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 The Food and Drug Administration said AbbVie had identified cases of
hepatic decompensation and liver failure in patients with liver
cirrhosis who were taking the medicines.
"Some of these events resulted in liver transplantation or death,"
the agency said in a posting on its website. It did not say how many
deaths were reported.
Shares of Gilead Sciences, which makes the top-selling rival
hepatitis C treatments Sovaldi and Harvoni, rose 5.7 percent to
$107.60. Shares of much smaller Enanta Pharmaceuticals, which helped
develop the AbbVie drugs, plunged 40.6 percent to close at $23.90.
Len Yaffe, portfolio manager of the StockDoc Partners healthcare
fund, called the liver toxicity warning a "huge positive for
Gilead."
The FDA said it is requiring AbbVie to include warnings about the
risk of serious liver injury in the labels of its combination
hepatitis C treatments.
Since the approvals of Viekira Pak in December 2014 and Technivie in
July 2015, at least 26 worldwide cases submitted to FDA Adverse
Event Reporting System were considered possibly or probably related
to Viekira Pak or Technivie, the agency said.
"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," AbbVie spokeswoman Jackie Finley said in an emailed
statement.
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.
The new information also includes a recommendation for physicians to
assess evidence of liver decompensation prior to treatment and
during treatment in cirrhotic patients.
In most of the cases, liver injury occurred within 1 to 4 weeks of
starting treatment, the FDA said, adding that some cases occurred in
patients who should not have been using the medicines.
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"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," the FDA said.
Gilead, which was first to market with the new treatments that
virtually guarantee a cure for the serious liver disease without any
of the side effects of older treatments, came under intense fire for
the high price of its drugs, which were listed for about $90,000 for
a course of treatment.
With competition from Viekira Pak, pharmacy benefit managers were
able to negotiate steep discounts by playing one drugmaker against
the other. Express Scripts Holding, the largest U.S. PBM backed
Viekira, while CVS Health chose to favor Gilead's drugs.
Express Scripts said it will evaluate the warning "to determine if
any additional action is required, especially for those with
late-stage cirrhosis requesting coverage of Viekira Pak."
The PBM said it closely reviews all new clinical evidence and is
able to rapidly respond to changes in drug labeling to ensure
patients are well cared for.
Express Scripts shares fell 4 percent, while CVS shares rose 1
percent.
(Reporting by Bill Berkrot; Editing by Alan Crosby and Diane Craft)
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