FDA approves dolutegravir dispersible tablets for HIV-infected newborns

The FDA has approved Tivicay PD (dolutegravir) tablets for oral suspension to treat HIV-1 infection in newborns from birth up to 4 weeks of age, provided they weigh at least 2 kg, when used in combination with other antiretroviral agents.¹ The decision closes a treatment gap for the youngest and most vulnerable patients living with HIV, who have historically had access to fewer age-appropriate regimens than older children and adults.²

"Early HIV treatment can help shape a child's future, yet newborns have historically had the fewest age-appropriate treatment options," Jean van Wyk, MBChB, MFPM, chief medical officer at ViiV Healthcare, said when the FDA accepted the application for review earlier this year. "ViiV Healthcare has a long-standing commitment to changing that and helping ensure children are not left behind in HIV innovation."²

FDA approval expands Tivicay PD to the newborn population

Tivicay and Tivicay PD were previously approved only for adults and children older than 4 weeks.¹ The newly approved indication lowers that threshold to birth, provided the infant weighs at least 2 kg, and the application received Priority Review.¹ Tivicay tablets and Tivicay PD tablets for oral suspension are not interchangeable on a milligram-per-milligram basis, a distinction clinicians will need to account for when transitioning patients between formulations.¹

IMPAACT 2023 trial data supporting dolutegravir in neonates

The approval was supported by data from the IMPAACT 2023 study (NCT05406583) together with pharmacokinetic modeling.^1,3 In that trial, 48 newborns with HIV-1 exposure and weighing at least 2 kg received Tivicay PD from birth for up to 6 weeks alongside standard-of-care antiretrovirals used to prevent mother-to-child transmission, with follow-up through 16 weeks.¹ Drug exposures in these newborns were comparable to levels associated with efficacy in adults, and the safety profile observed was consistent with that seen in older pediatric and adult patients.¹

HIV burden in newborns and the case for earlier treatment

Untreated HIV can progress rapidly in infancy, and without early diagnosis and treatment, roughly half of untreated infants living with HIV die by age 2.² Mother-to-child transmission, delayed testing, and a scarcity of optimized pediatric formulations have all been cited as persistent barriers to timely treatment in this population.² A dispersible tablet that can be dosed from birth addresses one of those barriers directly.

Dolutegravir mechanism and regulatory history

Dolutegravir is a second-generation integrase strand transfer inhibitor with a higher barrier to resistance than earlier-generation agents in its class.² Tivicay was first approved for adults in 2013, and the Tivicay PD dispersible formulation was approved in 2020 for children at least 4 weeks old and weighing at least 3 kg.⁴ This latest approval extends that lower boundary to birth and to infants weighing as little as 2 kg.

Safety considerations for prescribers

Tivicay and Tivicay PD are contraindicated in patients with prior hypersensitivity reactions to the drug or in those taking dofetilide concurrently.¹ Serious allergic reactions have been reported, and patients should be monitored for hepatotoxicity.¹ Immune reconstitution syndrome has occurred in patients on combination antiretroviral therapy, and clinicians should review all concomitant medications, since certain drug interactions can reduce dolutegravir's antiviral activity or increase the risk of adverse effects.¹

Limitations and next steps

The pivotal newborn data come from a single-arm, 48-patient study with 16 weeks of follow-up, a relatively short window for assessing durability of virologic response and long-term safety in this age group.¹ Efficacy conclusions rely partly on pharmacokinetic bridging to adult exposure data rather than newborn-specific efficacy endpoints, an accepted but inherently indirect approach in neonatal drug development. Longer-term follow-up and real-world postmarketing data will help clarify durability and safety as use expands.

References

1. US Food and Drug Administration. FDA approves drug to treat HIV infection in newborns. Published August 25, 2026. Accessed August 26, 2026. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-drug-treat-hiv-infection-newborns

2. ViiV Healthcare advances paediatric HIV regulatory submissions with FDA Priority Review for Tivicay PD and EMA validation of marketing application for Tivicay. News release. ViiV Healthcare. June 22, 2026. Accessed August 26, 2026. https://viivhealthcare.com/hiv-news-and-media/news/press-releases/2026/june/marketing-application-for-tivicay/

3. International Maternal Pediatric Adolescent AIDS Clinical Trials Network. IMPAACT 2023: pharmacokinetics, safety and antiviral activity of dolutegravir in neonates. ClinicalTrials.gov. NCT05406583. Accessed August 26, 2026. https://clinicaltrials.gov/study/NCT05406583

4. FDA approves Tivicay and Tivicay PD for treatment of HIV-1 in kids. Contemporary Pediatrics. Published June 15, 2020. Accessed August 26, 2026. https://www.contemporarypediatrics.com/view/fda-approves-tivicay-and-tivicay-pd-for-treatment-of-hiv-1-in-kids