Safety Warning Issued for Hepatitis C Drugs

August 28, 2019

Rare instances of worsening liver function reported to FDA.

Mavyret, Zepatier, or Vosevi have resulted in rare instances of worsening liver function or liver failure when used to treat Hepatitis C in patients with moderate to severe liver impairment, as indicated in reports issued to the FDA.

According to the FDA, each of the drugs contains a protease inhibitor and are not indicated for the use in patients with moderate to severe liver impairment. After medication was stopped in patients experiencing worsening liver functions, symptoms resolved or the new onset worsening improved. 

Mavyret, Zepatier, and Vosevi are FDA-approved to treat chronic hepatitis C in patients without liver impairment and have been shown to be well tolerated and highly effective in patients with compensated cirrhosis or mild liver impairment (Child-Pugh A). 

The FDA says healthcare providers should still continue to prescribe Mavyret, Zepatier, and/or Vosevi as indicated in each drug’s prescribing information. Patients should be monitored for signs and symptoms of worsening liver function such as increases in liver enzymes, jaundice, ascites, encephalopathy, and variceal hemorrhage. Treatments should be discontinued if liver decompensation presents or as clinically indicated.

 

Mavyret Prescribing Information

Zepatier Prescribing Information

Vosevi Prescribing Information