ViiV Healthcare’s two-drug HIV regimen Dovato was non-inferior to the three-drug regimen Biktarvy in treatment-naïve adults in a Phase 3b head-to-head study.

The Week 48 findings from the VOGUE study, which are due to be presented at the 26th International AIDS Conference in Rio de Janeiro, Brazil, found that 89% of participants receiving Dovato achieved virologic suppression compared with 92% of those receiving Biktarvy.

The study met its non-inferiority endpoint, with an adjusted difference of -3% between the two treatment groups and a 95% confidence interval of -8% to 2%.

VOGUE is described by ViiV Healthcare as the first randomised, head-to-head study comparing dolutegravir/lamivudine (DTG/3TC), the two-drug combination in Dovato, with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF), the three-drug combination in Biktarvy, in treatment-naïve adults living with HIV-1.

Dovato matches Biktarvy for viral suppression

The multi-country, open-label study randomised 509 adults to receive either DTG/3TC or BIC/FTC/TAF. Treatment was started before baseline resistance testing results were available.

Participants included people with higher viral loads and lower CD4+ cell counts, groups that can present additional challenges when starting HIV treatment. Overall, 47% of participants had a baseline viral load of at least 100,000 copies/mL, while 16% had a viral load of at least 500,000 copies/mL. A further 16% had a CD4+ cell count below 200 cells/mm3.

At Week 48, virologic suppression, defined as HIV-1 RNA below 50 copies/mL, was achieved in 226 of 254 participants receiving Dovato and 235 of 255 participants receiving Biktarvy.

The median time to viral suppression was similar between the groups at 4.1 weeks.

No treatment-emergent resistance reported in either group

No cases of treatment-emergent resistance were identified in either treatment arm, supporting the high barrier to resistance associated with the treatment combinations in the study.

Jean van Wyk, chief medical officer at ViiV Healthcare, said: “As the first randomised, head-to-head study comparing DTG/3TC with BIC/FTC/TAF in treatment-naïve adults living with HIV, VOGUE adds to 10 years of real-world evidence showing that people starting treatment can successfully manage their HIV with fewer daily drugs.”

The overall safety profiles were comparable between the two groups, with no new safety signals reported. Seven participants in each treatment group stopped treatment because they did not achieve or maintain viral suppression.

The findings add to evidence around two-drug antiretroviral therapy for people starting HIV treatment and provide comparative data against a commonly used three-drug regimen.

ViiV Healthcare said the results also reinforce the potential role of Dovato as a treatment option for treatment-naïve adults living with HIV, including people presenting with high viral loads or low CD4+ cell counts.

Dovato combines dolutegravir and lamivudine and is indicated for the treatment of HIV-1 infection in eligible adults and adolescents in the European Union and USA. Its use is subject to restrictions relating to age, weight and known or suspected resistance to the integrase inhibitor class or lamivudine.

The VOGUE findings are being presented as part of the scientific programme at AIDS 2026, providing further clinical data on the use of two-drug regimens in the initial treatment of HIV.