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.

The supplemental New Drug Application (sNDA) accepted by the FDA seeks to extend the use of dolutegravir, marketed as Tivicay PD, to newborns from birth, expanding the current indication that covers pediatric patients aged at least four weeks and weighing 3 kilograms or more, according to a June 22, 2026, press release from ViiV Healthcare. Tivicay PD is a pediatric formulation consisting of tablets for oral suspension, designed to meet the dosing needs of very young infants and children, the company noted.

The FDA assigned a Prescription Drug User Fee Act (PDUFA) action date of August 25, 2026, for this review, officials said.

Previously, Tivicay and Tivicay PD were approved for use in pediatric patients four weeks and older, including those who are treatment-naive or treatment-experienced but integrase strand transfer inhibitor (INSTI)-naive, according to FDA records and U.S. Department of Health and Human Services (HHS) HIV treatment guidelines. The new application aims to lower the age limit to include neonates in the first days of life, a move that would allow earlier initiation of antiretroviral therapy (ART) in infants diagnosed with HIV at birth.

The priority review designation follows extensive clinical and pharmacokinetic data supporting the safety and dosing of dolutegravir in neonates. Published case reports and population pharmacokinetic modeling indicate that neonatal dosing requirements vary depending on maternal dolutegravir exposure prior to delivery, officials said. Transplacental transfer of the drug affects neonatal drug levels, necessitating weight-band and age-specific dosing to maintain therapeutic concentrations while avoiding toxicity, according to pharmacokinetic analyses cited in the FDA briefing documents. These findings underscore the need for a dedicated newborn indication to optimize treatment protocols.

Safety considerations remain a critical aspect of the review. Data from an NIH-funded observational study in Botswana suggested a possible increased risk of neural tube defects in infants born to women who received dolutegravir at conception, according to published studies and FDA safety communications. Ongoing observational studies cited by the FDA reaffirm this association but note that further analyses are needed to confirm the signal. U.S. pediatric HIV guidelines recommend that providers discuss this potential risk with adolescents and caregivers when initiating dolutegravir in patients of childbearing potential. However, the safety concerns pertain to maternal periconception exposure and not to dolutegravir use in newborns after birth, officials clarified. Despite these findings, dolutegravir-based regimens remain preferred options for children weighing 25 kilograms or more, reflecting their favorable efficacy and safety profiles when used appropriately.

ViiV Healthcare, described in its press release as the global specialist HIV company majority-owned by GlaxoSmithKline with Shionogi as a shareholder, is the sponsor of Tivicay PD. The company provided media contacts Kate Senter in London and Melinda Stubbee in North Carolina for inquiries related to the announcement. The FDA previously communicated the pediatric approval of Tivicay and Tivicay PD for children aged four weeks and older through a press release listing Alison Hunt as the media contact and the “888-INFO-FDA” line for consumer information.

The proposed extension of dolutegravir use to neonates aligns with U.S. pediatric HIV treatment guidelines, which recommend initiating ART in all treatment-naive infants and children with HIV infection, with rapid initiation within one to two weeks for young infants or those with advanced disease, according to HHS clinical guidelines. Dolutegravir combined with two nucleoside reverse transcriptase inhibitors is classified as a preferred INSTI-based regimen for children weighing 25 kilograms or more. The expansion to newborns would facilitate earlier treatment initiation, potentially improving virologic control and reducing the HIV reservoir size in infants, researchers have noted.

Population pharmacokinetic studies emphasize the importance of accounting for maternal dolutegravir exposure when determining neonatal dosing, which has implications for clinical protocols in labor and delivery settings and early infant HIV services. This regulatory development in the United States may influence updates to World Health Organization and national guidelines, supporting broader global adoption of dolutegravir-based regimens for infants once safety, dosing, and implementation issues are fully addressed, according to experts in pediatric HIV treatment.

The FDA’s upcoming decision on the sNDA will be closely watched by clinicians and public health officials, as extending access to potent antiretroviral therapy from birth could have significant implications for the management of HIV in newborns, particularly in regions with high maternal HIV prevalence.