The FDA is warning that hepatitis C treatments Viekira Pak and Technivie can cause serious liver injury mostly in patients with underlying advanced liver disease. As a result, they are requiring the manufacturer to add new information about this safety risk to the drug labels.
Patients taking these medicines should contact their health care professional immediately if they develop fatigue, weakness, loss of appetite, nausea and vomiting, yellow eyes or skin, or light-colored stools, as these may be signs of liver injury. Patients should not stop taking these medicines without first talking to their health care professionals. Stopping treatment early could result in drug resistance to other hepatitis C medicines.
Health care 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. Viekira Pak and Technivie are used to treat chronic hepatitis C, a viral infection that can last a lifetime and lead to serious liver and other health problems, including cirrhosis, liver cancer, and death.
Viekira Pak is a fixed-dose combination of dasabuvir, ombitasvir, paritaprevir, and ritonavir used with or without ribavirin, another hepatitis C medicine. Viekira Pak is FDA-approved for use in patients with genotype 1 chronic hepatitis C infection including those with compensated cirrhosis.
Technivie is a fixed-dose combination of ombitasvir, paritaprevir, and ritonavir, used in combination with ribavirin. It is FDA-approved for use in patients with genotype 4 chronic hepatitis C virus infection without cirrhosis.
These medicines reduce the amount of hepatitis C virus in the body by preventing it from multiplying and may slow down the disease. They are made by AbbVie, Inc., a research based biopharmaceutical company, headquartered in No. Chicago, IL.
The 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. Some of these events resulted in liver transplantation or death. These serious outcomes were reported mostly in patients taking Viekira Pak who had evidence of advanced cirrhosis even before starting treatment with it.
Since the approvals of Viekira Pak in December 2014 and Technivie in July 2015, at least 26 worldwide cases submitted to FAERS were considered to be possibly or probably related to Viekira Pak or Technivie. In most of the cases, liver injury occurred within one to four weeks of starting treatment. Some of the cases occurred in patients for whom these medicines were contraindicated or not recommended. FAERS includes only reports submitted to FDA, so there are likely additional cases about which they are unaware.
The FDA is requiring AbbVie to include information about serious liver injury adverse events to the Contraindications, Warnings and Precautions, Postmarketing Experience, and Hepatic Impairment sections of the Viekira Pak and Technivie drug labels.
See the FDA Drug Safety Announcement
See also Medical Law Perspectives, September 2014 Report: Hepatitis: Provider Malpractice and Patient Injury
See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication