FDA approves Tivicay PD for the youngest patients living with HIV

ViiV Healthcare’s Tivicay PD has received approval from the U.S. Food and Drug Administration (FDA) for use with other antiretroviral medicines in paediatric patients living with HIV-1 who weigh at least 2 kg.

The decision makes Tivicay PD the first second-generation integrase inhibitor approved for eligible newborns.

The treatment enables dolutegravir-based therapy from birth for full-term newborns weighing at least 2 kg.

Study data showed that dolutegravir reached therapeutic levels in newborns, with a safety profile consistent with that observed in older children and adults.

Experts note that without early diagnosis and treatment, HIV can progress rapidly in infants. Around 50% of untreated infants may die by the age of two.

Source: PharmaTimes