Trial Outcomes & Findings for Safety and Efficacy of Switching to a FDC of B/F/TAF From E/C/F/TAF, E/C/F/TDF, or ATV+RTV+FTC/TDF in Virologically Suppressed HIV-1 Infected Women (NCT NCT02652624)

Last Updated: 2020-03-04

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

472 participants

Primary outcome timeframe

Week 48

Results posted on

2020-03-04

Participant Flow

Participants were enrolled at study sites in the United States, Russian Federation, Thailand, Dominican Republic, and Uganda. The first participant was screened on 19 February 2016. The last study visit occurred on 26 November 2018.

491 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 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 (50/200/25 mg) FDC tablet once daily for up to 48 additional weeks, or until the product became accessible to participants through an access program, or until Gilead elected to discontinue the study in that country, whichever occurred first.	Stay on Baseline Regimen (SBR) Randomized Phase: Participants remained on their baseline regimen of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) tablet, elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF) (150/150/200/300 mg) tablet, or atazanavir (ATV) 300 mg capsule + ritonavir (RTV) 100 mg tablet + emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300 mg) tablet 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 (50/200/25 mg) FDC tablet once daily for up to 48 additional weeks, or until the product became accessible to participants through an access program, or until Gilead elected to discontinue the study in that country, whichever occurred first.
Randomized Phase STARTED	234	236
Randomized Phase COMPLETED	231	231
Randomized Phase NOT COMPLETED	3	5
Extension Phase STARTED	231	228
Extension Phase COMPLETED	227	224
Extension Phase NOT COMPLETED	4	4

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 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 (50/200/25 mg) FDC tablet once daily for up to 48 additional weeks, or until the product became accessible to participants through an access program, or until Gilead elected to discontinue the study in that country, whichever occurred first.	Stay on Baseline Regimen (SBR) Randomized Phase: Participants remained on their baseline regimen of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) tablet, elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF) (150/150/200/300 mg) tablet, or atazanavir (ATV) 300 mg capsule + ritonavir (RTV) 100 mg tablet + emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300 mg) tablet 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 (50/200/25 mg) FDC tablet once daily for up to 48 additional weeks, or until the product became accessible to participants through an access program, or until Gilead elected to discontinue the study in that country, whichever occurred first.
Randomized Phase Pregnancy	3	1
Randomized Phase Investigator's Discretion	0	2
Randomized Phase Death	0	1
Randomized Phase Lost to Follow-up	0	1
Extension Phase Lost to Follow-up	3	1
Extension Phase Pregnancy	1	1
Extension Phase Adverse Event	0	1
Extension Phase Withdrew Consent	0	1

Baseline Characteristics

Safety and Efficacy of Switching to a FDC of B/F/TAF From E/C/F/TAF, E/C/F/TDF, or ATV+RTV+FTC/TDF in Virologically Suppressed HIV-1 Infected Women

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	B/F/TAF n=234 Participants B/F/TAF (50/200/25 mg) FDC tablet once daily without regard to food for 48 weeks.	Stay on Baseline Regimen n=236 Participants Participants remained on their baseline regimen of E/C/F/TAF (150/150/200/10 mg) tablet, E/C/F/TDF (150/150/200/300 mg) tablet, or ATV 300 mg capsule + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet for 48 weeks.	Total n=470 Participants Total of all reporting groups
Age, Continuous	40 years STANDARD_DEVIATION 9.5 • n=5 Participants	40 years STANDARD_DEVIATION 9.1 • n=7 Participants	40 years STANDARD_DEVIATION 9.3 • n=5 Participants
Sex: Female, Male Female	234 Participants n=5 Participants	236 Participants n=7 Participants	470 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	36 Participants n=5 Participants	38 Participants n=7 Participants	74 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	198 Participants n=5 Participants	198 Participants n=7 Participants	396 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Asian	48 Participants n=5 Participants	54 Participants n=7 Participants	102 Participants n=5 Participants
Race/Ethnicity, Customized Black	91 Participants n=5 Participants	83 Participants n=7 Participants	174 Participants n=5 Participants
Race/Ethnicity, Customized White	66 Participants n=5 Participants	67 Participants n=7 Participants	133 Participants n=5 Participants
Race/Ethnicity, Customized Other	29 Participants n=5 Participants	32 Participants n=7 Participants	61 Participants n=5 Participants
Region of Enrollment United States	36 Participants n=5 Participants	36 Participants n=7 Participants	72 Participants n=5 Participants
Region of Enrollment Dominican Republic	28 Participants n=5 Participants	30 Participants n=7 Participants	58 Participants n=5 Participants
Region of Enrollment Uganda	65 Participants n=5 Participants	62 Participants n=7 Participants	127 Participants n=5 Participants
Region of Enrollment Thailand	47 Participants n=5 Participants	54 Participants n=7 Participants	101 Participants n=5 Participants
Region of Enrollment Russia	58 Participants n=5 Participants	54 Participants n=7 Participants	112 Participants n=5 Participants
HIV-1 RNA Category < 50 copies/mL	234 Participants n=5 Participants	233 Participants n=7 Participants	467 Participants n=5 Participants
HIV-1 RNA Category ≥ 50 copies/mL	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
CD4 Cell Count	712 cells/µL STANDARD_DEVIATION 268.1 • n=5 Participants	738 cells/µL STANDARD_DEVIATION 268.4 • n=7 Participants	725 cells/µL STANDARD_DEVIATION 268.3 • n=5 Participants
CD4 Cell Count Category ≥ 50 to < 200 cells/µL	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
CD4 Cell Count Category ≥ 200 to < 350 cells/µL	10 Participants n=5 Participants	9 Participants n=7 Participants	19 Participants n=5 Participants
CD4 Cell Count Category ≥ 350 to < 500 cells/µL	33 Participants n=5 Participants	25 Participants n=7 Participants	58 Participants n=5 Participants
CD4 Cell Count Category ≥ 500 cells/µL	190 Participants n=5 Participants	201 Participants n=7 Participants	391 Participants n=5 Participants
Prior Antiretroviral (ARV) Regimen E/C/F/TAF	124 Participants n=5 Participants	125 Participants n=7 Participants	249 Participants n=5 Participants
Prior Antiretroviral (ARV) Regimen E/C/F/TDF	99 Participants n=5 Participants	98 Participants n=7 Participants	197 Participants n=5 Participants
Prior Antiretroviral (ARV) Regimen RTV + ATV + FTC/TDF	11 Participants n=5 Participants	13 Participants n=7 Participants	24 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 48

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

Outcome measures

Outcome measures
Measure	B/F/TAF n=234 Participants B/F/TAF (50/200/25 mg) FDC tablet once daily without regard to food for 48 weeks.	Stay on Baseline Regimen n=236 Participants Participants remained on their baseline regimen of E/C/F/TAF (150/150/200/10 mg) tablet, E/C/F/TDF (150/150/200/300 mg) tablet, or ATV 300 mg capsule + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet for 48 weeks.
Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Determined by the US FDA-Defined Snapshot Algorithm	1.7 percentage of participants	1.7 percentage of participants

SECONDARY outcome

Timeframe: Week 48

Population: Participants in the Full Analysis Set were analyzed.

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=234 Participants B/F/TAF (50/200/25 mg) FDC tablet once daily without regard to food for 48 weeks.	Stay on Baseline Regimen n=236 Participants Participants remained on their baseline regimen of E/C/F/TAF (150/150/200/10 mg) tablet, E/C/F/TDF (150/150/200/300 mg) tablet, or ATV 300 mg capsule + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet for 48 weeks.
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Determined by the US FDA-Defined Snapshot Algorithm	95.7 percentage of participants	95.3 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=225 Participants B/F/TAF (50/200/25 mg) FDC tablet once daily without regard to food for 48 weeks.	Stay on Baseline Regimen n=225 Participants Participants remained on their baseline regimen of E/C/F/TAF (150/150/200/10 mg) tablet, E/C/F/TDF (150/150/200/300 mg) tablet, or ATV 300 mg capsule + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet for 48 weeks.
Change From Baseline in CD4+ Cell Count at Week 48	29 cells/µL Standard Deviation 159.4	26 cells/µL Standard Deviation 170.3

Adverse Events

B/F/TAF (Randomized Phase)

Serious events: 7 serious events

Other events: 61 other events

Deaths: 0 deaths

Stay on Baseline Regimen (Randomized Phase)

Serious events: 9 serious events

Other events: 47 other events

Deaths: 0 deaths

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

Serious events: 8 serious events

Other events: 52 other events

Deaths: 0 deaths

Extension Phase B/F/TAF From Stay on Baseline Regimen

Serious events: 10 serious events

Other events: 41 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	B/F/TAF (Randomized Phase) n=234 participants at risk Adverse events reported occurred during the Randomized Phase in participants from the B/F/TAF group, who received B/F/TAF (50/200/25 mg) FDC tablet once daily without regard to food for 48 weeks.	Stay on Baseline Regimen (Randomized Phase) n=236 participants at risk Adverse events reported occurred during the Randomized Phase in participants from the SBR group, who remained on their baseline regimen of E/C/F/TAF (150/150/200/10 mg) tablet, E/C/F/TDF (150/150/200/300 mg) tablet, or ATV 300 mg capsule + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet for 48 weeks.	Extension Phase B/F/TAF From B/F/TAF n=231 participants at risk Adverse events reported occurred during the Extension Phase in participants who enrolled into the Extension Phase from the B/F/TAF group and received B/F/TAF (50/200/25 mg) FDC tablet for up to 48 additional weeks, or until the product became accessible to participants through an access program, or until Gilead elected to discontinue the study in that country, whichever occurred first.	Extension Phase B/F/TAF From Stay on Baseline Regimen n=228 participants at risk Adverse events reported occurred during the Extension Phase in participants who enrolled into the Extension Phase from the SBR group and received B/F/TAF (50/200/25 mg) FDC tablet for up to 48 additional weeks, or until the product became accessible to participants through an access program, or until Gilead elected to discontinue the study in that country, whichever occurred first.
Infections and infestations Nasopharyngitis	7.7% 18/234 • First dose date to last dose date (maximum duration: 128.4 weeks) plus 30 days The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.	6.4% 15/236 • First dose date to last dose date (maximum duration: 128.4 weeks) plus 30 days The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.	8.2% 19/231 • First dose date to last dose date (maximum duration: 128.4 weeks) plus 30 days The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.	5.7% 13/228 • First dose date to last dose date (maximum duration: 128.4 weeks) plus 30 days The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
Infections and infestations Upper respiratory tract infection	6.4% 15/234 • First dose date to last dose date (maximum duration: 128.4 weeks) plus 30 days The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.	5.9% 14/236 • First dose date to last dose date (maximum duration: 128.4 weeks) plus 30 days The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.	8.2% 19/231 • First dose date to last dose date (maximum duration: 128.4 weeks) plus 30 days The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.	6.6% 15/228 • First dose date to last dose date (maximum duration: 128.4 weeks) plus 30 days The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
Infections and infestations Urinary tract infection	6.8% 16/234 • First dose date to last dose date (maximum duration: 128.4 weeks) plus 30 days The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.	1.7% 4/236 • First dose date to last dose date (maximum duration: 128.4 weeks) plus 30 days The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.	3.5% 8/231 • First dose date to last dose date (maximum duration: 128.4 weeks) plus 30 days The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.	2.2% 5/228 • First dose date to last dose date (maximum duration: 128.4 weeks) plus 30 days The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
Infections and infestations Vulvovaginal candidiasis	5.1% 12/234 • First dose date to last dose date (maximum duration: 128.4 weeks) plus 30 days The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.	3.8% 9/236 • First dose date to last dose date (maximum duration: 128.4 weeks) plus 30 days The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.	3.9% 9/231 • First dose date to last dose date (maximum duration: 128.4 weeks) plus 30 days The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.	3.9% 9/228 • First dose date to last dose date (maximum duration: 128.4 weeks) plus 30 days The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
Nervous system disorders Headache	5.1% 12/234 • First dose date to last dose date (maximum duration: 128.4 weeks) plus 30 days The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.	5.5% 13/236 • First dose date to last dose date (maximum duration: 128.4 weeks) plus 30 days The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.	5.6% 13/231 • First dose date to last dose date (maximum duration: 128.4 weeks) plus 30 days The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.	3.5% 8/228 • First dose date to last dose date (maximum duration: 128.4 weeks) plus 30 days The Safety Analysis Set included participants who were randomized 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