The U.S. Food and Drug Administration has granted approval to Tivicay PD (dolutegravir) for treating HIV-1 infection in pediatric patients weighing at least 2 kg, including newborns, the agency said on Wednesday.
The clearance marks the first approval of a second-generation integrase inhibitor for children in this weight category. Tivicay PD is indicated for use in combination with other antiretroviral therapies in both treatment-naïve and treatment-experienced patients who are integrase strand transfer inhibitor-naïve.
Regulatory documents show the FDA granted Priority Review for the pediatric indication. The approval was supported by data from the National Institutes of Health-funded IMPAACT 2023 study, supplemented by pharmacokinetic modeling from additional pediatric datasets.
Results demonstrated that dolutegravir achieved therapeutic drug levels in term neonates while maintaining a safety profile consistent with that observed in older pediatric and adult populations.
According to UNICEF and UNAIDS estimates, approximately 50% of untreated infants with HIV die by age two without early diagnosis and treatment. The new approval addresses a critical gap in pediatric HIV care by providing a treatment option designed for infants as young as newborns.
ViiV Healthcare, majority-owned by GSK with Shionogi as a partner, developed Tivicay PD. Diana F. Clarke, Pharm.D., Assistant Professor of Pediatrics at Boston University School of Medicine and Lead Investigator of the IMPAACT 2023 study, noted the longstanding lack of treatment options tailored to newborns living with HIV despite the urgency of early intervention.
