Open forum infectious diseases · 2026
VOGUE: Noninferior Efficacy of Dolutegravir/Lamivudine Versus Bictegravir/Emtricitabine/Tenofovir Alafenamide in Adults With HIV-1 Naive to Treatment.
Клиническое исследованиеСтатьяНазвание и аннотация: Перевод в очереди
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Ghosn Jade, Pulido Federico, Lopardo Gustavo D, Olczak Anita, Ripamonti Diego, Martin Charlotte, Paredes Ceballos Orlando, Stocker Hartmut, Mendez Vazquez Maria Josefina, Gatanaga Hiroyuki, Metallidis Simeon, Elbirt Daniel, Whitlock Gary, Mateo González José Ignacio, Mohammed Perry, Wang Kehui, Grove Richard, Wang Ruolan, Jewell Adelaide, Sutton Kenneth, Elliot Emilie, Moodley Riya, Borsi Rebecca, Jones Bryn, Kisare Michelle, Budnik Piotr, van Wyk Jean, VOGUE Study Group, VOGUE Study Group
Аннотация
BACKGROUND: Antiretroviral therapy (ART) that achieves virologic suppression using fewer antiretroviral agents is an optimized approach to HIV-1 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.
METHOD: This phase 3b, randomized (1:1), open-label, noninferiority study compared DTG/3TC versus 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% noninferiority 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 noninferior 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 noninferior 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. Clinical trial registration: ClinicalTrials.gov identification number, NCT05979311; URL, https://clinicaltrials.gov/study/NCT05979311.
METHOD: This phase 3b, randomized (1:1), open-label, noninferiority study compared DTG/3TC versus 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% noninferiority 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 noninferior 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 noninferior 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. Clinical trial registration: ClinicalTrials.gov identification number, NCT05979311; URL, https://clinicaltrials.gov/study/NCT05979311.