FDA approves sNDA for Tivicay (dolutegravir), changing weight limit in HIV treatment- Viiv Healthcare

The FDA has approved a supplemental New Drug Application (sNDA) for Tivicay (dolutegravir) 10mg and 25mg oral tablets, from Viiv Healthcare, reducing the weight limit from at least 40kg to at least 30kg, in ages 6 to less than 12 years old, for the treatment of HIV-1 in children and adolescents. Dolutegravir, in line with the current label, will be available for use in two paediatric populations: paediatric patients weighing at least 30kg living with HIV-1 who are treatment na�ve (not previously treated) and who are treatment experienced (previously treated), as long as they have not taken an integrase inhibitor.

This approval is based on 24-week data from the Phase I/II multi-centre, open-label P1093 study conducted in collaboration with the International Maternal Pediatric Adolescent AIDS Clinical Trial (IMPAACT) Network. IMPAACT P1093 is an ongoing pharmacokinetic (PK), safety and efficacy study of dolutegravir plus optimised background regimen (OBR) in children and adolescents infected with HIV-1 in age defined cohorts. Results from the study show that treatment with dolutegravir plus OBR was generally well tolerated and provided efficacy through to week 24 in HIV-1 infected children and adolescents from 6 to 12 years of age weighing at least 30kg. The adverse event (AE) profile in the study was similar to that for adults. Grade 2 AEs reported by more than one patient were decreased neutrophil count (n = 3) and diarrhoea (n = 2). There were no Grade 3 or 4 drug-related AEs reported, and no AEs led to discontinuation.