FDA expands dolutegravir dispersible tablets to children with HIV-1 weighing at least 2 kg, including eligible term newborns.
ViiV Healthcare announced that the FDA has approved
“For too long, newborns living with HIV have had too few treatment options designed and studied to meet their unique needs,” Diana F. Clarke, PharmD, assistant professor of pediatrics at Boston University School of Medicine and lead investigator of the IMPAACT 2023 study, said in a press release. Clarke said the new dosing regimen permits dolutegravir-based treatment from birth for eligible term infants weighing at least 2 kg.¹
The August 2026 decision followed FDA Priority Review and extends access to a second-generation INSTI to the smallest pediatric weight group included in the indication.¹ Clinically, the availability of an age-appropriate formulation may simplify construction of combination antiretroviral therapy for newborns, although dosing must follow the product labeling and dolutegravir is not intended for use as monotherapy.
The approval was supported by the National Institutes of Health–funded IMPAACT 2023 study and pharmacokinetic modeling that incorporated additional pediatric data.2 According to ViiV, dolutegravir achieved therapeutic drug concentrations in term neonates, with a safety profile consistent with experience in older children and adults.¹
Dolutegravir inhibits HIV integrase by binding to its active site and blocking the strand-transfer step required to integrate retroviral DNA into the host genome. The drug must be administered with other active antiretroviral agents. The expanded indication applies only to children who are INSTI-naive if they have previously received HIV treatment; it should not be extrapolated to patients with known or suspected INSTI resistance.
Early diagnosis and prompt treatment are particularly important in perinatal HIV because disease may progress rapidly without antiretroviral therapy. The company cited an estimate that approximately half of untreated infants with HIV die by 2 years of age.¹ For clinicians, the approval addresses a practical treatment gap by providing a dispersible dolutegravir formulation and dosing pathway for eligible infants at the lower end of the pediatric weight range.
Interpretation should remain cautious. The regulatory action does not establish superiority over other neonatal regimens, and the release did not report head-to-head data or clinical outcomes from a randomized trial. Additional evidence will be needed regarding real-world dosing, adherence, virologic response, resistance emergence, and longer-term safety among infants who begin dolutegravir at birth. Evidence also remains limited for premature neonates because the supporting findings described in the announcement concerned term newborns.
