ViiV's Tivicay PD Becomes First HIV Drug Approved for Newborns from Birth

ViiV Healthcare, majority-owned by GSK (NYSE: GSK), won FDA approval for Tivicay PD tablets for oral suspension (dolutegravir) to treat HIV infection in newborns from birth to four weeks weighing at least 2 kg, in combination with other antiretrovirals. The decision extends dolutegravir to the youngest patients, who previously had no approved integrase inhibitor. GSK closed at $52.07 on August 25, up 0.6%.

The approval rests on the IMPAACT 2023 study (NCT05406583), in which 48 HIV-exposed newborns weighing at least 2 kg received Tivicay PD from birth for up to six weeks alongside standard-of-care antiretrovirals to prevent mother-to-child transmission. Pharmacokinetic modeling showed drug levels in newborns matched those tied to efficacy in adults, and the safety profile was consistent with older pediatric and adult patients. Patients must be monitored for liver damage, and immune reconstitution syndrome has been reported with combination antiretroviral therapy. Tivicay PD tablets for oral suspension are not substitutable milligram-for-milligram with Tivicay tablets. The FDA granted the application Priority Review.

Why It Matters

Newborns have been a gap in the HIV arsenal. Tivicay and Tivicay PD were previously approved only for adults and children older than four weeks, leaving the first month of life, the window in which blocking the virus from taking hold matters most, without an integrase inhibitor option. Dolutegravir is a second-generation integrase inhibitor and a cornerstone of global HIV therapy, and ViiV’s Cabenuva long-acting regimen already anchors adolescent and adult treatment.

The label expansion is more a public-health milestone than a near-term financial catalyst for GSK. Pediatric HIV in the U.S. is rare, so the commercial read-through is small. But it closes a real treatment gap and stretches dolutegravir’s franchise across every age group, from prevention through long-acting treatment. We’ve followed ViiV’s HIV work in our coverage of Cabenuva’s adolescent superiority data.

What Happens Next

Watch whether ViiV pursues a newborn label for its long-acting cabotegravir injectables and how quickly global HIV treatment guidelines fold dolutegravir into neonatal protocols. The sNDA is now approved; the practical question is how fast neonatal treatment protocols adopt the dosing.