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

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 outcomes were comparable. Conclusions Dolutegravir/Lamivudine demonstrated non-inferior efficacy to BIC/FTC/TAF as initial ART, with no treatment-emergent resistance through Week 48. These findings establish DTG/3TC as an effective and simplified initial ART regimen across a broad clinical spectrum.

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Journal
Open Forum Infectious Diseases
Published
2026-07-28
DOI
https://doi.org/10.1093/ofid/ofag471
Primary Topic
HIV/AIDS drug development and treatment
Type
article
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article

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

Federico Pulido, Daniel Elbirt, Anita Olczak, Emilie R Elliot et al.
Open Forum Infectious Diseases
HIV/AIDS drug development and treatment
article

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

Federico Pulido, Daniel Elbirt, Anita Olczak, Emilie R Elliot, Jean van Wyk, José Ignacio Mateo González, Hiroyuki Gatanaga, Jade Ghosn, Adelaide Jewell, Gary Whitlock, Michelle Kisare, Kehui Wang, Symeon Metallidis, Gustavo Lopardo, Charlotte Martin, Piotr Budnik, Riya Moodley, Richard Grove, J Mendez, Diego Ripamonti, Bryn Jones, Perry Mohammed, Kenneth Sutton, Orlando Paredes Ceballos, Rebecca Borsi, Ruolan Wang, Hartmut Stocker
article en

Abstract

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 outcomes were comparable. Conclusions Dolutegravir/Lamivudine demonstrated non-inferior efficacy to BIC/FTC/TAF as initial ART, with no treatment-emergent resistance through Week 48. These findings establish DTG/3TC as an effective and simplified initial ART regimen across a broad clinical spectrum.

Open Forum Infectious Diseases
Délégation Paris 5 (FR), Inserm (FR), ViiV Healthcare (Spain) (ES), Université Paris Cité (FR), Chelsea and Westminster Hospital NHS Foundation Trust (GB), Kaplan Medical Center (IL), AHEPA University Hospital (GR), Nicolaus Copernicus University (PL), Sorbonne Paris Cité (FR), National Center for Global Health and Medicine (JP), Hospital Universitario 12 De Octubre (ES), ViiV Healthcare (United Kingdom) (GB), Ospedale Papa Giovanni XXIII (IT), CUF Porto Hospital (PT), GlaxoSmithKline (United States) (US), Affimed Therapeutics (Germany) (DE), Secretaría de Investigación, Innovación y Educación Superior (MX), Hospital General Universitario De Valencia (ES), Hôpital Bichat-Claude-Bernard (FR), Fundación Centro de Estudios Infectológicos (AR), St. Joseph-Krankenhaus (DE), Centre Hospitalier Universitaire de Saint-Pierre (BE)
Good health and well-being
Openalex Percentile: Top 8%
HIV/AIDS drug development and treatment
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