In the Phase IIIb VOGUE trial (NCT05979311) of 509 treatment‑naïve adults, ViiV’s two‑drug Dovato (DTG/3TC) matched Gilead’s three‑drug Biktarvy (BIC/FTC/TAF), achieving 89% versus 92% virologic suppression at Week 48. Median time to suppression was ~4.1 weeks in both arms and no treatment‑emergent resistance was observed. Safety profiles were comparable; results will be presented at AIDS 2026 in Rio de Janeiro.
Phase IIIb VOGUE Trial: ViiV’s Two‑Drug Dovato Matches Biktarvy in Treatment‑Naïve Adults
ViiV's HIV two-drug regimen was first approved in 2019. Credit: Tatyana Frolova / Shutterstock.com
ViiV Healthcare’s two‑drug regimen Dovato (dolutegravir/lamivudine; DTG/3TC) demonstrated non‑inferior virologic efficacy to Gilead’s three‑drug single‑tablet regimen Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide; BIC/FTC/TAF) in the Phase IIIb, randomized, open‑label VOGUE study (NCT05979311).
Study Design and Participants
The multi‑country VOGUE trial randomized 509 treatment‑naïve adults living with HIV and included participants with high baseline viral loads and low CD4+ cell counts. The primary endpoint was virologic suppression at Week 48.
Key Results
Virologic Suppression: At Week 48, 89% of participants receiving Dovato achieved virologic suppression versus 92% receiving Biktarvy, meeting the trial’s non‑inferiority criteria.
Time to Suppression: Median time to viral suppression was rapid and comparable between arms at approximately 4.1 weeks.
Resistance and Safety
The analysis found no cases of treatment‑emergent resistance in either treatment arm during the reporting period, reinforcing the high barrier to resistance observed with DTG/3TC. Safety profiles were similar across groups, and investigators reported no new safety signals through Week 48.
Jean van Wyk, MBChB, MFPM, Chief Medical Officer at ViiV Healthcare: “HIV treatment is lifelong, and reducing the number of daily medicines can matter over decades of care. As the first randomized head‑to‑head comparison of DTG/3TC versus BIC/FTC/TAF in treatment‑naïve adults, VOGUE adds to a decade of evidence that some people can successfully start therapy with fewer daily drugs without compromising efficacy or resistance protection.”
Regulatory, Commercial and Market Context
Dovato was first approved by the US Food and Drug Administration in April 2019 and had its US label expanded in 2024 to include adolescents aged 12 years and over who weigh at least 25 kg (with no known or suspected resistance to the integrase inhibitor class or lamivudine). The combination was also approved in the EU in 2019 for adults and children aged 12+ who weigh at least 40 kg.
Commercially, Dovato generated £2.7 billion (~$3.4 billion) in fiscal year 2025. Biktarvy's 2025 sales were substantially larger at $14.3 billion.
Market analysis from GlobalData forecasts the HIV drug market across the Seven Major Markets (7MM: US, France, Germany, Italy, Spain, the UK and Japan) to grow from $26.5 billion in 2023 to $32.1 billion by 2033 (CAGR 1.9%), with the US accounting for most sales. Growth will be driven in part by increasing uptake of long‑acting injectables and new single‑tablet regimens.
Notable emerging options include Gilead’s biannual injectable Yeztugo (lenacapavir) for PrEP, which reported 100% efficacy in the PURPOSE1 Phase III trial and is expected to be an important new PrEP option pending regulatory review and wider uptake.
What’s Next
These Week 48 results will be presented at the 26th International AIDS Conference (AIDS 2026) in Rio de Janeiro, Brazil (27–31 July). Longer‑term follow‑up and real‑world evidence will help define the role of two‑drug regimens like Dovato in initial HIV therapy over decades of care.
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