Trial Outcomes & Findings for Study to Evaluate Switching From Regimens Consisting of a Ritonavir-boosted Protease Inhibitor (PI) and Two Nucleoside Reverse Transcriptase Inhibitors (NRTIs) to a Fixed-dose Tablet Containing Emtricitabine/Rilpivirine/Tenofovir DF (NCT NCT01252940)
NCT ID: NCT01252940
Last Updated: 2015-12-04
Results Overview
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 24 was analyzed using the FDA snapshot analysis.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
482 participants
Primary outcome timeframe
Week 24
Results posted on
2015-12-04
Participant Flow
Participants were enrolled at 110 sites in the North America and Europe. The first participant was screened on 17 November 2010. The last participant observation was on 28 October 2014.
617 participants were screened.
Participant milestones
| Measure |
FTC/RPV/TDF
Participants were randomized to switch from their existing treatment regimen to the emtricitabine (FTC)/rilpivirine (RPV)/tenofovir disoproxil fumarate (TDF) single-tablet regimen (STR) at the beginning of the study.
|
SBR/Delayed Switch
Participants were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study through Week 24, and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
|
|---|---|---|
|
Main Study Phase
STARTED
|
321
|
161
|
|
Main Study Phase
Completed 24 Weeks
|
0
|
153
|
|
Main Study Phase
COMPLETED
|
295
|
149
|
|
Main Study Phase
NOT COMPLETED
|
26
|
12
|
|
Extension Phase
STARTED
|
110
|
49
|
|
Extension Phase
COMPLETED
|
100
|
46
|
|
Extension Phase
NOT COMPLETED
|
10
|
3
|
Reasons for withdrawal
| Measure |
FTC/RPV/TDF
Participants were randomized to switch from their existing treatment regimen to the emtricitabine (FTC)/rilpivirine (RPV)/tenofovir disoproxil fumarate (TDF) single-tablet regimen (STR) at the beginning of the study.
|
SBR/Delayed Switch
Participants were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study through Week 24, and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
|
|---|---|---|
|
Main Study Phase
Randomized but not treated
|
4
|
2
|
|
Main Study Phase
Adverse Event
|
3
|
1
|
|
Main Study Phase
Lack of Efficacy
|
1
|
0
|
|
Main Study Phase
Lost to Follow-up
|
6
|
1
|
|
Main Study Phase
Physician Decision
|
1
|
0
|
|
Main Study Phase
Protocol Violation
|
4
|
2
|
|
Main Study Phase
Withdrawal by Subject
|
6
|
5
|
|
Main Study Phase
Subject Non-compliance
|
1
|
1
|
|
Extension Phase
Adverse Event
|
2
|
1
|
|
Extension Phase
Lack of Efficacy
|
1
|
0
|
|
Extension Phase
Lost to Follow-up
|
5
|
0
|
|
Extension Phase
Physician Decision
|
0
|
1
|
|
Extension Phase
Subject Non-compliance
|
1
|
0
|
|
Extension Phase
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Study to Evaluate Switching From Regimens Consisting of a Ritonavir-boosted Protease Inhibitor (PI) and Two Nucleoside Reverse Transcriptase Inhibitors (NRTIs) to a Fixed-dose Tablet Containing Emtricitabine/Rilpivirine/Tenofovir DF
Baseline characteristics by cohort
| Measure |
FTC/RPV/TDF
n=317 Participants
Participants were randomized to switch from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study.
|
SBR/Delayed Switch
n=159 Participants
Participants were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study through Week 24, and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
|
Total
n=476 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41 years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
43 years
STANDARD_DEVIATION 9.7 • n=7 Participants
|
42 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
273 Participants
n=5 Participants
|
144 Participants
n=7 Participants
|
417 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
51 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
264 Participants
n=5 Participants
|
128 Participants
n=7 Participants
|
392 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
241 participants
n=5 Participants
|
124 participants
n=7 Participants
|
365 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
61 participants
n=5 Participants
|
22 participants
n=7 Participants
|
83 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
6 participants
n=5 Participants
|
2 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
6 participants
n=5 Participants
|
9 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
18 participants
n=5 Participants
|
8 participants
n=7 Participants
|
26 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
15 participants
n=5 Participants
|
13 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
15 participants
n=5 Participants
|
10 participants
n=7 Participants
|
25 participants
n=5 Participants
|
|
Region of Enrollment
France
|
29 participants
n=5 Participants
|
14 participants
n=7 Participants
|
43 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
31 participants
n=5 Participants
|
12 participants
n=7 Participants
|
43 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
16 participants
n=5 Participants
|
10 participants
n=7 Participants
|
26 participants
n=5 Participants
|
|
Region of Enrollment
Puerto Rico
|
16 participants
n=5 Participants
|
2 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
15 participants
n=5 Participants
|
5 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
17 participants
n=5 Participants
|
6 participants
n=7 Participants
|
23 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
149 participants
n=5 Participants
|
81 participants
n=7 Participants
|
230 participants
n=5 Participants
|
|
Baseline HIV-1 RNA Category
< 50 Copies/mL
|
299 participants
n=5 Participants
|
152 participants
n=7 Participants
|
451 participants
n=5 Participants
|
|
Baseline HIV-1 RNA Category
50 to < 200 Copies/mL
|
10 participants
n=5 Participants
|
6 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Baseline HIV-1 RNA Category
200 to < 400 Copies/mL
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Baseline HIV-1 RNA Category
400 to < 1000 Copies/mL
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Baseline HIV-1 RNA Category
≥ 1000 Copies/mL
|
4 participants
n=5 Participants
|
1 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Stratification based on antiretroviral (ARV) use
TDF or FTC/TDF + lopinavir (LPV)/ritonavir (RTV)
|
82 participants
n=5 Participants
|
49 participants
n=7 Participants
|
131 participants
n=5 Participants
|
|
Stratification based on antiretroviral (ARV) use
TDF or FTC/TDF + Other PI+RTV
|
178 participants
n=5 Participants
|
81 participants
n=7 Participants
|
259 participants
n=5 Participants
|
|
Stratification based on antiretroviral (ARV) use
Non-TDF-containing regimen + LPV/RTV
|
15 participants
n=5 Participants
|
9 participants
n=7 Participants
|
24 participants
n=5 Participants
|
|
Stratification based on antiretroviral (ARV) use
Non-TDF-containing regimen + Other PI+RTV
|
42 participants
n=5 Participants
|
20 participants
n=7 Participants
|
62 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 24Population: Full Analysis Set: participants who were randomized into the study and received at least one dose of study drug.
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 24 was analyzed using the FDA snapshot analysis.
Outcome measures
| Measure |
FTC/RPV/TDF
n=317 Participants
Participants were randomized to switch from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study.
|
SBR/Delayed Switch
n=159 Participants
Participants were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study through Week 24, and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
|
|---|---|---|
|
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 (FDA Snapshot Analysis)
|
93.7 percentage of participants
|
89.9 percentage of participants
|
SECONDARY outcome
Timeframe: Week 48Population: Participants in the Full Analysis Set in the FTC/RPV/TDF and the Delayed Switch to FTC/RPV/TDF groups were analyzed.
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed using the FDA snapshot analysis. By Week 48, participants FTC/RPV/TDF had received 48 weeks of treatment with FTC/RPV/TDF, while those in the SBR/Delayed Switch group had received only 24 weeks of treatment with FTC/RPV/TDF.
Outcome measures
| Measure |
FTC/RPV/TDF
n=317 Participants
Participants were randomized to switch from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study.
|
SBR/Delayed Switch
n=152 Participants
Participants were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study through Week 24, and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
|
|---|---|---|
|
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 (FDA Snapshot Analysis)
|
89.3 percentage of participants
|
92.1 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Participants in the Full Analysis Set who had CD4 measurements at both baseline and Week 24 were analyzed.
The mean (SD) change in CD4 count was analyzed from baseline through Week 24.
Outcome measures
| Measure |
FTC/RPV/TDF
n=298 Participants
Participants were randomized to switch from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study.
|
SBR/Delayed Switch
n=148 Participants
Participants were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study through Week 24, and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
|
|---|---|---|
|
Change From Baseline in Cluster of Differentiation 4 (CD4) Count Through Week 24
|
20 cells/mm^3
Standard Deviation 149.3
|
32 cells/mm^3
Standard Deviation 158.1
|
SECONDARY outcome
Timeframe: Baseline to Week 48Population: Participants in the Full Analysis Set who had CD4 measurements at both baseline and Week 48 were analyzed.
The mean (SD) change in CD4 count was analyzed from baseline through Week 48. By Week 48, participants FTC/RPV/TDF had received 48 weeks of treatment with FTC/RPV/TDF, while those in the SBR/Delayed Switch group had received only 24 weeks of treatment with FTC/RPV/TDF.
Outcome measures
| Measure |
FTC/RPV/TDF
n=287 Participants
Participants were randomized to switch from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study.
|
SBR/Delayed Switch
n=143 Participants
Participants were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study through Week 24, and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
|
|---|---|---|
|
Change From Baseline in CD4 Count Through Week 48
|
10 cells/mm^3
Standard Deviation 144.1
|
-7 cells/mm^3
Standard Deviation 154.1
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Participants in the Safety Analysis Set who had measurements for total cholesterol at both baseline and Week 24 were analyzed.
The mean (SD) change from baseline in fasting total cholesterol (mg/dL) through Week 24 was analyzed.
Outcome measures
| Measure |
FTC/RPV/TDF
n=269 Participants
Participants were randomized to switch from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study.
|
SBR/Delayed Switch
n=134 Participants
Participants were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study through Week 24, and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
|
|---|---|---|
|
Change From Baseline in Fasting Total Cholesterol Through Week 24
|
-25 mg/dL
Standard Deviation 30.2
|
-1 mg/dL
Standard Deviation 25.9
|
SECONDARY outcome
Timeframe: Baseline to Week 48Population: Participants in the Safety Analysis Set who had measurements for total cholesterol at both baseline and Week 48 were analyzed.
The mean (SD) change from baseline in fasting total cholesterol (mg/dL) through Week 48 was analyzed. By Week 48, participants FTC/RPV/TDF had received 48 weeks of treatment with FTC/RPV/TDF, while those in the SBR/Delayed Switch group had received only 24 weeks of treatment with FTC/RPV/TDF.
Outcome measures
| Measure |
FTC/RPV/TDF
n=265 Participants
Participants were randomized to switch from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study.
|
SBR/Delayed Switch
n=139 Participants
Participants were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study through Week 24, and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
|
|---|---|---|
|
Change From Baseline in Fasting Total Cholesterol Through Week 48
|
-24 mg/dL
Standard Deviation 32.9
|
-24 mg/dL
Standard Deviation 32.0
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Participants in the Safety Analysis Set who had measurements for HDL cholesterol at both baseline and Week 24 were analyzed.
The mean (SD) change from baseline in fasting HDL cholesterol (mg/dL) through Week 24 was analyzed.
Outcome measures
| Measure |
FTC/RPV/TDF
n=269 Participants
Participants were randomized to switch from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study.
|
SBR/Delayed Switch
n=134 Participants
Participants were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study through Week 24, and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
|
|---|---|---|
|
Change From Baseline in Fasting High-density Lipoprotein (HDL) Cholesterol Through Week 24
|
-4 mg/dL
Standard Deviation 10.3
|
-1 mg/dL
Standard Deviation 8.2
|
SECONDARY outcome
Timeframe: Baseline to Week 48Population: Participants in the Safety Analysis Set who had measurements for HDL cholesterol at both baseline and Week 48 were analyzed.
The mean (SD) change from baseline in fasting HDL cholesterol (mg/dL) through Week 48 was analyzed. By Week 48, participants FTC/RPV/TDF had received 48 weeks of treatment with FTC/RPV/TDF, while those in the SBR/Delayed Switch group had received only 24 weeks of treatment with FTC/RPV/TDF.
Outcome measures
| Measure |
FTC/RPV/TDF
n=265 Participants
Participants were randomized to switch from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study.
|
SBR/Delayed Switch
n=139 Participants
Participants were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study through Week 24, and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
|
|---|---|---|
|
Change From Baseline in Fasting HDL Cholesterol Through Week 48
|
-2 mg/dL
Standard Deviation 11.6
|
-2 mg/dL
Standard Deviation 8.0
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Participants in the Safety Analysis Set who had measurements for direct LDL cholesterol at both baseline and Week 24 were analyzed.
The mean (SD) change from baseline in fasting direct LDL cholesterol (mg/dL) through Week 24 was analyzed.
Outcome measures
| Measure |
FTC/RPV/TDF
n=270 Participants
Participants were randomized to switch from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study.
|
SBR/Delayed Switch
n=134 Participants
Participants were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study through Week 24, and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
|
|---|---|---|
|
Change From Baseline in Fasting Direct Low-density Lipoprotein (LDL) Cholesterol Through Week 24
|
-16 mg/dL
Standard Deviation 25.6
|
0 mg/dL
Standard Deviation 23.7
|
SECONDARY outcome
Timeframe: Baseline to Week 48Population: Participants in the Safety Analysis Set who had measurements for direct LDL cholesterol at both baseline and Week 48 were analyzed.
The mean (SD) change from baseline in fasting direct LDL cholesterol (mg/dL) through Week 48 was analyzed. By Week 48, participants FTC/RPV/TDF had received 48 weeks of treatment with FTC/RPV/TDF, while those in the SBR/Delayed Switch group had received only 24 weeks of treatment with FTC/RPV/TDF.
Outcome measures
| Measure |
FTC/RPV/TDF
n=265 Participants
Participants were randomized to switch from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study.
|
SBR/Delayed Switch
n=139 Participants
Participants were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study through Week 24, and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
|
|---|---|---|
|
Change From Baseline in Fasting Direct LDL Cholesterol Through Week 48
|
-16 mg/dL
Standard Deviation 27.1
|
-14 mg/dL
Standard Deviation 26.8
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Participants in the Safety Analysis Set who had measurements for triglycerides at both baseline and Week 24 were analyzed.
The mean (SD) change from baseline in fasting triglycerides through Week 24 was analyzed.
Outcome measures
| Measure |
FTC/RPV/TDF
n=269 Participants
Participants were randomized to switch from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study.
|
SBR/Delayed Switch
n=134 Participants
Participants were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study through Week 24, and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
|
|---|---|---|
|
Change From Baseline in Fasting Triglycerides Through Week 24
|
-53 mg/dL
Standard Deviation 110.0
|
3 mg/dL
Standard Deviation 100.1
|
SECONDARY outcome
Timeframe: Baseline to Week 48Population: Participants in the Safety Analysis Set who had measurements for triglycerides at both baseline and Week 48 were analyzed.
The mean (SD) change from baseline in fasting triglycerides through Week 48 was analyzed. By Week 48, participants FTC/RPV/TDF had received 48 weeks of treatment with FTC/RPV/TDF, while those in the SBR/Delayed Switch group had received only 24 weeks of treatment with FTC/RPV/TDF.
Outcome measures
| Measure |
FTC/RPV/TDF
n=265 Participants
Participants were randomized to switch from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study.
|
SBR/Delayed Switch
n=139 Participants
Participants were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study through Week 24, and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
|
|---|---|---|
|
Change From Baseline in Fasting Triglycerides Through Week 48
|
-64 mg/dL
Standard Deviation 126.4
|
-80 mg/dL
Standard Deviation 141.1
|
Adverse Events
FTC/RPV/TDF
Serious events: 21 serious events
Other events: 150 other events
Deaths: 0 deaths
SBR/Delayed Switch (up to Week 24)
Serious events: 8 serious events
Other events: 38 other events
Deaths: 0 deaths
SBR/Delayed Switch (After Week 24)
Serious events: 9 serious events
Other events: 59 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
FTC/RPV/TDF
n=317 participants at risk
The adverse events reported in this group are those that occurred at any time during the study in participants who were randomized to switch from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study.
|
SBR/Delayed Switch (up to Week 24)
n=159 participants at risk
The adverse events reported in this group are those that occurred in the first 24 weeks of the study in participants who were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
|
SBR/Delayed Switch (After Week 24)
n=152 participants at risk
The adverse events reported in this group are those that occurred after Week 24 in participants who were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study and switch to the FTC/RPV/TDF STR (Delayed Switch) at Week 24 visit.
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.32%
1/317 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/159 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/152 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.32%
1/317 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/159 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/152 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Arthritis reactive
|
0.00%
0/317 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/159 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.66%
1/152 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.32%
1/317 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/159 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/152 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/317 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/159 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.66%
1/152 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Cardiac disorders
Myocardial infarction
|
0.32%
1/317 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/159 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/152 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Cardiac disorders
Palpitations
|
0.00%
0/317 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/159 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.66%
1/152 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/317 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.63%
1/159 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/152 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/317 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/159 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.66%
1/152 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Pancreatitis
|
0.32%
1/317 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/159 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/152 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
General disorders
Chest pain
|
0.32%
1/317 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/159 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.66%
1/152 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
General disorders
Pyrexia
|
0.32%
1/317 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.63%
1/159 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/152 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Hepatobiliary disorders
Cholecystitis
|
0.32%
1/317 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/159 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/152 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/317 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.63%
1/159 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/152 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Anal abscess
|
0.32%
1/317 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/159 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/152 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Cellulitis
|
0.32%
1/317 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/159 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/152 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/317 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.63%
1/159 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/152 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Lung infection
|
0.32%
1/317 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/159 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/152 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.32%
1/317 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/159 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/152 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Pneumonia
|
0.95%
3/317 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/159 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/152 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Pneumonia bacterial
|
0.32%
1/317 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/159 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/152 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Shigella infection
|
0.00%
0/317 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.63%
1/159 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/152 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/317 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/159 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.66%
1/152 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Urosepsis
|
0.00%
0/317 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.63%
1/159 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/152 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Viral infection
|
0.32%
1/317 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/159 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/152 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/317 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.63%
1/159 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/152 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Fall
|
0.32%
1/317 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/159 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/152 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.32%
1/317 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/159 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/152 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/317 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/159 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.66%
1/152 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Stab wound
|
0.00%
0/317 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.63%
1/159 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/152 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/317 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/159 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.66%
1/152 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.32%
1/317 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/159 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/152 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
0.00%
0/317 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.63%
1/159 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/152 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of thyroid gland
|
0.32%
1/317 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/159 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/152 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Nervous system disorders
Hypoaesthesia
|
0.32%
1/317 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/159 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/152 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/317 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/159 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.66%
1/152 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Nervous system disorders
Sensory loss
|
0.00%
0/317 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/159 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.66%
1/152 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Psychiatric disorders
Bipolar disorder
|
0.32%
1/317 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/159 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/152 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Psychiatric disorders
Substance-induced mood disorder
|
0.32%
1/317 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/159 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/152 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Psychiatric disorders
Suicidal ideation
|
0.32%
1/317 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/159 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.66%
1/152 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Renal and urinary disorders
Nephropathy toxic
|
0.32%
1/317 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/159 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/152 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Renal and urinary disorders
Renal impairment
|
0.32%
1/317 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/159 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/152 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Reproductive system and breast disorders
Prostatism
|
0.00%
0/317 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/159 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.66%
1/152 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.32%
1/317 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/159 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/152 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.32%
1/317 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/159 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/152 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.32%
1/317 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/159 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.66%
1/152 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.32%
1/317 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/159 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/152 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Vascular disorders
Arterial occlusive disease
|
0.32%
1/317 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/159 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/152 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
Other adverse events
| Measure |
FTC/RPV/TDF
n=317 participants at risk
The adverse events reported in this group are those that occurred at any time during the study in participants who were randomized to switch from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study.
|
SBR/Delayed Switch (up to Week 24)
n=159 participants at risk
The adverse events reported in this group are those that occurred in the first 24 weeks of the study in participants who were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
|
SBR/Delayed Switch (After Week 24)
n=152 participants at risk
The adverse events reported in this group are those that occurred after Week 24 in participants who were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study and switch to the FTC/RPV/TDF STR (Delayed Switch) at Week 24 visit.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
10.7%
34/317 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
5.0%
8/159 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
3.9%
6/152 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Nausea
|
4.1%
13/317 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
3.1%
5/159 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
6.6%
10/152 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
General disorders
Fatigue
|
6.9%
22/317 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
3.1%
5/159 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
2.6%
4/152 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Nasopharyngitis
|
11.0%
35/317 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
5.0%
8/159 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
7.9%
12/152 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Upper respiratory tract infection
|
4.7%
15/317 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
3.1%
5/159 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
8.6%
13/152 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.7%
18/317 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
1.3%
2/159 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
2.0%
3/152 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.1%
13/317 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
3.8%
6/159 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
5.3%
8/152 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Nervous system disorders
Headache
|
9.8%
31/317 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
3.8%
6/159 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
3.9%
6/152 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Psychiatric disorders
Depression
|
5.7%
18/317 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
2.5%
4/159 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
3.9%
6/152 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Psychiatric disorders
Insomnia
|
6.6%
21/317 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
1.9%
3/159 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
5.9%
9/152 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.3%
23/317 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.63%
1/159 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
1.3%
2/152 • Baseline through end of study (average 54 weeks)
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
- Publication restrictions are in place
Restriction type: OTHER