Gilead’s Epclusa Approved for Hepatitis C in Children

The FDA approved Gilead’s Epclusa (sofosbuvir/velpatasvir) for treatment of hepatitis C virus (HCV) in children ages six years and older or weighing at least 37 pounds.

The agency is requiring a boxed warning stating that hepatitis B virus (HBV) reactivation has been reported in patients infected with both HCV and HBV who were taking or had completed treatment with HCV antivirals.

The drug is currently indicated in combination with ribavirin to treat pediatric patients six years and older or weighing at least 37 pounds with severe cirrhosis.