phenotypic Resistance- Maintenance Phase
PI, RTV, resistant, n=7, 2
|
0 Participants
|
1 Participants
|
|
Number of Participants With Phenotypic Resistance- Maintenance Phase
PI, RTV, sensitive, n=7, 2
|
7 Participants
|
1 Participants
|
|
Number of Participants With Phenotypic Resistance- Maintenance Phase
PI, SQV, resistant, n=7, 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Phenotypic Resistance- Maintenance Phase
PI, SQV, partially sensitive, n=7, 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Phenotypic Resistance- Maintenance Phase
PI, SQV, sensitive, n=7, 2
|
7 Participants
|
2 Participants
|
|
Number of Participants With Phenotypic Resistance- Maintenance Phase
PI, TPV, resistant, n=7, 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Phenotypic Resistance- Maintenance Phase
PI, TPV, partially sensitive, n=7, 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Phenotypic Resistance- Maintenance Phase
PI, TPV, sensitive, n=7, 2
|
7 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to Week 48 analysisPopulation: CVF Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Genotypic resistance was analyzed in participants who met confirmed virologic withdrawal criteria. Genotypic Resistance data for the following Baseline third agent drugs, INI: BIC, DTG, EVG, RAL; NNRTI: DLV, EFV, ETR, NVP, RPV; NRTI: 3TC, ABC, FTC, TDF, ZDV, d4T, ddI and PI: ATV, ATV/ritonavir (r), DRV/r, FPV/r, IDV/r, LPV/r, NFV, RTV, SQV/r and TPV/r in participants meeting CVF criteria has been presented.
Outcome measures
| Measure |
CAB LA + RPV LA Q8W
n=8 Participants
Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
|
CAB LA + RPV LA Q4W
n=2 Participants
Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
|
|---|---|---|
|
Number of Participants With Genotypic Resistance-Maintenance Phase
INI, BIC, resistant, n=6, 2
|
1 Participants
|
0 Participants
|
|
Number of Participants With Genotypic Resistance-Maintenance Phase
INI, BIC, resistance possible, n=6, 2
|
2 Participants
|
1 Participants
|
|
Number of Participants With Genotypic Resistance-Maintenance Phase
INI, BIC, sensitive, n=6, 2
|
3 Participants
|
1 Participants
|
|
Number of Participants With Genotypic Resistance-Maintenance Phase
INI, DTG, resistant, n=6, 2
|
1 Participants
|
0 Participants
|
|
Number of Participants With Genotypic Resistance-Maintenance Phase
INI, DTG, resistance possible, n=6, 2
|
2 Participants
|
1 Participants
|
|
Number of Participants With Genotypic Resistance-Maintenance Phase
INI, DTG, sensitive, n=6, 2
|
3 Participants
|
1 Participants
|
|
Number of Participants With Genotypic Resistance-Maintenance Phase
INI, EVG, resistant, n=6, 2
|
4 Participants
|
2 Participants
|
|
Number of Participants With Genotypic Resistance-Maintenance Phase
INI, EVG, resistance possible, n=6, 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Genotypic Resistance-Maintenance Phase
INI, EVG, sensitive, n=6, 2
|
2 Participants
|
0 Participants
|
|
Number of Participants With Genotypic Resistance-Maintenance Phase
INI, RAL, resistant, n=6, 2
|
4 Participants
|
2 Participants
|
|
Number of Participants With Genotypic Resistance-Maintenance Phase
INI, RAL, resistance possible, n=6, 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Genotypic Resistance-Maintenance Phase
INI, RAL, sensitive, n=6, 2
|
2 Participants
|
0 Participants
|
|
Number of Participants With Genotypic Resistance-Maintenance Phase
NNRTI, DLV, resistant, n=8, 2
|
2 Participants
|
1 Participants
|
|
Number of Participants With Genotypic Resistance-Maintenance Phase
NNRTI, DLV, resistance possible, n=8, 2
|
2 Participants
|
1 Participants
|
|
Number of Participants With Genotypic Resistance-Maintenance Phase
NNRTI, DLV, sensitive, n=8, 2
|
4 Participants
|
0 Participants
|
|
Number of Participants With Genotypic Resistance-Maintenance Phase
NNRTI, EFV, resistant, n=8, 2
|
4 Participants
|
2 Participants
|
|
Number of Participants With Genotypic Resistance-Maintenance Phase
NNRTI, EFV, resistance possible, n=8, 2
|
2 Participants
|
0 Participants
|
|
Number of Participants With Genotypic Resistance-Maintenance Phase
NNRTI, EFV, sensitive, n=8, 2
|
2 Participants
|
0 Participants
|
|
Number of Participants With Genotypic Resistance-Maintenance Phase
NNRTI, ETR, resistant, n=8, 2
|
0 Participants
|
1 Participants
|
|
Number of Participants With Genotypic Resistance-Maintenance Phase
NNRTI, ETR, resistance possible, n=8, 2
|
2 Participants
|
1 Participants
|
|
Number of Participants With Genotypic Resistance-Maintenance Phase
NNRTI, ETR, sensitive, n=8, 2
|
6 Participants
|
0 Participants
|
|
Number of Participants With Genotypic Resistance-Maintenance Phase
NNRTI, NVP, resistant, n=8, 2
|
4 Participants
|
2 Participants
|
|
Number of Participants With Genotypic Resistance-Maintenance Phase
NNRTI, NVP, resistance possible, n=8, 2
|
2 Participants
|
0 Participants
|
|
Number of Participants With Genotypic Resistance-Maintenance Phase
NNRTI, NVP, sensitive, n=8, 2
|
2 Participants
|
0 Participants
|
|
Number of Participants With Genotypic Resistance-Maintenance Phase
NNRTI, RPV, resistant, n=8, 2
|
6 Participants
|
1 Participants
|
|
Number of Participants With Genotypic Resistance-Maintenance Phase
NNRTI, RPV, resistance possible, n=8, 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Genotypic Resistance-Maintenance Phase
NNRTI, RPV, sensitive, n=8, 2
|
2 Participants
|
1 Participants
|
|
Number of Participants With Genotypic Resistance-Maintenance Phase
NRTI, 3TC, resistant, n=8, 2
|
1 Participants
|
1 Participants
|
|
Number of Participants With Genotypic Resistance-Maintenance Phase
NRTI, 3TC, resistance possible, n=8, 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Genotypic Resistance-Maintenance Phase
NRTI, 3TC, sensitive, n=8, 2
|
7 Participants
|
1 Participants
|
|
Number of Participants With Genotypic Resistance-Maintenance Phase
NRTI, ABC, resistant, n=8, 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Genotypic Resistance-Maintenance Phase
NRTI, ABC, resistance possible, n=8, 2
|
0 Participants
|
1 Participants
|
|
Number of Participants With Genotypic Resistance-Maintenance Phase
NRTI, ABC, sensitive, n=8, 2
|
8 Participants
|
1 Participants
|
|
Number of Participants With Genotypic Resistance-Maintenance Phase
NRTI, FTC, resistant, n=8, 2
|
1 Participants
|
1 Participants
|
|
Number of Participants With Genotypic Resistance-Maintenance Phase
NRTI, FTC, resistance possible, n=8, 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Genotypic Resistance-Maintenance Phase
NRTI, FTC, sensitive, n=8, 2
|
7 Participants
|
1 Participants
|
|
Number of Participants With Genotypic Resistance-Maintenance Phase
NRTI, TDF, resistant, n=8, 2
|
0 Participants
|
1 Participants
|
|
Number of Participants With Genotypic Resistance-Maintenance Phase
NRTI, TDF, resistance possible, n=8, 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Genotypic Resistance-Maintenance Phase
NRTI, TDF, sensitive, n=8, 2
|
8 Participants
|
1 Participants
|
|
Number of Participants With Genotypic Resistance-Maintenance Phase
NRTI, ZDV, resistant, n=8, 2
|
0 Participants
|
1 Participants
|
|
Number of Participants With Genotypic Resistance-Maintenance Phase
NRTI, ZDV, resistance possible, n=8, 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Genotypic Resistance-Maintenance Phase
NRTI, ZDV, sensitive, n=8, 2
|
8 Participants
|
1 Participants
|
|
Number of Participants With Genotypic Resistance-Maintenance Phase
NRTI, d4T, resistant, n=8, 2
|
0 Participants
|
1 Participants
|
|
Number of Participants With Genotypic Resistance-Maintenance Phase
NRTI, d4T, resistance possible, n=8, 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Genotypic Resistance-Maintenance Phase
NRTI, d4T, sensitive, n=8, 2
|
8 Participants
|
1 Participants
|
|
Number of Participants With Genotypic Resistance-Maintenance Phase
NRTI, ddI, resistant, n=8, 2
|
0 Participants
|
1 Participants
|
|
Number of Participants With Genotypic Resistance-Maintenance Phase
NRTI, ddI, resistance possible, n=8, 2
|
1 Participants
|
0 Participants
|
|
Number of Participants With Genotypic Resistance-Maintenance Phase
NRTI, ddI, sensitive, n=8, 2
|
7 Participants
|
1 Participants
|
|
Number of Participants With Genotypic Resistance-Maintenance Phase
PI, ATV, resistant, n=8, 2
|
0 Participants
|
1 Participants
|
|
Number of Participants With Genotypic Resistance-Maintenance Phase
PI, ATV, resistance possible, n=8, 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Genotypic Resistance-Maintenance Phase
PI, ATV, sensitive, n=8, 2
|
8 Participants
|
1 Participants
|
|
Number of Participants With Genotypic Resistance-Maintenance Phase
PI, ATV/r, resistant, n=8, 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Genotypic Resistance-Maintenance Phase
PI, ATV/r, resistance possible, n=8, 2
|
0 Participants
|
1 Participants
|
|
Number of Participants With Genotypic Resistance-Maintenance Phase
PI, ATV/r, sensitive, n=8, 2
|
8 Participants
|
1 Participants
|
|
Number of Participants With Genotypic Resistance-Maintenance Phase
PI, DRV/r, resistant, n=8, 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Genotypic Resistance-Maintenance Phase
PI, DRV/r, resistance possible, n=8, 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Genotypic Resistance-Maintenance Phase
PI, DRV/r, sensitive, n=8, 2
|
8 Participants
|
2 Participants
|
|
Number of Participants With Genotypic Resistance-Maintenance Phase
PI, FPV/r, resistant, n=8, 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Genotypic Resistance-Maintenance Phase
PI, FPV/r, resistance possible, n=8, 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Genotypic Resistance-Maintenance Phase
PI, FPV/r, sensitive, n=8, 2
|
8 Participants
|
2 Participants
|
|
Number of Participants With Genotypic Resistance-Maintenance Phase
PI, IDV/r, resistant, n=8, 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Genotypic Resistance-Maintenance Phase
PI, IDV/r, resistance possible, n=8, 2
|
0 Participants
|
1 Participants
|
|
Number of Participants With Genotypic Resistance-Maintenance Phase
PI, IDV/r, sensitive, n=8, 2
|
8 Participants
|
1 Participants
|
|
Number of Participants With Genotypic Resistance-Maintenance Phase
PI, LPV/r, resistant, n=8, 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Genotypic Resistance-Maintenance Phase
PI, LPV/r, resistance possible, n=8, 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Genotypic Resistance-Maintenance Phase
PI, LPV/r, sensitive, n=8, 2
|
8 Participants
|
2 Participants
|
|
Number of Participants With Genotypic Resistance-Maintenance Phase
PI, NFV, resistant, n=8, 2
|
0 Participants
|
1 Participants
|
|
Number of Participants With Genotypic Resistance-Maintenance Phase
PI, NFV, resistance possible, n=8, 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Genotypic Resistance-Maintenance Phase
PI, NFV, sensitive, n=8, 2
|
8 Participants
|
1 Participants
|
|
Number of Participants With Genotypic Resistance-Maintenance Phase
PI, RTV, resistant, n=8, 2
|
0 Participants
|
1 Participants
|
|
Number of Participants With Genotypic Resistance-Maintenance Phase
PI, RTV, resistance possible, n=8, 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Genotypic Resistance-Maintenance Phase
PI, RTV, sensitive, n=8, 2
|
8 Participants
|
1 Participants
|
|
Number of Participants With Genotypic Resistance-Maintenance Phase
PI, SQV/r, resistant, n=8, 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Genotypic Resistance-Maintenance Phase
PI, SQV/r, resistance possible, n=8, 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Genotypic Resistance-Maintenance Phase
PI, SQV/r, sensitive, n=8, 2
|
8 Participants
|
2 Participants
|
|
Number of Participants With Genotypic Resistance-Maintenance Phase
PI, TPV/r, resistant, n=8, 2
|
0 Participants
|
1 Participants
|
|
Number of Participants With Genotypic Resistance-Maintenance Phase
PI, TPV/r, resistance possible, n=8, 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Genotypic Resistance-Maintenance Phase
PI, TPV/r, sensitive, n=8, 2
|
8 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Week 48Population: ITT-E Population. Only those participants with data available at indicated time point is analyzed.
Participants were administered the preference questionnaire which had 3 questions. For treatment preference, participants were required to provide their response to Question 1, which stated "Based on your experience which HIV treatment do you prefer". The responses included 1) Injectable LA HIV treatment Q4W, 2) Injectable LA HIV Treatment Q8W (only select this answer if you received the 8-week injectable regimen of CAB LA + RPV LA during study), 3) Oral daily HIV treatment and 4) No preference. Oral daily HIV Treatment refers to the oral medication of CAB + RPV subjects received during the oral lead-in period. Number of participants without prior exposure to CAB+RPV who selected each of the responses based on their treatment preference is presented.
Outcome measures
| Measure |
CAB LA + RPV LA Q8W
n=306 Participants
Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
|
CAB LA + RPV LA Q4W
Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
|
|---|---|---|
|
Number of Participants With Their Treatment Preference as Assessed Using Preference Questionnaire at Week 48 Without (w/o) Prior Exposure to CAB+RPV-CAB 600 mg LA +RPV 900 mg LA Q8W Arm Only
Injectable LA HIV treatment Q4W
|
0 Participants
|
—
|
|
Number of Participants With Their Treatment Preference as Assessed Using Preference Questionnaire at Week 48 Without (w/o) Prior Exposure to CAB+RPV-CAB 600 mg LA +RPV 900 mg LA Q8W Arm Only
Injectable LA HIV treatment Q8W
|
300 Participants
|
—
|
|
Number of Participants With Their Treatment Preference as Assessed Using Preference Questionnaire at Week 48 Without (w/o) Prior Exposure to CAB+RPV-CAB 600 mg LA +RPV 900 mg LA Q8W Arm Only
Oral daily HIV treatment
|
4 Participants
|
—
|
|
Number of Participants With Their Treatment Preference as Assessed Using Preference Questionnaire at Week 48 Without (w/o) Prior Exposure to CAB+RPV-CAB 600 mg LA +RPV 900 mg LA Q8W Arm Only
No preference
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 48Population: ITT-E Population. Only those participants with data available at indicated time point is analyzed.
Participants were administered the preference questionnaire which had 3 questions. For treatment preference, participants were required to provide their response to Question 1, which stated "Based on your experience which HIV treatment do you prefer". The responses included 1) Injectable LA HIV treatment Q4W, 2) Injectable LA HIV Treatment Q8W (only select this answer if you received the 8-week injectable regimen of CAB LA + RPV LA during study), 3) Oral daily HIV treatment and 4) No preference. Oral daily HIV Treatment refers to the oral medication of CAB + RPV subjects received during the oral lead-in period. Number of participants with \>=1 weeks of prior exposure to CAB+RPV who selected each of the responses based on their treatment preference is presented.
Outcome measures
| Measure |
CAB LA + RPV LA Q8W
n=191 Participants
Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
|
CAB LA + RPV LA Q4W
Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
|
|---|---|---|
|
Number of Participants With Their Treatment Preference as Assessed Using Preference Questionnaire at Week 48 With >=1 Weeks of Prior Exposure to CAB+RPV-CAB 600 mg LA +RPV 900 mg LA Q8W Arm Only
Injectable LA HIV treatment Q4W
|
6 Participants
|
—
|
|
Number of Participants With Their Treatment Preference as Assessed Using Preference Questionnaire at Week 48 With >=1 Weeks of Prior Exposure to CAB+RPV-CAB 600 mg LA +RPV 900 mg LA Q8W Arm Only
Injectable LA HIV treatment Q8W
|
179 Participants
|
—
|
|
Number of Participants With Their Treatment Preference as Assessed Using Preference Questionnaire at Week 48 With >=1 Weeks of Prior Exposure to CAB+RPV-CAB 600 mg LA +RPV 900 mg LA Q8W Arm Only
Oral daily HIV treatment
|
4 Participants
|
—
|
|
Number of Participants With Their Treatment Preference as Assessed Using Preference Questionnaire at Week 48 With >=1 Weeks of Prior Exposure to CAB+RPV-CAB 600 mg LA +RPV 900 mg LA Q8W Arm Only
No preference
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 48Population: ITT-E Population. Only those participants with data available at indicated time point is analyzed.
Participants were administered the preference questionnaire which had 3 questions. For treatment preference, participants were required to provide their response to Question 1, which stated "Based on your experience which HIV treatment do you prefer". The responses included 1) Injectable LA HIV treatment Q4W, 2) Injectable LA HIV Treatment Q8W (only select this answer if you received the 8-week injectable regimen of CAB LA + RPV LA during study), 3) Oral daily HIV treatment and 4) No preference. Oral daily HIV Treatment refers to the oral medication of CAB + RPV participants received during the oral lead-in period. Number of participants who selected each of the responses based on their treatment preference is presented.
Outcome measures
| Measure |
CAB LA + RPV LA Q8W
n=497 Participants
Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
|
CAB LA + RPV LA Q4W
Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
|
|---|---|---|
|
Number of Participants With Their Treatment Preference as Assessed Using Preference Questionnaire at Week 48-CAB 400 mg LA +RPV 600 mg LA Q4W Arm Only
Injectable LA HIV treatment Q4W
|
468 Participants
|
—
|
|
Number of Participants With Their Treatment Preference as Assessed Using Preference Questionnaire at Week 48-CAB 400 mg LA +RPV 600 mg LA Q4W Arm Only
Injectable LA HIV treatment Q8W
|
0 Participants
|
—
|
|
Number of Participants With Their Treatment Preference as Assessed Using Preference Questionnaire at Week 48-CAB 400 mg LA +RPV 600 mg LA Q4W Arm Only
Oral daily HIV treatment
|
16 Participants
|
—
|
|
Number of Participants With Their Treatment Preference as Assessed Using Preference Questionnaire at Week 48-CAB 400 mg LA +RPV 600 mg LA Q4W Arm Only
No preference
|
13 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Weeks 24 and 48Population: ITT-E Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
The HATQoL questionnaire was used to assess the health related QoL (HRQoL). It comprises of three dimensions:LISAT, medication worries (MEDWO) and disclosure worries (DISWO). Total imputed value score for LISAT is calculated on a 0-100 scale using the formula: LISAT 100=\[100 divided by (20 minus 4)\]\*(LISAT minus 4). A response of 5 in LISAT score shows satisfaction all of the time and 1 as none of the time. The higher the score, the greater satisfaction to life and the less worry. The transformed dimension score for each domain was summarized and analyzed. Last Observation Carried Forward (LOCF) was used as primary method of analysis. Data for participants without/with prior exposure to CAB+RPV (0 Weeks \[without exposure\] and \>=1 Weeks \[with exposure\]) has been presented. Baseline value is defined as last available recorded value up to and including the Maintenance treatment start. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Outcome measures
| Measure |
CAB LA + RPV LA Q8W
n=522 Participants
Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
|
CAB LA + RPV LA Q4W
n=523 Participants
Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
|
|---|---|---|
|
Change From Baseline in Life Satisfaction (LISAT) Using HIV/AIDs-targeted Quality of Life (HATQoL) Questionnaire in Participants With or Without Prior Exposure to CAB+RPV
Without exposure, Week 24, n=318, 324
|
1.5 Scores on a scale
Standard Deviation 14.87
|
-0.5 Scores on a scale
Standard Deviation 18.00
|
|
Change From Baseline in Life Satisfaction (LISAT) Using HIV/AIDs-targeted Quality of Life (HATQoL) Questionnaire in Participants With or Without Prior Exposure to CAB+RPV
Without exposure, Week 48, n=319, 324
|
-0.8 Scores on a scale
Standard Deviation 15.24
|
0.6 Scores on a scale
Standard Deviation 17.51
|
|
Change From Baseline in Life Satisfaction (LISAT) Using HIV/AIDs-targeted Quality of Life (HATQoL) Questionnaire in Participants With or Without Prior Exposure to CAB+RPV
With exposure, Week 24, n=192, 194
|
-0.8 Scores on a scale
Standard Deviation 14.31
|
0.8 Scores on a scale
Standard Deviation 13.73
|
|
Change From Baseline in Life Satisfaction (LISAT) Using HIV/AIDs-targeted Quality of Life (HATQoL) Questionnaire in Participants With or Without Prior Exposure to CAB+RPV
With exposure, Week 48, n=192, 194
|
0.3 Scores on a scale
Standard Deviation 14.03
|
-1.3 Scores on a scale
Standard Deviation 14.50
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Weeks 24 and 48Population: ITT-E Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
The HATQoL questionnaire was used to assess the HRQoL. It comprises of three dimensions:LISAT, MEDWO and DISWO. The total imputed value score for MEDWO is calculated on a 0-100 scale using the formula: MEDWO 100=\[100 divided by (25 minus 5)\]\*(MEDWO minus 5). A response of 1 in MEDWO score shows medication worries all of the time and 5 as none of the time. The higher the score, the greater satisfaction to life and the less worry. The transformed dimension score for each domain was summarized and analyzed. LOCF was used as primary method of analysis. Participants without/with prior exposure to CAB+RPV (0 Weeks \[without exposure\] and \>=1 Weeks \[with exposure\]) has been presented. Baseline value is defined as last available recorded value up to and including the Maintenance treatment start. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Outcome measures
| Measure |
CAB LA + RPV LA Q8W
n=522 Participants
Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
|
CAB LA + RPV LA Q4W
n=523 Participants
Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
|
|---|---|---|
|
Change From Baseline in HIV Medication, MEDWO Using HATQoL Questionnaire in Participants With or Without Prior Exposure to CAB+RPV
Without exposure, Week 24, n=318, 324
|
2.7 Scores on a scale
Standard Deviation 16.53
|
2.6 Scores on a scale
Standard Deviation 15.61
|
|
Change From Baseline in HIV Medication, MEDWO Using HATQoL Questionnaire in Participants With or Without Prior Exposure to CAB+RPV
Without exposure, Week 48, n=319, 324
|
3.0 Scores on a scale
Standard Deviation 15.87
|
1.9 Scores on a scale
Standard Deviation 15.97
|
|
Change From Baseline in HIV Medication, MEDWO Using HATQoL Questionnaire in Participants With or Without Prior Exposure to CAB+RPV
With exposure, Week 24, n=192, 194
|
0.7 Scores on a scale
Standard Deviation 10.57
|
1.7 Scores on a scale
Standard Deviation 14.86
|
|
Change From Baseline in HIV Medication, MEDWO Using HATQoL Questionnaire in Participants With or Without Prior Exposure to CAB+RPV
With exposure, Week 48, n=192, 194
|
1.3 Scores on a scale
Standard Deviation 8.82
|
1.3 Scores on a scale
Standard Deviation 17.95
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Weeks 24 and 48Population: ITT-E Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
The HATQoL questionnaire was used to assess the HRQoL. It comprises of three dimensions:LISAT, MEDWO and DISWO. The total imputed value score for DISWO is calculated on a 0-100 scale using the formula: DISWO 100=\[100 divided by (25 minus 5)\]\*(DISWO minus 5). A response of 1 in DISWO score shows disclosure worries all of the time and 5 as none of the time. The higher the score, the greater satisfaction to life and the less worry. The transformed dimension score for each domain was summarized and analyzed. LOCF was used as primary method of analysis. Participants without/with prior exposure to CAB+RPV (0 Weeks \[without exposure\] and \>=1 Weeks \[with exposure\]) has been presented. Baseline value is defined as last available recorded value up to and including the Maintenance treatment start. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Outcome measures
| Measure |
CAB LA + RPV LA Q8W
n=522 Participants
Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
|
CAB LA + RPV LA Q4W
n=523 Participants
Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
|
|---|---|---|
|
Change From Baseline in DISWO Using HATQoL Questionnaire in Participants With or Without Prior Exposure to CAB+RPV
Without exposure, Week 24, n=317, 324
|
1.4 Scores on a scale
Standard Deviation 25.58
|
1.2 Scores on a scale
Standard Deviation 23.18
|
|
Change From Baseline in DISWO Using HATQoL Questionnaire in Participants With or Without Prior Exposure to CAB+RPV
Without exposure, Week 48, n=318, 324
|
-0.5 Scores on a scale
Standard Deviation 28.14
|
-0.5 Scores on a scale
Standard Deviation 23.86
|
|
Change From Baseline in DISWO Using HATQoL Questionnaire in Participants With or Without Prior Exposure to CAB+RPV
With exposure, Week 24, n=192, 194
|
0.9 Scores on a scale
Standard Deviation 21.13
|
1.8 Scores on a scale
Standard Deviation 24.20
|
|
Change From Baseline in DISWO Using HATQoL Questionnaire in Participants With or Without Prior Exposure to CAB+RPV
With exposure, Week 48, n=192, 194
|
-0.6 Scores on a scale
Standard Deviation 24.11
|
1.5 Scores on a scale
Standard Deviation 26.84
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Weeks 24 and 48Population: ITT-E Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
The HIVTSQs treatment satisfaction questionnaire comprises of 1-12 questions and the total treatment satisfaction score is computed with items 1-11 and summed to produce a score with a possible range of 0 to 66. Higher scores represent greater treatment satisfaction as compared to the past few weeks. LOCF was used as primary method of analysis. Participants without/with prior exposure to CAB+RPV (0 Weeks \[without exposure\] and \>=1 Weeks \[with exposure\]) has been presented. Baseline value is defined as last available recorded value up to and including the Maintenance treatment start. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Outcome measures
| Measure |
CAB LA + RPV LA Q8W
n=522 Participants
Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
|
CAB LA + RPV LA Q4W
n=523 Participants
Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
|
|---|---|---|
|
Change From Baseline in Total Treatment Satisfaction Score Using HIV Treatment Satisfaction Status Questionnaire (HIVTSQs) at Weeks 24 and 48
Without exposure, Week 24, n=319, 323
|
4.63 Scores on a scale
Standard Deviation 9.818
|
4.44 Scores on a scale
Standard Deviation 9.709
|
|
Change From Baseline in Total Treatment Satisfaction Score Using HIV Treatment Satisfaction Status Questionnaire (HIVTSQs) at Weeks 24 and 48
Without exposure, Week 48, n=319, 323
|
4.42 Scores on a scale
Standard Deviation 10.351
|
3.55 Scores on a scale
Standard Deviation 10.224
|
|
Change From Baseline in Total Treatment Satisfaction Score Using HIV Treatment Satisfaction Status Questionnaire (HIVTSQs) at Weeks 24 and 48
With exposure, Week 24, n=191, 193
|
0.55 Scores on a scale
Standard Deviation 5.050
|
0.55 Scores on a scale
Standard Deviation 5.347
|
|
Change From Baseline in Total Treatment Satisfaction Score Using HIV Treatment Satisfaction Status Questionnaire (HIVTSQs) at Weeks 24 and 48
With exposure, Week 48, n=191, 194
|
0.40 Scores on a scale
Standard Deviation 5.242
|
-0.01 Scores on a scale
Standard Deviation 6.521
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Weeks 24 and 48Population: ITT-E Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
HIVTSQs is a 12 item questionnaire. The individual item scores on HIVTSQs scale are rated as 6 (very satisfied, convenient, flexible, etc.) to 0 (very dissatisfied, inconvenient, inflexible, etc.). Higher scores represent greater satisfaction with each aspect of treatment. LOCF was used as primary method of analysis. Participants without/with prior exposure to CAB+RPV (0 Weeks \[without exposure\] and \>=1 Weeks \[with exposure\]) has been presented. Baseline value is defined as last available recorded value up to and including the Maintenance treatment start. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Outcome measures
| Measure |
CAB LA + RPV LA Q8W
n=522 Participants
Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
|
CAB LA + RPV LA Q4W
n=523 Participants
Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
|
|---|---|---|
|
Change From Baseline in Individual Item Scores Using HIVTSQs at Weeks 24 and 48
Item 1, Without exposure, Week 24, n=319, 323
|
0.3 Scores on a scale
Standard Deviation 1.19
|
0.3 Scores on a scale
Standard Deviation 1.18
|
|
Change From Baseline in Individual Item Scores Using HIVTSQs at Weeks 24 and 48
Item 1, Without exposure, Week 48, n=319, 323
|
0.3 Scores on a scale
Standard Deviation 1.23
|
0.2 Scores on a scale
Standard Deviation 1.27
|
|
Change From Baseline in Individual Item Scores Using HIVTSQs at Weeks 24 and 48
Item 1, With exposure, Week 24, n=191, 193
|
0.1 Scores on a scale
Standard Deviation 0.77
|
0.0 Scores on a scale
Standard Deviation 0.78
|
|
Change From Baseline in Individual Item Scores Using HIVTSQs at Weeks 24 and 48
Item 1, With exposure, Week 48, n=191, 194
|
0.1 Scores on a scale
Standard Deviation 0.81
|
0.0 Scores on a scale
Standard Deviation 0.90
|
|
Change From Baseline in Individual Item Scores Using HIVTSQs at Weeks 24 and 48
Item 2, Without exposure, Week 24, n=319, 323
|
0.0 Scores on a scale
Standard Deviation 0.73
|
0.1 Scores on a scale
Standard Deviation 0.67
|
|
Change From Baseline in Individual Item Scores Using HIVTSQs at Weeks 24 and 48
Item 2, Without exposure, Week 48, n=319, 323
|
0.0 Scores on a scale
Standard Deviation 0.78
|
0.0 Scores on a scale
Standard Deviation 0.65
|
|
Change From Baseline in Individual Item Scores Using HIVTSQs at Weeks 24 and 48
Item 2, With exposure, Week 24, n=191, 193
|
0.0 Scores on a scale
Standard Deviation 0.42
|
0.1 Scores on a scale
Standard Deviation 0.61
|
|
Change From Baseline in Individual Item Scores Using HIVTSQs at Weeks 24 and 48
Item 2, With exposure, Week 48, n=191, 194
|
0.0 Scores on a scale
Standard Deviation 0.49
|
0.1 Scores on a scale
Standard Deviation 0.63
|
|
Change From Baseline in Individual Item Scores Using HIVTSQs at Weeks 24 and 48
Item 3, Without exposure, Week 24, n=319, 323
|
0.0 Scores on a scale
Standard Deviation 1.42
|
0.0 Scores on a scale
Standard Deviation 1.49
|
|
Change From Baseline in Individual Item Scores Using HIVTSQs at Weeks 24 and 48
Item 3, Without exposure, Week 48, n=319, 323
|
0.0 Scores on a scale
Standard Deviation 1.45
|
0.0 Scores on a scale
Standard Deviation 1.48
|
|
Change From Baseline in Individual Item Scores Using HIVTSQs at Weeks 24 and 48
Item 3, With exposure, Week 24, n=191, 193
|
0.0 Scores on a scale
Standard Deviation 0.82
|
0.1 Scores on a scale
Standard Deviation 1.03
|
|
Change From Baseline in Individual Item Scores Using HIVTSQs at Weeks 24 and 48
Item 3, With exposure, Week 48, n=191, 194
|
0.0 Scores on a scale
Standard Deviation 1.05
|
0.0 Scores on a scale
Standard Deviation 1.20
|
|
Change From Baseline in Individual Item Scores Using HIVTSQs at Weeks 24 and 48
Item 4, Without exposure, Week 24, n=319, 323
|
0.3 Scores on a scale
Standard Deviation 1.05
|
0.3 Scores on a scale
Standard Deviation 1.28
|
|
Change From Baseline in Individual Item Scores Using HIVTSQs at Weeks 24 and 48
Item 4, Without exposure, Week 48, n=319, 323
|
0.2 Scores on a scale
Standard Deviation 1.20
|
0.2 Scores on a scale
Standard Deviation 1.28
|
|
Change From Baseline in Individual Item Scores Using HIVTSQs at Weeks 24 and 48
Item 4, With exposure, Week 24, n=191, 193
|
0.1 Scores on a scale
Standard Deviation 0.73
|
0.0 Scores on a scale
Standard Deviation 0.80
|
|
Change From Baseline in Individual Item Scores Using HIVTSQs at Weeks 24 and 48
Item 4, With exposure, Week 48, n=191, 194
|
0.1 Scores on a scale
Standard Deviation 0.73
|
0.0 Scores on a scale
Standard Deviation 0.98
|
|
Change From Baseline in Individual Item Scores Using HIVTSQs at Weeks 24 and 48
Item 5, Without exposure, Week 24, n=319, 323
|
0.7 Scores on a scale
Standard Deviation 1.41
|
0.6 Scores on a scale
Standard Deviation 1.37
|
|
Change From Baseline in Individual Item Scores Using HIVTSQs at Weeks 24 and 48
Item 5, Without exposure, Week 48, n=319, 323
|
0.7 Scores on a scale
Standard Deviation 1.36
|
0.5 Scores on a scale
Standard Deviation 1.42
|
|
Change From Baseline in Individual Item Scores Using HIVTSQs at Weeks 24 and 48
Item 5, With exposure, Week 24, n=191, 193
|
0.0 Scores on a scale
Standard Deviation 0.58
|
0.1 Scores on a scale
Standard Deviation 0.72
|
|
Change From Baseline in Individual Item Scores Using HIVTSQs at Weeks 24 and 48
Item 5, With exposure, Week 48, n=191, 194
|
0.0 Scores on a scale
Standard Deviation 0.69
|
0.0 Scores on a scale
Standard Deviation 0.88
|
|
Change From Baseline in Individual Item Scores Using HIVTSQs at Weeks 24 and 48
Item 6, Without exposure, Week 24, n=319, 323
|
0.9 Scores on a scale
Standard Deviation 1.72
|
0.8 Scores on a scale
Standard Deviation 1.71
|
|
Change From Baseline in Individual Item Scores Using HIVTSQs at Weeks 24 and 48
Item 6, Without exposure, Week 48, n=319, 323
|
0.8 Scores on a scale
Standard Deviation 1.71
|
0.8 Scores on a scale
Standard Deviation 1.80
|
|
Change From Baseline in Individual Item Scores Using HIVTSQs at Weeks 24 and 48
Item 6, With exposure, Week 24, n=191, 193
|
0.2 Scores on a scale
Standard Deviation 0.96
|
0.1 Scores on a scale
Standard Deviation 0.90
|
|
Change From Baseline in Individual Item Scores Using HIVTSQs at Weeks 24 and 48
Item 6, With exposure, Week 48, n=191, 194
|
0.1 Scores on a scale
Standard Deviation 1.13
|
-0.1 Scores on a scale
Standard Deviation 1.12
|
|
Change From Baseline in Individual Item Scores Using HIVTSQs at Weeks 24 and 48
Item 7, Without exposure, Week 24, n=319, 323
|
0.3 Scores on a scale
Standard Deviation 0.78
|
0.2 Scores on a scale
Standard Deviation 0.98
|
|
Change From Baseline in Individual Item Scores Using HIVTSQs at Weeks 24 and 48
Item 7, Without exposure, Week 48, n=319, 323
|
0.2 Scores on a scale
Standard Deviation 0.94
|
0.2 Scores on a scale
Standard Deviation 0.92
|
|
Change From Baseline in Individual Item Scores Using HIVTSQs at Weeks 24 and 48
Item 7, With exposure, Week 24, n=191, 193
|
0.0 Scores on a scale
Standard Deviation 0.55
|
0.0 Scores on a scale
Standard Deviation 0.70
|
|
Change From Baseline in Individual Item Scores Using HIVTSQs at Weeks 24 and 48
Item 7, With exposure, Week 48, n=191, 194
|
0.1 Scores on a scale
Standard Deviation 0.73
|
0.1 Scores on a scale
Standard Deviation 0.69
|
|
Change From Baseline in Individual Item Scores Using HIVTSQs at Weeks 24 and 48
Item 8, Without exposure, Week 24, n=318, 322
|
0.5 Scores on a scale
Standard Deviation 1.31
|
0.6 Scores on a scale
Standard Deviation 1.30
|
|
Change From Baseline in Individual Item Scores Using HIVTSQs at Weeks 24 and 48
Item 8, Without exposure, Week 48, n=319, 323
|
0.5 Scores on a scale
Standard Deviation 1.31
|
0.5 Scores on a scale
Standard Deviation 1.41
|
|
Change From Baseline in Individual Item Scores Using HIVTSQs at Weeks 24 and 48
Item 8, With exposure, Week 24, n=191, 194
|
0.1 Scores on a scale
Standard Deviation 0.61
|
0.1 Scores on a scale
Standard Deviation 0.58
|
|
Change From Baseline in Individual Item Scores Using HIVTSQs at Weeks 24 and 48
Item 8, With exposure, Week 48, n=191, 194
|
0.0 Scores on a scale
Standard Deviation 0.64
|
0.0 Scores on a scale
Standard Deviation 0.80
|
|
Change From Baseline in Individual Item Scores Using HIVTSQs at Weeks 24 and 48
Item 9, Without exposure, Week 24, n=319, 322
|
0.4 Scores on a scale
Standard Deviation 1.16
|
0.4 Scores on a scale
Standard Deviation 1.30
|
|
Change From Baseline in Individual Item Scores Using HIVTSQs at Weeks 24 and 48
Item 9, Without exposure, Week 48, n=319, 323
|
0.4 Scores on a scale
Standard Deviation 1.23
|
0.3 Scores on a scale
Standard Deviation 1.36
|
|
Change From Baseline in Individual Item Scores Using HIVTSQs at Weeks 24 and 48
Item 9, With exposure, Week 24, n=191, 194
|
0.0 Scores on a scale
Standard Deviation 0.52
|
0.0 Scores on a scale
Standard Deviation 0.72
|
|
Change From Baseline in Individual Item Scores Using HIVTSQs at Weeks 24 and 48
Item 9, With exposure, Week 48, n=191, 194
|
0.1 Scores on a scale
Standard Deviation 0.55
|
0.0 Scores on a scale
Standard Deviation 0.85
|
|
Change From Baseline in Individual Item Scores Using HIVTSQs at Weeks 24 and 48
Item 10, Without exposure, Week 24, n=319, 322
|
0.8 Scores on a scale
Standard Deviation 1.44
|
0.9 Scores on a scale
Standard Deviation 1.50
|
|
Change From Baseline in Individual Item Scores Using HIVTSQs at Weeks 24 and 48
Item 10, Without exposure, Week 48, n=319, 323
|
0.8 Scores on a scale
Standard Deviation 1.52
|
0.7 Scores on a scale
Standard Deviation 1.63
|
|
Change From Baseline in Individual Item Scores Using HIVTSQs at Weeks 24 and 48
Item 10, With exposure, Week 24, n=191, 194
|
0.0 Scores on a scale
Standard Deviation 0.78
|
0.0 Scores on a scale
Standard Deviation 0.67
|
|
Change From Baseline in Individual Item Scores Using HIVTSQs at Weeks 24 and 48
Item 10, With exposure, Week 48, n=191, 194
|
0.0 Scores on a scale
Standard Deviation 0.79
|
0.0 Scores on a scale
Standard Deviation 0.77
|
|
Change From Baseline in Individual Item Scores Using HIVTSQs at Weeks 24 and 48
Item 11, Without exposure, Week 24, n=319, 322
|
0.4 Scores on a scale
Standard Deviation 1.22
|
0.4 Scores on a scale
Standard Deviation 1.25
|
|
Change From Baseline in Individual Item Scores Using HIVTSQs at Weeks 24 and 48
Item 11, Without exposure, Week 48, n=319, 323
|
0.4 Scores on a scale
Standard Deviation 1.26
|
0.3 Scores on a scale
Standard Deviation 1.31
|
|
Change From Baseline in Individual Item Scores Using HIVTSQs at Weeks 24 and 48
Item 11, With exposure, Week 24, n=191, 194
|
0.0 Scores on a scale
Standard Deviation 0.73
|
0.1 Scores on a scale
Standard Deviation 0.65
|
|
Change From Baseline in Individual Item Scores Using HIVTSQs at Weeks 24 and 48
Item 11, With exposure, Week 48, n=191, 194
|
0.0 Scores on a scale
Standard Deviation 0.62
|
-0.1 Scores on a scale
Standard Deviation 0.84
|
|
Change From Baseline in Individual Item Scores Using HIVTSQs at Weeks 24 and 48
Item 12, Without exposure, Week 24, n=319, 322
|
-0.4 Scores on a scale
Standard Deviation 1.46
|
-0.4 Scores on a scale
Standard Deviation 1.48
|
|
Change From Baseline in Individual Item Scores Using HIVTSQs at Weeks 24 and 48
Item 12, Without exposure, Week 48, n=319, 323
|
-0.3 Scores on a scale
Standard Deviation 1.46
|
-0.5 Scores on a scale
Standard Deviation 1.57
|
|
Change From Baseline in Individual Item Scores Using HIVTSQs at Weeks 24 and 48
Item 12, With exposure, Week 24, n=191, 194
|
-0.1 Scores on a scale
Standard Deviation 0.92
|
0.0 Scores on a scale
Standard Deviation 0.92
|
|
Change From Baseline in Individual Item Scores Using HIVTSQs at Weeks 24 and 48
Item 12, With exposure, Week 48, n=191, 194
|
-0.1 Scores on a scale
Standard Deviation 1.08
|
0.0 Scores on a scale
Standard Deviation 1.02
|
SECONDARY outcome
Timeframe: Week 48Population: ITT-E Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
The HIVTSQc is a 1-12 items questionnaire. Each item is scored -3 to 3. Total treatment satisfaction change score is computed using items 1 to 11 and are summed to produce a score with a possible range of -33 to 33. Higher the score, greater the improvement in satisfaction with treatment; the lower the score, the greater the deterioration in satisfaction with treatment. A score of 0 represented no change. LOCF was used as primary method of analysis. Total treatment satisfaction change score for participants who entered the current study from Q4W arm of ATLAS (NCT number: NCT02951052) and from either standard of care (SOC) arms of ATLAS or the new SOC participants) has been presented.
Outcome measures
| Measure |
CAB LA + RPV LA Q8W
n=522 Participants
Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
|
CAB LA + RPV LA Q4W
n=523 Participants
Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
|
|---|---|---|
|
Total Treatment Satisfaction Change Score Using HIV Treatment Satisfaction Change Questionnaire (HIVTSQc) at Week 48
Q4W ATLAS, n=124, 125
|
29.1 Scores on a scale
Standard Deviation 6.72
|
24.7 Scores on a scale
Standard Deviation 12.33
|
|
Total Treatment Satisfaction Change Score Using HIV Treatment Satisfaction Change Questionnaire (HIVTSQc) at Week 48
SOC, n=380, 382
|
28.9 Scores on a scale
Standard Deviation 7.68
|
27.3 Scores on a scale
Standard Deviation 9.50
|
SECONDARY outcome
Timeframe: Week 8 and Weeks 24 and 48Population: ITT-E Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
The PIN questionnaire explores bother of pain at injection site and injection site reactions (ISR), anxiety before and after injection, willingness to receive an HIV injectable treatment the following visit and satisfaction with mode of treatment administration of individuals receiving injection and perceptions of individuals associated with receiving injections. This measure contains 21 items that measure pain at injection site, local site reactions, impact on functioning and willingness to pursue injectable treatment outside of a clinical trial. Scores range from 1 to 5, and questions are phrased in such a way as to ensure that 1 always equated with the most favourable perception of vaccination, and 5 most unfavourable. Dimension scores include bother from ISR, leg movement, sleep and acceptability. Score of a domain is calculated as mean of all items within the domain. Higher scores represent worse perception of injection. LOCF was used as primary method of analysis.
Outcome measures
| Measure |
CAB LA + RPV LA Q8W
n=522 Participants
Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
|
CAB LA + RPV LA Q4W
n=523 Participants
Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
|
|---|---|---|
|
Change From Week 8 in Dimension Scores Using Perception of Injection (PIN) Questionnaire.
Bother of ISRs, Week 24, n=515, 515
|
-0.00 Scores on a scale
Standard Deviation 0.459
|
-0.01 Scores on a scale
Standard Deviation 0.509
|
|
Change From Week 8 in Dimension Scores Using Perception of Injection (PIN) Questionnaire.
Bother of ISRs, Week 48, n=515, 515
|
-0.00 Scores on a scale
Standard Deviation 0.531
|
0.01 Scores on a scale
Standard Deviation 0.543
|
|
Change From Week 8 in Dimension Scores Using Perception of Injection (PIN) Questionnaire.
Leg Movement, Week 24, n=515, 514
|
-0.11 Scores on a scale
Standard Deviation 0.804
|
-0.23 Scores on a scale
Standard Deviation 0.809
|
|
Change From Week 8 in Dimension Scores Using Perception of Injection (PIN) Questionnaire.
Leg Movement, Week 48, n=515, 514
|
-0.12 Scores on a scale
Standard Deviation 0.818
|
-0.24 Scores on a scale
Standard Deviation 0.789
|
|
Change From Week 8 in Dimension Scores Using Perception of Injection (PIN) Questionnaire.
Sleep, Week 24, n=515, 514
|
-0.00 Scores on a scale
Standard Deviation 0.772
|
-0.20 Scores on a scale
Standard Deviation 0.793
|
|
Change From Week 8 in Dimension Scores Using Perception of Injection (PIN) Questionnaire.
Sleep, Week 48, n=515, 514
|
-0.03 Scores on a scale
Standard Deviation 0.814
|
-0.18 Scores on a scale
Standard Deviation 0.804
|
|
Change From Week 8 in Dimension Scores Using Perception of Injection (PIN) Questionnaire.
Acceptance, Week 24, n=514, 515
|
-0.13 Scores on a scale
Standard Deviation 0.813
|
-0.13 Scores on a scale
Standard Deviation 0.837
|
|
Change From Week 8 in Dimension Scores Using Perception of Injection (PIN) Questionnaire.
Acceptance, Week 48, n=514, 515
|
-0.18 Scores on a scale
Standard Deviation 0.829
|
-0.13 Scores on a scale
Standard Deviation 0.880
|
SECONDARY outcome
Timeframe: Week 8 and Weeks 24 and 48Population: ITT-E Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
The PIN questionnaire explores the bother of pain at the injection site and ISRs, anxiety before and after injection, willingness to receive an HIV injectable treatment the following visit and satisfaction with the mode of treatment administration of individuals receiving injection and perceptions of individuals associated with receiving injections. This measure contains 21 items that measure pain at injection site, local site reactions, impact on functioning and willingness to pursue injectable treatment outside of a clinical trial. The items in the scale are rated on a 5-point scale ranging from 1(very dissatisfied, extremely, etc.) to 5 (very satisfied, not at all, etc.). Lower scores represent worse perception of injection. LOCF was used as primary method of analysis.
Outcome measures
| Measure |
CAB LA + RPV LA Q8W
n=522 Participants
Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
|
CAB LA + RPV LA Q4W
n=523 Participants
Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
|
|---|---|---|
|
Change From Week 8 in Individual Item Scores (Anxiety Before, Pain, Satisfaction, Anxiety After and Willingness) Using Perception of Injection (PIN) Questionnaire.
Anxiety before, Week 24, n=515, 515
|
0.0 Scores on a scale
Standard Deviation 0.83
|
-0.1 Scores on a scale
Standard Deviation 0.85
|
|
Change From Week 8 in Individual Item Scores (Anxiety Before, Pain, Satisfaction, Anxiety After and Willingness) Using Perception of Injection (PIN) Questionnaire.
Anxiety before, Week 48, n=515, 515
|
-0.1 Scores on a scale
Standard Deviation 0.82
|
-0.1 Scores on a scale
Standard Deviation 0.85
|
|
Change From Week 8 in Individual Item Scores (Anxiety Before, Pain, Satisfaction, Anxiety After and Willingness) Using Perception of Injection (PIN) Questionnaire.
Pain, Week 24, n=515, 515
|
0.1 Scores on a scale
Standard Deviation 0.83
|
0.1 Scores on a scale
Standard Deviation 0.84
|
|
Change From Week 8 in Individual Item Scores (Anxiety Before, Pain, Satisfaction, Anxiety After and Willingness) Using Perception of Injection (PIN) Questionnaire.
Pain, Week 48, n=515, 515
|
0.0 Scores on a scale
Standard Deviation 0.85
|
0.0 Scores on a scale
Standard Deviation 0.84
|
|
Change From Week 8 in Individual Item Scores (Anxiety Before, Pain, Satisfaction, Anxiety After and Willingness) Using Perception of Injection (PIN) Questionnaire.
Satisfaction, Week 24, n=514, 515
|
0.1 Scores on a scale
Standard Deviation 0.77
|
-0.0 Scores on a scale
Standard Deviation 0.77
|
|
Change From Week 8 in Individual Item Scores (Anxiety Before, Pain, Satisfaction, Anxiety After and Willingness) Using Perception of Injection (PIN) Questionnaire.
Satisfaction, Week 48, n=514, 515
|
-0.0 Scores on a scale
Standard Deviation 0.77
|
-0.0 Scores on a scale
Standard Deviation 0.84
|
|
Change From Week 8 in Individual Item Scores (Anxiety Before, Pain, Satisfaction, Anxiety After and Willingness) Using Perception of Injection (PIN) Questionnaire.
Anxiety after, Week 24, n=514, 515
|
-0.0 Scores on a scale
Standard Deviation 0.76
|
0.0 Scores on a scale
Standard Deviation 0.83
|
|
Change From Week 8 in Individual Item Scores (Anxiety Before, Pain, Satisfaction, Anxiety After and Willingness) Using Perception of Injection (PIN) Questionnaire.
Anxiety after, Week 48, n=514, 515
|
-0.1 Scores on a scale
Standard Deviation 0.79
|
-0.1 Scores on a scale
Standard Deviation 0.89
|
|
Change From Week 8 in Individual Item Scores (Anxiety Before, Pain, Satisfaction, Anxiety After and Willingness) Using Perception of Injection (PIN) Questionnaire.
Willingness, Week 24, n=514, 514
|
-0.1 Scores on a scale
Standard Deviation 0.55
|
-0.1 Scores on a scale
Standard Deviation 0.65
|
|
Change From Week 8 in Individual Item Scores (Anxiety Before, Pain, Satisfaction, Anxiety After and Willingness) Using Perception of Injection (PIN) Questionnaire.
Willingness, Week 48, n=514, 514
|
-0.0 Scores on a scale
Standard Deviation 0.66
|
-0.1 Scores on a scale
Standard Deviation 0.72
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Weeks 24 and 48Population: ITT-E Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
The ACCEPT questionnaire is a generic medication acceptance measure assessing how participants weigh advantages and disadvantages of long-term medication.The questionnaire consists of 25 items that capture six dimensions.3 questions that focus on general acceptance of study medication were analyzed.Items on the scale are rated as 1-5 scores:1:not at all acceptable,2:not very acceptable,3:somewhat acceptable, 4:totally acceptable and 5:I don't know.Total score of the dimension is calculated as the mean of recoded items of the dimension and then linearly transformed to be on a scale from 0 to 100:Total Score=(mean of the recoded items in the dimension minus1)divided by2\*100. LOCF was used as primary method of analysis. Data for participants without or with prior exposure has been presented. Baseline value is defined as last available value up to and including the Maintenance treatment. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Outcome measures
| Measure |
CAB LA + RPV LA Q8W
n=522 Participants
Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
|
CAB LA + RPV LA Q4W
n=523 Participants
Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
|
|---|---|---|
|
Change From Baseline in Treatment Acceptance a Using "General Acceptance" Dimension of the Chronic Treatment Acceptance (ACCEPT) Questionnaire in Participants With or Without Prior Exposure to CAB+RPV
Without exposure, Week 24, n=319, 323
|
6.0 Scores on a scale
Standard Deviation 27.96
|
4.0 Scores on a scale
Standard Deviation 33.53
|
|
Change From Baseline in Treatment Acceptance a Using "General Acceptance" Dimension of the Chronic Treatment Acceptance (ACCEPT) Questionnaire in Participants With or Without Prior Exposure to CAB+RPV
Without exposure, Week 48, n=319, 324
|
6.9 Scores on a scale
Standard Deviation 30.96
|
5.6 Scores on a scale
Standard Deviation 31.77
|
|
Change From Baseline in Treatment Acceptance a Using "General Acceptance" Dimension of the Chronic Treatment Acceptance (ACCEPT) Questionnaire in Participants With or Without Prior Exposure to CAB+RPV
With exposure, Week 24, n=192, 194
|
0.3 Scores on a scale
Standard Deviation 21.37
|
-1.7 Scores on a scale
Standard Deviation 21.79
|
|
Change From Baseline in Treatment Acceptance a Using "General Acceptance" Dimension of the Chronic Treatment Acceptance (ACCEPT) Questionnaire in Participants With or Without Prior Exposure to CAB+RPV
With exposure, Week 48, n=192, 194
|
-0.1 Scores on a scale
Standard Deviation 24.92
|
-2.7 Scores on a scale
Standard Deviation 24.25
|
SECONDARY outcome
Timeframe: Pre-dose at Weeks 4, 8, 16, 24, 32, 40 and 48Population: PK Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of CAB LA. PK Population comprises of all participants who received CAB and / or RPV and underwent PK sampling during the study and provide at least 1 non-missing CAB and / or RPV plasma concentration value (Non-quantifiable \[NQ\] values will be considered as non-missing values).
Outcome measures
| Measure |
CAB LA + RPV LA Q8W
n=521 Participants
Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
|
CAB LA + RPV LA Q4W
n=521 Participants
Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
|
|---|---|---|
|
Plasma Trough Concentration (Ctrough) for CAB LA Evaluable
Pre-dose, Week 4, n=314, 513
|
5.1543 Micrograms per milliliter
Interval 4.8702 to 5.455
|
4.0285 Micrograms per milliliter
Interval 3.8303 to 4.2369
|
|
Plasma Trough Concentration (Ctrough) for CAB LA Evaluable
Pre-dose, Week 8, n=516, 513
|
1.7938 Micrograms per milliliter
Interval 1.7007 to 1.892
|
1.9011 Micrograms per milliliter
Interval 1.7965 to 2.0119
|
|
Plasma Trough Concentration (Ctrough) for CAB LA Evaluable
Pre-dose, Week 16, n=512, 514
|
1.5983 Micrograms per milliliter
Interval 1.5223 to 1.6781
|
2.3358 Micrograms per milliliter
Interval 2.2436 to 2.4317
|
|
Plasma Trough Concentration (Ctrough) for CAB LA Evaluable
Pre-dose, Week 24, n=506, 510
|
1.5955 Micrograms per milliliter
Interval 1.5203 to 1.6744
|
2.5795 Micrograms per milliliter
Interval 2.4826 to 2.6802
|
|
Plasma Trough Concentration (Ctrough) for CAB LA Evaluable
Pre-dose, Week 32, n=499, 498
|
1.7414 Micrograms per milliliter
Interval 1.6612 to 1.8254
|
2.8529 Micrograms per milliliter
Interval 2.7408 to 2.9696
|
|
Plasma Trough Concentration (Ctrough) for CAB LA Evaluable
Pre-dose, Week 40, n=496, 497
|
1.7873 Micrograms per milliliter
Interval 1.7058 to 1.8727
|
2.9739 Micrograms per milliliter
Interval 2.8713 to 3.0801
|
|
Plasma Trough Concentration (Ctrough) for CAB LA Evaluable
Pre-dose, Week 48, n=494, 486
|
1.6747 Micrograms per milliliter
Interval 1.6033 to 1.7493
|
2.7449 Micrograms per milliliter
Interval 2.6492 to 2.8441
|
SECONDARY outcome
Timeframe: Pre-dose at Weeks 4, 8, 16, 24, 32, 40 and 48Population: PK Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Blood samples were collected at indicated time points for PK analysis of RPV LA.
Outcome measures
| Measure |
CAB LA + RPV LA Q8W
n=521 Participants
Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
|
CAB LA + RPV LA Q4W
n=521 Participants
Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
|
|---|---|---|
|
Plasma Ctrough for RPV LA Evaluable
Pre-dose, Week 4, n=315, 514
|
78.05 Nanograms per milliliters
Interval 73.32 to 83.09
|
78.60 Nanograms per milliliters
Interval 75.03 to 82.35
|
|
Plasma Ctrough for RPV LA Evaluable
Pre-dose, Week 8, n=515, 512
|
56.35 Nanograms per milliliters
Interval 53.73 to 59.09
|
57.95 Nanograms per milliliters
Interval 55.09 to 60.96
|
|
Plasma Ctrough for RPV LA Evaluable
Pre-dose, Week 16, n=512, 513
|
54.84 Nanograms per milliliters
Interval 52.55 to 57.22
|
68.12 Nanograms per milliliters
Interval 65.15 to 71.23
|
|
Plasma Ctrough for RPV LA Evaluable
Pre-dose, Week 24, n=506, 509
|
57.16 Nanograms per milliliters
Interval 54.77 to 59.66
|
75.76 Nanograms per milliliters
Interval 72.64 to 79.02
|
|
Plasma Ctrough for RPV LA Evaluable
Pre-dose, Week 32, n=498, 498
|
62.07 Nanograms per milliliters
Interval 59.54 to 64.71
|
85.76 Nanograms per milliliters
Interval 82.35 to 89.3
|
|
Plasma Ctrough for RPV LA Evaluable
Pre-dose, Week 40, n=497, 497
|
67.22 Nanograms per milliliters
Interval 64.58 to 69.97
|
89.49 Nanograms per milliliters
Interval 86.22 to 92.88
|
|
Plasma Ctrough for RPV LA Evaluable
Pre-dose, Week 48, n=495, 488
|
72.29 Nanograms per milliliters
Interval 69.5 to 75.19
|
97.22 Nanograms per milliliters
Interval 93.49 to 101.09
|
SECONDARY outcome
Timeframe: Predose at Weeks 4, 8, 13, 24, 32, 40, 48; 1 Week post-dose at Week 9 and 41Population: PK Population. Only those participants with data available at specified time points has been analyzed.
Blood samples were collected at indicated time points to analyze concentration in plasma for CAB LA. Participants who transitioned from ATLAS (201585 - NCT02951052) into this ATLAS-2M (207966) study had been treated with CAB + RPV for at least one year, were approaching steady state exposures, and were therefore excluded in order to focus the population analysis on those without prior exposure.
Outcome measures
| Measure |
CAB LA + RPV LA Q8W
n=321 Participants
Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
|
CAB LA + RPV LA Q4W
n=321 Participants
Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
|
|---|---|---|
|
Area Under the Curve (AUC) for CAB LA
|
3756.03 Micrograms*hours per milliliter
Interval 3648.02 to 3867.25
|
2449.75 Micrograms*hours per milliliter
Interval 2378.56 to 2523.07
|
SECONDARY outcome
Timeframe: Predose at Weeks 4, 8, 13, 24, 32, 40, 48; 1 Week post-dose at Week 9 and 41Population: PK Population. Only those participants with data available at specified time points has been analyzed.
Blood samples were collected at indicated time points to analyze concentration in plasma for RPV LA. Participants who transitioned from ATLAS (201585 - NCT02951052) into this ATLAS-2M (207966) study had been treated with CAB + RPV for at least one year, were approaching steady state exposures, and were therefore excluded in order to focus the population analysis on those without prior exposure.
Outcome measures
| Measure |
CAB LA + RPV LA Q8W
n=321 Participants
Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
|
CAB LA + RPV LA Q4W
n=320 Participants
Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
|
|---|---|---|
|
AUC for RPV LA
|
126467.59 Nanograms*hours per milliliter
Interval 122284.26 to 130794.04
|
70306.62 Nanograms*hours per milliliter
Interval 67814.64 to 72890.17
|
SECONDARY outcome
Timeframe: Predose at Weeks 4, 8, 13, 24, 32, 40, 48; 1 Week post-dose at Week 9 and 41Population: PK Population. Only those participants with data available at specified time points has been analyzed.
Blood samples were collected at indicated time points to analyze Cmax in plasma for CAB LA. Participants who transitioned from ATLAS (201585 - NCT02951052) into this ATLAS-2M (207966) study had been treated with CAB + RPV for at least one year, were approaching steady state exposures, and were therefore excluded in order to focus the population analysis on those without prior exposure.
Outcome measures
| Measure |
CAB LA + RPV LA Q8W
n=321 Participants
Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
|
CAB LA + RPV LA Q4W
n=321 Participants
Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
|
|---|---|---|
|
Maximum Concentration (Cmax) in Plasma for CAB LA Evaluable
|
3.976 Micrograms per milliliter
Interval 3.839 to 4.117
|
4.277 Micrograms per milliliter
Interval 4.14 to 4.418
|
SECONDARY outcome
Timeframe: Predose at Weeks 4, 8, 13, 24, 32, 40, 48; 1 Week post-dose at Week 9 and 41Population: PK Population. Only those participants with data available at specified time points has been analyzed.
Blood samples were collected at indicated time points to analyze Cmax in plasma for RPV LA. Participants who transitioned from ATLAS (201585 - NCT02951052) into this ATLAS-2M (207966) study had been treated with CAB + RPV for at least one year, were approaching steady state exposures, and were therefore excluded in order to focus the population analysis on those without prior exposure.
Outcome measures
| Measure |
CAB LA + RPV LA Q8W
n=321 Participants
Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
|
CAB LA + RPV LA Q4W
n=320 Participants
Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
|
|---|---|---|
|
Cmax in Plasma for RPV LA Evaluable
|
133.062 Nanograms per milliliter
Interval 128.452 to 137.837
|
124.279 Nanograms per milliliter
Interval 119.825 to 128.899
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to Week 48Population: PK Population. This was an exploratory Outcome Measure. Data will not be analyzed and reported.
Blood samples were planned to be collected at indicated time points for PK analysis of CAB LA and RPV LA. Demographic parameters including, but not limited to, age, sex, race, body weight, body mass index, and relevant laboratory parameters were planned to be evaluated as potential predictors of inter participant variability for pharmacokinetic parameters.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to Week 48Population: PK Population. This was an exploratory Outcome Measure. Data will not be analyzed and reported.
Blood samples were planned to be collected at indicated time points for PK analysis of CAB LA and RPV LA. Demographic parameters including, but not limited to, age, sex, race, body weight, body mass index, and relevant laboratory parameters were planned to be evaluated as potential predictors of intra participant variability for pharmacokinetic parameters.
Outcome measures
Outcome data not reported
Adverse Events
CAB LA + RPV LA Q8W
Serious events: 27 serious events
Other events: 429 other events
Deaths: 1 deaths
CAB LA + RPV LA Q4W
Serious events: 19 serious events
Other events: 427 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CAB LA + RPV LA Q8W
n=522 participants at risk
Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
|
CAB LA + RPV LA Q4W
n=523 participants at risk
Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
|
|---|---|---|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.19%
1/522 • Number of events 1 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
0.00%
0/523 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.19%
1/522 • Number of events 1 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
0.00%
0/523 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.19%
1/522 • Number of events 1 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
0.00%
0/523 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.19%
1/522 • Number of events 1 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
0.00%
0/523 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/522 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
0.19%
1/523 • Number of events 1 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.19%
1/522 • Number of events 1 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
0.00%
0/523 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
|
General disorders
Chest pain
|
0.19%
1/522 • Number of events 1 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
0.00%
0/523 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/522 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
0.19%
1/523 • Number of events 1 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/522 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
0.19%
1/523 • Number of events 1 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.19%
1/522 • Number of events 1 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
0.00%
0/523 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
|
Infections and infestations
Pneumonia
|
0.38%
2/522 • Number of events 2 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
0.38%
2/523 • Number of events 2 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
|
Infections and infestations
Acute hepatitis B
|
0.19%
1/522 • Number of events 1 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
0.19%
1/523 • Number of events 1 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
|
Infections and infestations
Appendicitis
|
0.38%
2/522 • Number of events 2 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
0.00%
0/523 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
|
Infections and infestations
Abdominal abscess
|
0.19%
1/522 • Number of events 1 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
0.00%
0/523 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
|
Infections and infestations
Acute hepatitis C
|
0.00%
0/522 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
0.19%
1/523 • Number of events 1 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
|
Infections and infestations
Anal abscess
|
0.19%
1/522 • Number of events 1 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
0.00%
0/523 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/522 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
0.19%
1/523 • Number of events 1 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
|
Infections and infestations
Epiglottitis obstructive
|
0.19%
1/522 • Number of events 1 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
0.00%
0/523 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
|
Infections and infestations
Erysipelas
|
0.19%
1/522 • Number of events 1 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
0.00%
0/523 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
|
Infections and infestations
Gastritis viral
|
0.00%
0/522 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
0.19%
1/523 • Number of events 1 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
|
Infections and infestations
Gastroenteritis Escherichia coli
|
0.19%
1/522 • Number of events 1 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
0.00%
0/523 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
|
Infections and infestations
Infectious pleural effusion
|
0.19%
1/522 • Number of events 1 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
0.00%
0/523 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
|
Infections and infestations
Injection site abscess
|
0.19%
1/522 • Number of events 1 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
0.00%
0/523 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
|
Infections and infestations
Peritonsillar abscess
|
0.19%
1/522 • Number of events 1 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
0.00%
0/523 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
|
Infections and infestations
Sepsis
|
0.19%
1/522 • Number of events 1 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
0.00%
0/523 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
|
Infections and infestations
Septic shock
|
0.19%
1/522 • Number of events 1 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
0.00%
0/523 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
|
Infections and infestations
Sialoadenitis
|
0.00%
0/522 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
0.19%
1/523 • Number of events 1 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/522 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
0.19%
1/523 • Number of events 1 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
|
Infections and infestations
Urinary tract infection
|
0.19%
1/522 • Number of events 1 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
0.00%
0/523 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
|
Infections and infestations
Wound infection
|
0.00%
0/522 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
0.19%
1/523 • Number of events 1 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.38%
2/522 • Number of events 2 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
0.00%
0/523 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
|
Gastrointestinal disorders
Anal fistula
|
0.19%
1/522 • Number of events 1 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
0.00%
0/523 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/522 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
0.19%
1/523 • Number of events 1 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
|
Gastrointestinal disorders
Haematemesis
|
0.19%
1/522 • Number of events 1 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
0.00%
0/523 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
|
Gastrointestinal disorders
Oroantral fistula
|
0.19%
1/522 • Number of events 1 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
0.00%
0/523 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
|
Gastrointestinal disorders
Pancreatic pseudocyst
|
0.19%
1/522 • Number of events 1 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
0.00%
0/523 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.19%
1/522 • Number of events 1 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
0.00%
0/523 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.19%
1/522 • Number of events 1 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
0.19%
1/523 • Number of events 1 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.19%
1/522 • Number of events 1 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
0.00%
0/523 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/522 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
0.19%
1/523 • Number of events 1 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
|
Nervous system disorders
Cerebral infarction
|
0.19%
1/522 • Number of events 1 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
0.00%
0/523 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/522 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
0.19%
1/523 • Number of events 1 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
|
Nervous system disorders
Epilepsy
|
0.19%
1/522 • Number of events 1 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
0.00%
0/523 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
|
Nervous system disorders
Presyncope
|
0.19%
1/522 • Number of events 1 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
0.00%
0/523 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/522 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
0.19%
1/523 • Number of events 1 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.19%
1/522 • Number of events 1 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
0.00%
0/523 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.19%
1/522 • Number of events 1 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
0.00%
0/523 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/522 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
0.19%
1/523 • Number of events 1 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma
|
0.19%
1/522 • Number of events 1 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
0.00%
0/523 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
|
0.00%
0/522 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
0.19%
1/523 • Number of events 1 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
|
Psychiatric disorders
Bipolar disorder
|
0.19%
1/522 • Number of events 1 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
0.00%
0/523 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
|
Psychiatric disorders
Drug dependence
|
0.00%
0/522 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
0.19%
1/523 • Number of events 1 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
|
Psychiatric disorders
Major depression
|
0.19%
1/522 • Number of events 1 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
0.00%
0/523 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
|
Psychiatric disorders
Substance-induced psychotic disorder
|
0.19%
1/522 • Number of events 1 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
0.00%
0/523 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.19%
1/522 • Number of events 1 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
0.00%
0/523 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.19%
1/522 • Number of events 1 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
0.00%
0/523 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/522 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
0.19%
1/523 • Number of events 1 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
|
Reproductive system and breast disorders
Priapism
|
0.00%
0/522 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
0.19%
1/523 • Number of events 1 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
|
Vascular disorders
Deep vein thrombosis
|
0.19%
1/522 • Number of events 1 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
0.00%
0/523 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
Other adverse events
| Measure |
CAB LA + RPV LA Q8W
n=522 participants at risk
Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
|
CAB LA + RPV LA Q4W
n=523 participants at risk
Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
|
|---|---|---|
|
General disorders
Injection site pain
|
71.1%
371/522 • Number of events 2014 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
69.4%
363/523 • Number of events 2568 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
|
General disorders
Injection site nodule
|
10.3%
54/522 • Number of events 113 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
17.0%
89/523 • Number of events 204 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
|
General disorders
Injection site induration
|
7.9%
41/522 • Number of events 86 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
7.5%
39/523 • Number of events 96 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
|
General disorders
Injection site discomfort
|
6.9%
36/522 • Number of events 92 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
7.8%
41/523 • Number of events 110 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
|
General disorders
Pyrexia
|
5.4%
28/522 • Number of events 46 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
8.4%
44/523 • Number of events 70 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
|
General disorders
Injection site swelling
|
6.1%
32/522 • Number of events 70 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
5.2%
27/523 • Number of events 45 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
|
General disorders
Injection site pruritus
|
5.2%
27/522 • Number of events 63 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
4.8%
25/523 • Number of events 55 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
|
General disorders
Fatigue
|
2.5%
13/522 • Number of events 18 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
6.3%
33/523 • Number of events 41 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
|
Infections and infestations
Nasopharyngitis
|
13.6%
71/522 • Number of events 86 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
14.1%
74/523 • Number of events 101 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
|
Infections and infestations
Upper respiratory tract infection
|
9.6%
50/522 • Number of events 65 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
13.6%
71/523 • Number of events 99 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
|
Infections and infestations
Gastroenteritis
|
3.1%
16/522 • Number of events 17 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
5.4%
28/523 • Number of events 28 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
|
Infections and infestations
Pharyngitis
|
3.1%
16/522 • Number of events 16 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
5.4%
28/523 • Number of events 31 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
|
Nervous system disorders
Headache
|
6.7%
35/522 • Number of events 45 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
6.9%
36/523 • Number of events 53 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.3%
33/522 • Number of events 35 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
7.1%
37/523 • Number of events 39 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.4%
28/522 • Number of events 32 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
5.5%
29/523 • Number of events 39 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.3%
17/522 • Number of events 17 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
5.5%
29/523 • Number of events 30 • Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis
Non-SAEs and SAEs were collected in Safety Population.
|
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