Viiv's dolutegravir nodded by FDA for HIV treatment in newborns

The US FDA has approved Tivicay PD (dolutegravir) tablets for oral suspension, developed and marketed by ViiV Healthcare, for the treatment of HIV infection in newborns from birth up to four weeks of age weighing at least 2 kg, in combination with other antiretroviral agents. ViiV, a specialist HIV company majority owned by GSK with Shionogi as a shareholder, previously secured FDA approval for Tivicay PD in children aged four weeks and older in 2020. The approval extends the second-generation integrase strand transfer inhibitor (INSTI) into the earliest neonatal window, giving newborns a newer integrase inhibitor option alongside the older INSTI raltegravir.

Tivicay PD was previously approved for patients aged four weeks and older; standard Tivicay tablets have been approved for adults since 2013. The new indication received Priority Review.

The application was supported by data from the IMPAACT 2023 study (NCT05406583), an open-label trial enrolling 48 newborns weighing at least 2 kg who were exposed to HIV-1. Participants received Tivicay PD from birth for up to six weeks alongside standard-of-care antiretrovirals to prevent mother-to-child transmission, with follow-up to 16 weeks. The FDA reported that dolutegravir plasma levels in newborns were similar to those associated with efficacy in adults, and the safety profile was consistent with that observed in older pediatric and adult patients.

Dolutegravir is a second-generation INSTI that blocks HIV-1 integrase strand transfer, preventing viral cDNA from integrating into host chromosomal DNA. The oral suspension formulation allows weight-based dosing in neonates, for whom tablet administration is not feasible. The FDA noted that Tivicay tablets and Tivicay PD tablets for oral suspension are not substitutable on a milligram-per-milligram basis.

The most direct comparator in this specific population is raltegravir (Isentress oral suspension, Merck), which also carries FDA approval for HIV-1 treatment in newborns from birth to four weeks weighing at least 2 kg. Dolutegravir's second-generation INSTI profile confers a higher barrier to resistance than raltegravir — including the head-to-head data supporting dolutegravir-based two-drug regimens in adults. Nevirapine (Viramune, Boehringer Ingelheim), a non-nucleoside reverse transcriptase inhibitor, remains an established backbone agent in neonatal HIV regimens under current clinical guidelines, representing the incumbent comparator from a different mechanistic class.

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