Trial Outcomes & Findings for Safety and Efficacy of Switching From Dolutegravir and ABC/3TC or ABC/DTG/3TC to B/F/TAF in HIV-1 Infected Adults Who Are Virologically Suppressed (NCT NCT02603120)

Last Updated: 2020-11-12

Results Overview

The percentage of participants achieving HIV-1 RNA ≥ 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

567 participants

Primary outcome timeframe

Week 48

Results posted on

2020-11-12

Participant Flow

Participants were enrolled at study sites in North America, Europe, and Australia. The first participant was screened on 11 November 2015. The last study visit occurred on 23 October 2019.

646 participants were screened.

Participant milestones

Participant milestones
Measure	B/F/TAF Double-Blind Phase: Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) 50/200/25 mg fixed dose combination (FDC) tablet + abacavir/dolutegravir/lamivudine (ABC/DTG/3TC) placebo orally once daily for at least 48 weeks, without regard to food. Open-label (OL) Extension Phase: After Week 48, participants in a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.	ABC/DTG/3TC Double-Blind Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 48 weeks, without regard to food. OL Extension Phase: After Week 48, participants in a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.
Double-Blind Treatment Phase STARTED	284	283
Double-Blind Treatment Phase COMPLETED	265	267
Double-Blind Treatment Phase NOT COMPLETED	19	16
OL Extension B/F/TAF Treatment Phase STARTED	259	265
OL Extension B/F/TAF Treatment Phase COMPLETED	254	254
OL Extension B/F/TAF Treatment Phase NOT COMPLETED	5	11

Reasons for withdrawal

Reasons for withdrawal
Measure	B/F/TAF Double-Blind Phase: Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) 50/200/25 mg fixed dose combination (FDC) tablet + abacavir/dolutegravir/lamivudine (ABC/DTG/3TC) placebo orally once daily for at least 48 weeks, without regard to food. Open-label (OL) Extension Phase: After Week 48, participants in a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.	ABC/DTG/3TC Double-Blind Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 48 weeks, without regard to food. OL Extension Phase: After Week 48, participants in a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.
Double-Blind Treatment Phase Withdrew consent	4	8
Double-Blind Treatment Phase Adverse Event	3	3
Double-Blind Treatment Phase Lost to Follow-up	4	2
Double-Blind Treatment Phase Death	2	0
Double-Blind Treatment Phase Investigator's discretion	2	0
Double-Blind Treatment Phase Pregnancy	1	1
Double-Blind Treatment Phase Non-compliance with study drug	1	0
Double-Blind Treatment Phase Did not receive study drug	2	2
OL Extension B/F/TAF Treatment Phase Lost to Follow-up	3	4
OL Extension B/F/TAF Treatment Phase Investigator's discretion	1	2
OL Extension B/F/TAF Treatment Phase Withdrew consent	1	2
OL Extension B/F/TAF Treatment Phase Adverse Event	0	1
OL Extension B/F/TAF Treatment Phase Death	0	1
OL Extension B/F/TAF Treatment Phase Lack of Efficacy	0	1

Baseline Characteristics

Safety and Efficacy of Switching From Dolutegravir and ABC/3TC or ABC/DTG/3TC to B/F/TAF in HIV-1 Infected Adults Who Are Virologically Suppressed

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	B/F/TAF n=282 Participants Double-Blind Phase: B/F/TAF 50/200/25 mg FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 48 weeks, without regard to food. OL Extension Phase: After Week 48, participants in a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.	ABC/DTG/3TC n=281 Participants Double-Blind Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 48 weeks, without regard to food. OL Extension Phase: After Week 48, participants in a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.	Total n=563 Participants Total of all reporting groups
Age, Continuous	46 years STANDARD_DEVIATION 11.1 • n=93 Participants	45 years STANDARD_DEVIATION 11.5 • n=4 Participants	45 years STANDARD_DEVIATION 11.3 • n=27 Participants
Sex: Female, Male Female	35 Participants n=93 Participants	29 Participants n=4 Participants	64 Participants n=27 Participants
Sex: Female, Male Male	247 Participants n=93 Participants	252 Participants n=4 Participants	499 Participants n=27 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	2 Participants n=93 Participants	2 Participants n=4 Participants	4 Participants n=27 Participants
Race/Ethnicity, Customized Asian	9 Participants n=93 Participants	9 Participants n=4 Participants	18 Participants n=27 Participants
Race/Ethnicity, Customized Black	59 Participants n=93 Participants	62 Participants n=4 Participants	121 Participants n=27 Participants
Race/Ethnicity, Customized Native Hawaiian or Pacific Islander	3 Participants n=93 Participants	0 Participants n=4 Participants	3 Participants n=27 Participants
Race/Ethnicity, Customized White	206 Participants n=93 Participants	202 Participants n=4 Participants	408 Participants n=27 Participants
Race/Ethnicity, Customized Other	3 Participants n=93 Participants	3 Participants n=4 Participants	6 Participants n=27 Participants
Race/Ethnicity, Customized Not Permitted	0 Participants n=93 Participants	2 Participants n=4 Participants	2 Participants n=27 Participants
Race/Ethnicity, Customized Hispanic or Latino	46 Participants n=93 Participants	52 Participants n=4 Participants	98 Participants n=27 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	236 Participants n=93 Participants	227 Participants n=4 Participants	463 Participants n=27 Participants
Region of Enrollment Canada	13 Participants n=93 Participants	22 Participants n=4 Participants	35 Participants n=27 Participants
Region of Enrollment Belgium	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Region of Enrollment United States	203 Participants n=93 Participants	198 Participants n=4 Participants	401 Participants n=27 Participants
Region of Enrollment Italy	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Region of Enrollment United Kingdom	3 Participants n=93 Participants	3 Participants n=4 Participants	6 Participants n=27 Participants
Region of Enrollment France	4 Participants n=93 Participants	8 Participants n=4 Participants	12 Participants n=27 Participants
Region of Enrollment Germany	17 Participants n=93 Participants	11 Participants n=4 Participants	28 Participants n=27 Participants
Region of Enrollment Spain	31 Participants n=93 Participants	31 Participants n=4 Participants	62 Participants n=27 Participants
Region of Enrollment Australia	9 Participants n=93 Participants	6 Participants n=4 Participants	15 Participants n=27 Participants
HIV-1 RNA Categories < 50 copies/mL	278 Participants n=93 Participants	272 Participants n=4 Participants	550 Participants n=27 Participants
HIV-1 RNA Categories ≥ 50 copies/mL	4 Participants n=93 Participants	9 Participants n=4 Participants	13 Participants n=27 Participants
CD4 Cell Count	752 cell/µL STANDARD_DEVIATION 302.2 • n=93 Participants	694 cell/µL STANDARD_DEVIATION 291.6 • n=4 Participants	723 cell/µL STANDARD_DEVIATION 298.1 • n=27 Participants
CD4 Cell Count Category ≥ 50 to < 200 cells/μL	6 Participants n=93 Participants	4 Participants n=4 Participants	10 Participants n=27 Participants
CD4 Cell Count Category ≥ 200 to < 350 cells/μL	16 Participants n=93 Participants	30 Participants n=4 Participants	46 Participants n=27 Participants
CD4 Cell Count Category ≥ 350 to < 500 cells/μL	33 Participants n=93 Participants	42 Participants n=4 Participants	75 Participants n=27 Participants
CD4 Cell Count Category ≥ 500 cells/μL	227 Participants n=93 Participants	205 Participants n=4 Participants	432 Participants n=27 Participants

PRIMARY outcome

Timeframe: Week 48

Population: The Full Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.

Outcome measures

Outcome measures
Measure	B/F/TAF n=282 Participants Double-Blind Phase: B/F/TAF 50/200/25 mg FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 48 weeks, without regard to food. OL Extension Phase: After Week 48, participants in a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.	ABC/DTG/3TC n=281 Participants Double-Blind Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 48 weeks, without regard to food. OL Extension Phase: After Week 48, participants in a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.
Percentage of Participants With Virologic Failure (HIV-1 RNA ≥ 50 Copies/mL) as Defined by the Modified US FDA-defined Snapshot Algorithm	1.1 percentage of participants	0.4 percentage of participants

SECONDARY outcome

Timeframe: Week 48

Population: Participants in the Full Analysis were analyzed.

The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.

Outcome measures

Outcome measures
Measure	B/F/TAF n=282 Participants Double-Blind Phase: B/F/TAF 50/200/25 mg FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 48 weeks, without regard to food. OL Extension Phase: After Week 48, participants in a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.	ABC/DTG/3TC n=281 Participants Double-Blind Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 48 weeks, without regard to food. OL Extension Phase: After Week 48, participants in a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.
Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Defined by the US FDA-defined Snapshot Algorithm	93.6 percentage of participants	95.0 percentage of participants

SECONDARY outcome

Timeframe: Baseline; Week 48

Population: Participants in the Full Analysis Set with available data were analyzed.

Outcome measures

Outcome measures
Measure	B/F/TAF n=265 Participants Double-Blind Phase: B/F/TAF 50/200/25 mg FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 48 weeks, without regard to food. OL Extension Phase: After Week 48, participants in a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.	ABC/DTG/3TC n=267 Participants Double-Blind Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 48 weeks, without regard to food. OL Extension Phase: After Week 48, participants in a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.
Change From Baseline in CD4+ Cell Count at Week 48	-31 cells/µL Standard Deviation 181.3	4 cells/µL Standard Deviation 191.0

SECONDARY outcome

Timeframe: Baseline

Population: The Spine dual X-ray absorptiometry (DXA) analysis Set included participants who were randomized into the study, received at least 1 dose of study drug, and had nonmissing baseline spine BMD values.

Outcome measures

Outcome measures
Measure	B/F/TAF n=256 Participants Double-Blind Phase: B/F/TAF 50/200/25 mg FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 48 weeks, without regard to food. OL Extension Phase: After Week 48, participants in a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.	ABC/DTG/3TC n=262 Participants Double-Blind Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 48 weeks, without regard to food. OL Extension Phase: After Week 48, participants in a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.
Spine Bone Mineral Density (BMD) at Baseline	1.124 g/cm^2 Standard Deviation 0.1833	1.103 g/cm^2 Standard Deviation 0.1548

SECONDARY outcome

Timeframe: Baseline; Week 48

Population: Participants in the Spine DXA Analysis Set with available data were analyzed.

Outcome measures

Outcome measures
Measure	B/F/TAF n=233 Participants Double-Blind Phase: B/F/TAF 50/200/25 mg FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 48 weeks, without regard to food. OL Extension Phase: After Week 48, participants in a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.	ABC/DTG/3TC n=244 Participants Double-Blind Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 48 weeks, without regard to food. OL Extension Phase: After Week 48, participants in a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.
Percentage Change From Baseline in Spine BMD at Week 48	0.692 percentage change Standard Deviation 3.1296	0.416 percentage change Standard Deviation 2.9973

SECONDARY outcome

Timeframe: Baseline

Population: The Hip DXA Analysis Set included participants who were randomized into the study, received at least 1 dose of study drug, and had nonmissing baseline hip BMD values.

Outcome measures

Outcome measures
Measure	B/F/TAF n=256 Participants Double-Blind Phase: B/F/TAF 50/200/25 mg FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 48 weeks, without regard to food. OL Extension Phase: After Week 48, participants in a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.	ABC/DTG/3TC n=265 Participants Double-Blind Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 48 weeks, without regard to food. OL Extension Phase: After Week 48, participants in a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.
Hip Bone Mineral Density at Baseline	1.006 g/cm^2 Standard Deviation 0.1471	0.996 g/cm^2 Standard Deviation 0.1363

SECONDARY outcome

Timeframe: Baseline; Week 48

Population: Participants in the Hip DXA Analysis Set with available data were analyzed.

Outcome measures

Outcome measures
Measure	B/F/TAF n=229 Participants Double-Blind Phase: B/F/TAF 50/200/25 mg FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 48 weeks, without regard to food. OL Extension Phase: After Week 48, participants in a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.	ABC/DTG/3TC n=242 Participants Double-Blind Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 48 weeks, without regard to food. OL Extension Phase: After Week 48, participants in a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.
Percentage Change From Baseline in Hip BMD at Week 48	0.156 percentage change Standard Deviation 2.2138	0.299 percentage change Standard Deviation 2.1077

Adverse Events

Double-Blind: B/F/TAF

Serious events: 17 serious events

Other events: 122 other events

Deaths: 2 deaths

Double-Blind: ABC/DTG/3TC

Serious events: 26 serious events

Other events: 132 other events

Deaths: 0 deaths

Open-label Extension: B/F/TAF From B/F/TAF

Serious events: 24 serious events

Other events: 84 other events

Deaths: 1 deaths

Open-label Extension: B/F/TAF From ABC/DTG/3TC

Serious events: 11 serious events

Other events: 82 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Double-Blind: B/F/TAF n=282 participants at risk B/F/TAF (50/200/25 mg) FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 48 weeks, without regard to food.	Double-Blind: ABC/DTG/3TC n=281 participants at risk ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 48 weeks, without regard to food.	Open-label Extension: B/F/TAF From B/F/TAF n=259 participants at risk Participants who received B/F/TAF in double-blind phase and from country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.	Open-label Extension: B/F/TAF From ABC/DTG/3TC n=265 participants at risk Participants who received ABC/DTG/3TC in double-blind phase and from country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.
Gastrointestinal disorders Diarrhoea	9.2% 26/282 • First dose date up to 169 weeks plus 30 days The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.	6.4% 18/281 • First dose date up to 169 weeks plus 30 days The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.	7.7% 20/259 • First dose date up to 169 weeks plus 30 days The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.	4.2% 11/265 • First dose date up to 169 weeks plus 30 days The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
Gastrointestinal disorders Nausea	2.1% 6/282 • First dose date up to 169 weeks plus 30 days The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.	5.7% 16/281 • First dose date up to 169 weeks plus 30 days The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.	1.2% 3/259 • First dose date up to 169 weeks plus 30 days The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.	0.38% 1/265 • First dose date up to 169 weeks plus 30 days The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
Infections and infestations Bronchitis	3.9% 11/282 • First dose date up to 169 weeks plus 30 days The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.	5.3% 15/281 • First dose date up to 169 weeks plus 30 days The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.	4.2% 11/259 • First dose date up to 169 weeks plus 30 days The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.	3.0% 8/265 • First dose date up to 169 weeks plus 30 days The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
Infections and infestations Nasopharyngitis	7.4% 21/282 • First dose date up to 169 weeks plus 30 days The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.	7.8% 22/281 • First dose date up to 169 weeks plus 30 days The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.	7.7% 20/259 • First dose date up to 169 weeks plus 30 days The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.	8.3% 22/265 • First dose date up to 169 weeks plus 30 days The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
Infections and infestations Sinusitis	3.9% 11/282 • First dose date up to 169 weeks plus 30 days The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.	5.3% 15/281 • First dose date up to 169 weeks plus 30 days The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.	3.5% 9/259 • First dose date up to 169 weeks plus 30 days The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.	4.9% 13/265 • First dose date up to 169 weeks plus 30 days The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
Infections and infestations Upper respiratory tract infection	12.1% 34/282 • First dose date up to 169 weeks plus 30 days The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.	11.4% 32/281 • First dose date up to 169 weeks plus 30 days The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.	8.5% 22/259 • First dose date up to 169 weeks plus 30 days The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.	9.8% 26/265 • First dose date up to 169 weeks plus 30 days The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Arthralgia	7.4% 21/282 • First dose date up to 169 weeks plus 30 days The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.	6.4% 18/281 • First dose date up to 169 weeks plus 30 days The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.	3.1% 8/259 • First dose date up to 169 weeks plus 30 days The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.	2.3% 6/265 • First dose date up to 169 weeks plus 30 days The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Back pain	4.6% 13/282 • First dose date up to 169 weeks plus 30 days The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.	4.6% 13/281 • First dose date up to 169 weeks plus 30 days The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.	5.0% 13/259 • First dose date up to 169 weeks plus 30 days The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.	2.3% 6/265 • First dose date up to 169 weeks plus 30 days The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
Nervous system disorders Headache	6.7% 19/282 • First dose date up to 169 weeks plus 30 days The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.	8.2% 23/281 • First dose date up to 169 weeks plus 30 days The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.	1.9% 5/259 • First dose date up to 169 weeks plus 30 days The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.	3.4% 9/265 • First dose date up to 169 weeks plus 30 days The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
Psychiatric disorders Insomnia	3.2% 9/282 • First dose date up to 169 weeks plus 30 days The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.	7.8% 22/281 • First dose date up to 169 weeks plus 30 days The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.	0.39% 1/259 • First dose date up to 169 weeks plus 30 days The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.	2.6% 7/265 • First dose date up to 169 weeks plus 30 days The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.

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