Switch to bictegravir/emtricitabine/tenofovir alafenamide from dolutegravir-based therapy

作者：Chloe Orkin, Andrea Antinori, Jürgen K. Rockstroh, Santiago Moreno, Claudia Martorell, Jean‐Michel Molina, Adriano Lazzarin, Franco Maggiolo, Yazdan Yazdanpanah, Kristen Andreatta, Hailin Huang, Jason T. Hindman, Hal Martin, Anton Pozniak · 发表于：AIDS · 年份：2024 · DOI：10.1097/qad.0000000000003865 · 被引用次数：19 · 研究领域：HIV/AIDS drug development and treatment、HIV-related health complications and treatments、Hepatitis C virus research

OBJECTIVE: To evaluate the efficacy and safety of 96 weeks of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) treatment in participants switching from dolutegravir (DTG)-based therapy. DESIGN: Studies 1489 (NCT02607930) and 1490 (NCT02607956) were phase 3 randomized, double-blind, active-controlled, first-line therapy trials in people with HIV-1. After 144 weeks of DTG-based or B/F/TAF treatment, participants could enter a 96-week open-label extension (OLE) of B/F/TAF. METHODS: A pooled analysis evaluated viral suppression (HIV-1 RNA <50 copies/ml) and changes in CD4 + cell count at OLE Weeks 48 and 96, treatment-emergent resistance, safety, and tolerability after switch from a DTG-based regimen to B/F/TAF. Outcomes by prior treatment were summarized using descriptive statistics and compared by two-sided Wilcoxon rank sum test. RESULTS: At OLE Week 96, participants who switched to B/F/TAF ( N = 519) maintained high levels of virologic suppression (99.5 and 99.1% in those switching from DTG/abacavir/lamivudine and DTG+F/TAF, respectively) and CD4 + cell count, with no treatment-emergent resistance to B/F/TAF. Twenty-one participants experienced drug-related adverse events after switching, with diarrhea, weight gain, and headache occurring most commonly. There were no cases of proximal renal tubulopathy, drug-related Grade 4 adverse events, or serious adverse events. Two participants discontinued B/F/TAF due to treatment-related adverse events. Participants who switch...