Clinical Report: FDA approves HIV treatment for newborns

Overview

The FDA has approved dolutegravir (Tivicay PD) for treating HIV in newborns from birth to 4 weeks of age who weigh at least 2 kg. This approval is based on data from the IMPAACT 2023 study, which demonstrated comparable dolutegravir levels in newborns to those associated with efficacy in adults.

Background

HIV infection poses a significant risk to the immune system, leading to serious infections or cancer and potentially progressing to AIDS without treatment.

Data Highlights

Key Findings

• The FDA approved dolutegravir for newborns from birth to 4 weeks weighing at least 2 kg.
• Dolutegravir was previously approved for adults and pediatric patients older than 4 weeks.
• Participants in the IMPAACT 2023 study received dolutegravir in combination with standard-of-care antiretroviral medications.
• Dolutegravir levels in newborns were comparable to those associated with efficacy in adults.
• The safety profile in newborns was similar to that observed in older pediatric and adult patients.

Clinical Implications

Healthcare providers should consider dolutegravir as a treatment option for newborns at risk of HIV infection.

Conclusion

The approval of dolutegravir for newborns represents a significant advancement in the treatment of HIV in this population, providing a new tool to combat mother-to-child transmission.

Related Resources & Content

1. FDA, FDA, 2026 -- FDA Approves Drug to Treat HIV Infection in Newborns
2. NIH, NIH, 2026 -- Antiretroviral Management of Infants With In Utero, Intrapartum, or Breastfeeding Exposure to HIV
3. the medicine maker — From Monkeys to Medicine Cabinets: Gene Therapy for Lifelong HIV Immunity in Infants
4. MDSpire News — HIV & Infant Feeding: New AAP Guidelines
5. MDSpire News — Two-Drug HIV Regimen Gains FDA Approval
6. the medicine maker — Closing the Treatment Gap
7. From Monkeys to Medicine Cabinets: Gene Therapy for Lifelong HIV Immunity in Infants
8. HIV & Infant Feeding: New AAP Guidelines
9. Two-Drug HIV Regimen Gains FDA Approval
10. FDA Approves Drug to Treat HIV Infection in Newborns | FDA
11. Antiretroviral Management of Infants With In Utero, Intrapartum, or Breastfeeding Exposure to HIV | NIH
12. WHO optimal antiretroviral dosing guidance: recommendations for dosing medicines for HIV prevention and treatment in paediatric populations