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

ViiV Healthcare’s Dovato has been shown in a phase 3 trial to be noninferior to Gilead Sciences’ Biktarvy in treatment-naive adults living with HIV, including people with high viral loads or a low CD4+ cell count, according to data presented at AIDS 2026, the International AIDS Conference in Rio de Janeiro.

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, and 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 aged 12 years or older who weigh 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 approximately 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. Approximately 83% of prescriptions are 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 VOGUE study, sponsored by ViiV Healthcare, is an ongoing open-label, phase 3b study that randomly assigned 509 treatment-naive adults living with HIV-1 to receive either Dovato (254 patients) or Biktarvy (255 patients). At baseline, 47% of participants had a viral load of greater than or equal to 100,000 copies/mL, and 16% had a CD4+ cell count of less than 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 received Biktarvy. The 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 and a European application for a new dispersible tablet formulation of Dovato for younger children and to extend its use into lower weight classes. The tablet formulation would be for children aged 3 months or older, weighing at least 6 kg but less than 25 kg, and would extend the film-coated tablet indication to pediatric patients weighing at least 20 kg.