FDA Warns of Rare Occurrence of Serious Liver Damage Due to Hepatitis C Drugs

August 29, 2019
Kenny Walter

Kenny Walter is an editor with HCPLive. Prior to joining MJH Life Sciences in 2019, he worked as a digital reporter covering nanotechnology, life sciences, material science and more with R&D Magazine. He graduated with a degree in journalism from Temple University in 2008 and began his career as a local reporter for a chain of weekly newspapers based on the Jersey shore. When not working, he enjoys going to the beach and enjoying the shore in the summer and watching North Carolina Tar Heel basketball in the winter.

The FDA warns of liver failure in rare cases from taking Mavyret, Zepatier, and Vosevi to treat hepatitis C.

A trio of common hepatitis C virus (HCV) medications—Mavyret, Zepatier, and Vosevi—could cause worsening liver function or liver failure in rare cases.

The US Food and Drug Administration (FDA) has received 63 reports regarding the 3 drugs, which contain a HCV protease inhibitor, and warned that the drugs are not indicated for use in patients with moderate to severe liver impairment.

“In most patients, symptoms resolved or new onset worsening of liver function improved after stopping the medicine,” the FDA said in a statement. “These medicines have been widely used and are safe and effective in patients with no or mild liver impairment.”

In several reported cases, liver failure occurred in patients who had signs and symptoms of moderate to severe liver impairment—Child-Pugh B or C—as well as some other serious liver problems.

Some cases also involved patients who have no cirrhosis or compensated cirrhosis with mild liver impairment—Child-Pugh A—despite having evidence of decreased platelets at baseline or an increase in the pressure within the portal vein that carries blood from digestive organs to the liver.

Additional cases involved patients with significant pre-existing risk factors, including liver cancer, alcohol abuse, or serious medical illnesses associated with serious liver problems.

These factors may have contributed to clinical worsening of liver function or liver failure during treatment with the 3 hepatitis C medications, where most of the liver failure or decompensation cases occurred within the first 4 weeks of starting treatment.

Mavyret, Zepatier, and Vosevi are FDA-approved to treat chronic hepatitis C in patients without liver impairment or with mild liver impairment, reducing the amount of HCV in the body by preventing it from multiplying, over time leading to clearing the virus from the body.


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