International study helps support FDA approval of HIV drug for newborns

In August 2026 the FDA approved dolutegravir, in combination with other antiretroviral drugs, for full-term newborns with HIV-1 infection from birth to 4 weeks of age weighing at least 2 kg. The phase 1 IMPAACT 2023 trial enrolled 48 full-term newborns in South Africa, Thailand and the United States and followed them for 16 weeks, finding drug levels comparable to those in treated older children and adults and generally good tolerability.