FDA Approves Dolutegravir for Newborns With HIV
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In August 2026 the FDA approved dolutegravir, in combination with other antiretrovirals, for HIV-1-infected full-term newborns from birth to 4 weeks of age weighing at least 2 kg. The approval rests on the international phase 1 IMPAACT 2023 trial, which enrolled 48 full-term newborns in South Africa, Thailand and the United States and followed them for 16 weeks. The trial found drug levels in the newborns comparable to those in treated older children and adults, and the treatment was generally well tolerated. The approval extends an integrase inhibitor to the youngest patient population; open questions include longer-term safety and outcomes beyond the trial's 16-week follow-up.
Written by a model from the reports · updated 1 day ago
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- medicalxpress.comPickInternational study helps support FDA approval of HIV drug for newborns
In August 2026 the FDA approved dolutegravir, in combination with other antiretrovirals, 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; drug levels were comparable to those in treated older children and adults, and the drug was generally well tolerated.
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