FDA approves ViiV Healthcare’s Tivicay PD for pediatric HIV therapy

The US Food and Drug Administration (FDA) has approved ViiV Healthcare’s Tivicay PD (dolutegravir) for use in pediatric patients with HIV-1 who weigh at least 2kg. The therapy is intended for children who are new to treatment or those with prior antiretroviral experience but who have not previously been treated with integrase strand transfer inhibitors (INSTIs).

The approval follows a Priority Review and is supported by data from the International Maternal Paediatric Adolescent AIDS Clinical Trials (IMPAACT) 2023 study, as well as pediatric pharmacokinetic modeling. Research indicated that the drug reached therapeutic levels in term neonates and maintained a safety profile similar to that of older children and adults.