ViiV Healthcare has secured US FDA approval for Tivicay PD for use with other antiretroviral agents in paediatric patients living with HIV‑1 who weigh at least 2 kg. The decision makes Tivicay PD the first second‑generation integrase inhibitor authorised for eligible newborns.
Diana F Clarke, Assistant Professor of Paediatrics at Boston University School of Medicine and Lead Investigator of the IMPAACT 2023 study, said: “For too long, newborns living with HIV have had too few treatment options designed and studied to meet their unique needs, despite the importance of starting treatment as early as possible.”
She added: “With the approval of a Tivicay PD dosing regimen, babies born at term and weighing at least 2 kg will now have access to dolutegravir-based therapy starting at birth. This represents an important advance for the care of newborns, as early treatment with the most effective therapies results in the best possible outcomes.”
Without early diagnosis and treatment, HIV can progress rapidly in infants, with around 50% of untreated infants dying by age two. The expanded indication supports broader access to modern, age‑appropriate HIV medicines for this vulnerable group.
Jean van Wyk, Chief Medical Officer at ViiV Healthcare, explained: “Today’s approval of Tivicay PD expands the options available for paediatric HIV care, giving families and clinicians in the US greater choice from the very beginning of life.”
He added: “For ViiV Healthcare, it reflects our commitment to bringing INSTI-based innovation to children and addressing persistent gaps in HIV care. This progress has been made possible through vital collaboration with the HIV community, united by a shared focus on ensuring children living with HIV are not left behind.”
The approval follows Priority Review and is supported by data from the NIH‑funded IMPAACT 2023 study and pharmacokinetic modelling. These showed that dolutegravir reached therapeutic levels in term neonates with a safety profile consistent with older paediatric and adult populations.
