Bictegravir/emtricitabine/tenofovir alafenamide as initial treatment for HIV-1: five-year follow-up from two randomized trials

作者：Paul E. Sax, José Ramón Arribas, Chloe Orkin, Adriano Lazzarin, Anton Pozniak, Edwin DeJesus, Franco Maggiolo, Hans‐Jürgen Stellbrink, Yazdan Yazdanpanah, Rima Acosta, Hailin Huang, Jason T. Hindman, Hal D. Martin, Jared M. Baeten, David A. Wohl · 发表于：EClinicalMedicine · 年份：2023 · DOI：10.1016/j.eclinm.2023.101991 · 被引用次数：90 · 研究领域：HIV/AIDS drug development and treatment、HIV-related health complications and treatments、HIV/AIDS Research and Interventions

Background Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) is a single-tablet regimen recommended for HIV-1 treatment. The safety and efficacy of B/F/TAF as initial therapy was established in two Phase 3 studies: 1489 (vs dolutegravir [DTG]/abacavir/lamivudine) and 1490 (vs DTG + F/TAF). After 144 weeks of randomized follow-up, an open-label extension evaluated B/F/TAF to 240 weeks. Methods Of 634 participants randomized to B/F/TAF, 519 completed the double-blinded treatment, and 506/634 (80%) chose the 96-week open-label B/F/TAF extension, which was completed by 444/506 (88%) participants. Efficacy was based on the secondary outcome of the proportion of participants with HIV-1 RNA <50 copies/mL at Week 240 by missing = excluded and missing = failure methods. All 634 participants who were randomized to B/F/TAF and received at least one dose of B/F/TAF were included in efficacy and safety analyses. (Study 1489: ClinicalTrials.gov NCT02607930; EudraCT 2015-004024-54. Study 1490: ClinicalTrials.gov NCT02607956; EudraCT 2015-003988-10). Findings Of those with available virologic data, 98.6% (95% CI [97.0%–99.5%], 426/432) maintained HIV-1 RNA <50 copies/mL at Week 240 (missing = excluded); when missing virologic data were considered as failure, 67.2% (95% CI [63.4%–70.8%], 426/634) maintained HIV-1 RNA <50 copies/mL. Mean (SD) change in CD4+ count from baseline was +338 (236.2) cells/μL. No treatment-emergent resistance to B/F/TAF was detected. Adverse events led to dru...