A phase 2, open-label clinical trial of Epclusa for the treatment of chronic hepatitis C virus (HCV) in children
Latest Information Update: 17 Jun 2021
At a glance
- Drugs Sofosbuvir/velpatasvir (Primary)
- Indications Hepatitis C
- Focus Registrational; Therapeutic Use
- Sponsors Gilead Sciences
- 17 Jun 2021 New trial record
- 10 Jun 2021 According to a Gilead Sciences media release, The FDA approved a New Drug Application (NDA) for two strengths of an oral pellet formulation of Epclusa (sofosbuvir 200 mg/velpatasvir 50 mg and sofosbuvir 150 mg/velpatasvir 37.5 mg) developed for use by younger children who cannot swallow tablets. The recommended dosage of Epclusa in children ages 3 years and older is based on weight.
- 10 Jun 2021 According to a Gilead Sciences media release, based on the data from this trial, the U.S. FDA has approved an expansion of the pediatric indication of Epclusa for the treatment of chronic hepatitis C virus to now include children as young as 3 years of age, regardless of HCV genotype or liver disease severity.