B/F/TAF in People with Both HIV-1 and Hepatitis B: Outcomes from the ALLIANCE Open-Label Extension Phase

Data on bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in people with both HIV-1 and HBV are limited, particularly for treatment-experienced people. ALLIANCE was a randomized, double-blind, active-controlled, phase 3 study of B/F/TAF versus dolutegravir (DTG) + emtricitabine/tenofovir disoproxil fumarate (F/TDF) in treatment-naïve adults with HIV-1 RNA ≥ 500 copies/mL and HBV DNA ≥ 2000 IU/mL. Participants received continuous B/F/TAF through 144 weeks (≥ 96 weeks of blinded treatment plus 48-week optional open-label extension [OLE]) or switched to B/F/TAF after ≥ 96 weeks of DTG + F/TDF through 48 weeks of OLE. Here we report outcomes from the OLE. 121 participants were included in the continuous B/F/TAF group; 89 in the switch group. Median B/F/TAF exposure was 186.4 and 48 weeks, respectively. HIV-1 and HBV suppression rates (missing = excluded) were maintained in both groups (B/F/TAF Week 144: 99.0