FDA Approves Dolutegravirfor HIV Treatment in Newborns

The FDA has approved dolutegravir (Tivicay PD; ViiV Healthcare) tablets for oral suspension for the treatment of HIV infection in newborns from birth to younger than 4 weeks who weigh at least 2 kg when used in combination with other antiretroviral agents.¹

Tivicay and Tivicay PD were previously approved for adults and pediatric patients aged 4 weeks and older. The expanded indication moves dolutegravir treatment into the first weeks of life, a period in which age-appropriate antiretroviral options have historically been limited.¹˒²

IMPAACT 2023 Supports Neonatal Dolutegravir Use

The FDA based the expanded indication on findings from the phase 1 IMPAACT 2023 study (NCT05406583) and pharmacokinetic modeling incorporating additional pediatric data.¹

IMPAACT 2023 was a multicenter, open-label, noncomparative dose-finding study evaluating the safety, tolerability, and pharmacokinetics of dolutegravir in full-term newborns exposed to HIV-1. The study was designed to identify a neonatal dosing regimen that would achieve pharmacokinetic exposures associated with effective dolutegravir use in older populations.³

According to the FDA, 48 newborns weighing at least 2 kg received dolutegravir beginning at birth and continuing for up to 6 weeks in addition to standard-of-care antiretroviral medications used to prevent mother-to-child HIV transmission. The infants were followed through 16 weeks of age.¹

Dolutegravir concentrations observed in the newborns were comparable with drug exposures associated with efficacy in adults. The FDA also reported that the safety profile in newborns was similar to that previously observed in older pediatric patients and adults.¹

NIH pediatric HIV guidance published before the FDA action had already incorporated neonatal dolutegravir based on the emerging pharmacokinetic data. The guidelines recommend dolutegravir with zidovudine plus either lamivudine or emtricitabine as a preferred initial regimen for full-term infants with HIV who weigh at least 2 kg.⁴

Approval Addresses an Early Treatment Gap

Dolutegravir is a second-generation integrase strand transfer inhibitor that prevents HIV replication by blocking the strand-transfer step required for integration of viral DNA into host cells.²

Before the expanded approval, use of dolutegravir in the United States began at 4 weeks of age. ViiV Healthcare noted during regulatory review that approval for newborns would make dolutegravir the first second-generation integrase inhibitor available for this age group.²

The distinction is clinically important because HIV can progress rapidly in infants. Contemporary pediatric HIV guidance emphasizes initiating antiretroviral therapy promptly after diagnosis and recommends multidrug therapy for infants and children starting treatment.⁴

Dolutegravir also offers continuity across age groups. NIH guidelines describe the agent as a preferred integrase inhibitor that can be initiated at birth in eligible infants and continued as children grow, although dosing changes according to age and weight.⁴

Pharmacists Should Note Formulation and Dosing Differences

The expanded indication places additional emphasis on accurate preparation and administration of the pediatric formulation. Dolutegravir is supplied as tablets for oral suspension and should not be treated as interchangeable with conventional Tivicay tablets on a milligram-per-milligram basis.¹

That distinction is particularly relevant during transitions between pediatric formulations or when medication histories are reconciled across inpatient and outpatient settings.

Dolutegravir is contraindicated in patients with a previous hypersensitivity reaction to the drug and in patients receiving dofetilide. Serious hypersensitivity reactions and hepatic adverse events have been reported, and immune reconstitution syndrome can occur after combination antiretroviral therapy is initiated.¹

Clinicians and pharmacists should also review concomitant medications because drug interactions can alter dolutegravir exposure or increase the risk of adverse effects.¹

References

1. US Food and Drug Administration. FDA approves drug to treat HIV infection in newborns. Published August 25, 2026. Accessed August 25, 2026.https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-drug-treat-hiv-infection-newborns

2. ViiV Healthcare. ViiV Healthcare advances paediatric HIV regulatory submissions with FDA Priority Review for Tivicay PD and EMA validation of marketing application for Tivicay. Published June 22, 2026. Accessed August 25, 2026.https://viivhealthcare.com/hiv-news-and-media/news/press-releases/2026/june/marketing-application-for-tivicay/

3. ClinicalTrials.gov. A study of the safety, tolerability, and pharmacokinetics of dolutegravir in neonates exposed to HIV-1 (IMPAACT 2023). NCT05406583. Updated May 22, 2026. Accessed August 25, 2026.​​https://clinicaltrials.gov/study/NCT05406583

4. Panel on Antiretroviral Therapy and Medical Management of Children Living With HIV. What to start: antiretroviral regimens for initial therapy in infants and children with HIV. ClinicalInfo.HIV.gov. Updated June 25, 2026. Accessed August 25, 2026.https://clinicalinfo.hiv.gov/en/guidelines/pediatric-arv/regimens-recommended-initial-therapy-antiretroviral-naive-children