FDA Reports Rare Cases of Liver Injury, Failure With Hep C Therapies

The U.S. Food and Drug Administration has received reports of rare cases of worsening liver function or liver failure in patients with chronic hepatitis C virus (HCV) who had moderate-to-severe liver impairment and were treated with Mavyret, Zepatier, or Vosevi, despite these drugs being contraindicated in this group of patients, the agency reported yesterday.

Mavyret, Zepatier, and Vosevi have demonstrated safety and effectiveness in patients with no or mild liver impairment but are not indicated for use in patients with moderate-to-severe impairment. In a Drug Safety Communication issued yesterday, the FDA advised health care professionals to prescribe Mavyret, Zepatier, and Vosevi as indicated but to stop treatment with these medications in patients with signs and symptoms of worsening liver function.

The FDA is aware of 63 cases of liver decompensation in 46, 14, and three patients taking Mavyret, Zepatier, and Vosevi, respectively. Some of these cases led to liver failure or death, and in many of the cases, patients had signs and symptoms of moderate-to-severe liver disease or other serious liver problems. In more than 50 percent of cases, patients were incorrectly classified as having no cirrhosis or compensated cirrhosis at baseline and had indications of advanced liver disease or risk factors for liver impairment including decreased platelets, portal hypertension, alcohol abuse, and other serious medical illnesses related to liver problems. The most frequently reported liver-related events included hyperbilirubinemia, jaundice, ascites, and hepatic encephalopathy. In 39 of the 63 cases, after stopping treatment with Mavyret, Zepatier, or Vosevi, patients' symptoms resolved or new-onset worsening liver function improved.

"It's important for patients and health care professionals to recognize these drugs are not indicated for use in patients with moderate-to-severe liver impairment and that there are other effective FDA-approved treatment options available for those patients with those conditions," Debra Birnkrant, M.D., director of the Division of Antiviral Products in the FDA Center for Drug Evaluation and Research, said in a statement. "Approved HCV treatments can save lives and when prescribed as indicated, these medicines continue to be safe and effective."

The FDA is monitoring the safety concern and will communicate new information as it becomes available.

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