(August 28, 2019) The Food and Drug Administration issued an urgent warning about a class of drugs that may cause serious liver injury while treating hepatitis C.
Mavyret (glecaprevir/pibrentasvir), Zepatier (elbasvir/grazoprevir), and Vosevi (sofosbuvir/velpatasvir/voxilaprevir) are widely prescribed drugs used to treat chronic hepatitis C. But these drugs have been linked to worsening liver function and contributing to liver failure in individuals. Furthermore, these drugs have previously caused outrage due to an astronomical price tag attached to them.
Clinical trials with patients who have compensated cirrhosis or mild liver impairment have tolerated the medicine; it’s even been considered highly effective. The medication works by reducing the amount of HCV in the body and prevents it from multiplying and contains the hepatitis C virus (HCV) protease inhibitor.
HCV is a contagious disease and can lead to cirrhosis, liver cancer, and death. Nearly 71 million people are living with chronic hepatitis C.
However, liver failure has been found to occur in patients who already had signs or symptoms of moderate to severe liver impairment within four weeks of starting treatment. The FDA update said it received reports of 63 cases of “worsening liver function called liver decompensation.” According to the FDA update, most patients who discontinued treatment after taking one of the three medications actually experienced an improvement in liver function.
This basically means that if you have moderate to severe stages of liver damage or disease, these medications may actually worsen your symptoms.
Doctors will still prescribe these medications to patients, but if any of the following side effects are detected, you should speak to your doctor immediately.
The press release said, “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,” the agency said.
Mavyret is manufactured by AbbVie Inc., Zepatier is manufactured by Merck, and Vosevi is manufactured by Gilead.
According to the Centers for Disease Control and Prevention, there are roughly 3 million Americans infected with HCV, “of which genotype 1 is the most common and genotype 4 is one of the least common.”
Zepatier was approved by the FDA in 2016, while Mavyret and Vosevi were only approved in 2017.
Hepatitis C is introduced to the body primarily through exposure to infected blood or body fluids. According to the CDC, HCV is transmitted through:
- Injection drug use (currently the most common means of HCV transmission in the United States)
- Receipt of donated blood, blood products, and organs (once a common means of transmission but now rare in the United States since blood screening became available in 1992)
- Needlestick injuries in health care settings
- Birth to an HCV-infected mother
- Sex with an HCV-infected person (an inefficient means of transmission, although HIV-infected men who have sex with men [MSM] have increased risk of sexual transmission)
- Sharing personal items contaminated with infectious blood, such as razors or toothbrushes (also inefficient vectors of transmission)
- Other health care procedures that involve invasive procedures, such as injections (usually recognized in the context of outbreaks)
- Unregulated tattooing
Questions About a HCV Medication Lawsuit? Contact a Johnson//Becker Lawyer for a Free Case Review.
If you were injured by taking one of the three above mentioned drugs, you may want to speak with the lawyers at Johnson//Becker. We are currently accepting new drug recall cases across the country, and you may be entitled to financial compensation.
We offer a Free Case Evaluation. Please contact us using the form below or by calling us at (800) 279-6386.
We would be honored to speak with you and respond promptly to every inquiry we receive.
Free Case Evaluation
To contact us for a free review of your potential case, please fill out the form below or call us toll free 24 hrs/day by dialing: (800) 279-6386.