FDA approves dolutegravir for full-term newborns with HIV — News-Medical

In the United States, the Food and Drug Administration (FDA) has approved the use of dolutegravir to treat HIV-1 in full-term newborns weighing at least 2 kg, from birth through four weeks of age. The drug must be used in combination with other antiretroviral medicines, News-Medical reports.

Clinical trial data

The FDA decision was announced in August 2026. It was informed in part by the results of the international IMPAACT 2023 study. The phase 1 trial involved 48 full-term newborns born to women living with HIV-1. The study was conducted at sites in South Africa, Thailand, and the United States under the leadership of specialists from Boston Medical Center.

Depending on the group, the infants received two separate single doses of dolutegravir or repeated doses of the drug during the first weeks of life. All participants also received standard antiretroviral prophylaxis. The children’s safety was monitored for 16 weeks.

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Drug levels and safety

Scientists found that dolutegravir concentrations in newborns’ bodies were comparable to levels observed in older children and adults receiving the drug for HIV treatment. The medicine was generally well tolerated, and its safety profile was similar to that previously observed in older infants and children.

Dolutegravir is a second-generation integrase inhibitor. Before the new FDA decision, it had been approved for adults and children aged four weeks and older. The results of the IMPAACT 2023 study were published in The Lancet HIV.