Hepatitis C Drug Safety Communication

FDA warns patients and health care professionals about rare instances of serious liver injury or failure with certain hepatitis C treatments in some patients with advanced liver disease

The U.S. Food and Drug Administration has received reports that the use of Mavyret, Zepatier, or Vosevi to treat chronic hepatitis C (HCV) in patients with moderate to severe liver impairment has resulted in rare cases of worsening liver function or liver failure. These medicines are not indicated for use in patients with moderate to severe liver impairment, but are safe and effective in patients with no or mild liver impairment. Through reports submitted to the FDA as well as other sources, the agency identified 63 cases of worsening liver function, called decompensation, some leading to liver failure or death, in patients using Mavyret, Zepatier and Vosevi. In many of the reported cases, liver failure occurred in patients who had signs and symptoms of moderate-to-severe liver disease or other serious liver problems and should not have been treated with these medicines. In some cases, patients were reported as having no cirrhosis, or liver scarring, or cirrhosis with mild liver impairment (compensated cirrhosis) but had indications of advanced liver disease or risk factors for liver impairment, such as decreased platelets, portal hypertension (increased pressure in the portal vein, the vein that carries blood from the digestive organs to the liver) caused by a blockage in the blood flow through the liver, alcohol abuse or other serious medical illnesses associated with significant liver problems before starting treatment. In most patients, symptoms resolved or new onset worsening liver function improved after stopping the medicine. As noted in the Drug Safety Communication issued today, health care professionals should continue to prescribe Mavyret, Zepatier or Vosevi as indicated, but should discontinue the use of these medicines in patients with signs and symptoms of worsening liver function. Patients should understand that the risk of serious liver injury is rare and should not stop taking these medicines without first talking to a health care professional. Patients should read the patient information leaflet every time they are prescribed Mavyret, Zepatier or Vosevi because there may be important new information about these medicines. Patients with liver disease should talk with a health care professional about the benefits and risks of these medicines. The FDA will continue to monitor this safety concern and will communicate any new information to the public as it becomes available. Link to FDA In Brief: https://www.fda.gov/news-events/fda-brief/fda-brief-fda-warns-patients-and-health-care-professionals-about-rare-instances-serious-liver-injury Link to Drug Safety Communication https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-about-rare-occurrence-serious-liver-injury-use-hepatitis-c-medicines-mavyret-zepatier-and

Kimberly Struble Division of Antiviral Products Food and Drug Administration Elizabeth Thompson Division of Antiviral Products Food and Drug Administration Michael Stanfield Jr. Division of Antiviral Products Food and Drug Administration