AUDIENCE: Gastroenterology, Infectious Disease, Health Professional, Patient, Pharmacy
ISSUE: FDA has received reports that the use of Mavyret, Zepatier, or Vosevi 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.
FDA identified 63 cases of worsening liver function called liver decompensation with regimens Mavyret, Zepatier, and Vosevi to treat Hepatitis C. Some of these cases led to liver failure and death. Most of these patients had moderate to severe liver impairment and should not have been prescribed these medicines.
BACKGROUND: Mavyret, Zepatier, and Vosevi are FDA-approved to treat chronic hepatitis C in patients without liver impairment or with mild liver impairment (Child-Pugh A). Clinical trials in patients with compensated cirrhosis or mild liver impairment (Child-Pugh A) have shown that these medicines are well tolerated and highly effective. These medicines reduce the amount of HCV in the body by preventing it from multiplying, which over time leads to clearing the virus from the body, or HCV cure, which can prevent or limit liver damage from HCV. HCV is a contagious disease, and without treatment it can lead to serious liver problems, including cirrhosis, liver cancer, and death. When prescribed as indicated, these medicines continue to be safe and effective.
RECOMMENDATION: Health professionals should:
- Continue to prescribe Mavyret, Zepatier, or Vosevi as indicated in the prescribing information for patients without liver impairment or with mild liver impairment (Child-Pugh A).
- Assess 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.
- Discontinue these medicines in patients who develop signs and symptoms of liver decompensation or as clinically indicated. Mavyret and Zepatier should not be prescribed in patients with any history of prior hepatic decompensation.
- Be aware that the risk of serious liver injury is rare.
- Contact a health care professional right away if they 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.
- Do not stop taking these medicines without first talking with your health care professionals because stopping treatment early can lead to inadequate treatment, which could allow your HCV to come back.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[08/28/2019 - Drug Safety Communication - FDA]