FDA Warns on AbbVie’s Hepatitis C Treatments

The FDA Adverse Event Reporting System (FAERS) includes only reports submitted to the FDA, so there are likely additional cases about which the FDA is unaware.

The USPIs for VIEKIRA PAK and TECHNIVIE were updated following post-marketing reports of hepatic decompensation and hepatic failure, including liver transplantation or fatal outcomes, in patients receiving AbbVie’s HCV treatment, with or without RBV.

Advanced stages of the disease are marked by severe scarring on the liver, along with bleeding, fluid in the stomach, difficulty thinking or other symptoms. Shares of Gilead Sciences ($GILD), which has the market-leading Sovaldi and Harvoni, closed up 5.77%. A few of the cases occurred in patients for whom these medicines were contraindicated or not recommended. The FDA warning comes shortly after healthcare informatics firm Advera Health Analytics issued a new side effect report on hep C treatments and found that AbbVie’s Viekira Pak was the riskiest option among it and Gilead’s meds.

AbbVie defended its two medicines for treating hepatitis C as safe and effective for the vast majority of patients, and said risks of serious liver injury are limited to only 3 percent to 5 percent of patients with the most serious stage of the disease.

She said the Viekira Pak and Technivie package inserts have been changed to say they should not be used in patients with a type of cirrhosis, which is advanced liver damage that can be caused by hepatitis.

We are 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.

In its warning, the FDA said 26 cases of liver issues have been reported since the drugs were approved that were related or probably related.

Viekira Pak was approved in December for the most common form of hepatitis C and it belongs to a generation of drugs that have gained popularity due to their better results. In most situations, liver injury occurred within 1-4 weeks of beginning treatment. The health agency cautions individuals taking the therapies not to discontinue their use without first discussing the matter with a health professional, given that stopping treatment early may lead hep C to become resistant to other treatments and undermine future efforts to cure the virus.

Medical professionals should strictly monitor their patients for clinical manifestations of worsening liver conditions, including hepatic encephalopathy, ascites and/or elevated indirect bilirubin levels in the blood.

Viekira Pak and Technivie are part of a number of recent medications developed to treat Hepatitis C. Viekira Pak is a fixed-dose combination of dasabuvir, ombitasvir, paritaprevir, and ritonavir used with or without ribavirin, another hepatitis C medicine.