Trial Outcomes & Findings for Study to Evaluate Switching From a Regimen of Two Nucleos(t)Ide Reverse Transcriptase Inhibitors (NRTI) Plus a Third Agent to a Fixed Dose Combination (FDC) of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF), in Virologically-Suppressed, HIV-1 Infected African American Participants (NCT NCT03631732)

Last Updated: 2021-09-05

Results Overview

The percentage of participants who had HIV-1 RNA ≥ 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defined 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

496 participants

Primary outcome timeframe

Week 24

Results posted on

2021-09-05

Participant Flow

Participants were enrolled at study centers in the United States. The first participant was screened on 28 August 2018. The last study visit occurred on 19 August 2020.

The following NRTIs \& 3rd agents were allowed: NRTIs:abacavir, emtricitabine, lamivudine, tenofovir alafenamide, tenofovir disoproxil fumarate, zidovudine; 3rd agents:delavirdine,efavirenz, nevirapine, rilpivirine,dolutegravir, elvitegravir,raltegravir, doravirine, atazanavir, darunavir, lopinavir, nelfinavir, saquinavir, tipranavir, maraviroc

Participant milestones

Participant milestones
Measure	B/F/TAF Participants received bictegravir /emtricitabine/tenofovir alafenamide (B/F/TAF) (50/200/25 mg) fixed dose combination (FDC) tablet orally once daily for 48 weeks, without regard to food. At Week 48, participants who wished to continue on B/F/TAF were given the option to receive B/F/TAF FDC for up to an additional 24 weeks or until they had access to B/F/TAF, whichever occurred first.	Stay on Baseline Regimen (SBR)/ Delayed B/F/TAF Participants stayed on baseline regimen consisting of 2 nucleos(t)Ide reverse transcriptase inhibitors (NRTIs) and a third agent (each taken as prescribed) for 24 weeks with a delayed switch to B/F/TAF (50/200/25 mg) FDC tablet administered orally, once daily until Week 48 without regard to food. At Week 48, participants who wished to continue on B/F/TAF were given the option to receive B/F/TAF FDC for up to an additional 24 weeks or until they had access to B/F/TAF, whichever occurred first.
Randomized Phase Up to Week 24 STARTED	331	165
Randomized Phase Up to Week 24 COMPLETED	324	163
Randomized Phase Up to Week 24 NOT COMPLETED	7	2
B/F/TAF Treatment Phase (After Week 24) STARTED	319	163
B/F/TAF Treatment Phase (After Week 24) COMPLETED	303	158
B/F/TAF Treatment Phase (After Week 24) NOT COMPLETED	16	5

Reasons for withdrawal

Reasons for withdrawal
Measure	B/F/TAF Participants received bictegravir /emtricitabine/tenofovir alafenamide (B/F/TAF) (50/200/25 mg) fixed dose combination (FDC) tablet orally once daily for 48 weeks, without regard to food. At Week 48, participants who wished to continue on B/F/TAF were given the option to receive B/F/TAF FDC for up to an additional 24 weeks or until they had access to B/F/TAF, whichever occurred first.	Stay on Baseline Regimen (SBR)/ Delayed B/F/TAF Participants stayed on baseline regimen consisting of 2 nucleos(t)Ide reverse transcriptase inhibitors (NRTIs) and a third agent (each taken as prescribed) for 24 weeks with a delayed switch to B/F/TAF (50/200/25 mg) FDC tablet administered orally, once daily until Week 48 without regard to food. At Week 48, participants who wished to continue on B/F/TAF were given the option to receive B/F/TAF FDC for up to an additional 24 weeks or until they had access to B/F/TAF, whichever occurred first.
Randomized Phase Up to Week 24 Lost to Follow-up	3	0
Randomized Phase Up to Week 24 Withdrew Consent	1	2
Randomized Phase Up to Week 24 Adverse Event	2	0
Randomized Phase Up to Week 24 Randomized but not treated	1	0
B/F/TAF Treatment Phase (After Week 24) Lost to Follow-up	6	1
B/F/TAF Treatment Phase (After Week 24) Withdrew Consent	3	3
B/F/TAF Treatment Phase (After Week 24) Adverse Event	4	1
B/F/TAF Treatment Phase (After Week 24) Death	1	0
B/F/TAF Treatment Phase (After Week 24) Investigator's discretion	1	0
B/F/TAF Treatment Phase (After Week 24) Lack of Efficacy	1	0

Baseline Characteristics

Study to Evaluate Switching From a Regimen of Two Nucleos(t)Ide Reverse Transcriptase Inhibitors (NRTI) Plus a Third Agent to a Fixed Dose Combination (FDC) of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF), in Virologically-Suppressed, HIV-1 Infected African American Participants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	B/F/TAF n=330 Participants Participants received B/F/TAF (50/200/25 mg) FDC tablet orally once daily for 48 weeks, without regard to food. At Week 48, participants who wished to continue on B/F/TAF were given the option to receive B/F/TAF FDC for up to an additional 24 weeks or until they had access to B/F/TAF, whichever occurred first.	Stay on Baseline Regimen/ Delayed B/F/TAF n=165 Participants Participants stayed on baseline regimen consisting of 2 NRTIs and a third agent (each taken as prescribed) for 24 weeks with a delayed switch to B/F/TAF (50/200/25 mg) FDC tablet administered orally, once daily until Week 48 without regard to food. At Week 48, participants who wished to continue on B/F/TAF were given the option to receive B/F/TAF FDC for up to an additional 24 weeks or until they had access to B/F/TAF, whichever occurred first.	Total n=495 Participants Total of all reporting groups
Age, Continuous	47 years STANDARD_DEVIATION 12.3 • n=93 Participants	48 years STANDARD_DEVIATION 12.2 • n=4 Participants	47 years STANDARD_DEVIATION 12.2 • n=27 Participants
Sex: Female, Male Female	101 Participants n=93 Participants	55 Participants n=4 Participants	156 Participants n=27 Participants
Sex: Female, Male Male	229 Participants n=93 Participants	110 Participants n=4 Participants	339 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	15 Participants n=93 Participants	5 Participants n=4 Participants	20 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	315 Participants n=93 Participants	160 Participants n=4 Participants	475 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race/Ethnicity, Customized Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race/Ethnicity, Customized Black or African American	285 Participants n=93 Participants	154 Participants n=4 Participants	439 Participants n=27 Participants
Race/Ethnicity, Customized Native Hawaiian or Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race/Ethnicity, Customized White	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race/Ethnicity, Customized Other	45 Participants n=93 Participants	11 Participants n=4 Participants	56 Participants n=27 Participants
HIV-1 RNA Category < 50 copies/mL	325 Participants n=93 Participants	163 Participants n=4 Participants	488 Participants n=27 Participants
HIV-1 RNA Category ≥ 50 copies/mL	5 Participants n=93 Participants	2 Participants n=4 Participants	7 Participants n=27 Participants
CD4+ Cell Count	765 cells/µL STANDARD_DEVIATION 313.4 • n=93 Participants	757 cells/µL STANDARD_DEVIATION 323.0 • n=4 Participants	763 cells/µL STANDARD_DEVIATION 316.3 • n=27 Participants

PRIMARY outcome

Timeframe: Week 24

Population: Participants in the Full Analysis Set \[included all participants who were randomized into the study, and had received at least 1 dose of study treatment (either B/F/TAF or baseline regimen on Day 1), and did not have pre-existing integrase strand transfer inhibitor resistance-associated mutations (based on historical data)\] in B/F/TAF and SBR groups were analyzed.

Outcome measures

Outcome measures
Measure	B/F/TAF n=328 Participants Participants received B/F/TAF (50/200/25 mg) FDC tablet orally once daily for 48 weeks, without regard to food.	Stay on Baseline Regimen (SBR) n=165 Participants Participants stayed on baseline regimen consisting of 2 NRTIs and a third agent (each taken as prescribed) for 24 weeks administered orally once daily.
Percentage of Participants Who Had HIV-1 RNA ≥ 50 Copies/mL at Week 24 as Defined by the US FDA-Defined Snapshot Algorithm: Full Analysis Set	0.6 percentage of participants Interval 0.1 to 2.2	1.8 percentage of participants Interval 0.4 to 5.2

SECONDARY outcome

Timeframe: Week 48

Population: Participants in the Full Analysis Set in the B/F/TAF and the Delayed B/F/TAF groups with available data were analyzed.

The percentage of participants who had HIV-1 RNA ≥ 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defined 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. By Week 48, participants in B/F/TAF had received 48 weeks of treatment with B/F/TAF, while those in the Delayed B/F/TAF group had received only 24 weeks of treatment with B/F/TAF.

Outcome measures

Outcome measures
Measure	B/F/TAF n=328 Participants Participants received B/F/TAF (50/200/25 mg) FDC tablet orally once daily for 48 weeks, without regard to food.	Stay on Baseline Regimen (SBR) n=163 Participants Participants stayed on baseline regimen consisting of 2 NRTIs and a third agent (each taken as prescribed) for 24 weeks administered orally once daily.
Percentage of Participants Who Had HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm: Full Analysis Set	0.9 percentage of participants Interval 0.2 to 2.6	0 percentage of participants Interval 0.0 to 2.2

SECONDARY outcome

Timeframe: Week 24

Population: Participants in the Full Analysis Set in the B/F/TAF and SBR groups were analyzed.

The percentage of participants who had HIV-1 RNA \< 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defined 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=328 Participants Participants received B/F/TAF (50/200/25 mg) FDC tablet orally once daily for 48 weeks, without regard to food.	Stay on Baseline Regimen (SBR) n=165 Participants Participants stayed on baseline regimen consisting of 2 NRTIs and a third agent (each taken as prescribed) for 24 weeks administered orally once daily.
Percentage of Participants Who Had HIV-1 RNA < 50 Copies/mL at Week 24 as Defined by the US FDA-Defined Snapshot Algorithm: Full Analysis Set	96.3 percentage of participants Interval 93.7 to 98.1	94.5 percentage of participants Interval 89.9 to 97.5

SECONDARY outcome

Timeframe: Week 24

Population: Participants in the Week 24 Per Protocol Analysis Set \[included all participants who were randomized into the study and had received at least 1 dose of study treatment (either B/F/TAF or baseline regimen on Day 1), and had not committed any major protocol violation, including the violation of key entry criteria\] in the B/F/TAF and SBR groups were analyzed.

Outcome measures

Outcome measures
Measure	B/F/TAF n=306 Participants Participants received B/F/TAF (50/200/25 mg) FDC tablet orally once daily for 48 weeks, without regard to food.	Stay on Baseline Regimen (SBR) n=148 Participants Participants stayed on baseline regimen consisting of 2 NRTIs and a third agent (each taken as prescribed) for 24 weeks administered orally once daily.
Percentage of Participants Who Had HIV-1 RNA < 50 Copies/mL at Week 24 as Defined by the US FDA-Defined Snapshot Algorithm: Week 24 Per Protocol Analysis Set	99.3 percentage of participants Interval 97.7 to 99.9	98.0 percentage of participants Interval 94.2 to 99.6

SECONDARY outcome

Timeframe: Week 48

Population: Participants in the Full Analysis Set in the B/F/TAF and the Delayed B/F/TAF groups with available data were analyzed.

The percentage of participants who had HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defined 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. By Week 48, participants in B/F/TAF had received 48 weeks of treatment with B/F/TAF, while those in the Delayed B/F/TAF group had received only 24 weeks of treatment with B/F/TAF.

Outcome measures

Outcome measures
Measure	B/F/TAF n=328 Participants Participants received B/F/TAF (50/200/25 mg) FDC tablet orally once daily for 48 weeks, without regard to food.	Stay on Baseline Regimen (SBR) n=163 Participants Participants stayed on baseline regimen consisting of 2 NRTIs and a third agent (each taken as prescribed) for 24 weeks administered orally once daily.
Percentage of Participants Who Had HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm: Full Analysis Set	94.5 percentage of participants Interval 91.5 to 96.7	96.9 percentage of participants Interval 93.0 to 99.0

SECONDARY outcome

Timeframe: Baseline to Week 24

Population: Participants in the Full Analysis Set in the B/F/TAF and SBR groups with available data were analyzed.

The analysis includes values up to 1 day after permanent discontinuation of study treatment.

Outcome measures

Outcome measures
Measure	B/F/TAF n=319 Participants Participants received B/F/TAF (50/200/25 mg) FDC tablet orally once daily for 48 weeks, without regard to food.	Stay on Baseline Regimen (SBR) n=156 Participants Participants stayed on baseline regimen consisting of 2 NRTIs and a third agent (each taken as prescribed) for 24 weeks administered orally once daily.
Change From Baseline in CD4+ Cell Count at Week 24: Full Analysis Set	13 cells/uL Standard Deviation 209.3	1 cells/uL Standard Deviation 171.2

SECONDARY outcome

Timeframe: Baseline to Week 24

Population: Participants in the Week 24 Per Protocol Analysis Set in the B/F/TAF and SBR groups with available data were analyzed.

The analysis includes values up to 1 day after permanent discontinuation of study treatment.

Outcome measures

Outcome measures
Measure	B/F/TAF n=305 Participants Participants received B/F/TAF (50/200/25 mg) FDC tablet orally once daily for 48 weeks, without regard to food.	Stay on Baseline Regimen (SBR) n=144 Participants Participants stayed on baseline regimen consisting of 2 NRTIs and a third agent (each taken as prescribed) for 24 weeks administered orally once daily.
Change From Baseline in CD4+ Cell Count at Week 24: Week 24 Per Protocol Analysis Set	13 cells/uL Standard Deviation 210.1	4 cells/uL Standard Deviation 171.3

SECONDARY outcome

Timeframe: Baseline to Week 48

Population: Participants in the Full Analysis Set in the B/F/TAF and the Delayed B/F/TAF groups with available data were analyzed.

The analysis includes values up to 1 day after permanent discontinuation of study treatment. By Week 48, participants in B/F/TAF had received 48 weeks of treatment with B/F/TAF, while those in the Delayed B/F/TAF group had received only 24 weeks of treatment with B/F/TAF.

Outcome measures

Outcome measures
Measure	B/F/TAF n=309 Participants Participants received B/F/TAF (50/200/25 mg) FDC tablet orally once daily for 48 weeks, without regard to food.	Stay on Baseline Regimen (SBR) n=159 Participants Participants stayed on baseline regimen consisting of 2 NRTIs and a third agent (each taken as prescribed) for 24 weeks administered orally once daily.
Change From Baseline in CD4+ Cell Count at Week 48: Full Analysis Set	7 cells/uL Standard Deviation 188.6	-8 cells/uL Standard Deviation 159.2

SECONDARY outcome

Timeframe: First B/F/TAF dose date up to Week 72 plus 30 days

Population: The B/F/TAF (BVY) Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of BVY study drug.

An adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a medicinal product, which did not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A treatment-emergent adverse event was defined as any adverse event with onset date on or after the study treatment start date and no later than 30 days after the study drug stop date; or any adverse event leading to study drug discontinuation.

Outcome measures

Outcome measures
Measure	B/F/TAF n=330 Participants Participants received B/F/TAF (50/200/25 mg) FDC tablet orally once daily for 48 weeks, without regard to food.	Stay on Baseline Regimen (SBR) n=163 Participants Participants stayed on baseline regimen consisting of 2 NRTIs and a third agent (each taken as prescribed) for 24 weeks administered orally once daily.
Percentage of Participants Experiencing Treatment-Emergent Adverse Events	83.3 percentage of participants	69.3 percentage of participants

SECONDARY outcome

Timeframe: First B/F/TAF dose date up to Week 72 plus 30 days

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

Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. The most severe graded abnormality from all tests was counted for each participant. Severity grades were defined by 'Gilead Grading Scale for Severity of AEs and Laboratory Abnormalities'.

Outcome measures

Outcome measures
Measure	B/F/TAF n=329 Participants Participants received B/F/TAF (50/200/25 mg) FDC tablet orally once daily for 48 weeks, without regard to food.	Stay on Baseline Regimen (SBR) n=163 Participants Participants stayed on baseline regimen consisting of 2 NRTIs and a third agent (each taken as prescribed) for 24 weeks administered orally once daily.
Percentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormalities	87.8 percentage of participants	80.4 percentage of participants

Adverse Events

B/F/TAF up to Week 24

Serious events: 13 serious events

Other events: 38 other events

Deaths: 1 deaths

SBR up to Week 24

Serious events: 7 serious events

Other events: 13 other events

Deaths: 0 deaths

B/F/TAF After Week 24

Serious events: 20 serious events

Other events: 53 other events

Deaths: 2 deaths

Delayed B/F/TAF

Serious events: 7 serious events

Other events: 26 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	B/F/TAF up to Week 24 n=330 participants at risk Participants received B/F/TAF (50/200/25 mg) FDC tablet orally once daily for 24 weeks, without regard to food.	SBR up to Week 24 n=165 participants at risk Participants stayed on baseline regimen consisting of 2 NRTIs and a third agent (each taken as prescribed) for 24 weeks administered orally once daily.	B/F/TAF After Week 24 n=319 participants at risk Participants received B/F/TAF (50/200/25 mg) FDC tablet orally once daily from Week 24 to Week 48, without regard to food. At Week 48, participants who wished to continue on B/F/TAF were given the option to receive B/F/TAF FDC for up to an additional 24 weeks or until they had access to B/F/TAF, whichever occurred first.	Delayed B/F/TAF n=163 participants at risk Participants in SBR group who switched to B/F/TAF group at Week 24 received B/F/TAF (50/200/25 mg) FDC tablet orally, once daily from Week 24 until Week 48 without regard to food. At Week 48, participants who wished to continue on B/F/TAF were given the option to receive B/F/TAF FDC for up to an additional 24 weeks or until they had access to B/F/TAF, whichever occurred first.
Gastrointestinal disorders Diarrhoea	3.3% 11/330 • Adverse Events: First B/F/TAF dose date up to Week 72 plus 30 days. All-Cause Mortality: Randomization up to Week 72 plus 30 days. The Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study treatment (either B/F/TAF or baseline regimen on Day 1). All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	3.0% 5/165 • Adverse Events: First B/F/TAF dose date up to Week 72 plus 30 days. All-Cause Mortality: Randomization up to Week 72 plus 30 days. The Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study treatment (either B/F/TAF or baseline regimen on Day 1). All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	1.3% 4/319 • Adverse Events: First B/F/TAF dose date up to Week 72 plus 30 days. All-Cause Mortality: Randomization up to Week 72 plus 30 days. The Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study treatment (either B/F/TAF or baseline regimen on Day 1). All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	5.5% 9/163 • Adverse Events: First B/F/TAF dose date up to Week 72 plus 30 days. All-Cause Mortality: Randomization up to Week 72 plus 30 days. The Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study treatment (either B/F/TAF or baseline regimen on Day 1). All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Infections and infestations Syphilis	1.2% 4/330 • Adverse Events: First B/F/TAF dose date up to Week 72 plus 30 days. All-Cause Mortality: Randomization up to Week 72 plus 30 days. The Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study treatment (either B/F/TAF or baseline regimen on Day 1). All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.61% 1/165 • Adverse Events: First B/F/TAF dose date up to Week 72 plus 30 days. All-Cause Mortality: Randomization up to Week 72 plus 30 days. The Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study treatment (either B/F/TAF or baseline regimen on Day 1). All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	5.6% 18/319 • Adverse Events: First B/F/TAF dose date up to Week 72 plus 30 days. All-Cause Mortality: Randomization up to Week 72 plus 30 days. The Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study treatment (either B/F/TAF or baseline regimen on Day 1). All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	4.3% 7/163 • Adverse Events: First B/F/TAF dose date up to Week 72 plus 30 days. All-Cause Mortality: Randomization up to Week 72 plus 30 days. The Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study treatment (either B/F/TAF or baseline regimen on Day 1). All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Infections and infestations Upper respiratory tract infection	6.1% 20/330 • Adverse Events: First B/F/TAF dose date up to Week 72 plus 30 days. All-Cause Mortality: Randomization up to Week 72 plus 30 days. The Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study treatment (either B/F/TAF or baseline regimen on Day 1). All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	3.6% 6/165 • Adverse Events: First B/F/TAF dose date up to Week 72 plus 30 days. All-Cause Mortality: Randomization up to Week 72 plus 30 days. The Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study treatment (either B/F/TAF or baseline regimen on Day 1). All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	5.3% 17/319 • Adverse Events: First B/F/TAF dose date up to Week 72 plus 30 days. All-Cause Mortality: Randomization up to Week 72 plus 30 days. The Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study treatment (either B/F/TAF or baseline regimen on Day 1). All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	6.1% 10/163 • Adverse Events: First B/F/TAF dose date up to Week 72 plus 30 days. All-Cause Mortality: Randomization up to Week 72 plus 30 days. The Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study treatment (either B/F/TAF or baseline regimen on Day 1). All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Musculoskeletal and connective tissue disorders Pain in extremity	1.5% 5/330 • Adverse Events: First B/F/TAF dose date up to Week 72 plus 30 days. All-Cause Mortality: Randomization up to Week 72 plus 30 days. The Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study treatment (either B/F/TAF or baseline regimen on Day 1). All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	1.2% 2/165 • Adverse Events: First B/F/TAF dose date up to Week 72 plus 30 days. All-Cause Mortality: Randomization up to Week 72 plus 30 days. The Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study treatment (either B/F/TAF or baseline regimen on Day 1). All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	5.0% 16/319 • Adverse Events: First B/F/TAF dose date up to Week 72 plus 30 days. All-Cause Mortality: Randomization up to Week 72 plus 30 days. The Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study treatment (either B/F/TAF or baseline regimen on Day 1). All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	3.7% 6/163 • Adverse Events: First B/F/TAF dose date up to Week 72 plus 30 days. All-Cause Mortality: Randomization up to Week 72 plus 30 days. The Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study treatment (either B/F/TAF or baseline regimen on Day 1). All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the 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