FDA Grants Priority Review for Dolutegravir in Newborns With HIV
The U.S. Food and Drug Administration accepted a supplemental New Drug Application and granted Priority Review on Tuesday for ViiV Healthcare’s Tivicay PD (dolutegravir) to treat newborns with HIV from birth. The agency assigned a Prescription Drug User Fee Act action date of August 25, 2026, to evaluate the pediatric formulation designed for infants younger than four weeks, according to FDA officials and company statements.
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.
