ViiV Healthcare to present phase IIIb data comparing Dovato against Biktarvy in HIV treatment-naïve adults at AIDS 2026

ViiV Healthcare presented Phase IIIb data comparing its two-drug regimen Dovato with the three-drug regimen Biktarvy in treatment-naïve adults living with HIV at the 26th International AIDS Conference in Rio de Janeiro in July 2026. According to ViiV officials, the VOGUE trial evaluated whether dropping a third antiretroviral drug could maintain virologic suppression as effectively as the standard three-drug therapy.

The VOGUE trial, registered as NCT05979311, is a randomized, open-label Phase IIIb study designed to directly compare ViiV Healthcare’s two-drug regimen Dovato with Gilead Sciences’ three-drug regimen Biktarvy in treatment-naïve adults living with HIV-1, officials said. Conducted across 17 countries including Spain, Germany, Japan, and Argentina, the trial evaluates whether dropping a third antiretroviral drug can maintain virologic suppression as effectively as the standard three-drug therapy, even in individuals with high baseline viral loads, according to ViiV Healthcare. The study population consists of adults with no prior antiretroviral treatment history at baseline.

The trial aims to demonstrate whether the simpler two-drug regimen can provide non-inferior efficacy and an acceptable safety profile compared with the three-drug backbone that includes TAF, a widely used tenofovir prodrug.

Dovato combines dolutegravir (DTG) 50 mg and lamivudine (3TC) 300 mg in a once-daily, single-tablet regimen, while Biktarvy includes bictegravir (BIC) plus emtricitabine (FTC) and tenofovir alafenamide (TAF) as a once-daily, single-tablet three-drug regimen. Both regimens are administered orally once daily, allowing a direct comparison in first-line HIV treatment, ViiV officials said.

ViiV Healthcare plans to present Week 48 data from VOGUE as an in-person poster at the 26th International AIDS Conference (AIDS 2026) scheduled for July 29, 2026, in Rio de Janeiro, according to conference records and Applied XL’s report on the study. The trial recently reached its revised enrollment target and moved to “Active, not recruiting” status after several extensions of its completion date, sources confirmed. ViiV’s July 2026 press materials highlight VOGUE among new data from its daily-oral portfolio, to be showcased alongside long-acting injectable innovations at major HIV scientific meetings, including AIDS 2026.

The VOGUE study builds on prior evidence supporting Dovato as a complete, once-daily, single-tablet regimen for adults with no antiretroviral treatment history and no known resistance to DTG or 3TC. The U.S. Food and Drug Administration approved Dovato based on pivotal GEMINI trials, which demonstrated non-inferior efficacy at Week 48 compared with a traditional three-drug regimen of dolutegravir plus tenofovir disoproxil fumarate/emtricitabine (TDF/FTC). In GEMINI, virologic control was defined as HIV-1 RNA below 50 copies per milliliter, with no treatment-emergent resistance observed in either arm, according to FDA documents.

Further supporting the two-drug approach, ViiV’s TANGO study in virologically suppressed adults showed that switching to dolutegravir/lamivudine maintained non-inferior virologic efficacy versus a three-or-more-drug TAF-based regimen over three years, with no confirmed virologic withdrawals or resistance in the Dovato arm. At Week 96 in TANGO, 73% of participants on DTG/3TC had viral loads “target not detected,” compared with 69% on TAF-based regimens, ViiV officials said.

In February 2026, ViiV Healthcare announced 96-week data from the PASO DOBLE study (GeSIDA 11720), which analyzed virologically suppressed adults switching from Biktarvy to Dovato. Presented at the 33rd Conference on Retroviruses and Opportunistic Infections (CROI 2026) in Denver, Colorado, the data showed a statistically significant lower proportion of steatotic liver disease in the Dovato arm (29%) compared with Biktarvy (49%), with a p-value of 0.033. These findings contribute to the safety and metabolic profile discussion around TAF-based triple regimens versus DTG/3TC two-drug regimens, officials said.

ViiV Healthcare, majority owned by GlaxoSmithKline with Pfizer and Shionogi as shareholders, positions the VOGUE trial within its broader strategy to evaluate two-drug regimens as complete first-line treatments for HIV-1 infection in adults. The company emphasizes its “diverse portfolio and pipeline,” which includes daily-oral regimens such as Dovato and long-acting injectable treatments like Cabenuva, according to ViiV’s July 2026 press releases. Media contacts for ViiV include Kate Senter, Head of Global Communications, reachable at +44 7796 707446, and Rachel Jaikaran for U.S. media inquiries at +1 919 357 8932.

The VOGUE trial’s head-to-head comparison of Dovato and Biktarvy in treatment-naïve adults is expected to inform global first-line treatment discussions among clinicians and researchers. The upcoming data presentation at AIDS 2026 will add to the growing evidence base assessing the efficacy and safety of two-drug regimens against integrase inhibitor-based three-drug standards of care.