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

Gilead Sciences

Status and phase: Completed; Phase 3

Conditions: HIV-1 Infection

Treatments: Drug: ATV; Drug: E/C/F/TDF; Drug: FTC/TDF; Drug: E/C/F/TAF; Drug: RTV; Drug: B/F/TAF

Study type: Interventional

Funder types: Industry

Identifiers

NCT02652624

GS-US-380-1961

Details and patient eligibility

About

The primary objective of this study is to evaluate the efficacy of switching to a fixed-dose combination (FDC) of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus continuing on a regimen consisting of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF), elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF), or atazanavir (ATV) + ritonavir (RTV) + emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) in virologically suppressed HIV-1 infected women.

Enrollment: 472 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria

Medically stable HIV-1 infected women who meet the following criteria:

• Completion of the Week 48 open-label extension (OLE) visit or any post Week 48 OLE visits in Gilead-sponsored study GS-US-236-0128, or Completion of the Week 96 visit or any post Week 96 visits in Gilead-sponsored study GS-US-292-0109 or completion of the Week 144 visit or any post Week 144 visits in Gilead sponsored studies GS-US-292-0104 or GS-US-292-0111.

• Currently on a stable antiretroviral regimen consisting of E/C/F/TAF, E/C/F/TDF, or ATV+RTV+FTC/TDF continuously for ≥ 12 consecutive weeks preceding the Screening visit

• Documented plasma HIV-1 RNA levels < 50 copies/mL for ≥ 12 weeks preceding the Screening visit. After reaching HIV-1 RNA < 50 copies/mL, single values of HIV-1 RNA

  ≥ 50 copies/mL followed by re-suppression to < 50 copies/mL is allowed

• HIV-1 RNA <50 copies/mL at screening

• Estimated glomerular filtration rate (eGFR) ≥ 50 mL/min (≥ 0.83 mL/sec) according to the Cockcroft-Gault formula at the Screening visit

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

472 participants in 3 patient groups

B/F/TAF

Experimental group

Description:

Participants will switch to B/F/TAF FDC and receive treatment for 48 weeks.

Treatment:

Drug: B/F/TAF

Baseline Regimen

Active Comparator group

Description:

Participants will remain on their baseline regimen of E/C/F/TAF, E/C/F/TDF, or ATV+RTV+FTC/TDF for 48 weeks.

Treatment:

Drug: RTV

Drug: E/C/F/TAF

Drug: FTC/TDF

Drug: E/C/F/TDF

Drug: ATV

Extension Phase

Experimental group

Description:

Following Week 48, participants in countries where B/F/TAF is not available may have the option to receive B/F/TAF for up to 48 additional weeks.

Treatment:

Drug: B/F/TAF