FDA approves treatment for pediatric patients with any strain of hepatitis C

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FDA approves treatment for pediatric patients with any strain of hepatitis C

The U.S. Food and Drug Administration today approved a supplemental application for Epclusa (sofosbuvir and velpatasvir) to treat hepatitis C virus (HCV) 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 pediatric patients 6 years and older or weighing at least 37 pounds with severe cirrhosis. The FDA previously approved Epclusa to treat HCV in adults. The most common adverse reactions observed with treatment with Epclusa were fatigue and headache. The adverse reactions observed were consistent with those observed in clinical trials of Epclusa in adults. Epclusa includes a boxed warning 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 and were not taking HBV antivirals. HBV reactivation has resulted in hepatitis that occurs suddenly and escalates quickly (fulminant), kidney failure and death. Health care providers should test all patients for evidence of current or prior HBV infection before initiation of Epclusa and continue to monitor patients throughout the treatment.

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