In August 2026, the FDA approved dolutegravir for treating HIV-1 in full-term newborns weighing at least 2 kg from birth up to 4 weeks of age. The decision was informed by the phase 1 IMPAACT 2023 clinical trial across South Africa, Thailand, and the US, which established effective dosing and safety profiles. Early antiretroviral therapy limits viral replication and reservoir seeding in the over 1 million infants born annually to women with HIV-1.
FDA approval updates for dolutegravir
- ▪Prior to the August 2026 FDA expansion, dolutegravir was approved only for adults and children aged at least 4 weeks and weighing at least 3 kilograms.
- ▪In August 2026, the FDA expanded approval of dolutegravir to treat HIV-1 infection in full-term infants weighing at least 2 kilograms from birth up to 4 weeks of age in combination with other antiretrovirals.
Clinical trial results and dosing
- ▪In the IMPAACT 2023 trial, 2 of 48 enrolled infants experienced grade 1–2 adverse events related to dolutegravir, with zero study drug-related safety failures reported in cohort 1 and four safety failures in cohort 2.
- ▪Pharmacokinetic evaluations in cohort 2 of the IMPAACT 2023 study showed geometric mean trough concentration and area under the curve at day 7 post-initial dose were within target ranges for full-term neonates.
- ▪The IMPAACT 2023 study evaluated a dosing regimen of dolutegravir 5 mg dispersible tablets administered every 48 hours for the first 14 days of life, followed by once-daily dosing up to 4 to 6 weeks of age.
- ▪The phase 1 IMPAACT 2023 clinical trial enrolled 48 full-term infants born to women living with HIV-1 across 15 sites in South Africa, Thailand, and the United States between October 2022 and January 2025.
- ▪An IMPAACT Network study published in The Lancet HIV demonstrated that dolutegravir achieved drug concentration levels in full-term newborns comparable to target levels observed in older children and adults.
Integrase inhibitors in neonates
- ▪In 2025, the PETITE-DTG study reported appropriate pharmacokinetic exposures and acceptable safety with dolutegravir dispersible tablets and oral films in term neonates born to women receiving long-term dolutegravir-based therapy.
- ▪Prior to dolutegravir's expansion for newborns, raltegravir was the only integrase inhibitor approved for use from birth, but it requires complex neonatal dosing and has a lower resistance barrier.
Global impact and treatment rationale
- ▪Early initiation of antiretroviral therapy in neonates living with HIV-1 limits viral replication, reduces the seeding of long-lived viral reservoirs, and preserves immune function.
- ▪More than 1 million neonates worldwide are born annually to women living with HIV-1 and require antiretroviral regimens from birth for presumptive therapy or early treatment.
- ▪United States and WHO treatment guidelines recommend three-drug antiretroviral therapy regimens as presumptive therapy or enhanced prophylaxis for infants at high risk of HIV-1 acquisition.
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