FDA Extends Tivicay PD Approval to Eligible Newborns

Tivicay PD, a dolutegravir tablet formulation for oral suspension, has U.S. Food and Drug Administration approval to treat HIV-1 from birth in eligible full-term newborns. Effective August 25, 2026, the approval covers infants weighing at least 2 kg during their first four weeks, with treatment given alongside other antiretroviral medicines.

According to the FDA, the earlier indications for Tivicay and Tivicay PD covered adults and children over four weeks of age. The expanded indication includes eligible term infants from birth. The prescribing information limits pediatric use to patients with no previous HIV treatment or those previously treated who have never received an integrase strand transfer inhibitor.

For full-term newborns meeting the 2 kg minimum weight, the FDA label specifies a two-stage dosing schedule. From birth through day 14, the Tivicay PD dose is 5 mg on alternate days. For days 15 to 28, the label specifies 5 mg each day.

The research included IMPAACT 2023, which the IMPAACT Network describes as a multicenter Phase I study examining safety, tolerability and pharmacokinetics, or drug levels in the body. Its design covered the first four to six weeks after birth in infants whose mothers were living with HIV-1. According to a University of California San Diego release, Boston Medical Center researchers led the study, with sites across the United States, South Africa and Thailand.

The FDA's account describes 48 newborn participants exposed to HIV-1, each weighing at least 2 kg. They received dolutegravir for a maximum of six weeks together with standard antiretroviral medicines used to prevent transmission from mother to child. The follow-up period lasted 16 weeks.

According to the FDA, dolutegravir concentrations in the newborns resembled those linked to effectiveness in adults. That comparison concerns pharmacokinetics; it is not a reported finding that dolutegravir cured HIV or controlled infection in newborns with the virus.

The prescribing information describes newborn safety findings as comparable with those in older age groups. It records two cases of immune reconstitution inflammatory syndrome attributed to the drug, with severity ranging from mild to moderate. The FDA label records neither severe drug-related reactions nor adverse reactions that required treatment to stop.

The label also sets out restrictions and monitoring advice. It prohibits Tivicay PD use for patients taking dofetilide and for those with a previous allergic reaction to dolutegravir. It also directs monitoring for liver injury and checks for interactions with other medicines.

* This article is based on publicly available information at the time of writing.