Posted by Michael Wonder on 19 Mar 2020
FDA approves new treatment for paediatric patients with any strain of hepatitis C
19 March 2020 - The U.S. Food and Drug Administration today approved a supplemental application for Epclusa (sofosbuvir and velpatasvir) to treat hepatitis C virus in children ages 6 years and older or weighing at least 37 pounds (17 kilograms) with any of the six HCV genotypes—or strains—without cirrhosis (liver disease) or with mild cirrhosis.
Epclusa in combination with ribavirin is indicated for the treatment of paediatric patients 6 years and older or weighing at least 37 pounds with severe cirrhosis. The FDA previously approved Epclusa to treat hepatitis C virus (HCV) in adults.
The safety and efficacy of Epclusa for treatment of HCV genotype 5 in pediatric patients 6 years and older or weighing at least 37 pounds without cirrhosis or with mild cirrhosis are supported by sofosbuvir and velpatasvir exposures in adults and paediatric patients with HCV genotype 1, 2, 3, 4 or 6 infection.
