Hepatitis C medicines have led to liver decompensation in some patients

The FDA has identified 63 cases of liver decompensation with medications to treat hepatitis C, most of which occurred in patients with moderate to severe liver impairment who should not have been prescribed the drugs.


The FDA announced on Aug. 28 that it has received reports of rare cases of worsening liver function or liver failure with the use of medications to treat chronic hepatitis C in patients with moderate to severe liver impairment.

The agency has identified 63 cases of liver decompensation with the use of glecaprevir/pibrentasvir (Mavyret), elbasvir/grazoprevir (Zepatier), or sofosbuvir/velpatasvir (Vosevi) to treat hepatitis C, most of which occurred in patients with moderate to severe liver impairment who should not have been prescribed these medicines. Some of the cases led to liver failure and death.

The medications are FDA-approved to treat chronic hepatitis C in patients without liver impairment or with mild liver impairment (Child-Pugh A). The FDA recommended that clinicians continue to prescribe the drugs as indicated, assess severity of liver disease at baseline, closely monitor for signs and symptoms of worsening liver function, and discontinue them in patients with signs and symptoms of liver decompensation or as clinically indicated.