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FDA Issues Warning for 3 Hepatitis C Virus Medications

September 03, 2019

The US Food and Drug Administration (FDA) has issued a drug safety warning about the use of 3 medications for hepatitis C virus (HCV) among individuals with moderate to severe liver impairment.

The warning comes after 63 individuals who received treatment for chronic HCV with glecaprevir/pibrentasvir (Mavyret), elbasvir/grazoprevir (Zepatier), or sofosbuvir/velpatasvir/voxilaprevir (Vosevi) experienced worsened liver function or liver failure.

It is recommended that the medications be used for the treatment of HCV only among individuals with mild or no liver impairment.

“In many of the reported cases, liver failure occurred in patients who had signs and symptoms of moderate to severe liver impairment (Child-Pugh B or C) or other serious liver problems and should not have been treated with these medicines,” according to the FDA press release.

Although liver failure or decompensation was a rare occurrence, most of the cases developed within the first 4 weeks of the start of treatment.

“Assess severity of liver disease at baseline and closely monitor for signs and symptoms of worsening liver function such as increases in liver enzymes, jaundice, ascites, encephalopathy, and variceal hemorrhage,” FDA officials wrote in the press release. “Discontinue these medicines in patients who develop signs and symptoms of liver decompensation or as clinically indicated.”

—Colleen Murphy


FDA warns about rare occurrence of serious liver injury with use of hepatitis C medicines Mavyret, Zepatier, and Vosevi in some patients with advanced liver disease [press release]. Silver Spring, MD: US Food and Drug Administration; August 28, 2019. Accessed August 29, 2019. 

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