FDA Warns of Rare Occurrence of Serious Liver Damage Due to Hepatitis C Drugs

A trio of common hepatitis C virus (HCV) medications—Mavyret, Zepatier, and Vosevi—could cause worsening liver function or liver failure in rare cases.

The US Food and Drug Administration (FDA) has received 63 reports regarding the 3 drugs, which contain a HCV protease inhibitor, and warned that the drugs 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,” the FDA said in a statement. “These medicines have been widely used and are safe and effective in patients with no or mild liver impairment.”

In several reported cases, liver failure occurred in patients who had signs and symptoms of moderate to severe liver impairment—Child-Pugh B or C—as well as some other serious liver problems.

Some cases also involved patients who 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 digestive organs to the liver.

Additional cases involved patients with significant pre-existing risk factors, including 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 the 3 hepatitis C medications, where most of the liver failure or decompensation cases occurred within the first 4 weeks of starting treatment.

Mavyret, Zepatier, and Vosevi are FDA-approved to treat chronic hepatitis C in patients without liver impairment or with mild liver impairment, reducing the amount of HCV in the body by preventing it from multiplying, over time leading to clearing the virus from the body.