FDA Issues Safety Communication Regarding Use of Hepatitis C Drugs
August 28, 2019 – The U.S. FDA has received reports of rare worsening liver function or liver failure in patients with moderate to severe liver impairment who have received the following treatments for chronic hepatitis C virus (HCV):
- Mavyret™ (glecaprevir/pibrentasvir – AbbVie)
- Zepatier (elbasvir/grazoprevir – Merck)
- Vosevi® (sofosbuvir/velpatasvir/voxilaprevir – Gilead)
These medications are not indicated for use in patients who have moderate to severe liver impairment, and the FDA stresses that they are safe and effective in patients with no or mild liver impairment. In most of the reported instances of liver injury, the patient’s symptoms resolved or the new onset of worsening of liver function improved after stopping the medication.
Patients who experienced worsening liver function or liver failure typically had significant pre-existing risk factors. These factors included:
- Signs and symptoms of moderate to severe liver impairment;
- Evidence of decreased platelets at baseline or an increase in the pressure within the portal vein that carries blood from the digestive organs to the liver;
- Liver cancer;
- Alcohol abuse; and
- Serious medical illnesses associated with serious liver problems.
The FDA believes these factors may have contributed to clinical worsening of liver function or liver failure during treatment. In most cases, worsening liver function or liver failure occurred within the first four weeks of starting treatment.
When used as indicated, Mavyret, Zepatier, and Vosevi are well tolerated and highly effective. They cure HCV infection by preventing virus replication. Without treatment, HCV patients are at risk of serious and potentially fatal liver disease. They may also spread the infection to others.
The FDA advises healthcare professionals to continue to prescribe Mavyret, Zepatier, and Vosevi as indicated according to the prescribing information. They should assess the severity of liver disease before starting patients on treatment, and closely monitor patients for signs and symptoms of worsening liver function. This is particularly important in patients who have pre-existing significant liver problems or risk factors. The medication should be discontinued if the patient develops signs and symptoms of liver decompensation.
Patients should speak to their healthcare provider about pre-existing risk factors, and contact their healthcare provider immediately if they experience signs or symptoms of liver injury. Patients should also understand that liver injury due to these medications is rare. Treatment with Mavyret, Zepatier, or Vosevi should not be discontinued without first consulting a healthcare provider.
To see the full safety communication, please visit the FDA’s website.