FDA approves HIV drug dolutegravir for full-term newborns

The United States Food and Drug Administration approved the use of dolutegravir in August 2026 to treat HIV-1 in full-term newborns from birth through four weeks of age. UA.NEWS and Medical Xpress both report that the approval applies to babies weighing at least two kilograms. The drug must be administered in combination with other antiretroviral medicines, according to UA.NEWS. [1][2]

Medical Xpress describes dolutegravir as a second-generation integrase inhibitor. The regulatory decision was informed by data from an international trial known as the IMPAACT 2023 study. The trial was conducted through the International Maternal Pediatric Adolescent AIDS Clinical Trials Network, according to Medical Xpress. [1][2]

UA.NEWS reports that the phase 1 trial involved 48 full-term newborns born to women living with HIV-1. Specialists from Boston Medical Center led the study, which enrolled participants at clinical sites located in South Africa, Thailand, and the United States. Researchers from the University of California San Diego also participated in the research effort, according to Medical Xpress. [1][2]