FDA Expands Hepatitis C Drug Indication

The US Food and Drug Administration have approved a supplemental application for Epclusa (sofosbuvir and velpatasvir) for the treatment of hepatitis C virus (HCV) in children aged 6 years and older or weighing at least 37 pounds with any of the 6 genotypes of HCV but without cirrhosis.

For pediatric patients with HCV infection and severe cirrhosis, Epclusa is indicated for use in combination with ribavirin.

The safety and efficacy of Epclusa for treatment of genotypes 1, 2, 3, 4, or 6 infection was evaluated in an open-label, multicenter trial including 173 pediatric patients aged 6 years and older without or with only mild cirrhosis. Overall, the safety and efficacy were comparable to those observed in adults, for whom Epclusa was previously approved.

Safety and efficacy for treatment of genotype 5 infection are supported by data on sofosbuvir and velpatasvir use in adults and pediatric patients with HCV genotype 1, 2, 3, 4 or 6 infection.

The most commonly reported adverse effects were fatigue and headache, which were consistent with those observed in adults.

A boxed warning that hepatitis B virus reactivation has been reported in patients infected with both hepatitis C and hepatitis B virus who were taking or had completed treatment with HCV antivirals but were not taking antivirals for hepatitis B is included with Epclusa.

—Michael Potts

Reference:
FDA approves new treatment for pediatric patients with any strain of hepatitis c. News release. FDA; March 19, 2020. Accessed March 20, 2020. https://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-pediatric-patients-any-strain-hepatitis-c.