Federal regulators warn that some hepatitis C drugs, including Mavyret, Zepatier and Vosevi may cause serious liver injury in patients already suffering from advanced liver disease, which has resulted in cases of liver failure and some deaths.
In a drug safety communication issued on August 28, the FDA indicates that side effects of the hepatitis C drugs may be responsible for dozens of identified cases where patients suffered liver decompensation, a form of liver damage.
Mavyret, Zepatier and Vosevi are used to treat chronic hepatitis C for patients without liver impairment, or those with a mild liver impairment condition known as Child-Pugh A.
All three drugs contain a hepatitis C virus (HCV) protease inhibitor, and the FDA found that many cases involved patients who had moderate to severe liver impairment and should not have been given the drugs in the first place. Most patients saw improvement or symptoms resolved after they stopped taking the medication.
In total, the FDA identified 63 cases of liver decompensation, liver failure and death linked to the drugs. That included 46 cases involving side effects of Mavyret, 14 involving side effects of Zepatier, and three involving side effects of Vosevi, which were reported to both the FDA’s Adverse Event Reporting System and in medical literature as of January 8, 2019. Those reports involved eight deaths.
More than half of the cases involved patients who had been misdiagnosed with as having mild or no liver damage, when in fact there was evidence they suffered advanced liver disease or other pre-existing risk factors.
The median onset time of liver damage was 22 days, but ranged from occurring after just two days to waiting as long as 16 weeks.
The FDA advises health care professionals to continue to prescribe the drugs for patients without liver impairment or mild impairment, but to assess the severity of liver disease at baseline and to closely monitor patients for signs of worsening liver function. The agency urges them to use care in assessing baseline liver disease and to discontinue these medicines in patients who develop signs of worsening liver function.
Patients are being advised to contact their healthcare professional if they are taking these drugs and experience:
- Loss of appetite
- Yellow eyes or skin
- Light-colored stools.
They should let their doctor know of any liver impairment or pre-existing risk factors, such as alcohol abuse, and should not stop taking these medications without first consulting a healthcare professional.
The FDA urges healthcare professionals and patients to report side effects involving Mavyret, Zepatier and Vosevi to the FDA MedWatch adverse event reporting system.