Head-to-head study shows Dovato as effective as Biktarvy in HIV | AIDS 2026

ViiV Healthcare’s Dovato has demonstrated in a phase 3 trial to be noninferior to Gilead’s Biktarvy in treatment-naïve adults living with HIV, including people with high viral loads or a low CD4+ cell count, according to data presented at the International AIDS Conference (AIDS 2026) being held this week in Rio de Janeiro, Brazil.

HIV is the virus that causes AIDS. Approximately 40.8 million people worldwide are currently living with HIV; about 1.2 million people in the United States are living with HIV. About 1.3 million people worldwide are diagnosed each year.

Marketed by ViiV Healthcare, Dovato is a combination of dolutegravir and lamivudine that is used to treat HIV-1 in people who have not previously received HIV-1 medicines. It is indicated for adults and adolescents above 12 years of age who weigh at at least 25 kg in the United States.

GSK holds a 78.3% majority in ViiV Healthcare, with the remaining interest held by Shionogi. GSK officials report that around 758,000 people living with HIV take Dovato, and the company reported Dovato’s 2025 sales as £2.7 billion (about $3.6 billion).

The list price for a 30-day supply of Dovato is $3,250.47. About 83% of prescriptions covered through commercial insurance and about 80% of Medicare prescriptions cost less than $10 per month, according to ViiV Healthcare. In Medicaid, about 88% of patients have no copay for Dovato.

Biktarvy is a combination of three medications: bictegravir, emtricitabine and tenofovir alafenamide.

The phase 3b VOGUE study, which was sponsored by ViiV Healthcare, is an ongoing open-label, phase 3b VOGUE study randomized 509 treatment-naïve adults living with HIV-1 to receive either Dovato (254 patients) or Biktarvy (255 patients). At baseline, 47% of participants had a viral load ≥100,000 copies/mL, and 16% had a CD4+ cell count <200 cells/mm3.

At week 48, suppression of HIV-1 was achieved in 89% of patients who received Dovato compared with 92% of patients who had received Biktarvy. Median time to viral suppression was rapid and similar in both groups (4.1 weeks).

No treatment-emergent resistance was identified in either arm. The overall safety profiles for both treatment groups were comparable, with no new safety signals observed. In the study 14 patients (seven in each arm) stopped treatment due to not achieving or maintaining viral suppression.

Data from the VOGUE trial support previous studies of Dovato. Results of the PASO DOBLE study were announced in October 2025, which found that at 96 weeks Dovato was as effective as Biktarvy in maintaining virological suppression in adults with HIV-1.

Additionally, in May 2026, ViiV announced that it had submitted a U.S. new drug application (NDA), as well as a European application, for a new dispersible tablet formulation of Dovato for younger children and to extend use into lower weight classes. The tablet formulation would be for children aged ≥3 months and weighing ≥6 kg to <25kg and an extension of the film-coated tablet indication to pediatric patients weighing at least 20 kg.