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  1. FDA Drug Safety Podcasts

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

FDA Drug Safety Podcast

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Welcome to the FDA Drug Safety Podcast for health care professionals from the Division of Drug Information. This is Lesley Navin Advanced Practice Nurse.

On August 28, 2019, FDA announced we have received reports that the use of Mavyret, Zepatier, or Vosevi to treat chronic hepatitis C in patients with moderate to severe liver impairment has resulted in rare cases of worsening liver function or liver failure. All these medicines contain a hepatitis C virus (HCV) protease inhibitor and 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. These medicines have been widely used and are safe and effective in patients with no or mild 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. In most cases, liver failure or decompensation typically occurred within the first 4 weeks of starting treatment. Mavyret, Zepatier, and Vosevi are FDA-approved to treat chronic hepatitis C in patients with or without mild liver impairment (Child-Pugh A). Clinical trials in these patients have shown that these medicines are well tolerated and highly effective and reduce the amount of HCV in the body by preventing it from multiplying, which over time leads to clearing the virus from the body, or cure, preventing or limiting liver damage from HCV.

Health care professionals should continue to prescribe Mavyret, Zepatier, or Vosevi as indicated in the prescribing information. Assess liver disease severity at baseline and closely monitor for signs and symptoms of worsening liver function. Discontinue these medicines in patients who develop signs and symptoms of liver decompensation or as clinically indicated.

We identified 63 cases of liver decompensation with Mavyret, Zepatier, and Vosevi to treat hepatitis C. Some of these cases led to liver failure and death. Most of these patients had moderate to severe liver impairment and should not have been prescribed these medicines.

Side effects involving Mavyret, Zepatier or Vosevi, should be reported to the FDA MedWatch program at www.fda.gov/medwatch.

A link to the full communication detailing specific information for health care professionals and the complete Data Summary can be found at www.fda.gov/DrugSafetyCommunications. If you have drug questions, you can reach us at druginfo@fda.hhs.gov.

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