FDA warns AbbVie hep C drugs linked to serious liver damage
pharmafile | October 23, 2015 | News story | Medical Communications | AbbVie
AbbVie stocks tumbled 14% yesterday after the FDA warned that two of the company’s hepatitis C drugs could cause serious liver injury in patients with underlying advanced liver disease.
The US regulator says AbbVie must add new warnings about liver damage to the labels of its Viekira Pak and Technivie tablets. It also recommended health care professionals should closely monitor patients for signs and symptoms of worsening liver disease.
The FDA took these steps after reviewing adverse event reports from its database FAERS that identified cases of liver failure in patients with liver cirrhosis who were taking the medicines. Some of the most serious cases resulted in liver transplantation or death, mostly in users of Viekira Pak who had evidence of advanced cirrhosis before starting treatment with it.
Viekira Pak is a fixed-dose combination of dasabuvir, ombitasvir, paritaprevir, and ritonavir used with or without ribavirin, another hepatitis C medicine. It was approved in December 2014 by the FDA. Technivie – which received approval in July 2015 – is a fixed-dose combination of ombitasvir, paritaprevir, and ritonavir, used in combination with ribavirin.
Since the approvals, at least 26 cases worldwide that have been submitted to FAERS were considered to be possibly or probably related to Viekira Pak or Technivie. In the majority of cases, liver damage occurred within one to four weeks of the patient starting treatment. The FDA said there were likely more cases of which it was unaware.
The market for new hepatitis C treatments was dominated by Gilead Sciences prior to AbbVie obtaining approvals for its treatments. Gilead’s Sovaldi achieved about $9.4 billion in sales in its first year on the market, and this success was followed up by that of a combination pill, Harvoni, which treats a broader group of patients than its predecessor.
This new group of oral hepatitis C drugs have proven successful for their ability to cure a larger number of patients than older injection treatments, without the drawback of flu-like side effects. However, the prices have been a concern; Solvadi for example costing around $1,000 per pill.
Viekira Pak was welcomed as a challenger in the market that would encourage a price war resulting in lower prices from both Gilead and AbbVie. Merck is expected to enter the space with the launch of a similar drug in 2016: a combination of its grazoprevir and elbasvir treatments, which the US company claims cured 95% of patients in trials.
Whatever the shape of the competition, AbbVie has been dealt a blow by the FDA’s warning. The Illinois-based company responded with a statement, claiming that the fact patients already had liver damage before starting treatment means it is difficult to confirm a link to its drugs.
AbbVie says: “Patient safety is of the utmost concern to AbbVie. In consultation with the FDA, the US product inserts for Viekara Pak and Technivie have been updated. The update for Viekira Pak also includes a recommendation for physicians to assess evidence of hepatic decompensation prior to treatment and during treatment in cirrhotic patients.”
“Most patients with these severe outcomes had evidence of advanced cirrhosis prior to initiating therapy. Because post-marketing events are reported voluntarily during clinical practice, estimates of frequency cannot be made and a causal relationship between treatment and these events has not been established.”
Joel Levy
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