FDA Alert

FDA approves Tivicay PD for Newborns with HIV in the United States

Edited by:
Ashton L. Stahl

Key Highlights

  • Tivicay PD is now approved for newborns with HIV from birth to 4 weeks who weigh at least 2 kg.
  • Treatment must be administered with other antiretroviral agents.
  • Approval was supported by IMPAACT 2023 data and pharmacokinetic modeling.
  • Newborn drug levels and safety findings were comparable to those observed in older populations.

On August 26, the FDA approved dolutegravir (Tivicay PD; ViiV Healthcare) in combination with other antiretroviral agents to treat HIV infection in newborns from birth to 4 weeks who weigh at least 2 kg. Tivicay and Tivicay PD were already approved for adults and children older than 4 weeks.

The approval was supported by pharmacokinetic modeling and findings from IMPAACT 2023 (NCT05406583). In the study, 48 newborns exposed to HIV-1 who weighed at least 2 kg received dolutegravir from birth for up to 6 weeks alongside standard-of-care antiretroviral medications intended to prevent mother-to-child HIV transmission. Investigators followed the newborns for 16 weeks. Dolutegravir concentrations in newborns were comparable to levels associated with efficacy in adults, and the safety profile was consistent with those observed in older pediatric and adult patients. Dolutegravir received priority review for this population.

“Results showed the drug levels of Tivicay PD in newborns were similar to those associated with efficacy in adults,” the FDA stated in a press release.

The FDA noted reports of serious allergic reactions and immune reconstitution syndrome and advised monitoring patients for liver damage. Dolutegravir is contraindicated in patients with a previous allergic reaction to the drug and those receiving dofetilide. Drug interactions may reduce its activity against HIV or cause serious adverse effects.

Dolutegravir tablets for oral suspension are not interchangeable on a milligram-per-milligram basis.

Reference

US Food and Drug Administration. FDA approves drug to treat HIV infection in newborns. Accessed August 27, 2026. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-drug-treat-hiv-infection-newborns