B/F/TAF in people with both HIV-1 and hepatitis B: outcomes from the ALLIANCE open-label extension phase

BACKGROUND: Data on bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in people with both HIV-1 and HBV are limited, particularly for treatment-experienced people. METHODS: 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. RESULTS: 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% and 80.2%; switch OLE Week 48: 95.4% and 86.6%, respectively). Both groups had improved alanine aminotransferase normalization. HBV envelope antigen loss and seroconversion occurred in 44.8% and 29.3%, respectively, of participants receiving continuous B/F/TAF (Week 144) and 17.0% and 12.8% in the switch group (OLE Week 48). HBV surface antigen loss and seroconversion occurred in 22.5% and 15.5% (continuous B/F/TAF), and 4.3% and 0% (switch group) of participants, respectively. One participant (continuous B/F/TAF) discontinued due to study drug-unrelated treatment-emergent adverse event. No treatment-emergent resistance was reported. CONCLUSION: B/F/TAF was effective in HIV-1 and HBV suppression and well tolerated in treatment-naïve individuals for ≤ 3 years and ≤ 1 year after switching from a TDF-based regimen. Trial registration ClinicalTrials.gov NCT03547908 (first registration 2018-05-24).