August 28, 2019
“Hepatitis C virus remains a significant public health issue, but effective therapeutic options have helped patients to receive important curative treatments,” said Debra Birnkrant, M.D., director of the Division of Antiviral Products within the FDA’s Center for Drug Evaluation and Research. “Chronic hepatitis C, or HCV, is a viral disease that causes inflammation of the liver that can lead to serious liver problems if left untreated. Hepatitis C medicines reduce the amount of HCV in the body by preventing it from multiplying and eventually curing a patient of HCV, which can prevent or slow down the progression of liver disease. While FDA-approved treatments for HCV, including Mavyret, Zepatier and Vosevi, have been widely used for many years and are safe and effective, the FDA has received reports of rare but serious instances of worsening liver function or failure when these treatments were used in patients with signs and symptoms of moderate-to-severe liver impairment or other serious liver problems. 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.”
The U.S. Food and Drug Administration has received reports that the use of Mavyret, Zepatier, or Vosevi to treat chronic hepatitis C (HCV) in patients with moderate to severe liver impairment has resulted in rare cases of worsening liver function or liver failure. These medicines are not indicated for use in patients with moderate to severe liver impairment, but are safe and effective in patients with no or mild liver impairment.
Through reports submitted to the FDA as well as other sources, the agency identified 63 cases of worsening liver function, called decompensation, 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. 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 (increased pressure in the portal vein, the vein that carries blood from the digestive organs to the liver) 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.
As noted in the Drug Safety Communication issued today, health care 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. Patients should read the patient information leaflet every time they are prescribed Mavyret, Zepatier or Vosevi because there may be important new information about these medicines. Patients with liver disease should talk with a health care professional about the benefits and risks of these medicines.
The FDA will continue to monitor this safety concern and will communicate any new information to the public as it becomes available.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.