FDA approves Tivicay PD for infants and children with HIV weighing at least 2 kg

The FDA has approved ViiV Healthcare’s Tivicay PD (dolutegravir) for pediatric patients weighing at least 2 kg, according to a ViiV Healthcare news release. This therapy should be used with other antiretroviral agents and should be treatment-naive or treatment-experienced but naive to integrase strand transfer inhibitors (INSTIs).

Tivicay was first approved for adults in 2013, followed by the initial 2020 approval of Tivicay PD for pediatric patients at least 4 years of age, weighing at least 3 kg. This latest expansion lowers that threshold to 2 kg, extending eligibility to newborns.

This therapy is available in oral tablets for suspension that contain dolutegravir, which is a second-generation INSTI that blocks the enzyme integrase, which HIV needs to make copies. Dolutegravir also has a higher barrier to resistance than previous generations.

The approval was made using the results of the National Institutes of Health-funded IMPAACT 2023 and pharmacokinetic modeling, in which 48 newborns who met the above criteria were given Tivicay PD from birth for up to six weeks and observed for 16 weeks. The data showed Tivicay PD had a safety and efficacy profile consistent with what has been established in older pediatric and adult populations who have taken dolutegravir.

“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, Pharm.D., assistant pediatrics professor at the Boston University School of Medicine, and lead investigator of the IMPAACT 2023 study, said in the news release. “With the approval of a TivicayPD 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.”

HIV can progress rapidly in infants without early diagnosis and treatment. Approximately half of untreated infants with HIV die by age 2. Globally, 55% of children ages 0 to 14 living with HIV had access to antiretroviral therapy in 2025, compared with 78% of all people living with HIV, according to UNAIDS's 2025 global HIV statistics fact sheet. UNAIDS estimated 1.3 million children were living with HIV worldwide that year, a population that has historically had fewer age-appropriate treatment options than adults.

“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 the news release. “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.”

This therapy follows Priority Review, a designation the FDA reserves for therapies that could offer a significant improvement in the safety or effectiveness of treating a serious condition.