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