AbbVie's Hepatitis C Drugs Label Changed After Patient Deaths

  • Most of the patients already had cirrhosis, drugmaker says
  • Gilead, maker of rival treatment, climbs in New York trading

Seven patients on AbbVie Inc.’s drugs for hepatitis C died after liver failure, prompting U.S. regulators to change their advice on how the medicine should be administered.

Doctors should monitor patients using Viekira Pak or Technivie for signs of worsening liver disease, the U.S. Food and Drug Administration said in a statement Thursday. The medication is AbbVie’s second-best selling drug.

AbbVie shares dropped 10 percent to $48.27 at the close in New York, while Gilead Sciences Inc. -- its only competitor in the market for hepatitis C cures -- jumped 5.8 percent to $107.60.

"Most patients with these severe outcomes had evidence of advanced cirrhosis prior to initiating therapy," Jackie Finley, a spokeswoman for AbbVie, wrote in an e-mail. "Estimates of frequency cannot be made and a causal relationship between treatment and these events has not been established."

While it’s difficult to evaluate liver failure cases in patients with advanced liver disease, some patients’ symptoms cleared up after they stopped taking AbbVie’s drugs, suggesting the drugs potentially played a role in causing the symptoms, the FDA said in the alert.

Viekira Pak’s label approved by the FDA last year already said it wasn’t recommended for use in patients with serious liver disease.

Gilead Battle

Gilead was first to market with a hepatitis C cure, and its Harvoni treatment is a once-a-day pill, in contrast to AbbVie’s treatment, which requires multiple pills. Both companies have faced criticism for their drugs’ list prices, which amount to as much as $1,000 a day, though insurers have negotiated much lower rates by pitting the companies against each other.

Express Scripts Holding Co., the nation’s largest manager of drug benefits for employers and insurers, has an agreement to offer coverage exclusively for AbbVie’s hepatitis C regimen instead of Gilead’s, in exchange for a discount. Express Scripts will evaluate the FDA alert “to determine if any additional action is required," especially in patients with liver damage, spokesman Brian Henry said in an e-mail.

"We haven’t seen any hint of this really with the Gilead data," Asthika Goonewardene, an analyst at Bloomberg Intelligence, said by phone. Gilead’s drugs have different methods of clearing hepatitis C than AbbVie’s do, he said.

The label change may mean that Gilead "doesn’t have to offer as aggressive a rebate for its drugs anymore," Goonewardene said.

Enanta Pharmaceuticals Inc., which worked with AbbVie to develop Viekira Pak, sank 41 percent to $23.90. Merck & Co., which is developing a hepatitis C treatment, rose 2.8 percent to $52.01.

In April, the FDA recommended that Johnson & Johnson add information on its label for hepatitis C treatment Olysio on reports of liver failure and deaths of patients using the medication in combination with Gilead’s Sovaldi or with another pair of drugs.

AbbVie has a separate, experimental drug combination in development for hepatitis C. That treatment cleared two common strains of the virus in a mid-stage trial, the company said earlier this month.

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