According to the FDA Drug Safety Communications, the agency has received reports stating that Mavyret, Zepatier or Vosevi, the drugs used for the treatment of chronic hepatitis C in those who have moderate to severe liver disease, have resulted in rare cases of liver failure or liver injury.
The FDA has warned about a rare liver injury in patients with hepatitis C virus (HCV) infection receiving drugs such as Mavyret (glecaprevir/pibrentasvir), Zepatier (elbasvir/grazoprevir) or Vosevi (sofosbuvir/velpatasvir/voxilaprevir).
Dr. Debra Birnkrant from the FDA’s Center for Drug Evaluation and Research said, “While FDA-approved treatments for HCV, including Mavyret, Zepatier and Vosevi, have been widely used for many years and are safe and effective, [it’s] important for patients and health care professionals to recognize these drugs are not indicated for use in patients with moderate-to-severe liver impairment and that there are other effective FDA-approved treatment options available for those patients with those conditions. Approved HCV treatments can save lives and when prescribed as indicated, these medicines continue to be safe and effective.”
According to the agency, there were 63 cases of worsening liver function, some resulting in liver failure and death.
In most of the reported cases, patients had a liver impairment or other serious liver problems who should not take Mavyret, Zepatier, or Vosevi. These medications contain a protease inhibitor and are not advised to patients who have moderate-to-severe liver impairment.
In some of the reported cases, patients had no cirrhosis or liver disease in spite of evidence of reduced platelets at baseline. And in some cases, patients had a history of alcohol misuse, liver cancer, or serious medical conditions associated with liver complications.
The FDA said, “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,” the agency added. Having said that, the FDA recommends that medical providers can continue prescribing these HCV medications as indicated and should assess patients’ severity of liver disease at baseline and closely monitor for any signs or symptoms of worsening liver function.