Sofosbuvir-velpatasvir (Epclusa), a direct-acting antiviral combination drug previously approved by the Food and Drug Administration to treat hepatitis C virus (HCV) in adults, is now approved to treat HCV in children six years of age or older or weighing at least 37 lbs (17 kg) who do not have cirrhosis. It can be used in patients with any of the six strains of the virus. For children with HCV and severe cirrhosis, Epclusa can be given in combination with ribavirin.

The safety, efficacy, and pharmacokinetics of Epclusa were studied in clinical trials of children with HCV and were found to be comparable to those observed in clinical trials of adults. The drug's labeling includes a boxed warning that hepatitis B virus (HBV) reactivation can occur in individuals taking or completing treatment with HCV antivirals. Nurses and NPs should confirm that patients have been tested for evidence of current or prior coinfection with HBV by measuring hepatitis B surface antigen and hepatitis B core antibody before starting Epclusa treatment. Nurses and NPs should monitor patients with serologic evidence of HBV infection while receiving Epclusa for clinical and laboratory signs of hepatitis flare. Reactivation can include fulminant hepatitis and in severe cases lead to increases in bilirubin, liver failure, or death.

For complete prescribing information for Epclusa, see http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208341s014lbl.pdf.