Durable Efficacy of Switching From a 3- or 4-Drug Tenofovir Alafenamide–Based Regimen to the 2-Drug Regimen Dolutegravir/Lamivudine in the TANGO Study Through Week 196

作者：Stéphane De Wit, Fabrice Bonnet, Olayemi Osiyemi, Fiona Bisshop, Julián Olalla, Jean‐Pierre Routy, Christoph Wyen, Riya Moodley, Keith A. Pappa, Ruolan Wang, J Oyee, Parminder Saggu, Emilio Letang, Brian Wynne, Bryn Jones, Kimberly Y. Smith, Mounir Ait‐Khaled · 发表于：JAIDS Journal of Acquired Immune Deficiency Syndromes · 年份：2024 · DOI：10.1097/qai.0000000000003395 · 被引用次数：8 · 研究领域：HIV/AIDS drug development and treatment、HIV/AIDS Research and Interventions、Pharmaceutical Economics and Policy

BACKGROUND: Switching to the 2-drug regimen dolutegravir/lamivudine demonstrated durable non-inferior efficacy vs continuing 3- or 4-drug tenofovir alafenamide-based regimens for maintaining virologic suppression in people with HIV-1 through Week 144 in TANGO. SETTING: 134 centers, 10 countries. METHODS: Adults with HIV-1 RNA <50 copies/mL for >6 months and no history of virologic failure were randomized to switch from stable tenofovir alafenamide-based regimens to dolutegravir/lamivudine on Day 1 (early-switch group) for 196 weeks. Those randomized to continue tenofovir alafenamide-based regimens on Day 1 who maintained virologic suppression at Week 144 switched to dolutegravir/lamivudine at Week 148 (late-switch group). Efficacy, safety, and tolerability (including weight and biomarker changes) of dolutegravir/lamivudine in early-switch and late-switch groups were assessed through Week 196. RESULTS: Overall, 369 participants switched to dolutegravir/lamivudine on Day 1 (early-switch) and 298 switched at Week 148 (late-switch). In the early-switch group, 83% (306/369) maintained virologic suppression through Year 4, and 3% (11/369) reported new adverse events between Weeks 144 and 196. The late-switch group at Week 196 and early-switch group at Week 48 had comparable proportions with virologic suppression (93% each) and similar safety profiles. No late-switch participants and 1 early-switch participant met confirmed virologic withdrawal criteria through Week 196, with no res...