Trial Outcomes & Findings for Study to Evaluate the Safety and Efficacy of Switching From Regimens Consisting of Boosted Atazanavir or Darunavir Plus Either Emtricitabine/Tenofovir or Abacavir/Lamivudine to Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed HIV-1 Infected Adults (NCT NCT02603107)

Last Updated: 2020-12-29

Results Overview

The percentage of participants with 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

578 participants

Primary outcome timeframe

Week 48

Results posted on

2020-12-29

Participant Flow

Participants were enrolled at study sites in Dominican Republic, North America, Australia, and Europe. The first participant was screened on 20 November 2015. The last study visit occurred on 23 December 2019.

707 participants were screened.

Participant milestones

Participant milestones
Measure	B/F/TAF Randomized Phase: Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) 50/200/25 mg fixed-dose combination (FDC) tablet orally once daily for at least 48 weeks, without regard to food. Extension Phase: After Week 48, participants in countries where B/F/TAF was not available were given the option to receive B/F/TAF for up to 96 additional weeks or until the product became accessible to participants through an access program, or until Gilead Sciences elected to discontinue the study in that country, whichever occurred first.	Stay on Baseline Regimen (SBR) Randomized Phase: Participants remained on current antiretroviral (ARV) regimen consisting of ritonavir (RTV)-boosted or cobicistat (COBI)-boosted atazanavir (ATV) or darunavir (DRV), plus either emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300 mg) FDC tablet or abacavir/lamivudine (ABC/3TC) (600/300 mg) FDC tablet administered orally once daily for at least 48 weeks with food. Extension Phase: After Week 48, participants in countries where B/F/TAF was not available were given the option to receive B/F/TAF for up to 96 additional weeks or until the product became accessible to participants through an access program, or until Gilead Sciences elected to discontinue the study in that country, whichever occurred first.
Randomized Phase STARTED	290	287
Randomized Phase COMPLETED	275	266
Randomized Phase NOT COMPLETED	15	21
Optional Extension Phase STARTED	272	245
Optional Extension Phase COMPLETED	263	232
Optional Extension Phase NOT COMPLETED	9	13

Reasons for withdrawal

Reasons for withdrawal
Measure	B/F/TAF Randomized Phase: Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) 50/200/25 mg fixed-dose combination (FDC) tablet orally once daily for at least 48 weeks, without regard to food. Extension Phase: After Week 48, participants in countries where B/F/TAF was not available were given the option to receive B/F/TAF for up to 96 additional weeks or until the product became accessible to participants through an access program, or until Gilead Sciences elected to discontinue the study in that country, whichever occurred first.	Stay on Baseline Regimen (SBR) Randomized Phase: Participants remained on current antiretroviral (ARV) regimen consisting of ritonavir (RTV)-boosted or cobicistat (COBI)-boosted atazanavir (ATV) or darunavir (DRV), plus either emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300 mg) FDC tablet or abacavir/lamivudine (ABC/3TC) (600/300 mg) FDC tablet administered orally once daily for at least 48 weeks with food. Extension Phase: After Week 48, participants in countries where B/F/TAF was not available were given the option to receive B/F/TAF for up to 96 additional weeks or until the product became accessible to participants through an access program, or until Gilead Sciences elected to discontinue the study in that country, whichever occurred first.
Randomized Phase Withdrew consent	8	15
Randomized Phase Lost to Follow-up	1	3
Randomized Phase Adverse Event	2	0
Randomized Phase Death	1	1
Randomized Phase Non-compliance with study drug	1	1
Randomized Phase Investigator's discretion	0	1
Randomized Phase Lack of Efficacy	1	0
Randomized Phase Protocol Violation	1	0
Optional Extension Phase Lost to Follow-up	3	3
Optional Extension Phase Withdrew consent	3	2
Optional Extension Phase Investigator's discretion	2	2
Optional Extension Phase Pregnancy	0	3
Optional Extension Phase Adverse Event	0	2
Optional Extension Phase Not treated in extension phase	0	1
Optional Extension Phase Protocol Violation	1	0

Baseline Characteristics

Study to Evaluate the Safety and Efficacy of Switching From Regimens Consisting of Boosted Atazanavir or Darunavir Plus Either Emtricitabine/Tenofovir or Abacavir/Lamivudine to Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed HIV-1 Infected Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	B/F/TAF n=290 Participants Randomized Phase: B/F/TAF (50/200/25 mg) FDC tablet administered orally once daily for at least 48 weeks without regard to food. Extension Phase: After Week 48, participants in countries where B/F/TAF was not available were given the option to receive B/F/TAF for up to 96 additional weeks or until the product became accessible to participants through an access program, or until Gilead Sciences elected to discontinue the study in that country, whichever occurred first.	Stay on Baseline Regimen (SBR) n=287 Participants Randomized Phase: Participants remained on current ARV regimen consisting of RTV or COBI boosted ATV or DRV, plus either FTC/TDF (200/300 mg) FDC tablets or ABC/3TC (600/300 mg) FDC tablet administered orally once daily for at least 48 weeks with food. Extension Phase: After Week 48, participants in countries where B/F/TAF was not available were given the option to receive B/F/TAF for up to 96 additional weeks or until the product became accessible to participants through an access program, or until Gilead Sciences elected to discontinue the study in that country, whichever occurred first.	Total n=577 Participants Total of all reporting groups
Age, Continuous	47 years STANDARD_DEVIATION 10.5 • n=5 Participants	46 years STANDARD_DEVIATION 10.5 • n=7 Participants	46 years STANDARD_DEVIATION 10.5 • n=5 Participants
Sex: Female, Male Female	47 Participants n=5 Participants	53 Participants n=7 Participants	100 Participants n=5 Participants
Sex: Female, Male Male	243 Participants n=5 Participants	234 Participants n=7 Participants	477 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race/Ethnicity, Customized Asian	6 Participants n=5 Participants	10 Participants n=7 Participants	16 Participants n=5 Participants
Race/Ethnicity, Customized Black	79 Participants n=5 Participants	72 Participants n=7 Participants	151 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized White	188 Participants n=5 Participants	190 Participants n=7 Participants	378 Participants n=5 Participants
Race/Ethnicity, Customized Other	14 Participants n=5 Participants	12 Participants n=7 Participants	26 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	60 Participants n=5 Participants	47 Participants n=7 Participants	107 Participants n=5 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	230 Participants n=5 Participants	240 Participants n=7 Participants	470 Participants n=5 Participants
Region of Enrollment Australia	15 Participants n=5 Participants	16 Participants n=7 Participants	31 Participants n=5 Participants
Region of Enrollment Canada	18 Participants n=5 Participants	15 Participants n=7 Participants	33 Participants n=5 Participants
Region of Enrollment Belgium	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment France	17 Participants n=5 Participants	17 Participants n=7 Participants	34 Participants n=5 Participants
Region of Enrollment Germany	28 Participants n=5 Participants	33 Participants n=7 Participants	61 Participants n=5 Participants
Region of Enrollment Italy	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Region of Enrollment Spain	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Region of Enrollment United Kingdom	31 Participants n=5 Participants	23 Participants n=7 Participants	54 Participants n=5 Participants
Region of Enrollment United States	166 Participants n=5 Participants	164 Participants n=7 Participants	330 Participants n=5 Participants
Region of Enrollment Dominican Republic	4 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants
HIV-1 RNA Category < 50 copies/mL	285 Participants n=5 Participants	277 Participants n=7 Participants	562 Participants n=5 Participants
HIV-1 RNA Category ≥ 50 copies/mL	5 Participants n=5 Participants	10 Participants n=7 Participants	15 Participants n=5 Participants
CD4 Cell Count	669 cells/μL STANDARD_DEVIATION 303.4 • n=5 Participants	657 cells/μL STANDARD_DEVIATION 285.0 • n=7 Participants	663 cells/μL STANDARD_DEVIATION 294.2 • n=5 Participants
CD4 Cell Count Category < 50 cells/μL	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
CD4 Cell Count Category ≥ 50 to < 200 cells/μL	4 Participants n=5 Participants	8 Participants n=7 Participants	12 Participants n=5 Participants
CD4 Cell Count Category ≥ 200 to < 350 cells/μL	26 Participants n=5 Participants	30 Participants n=7 Participants	56 Participants n=5 Participants
CD4 Cell Count Category ≥ 350 to < 500 cells/μL	62 Participants n=5 Participants	60 Participants n=7 Participants	122 Participants n=5 Participants
CD4 Cell Count Category ≥ 500 cells/μL	198 Participants n=5 Participants	189 Participants n=7 Participants	387 Participants n=5 Participants
HIV Disease Status Asymptomatic	240 Participants n=5 Participants	234 Participants n=7 Participants	474 Participants n=5 Participants
HIV Disease Status Symptomatic HIV Infection	16 Participants n=5 Participants	20 Participants n=7 Participants	36 Participants n=5 Participants
HIV Disease Status Acquired Immunodeficiency Syndrome (AIDS)	34 Participants n=5 Participants	33 Participants n=7 Participants	67 Participants n=5 Participants
Prior ARV Regimen Boosted ATV + ABC/3TC	21 Participants n=5 Participants	23 Participants n=7 Participants	44 Participants n=5 Participants
Prior ARV Regimen Boosted DRV + ABC/3TC	24 Participants n=5 Participants	21 Participants n=7 Participants	45 Participants n=5 Participants
Prior ARV Regimen Boosted ATV + FTC/TDF	105 Participants n=5 Participants	110 Participants n=7 Participants	215 Participants n=5 Participants
Prior ARV Regimen Boosted DRV + FTC/TDF	140 Participants n=5 Participants	133 Participants n=7 Participants	273 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 48

Population: Full Analysis Set: all 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=290 Participants Randomized Phase: B/F/TAF (50/200/25 mg) FDC tablet administered orally once daily for at least 48 weeks without regard to food.	Stay on Baseline Regimen (SBR) n=287 Participants Randomized Phase: Participants remained on current ARV regimen consisting of RTV or COBI boosted ATV or DRV, plus either FTC/TDF (200/300 mg) FDC tablet or ABC/3TC (600/300 mg) FDC tablet administered orally once daily for at least 48 weeks with food.
Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Determined by the FDA-Defined Snapshot Algorithm	1.7 percentage of participants	1.7 percentage of participants

SECONDARY outcome

Timeframe: Week 48

Population: Full Analysis Set

The percentage of participants with 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=290 Participants Randomized Phase: B/F/TAF (50/200/25 mg) FDC tablet administered orally once daily for at least 48 weeks without regard to food.	Stay on Baseline Regimen (SBR) n=287 Participants Randomized Phase: Participants remained on current ARV regimen consisting of RTV or COBI boosted ATV or DRV, plus either FTC/TDF (200/300 mg) FDC tablet or ABC/3TC (600/300 mg) FDC tablet administered orally once daily for at least 48 weeks with food.
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Determined by the FDA-Defined Snapshot Algorithm	92.1 percentage of participants	88.9 percentage of participants

SECONDARY outcome

Timeframe: Baseline to 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 Randomized Phase: B/F/TAF (50/200/25 mg) FDC tablet administered orally once daily for at least 48 weeks without regard to food.	Stay on Baseline Regimen (SBR) n=256 Participants Randomized Phase: Participants remained on current ARV regimen consisting of RTV or COBI boosted ATV or DRV, plus either FTC/TDF (200/300 mg) FDC tablet or ABC/3TC (600/300 mg) FDC tablet administered orally once daily for at least 48 weeks with food.
Change From Baseline in CD4 Cell Count at Week 48	25 cells/μL Standard Deviation 151.2	0 cells/μL Standard Deviation 159.4

Adverse Events

B/F/TAF (Randomized Phase)

Serious events: 17 serious events

Other events: 117 other events

Deaths: 1 deaths

Stay on Baseline Regimen (SBR) (Randomized Phase)

Serious events: 21 serious events

Other events: 126 other events

Deaths: 1 deaths

Extension B/F/TAF From B/F/TAF

Serious events: 20 serious events

Other events: 108 other events

Deaths: 0 deaths

Extension B/F/TAF From SBR

Serious events: 29 serious events

Other events: 113 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	B/F/TAF (Randomized Phase) n=290 participants at risk Randomized Phase: B/F/TAF (50/200/25 mg) FDC tablet administered orally once daily for at least 48 weeks without regard to food.	Stay on Baseline Regimen (SBR) (Randomized Phase) n=287 participants at risk Randomized Phase: Participants remained on current ARV regimen consisting of RTV or COBI boosted ATV or DRV, plus either FTC/TDF (200/300 mg) FDC tablet or ABC/3TC (600/300 mg) FDC tablet administered orally once daily for at least 48 weeks with food.	Extension B/F/TAF From B/F/TAF n=272 participants at risk After Week 48, participants in countries where B/F/TAF was not available were given the option to receive B/F/TAF for up to 96 additional weeks or until the product became accessible to participants through an access program, or until Gilead Sciences elected to discontinue the study in that country, whichever occurred first.	Extension B/F/TAF From SBR n=244 participants at risk After Week 48, participants in countries where B/F/TAF was not available were given the option to receive B/F/TAF for up to 96 additional weeks or until the product became accessible to participants through an access program, or until Gilead Sciences elected to discontinue the study in that country, whichever occurred first.
Gastrointestinal disorders Diarrhoea	8.3% 24/290 • From the first dose date up to last dose date (maximum: 181 weeks) plus 30 days Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.	5.9% 17/287 • From the first dose date up to last dose date (maximum: 181 weeks) plus 30 days Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.	7.0% 19/272 • From the first dose date up to last dose date (maximum: 181 weeks) plus 30 days Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.	4.9% 12/244 • From the first dose date up to last dose date (maximum: 181 weeks) plus 30 days Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
Infections and infestations Influenza	2.4% 7/290 • From the first dose date up to last dose date (maximum: 181 weeks) plus 30 days Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.	4.2% 12/287 • From the first dose date up to last dose date (maximum: 181 weeks) plus 30 days Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.	3.7% 10/272 • From the first dose date up to last dose date (maximum: 181 weeks) plus 30 days Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.	6.1% 15/244 • From the first dose date up to last dose date (maximum: 181 weeks) plus 30 days Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
Infections and infestations Nasopharyngitis	7.9% 23/290 • From the first dose date up to last dose date (maximum: 181 weeks) plus 30 days Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.	12.2% 35/287 • From the first dose date up to last dose date (maximum: 181 weeks) plus 30 days Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.	8.8% 24/272 • From the first dose date up to last dose date (maximum: 181 weeks) plus 30 days Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.	15.6% 38/244 • From the first dose date up to last dose date (maximum: 181 weeks) plus 30 days Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
Infections and infestations Syphilis	3.1% 9/290 • From the first dose date up to last dose date (maximum: 181 weeks) plus 30 days Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.	3.8% 11/287 • From the first dose date up to last dose date (maximum: 181 weeks) plus 30 days Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.	5.1% 14/272 • From the first dose date up to last dose date (maximum: 181 weeks) plus 30 days Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.	5.7% 14/244 • From the first dose date up to last dose date (maximum: 181 weeks) plus 30 days 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	7.9% 23/290 • From the first dose date up to last dose date (maximum: 181 weeks) plus 30 days Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.	8.4% 24/287 • From the first dose date up to last dose date (maximum: 181 weeks) plus 30 days Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.	8.8% 24/272 • From the first dose date up to last dose date (maximum: 181 weeks) plus 30 days Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.	11.1% 27/244 • From the first dose date up to last dose date (maximum: 181 weeks) plus 30 days 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	5.2% 15/290 • From the first dose date up to last dose date (maximum: 181 weeks) plus 30 days Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.	5.6% 16/287 • From the first dose date up to last dose date (maximum: 181 weeks) plus 30 days Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.	4.4% 12/272 • From the first dose date up to last dose date (maximum: 181 weeks) plus 30 days Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.	3.7% 9/244 • From the first dose date up to last dose date (maximum: 181 weeks) plus 30 days 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	4.5% 13/290 • From the first dose date up to last dose date (maximum: 181 weeks) plus 30 days Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.	6.6% 19/287 • From the first dose date up to last dose date (maximum: 181 weeks) plus 30 days Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.	5.5% 15/272 • From the first dose date up to last dose date (maximum: 181 weeks) plus 30 days Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.	5.3% 13/244 • From the first dose date up to last dose date (maximum: 181 weeks) plus 30 days Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
Nervous system disorders Headache	11.7% 34/290 • From the first dose date up to last dose date (maximum: 181 weeks) plus 30 days Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.	4.9% 14/287 • From the first dose date up to last dose date (maximum: 181 weeks) plus 30 days Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.	4.8% 13/272 • From the first dose date up to last dose date (maximum: 181 weeks) plus 30 days Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.	7.0% 17/244 • From the first dose date up to last dose date (maximum: 181 weeks) plus 30 days Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Cough	4.1% 12/290 • From the first dose date up to last dose date (maximum: 181 weeks) plus 30 days Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.	3.1% 9/287 • From the first dose date up to last dose date (maximum: 181 weeks) plus 30 days Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.	5.1% 14/272 • From the first dose date up to last dose date (maximum: 181 weeks) plus 30 days Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.	3.3% 8/244 • From the first dose date up to last dose date (maximum: 181 weeks) plus 30 days 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