Bictegravir/Emtricitabine/Tenofovir Alafenamide in Adults with HIV/HBV Coinfection: An Open-Label, Single-Arm, Safety and Efficacy Switch Study

HIV and hepatitis B virus (HBV) coinfection has been associated with higher risk of morbidity and mortality. HBV-active antiretroviral regimens has significantly improved the outcome of coinfected people. Although bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) is safe and efficacious in the treatment of HIV, there are few randomized studies on treatment of HIV/HBV coinfection. This open label switch study enrolled adults with HIV/HBV coinfection from two clinical centers. Participants were switched from their current antiretroviral regimen (regardless of viral suppression) to B/F/TAF, taken once daily for 48 weeks. Primary endpoints were proportion of participants with HIV RNA <50 copies/mL and HBV DNA <29 IU/mL at Week 24. Twenty-eight participants were enrolled with a median age of 51 years - majority were Black (89%) and male (86%). At baseline, 71% (20/28) and 79% (22/28) were HIV and HBV suppressed, respectively, and 64% (18/28) were suppressed for both. At week 24, 89% (25/28) and 86% (24/28) were HIV and HBV suppressed, respectively, and 82% (23/28) were suppressed for both. Most common treatment-related adverse event was nausea (2/28). None discontinued due to an adverse event. No serious adverse events or hepatitis flares observed. B/F/TAF is a safe and suitable option for treatment of HIV/HBV coinfected patients.