ViiV Healthcare, a specialist HIV company majority owned by GSK (NYSE: GSK), announced results from the phase IIIb VOGUE study showing that its two-drug regimen Dovato was non-inferior to the three-drug regimen Biktarvy in treatment-naïve adults living with HIV.

The data were presented at the 26th International AIDS Conference (AIDS 2026) in Rio de Janeiro, Brazil. The multi-country, open-label study randomized 509 treatment-naïve adults living with HIV-1 to receive either Dovato (dolutegravir/lamivudine, DTG/3TC) or Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide, BIC/FTC/TAF). At baseline, 47% of participants had a viral load of 100,000 copies/mL or higher, and 16% had a CD4+ cell count below 200 cells/mm3.

At week 48, virologic suppression was achieved in 89% of participants receiving Dovato compared with 92% receiving Biktarvy, meeting the study's non-inferiority endpoint. Median time to viral suppression was similar in both groups at 4.1 weeks. No treatment-emergent resistance was identified in either arm, and the overall safety profiles were comparable, with no new safety signals observed.

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."

Seven participants in each treatment group stopped treatment due to not achieving or maintaining viral suppression. The findings are based on a press release statement from ViiV Healthcare.