The FDA has approved ViiV Healthcare’s Tivicay PD (dolutegravir) for HIV-positive newborns weighing at least 2 kilograms, creating the first treatment specifically approved for infants in their first month of life. This update lowers the prior weight threshold from 3 kg and removes the minimum age requirement, filling a key gap in early pediatric HIV care. The dispersible formulation was initially cleared in 2020 for infants aged four weeks or older, but the new approval addresses the urgent need for neonatal treatment, where untreated infections carry a high mortality risk.
UNICEF estimates that roughly half of HIV-positive babies die before age 2 without treatment, though perinatal HIV cases in the U.S. have declined sharply, fewer than 50 annually since 2018, thanks to preventive measures that have reduced mother-to-child transmission to 1% or less. The drug was originally approved in 2013 for adults and adolescents aged 12 or older, and its expanded use now reflects growing recognition of the urgency in treating HIV in newborns.
The approval follows data from the IMPAACT 2023 study, a phase 1 trial involving 48 mother-infant pairs across South Africa, Thailand, and the U.S.. The study evaluated safety and drug levels in newborns weighing at least 2 kg, with results showing exposures comparable to those in adults. A subset of 15 infants received dosing within five days of birth, demonstrating tolerability over a six-week period. The FDA’s decision was supported by pharmacokinetic modeling and data from the NIH-funded IMPAACT 2023 trial, which tracked drug levels and safety in newborns for up to 16 weeks.
ViiV described Tivicay PD as the first second-generation integrase inhibitor approved for this age group, offering a more flexible dosing option for infants. The safety profile aligned with that of older pediatric and adult patients, though long-term data remain limited. For infants weighing 2.3 to 3.6 kg, the study’s dosing regimen began with a 5-mg tablet every other day for two weeks, transitioning to daily dosing. The approval covers both treatment-naive and treatment-experienced infants who have not previously received integrase inhibitors, expanding access to a drug class that has become a cornerstone of HIV therapy.
While the approval broadens treatment options, it arrives amid a shifting market for HIV drugs. GSK, which markets Tivicay, reported £1.323 billion in sales for the brand in 2025, a 2% decline from the prior year. However, the broader HIV portfolio grew by 11% to £7.687 billion, driven by newer therapies like Dovato and long-acting injectables such as Cabenuva. The approval may help sustain demand for dolutegravir in pediatric care, where alternatives remain limited.
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