FDA Approves Tivicay PD for Infants With HIV

The FDA has approved dolutegravir (Tivicay PD; ViiV Healthcare) in combination with other antiretroviral agents for HIV infection in pediatric patients who are treatment-naïve or treatment-experienced but INSTI-naïve and weigh at least 2 kg (4.4 lbs).¹ The approval covers eligible term newborns, making dolutegravir-based therapy available starting at birth for babies who meet the weight threshold.¹ According to a new announcement from ViiV Healthcare, Tivicay PD is the first second-generation INSTI cleared for this population.¹

The FDA granted Priority Review ahead of this decision.¹ Supporting data came from the NIH-funded IMPAACT 2023 study, combined with pharmacokinetic modeling incorporating additional pediatric data.¹ This evidence base is pharmacokinetic and safety-focused rather than a traditional phase 3 efficacy trial, and it found dolutegravir reached therapeutic drug levels in term neonates.¹ The safety profile observed was consistent with what has already been established in older pediatric and adult populations taking dolutegravir.1

Dolutegravir carries a higher barrier to resistance than earlier-generation integrase inhibitors, a property relevant for a population where treatment often must continue for decades.¹ Without early diagnosis and treatment, HIV can progress rapidly in infants, and about 50% of untreated infants with HIV die by age two.² That statistic underscores the clinical stakes behind extending dolutegravir dosing down to newborns weighing at least 2 kg.²

Building Upon Pediatric HIV Care

The expanded indication extends dolutegravir's established adult and pediatric use into the neonatal period and adds to ViiV's existing portfolio of pediatric HIV treatments.¹ The company positioned the approval as part of a continued effort, alongside the broader HIV community, to close treatment gaps for children living with HIV.¹

Diana F. Clarke, PharmD, assistant professor of pediatrics at Boston University School of Medicine and lead investigator of the IMPAACT 2023 study, says the approval fills a long-standing gap in newborn HIV care.

“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,” Clarke said in a statement. “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.”¹

References
1.US FDA APPROVES ViiV HEALTHCARE’S TIVICAY PD, HELPING CLOSE A CRITICAL HIV TREATMENT GAP FOR YOUNG CHILDREN . ViiV Healthcare press release. August 26, 2026. Accessed August 26, 2026.
https://viivhealthcare.com/enus/ media-center/news/press-releases/2026/august/helping-close-a-critical-hiv-treatment-gap/.

2. The Cost of Inaction: Children and Adolescents Living with HIV in Eastern and Southern Africa. UNICEF and UNAIDS. Accessed August 26, 2026.
https://www.childrenandaids.org/media/6096/file/UNICEF_UNAIDS_CostofInaction_HIV_Final.pdf.