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June 15, 2021Epclusa and Mavyret Granted Expanded Hepatitis C Indications
June 14, 2021 – The U.S. FDA has approved expanded indications for Epclusa® (sofosbuvir/velpatasvir – Gilead) and Mavyret® (glecaprevir/pibrentasvir – AbbVie) to include patients as young as three years old who have chronic hepatitis C virus (HCV) infection. Previously, Epclusa was approved for use in patients ages six years and up or who weighed at least 17kg (37.5 pounds), while Mavyret was approved for patients at least 12 years of age or who weighed at least 45kg (99 pounds). Patients must meet the following criteria under current FDA approval for each drug:
Epclusa: HCV genotype 1, 2, 3, 4, 5, or 6 without cirrhosis or with compensated cirrhosis, or (when Epclusa is used with ribavirin) with decompensated cirrhosis.
Mavyret: HCV genotype 1, 2, 3, 4, 5, or 6 without cirrhosis or with compensated cirrhosis, as well as HCV genotype 1 previously treated with a regimen containing either an HCV NS5A inhibitor or an NS3/4A protease inhibitor (but not both).
HCV infects the liver and can cause permanent liver damage including cirrhosis (liver scarring). In the United States, young children who have HCV typically contract it at birth. This happens when the virus spreads from mother to infant during delivery. According to the American Liver Foundation, there is a 1 in 20 chance of a child contracting HCV at birth if their mother has been infected with the virus.
In clinical studies, Epclusa delivered an overall cure rate of 83% in patients three to less than six years of age while Mavyret delivered an overall cure rate of 98% or better in patients three to less than 18 years of age.
Recommended dosing for each medication is based on individual patient factors, such as treatment history, age, weight, and HCV genotype. Both medications have a black box warning that hepatitis B virus (HBV) reactivation has been reported in patients coinfected with HBV and HCV who are treated with Epclusa or Mavyret. In some cases, this has led to fulminant hepatitis (rapid, sudden liver failure), hepatic failure, and death.