The U.S. Food and Drug Administration is warning that some drugs that treat hepatitis C can, in rare cases, actually lead to the worsening of liver function or to live failure in patients with chronic hepatitis C.
The U.S. Food and Drug Administration (FDA) is warning that some drugs that treat hepatitis C can, in rare cases, actually lead to the worsening of liver function or to live failure in patients with chronic hepatitis C.
The branded drugs identified by the FDA are Mavyret, Zepatier and Vosevi. Last year, an estimated 72,000 prescriptions were written for the three drugs, the FDA said. Each of these drugs contains a hepatitis C virus protease inhibitor and are not indicated for use in patients with moderate to severe liver impairment, the FDA said. For the patients who had the reaction, the FDA said that the symptoms typically resolved and worsening liver function improved when the drugs were removed from use. All three drugs have a strong safety profile in patients with no or mild liver impairment.
In its announcement, the FDA said it had identified 63 cases in which one of the three drugs was involved in cases of worsening liver function called liver decompensation. In some of those 63 cases, the FDA said patients died after liver failure. The FDA did not provide an exact number of those patients who had died in its announcement.
Hepatitis causes inflammation of the liver. The most common hepatitis viruses are A, B and C. They have similar symptoms but are spread in different ways and can affect the liver differently. According to the U.S. Centers for Disease Control and Prevention, about 75% to 85% of patients infected with the hepatitis C virus (HCV) will develop a chronic infection.
AbbVie’s Mayvret was first approved for the treatment of all six strains of hepatitis C in adults in 2017. In May, the FDA expanded Mayvret’s indication for the treatment of children ages 12 to 17 with the disease.
Merck’s Zepatier was approved in 2016 for the treatment of chronic hepatitis C virus genotypes 1 and 4 infections in adult patients. Zepatier has not been a strong moneymaker for the company. Two years ago, Merck slashed the price of the HCV drug by 60%.
Gilead Sciences’ Vosevi was approved in 2017 to bolster its already impressive hepatitis pipeline that includes Harvoni and Sovaldi. When Vosevi was approved, the FDA included a black-box warning regarding the risk of hepatitis B virus (HBV) reactivation in HCV/HBV co-infected patients.
For this latest warning involving the three drugs, the FDA said liver failure occurred in patients who had signs and symptoms of moderate to severe liver impairment (Child-Pugh B or C) or other serious liver problems. With those signs and symptoms, the FDA said those patients should not have been treated with either of the three named medications. In most cases, liver failure or decompensation typically occurred within the first 4 weeks of starting treatment, the FDA said.
The regulatory agency said it will continue to monitor the safety concern and will issue any additional statements should it be necessary.
“When prescribed as indicated, these medicines continue to be safe and 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,” the FDA said in a statement.
