FDA is warning that certain chronic hepatitis C medications in patients with moderate to severe liver impairment have caused rare cases of worsening liver function or liver failure.
Glecaprevir and pibrentasvir (Mavyret, AbbVie), elbasvir and grazoprevir (Zepatier, Merck) and sofosbuvir, velpatasvir, and voxilaprevir (Vosevi, Gilead) are safe and effective in patients with no or mild liver impairment, FDA said in a notice on its website.
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However, FDA has received reports of “rare but serious instances of worsening liver function or failure” when the three drugs were used in patients with signs and symptoms of moderate-to-severe liver impairment or other serious liver problems, said Debra Birnkrant, MD, director of the Division of Antiviral Products within the FDA’s Center for Drug Evaluation and Research, in the notice.
“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,” Birnkrant said.
Through reports submitted to the FDA as well as other sources, the agency identified 63 cases of worsening liver function—some leading to liver failure or death—in patients using Mavyret, Zepatier and Vosevi.
“In many of the reported cases, liver failure occurred in patients who had signs and symptoms of moderate-to-severe liver disease or other serious liver problems and should not have been treated with these medicines,” FDA said.
In some cases, patients were reported as having no cirrhosis, or liver scarring, or cirrhosis with mild liver impairment (compensated cirrhosis) but had indications of advanced liver disease or risk factors for liver impairment, such as decreased platelets, portal hypertension caused by a blockage in the blood flow through the liver, alcohol abuse or other serious medical illnesses associated with significant liver problems before starting treatment.
In most patients, symptoms resolved or new onset worsening liver function improved after stopping the medicine, according to FDA.
Healthcare professionals should continue to prescribe Mavyret, Zepatier or Vosevi as indicated, but should discontinue the use of these medicines in patients with signs and symptoms of worsening liver function. “Patients should understand that the risk of serious liver injury is rare and should not stop taking these medicines without first talking to a health care professional,” FDA said.