IMPAACT 2023 Informs FDA Approval for Dolutegravir in Neonates

Based on data from IMPAACT 2023, the U.S. Food and Drug Administration (FDA) has approved Tivicay PD (dolutegravir), for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in paediatric patients (treatment-naïve or -experienced but integrase strand transfer inhibitor-naïve) weighing at least 2 kg. IMPAACT 2023 evaluated the safety, tolerability, and pharmacokinetics of dolutegravir given to infants during the first 4-6 weeks of life, with two sequential dosing cohorts stratified by maternal use of dolutegravir. The study took place at 15 sites across South Africa, Thailand, and the United States. 

Further information on the FDA approval is available at: U.S. FDA approves ViiV Healthcare’s Tivicay PD, helping close a critical HIV treatment gap for young children