FDA Warns on Hepatitis C Drugs
October 04 2016 - 6:03PM
Dow Jones News
By Thomas M. Burton
The Food and Drug Administration is warning about the risk of
reactivation of hepatitis B among patients who have had that
disease and who are taking some prominent and expensive newer
medicines for hepatitis C.
The federal agency said it is requiring a so-called black-box
warning in the labels for at least nine brand-name direct-acting
antiviral drugs, including Sovaldi and Harvoni from Gilead Sciences
Inc., Viekira Pak from AbbVie Inc. and Zepatier from Merck &
Co. That is the most serious kind of warning that can be levied by
the FDA.
The agency said serious liver problems or death occurred in "a
few cases." These medicines are already threatening the budgets of
private and government insurers and of prison systems because of
list prices ranging from $54,000 to $94,000 a person for a typical
12-week course. Hepatitis C infects millions of Americans and can
lead to death after decades in the body.
The newer hepatitis C medicines tend to achieve cure rates of
90% or more, compared with rates of 65% among older medications,
which also must be taken for up to a year.
The FDA said it identified 24 cases of hepatitis B reactivation,
either reported to it or found in medical literature, from Nov. 22,
2013 through July 18, 2016. Of the cases reported, two patients
died and one required a liver transplant. Reactivation of hepatitis
B wasn't reported as an adverse event in clinical trials submitted
to the FDA for approval of the drugs.
Write to Thomas M. Burton at tom.burton@wsj.com
(END) Dow Jones Newswires
October 04, 2016 17:48 ET (21:48 GMT)
Copyright (c) 2016 Dow Jones & Company, Inc.
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