Rare Occurrence of Serious Liver Injury with 3 Hepatitis C Drugs, FDA Warns
The US Food and Drug Administration (FDA) on Wednesday warned that it has received reports that the use of AbbVie’s Mavyret (glecaprevir/pibrentasvir), Merck’s Zepatier (elbasvir/grazoprevir) or Gilead’s Vosevi (sofosbuvir/velpatasvir/voxilaprevir) 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.In 2018, an estimated 72,000 patients received prescriptions for the three hepatitis C drugs. FDA said that it found 63 cases of worsening liver function in its adverse event reporting system (46 for Mavyret, 14 for Zepatier and three for Vosevi) and that some of the cases led to liver failure and eight cases reported deaths.
“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,” the agency said.
FDA called on health professionals to continue to prescribe the three drugs as indicated and to assess “the severity of liver disease at baseline and closely monitor for signs and symptoms of worsening liver function such as increases in liver enzymes, jaundice, ascites, encephalopathy, and variceal hemorrhage.”
For patients, FDA said they should not stop taking the medicines but to contact health professionals “right away if you develop fatigue, weakness, loss of appetite, nausea and vomiting, yellow eyes or skin, or light-colored stools as these may be signs of liver injury.”
FDA Drug Safety Communication