Viekira Pak (dasabuvir, ombitasvir, paritaprevir, ritonavir) and Technivie (ombitasvir, paritaprevir, ritonavir) can Cause Hepatic Decompensation and Liver Failure
October 30, 2015
FDA issued an alert stating hepatitis C treatments Viekira Pak (dasabuvir, ombitasvir, paritaprevir, ritonavir) and Technivie (ombitasvir, paritaprevir, ritonavir) can cause serious liver injury, including fulminant hepatic failure and death. Viekira Pak was approved in December 2014 for patients with genotype 1 chronic hepatitis C, including compensated cirrhosis, and is used with or without ribavirin. Technivie was approved in July 2015 for patients with genotype 4 chronic hepatitis C without cirrhosis, and is only used in combination with ribavirin.
At least 26 reports of hepatic decompensation or liver failure have been reported to the FDA Adverse Event Reporting System (FAERS) since the products were approved. Liver injury usually occurred in the first 4 weeks of therapy initiation. Most cases occurred in patients with pre-existing advanced chronic liver disease. FDA is requiring the manufacturer to update the package inserts to reflect the risks.
Monitor liver function tests, direct serum bilirubin, and for development of ascites, hepatic encephalopathy, or variceal bleeding. Avoid use of either medication in clinical scenarios where they are not recommended or are contraindicated.
Instruct patients to report any symptoms of liver failure, including fatigue, weakness, loss of appetite, nausea and vomiting, jaundice, or light colored stool. Patients should not discontinue therapy abruptly without consulting their provider due to the risk of drug resistance.
- MedWatch Safety Alert – October 22, 2015
- FDA Drug Safety Communication – October 22, 2015
October 30, 2015; University of Utah, Drug Information Service. Copyright 2015, Drug Information Service, University of Utah, Salt Lake City, UT.