London, July 27, 2026
ViiV Healthcare has announced positive Week 48 results from the Phase IIIb VOGUE study, demonstrating that Dovato (dolutegravir/lamivudine; DTG/3TC) achieved non-inferior efficacy compared with the 3-drug regimen Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide; BIC/FTC/TAF) in treatment-naïve adults living with HIV. Presented at the 26th International AIDS Conference (AIDS 2026) in Rio de Janeiro, Brazil, the findings mark the first randomized head-to-head comparison between the two widely used HIV treatment regimens. The results reinforce Dovato as the first and only oral 2-drug regimen to deliver long-term viral suppression while reducing the number of antiretroviral medicines patients receive over a lifetime. The study further strengthens a decade of scientific evidence supporting DTG/3TC as an effective, durable, and resistance-resistant treatment option for people newly diagnosed with HIV-1 infection.
Phase IIIb VOGUE Study Demonstrates Comparable HIV Control
The Phase IIIb VOGUE trial enrolled 509 treatment-naïve adults living with HIV-1, randomly assigning participants to receive either Dovato (DTG/3TC) or Biktarvy (BIC/FTC/TAF) before baseline resistance testing results were available. The study included a broad and diverse patient population, with nearly half of participants presenting with high viral loads and a significant proportion having low CD4+ cell counts, representing patients with advanced disease. At Week 48, 89% of participants treated with Dovato achieved virologic suppression (HIV-1 RNA below 50 copies/mL) compared with 92% receiving Biktarvy, successfully meeting the study’s non-inferiority endpoint. Median time to viral suppression was approximately 4.1 weeks in both treatment groups, demonstrating similarly rapid antiviral activity. Importantly, no cases of treatment-emergent resistance were identified in either treatment arm, reinforcing the high genetic barrier to resistance associated with DTG/3TC and confirming its long-term clinical durability.
Two-Drug Regimen Delivers Long-Term Benefits with Fewer Medicines
The VOGUE study highlights the growing clinical value of 2-drug HIV therapy, showing that patients can achieve effective viral suppression while taking fewer antiretroviral medicines than traditional 3-drug regimens. Because HIV treatment is lifelong, reducing medication exposure without compromising efficacy represents an important advancement in long-term patient care. Safety findings demonstrated comparable safety profiles between Dovato and Biktarvy, with no new safety signals observed throughout the study. An equal number of participants in each treatment arm discontinued therapy because viral suppression was not achieved or maintained, further supporting the comparable clinical performance of both regimens. These findings build upon more than 10 years of clinical and real-world evidence supporting Dovato as an effective first-line therapy for adults newly diagnosed with HIV while minimizing lifetime exposure to additional antiretroviral agents.
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Clinical Evidence Strengthens Dovato’s Position in HIV Treatment
The latest Phase IIIb data further strengthen ViiV Healthcare’s leadership in HIV innovation and reinforce the role of Dovato in modern antiretroviral therapy. As the first randomized head-to-head study comparing DTG/3TC with Biktarvy, the VOGUE trial provides robust comparative evidence supporting the effectiveness of a 2-drug regimen across diverse patient populations, including individuals with high viral burden and advanced immunosuppression. The findings presented at AIDS 2026 support continued evolution toward simplified HIV treatment strategies that maintain excellent viral control while reducing medication burden. With a proven efficacy profile, durable resistance barrier, and favorable safety outcomes, Dovato continues to expand the scientific foundation for 2-drug antiretroviral therapy, offering healthcare providers and patients an evidence-based treatment option for long-term HIV management.
Source: ViiV Healthcare press release
