Trial Outcomes & Findings for Phase 3 Open-Label Study to Evaluate Switching From Optimized Stable Antiretroviral Regimens Containing Darunavir to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Fixed Dose Combination (FDC) Plus Darunavir (DRV) in Treatment Experienced HIV-1 Positive Adults (NCT NCT01968551)
NCT ID: NCT01968551
Last Updated: 2018-11-16
Results Overview
The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
158 participants
Primary outcome timeframe
Week 24
Results posted on
2018-11-16
Participant Flow
Participants were enrolled at study sites in the United States and Canada. The first participant was screened on 3 September 2013. The last study visit occurred on 09 July 2016.
231 participants were screened.
Participant milestones
| Measure |
Cohort 1: E/C/F/TAF+DRV
Open-Label (OL) Phase: Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya®; E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus Darunavir (DRV) (800 mg) tablet administered orally once daily for up to 48 weeks
Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus Darunavir (DRV) (800 mg) tablet administered orally once daily
|
Cohort 2: E/C/F/TAF+DRV
Open-Label Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily for up to 48 weeks
Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily
|
Cohort 2: Stay on Baseline Regimen (SBR)
Open-Label Phase: Participants stayed on their baseline DRV- containing regimen administered according to the prescribing information for up to 48 weeks.
Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily
|
|---|---|---|---|
|
Open Label Phase (48 Weeks)
STARTED
|
22
|
90
|
46
|
|
Open Label Phase (48 Weeks)
COMPLETED
|
20
|
87
|
41
|
|
Open Label Phase (48 Weeks)
NOT COMPLETED
|
2
|
3
|
5
|
|
Extension Phase
STARTED
|
20
|
87
|
34
|
|
Extension Phase
COMPLETED
|
19
|
86
|
30
|
|
Extension Phase
NOT COMPLETED
|
1
|
1
|
4
|
Reasons for withdrawal
| Measure |
Cohort 1: E/C/F/TAF+DRV
Open-Label (OL) Phase: Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya®; E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus Darunavir (DRV) (800 mg) tablet administered orally once daily for up to 48 weeks
Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus Darunavir (DRV) (800 mg) tablet administered orally once daily
|
Cohort 2: E/C/F/TAF+DRV
Open-Label Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily for up to 48 weeks
Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily
|
Cohort 2: Stay on Baseline Regimen (SBR)
Open-Label Phase: Participants stayed on their baseline DRV- containing regimen administered according to the prescribing information for up to 48 weeks.
Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily
|
|---|---|---|---|
|
Open Label Phase (48 Weeks)
Randomized but Never Treated
|
1
|
1
|
0
|
|
Open Label Phase (48 Weeks)
Investigator's Discretion
|
0
|
1
|
0
|
|
Open Label Phase (48 Weeks)
Withdrew Consent
|
1
|
1
|
3
|
|
Open Label Phase (48 Weeks)
Lost to Follow-up
|
0
|
0
|
2
|
|
Extension Phase
Adverse Event
|
0
|
0
|
2
|
|
Extension Phase
Death
|
0
|
1
|
0
|
|
Extension Phase
Withdrew Consent
|
0
|
0
|
1
|
|
Extension Phase
Lost to Follow-up
|
1
|
0
|
1
|
Baseline Characteristics
Phase 3 Open-Label Study to Evaluate Switching From Optimized Stable Antiretroviral Regimens Containing Darunavir to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Fixed Dose Combination (FDC) Plus Darunavir (DRV) in Treatment Experienced HIV-1 Positive Adults
Baseline characteristics by cohort
| Measure |
Cohort 1: E/C/F/TAF+DRV
n=21 Participants
Open-Label Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily with food for up to 48 weeks
Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily
|
Cohort 2: E/C/F/TAF+DRV
n=89 Participants
Open-Label Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily with food for up to 48 weeks
Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily
|
Cohort 2: SBR
n=46 Participants
Open-Label Phase: Participants stayed on their baseline DRV- containing regimen administered according to the prescribing information for up to 48 weeks
Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily
|
Total
n=156 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
53 Years
STANDARD_DEVIATION 5.7 • n=5 Participants
|
49 Years
STANDARD_DEVIATION 8.2 • n=7 Participants
|
47 Years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
49 Years
STANDARD_DEVIATION 8.4 • n=4 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
114 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black
|
12 participants
n=5 Participants
|
35 participants
n=7 Participants
|
26 participants
n=5 Participants
|
73 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
9 participants
n=5 Participants
|
51 participants
n=7 Participants
|
17 participants
n=5 Participants
|
77 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Not Permitted
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
3 participants
n=5 Participants
|
3 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
2 participants
n=5 Participants
|
12 participants
n=7 Participants
|
7 participants
n=5 Participants
|
21 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
19 participants
n=5 Participants
|
77 participants
n=7 Participants
|
39 participants
n=5 Participants
|
135 participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
0 participants
n=5 Participants
|
9 participants
n=7 Participants
|
3 participants
n=5 Participants
|
12 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=5 Participants
|
80 participants
n=7 Participants
|
43 participants
n=5 Participants
|
144 participants
n=4 Participants
|
|
HIV-1 RNA Category
< 50 copies/mL
|
19 participants
n=5 Participants
|
87 participants
n=7 Participants
|
46 participants
n=5 Participants
|
152 participants
n=4 Participants
|
|
HIV-1 RNA Category
≥ 50 copies/mL
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
0 participants
n=5 Participants
|
4 participants
n=4 Participants
|
|
CD4 Cell Count
|
700 cells/µL
STANDARD_DEVIATION 372.5 • n=5 Participants
|
562 cells/µL
STANDARD_DEVIATION 260.8 • n=7 Participants
|
571 cells/µL
STANDARD_DEVIATION 245.2 • n=5 Participants
|
583 cells/µL
STANDARD_DEVIATION 275.9 • n=4 Participants
|
|
CD4 Cell Count Category
< 200 cells/µL
|
1 participants
n=5 Participants
|
5 participants
n=7 Participants
|
1 participants
n=5 Participants
|
7 participants
n=4 Participants
|
|
CD4 Cell Count Category
≥ 200 to < 350 cells/µL
|
3 participants
n=5 Participants
|
15 participants
n=7 Participants
|
7 participants
n=5 Participants
|
25 participants
n=4 Participants
|
|
CD4 Cell Count Category
≥ 350 cells/µL
|
17 participants
n=5 Participants
|
69 participants
n=7 Participants
|
38 participants
n=5 Participants
|
124 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Week 24Population: Full Analysis Set (FAS) in Cohort 2, included all participants who (1) were randomized to Cohort 2 and (2) received at least 1 dose of study drug during the open-label Phase.
The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Outcome measures
| Measure |
Cohort 2: E/C/F/TAF+DRV
n=89 Participants
Open-Label Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily for up to 48 weeks
Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily
|
Cohort 2: Stay on Baseline Regimen (SBR)
n=46 Participants
Open-Label Phase: Participants stayed on their baseline DRV- containing regimen administered according to the prescribing information for up to 48 weeks.
Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily
|
|---|---|---|
|
Percentage of Participants in Each Treatment Arm in Cohort 2 With HIV-1 RNA < 50 Copies/mL at Week 24
|
96.6 percentage of participants
|
91.3 percentage of participants
|
SECONDARY outcome
Timeframe: Week 48Population: Full Analysis Set included participants who (1) were randomized into Cohort 2 and (2) had received at least one dose of study drug during the OL phase of the study.
The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Outcome measures
| Measure |
Cohort 2: E/C/F/TAF+DRV
n=89 Participants
Open-Label Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily for up to 48 weeks
Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily
|
Cohort 2: Stay on Baseline Regimen (SBR)
n=46 Participants
Open-Label Phase: Participants stayed on their baseline DRV- containing regimen administered according to the prescribing information for up to 48 weeks.
Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily
|
|---|---|---|
|
Percentage of Participants in Each Treatment Arm in Cohort 2 With HIV-1 RNA < 50 Copies/mL at Week 48
|
94.4 percentage of participants
|
76.1 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline; Week 24Population: Full Analysis Set (FAS) included participants who (1) were randomized into Cohort 2 and (2) had received at least one dose of study drug during the OL phase of the study. Participants with available data were analyzed.
Outcome measures
| Measure |
Cohort 2: E/C/F/TAF+DRV
n=88 Participants
Open-Label Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily for up to 48 weeks
Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily
|
Cohort 2: Stay on Baseline Regimen (SBR)
n=42 Participants
Open-Label Phase: Participants stayed on their baseline DRV- containing regimen administered according to the prescribing information for up to 48 weeks.
Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily
|
|---|---|---|
|
Change From Baseline in CD4+ Cell Count at Week 24
|
23 cells/μL
Standard Deviation 155.2
|
12 cells/μL
Standard Deviation 100.9
|
SECONDARY outcome
Timeframe: Baseline; Week 48Population: Full Analysis Set (FAS) included participants who (1) were randomized into Cohort 2 and (2) had received at least one dose of study drug during the OL phase of the study. Participants with available data were analyzed.
Outcome measures
| Measure |
Cohort 2: E/C/F/TAF+DRV
n=85 Participants
Open-Label Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily for up to 48 weeks
Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily
|
Cohort 2: Stay on Baseline Regimen (SBR)
n=39 Participants
Open-Label Phase: Participants stayed on their baseline DRV- containing regimen administered according to the prescribing information for up to 48 weeks.
Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily
|
|---|---|---|
|
Change From Baseline in CD4+ Cell Count at Week 48
|
5 cells/μL
Standard Deviation 162.6
|
41 cells/μL
Standard Deviation 104.2
|
Adverse Events
Cohort 1: E/C/F/TAF+DRV
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Cohort 2: E/C/F/TAF+DRV
Serious events: 9 serious events
Other events: 56 other events
Deaths: 0 deaths
Cohort 2: SBR
Serious events: 1 serious events
Other events: 28 other events
Deaths: 0 deaths
All E/C/F/TAF
Serious events: 20 serious events
Other events: 104 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1: E/C/F/TAF+DRV
n=21 participants at risk
Open-Label Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily with food for up to 48 weeks
Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily
|
Cohort 2: E/C/F/TAF+DRV
n=89 participants at risk
Open-Label Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily with food for up to 48 weeks
Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily
|
Cohort 2: SBR
n=46 participants at risk
Open-Label Phase: Participants stayed on their baseline DRV- containing regimen administered according to the prescribing information for up to 48 weeks.
Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily
|
All E/C/F/TAF
n=144 participants at risk
Open- label or Extension Phase: All participants received E/C/F/TAF.
|
|---|---|---|---|---|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/21 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
0.00%
0/89 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
0.00%
0/46 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
0.69%
1/144 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/21 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
0.00%
0/89 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
0.00%
0/46 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
0.69%
1/144 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/21 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
0.00%
0/89 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
0.00%
0/46 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
0.69%
1/144 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/21 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
0.00%
0/89 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
0.00%
0/46 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
0.69%
1/144 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/21 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
1.1%
1/89 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
0.00%
0/46 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
0.69%
1/144 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/21 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
1.1%
1/89 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
0.00%
0/46 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
0.69%
1/144 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/21 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
1.1%
1/89 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
0.00%
0/46 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
0.69%
1/144 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.00%
0/21 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
1.1%
1/89 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
0.00%
0/46 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
0.69%
1/144 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/21 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
1.1%
1/89 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
0.00%
0/46 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
1.4%
2/144 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
|
General disorders
Chest pain
|
0.00%
0/21 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
1.1%
1/89 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
0.00%
0/46 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
1.4%
2/144 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
|
General disorders
Death
|
0.00%
0/21 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
0.00%
0/89 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
0.00%
0/46 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
0.69%
1/144 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/21 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
1.1%
1/89 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
0.00%
0/46 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
0.69%
1/144 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/21 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
1.1%
1/89 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
0.00%
0/46 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
0.69%
1/144 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/21 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
1.1%
1/89 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
0.00%
0/46 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
0.69%
1/144 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/21 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
1.1%
1/89 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
0.00%
0/46 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
0.69%
1/144 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/21 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
0.00%
0/89 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
0.00%
0/46 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
0.69%
1/144 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
|
Infections and infestations
Gastroenteritis clostridial
|
0.00%
0/21 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
1.1%
1/89 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
0.00%
0/46 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
0.69%
1/144 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
|
Infections and infestations
Pneumonia bacterial
|
4.8%
1/21 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
0.00%
0/89 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
0.00%
0/46 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
0.69%
1/144 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
|
Infections and infestations
Sepsis
|
0.00%
0/21 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
1.1%
1/89 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
0.00%
0/46 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
0.69%
1/144 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/21 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
1.1%
1/89 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
0.00%
0/46 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
0.69%
1/144 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/21 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
0.00%
0/89 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
0.00%
0/46 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
0.69%
1/144 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
|
Injury, poisoning and procedural complications
Splenic rupture
|
0.00%
0/21 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
1.1%
1/89 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
0.00%
0/46 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
0.69%
1/144 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/21 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
0.00%
0/89 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
0.00%
0/46 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
0.69%
1/144 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.00%
0/21 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
0.00%
0/89 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
2.2%
1/46 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
0.00%
0/144 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/21 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
0.00%
0/89 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
0.00%
0/46 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
0.69%
1/144 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma
|
0.00%
0/21 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
1.1%
1/89 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
0.00%
0/46 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
0.69%
1/144 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/21 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
0.00%
0/89 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
0.00%
0/46 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
0.69%
1/144 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
|
Nervous system disorders
Syncope
|
0.00%
0/21 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
1.1%
1/89 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
0.00%
0/46 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
0.69%
1/144 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
|
Psychiatric disorders
Alcohol abuse
|
0.00%
0/21 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
1.1%
1/89 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
0.00%
0/46 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
0.69%
1/144 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.00%
0/21 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
1.1%
1/89 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
0.00%
0/46 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
0.69%
1/144 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/21 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
0.00%
0/89 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
0.00%
0/46 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
0.69%
1/144 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
|
Psychiatric disorders
Substance abuse
|
0.00%
0/21 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
0.00%
0/89 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
0.00%
0/46 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
0.69%
1/144 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/21 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
1.1%
1/89 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
0.00%
0/46 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
0.69%
1/144 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/21 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
0.00%
0/89 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
0.00%
0/46 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
0.69%
1/144 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
|
Vascular disorders
Hypotension
|
0.00%
0/21 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
0.00%
0/89 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
0.00%
0/46 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
0.69%
1/144 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
Other adverse events
| Measure |
Cohort 1: E/C/F/TAF+DRV
n=21 participants at risk
Open-Label Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily with food for up to 48 weeks
Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily
|
Cohort 2: E/C/F/TAF+DRV
n=89 participants at risk
Open-Label Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily with food for up to 48 weeks
Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily
|
Cohort 2: SBR
n=46 participants at risk
Open-Label Phase: Participants stayed on their baseline DRV- containing regimen administered according to the prescribing information for up to 48 weeks.
Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily
|
All E/C/F/TAF
n=144 participants at risk
Open- label or Extension Phase: All participants received E/C/F/TAF.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/21 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
5.6%
5/89 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
4.3%
2/46 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
4.2%
6/144 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/21 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
5.6%
5/89 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
0.00%
0/46 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
4.9%
7/144 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/21 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
4.5%
4/89 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
8.7%
4/46 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
6.9%
10/144 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
9.5%
2/21 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
2.2%
2/89 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
2.2%
1/46 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
4.9%
7/144 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/21 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
5.6%
5/89 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
0.00%
0/46 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
5.6%
8/144 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/21 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
3.4%
3/89 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
4.3%
2/46 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
6.9%
10/144 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
|
General disorders
Fatigue
|
0.00%
0/21 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
4.5%
4/89 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
4.3%
2/46 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
5.6%
8/144 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
|
Infections and infestations
Acute sinusitis
|
19.0%
4/21 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
1.1%
1/89 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
0.00%
0/46 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
6.2%
9/144 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
|
Infections and infestations
Bronchitis
|
14.3%
3/21 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
6.7%
6/89 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
2.2%
1/46 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
9.7%
14/144 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
|
Infections and infestations
Influenza
|
0.00%
0/21 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
1.1%
1/89 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
6.5%
3/46 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
2.1%
3/144 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/21 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
6.7%
6/89 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
4.3%
2/46 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
5.6%
8/144 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
|
Infections and infestations
Oral candidiasis
|
9.5%
2/21 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
1.1%
1/89 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
0.00%
0/46 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
2.1%
3/144 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
|
Infections and infestations
Otitis media
|
9.5%
2/21 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
3.4%
3/89 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
0.00%
0/46 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
4.9%
7/144 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/21 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
5.6%
5/89 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
2.2%
1/46 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
4.9%
7/144 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
|
Infections and infestations
Sinusitis
|
14.3%
3/21 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
6.7%
6/89 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
8.7%
4/46 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
10.4%
15/144 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
|
Infections and infestations
Upper respiratory tract infection
|
14.3%
3/21 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
11.2%
10/89 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
4.3%
2/46 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
18.8%
27/144 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
4.8%
1/21 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
4.5%
4/89 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
4.3%
2/46 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
5.6%
8/144 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.5%
2/21 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
3.4%
3/89 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
4.3%
2/46 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
4.9%
7/144 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/21 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
12.4%
11/89 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
6.5%
3/46 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
8.3%
12/144 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
4.8%
1/21 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
2.2%
2/89 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
6.5%
3/46 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
4.2%
6/144 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.8%
1/21 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
5.6%
5/89 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
2.2%
1/46 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
5.6%
8/144 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/21 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
4.5%
4/89 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
8.7%
4/46 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
4.9%
7/144 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
|
Nervous system disorders
Headache
|
4.8%
1/21 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
6.7%
6/89 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
0.00%
0/46 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
11.1%
16/144 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
|
Nervous system disorders
Hypoaesthesia
|
9.5%
2/21 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
1.1%
1/89 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
0.00%
0/46 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
2.8%
4/144 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
|
Psychiatric disorders
Depression
|
9.5%
2/21 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
2.2%
2/89 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
0.00%
0/46 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
5.6%
8/144 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/21 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
4.5%
4/89 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
2.2%
1/46 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
6.2%
9/144 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.8%
1/21 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
4.5%
4/89 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
6.5%
3/46 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
6.9%
10/144 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
|
Vascular disorders
Hypertension
|
0.00%
0/21 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
4.5%
4/89 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
0.00%
0/46 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
5.6%
8/144 • Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Safety Analysis Set included all participants in: * Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase * Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase * All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER