Officials with ViiV Healthcare have announced that the US Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for dolutegravir 10 mg and 25 mg oral tablets, reducing the weight limit from at least 40 kg to at least 30 kg, in ages 6 to less than 12 years old, for the treatment of HIV-1 in children and adolescents.
This approval is based on 24-week data from the phase 1 and phase 2 multicenter, 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 optimized background regimen (OBR) in children and adolescents infected with HIV-1 in age defined cohorts.1
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 30 kg. 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 diarrhea (n=2).1 There were no Grade 3 or 4 drug-related AEs reported, and no AEs led to discontinuation.1
1. Tivicay® (dolutegravir) US prescribing information. Available at: https://www.gsksource.com/pharma/content/dam/GlaxoSmithKline/US/en/Prescribing_Information/Tivicay/pdf/TIVICAY-PI-PIL.PDF. Accessed June 2016.