The Food and Drug Administration (FDA) is requiring that two hepatitis C virus (HCV) treatments now include information on the risk of serious liver injury adverse events in the drug labeling.
An FDA review of adverse events reported to the FDA Adverse Event Reporting System (FAERS) database and to AbbVie, the manufacturer of Viekira Pak (ombitasvir/paritaprevir/ritonavir + dasabuvir) and Technivie (ombitasvir/paritaprevir/ritonavir), identified cases of hepatic decompensation and liver failure in patients with underlying liver cirrhosis who were taking these drugs. The adverse events, some of which resulted in liver transplantation or death, were mainly reported in patients taking Viekira Pak who had evidence of advanced cirrhosis prior to treatment initiation. Some of the cases reported occurred in patients for whom these medicines were contraindicated or not recommended, such as those with decompensated liver disease (Viekira Pak) or moderate hepatic impairment (Technivie).
Healthcare professionals should closely monitor for signs and symptoms of worsening liver disease, such as ascites, hepatic encephalopathy, variceal hemorrhage, and/or increases in direct bilirubin in the blood in patients taking these medications. Patients should not stop taking these medicines without first talking to their clinician, as stopping treatment early could result in drug resistance to other HCV treatments.
A spokesperson from AbbVie stated that the drug labels have been updated from “not recommended in Child Pugh B patients” to a contraindication in patients with Child-Pugh B cirrhosis. The updated labeling for Viekira Pak also includes a recommendation for clinicians to assess evidence of hepatic decompensation prior to treatment and during treatment in cirrhotic patients.
Viekira Pak is indicated for the treatment of chronic HCV genotype 1 infection, with or without ribavirin, including those with compensated cirrhosis. Technivie is indicated for the treatment of chronic HCV genotype 4 infection without cirrhosis, in combination with ribavirin.
For more information call (888) 463-6332 or visit FDA.gov.