On October 22, 2015, the US Food & Drug Administration warned that two hepatitis C drugs, Viekira Pak and Technivie, “can cause serious liver injury.”
The complication seems to be most likely in patients who already have underlying liver diseases like cirrhosis. Federal regulators have instructed AbbVie, the Chicago-based company who makes both drugs, to strengthen their warning labels.
Reports Of Liver Injury, Death Spur Warnings On Technivie & Viekira Pak
Whether the drugs are able to cause liver damage, or only exacerbate underlying diseases of the liver, is currently unknown.
The FDA’s warning was apparently spurred by 26 adverse event reports, submitted from around the world, of patients suffering severe liver damage after taking either Technivie or Viekira Pak. Some of the events involved patients who required liver transplantation or died.
- Jaundice (a yellow tint to the skin or eyes)
- Nausea and vomiting
- Excessive fatigue
- Loss of appetite
Reporting from Bloomberg Business added more detail to the situation; according to Bloomberg’s Doni Bloomfield, seven of the 26 patients died after experiencing liver failure.
Notably, the FDA said that a portion of these patients probably shouldn’t have been taking the medications in the first place. Upon its approval, Viekira Pak’s warning label already stated that the drug was contraindicated (should not be used) in patients with “severe hepatic impairment.”
As you can see below, the drug’s new warning label widens the contraindication from only patients with “severe” liver impairment to those with both “moderate and severe” impairment:
A new “Warning & Precaution” has also been added to the label. It reads:
“Hepatic decompensation and hepatic failure, including liver transplantation or fatal outcomes, have been reported mostly in patients with advanced cirrhosis. Monitor for clinical signs and symptoms of hepatic decompensation.”
Identical modifications have been made to Technivie’s warning label.
Has AbbVie Responded?
In correspondence with Bloomberg Business, AbbVie spokesperson Jackie Finley wrote:
“Most patients with these severe outcomes had evidence of advanced cirrhosis prior to initiating therapy. Estimates of frequency cannot be made and a causal relationship between treatment and these events has not been established.”
Her statement appears to contrast with the FDA’s rather frank assertion that Viekira Pak and Technivie “can cause” liver injury.
According to the Washington Post, AbbVie’s stock fell by more than 10% the day the FDA made its announcement. Shares in the company’s only hep C-competitor, Gilead Sciences, jumped 5.8%.
What Are Viekira Pak & Technivie?
Viekira Pak and Technivie are relatively recent additions to the US hepatitis treatment market, approved in December 2014 and July 2015 respectively.
The drugs have been approved to treat two different strains of the hep C virus. Viekira Pak is for patients with genotype 1 chronic hep C; Technivie is for patients with genotype 4 chronic hep C. Hepatitis C is a virus that infects the liver. In upwards of 85% of patients, the infection lingers and becomes chronic. Chronic hep C is a leading cause of cirrhosis and liver cancer.
Technivie contains the active ingredients ombitasvir, paritaprevir and ritonavir. Viekira Pak pairs a tablet containing those three drugs with a second pill containing dasabuvir.