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FDA warns of rare cases of serious liver injury with newer hepatitis C drugs

Keith Alcorn
29 August 2019

The US Food and Drug Administration (FDA) has issued a warning about the risk of serious liver injury in people with hepatitis C after starting recently approved direct-acting antiviral regimens that contain a hepatitis C virus protease inhibitor. The drug regimens are Zepatier (grazoprevir/elbasvir), Mavyret (glecaprevir/pibrentasvir) and Vosevi (sofosbuvir, velpatasvir and voxilaprevir).

FDA has received 63 reports of cases in which people with hepatitis C suffered worsening liver function or liver failure.

In many of the reported cases, liver failure occurred in people 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.


compensated cirrhosis

The earlier stage of cirrhosis, during which the liver is damaged but still able to perform most of its functions. See also ‘cirrhosis’ and ‘decompensated cirrhosis’.

In some cases, people 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.

FDA says that doctors can continue prescribing the drugs to people with mild cirrhosis (Child-Pugh A) but should monitor patients closely, especially if they are abusing alcohol or have liver cancer (hepatocellular carcinoma).

The agency emphasises that these medicines have been widely used and are safe and effective in people with no or mild liver impairment.

To put the number of cases of liver injury in context, FDA reports that 83,000 people in the United States underwent treatment for hepatitis C with one of the medications in 2018.