ViiV Healthcare's 2-drug regimen Dovato (dolutegravir/lamivudine [DTG/3TC]) met its primary noninferiority endpoint against Gilead's 3-drug regimen Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide [BIC/FTC/TAF]) in treatment-naive adults living with HIV-1, according to week 48 data from the phase 3b VOGUE study.1 The findings, presented this week at the 26th International AIDS Conference (AIDS 2026) in Rio de Janeiro, Brazil, mark the first randomized head-to-head comparison of the 2 regimens in this population.1
"HIV treatment is lifelong, so the number of medicines people take over decades of care can matter," Jean van Wyk, MBChB, MFPM, chief medical officer at ViiV Healthcare, said in a statement. "As the first randomized, head-to-head study comparing DTG/3TC with BIC/FTC/TAF in treatment-naive 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."2
Phase 3b VOGUE study is first randomized comparison of DTG/3TC and BIC/FTC/TAF
The multicountry, open-label trial randomized 509 treatment-naive adults to receive DTG/3TC (n = 254) or BIC/FTC/TAF (n = 255), with treatment started before baseline resistance testing results were available.1 At baseline, 47% of participants had a viral load of at least 100,000 copies/mL, 16% had a viral load of at least 500,000 copies/mL, and 16% had a CD4+ cell count below 200 cells/mm3.1
At week 48, virologic suppression, defined as HIV-1 RNA below 50 copies/mL, was achieved in 89% of participants (226 of 254) receiving DTG/3TC compared with 92% (235 of 255) receiving BIC/FTC/TAF, an adjusted difference of –3 percentage points (95% CI, –8 to 2), meeting the study's noninferiority end point.1 Median time to viral suppression was 4.1 weeks in both treatment groups.1 No treatment-emergent resistance was identified in either arm through week 48.1
Safety profiles were comparable between the 2 regimens, with no new safety signals reported.1 Seven participants in each arm discontinued treatment due to not achieving or maintaining viral suppression.1 The results held across prespecified subgroups with high baseline viral load or low CD4+ cell count, populations in which 2-drug regimens have historically faced more scrutiny.1
What Infectious Disease Specialists Need to Know
Dovato is a 2-drug regimen combining dolutegravir and lamivudine, indicated for treatment of HIV-1 infection in adults and adolescents without known or suspected resistance to integrase inhibitors or lamivudine.
What did the VOGUE trial show?
At week 48, Dovato met its noninferiority endpoint against Biktarvy, with 89% of patients on Dovato and 92% on Biktarvy achieving virologic suppression and no treatment-emergent resistance in either arm.
How does Dovato differ from Biktarvy?
Dovato uses 2 antiretroviral drugs compared with the 3 drugs in Biktarvy, an approach aimed at reducing the number of medicines patients take over a lifetime of HIV treatment without compromising efficacy.
Where Dovato Fits in the HIV Treatment Landscape
Dovato combines dolutegravir, an integrase strand transfer inhibitor, with lamivudine, a nucleoside reverse transcriptase inhibitor, and has been available as the first oral 2-drug regimen for treatment-naive adults for 10 years.2 It is indicated for HIV-1 infection in adults and adolescents 12 years and older weighing at least 40 kg in the European Union, and at least 25 kg in the United States, in patients with no known or suspected resistance to the integrase inhibitor class or to lamivudine.2 It joins a broader wave of HIV regimen data presented at AIDS 2026, including once-weekly oral combinations now in late-stage development.
Biktarvy, a single-tablet 3-drug regimen combining bictegravir, emtricitabine, and tenofovir alafenamide, has been among the most widely prescribed first-line options for treatment-naive patients.2 VOGUE is the first randomized trial to compare the 2 regimens directly rather than against a historical or indirect comparator, addressing a longstanding evidence gap for clinicians deciding between 2- and 3-drug starting regimens, a question ViiV's own leadership has framed around patient choice in other DTG/3TC research.
The VOGUE data add to a growing body of evidence supporting fewer-drug regimens in HIV treatment, following earlier trials establishing DTG/3TC's efficacy against 3-drug standards of care in other treatment-naive populations.1 ViiV Healthcare said it plans to continue presenting VOGUE data as the study progresses beyond week 48.2
References
van Wyk J, Ghosn J, et al. In VOGUE: DTG/3TC 2-drug regimen is non-inferior to BIC/FTC/TAF 3-drug regimen in a randomized trial in adults with HIV naive to treatment. Presented at: 26th International AIDS Conference (AIDS 2026); July 2026; Rio de Janeiro, Brazil.
