FDA News

FDA warns about rare instances of liver injury, failure with HCV therapies

The FDA has received reports that the use of Mavyret, Zepatier or Vosevi to treat chronic hepatitis C in patients with moderate to severe liver disease has resulted in rare cases of liver injury or liver failure, according to a drug safety communication.

“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,” Debra Birnkrant, MD, from the FDA’s Center for Drug Evaluation and Research, said in a press release. “Approved HCV treatments can save lives and when prescribed as indicated, these medicines continue to be safe and effective.”

In many of the reported cases, liver failure occurred in patients with signs and symptoms of Child-Pugh B or C or other serious liver problems who should not have been treated with Mavyret (glecaprevir/pibrentasvir, AbbVie), Zepatier (elbasvir/grazoprevir, Merck) or Vosevi (sofosbuvir/velpatasvir/voxilaprevir, Gilead Sciences), each of which contain protease inhibitors.

In some cases, patients were reported to have no cirrhosis or Child-Pugh A despite evidence of decreased platelets at baseline or increased portal vein pressure.

Additionally, some cases had other significant pre-existing risk factors such as liver cancer, alcohol misuse or serious medical illnesses correlated with liver complications.

“These factors may have contributed to clinical worsening of liver function or liver failure during treatment with these hepatitis C medicines,” according to the FDA brief. “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.”

Reference: www.fda.gov

The FDA has received reports that the use of Mavyret, Zepatier or Vosevi to treat chronic hepatitis C in patients with moderate to severe liver disease has resulted in rare cases of liver injury or liver failure, according to a drug safety communication.

“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,” Debra Birnkrant, MD, from the FDA’s Center for Drug Evaluation and Research, said in a press release. “Approved HCV treatments can save lives and when prescribed as indicated, these medicines continue to be safe and effective.”

In many of the reported cases, liver failure occurred in patients with signs and symptoms of Child-Pugh B or C or other serious liver problems who should not have been treated with Mavyret (glecaprevir/pibrentasvir, AbbVie), Zepatier (elbasvir/grazoprevir, Merck) or Vosevi (sofosbuvir/velpatasvir/voxilaprevir, Gilead Sciences), each of which contain protease inhibitors.

In some cases, patients were reported to have no cirrhosis or Child-Pugh A despite evidence of decreased platelets at baseline or increased portal vein pressure.

Additionally, some cases had other significant pre-existing risk factors such as liver cancer, alcohol misuse or serious medical illnesses correlated with liver complications.

“These factors may have contributed to clinical worsening of liver function or liver failure during treatment with these hepatitis C medicines,” according to the FDA brief. “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.”

Reference: www.fda.gov