VOGUE: Non-Inferior Efficacy of Dolutegravir/Lamivudine Versus Bictegravir/Emtricitabine/Tenofovir Alafenamide in Adults With HIV-1 Naive to Treatment

作者：Jade Ghosn, Federico Pulido, Gustavo Lopardo, Anita Olczak, Diego Ripamonti, Charlotte Martin, Orlando Paredes Ceballos, Hartmut Stocker, J Mendez, Hiroyuki Gatanaga, Symeon Metallidis, Daniel Elbirt, Gary Whitlock, José Ignacio Mateo González, Perry Mohammed, Kehui Wang, Richard Grove, Ruolan Wang, Adelaide Jewell, Kenneth Sutton, Emilie R Elliot, Riya Moodley, Rebecca Borsi, Bryn Jones, Michelle Kisare, Piotr Budnik, Jean van Wyk · 发表于：Open Forum Infectious Diseases · 年份：2026 · DOI：10.1093/ofid/ofag471 · 研究领域：HIV/AIDS drug development and treatment、HIV Research and Treatment、HIV/AIDS Research and Interventions

Abstract Background Antiretroviral therapy (ART) that achieves virologic suppression using fewer antiretroviral agents is an optimized approach to HIV treatment initiation. VOGUE is the first randomized, head-to-head study comparing the 2-drug regimen dolutegravir/lamivudine (DTG/3TC) with the 3-drug regimen bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) as initial ART, including among individuals with high viral loads (VLs) and/or low CD4+ cell counts. Methods This phase 3b, randomized (1:1), open-label, non-inferiority study compared DTG/3TC vs BIC/FTC/TAF as first-line ART in adults with HIV-1. Participants were enrolled without baseline VL or CD4+ cell count restrictions and initiated treatment before availability of resistance testing results. The primary endpoint was the proportion of participants with HIV-1 RNA <50 copies/mL at Week 48 (Snapshot; -10% non-inferiority margin). Results Among 509 randomized participants (DTG/3TC, n=254; BIC/FTC/TAF, n=255), 47% had baseline VL ≥100,000 copies/mL and 16% had CD4+ cell count <200 cells/mm3. At Week 48, DTG/3TC demonstrated non-inferior efficacy to BIC/FTC/TAF, with HIV-1 RNA <50 copies/mL achieved in 89% and 92% of participants, respectively (adjusted difference, -3% [95% CI, -8%, 2%]). Median time to virologic suppression was rapid (4.1 weeks) in both groups. Confirmed virologic withdrawals were similar between groups (n=7 each), with no treatment-emergent resistance identified. Safety o...