(RTTNews) - ViiV Healthcare, a specialist HIV company majority-owned by GSK plc., (GSK), announced that the U.S. FDA has approved Tivicay PD for use in combination with other antiretroviral agents in pediatric patients weighing at least 2 kg, including eligible newborns.
Tivicay PD (dolutegravir, DTG) is the first second-generation integrase inhibitor approved for this age group, addressing critical treatment gap for infants living with HIV. Without early intervention, HIV can progress rapidly in newborns, with nearly half of untreated infants dying by age two. The approval provides families and clinicians with a modern, age-appropriate option from birth, marking a significant advance in pediatric HIV care.
The FDA decision was supported by data from the NIH-funded IMPAACT 2023 study, which demonstrated that dolutegravir achieved therapeutic drug levels in term neonates with a safety profile consistent with older children and adults. Tivicay PD's higher barrier to resistance compared to earlier generations further strengthen'/s its role in long-term HIV management.
Tivicay itself was first approved by the FDA in August 2013 as a tablet formulation for use in combination with other antiretroviral agents to treat HIV-1 infection in adults and adolescents. This latest pediatric approval extends its reach to the youngest patients, reinforcing its role across the full HIV treatment journey.
ViiV Healthcare emphasized that this milestone reflects its commitment to closing persistent gaps in HIV treatment and ensuring children are not left behind in the fight against the epidemic. The company continues to expand its pediatric portfolio, aiming to deliver effective therapies across the full treatment journey.
GSK has traded between $38.63 and $61.70 over the past year. The stock closed Wednesday's trading at $51.43, down 1.23%. In pre-market trading the stock is at $51.28, up 0.30%.