Viekira Pak Lawsuit
What’s the Problem?
Use of the hepatitis C treatment Viekira Pak may cause liver damage, particularly in patients with pre-existing liver disease, according to an FDA Warning.
What is Viekira Pak?
Viekira Pak is an antiviral medication that contains dasabuvir, ombitasvir, paritaprevir and ritonavir. These drugs prevent hepatitis C virus (HCV) from multiplying in the body. Viekira Pak is used to treat genotype 1 chronic hepatitis C in adults, including people with compensated cirrhosis. The drug is manufactured by AbbVie, and was approved by the U.S. Food & Drug Administration (FDA) in December 2014.
Viekira Pak Liver Disease Warning
Less than a year after its approval, FDA issued a warning which stated that use of Viekira Pak and Technivie (another hepatitis C drug made by AbbVie) may lead to significant liver injury resulting in transplantation or death.
“Our review of adverse events reported to the FDA Adverse Event Reporting System (FAERS) database and to the manufacturer of these medicines, AbbVie, identified cases of hepatic decompensation and liver failure in patients with underlying liver cirrhosis who were taking these medicines,” FDA said. “Some of these events resulted in liver transplantation or death.”
Since Viekira Pak was approved in December 2014, at least 26 adverse events have been linked to it and Technivie. Of these, 10 patients experienced liver failure resulting in liver transplant or death. In most cases, liver injury occurred within 1 to 4 weeks of initiating treatment.
Symptoms of Liver Disease
- Loss of appetite
- Yellow eyes or skin (jaundice)
- Light-colored stools
FDA is also advising healthcare professionals to closely monitor Viekira Pak users for symptoms of exacerbating liver disease including ascites, hepatic encephalopathy, variceal hemorrhage and/or increases in direct bilirubin in the blood.
How Hepatitis C Affects the Liver
The hepatitis C virus slowly damages the liver over many years, often progressing from inflammation to permanent, irreversible scarring (cirrhosis). In many cases, patients have no signs of liver disease or have only mild symptoms for years until they have full-blown cirrhosis. Once a patient has cirrhosis, treatment focuses on keeping the condition from worsening.
Viekira Pak Side Effects
- Liver disease
- Liver failure
- Hepatic decompensation
- Hepatic failure
- Allergic reactions
- Thinning blood
- Difficulty sleeping
Viekira Pak Timeline
1970s – Hepatitis virus identified
1970s – Non-A, non-B hepatitis virus identified as causing cirrhosis and liver cancer.
1989 – Virus discovered
1989 – Hepatitis C virus discovered.
Dec 2014 – Approved by the FDA
December 19, 2014 – FDA approves Viekira Pak to treat hepatitis C genotype 1.
Jul 2015 – Approved for treatment
July 24, 2015 – Technivie approved for the treatment of chronic hepatitis C genotype 4.
Oct 2015 – FDA warning
October 22, 2015 – FDA warns of increased risk of liver disease with Technivie and Viekira Pak.
- “FDA approves Viekira Pak to treat hepatitis C”. U.S. Food & Drug Administration (FDA). December 19, 2014.
- “FDA Drug Safety Communication: FDA warns of serious liver injury risk with hepatitis C treatments Viekira Pak and Technivie”. U.S. Food & Drug Administration (FDA). October 22, 2015.
- “Medications to Treat Hepatitis C – A Timeline”. Hepatitis Central. June 2016.