FDA Approves Tivicay PD to Treat HIV Infection in Newborns

The FDA approved Tivicay PD tablets for oral suspension (dolutegravir) to treat HIV infection in infants from birth up to 4 weeks of age weighing at least 2 kg for use in combination with other antiretroviral agents.¹

The approval was granted under priority review by the FDA's Center for Drug Evaluation and Research. It was supported by data from the phase 1 IMPAACT 2023 trial (NCT05406583), which evaluated dolutegravir in 48 newborns exposed to HIV.^1-3

"Today's approval of Tivicay PD expands the options available for pediatric HIV care, giving families and clinicians in the U.S. greater choice from the very beginning of life," Jean van Wyk, MBChB, MFPM, chief medical officer at ViiV Healthcare, said in a news release.⁴ "For ViiV Healthcare, it reflects our commitment to bringing INSTI-based innovation to children and addressing persistent gaps in HIV care. This progress has been made possible through vital collaboration with the HIV community, united by a shared focus on ensuring children living with HIV are not left behind."

Closing a Gap in Newborn HIV Care

Manufacturer ViiV Healthcare, a global specialist HIV company majority owned by GSK with Shionogi as a shareholder, said the approval marks the first second-generation integrase strand transfer inhibitor (INSTI) approved for children weighing at least 2 kg, including eligible newborns. The company cited data showing that around 50% of untreated infants with HIV die by age 2.⁴

"For too long, newborns living with HIV have had too few treatment options designed and studied to meet their unique needs, despite the importance of starting treatment as early as possible," Diana F. Clarke, PharmD, assistant professor of pediatrics at Boston University School of Medicine and lead investigator of the IMPAACT 2023 study, said in the news release.⁴ "With the approval of a Tivicay PD dosing regimen, babies born at term and weighing at least 2 kg will now have access to dolutegravir-based therapy starting at birth. This represents an important advance for the care of newborns, as early treatment with the most effective therapies results in the best possible outcomes."

Trial Data Behind the Approval

According to the FDA, the IMPAACT 2023 trial enrolled 48 newborns exposed to HIV-1 and weighing at least 2 kg, who received Tivicay PD from birth for up to 6 weeks in combination with standard-of-care antiretroviral medications used to prevent mother-to-child HIV transmission. The newborns were followed for 16 weeks. Drug levels of Tivicay PD in the newborns were similar to those associated with efficacy in adults, and the safety profile was similar to that seen in older pediatric and adult patients.¹

The trial was a multicenter study with sequential dosing cohorts conducted at sites in Brazil, South Africa, Thailand, and the United States. It was led by study chair Diana Clarke and vice chair Mark Mirochnick and enrolled infants born to mothers with HIV-1 across two cohorts stratified by maternal dolutegravir use.^2,3

The IMPAACT Network is funded primarily by the National Institute of Allergy and Infectious Diseases, with co-funding from other National Institutes of Health institutes.⁴

Dosing, Safety, and Pharmacist Considerations

The FDA cautions that patients should not receive Tivicay or Tivicay PD if they have had previous allergic reactions to the drug or are also receiving dofetilide and notes that serious allergic reactions have been reported. Patients should be monitored for liver damage, and immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy.¹

Taking Tivicay or Tivicay PD with certain other medications may cause the drug to stop working against HIV or lead to serious side effects, and the original Tivicay tablets and Tivicay PD are not interchangeable on a dose-for-dose basis, a distinction pharmacists should flag at dispensing.¹

Even before this approval, clinicalinfo.HIV.gov's pediatric antiretroviral guidelines listed dolutegravir as a preferred anchor drug, paired with a 2-drug nucleoside/nucleotide reverse transcriptase inhibitor backbone, for term infants (at least 37 weeks gestation) weighing at least 2 kg, in combination with zidovudine plus lamivudine or emtricitabine.⁵

The guidelines describe a dosing schedule available as a single dose every other day for the first 2 weeks of life, followed by a daily dose thereafter. For preterm infants with a postmenstrual age younger than 32 weeks, the guidelines recommend consultation with pediatric HIV experts, reflecting how limited the treatment options remain for the youngest and smallest patients.⁵

REFERENCES

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

2. International Maternal Pediatric Adolescent AIDS Clinical Trials Network. IMPAACT 2023: a phase I study of the safety, tolerability, and pharmacokinetics of dolutegravir in neonates exposed to HIV-1. IMPAACT Network. Accessed August 26, 2026. https://www.impaactnetwork.org/studies/impaact2023

3. A phase I study of the safety, tolerability, and pharmacokinetics of dolutegravir in neonates exposed to HIV-1. ClinicalTrials.gov identifier: NCT05406583. Accessed August 26, 2026. https://clinicaltrials.gov/study/NCT05406583

4. ViiV Healthcare. U.S. FDA approves ViiV Healthcare's Tivicay PD, helping close a critical HIV treatment gap for young children. News release. ViiV Healthcare. August 26, 2026. Accessed August 26, 2026. https://viivhealthcare.com/hiv-news-and-media/news/press-releases/2026/august/helping-close-a-critical-hiv-treatment-gap/

5. Clinicalinfo.HIV.gov. Regimens recommended for initial therapy of antiretroviral-naive children. HIV.gov. Accessed August 26, 2026. https://clinicalinfo.hiv.gov/en/guidelines/pediatric-arv/regimens-recommended-initial-therapy-antiretroviral-naive-children