New FDA Drug Safety Communication on rare occurrence of serious liver injury with use of certain hepatitis C medicines in some patients with advanced liver disease - Drug Information Update

FDA warns about rare occurrence of serious liver injury with use of certain hepatitis C medicines in some patients with advanced liver disease

The Food and Drug Administration (FDA) has 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 some cases, patients were reported to 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 the digestive organs to the liver. In addition, some cases had other significant pre-existing risk factors such as 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 these hepatitis C medicines. In most cases, liver failure or decompensation typically occurred within the first 4 weeks of starting treatment. We will continue to monitor this safety concern and will communicate any new information to the public if it becomes available.

Mavyret, Zepatier, and Vosevi are FDA-approved to treat chronic hepatitis C in patients without liver impairment or with mild liver impairment (Child-Pugh A). Clinical trials in patients with compensated cirrhosis or mild liver impairment (Child-Pugh A) have shown that these medicines are well tolerated and highly effective. These medicines 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 HCV cure, which can prevent or limit liver damage from HCV. HCV is a contagious disease, and without treatment it can lead to serious liver problems, including cirrhosis, liver cancer, and death. When prescribed as indicated, these medicines continue to be safe and effective.

For more information, please visit: Drug Safety Communication .