A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Fixed Dose Combination of Bictegravir/Emtricitabine/Tenofovir Alafenamide versus Dolutegravir + Emtricitabine/Tenofovir Disoproxil Fumarate in Treatment Naïve, HIV-1 and Hepatitis B Co-Infected Adults

Bictegravir (GS-9883) is a potent inhibitor of HIV-1 integrase that is being evaluated for the treatment of HIV-1 infection. Integrase mutant viruses that are resistant to the INSTIs raltegravir (RAL) and elvitegravir (EVG) remain largely sensitive to bictegravir.  Coformulated bictegravir with the NRTI emtricitabine (FTC; F) and the NtRTI tenofovir alafenamide (TAF) into an FDC tablet that is suitable for once-daily use may provide a potent, convenient, tolerable, and practical regimen for the long-term treatment of patients with HBV and HIV co-infection. Therefore, this randomized, double-blind, multicenter, active-controlled study will evaluate the safety and efficacy of a FDC of B/F/TAF versus DTG + F/TDF in HIV and HBV treatment-naïve, HIV-1 and HBV coinfected adult subjects. Our site has contributed 1/3 global enrollment.