Trial Outcomes & Findings for Study of Novel Antiretrovirals in Participants With HIV-1 (NCT NCT05585307)
NCT ID: NCT05585307
Last Updated: 2025-05-08
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
49 participants
Primary outcome timeframe
Baseline, Day 11
Results posted on
2025-05-08
Participant Flow
100 participants were screened. Participants were enrolled at study sites in the United States, Thailand, and Dominican Republic.
Efficacy outcome measures (OM) included an additional cohort of Placebo. In this study, none of the participants received placebo. Placebo arm included 21 participants with HIV-1 from 3 other Gilead Phase 1b studies (GS-US-120-0104, GS-US-141-1219 (NCT02275065), and GS-US-200-4072 (NCT03739866)). Each bavtavirine, GS-1720, and GS-6212 cohort was compared to the pooled placebo cohort in the efficacy OMs #1, 2, and 17.
Participant milestones
| Measure |
Substudy 02: Cohort 4: GS-1720 900 mg
Participants received a single dose of GS-1720 900 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 03: Cohort 1: GS- 6212 100 mg
Participants received GS-6212 100 mg tablet orally, twice daily on Days 1 through 10. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 25.
|
Substudy 01: Cohort 1: Bavtavirine 675 mg (High-Fat Meal)
Participants received a single dose of bavtavirine 675 mg, tablets, orally, with a high-fat meal on Day 1. After assessments on Day 11 or upon early termination (ET), the participants initiated an oral regimen of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF), or an alternative standard of care (SOC) antiretroviral therapy (ART) regimen (example integrase strand-transfer inhibitor (INSTI) + nucleoside reverse transcriptase inhibitor (NRTIs): Dolutegravir/abacavir/lamivudine (DTG/ABC/3TC) or DTG/3TC), orally up to Day 39.
|
Substudy 01: Cohort 2: Bavtavirine 1200 mg (Low-Fat Meal)
Participants received a single dose of bavtavirine 1200 mg, tablets, orally, with a low-fat meal on Day 1. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 39.
|
Substudy 01: Cohort 3: Bavtavirine 900 mg (High-Fat Meal)
Participants received a single dose of bavtavirine 900 mg, tablets, orally, with a high-fat meal on Days 1 and 2. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 39.
|
Substudy 02: Cohort 1: GS-1720 450 mg
Participants received a single dose of GS-1720 450 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 02: Cohort 2: GS-1720 150 mg
Participants received a single dose of GS-1720 150 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 02: Cohort 3: GS-1720 30 mg
Participants received a single dose of GS-1720 30 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
8
|
6
|
6
|
1
|
7
|
7
|
7
|
|
Overall Study
COMPLETED
|
6
|
8
|
6
|
6
|
1
|
7
|
7
|
7
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Substudy 02: Cohort 4: GS-1720 900 mg
Participants received a single dose of GS-1720 900 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 03: Cohort 1: GS- 6212 100 mg
Participants received GS-6212 100 mg tablet orally, twice daily on Days 1 through 10. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 25.
|
Substudy 01: Cohort 1: Bavtavirine 675 mg (High-Fat Meal)
Participants received a single dose of bavtavirine 675 mg, tablets, orally, with a high-fat meal on Day 1. After assessments on Day 11 or upon early termination (ET), the participants initiated an oral regimen of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF), or an alternative standard of care (SOC) antiretroviral therapy (ART) regimen (example integrase strand-transfer inhibitor (INSTI) + nucleoside reverse transcriptase inhibitor (NRTIs): Dolutegravir/abacavir/lamivudine (DTG/ABC/3TC) or DTG/3TC), orally up to Day 39.
|
Substudy 01: Cohort 2: Bavtavirine 1200 mg (Low-Fat Meal)
Participants received a single dose of bavtavirine 1200 mg, tablets, orally, with a low-fat meal on Day 1. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 39.
|
Substudy 01: Cohort 3: Bavtavirine 900 mg (High-Fat Meal)
Participants received a single dose of bavtavirine 900 mg, tablets, orally, with a high-fat meal on Days 1 and 2. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 39.
|
Substudy 02: Cohort 1: GS-1720 450 mg
Participants received a single dose of GS-1720 450 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 02: Cohort 2: GS-1720 150 mg
Participants received a single dose of GS-1720 150 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 02: Cohort 3: GS-1720 30 mg
Participants received a single dose of GS-1720 30 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Study of Novel Antiretrovirals in Participants With HIV-1
Baseline characteristics by cohort
| Measure |
Substudy 02: Cohort 4: GS-1720 900 mg
n=7 Participants
Participants received a single dose of GS-1720 900 mg tablet, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 03: Cohort 1: GS- 6212 100 mg
n=8 Participants
Participants received GS-6212 100 mg tablet, orally, twice daily on Days 1 through 10. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 25.
|
Total
n=49 Participants
Total of all reporting groups
|
Substudy 01: Cohort 1: Bavtavirine 675 mg (High-Fat Meal)
n=6 Participants
Participants received a single dose of bavtavirine 675 mg tablet, orally, with a high-fat meal on Day 1. After assessments on Day 11 or upon early termination (ET), the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 39.
|
Substudy 01: Cohort 2: Bavtavirine 1200 mg (Low-Fat Meal)
n=6 Participants
Participants received a single dose of bavtavirine 1200 mg tablet, orally, with a low-fat meal on Day 1. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 39.
|
Substudy 01: Cohort 3: Bavtavirine 900 mg (High-Fat Meal)
n=1 Participants
Participants received a single dose of bavtavirine 900 mg tablet, orally, with a high-fat meal on Days 1 and 2. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 39.
|
Substudy 02: Cohort 1: GS-1720 450 mg
n=7 Participants
Participants received a single dose of GS-1720 450 mg tablet, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 02: Cohort 2: GS-1720 150 mg
n=7 Participants
Participants received a single dose of GS-1720 150 mg tablet, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 02: Cohort 3: GS-1720 30 mg
n=7 Participants
Participants received a single dose of GS-1720 30 mg tablet, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=8 Participants
|
8 Participants
n=24 Participants
|
47 Participants
n=42 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Age, Continuous
|
32 years
STANDARD_DEVIATION 6.5 • n=8 Participants
|
33 years
STANDARD_DEVIATION 11.9 • n=24 Participants
|
36 years
STANDARD_DEVIATION 11.6 • n=42 Participants
|
34 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
38 years
STANDARD_DEVIATION 13.9 • n=7 Participants
|
31 years
STANDARD_DEVIATION NA • n=5 Participants
|
35 years
STANDARD_DEVIATION 13.9 • n=4 Participants
|
42 years
STANDARD_DEVIATION 13.5 • n=21 Participants
|
39 years
STANDARD_DEVIATION 13.0 • n=8 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
8 Participants
n=42 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=8 Participants
|
7 Participants
n=24 Participants
|
41 Participants
n=42 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
19 Participants
n=42 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
30 Participants
n=42 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
16 Participants
n=42 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
18 Participants
n=42 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
8 Participants
n=42 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
3 Participants
n=8 Participants
|
7 Participants
n=24 Participants
|
42 Participants
n=42 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
|
Region of Enrollment
Dominican Republic
|
3 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
|
Region of Enrollment
Thailand
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 11Population: Participants in the Full Analysis Set with data available were analyzed. The Full Analysis Set included all participants who were enrolled and received full dose(s) of study drugs bavtavirine, GS-1720 and GS-6212 in these substudies. The placebo arm included pooled data from participants who received placebo in 3 historical Gilead HIV-1 phase 1b studies (GS-US-120-0104, GS-US-141-1219, and GS-US-200-4072) for HIV-1 efficacy parameters only.
Outcome measures
| Measure |
Substudy 01: Cohort 2: Bavtavirine 1200 mg (Low-Fat Meal)
n=6 Participants
Participants received a single dose of bavtavirine 1200 mg, tablets, orally, with a low-fat meal on Day 1. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 39.
|
Substudy 01: Cohort 3: Bavtavirine 900 mg (High-Fat Meal)
n=1 Participants
Participants received a single dose of bavtavirine 900 mg, tablets, orally, with a high-fat meal on Days 1 and 2. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 39.
|
Substudy 02: Cohort 1: GS-1720 450 mg
n=7 Participants
Participants received a single dose of GS-1720 450 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 02: Cohort 2: GS-1720 150 mg
n=7 Participants
Participants received a single dose of GS-1720 150 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 02: Cohort 3: GS-1720 30 mg
n=7 Participants
Participants received a single dose of GS-1720 30 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 02: Cohort 4: GS-1720 900 mg
n=7 Participants
Participants received a single dose of GS-1720 900 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 03: Cohort 1: GS- 6212 100 mg
n=8 Participants
Participants received GS-6212 100 mg tablet orally twice daily on Days 1 through 10. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 25.
|
Substudy 01: Cohort 1: Bavtavirine 675 mg (High-Fat Meal)
n=6 Participants
Participants received a single dose of bavtavirine 675 mg, tablets, orally, with a high-fat meal on Day 1. After assessments on Day 11 or upon early termination (ET), the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 39.
|
Placebo
n=21 Participants
Historical data for the placebo participants from 3 sponsor Phase 1b studies (GS-US-120-0104, GS-US-141-1219, and GS-US-200-4072) were combined to form a single placebo group for the purpose of analysis. For Study GS-US-200-4072, HIV-1 RNA (log10 copies/mL) collected on Day 10 was used for "Day 11", since HIV-1 RNA was not collected on Day 11 for this study. Each GS-1720 cohort was compared to the pooled placebo group with respect to the change from baseline in plasma HIV-1 RNA (log10 copies/mL) on Day 11.
|
|---|---|---|---|---|---|---|---|---|---|
|
Substudies 01, 02 and 03: Change From Baseline in Plasma Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) (log10 Copies/mL) at Day 11 Relative to Historical Placebo Data
Baseline
|
4.68 log10 copies/mL
Standard Deviation 0.488
|
4.27 log10 copies/mL
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
5.16 log10 copies/mL
Standard Deviation 0.562
|
4.72 log10 copies/mL
Standard Deviation 0.362
|
4.52 log10 copies/mL
Standard Deviation 0.565
|
4.93 log10 copies/mL
Standard Deviation 0.366
|
4.41 log10 copies/mL
Standard Deviation 0.850
|
4.68 log10 copies/mL
Standard Deviation 0.517
|
4.43 log10 copies/mL
Standard Deviation 0.508
|
|
Substudies 01, 02 and 03: Change From Baseline in Plasma Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) (log10 Copies/mL) at Day 11 Relative to Historical Placebo Data
Change from Baseline at Day 11
|
-1.46 log10 copies/mL
Standard Deviation 0.690
|
-1.54 log10 copies/mL
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
-2.44 log10 copies/mL
Standard Deviation 0.425
|
-2.18 log10 copies/mL
Standard Deviation 0.199
|
-1.74 log10 copies/mL
Standard Deviation 0.766
|
-2.37 log10 copies/mL
Standard Deviation 0.509
|
-2.43 log10 copies/mL
Standard Deviation 0.698
|
-1.40 log10 copies/mL
Standard Deviation 0.454
|
0.01 log10 copies/mL
Standard Deviation 0.338
|
SECONDARY outcome
Timeframe: Baseline, Day 8Population: Participants in the Full Analysis Set with available data were analyzed. The placebo arm included pooled data from participants who received placebo in 3 historical Gilead HIV-1 phase 1b studies (GS-US-120-0104, GS-US-141-1219, and GS-US-200-4072) for HIV-1 efficacy parameters only.
Outcome measures
| Measure |
Substudy 01: Cohort 2: Bavtavirine 1200 mg (Low-Fat Meal)
n=6 Participants
Participants received a single dose of bavtavirine 1200 mg, tablets, orally, with a low-fat meal on Day 1. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 39.
|
Substudy 01: Cohort 3: Bavtavirine 900 mg (High-Fat Meal)
n=1 Participants
Participants received a single dose of bavtavirine 900 mg, tablets, orally, with a high-fat meal on Days 1 and 2. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 39.
|
Substudy 02: Cohort 1: GS-1720 450 mg
n=7 Participants
Participants received a single dose of GS-1720 450 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 02: Cohort 2: GS-1720 150 mg
n=7 Participants
Participants received a single dose of GS-1720 150 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 02: Cohort 3: GS-1720 30 mg
n=7 Participants
Participants received a single dose of GS-1720 30 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 02: Cohort 4: GS-1720 900 mg
n=7 Participants
Participants received a single dose of GS-1720 900 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 03: Cohort 1: GS- 6212 100 mg
n=8 Participants
Participants received GS-6212 100 mg tablet orally twice daily on Days 1 through 10. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 25.
|
Substudy 01: Cohort 1: Bavtavirine 675 mg (High-Fat Meal)
n=6 Participants
Participants received a single dose of bavtavirine 675 mg, tablets, orally, with a high-fat meal on Day 1. After assessments on Day 11 or upon early termination (ET), the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 39.
|
Placebo
n=21 Participants
Historical data for the placebo participants from 3 sponsor Phase 1b studies (GS-US-120-0104, GS-US-141-1219, and GS-US-200-4072) were combined to form a single placebo group for the purpose of analysis. For Study GS-US-200-4072, HIV-1 RNA (log10 copies/mL) collected on Day 10 was used for "Day 11", since HIV-1 RNA was not collected on Day 11 for this study. Each GS-1720 cohort was compared to the pooled placebo group with respect to the change from baseline in plasma HIV-1 RNA (log10 copies/mL) on Day 11.
|
|---|---|---|---|---|---|---|---|---|---|
|
Substudies 01, 02 and 03: Change From Baseline in Plasma HIV-1 RNA (log10 Copies/mL) at Day 8 Relative to Historical Placebo Data
Baseline
|
4.68 log10 copies/mL
Standard Deviation 0.488
|
4.27 log10 copies/mL
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
5.16 log10 copies/mL
Standard Deviation 0.562
|
4.72 log10 copies/mL
Standard Deviation 0.362
|
4.52 log10 copies/mL
Standard Deviation 0.565
|
4.93 log10 copies/mL
Standard Deviation 0.366
|
4.41 log10 copies/mL
Standard Deviation 0.850
|
4.68 log10 copies/mL
Standard Deviation 0.517
|
4.43 log10 copies/mL
Standard Deviation 0.508
|
|
Substudies 01, 02 and 03: Change From Baseline in Plasma HIV-1 RNA (log10 Copies/mL) at Day 8 Relative to Historical Placebo Data
Change from Baseline at Day 8
|
-1.54 log10 copies/mL
Standard Deviation 0.497
|
-1.51 log10 copies/mL
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
-2.04 log10 copies/mL
Standard Deviation 0.346
|
-1.76 log10 copies/mL
Standard Deviation 0.185
|
-1.67 log10 copies/mL
Standard Deviation 0.326
|
-1.98 log10 copies/mL
Standard Deviation 0.249
|
-2.10 log10 copies/mL
Standard Deviation 0.417
|
-1.49 log10 copies/mL
Standard Deviation 0.239
|
0.01 log10 copies/mL
Standard Deviation 0.297
|
SECONDARY outcome
Timeframe: First dose up to last dose (Substudy 01: Up to Day 39; Substudy 02: Up to Day 60; Substudy 03: Up to Day 25)Population: Participants in the Safety Analysis Set were analyzed.
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs were defined as any AEs with an onset date on or after the study drug start date. Percentages were rounded-off.
Outcome measures
| Measure |
Substudy 01: Cohort 2: Bavtavirine 1200 mg (Low-Fat Meal)
n=6 Participants
Participants received a single dose of bavtavirine 1200 mg, tablets, orally, with a low-fat meal on Day 1. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 39.
|
Substudy 01: Cohort 3: Bavtavirine 900 mg (High-Fat Meal)
n=1 Participants
Participants received a single dose of bavtavirine 900 mg, tablets, orally, with a high-fat meal on Days 1 and 2. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 39.
|
Substudy 02: Cohort 1: GS-1720 450 mg
n=7 Participants
Participants received a single dose of GS-1720 450 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 02: Cohort 2: GS-1720 150 mg
n=7 Participants
Participants received a single dose of GS-1720 150 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 02: Cohort 3: GS-1720 30 mg
n=7 Participants
Participants received a single dose of GS-1720 30 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 02: Cohort 4: GS-1720 900 mg
n=7 Participants
Participants received a single dose of GS-1720 900 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 03: Cohort 1: GS- 6212 100 mg
n=8 Participants
Participants received GS-6212 100 mg tablet orally twice daily on Days 1 through 10. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 25.
|
Substudy 01: Cohort 1: Bavtavirine 675 mg (High-Fat Meal)
n=6 Participants
Participants received a single dose of bavtavirine 675 mg, tablets, orally, with a high-fat meal on Day 1. After assessments on Day 11 or upon early termination (ET), the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 39.
|
Placebo
Historical data for the placebo participants from 3 sponsor Phase 1b studies (GS-US-120-0104, GS-US-141-1219, and GS-US-200-4072) were combined to form a single placebo group for the purpose of analysis. For Study GS-US-200-4072, HIV-1 RNA (log10 copies/mL) collected on Day 10 was used for "Day 11", since HIV-1 RNA was not collected on Day 11 for this study. Each GS-1720 cohort was compared to the pooled placebo group with respect to the change from baseline in plasma HIV-1 RNA (log10 copies/mL) on Day 11.
|
|---|---|---|---|---|---|---|---|---|---|
|
Substudies 01, 02 and 03: Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
|
16.7 percentage of participants
|
100 percentage of participants
|
42.9 percentage of participants
|
85.7 percentage of participants
|
85.7 percentage of participants
|
71.4 percentage of participants
|
75.0 percentage of participants
|
50.0 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: First dose up to last dose (Substudy 01: Up to Day 39; Substudy 02: Up to Day 60; Substudy 03: Up to Day 25)Population: Participants in the Safety Analysis Set were analyzed.
Treatment-emergent laboratory abnormalities were defined as values that increased at least 1 toxicity grade from baseline at any time postbaseline. Laboratory abnormalities were graded using Division of AIDS (DAIDS) scale with grade 0 to 4 where 0 = no grade; 1 = mild, 2 = moderate, 3 = severe; 4 = potentially life-threatening. Participants with at least a 1 grade increased from baseline for an individual laboratory test where the maximum post baseline laboratory abnormality was 1) grade 1 or higher and 2) grade 3 or higher were reported. The maximum postbaseline toxicity grade across all tests for an individual participant was used in analysis. Percentages were rounded-off.
Outcome measures
| Measure |
Substudy 01: Cohort 2: Bavtavirine 1200 mg (Low-Fat Meal)
n=6 Participants
Participants received a single dose of bavtavirine 1200 mg, tablets, orally, with a low-fat meal on Day 1. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 39.
|
Substudy 01: Cohort 3: Bavtavirine 900 mg (High-Fat Meal)
n=1 Participants
Participants received a single dose of bavtavirine 900 mg, tablets, orally, with a high-fat meal on Days 1 and 2. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 39.
|
Substudy 02: Cohort 1: GS-1720 450 mg
n=7 Participants
Participants received a single dose of GS-1720 450 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 02: Cohort 2: GS-1720 150 mg
n=7 Participants
Participants received a single dose of GS-1720 150 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 02: Cohort 3: GS-1720 30 mg
n=7 Participants
Participants received a single dose of GS-1720 30 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 02: Cohort 4: GS-1720 900 mg
n=7 Participants
Participants received a single dose of GS-1720 900 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 03: Cohort 1: GS- 6212 100 mg
n=8 Participants
Participants received GS-6212 100 mg tablet orally twice daily on Days 1 through 10. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 25.
|
Substudy 01: Cohort 1: Bavtavirine 675 mg (High-Fat Meal)
n=6 Participants
Participants received a single dose of bavtavirine 675 mg, tablets, orally, with a high-fat meal on Day 1. After assessments on Day 11 or upon early termination (ET), the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 39.
|
Placebo
Historical data for the placebo participants from 3 sponsor Phase 1b studies (GS-US-120-0104, GS-US-141-1219, and GS-US-200-4072) were combined to form a single placebo group for the purpose of analysis. For Study GS-US-200-4072, HIV-1 RNA (log10 copies/mL) collected on Day 10 was used for "Day 11", since HIV-1 RNA was not collected on Day 11 for this study. Each GS-1720 cohort was compared to the pooled placebo group with respect to the change from baseline in plasma HIV-1 RNA (log10 copies/mL) on Day 11.
|
|---|---|---|---|---|---|---|---|---|---|
|
Substudies 01, 02 and 03: Percentage of Participants With Graded Laboratory Abnormalities
Grade 1 or Higher
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
87.5 percentage of participants
|
100 percentage of participants
|
—
|
|
Substudies 01, 02 and 03: Percentage of Participants With Graded Laboratory Abnormalities
Grade 3 or Higher
|
66.7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
14.3 percentage of participants
|
14.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
16.7 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Cohorts 1, 2 and 3 (Day 1: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, and 12 hours postdose); Cohort 3: Day 2: Predose, 0.5, 1, 2, 3, 4, 5, 6, and 8 hours postdosePopulation: Participants in PK Analysis Set in Substudy 01 were analyzed. The PK Analysis Set included all participants who were enrolled in the study, received at least 1 dose of study drug, and had at least 1 non-missing post baseline concentration value for bavtavirine. Per pre-specified analysis, Cmax at Day 2 was calculated only for Cohort 3.
Cmax was defined as the maximum observed concentration of drug.
Outcome measures
| Measure |
Substudy 01: Cohort 2: Bavtavirine 1200 mg (Low-Fat Meal)
n=6 Participants
Participants received a single dose of bavtavirine 1200 mg, tablets, orally, with a low-fat meal on Day 1. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 39.
|
Substudy 01: Cohort 3: Bavtavirine 900 mg (High-Fat Meal)
n=1 Participants
Participants received a single dose of bavtavirine 900 mg, tablets, orally, with a high-fat meal on Days 1 and 2. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 39.
|
Substudy 02: Cohort 1: GS-1720 450 mg
Participants received a single dose of GS-1720 450 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 02: Cohort 2: GS-1720 150 mg
Participants received a single dose of GS-1720 150 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 02: Cohort 3: GS-1720 30 mg
Participants received a single dose of GS-1720 30 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 02: Cohort 4: GS-1720 900 mg
Participants received a single dose of GS-1720 900 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 03: Cohort 1: GS- 6212 100 mg
Participants received GS-6212 100 mg tablet orally twice daily on Days 1 through 10. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 25.
|
Substudy 01: Cohort 1: Bavtavirine 675 mg (High-Fat Meal)
n=6 Participants
Participants received a single dose of bavtavirine 675 mg, tablets, orally, with a high-fat meal on Day 1. After assessments on Day 11 or upon early termination (ET), the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 39.
|
Placebo
Historical data for the placebo participants from 3 sponsor Phase 1b studies (GS-US-120-0104, GS-US-141-1219, and GS-US-200-4072) were combined to form a single placebo group for the purpose of analysis. For Study GS-US-200-4072, HIV-1 RNA (log10 copies/mL) collected on Day 10 was used for "Day 11", since HIV-1 RNA was not collected on Day 11 for this study. Each GS-1720 cohort was compared to the pooled placebo group with respect to the change from baseline in plasma HIV-1 RNA (log10 copies/mL) on Day 11.
|
|---|---|---|---|---|---|---|---|---|---|
|
Substudy 01: Pharmacokinetic (PK) Parameter: Cmax of Bavtavirine
Cmax (Day 1)
|
700 ng/mL
Standard Deviation 364
|
565 ng/mL
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
—
|
—
|
—
|
—
|
—
|
685 ng/mL
Standard Deviation 172
|
—
|
|
Substudy 01: Pharmacokinetic (PK) Parameter: Cmax of Bavtavirine
Cmax (Day 2)
|
—
|
1160 ng/mL
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 up to Day 11Population: Participants in the PK Analysis Set in Substudy 01 were analyzed.
AUC was defined as the area under the concentration versus time curve.
Outcome measures
| Measure |
Substudy 01: Cohort 2: Bavtavirine 1200 mg (Low-Fat Meal)
n=6 Participants
Participants received a single dose of bavtavirine 1200 mg, tablets, orally, with a low-fat meal on Day 1. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 39.
|
Substudy 01: Cohort 3: Bavtavirine 900 mg (High-Fat Meal)
n=1 Participants
Participants received a single dose of bavtavirine 900 mg, tablets, orally, with a high-fat meal on Days 1 and 2. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 39.
|
Substudy 02: Cohort 1: GS-1720 450 mg
Participants received a single dose of GS-1720 450 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 02: Cohort 2: GS-1720 150 mg
Participants received a single dose of GS-1720 150 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 02: Cohort 3: GS-1720 30 mg
Participants received a single dose of GS-1720 30 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 02: Cohort 4: GS-1720 900 mg
Participants received a single dose of GS-1720 900 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 03: Cohort 1: GS- 6212 100 mg
Participants received GS-6212 100 mg tablet orally twice daily on Days 1 through 10. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 25.
|
Substudy 01: Cohort 1: Bavtavirine 675 mg (High-Fat Meal)
n=6 Participants
Participants received a single dose of bavtavirine 675 mg, tablets, orally, with a high-fat meal on Day 1. After assessments on Day 11 or upon early termination (ET), the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 39.
|
Placebo
Historical data for the placebo participants from 3 sponsor Phase 1b studies (GS-US-120-0104, GS-US-141-1219, and GS-US-200-4072) were combined to form a single placebo group for the purpose of analysis. For Study GS-US-200-4072, HIV-1 RNA (log10 copies/mL) collected on Day 10 was used for "Day 11", since HIV-1 RNA was not collected on Day 11 for this study. Each GS-1720 cohort was compared to the pooled placebo group with respect to the change from baseline in plasma HIV-1 RNA (log10 copies/mL) on Day 11.
|
|---|---|---|---|---|---|---|---|---|---|
|
Substudy 01: PK Parameter: AUC of Bavtavirine
AUC (Days 1-8)
|
24,300 h*ng/mL
Standard Deviation 13700
|
71,400 h*ng/mL
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
—
|
—
|
—
|
—
|
—
|
33,300 h*ng/mL
Standard Deviation 10300
|
—
|
|
Substudy 01: PK Parameter: AUC of Bavtavirine
AUC (Days 1-11)
|
28,300 h*ng/mL
Standard Deviation 16100
|
89,100 h*ng/mL
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
—
|
—
|
—
|
—
|
—
|
38,800 h*ng/mL
Standard Deviation 11800
|
—
|
SECONDARY outcome
Timeframe: Days 8 and 11Population: Participants in the PK Analysis Set in Substudy 01 with available data were analyzed.
Outcome measures
| Measure |
Substudy 01: Cohort 2: Bavtavirine 1200 mg (Low-Fat Meal)
n=6 Participants
Participants received a single dose of bavtavirine 1200 mg, tablets, orally, with a low-fat meal on Day 1. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 39.
|
Substudy 01: Cohort 3: Bavtavirine 900 mg (High-Fat Meal)
n=1 Participants
Participants received a single dose of bavtavirine 900 mg, tablets, orally, with a high-fat meal on Days 1 and 2. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 39.
|
Substudy 02: Cohort 1: GS-1720 450 mg
Participants received a single dose of GS-1720 450 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 02: Cohort 2: GS-1720 150 mg
Participants received a single dose of GS-1720 150 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 02: Cohort 3: GS-1720 30 mg
Participants received a single dose of GS-1720 30 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 02: Cohort 4: GS-1720 900 mg
Participants received a single dose of GS-1720 900 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 03: Cohort 1: GS- 6212 100 mg
Participants received GS-6212 100 mg tablet orally twice daily on Days 1 through 10. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 25.
|
Substudy 01: Cohort 1: Bavtavirine 675 mg (High-Fat Meal)
n=6 Participants
Participants received a single dose of bavtavirine 675 mg, tablets, orally, with a high-fat meal on Day 1. After assessments on Day 11 or upon early termination (ET), the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 39.
|
Placebo
Historical data for the placebo participants from 3 sponsor Phase 1b studies (GS-US-120-0104, GS-US-141-1219, and GS-US-200-4072) were combined to form a single placebo group for the purpose of analysis. For Study GS-US-200-4072, HIV-1 RNA (log10 copies/mL) collected on Day 10 was used for "Day 11", since HIV-1 RNA was not collected on Day 11 for this study. Each GS-1720 cohort was compared to the pooled placebo group with respect to the change from baseline in plasma HIV-1 RNA (log10 copies/mL) on Day 11.
|
|---|---|---|---|---|---|---|---|---|---|
|
Substudy 01: PK Parameter: Plasma Concentration of Bavtavirine
Day 8
|
64.8 ng/mL
Standard Deviation 44.7
|
250 ng/mL
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
—
|
—
|
—
|
—
|
—
|
94.5 ng/mL
Standard Deviation 36.8
|
—
|
|
Substudy 01: PK Parameter: Plasma Concentration of Bavtavirine
Day 11
|
44.6 ng/mL
Standard Deviation 32.8
|
202 ng/mL
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
—
|
—
|
—
|
—
|
—
|
61.2 ng/mL
Standard Deviation 26.0
|
—
|
SECONDARY outcome
Timeframe: Days 1 and 2: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8 and (optional) 12 hours postdosePopulation: Participants in the PK Analysis Set in Substudy 02 with available data were analyzed.
Cmax was defined as the maximum observed concentration of drug.
Outcome measures
| Measure |
Substudy 01: Cohort 2: Bavtavirine 1200 mg (Low-Fat Meal)
n=7 Participants
Participants received a single dose of bavtavirine 1200 mg, tablets, orally, with a low-fat meal on Day 1. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 39.
|
Substudy 01: Cohort 3: Bavtavirine 900 mg (High-Fat Meal)
n=7 Participants
Participants received a single dose of bavtavirine 900 mg, tablets, orally, with a high-fat meal on Days 1 and 2. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 39.
|
Substudy 02: Cohort 1: GS-1720 450 mg
n=7 Participants
Participants received a single dose of GS-1720 450 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 02: Cohort 2: GS-1720 150 mg
Participants received a single dose of GS-1720 150 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 02: Cohort 3: GS-1720 30 mg
Participants received a single dose of GS-1720 30 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 02: Cohort 4: GS-1720 900 mg
Participants received a single dose of GS-1720 900 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 03: Cohort 1: GS- 6212 100 mg
Participants received GS-6212 100 mg tablet orally twice daily on Days 1 through 10. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 25.
|
Substudy 01: Cohort 1: Bavtavirine 675 mg (High-Fat Meal)
n=7 Participants
Participants received a single dose of bavtavirine 675 mg, tablets, orally, with a high-fat meal on Day 1. After assessments on Day 11 or upon early termination (ET), the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 39.
|
Placebo
Historical data for the placebo participants from 3 sponsor Phase 1b studies (GS-US-120-0104, GS-US-141-1219, and GS-US-200-4072) were combined to form a single placebo group for the purpose of analysis. For Study GS-US-200-4072, HIV-1 RNA (log10 copies/mL) collected on Day 10 was used for "Day 11", since HIV-1 RNA was not collected on Day 11 for this study. Each GS-1720 cohort was compared to the pooled placebo group with respect to the change from baseline in plasma HIV-1 RNA (log10 copies/mL) on Day 11.
|
|---|---|---|---|---|---|---|---|---|---|
|
Substudy 02: PK Parameter: Cmax of GS-1720
Cmax (Day 1)
|
9.77 µg/mL
Standard Deviation 3.09
|
3.00 µg/mL
Standard Deviation 0.691
|
33.7 µg/mL
Standard Deviation 11.6
|
—
|
—
|
—
|
—
|
17.2 µg/mL
Standard Deviation 8.37
|
—
|
|
Substudy 02: PK Parameter: Cmax of GS-1720
Cmax (Day 2)
|
15.6 µg/mL
Standard Deviation 5.59
|
5.39 µg/mL
Standard Deviation 1.48
|
48.3 µg/mL
Standard Deviation 9.85
|
—
|
—
|
—
|
—
|
30.8 µg/mL
Standard Deviation 10.7
|
—
|
SECONDARY outcome
Timeframe: Day 1 up to Day 11Population: Participants in the PK Analysis Set in Substudy 02 were analyzed.
AUC was defined as the area under the concentration versus time curve.
Outcome measures
| Measure |
Substudy 01: Cohort 2: Bavtavirine 1200 mg (Low-Fat Meal)
n=7 Participants
Participants received a single dose of bavtavirine 1200 mg, tablets, orally, with a low-fat meal on Day 1. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 39.
|
Substudy 01: Cohort 3: Bavtavirine 900 mg (High-Fat Meal)
n=7 Participants
Participants received a single dose of bavtavirine 900 mg, tablets, orally, with a high-fat meal on Days 1 and 2. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 39.
|
Substudy 02: Cohort 1: GS-1720 450 mg
n=7 Participants
Participants received a single dose of GS-1720 450 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 02: Cohort 2: GS-1720 150 mg
Participants received a single dose of GS-1720 150 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 02: Cohort 3: GS-1720 30 mg
Participants received a single dose of GS-1720 30 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 02: Cohort 4: GS-1720 900 mg
Participants received a single dose of GS-1720 900 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 03: Cohort 1: GS- 6212 100 mg
Participants received GS-6212 100 mg tablet orally twice daily on Days 1 through 10. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 25.
|
Substudy 01: Cohort 1: Bavtavirine 675 mg (High-Fat Meal)
n=7 Participants
Participants received a single dose of bavtavirine 675 mg, tablets, orally, with a high-fat meal on Day 1. After assessments on Day 11 or upon early termination (ET), the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 39.
|
Placebo
Historical data for the placebo participants from 3 sponsor Phase 1b studies (GS-US-120-0104, GS-US-141-1219, and GS-US-200-4072) were combined to form a single placebo group for the purpose of analysis. For Study GS-US-200-4072, HIV-1 RNA (log10 copies/mL) collected on Day 10 was used for "Day 11", since HIV-1 RNA was not collected on Day 11 for this study. Each GS-1720 cohort was compared to the pooled placebo group with respect to the change from baseline in plasma HIV-1 RNA (log10 copies/mL) on Day 11.
|
|---|---|---|---|---|---|---|---|---|---|
|
Substudy 02: PK Parameter: AUC of GS-1720
AUC (Day 8)
|
1670 h*µg/mL
Standard Deviation 780
|
503 h*µg/mL
Standard Deviation 134
|
4960 h*µg/mL
Standard Deviation 1360
|
—
|
—
|
—
|
—
|
2790 h*µg/mL
Standard Deviation 1060
|
—
|
|
Substudy 02: PK Parameter: AUC of GS-1720
AUC (Day 11)
|
2160 h*µg/mL
Standard Deviation 1020
|
648 h*µg/mL
Standard Deviation 169
|
6430 h*µg/mL
Standard Deviation 1740
|
—
|
—
|
—
|
—
|
3540 h*µg/mL
Standard Deviation 1330
|
—
|
SECONDARY outcome
Timeframe: Days 8 and 11Population: Participants in the PK Analysis Set in Substudy 02 were analyzed.
Outcome measures
| Measure |
Substudy 01: Cohort 2: Bavtavirine 1200 mg (Low-Fat Meal)
n=7 Participants
Participants received a single dose of bavtavirine 1200 mg, tablets, orally, with a low-fat meal on Day 1. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 39.
|
Substudy 01: Cohort 3: Bavtavirine 900 mg (High-Fat Meal)
n=7 Participants
Participants received a single dose of bavtavirine 900 mg, tablets, orally, with a high-fat meal on Days 1 and 2. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 39.
|
Substudy 02: Cohort 1: GS-1720 450 mg
n=7 Participants
Participants received a single dose of GS-1720 450 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 02: Cohort 2: GS-1720 150 mg
Participants received a single dose of GS-1720 150 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 02: Cohort 3: GS-1720 30 mg
Participants received a single dose of GS-1720 30 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 02: Cohort 4: GS-1720 900 mg
Participants received a single dose of GS-1720 900 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 03: Cohort 1: GS- 6212 100 mg
Participants received GS-6212 100 mg tablet orally twice daily on Days 1 through 10. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 25.
|
Substudy 01: Cohort 1: Bavtavirine 675 mg (High-Fat Meal)
n=7 Participants
Participants received a single dose of bavtavirine 675 mg, tablets, orally, with a high-fat meal on Day 1. After assessments on Day 11 or upon early termination (ET), the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 39.
|
Placebo
Historical data for the placebo participants from 3 sponsor Phase 1b studies (GS-US-120-0104, GS-US-141-1219, and GS-US-200-4072) were combined to form a single placebo group for the purpose of analysis. For Study GS-US-200-4072, HIV-1 RNA (log10 copies/mL) collected on Day 10 was used for "Day 11", since HIV-1 RNA was not collected on Day 11 for this study. Each GS-1720 cohort was compared to the pooled placebo group with respect to the change from baseline in plasma HIV-1 RNA (log10 copies/mL) on Day 11.
|
|---|---|---|---|---|---|---|---|---|---|
|
Substudy 02: PK Parameter: Plasma Concentration of GS-1720
Day 8
|
7.44 µg/mL
Standard Deviation 3.65
|
2.59 µg/mL
Standard Deviation 0.868
|
22.7 µg/mL
Standard Deviation 4.94
|
—
|
—
|
—
|
—
|
12.2 µg/mL
Standard Deviation 4.21
|
—
|
|
Substudy 02: PK Parameter: Plasma Concentration of GS-1720
Day 11
|
5.87 µg/mL
Standard Deviation 2.98
|
1.64 µg/mL
Standard Deviation 0.376
|
18.4 µg/mL
Standard Deviation 4.75
|
—
|
—
|
—
|
—
|
8.78 µg/mL
Standard Deviation 4.15
|
—
|
SECONDARY outcome
Timeframe: Days 1 and 10 (Predose, 0.25, 0.5, 1, 2, 3, 4, 6, 8 and (optional) 12 hours postdose)Population: Participants in the PK Analysis Set in Substudy 03 with available data were analyzed.
Cmax was defined as the maximum observed concentration of drug.
Outcome measures
| Measure |
Substudy 01: Cohort 2: Bavtavirine 1200 mg (Low-Fat Meal)
Participants received a single dose of bavtavirine 1200 mg, tablets, orally, with a low-fat meal on Day 1. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 39.
|
Substudy 01: Cohort 3: Bavtavirine 900 mg (High-Fat Meal)
Participants received a single dose of bavtavirine 900 mg, tablets, orally, with a high-fat meal on Days 1 and 2. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 39.
|
Substudy 02: Cohort 1: GS-1720 450 mg
Participants received a single dose of GS-1720 450 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 02: Cohort 2: GS-1720 150 mg
Participants received a single dose of GS-1720 150 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 02: Cohort 3: GS-1720 30 mg
Participants received a single dose of GS-1720 30 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 02: Cohort 4: GS-1720 900 mg
Participants received a single dose of GS-1720 900 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 03: Cohort 1: GS- 6212 100 mg
Participants received GS-6212 100 mg tablet orally twice daily on Days 1 through 10. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 25.
|
Substudy 01: Cohort 1: Bavtavirine 675 mg (High-Fat Meal)
n=8 Participants
Participants received a single dose of bavtavirine 675 mg, tablets, orally, with a high-fat meal on Day 1. After assessments on Day 11 or upon early termination (ET), the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 39.
|
Placebo
Historical data for the placebo participants from 3 sponsor Phase 1b studies (GS-US-120-0104, GS-US-141-1219, and GS-US-200-4072) were combined to form a single placebo group for the purpose of analysis. For Study GS-US-200-4072, HIV-1 RNA (log10 copies/mL) collected on Day 10 was used for "Day 11", since HIV-1 RNA was not collected on Day 11 for this study. Each GS-1720 cohort was compared to the pooled placebo group with respect to the change from baseline in plasma HIV-1 RNA (log10 copies/mL) on Day 11.
|
|---|---|---|---|---|---|---|---|---|---|
|
Substudy 03: PK Parameter: Cmax of GS-6212
Cmax (Day 1)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
1590 ng/mL
Standard Deviation 641
|
—
|
|
Substudy 03: PK Parameter: Cmax of GS-6212
Cmax (Day 10)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
1550 ng/mL
Standard Deviation 621
|
—
|
SECONDARY outcome
Timeframe: Days 1 and 10 (Predose, 0.25, 0.5, 1, 2, 3, 4, 6, 8 and (optional) 12 hours postdose)Population: Participants in the PK Analysis Set in Substudy 03 with available data were analyzed.
AUC0-8h was defined as the area under the concentration versus time curve spanning from 0 to 8 hours post dose.
Outcome measures
| Measure |
Substudy 01: Cohort 2: Bavtavirine 1200 mg (Low-Fat Meal)
Participants received a single dose of bavtavirine 1200 mg, tablets, orally, with a low-fat meal on Day 1. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 39.
|
Substudy 01: Cohort 3: Bavtavirine 900 mg (High-Fat Meal)
Participants received a single dose of bavtavirine 900 mg, tablets, orally, with a high-fat meal on Days 1 and 2. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 39.
|
Substudy 02: Cohort 1: GS-1720 450 mg
Participants received a single dose of GS-1720 450 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 02: Cohort 2: GS-1720 150 mg
Participants received a single dose of GS-1720 150 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 02: Cohort 3: GS-1720 30 mg
Participants received a single dose of GS-1720 30 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 02: Cohort 4: GS-1720 900 mg
Participants received a single dose of GS-1720 900 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 03: Cohort 1: GS- 6212 100 mg
Participants received GS-6212 100 mg tablet orally twice daily on Days 1 through 10. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 25.
|
Substudy 01: Cohort 1: Bavtavirine 675 mg (High-Fat Meal)
n=8 Participants
Participants received a single dose of bavtavirine 675 mg, tablets, orally, with a high-fat meal on Day 1. After assessments on Day 11 or upon early termination (ET), the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 39.
|
Placebo
Historical data for the placebo participants from 3 sponsor Phase 1b studies (GS-US-120-0104, GS-US-141-1219, and GS-US-200-4072) were combined to form a single placebo group for the purpose of analysis. For Study GS-US-200-4072, HIV-1 RNA (log10 copies/mL) collected on Day 10 was used for "Day 11", since HIV-1 RNA was not collected on Day 11 for this study. Each GS-1720 cohort was compared to the pooled placebo group with respect to the change from baseline in plasma HIV-1 RNA (log10 copies/mL) on Day 11.
|
|---|---|---|---|---|---|---|---|---|---|
|
Substudy 03: PK Parameter: AUC0-8h of GS-6212
AUC0-8h (Day 1)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
5030 h*ng/mL
Standard Deviation 2190
|
—
|
|
Substudy 03: PK Parameter: AUC0-8h of GS-6212
AUC0-8h (Day 10)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
5700 h*ng/mL
Standard Deviation 2300
|
—
|
SECONDARY outcome
Timeframe: Day 10 (Parameter estimated based on observed data from 0 to 8 hours postdose)Population: Participants in the PK Analysis Set in Substudy 03 with available data were analyzed.
AUCtau was defined as the area under the curve from time zero to end of dosing interval.
Outcome measures
| Measure |
Substudy 01: Cohort 2: Bavtavirine 1200 mg (Low-Fat Meal)
Participants received a single dose of bavtavirine 1200 mg, tablets, orally, with a low-fat meal on Day 1. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 39.
|
Substudy 01: Cohort 3: Bavtavirine 900 mg (High-Fat Meal)
Participants received a single dose of bavtavirine 900 mg, tablets, orally, with a high-fat meal on Days 1 and 2. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 39.
|
Substudy 02: Cohort 1: GS-1720 450 mg
Participants received a single dose of GS-1720 450 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 02: Cohort 2: GS-1720 150 mg
Participants received a single dose of GS-1720 150 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 02: Cohort 3: GS-1720 30 mg
Participants received a single dose of GS-1720 30 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 02: Cohort 4: GS-1720 900 mg
Participants received a single dose of GS-1720 900 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 03: Cohort 1: GS- 6212 100 mg
Participants received GS-6212 100 mg tablet orally twice daily on Days 1 through 10. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 25.
|
Substudy 01: Cohort 1: Bavtavirine 675 mg (High-Fat Meal)
n=6 Participants
Participants received a single dose of bavtavirine 675 mg, tablets, orally, with a high-fat meal on Day 1. After assessments on Day 11 or upon early termination (ET), the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 39.
|
Placebo
Historical data for the placebo participants from 3 sponsor Phase 1b studies (GS-US-120-0104, GS-US-141-1219, and GS-US-200-4072) were combined to form a single placebo group for the purpose of analysis. For Study GS-US-200-4072, HIV-1 RNA (log10 copies/mL) collected on Day 10 was used for "Day 11", since HIV-1 RNA was not collected on Day 11 for this study. Each GS-1720 cohort was compared to the pooled placebo group with respect to the change from baseline in plasma HIV-1 RNA (log10 copies/mL) on Day 11.
|
|---|---|---|---|---|---|---|---|---|---|
|
Substudy 03: PK Parameter: AUCtau of GS-6212
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
6450 h*ng/mL
Standard Deviation 2370
|
—
|
SECONDARY outcome
Timeframe: Days 1 and 10: 8 hours postdosePopulation: Participants in the PK Analysis Set in Substudy 03 with available data were analyzed.
Outcome measures
| Measure |
Substudy 01: Cohort 2: Bavtavirine 1200 mg (Low-Fat Meal)
Participants received a single dose of bavtavirine 1200 mg, tablets, orally, with a low-fat meal on Day 1. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 39.
|
Substudy 01: Cohort 3: Bavtavirine 900 mg (High-Fat Meal)
Participants received a single dose of bavtavirine 900 mg, tablets, orally, with a high-fat meal on Days 1 and 2. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 39.
|
Substudy 02: Cohort 1: GS-1720 450 mg
Participants received a single dose of GS-1720 450 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 02: Cohort 2: GS-1720 150 mg
Participants received a single dose of GS-1720 150 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 02: Cohort 3: GS-1720 30 mg
Participants received a single dose of GS-1720 30 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 02: Cohort 4: GS-1720 900 mg
Participants received a single dose of GS-1720 900 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 03: Cohort 1: GS- 6212 100 mg
Participants received GS-6212 100 mg tablet orally twice daily on Days 1 through 10. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 25.
|
Substudy 01: Cohort 1: Bavtavirine 675 mg (High-Fat Meal)
n=8 Participants
Participants received a single dose of bavtavirine 675 mg, tablets, orally, with a high-fat meal on Day 1. After assessments on Day 11 or upon early termination (ET), the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 39.
|
Placebo
Historical data for the placebo participants from 3 sponsor Phase 1b studies (GS-US-120-0104, GS-US-141-1219, and GS-US-200-4072) were combined to form a single placebo group for the purpose of analysis. For Study GS-US-200-4072, HIV-1 RNA (log10 copies/mL) collected on Day 10 was used for "Day 11", since HIV-1 RNA was not collected on Day 11 for this study. Each GS-1720 cohort was compared to the pooled placebo group with respect to the change from baseline in plasma HIV-1 RNA (log10 copies/mL) on Day 11.
|
|---|---|---|---|---|---|---|---|---|---|
|
Substudy 03: PK Parameter: Plasma Concentration of GS-6212
C8h (Day 1)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
221 ng/mL
Standard Deviation 165
|
—
|
|
Substudy 03: PK Parameter: Plasma Concentration of GS-6212
C8h (Day 10)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
260 ng/mL
Standard Deviation 194
|
—
|
SECONDARY outcome
Timeframe: Day 10 (Parameter estimated based on observed data from 0 to 8 hours postdose)Population: Participants in the PK Analysis Set in Substudy 03 with available data were analyzed.
Ctrough was defined as concentration at the end of the dosing interval.
Outcome measures
| Measure |
Substudy 01: Cohort 2: Bavtavirine 1200 mg (Low-Fat Meal)
Participants received a single dose of bavtavirine 1200 mg, tablets, orally, with a low-fat meal on Day 1. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 39.
|
Substudy 01: Cohort 3: Bavtavirine 900 mg (High-Fat Meal)
Participants received a single dose of bavtavirine 900 mg, tablets, orally, with a high-fat meal on Days 1 and 2. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 39.
|
Substudy 02: Cohort 1: GS-1720 450 mg
Participants received a single dose of GS-1720 450 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 02: Cohort 2: GS-1720 150 mg
Participants received a single dose of GS-1720 150 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 02: Cohort 3: GS-1720 30 mg
Participants received a single dose of GS-1720 30 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 02: Cohort 4: GS-1720 900 mg
Participants received a single dose of GS-1720 900 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 03: Cohort 1: GS- 6212 100 mg
Participants received GS-6212 100 mg tablet orally twice daily on Days 1 through 10. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 25.
|
Substudy 01: Cohort 1: Bavtavirine 675 mg (High-Fat Meal)
n=6 Participants
Participants received a single dose of bavtavirine 675 mg, tablets, orally, with a high-fat meal on Day 1. After assessments on Day 11 or upon early termination (ET), the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 39.
|
Placebo
Historical data for the placebo participants from 3 sponsor Phase 1b studies (GS-US-120-0104, GS-US-141-1219, and GS-US-200-4072) were combined to form a single placebo group for the purpose of analysis. For Study GS-US-200-4072, HIV-1 RNA (log10 copies/mL) collected on Day 10 was used for "Day 11", since HIV-1 RNA was not collected on Day 11 for this study. Each GS-1720 cohort was compared to the pooled placebo group with respect to the change from baseline in plasma HIV-1 RNA (log10 copies/mL) on Day 11.
|
|---|---|---|---|---|---|---|---|---|---|
|
Substudy 03: PK Parameter: Ctrough of GS-6212 (Day 10)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
140 ng/mL
Standard Deviation 207
|
—
|
SECONDARY outcome
Timeframe: Day 10 (predose to 8 hours postdose)Population: Participants in the PK Analysis Set in Substudy 03 with available data were analyzed.
Cavg was defined as average plasma concentration during dose administration.
Outcome measures
| Measure |
Substudy 01: Cohort 2: Bavtavirine 1200 mg (Low-Fat Meal)
Participants received a single dose of bavtavirine 1200 mg, tablets, orally, with a low-fat meal on Day 1. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 39.
|
Substudy 01: Cohort 3: Bavtavirine 900 mg (High-Fat Meal)
Participants received a single dose of bavtavirine 900 mg, tablets, orally, with a high-fat meal on Days 1 and 2. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 39.
|
Substudy 02: Cohort 1: GS-1720 450 mg
Participants received a single dose of GS-1720 450 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 02: Cohort 2: GS-1720 150 mg
Participants received a single dose of GS-1720 150 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 02: Cohort 3: GS-1720 30 mg
Participants received a single dose of GS-1720 30 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 02: Cohort 4: GS-1720 900 mg
Participants received a single dose of GS-1720 900 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 03: Cohort 1: GS- 6212 100 mg
Participants received GS-6212 100 mg tablet orally twice daily on Days 1 through 10. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 25.
|
Substudy 01: Cohort 1: Bavtavirine 675 mg (High-Fat Meal)
n=6 Participants
Participants received a single dose of bavtavirine 675 mg, tablets, orally, with a high-fat meal on Day 1. After assessments on Day 11 or upon early termination (ET), the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 39.
|
Placebo
Historical data for the placebo participants from 3 sponsor Phase 1b studies (GS-US-120-0104, GS-US-141-1219, and GS-US-200-4072) were combined to form a single placebo group for the purpose of analysis. For Study GS-US-200-4072, HIV-1 RNA (log10 copies/mL) collected on Day 10 was used for "Day 11", since HIV-1 RNA was not collected on Day 11 for this study. Each GS-1720 cohort was compared to the pooled placebo group with respect to the change from baseline in plasma HIV-1 RNA (log10 copies/mL) on Day 11.
|
|---|---|---|---|---|---|---|---|---|---|
|
Substudy 03: PK Parameter: Cavg of GS-6212 (Day 10)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
538 ng/mL
Standard Deviation 198
|
—
|
SECONDARY outcome
Timeframe: Up to Day 11Population: Participants in the Full Analysis Set were analyzed. The placebo arm included pooled data from participants who received placebo in 3 historical Gilead HIV-1 phase 1b studies (GS-US-120-0104, GS-US-141-1219, and GS-US-200-4072) for HIV-1 efficacy parameters only.
Percentages were rounded-off.
Outcome measures
| Measure |
Substudy 01: Cohort 2: Bavtavirine 1200 mg (Low-Fat Meal)
n=6 Participants
Participants received a single dose of bavtavirine 1200 mg, tablets, orally, with a low-fat meal on Day 1. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 39.
|
Substudy 01: Cohort 3: Bavtavirine 900 mg (High-Fat Meal)
n=1 Participants
Participants received a single dose of bavtavirine 900 mg, tablets, orally, with a high-fat meal on Days 1 and 2. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 39.
|
Substudy 02: Cohort 1: GS-1720 450 mg
n=7 Participants
Participants received a single dose of GS-1720 450 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 02: Cohort 2: GS-1720 150 mg
n=7 Participants
Participants received a single dose of GS-1720 150 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 02: Cohort 3: GS-1720 30 mg
n=7 Participants
Participants received a single dose of GS-1720 30 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 02: Cohort 4: GS-1720 900 mg
n=7 Participants
Participants received a single dose of GS-1720 900 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 03: Cohort 1: GS- 6212 100 mg
n=8 Participants
Participants received GS-6212 100 mg tablet orally twice daily on Days 1 through 10. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 25.
|
Substudy 01: Cohort 1: Bavtavirine 675 mg (High-Fat Meal)
n=6 Participants
Participants received a single dose of bavtavirine 675 mg, tablets, orally, with a high-fat meal on Day 1. After assessments on Day 11 or upon early termination (ET), the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 39.
|
Placebo
n=21 Participants
Historical data for the placebo participants from 3 sponsor Phase 1b studies (GS-US-120-0104, GS-US-141-1219, and GS-US-200-4072) were combined to form a single placebo group for the purpose of analysis. For Study GS-US-200-4072, HIV-1 RNA (log10 copies/mL) collected on Day 10 was used for "Day 11", since HIV-1 RNA was not collected on Day 11 for this study. Each GS-1720 cohort was compared to the pooled placebo group with respect to the change from baseline in plasma HIV-1 RNA (log10 copies/mL) on Day 11.
|
|---|---|---|---|---|---|---|---|---|---|
|
Substudies 01, 02 and 03: Percentage of Participants at Any Measurement Achieving HIV-1 RNA < 50 Copies/mL by Day 11 at Each Dose Level
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
28.6 percentage of participants
|
0 percentage of participants
|
37.5 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Up to Day 11Population: Participant in the Full Analysis Set were analyzed.
The antiretroviral (ARV) class of given drugs would be BVY or NNRTIs (Substudy 01) or INSTIs (Substudy 02) or INSTIs (Substudy 03). Percentages were rounded-off.
Outcome measures
| Measure |
Substudy 01: Cohort 2: Bavtavirine 1200 mg (Low-Fat Meal)
n=6 Participants
Participants received a single dose of bavtavirine 1200 mg, tablets, orally, with a low-fat meal on Day 1. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 39.
|
Substudy 01: Cohort 3: Bavtavirine 900 mg (High-Fat Meal)
n=1 Participants
Participants received a single dose of bavtavirine 900 mg, tablets, orally, with a high-fat meal on Days 1 and 2. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 39.
|
Substudy 02: Cohort 1: GS-1720 450 mg
n=7 Participants
Participants received a single dose of GS-1720 450 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 02: Cohort 2: GS-1720 150 mg
n=7 Participants
Participants received a single dose of GS-1720 150 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 02: Cohort 3: GS-1720 30 mg
n=7 Participants
Participants received a single dose of GS-1720 30 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 02: Cohort 4: GS-1720 900 mg
n=7 Participants
Participants received a single dose of GS-1720 900 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 03: Cohort 1: GS- 6212 100 mg
n=8 Participants
Participants received GS-6212 100 mg tablet orally twice daily on Days 1 through 10. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 25.
|
Substudy 01: Cohort 1: Bavtavirine 675 mg (High-Fat Meal)
n=6 Participants
Participants received a single dose of bavtavirine 675 mg, tablets, orally, with a high-fat meal on Day 1. After assessments on Day 11 or upon early termination (ET), the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 39.
|
Placebo
Historical data for the placebo participants from 3 sponsor Phase 1b studies (GS-US-120-0104, GS-US-141-1219, and GS-US-200-4072) were combined to form a single placebo group for the purpose of analysis. For Study GS-US-200-4072, HIV-1 RNA (log10 copies/mL) collected on Day 10 was used for "Day 11", since HIV-1 RNA was not collected on Day 11 for this study. Each GS-1720 cohort was compared to the pooled placebo group with respect to the change from baseline in plasma HIV-1 RNA (log10 copies/mL) on Day 11.
|
|---|---|---|---|---|---|---|---|---|---|
|
Substudies 01, 02 and 03: Percentage of Participants With Emergence of Viral Resistance to the ARV Class of the Given Drug
|
16.6 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
33.0 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Up to Day 11Population: The PK/PD Analysis Set included all participants who were in the Full Analysis Set and have both nonmissing Ct (and/or AUC) of study drug and the change from baseline at Day 11 in plasma HIV-1 RNA (log10 copies/mL).
Inhibitory quotient was calculated as the ratio of bavtavirine in vivo exposure to in vitro plasma concentration. IQ is defined as paEC95. paEC95 = protein-adjusted effective concentration to achieve 95% effective inhibition. The IQ ≥ 2 indicated higher reduction in viral load with less rebound.
Outcome measures
| Measure |
Substudy 01: Cohort 2: Bavtavirine 1200 mg (Low-Fat Meal)
n=6 Participants
Participants received a single dose of bavtavirine 1200 mg, tablets, orally, with a low-fat meal on Day 1. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 39.
|
Substudy 01: Cohort 3: Bavtavirine 900 mg (High-Fat Meal)
n=1 Participants
Participants received a single dose of bavtavirine 900 mg, tablets, orally, with a high-fat meal on Days 1 and 2. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 39.
|
Substudy 02: Cohort 1: GS-1720 450 mg
Participants received a single dose of GS-1720 450 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 02: Cohort 2: GS-1720 150 mg
Participants received a single dose of GS-1720 150 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 02: Cohort 3: GS-1720 30 mg
Participants received a single dose of GS-1720 30 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 02: Cohort 4: GS-1720 900 mg
Participants received a single dose of GS-1720 900 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 03: Cohort 1: GS- 6212 100 mg
Participants received GS-6212 100 mg tablet orally twice daily on Days 1 through 10. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 25.
|
Substudy 01: Cohort 1: Bavtavirine 675 mg (High-Fat Meal)
n=6 Participants
Participants received a single dose of bavtavirine 675 mg, tablets, orally, with a high-fat meal on Day 1. After assessments on Day 11 or upon early termination (ET), the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 39.
|
Placebo
Historical data for the placebo participants from 3 sponsor Phase 1b studies (GS-US-120-0104, GS-US-141-1219, and GS-US-200-4072) were combined to form a single placebo group for the purpose of analysis. For Study GS-US-200-4072, HIV-1 RNA (log10 copies/mL) collected on Day 10 was used for "Day 11", since HIV-1 RNA was not collected on Day 11 for this study. Each GS-1720 cohort was compared to the pooled placebo group with respect to the change from baseline in plasma HIV-1 RNA (log10 copies/mL) on Day 11.
|
|---|---|---|---|---|---|---|---|---|---|
|
Substudy 01: Maximum Inhibitory Quotient (IQ) of Bavtavirine by Mean Plasma Concentration (Ct) up to Day 11
|
5 ratio
|
5 ratio
|
—
|
—
|
—
|
—
|
—
|
5 ratio
|
—
|
SECONDARY outcome
Timeframe: Day 11Population: Participants in the PK/PD Analysis Set were analyzed.
Inhibitory quotient was calculated as the ratio of GS-1720 in vivo exposure to in vitro plasma concentration. IQ is defined as paEC95. paEC95 = protein-adjusted effective concentration to achieve 95% effective inhibition. The IQ ≥ 2 indicated higher reduction in viral load with less rebound.
Outcome measures
| Measure |
Substudy 01: Cohort 2: Bavtavirine 1200 mg (Low-Fat Meal)
n=7 Participants
Participants received a single dose of bavtavirine 1200 mg, tablets, orally, with a low-fat meal on Day 1. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 39.
|
Substudy 01: Cohort 3: Bavtavirine 900 mg (High-Fat Meal)
n=7 Participants
Participants received a single dose of bavtavirine 900 mg, tablets, orally, with a high-fat meal on Days 1 and 2. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 39.
|
Substudy 02: Cohort 1: GS-1720 450 mg
n=7 Participants
Participants received a single dose of GS-1720 450 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 02: Cohort 2: GS-1720 150 mg
Participants received a single dose of GS-1720 150 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 02: Cohort 3: GS-1720 30 mg
Participants received a single dose of GS-1720 30 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 02: Cohort 4: GS-1720 900 mg
Participants received a single dose of GS-1720 900 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 03: Cohort 1: GS- 6212 100 mg
Participants received GS-6212 100 mg tablet orally twice daily on Days 1 through 10. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 25.
|
Substudy 01: Cohort 1: Bavtavirine 675 mg (High-Fat Meal)
n=7 Participants
Participants received a single dose of bavtavirine 675 mg, tablets, orally, with a high-fat meal on Day 1. After assessments on Day 11 or upon early termination (ET), the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 39.
|
Placebo
Historical data for the placebo participants from 3 sponsor Phase 1b studies (GS-US-120-0104, GS-US-141-1219, and GS-US-200-4072) were combined to form a single placebo group for the purpose of analysis. For Study GS-US-200-4072, HIV-1 RNA (log10 copies/mL) collected on Day 10 was used for "Day 11", since HIV-1 RNA was not collected on Day 11 for this study. Each GS-1720 cohort was compared to the pooled placebo group with respect to the change from baseline in plasma HIV-1 RNA (log10 copies/mL) on Day 11.
|
|---|---|---|---|---|---|---|---|---|---|
|
Substudy 02: Inhibitory Quotient (IQ) of GS-1720 by Mean Plasma Concentration (Ct) at Day 11
|
3 ratio
|
0.8 ratio
|
9.5 ratio
|
—
|
—
|
—
|
—
|
4.5 ratio
|
—
|
SECONDARY outcome
Timeframe: Day 11Population: Participants in the PK/PD Analysis Set with available data were analyzed.
Ctrough is the plasma concentration of the drug just before the next dose. Inhibitory quotient was calculated as the ratio of GS-1720 in vivo exposure to in vitro Ctrough. IQ is defined as paEC95. paEC95 = protein-adjusted effective concentration to achieve 95% effective inhibition. The IQ ≥ 2 indicated higher reduction in viral load with less rebound.
Outcome measures
| Measure |
Substudy 01: Cohort 2: Bavtavirine 1200 mg (Low-Fat Meal)
Participants received a single dose of bavtavirine 1200 mg, tablets, orally, with a low-fat meal on Day 1. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 39.
|
Substudy 01: Cohort 3: Bavtavirine 900 mg (High-Fat Meal)
Participants received a single dose of bavtavirine 900 mg, tablets, orally, with a high-fat meal on Days 1 and 2. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 39.
|
Substudy 02: Cohort 1: GS-1720 450 mg
Participants received a single dose of GS-1720 450 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 02: Cohort 2: GS-1720 150 mg
Participants received a single dose of GS-1720 150 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 02: Cohort 3: GS-1720 30 mg
Participants received a single dose of GS-1720 30 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 02: Cohort 4: GS-1720 900 mg
Participants received a single dose of GS-1720 900 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 03: Cohort 1: GS- 6212 100 mg
Participants received GS-6212 100 mg tablet orally twice daily on Days 1 through 10. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 25.
|
Substudy 01: Cohort 1: Bavtavirine 675 mg (High-Fat Meal)
n=3 Participants
Participants received a single dose of bavtavirine 675 mg, tablets, orally, with a high-fat meal on Day 1. After assessments on Day 11 or upon early termination (ET), the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 39.
|
Placebo
Historical data for the placebo participants from 3 sponsor Phase 1b studies (GS-US-120-0104, GS-US-141-1219, and GS-US-200-4072) were combined to form a single placebo group for the purpose of analysis. For Study GS-US-200-4072, HIV-1 RNA (log10 copies/mL) collected on Day 10 was used for "Day 11", since HIV-1 RNA was not collected on Day 11 for this study. Each GS-1720 cohort was compared to the pooled placebo group with respect to the change from baseline in plasma HIV-1 RNA (log10 copies/mL) on Day 11.
|
|---|---|---|---|---|---|---|---|---|---|
|
Substudy 03: Inhibitory Quotient (IQ) of GS-6212 by Ctrough at Day 11
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
6.5 ratio
|
—
|
Adverse Events
Substudy 01: Cohort 1: Bavtavirine 675 mg (High-Fat Meal)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Substudy 01: Cohort 2: Bavtavirine 1200 mg (Low-Fat Meal)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Substudy 01: Cohort 3: Bavtavirine 900 mg (High-Fat Meal)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Substudy 02: Cohort 1: GS-1720 450 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Substudy 02: Cohort 2: GS-1720 150 mg
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Substudy 02: Cohort 3: GS-1720 30 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Substudy 02: Cohort 4: GS-1720 900 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Substudy 03: Cohort 1: GS- 6212 100 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Substudy 01: Cohort 1: Bavtavirine 675 mg (High-Fat Meal)
n=6 participants at risk
Participants received a single dose of bavtavirine 675 mg, tablets, orally, with a high-fat meal on Day 1. After assessments on Day 11 or upon early termination (ET), the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 39.
|
Substudy 01: Cohort 2: Bavtavirine 1200 mg (Low-Fat Meal)
n=6 participants at risk
Participants received a single dose of bavtavirine 1200 mg, tablets, orally, with a low-fat meal on Day 1. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 39.
|
Substudy 01: Cohort 3: Bavtavirine 900 mg (High-Fat Meal)
n=1 participants at risk
Participants received a single dose of bavtavirine 900 mg, tablets, orally, with a high-fat meal on Days 1 and 2. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 39.
|
Substudy 02: Cohort 1: GS-1720 450 mg
n=7 participants at risk
Participants received a single dose of GS-1720 450 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 02: Cohort 2: GS-1720 150 mg
n=7 participants at risk
Participants received a single dose of GS-1720 150 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 02: Cohort 3: GS-1720 30 mg
n=7 participants at risk
Participants received a single dose of GS-1720 30 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 02: Cohort 4: GS-1720 900 mg
n=7 participants at risk
Participants received a single dose of GS-1720 900 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 03: Cohort 1: GS- 6212 100 mg
n=8 participants at risk
Participants received GS-6212 100 mg, tablet, orally, twice daily on Days 1 through 10. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 25.
|
|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/1 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
14.3%
1/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/8 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
|
Psychiatric disorders
Suicidal behaviour
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
16.7%
1/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/1 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/8 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
Other adverse events
| Measure |
Substudy 01: Cohort 1: Bavtavirine 675 mg (High-Fat Meal)
n=6 participants at risk
Participants received a single dose of bavtavirine 675 mg, tablets, orally, with a high-fat meal on Day 1. After assessments on Day 11 or upon early termination (ET), the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 39.
|
Substudy 01: Cohort 2: Bavtavirine 1200 mg (Low-Fat Meal)
n=6 participants at risk
Participants received a single dose of bavtavirine 1200 mg, tablets, orally, with a low-fat meal on Day 1. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 39.
|
Substudy 01: Cohort 3: Bavtavirine 900 mg (High-Fat Meal)
n=1 participants at risk
Participants received a single dose of bavtavirine 900 mg, tablets, orally, with a high-fat meal on Days 1 and 2. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 39.
|
Substudy 02: Cohort 1: GS-1720 450 mg
n=7 participants at risk
Participants received a single dose of GS-1720 450 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 02: Cohort 2: GS-1720 150 mg
n=7 participants at risk
Participants received a single dose of GS-1720 150 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 02: Cohort 3: GS-1720 30 mg
n=7 participants at risk
Participants received a single dose of GS-1720 30 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 02: Cohort 4: GS-1720 900 mg
n=7 participants at risk
Participants received a single dose of GS-1720 900 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60.
|
Substudy 03: Cohort 1: GS- 6212 100 mg
n=8 participants at risk
Participants received GS-6212 100 mg, tablet, orally, twice daily on Days 1 through 10. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 25.
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
33.3%
2/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/1 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
14.3%
1/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/8 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/1 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
14.3%
1/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/8 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/1 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
14.3%
1/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/8 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/1 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
14.3%
1/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/8 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/1 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
12.5%
1/8 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
|
Eye disorders
Eye irritation
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/1 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
12.5%
1/8 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/1 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
12.5%
1/8 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/1 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
14.3%
1/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/8 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
1/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/1 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
14.3%
1/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
12.5%
1/8 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/1 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
12.5%
1/8 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/1 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
14.3%
1/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/8 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
|
General disorders
Hangover
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/1 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
14.3%
1/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/8 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/1 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
14.3%
1/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/8 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
|
General disorders
Pyrexia
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/1 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
14.3%
1/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/8 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
|
Infections and infestations
Anal fistula infection
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/1 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
14.3%
1/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/8 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
|
Infections and infestations
Body tinea
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/1 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
14.3%
1/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/8 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
|
Infections and infestations
Conjunctivitis bacterial
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/1 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
14.3%
1/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/8 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/1 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
14.3%
1/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/8 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/1 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
14.3%
1/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/8 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
100.0%
1/1 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
14.3%
1/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/8 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
|
Infections and infestations
Pyuria
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/1 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
14.3%
1/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/8 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
|
Infections and infestations
Syphilis
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/1 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
14.3%
1/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/8 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
|
Infections and infestations
Viral infection
|
16.7%
1/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/1 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
14.3%
1/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/8 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/1 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
12.5%
1/8 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
|
Injury, poisoning and procedural complications
Procedural headache
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/1 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
14.3%
1/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/8 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/1 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
14.3%
1/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/8 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/1 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
14.3%
1/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/8 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
|
Investigations
Creatinine renal clearance abnormal
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
100.0%
1/1 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/8 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
|
Investigations
Electrocardiogram ST segment abnormal
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/1 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
14.3%
1/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/8 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
|
Investigations
Electrocardiogram T wave abnormal
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/1 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
14.3%
1/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/8 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
|
Investigations
Neisseria test positive
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/1 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
14.3%
1/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/8 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
|
Investigations
Sars-cov-2 test positive
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/1 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
12.5%
1/8 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/1 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
14.3%
1/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/8 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/1 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
14.3%
1/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/8 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/1 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
14.3%
1/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/8 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/1 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
14.3%
1/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/8 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/1 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
14.3%
1/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/8 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/1 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
14.3%
1/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/8 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/1 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
14.3%
1/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/8 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/1 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
28.6%
2/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/8 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
|
Nervous system disorders
Migraine
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/1 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
14.3%
1/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/8 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/1 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
14.3%
1/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/8 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/1 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
12.5%
1/8 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
|
Product Issues
Device loosening
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/1 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
14.3%
1/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/8 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/1 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
12.5%
1/8 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
|
Psychiatric disorders
Mood altered
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/1 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
14.3%
1/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/8 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
|
Psychiatric disorders
Terminal insomnia
|
16.7%
1/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/1 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/8 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/1 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
14.3%
1/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/8 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
100.0%
1/1 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
14.3%
1/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/8 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/1 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
14.3%
1/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/8 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/1 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
28.6%
2/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/8 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/1 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
14.3%
1/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/8 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
|
Respiratory, thoracic and mediastinal disorders
Lower respiratory tract congestion
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/1 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
14.3%
1/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/8 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/1 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
14.3%
1/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
12.5%
1/8 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/1 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
14.3%
1/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
12.5%
1/8 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
16.7%
1/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/1 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/8 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
|
Skin and subcutaneous tissue disorders
Acne
|
16.7%
1/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/1 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/8 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/1 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
14.3%
1/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/8 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
16.7%
1/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/1 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/8 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/1 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
14.3%
1/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/8 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/1 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
14.3%
1/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/8 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/1 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
14.3%
1/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/8 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/1 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
14.3%
1/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
14.3%
1/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/8 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
|
Vascular disorders
Hypertension
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/6 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/1 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
14.3%
1/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/7 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
0.00%
0/8 • Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
|
Additional Information
Gilead Clinical Study Information Center
Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years.
- Publication restrictions are in place
Restriction type: OTHER