FDA Warns on Hepatitis C Drugs

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 [e-mail]

(END) Dow Jones Newswires

October 04, 2016 17:48 ET (21:48 GMT)

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