Trial reportAIDS research and therapy2026
B/F/TAF in people with both HIV-1 and hepatitis B: outcomes from the ALLIANCE open-label extension phase.
Trial report in AIDS research and therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03547908 (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), which is not on this map. Not yet cited in PubMed.
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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
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10 authors.
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Abstract
backgroundData on bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in people with both HIV-1 and HBV are limited, particularly for treatment-experienced people.
methodsALLIANCE 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.
results121 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.
conclusionB/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).
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