FDA Approves ViiV’s Tivicay PD for Newborn HIV Patients

The US Food and Drug Administration (FDA) has approved ViiV Healthcare’s Tivicay PD (dolutegravir) for use with other antiretroviral agents in paediatric HIV-1 patients weighing at least 2 kg. Announced on 3 September 2026 following Priority Review, the decision makes Tivicay PD the first second-generation integrase inhibitor authorised for eligible newborns, substantially expanding US paediatric HIV treatment options from birth in a category with historically limited neonatal-specific therapies.

Without early diagnosis and treatment, HIV can progress rapidly in infants, with approximately 50% of untreated infants dying by age two. Approval was supported by data from the NIH-funded IMPAACT 2023 study and pharmacokinetic modelling, which demonstrated that dolutegravir reached therapeutic levels in term neonates with a safety profile consistent with older paediatric and adult populations. Diana F Clarke, Assistant Professor of Paediatrics at Boston University School of Medicine and Lead Investigator of the IMPAACT 2023 study, positioned the approval as an important advance for newborn HIV care, noting that term babies weighing at least 2 kg now have access to dolutegravir-based therapy starting at birth.

Jean van Wyk, Chief Medical Officer at ViiV Healthcare, framed the approval as expanding paediatric HIV care options from the very beginning of life and reinforcing the company’s commitment to bringing INSTI-based innovation to children. ViiV Healthcare is the specialist HIV joint venture majority-owned by GSK, with Pfizer and Shionogi as shareholders. The approval extends ViiV’s dolutegravir franchise, one of the most widely prescribed antiretroviral backbones globally, and intensifies competitive pressure across paediatric HIV markets.

The commercial signal is a maturing paediatric HIV market where second-generation integrase inhibitor coverage expansion into neonatal populations creates substantial commercial differentiation. ViiV’s dolutegravir franchise strengthens its competitive position across paediatric HIV. Expect Gilead Sciences (Biktarvy, Descovy), Merck & Co (Isentress), Janssen and other HIV specialists to sharpen their paediatric positioning as the neonatal treatment window continues to open through 2027.

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