Common TitleGS-380-1961
Official Title A Phase 3, Randomized, Open Label Study to Evaluate the Safety and Efficacy of Switching to a Fixed Dose Combination (FDC) of Bictegravir (GS-9883)/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) From Elvitegravir/Cobicistat/Emtricitabine/ Tenofovir Alafenamide (E/C/F/TAF), Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate (E/C/F/TDF) or Atazanavir + Ritonavir + Emtricitabine/Tenofovir Disoproxil Fumarate (ATV+RTV+FTC/TDF) in Virologically Suppressed HIV-1 Infected Women
Phase Phase III
ClinicalTrials.gov NCT02652624
Treatments
Bictegravir-Tenofovir alafenamide-Emtricitabine
Bictegravir-Tenofovir alafenamide-Emtricitabine
Tradename:BiktarvyOther Names:BIC-TAF-FTCClass:Single-Tablet RegimensCategories Pregnancy/WomenSwitch/Simplification
Funding
IndustryGilead Sciences
References
- Kityo C, Hagins D, Koenig E, et al. Switching to Fixed-Dose Bictegravir, Emtricitabine, and Tenofovir Alafenamide (B/F/TAF) in Virologically Suppressed HIV-1 Infected Women: A Randomized, Open-Label, Multicenter, Active-Controlled, Phase 3, Noninferiority Trial. J Acquir Immune Defic Syndr. 2019;82:321-8.