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News From the Food and Drug Administration
November 15, 2016

HCV Drug Warning

Author Affiliations

Copyright 2016 American Medical Association. All Rights Reserved.

JAMA. 2016;316(19):1957. doi:10.1001/jama.2016.16352

The FDA will require boxed warnings on labels for certain direct-acting antiviral medications used to treat hepatitis C virus (HCV) infection following reports that the drugs reactivated hepatitis B virus (HBV) infection.

“Health care professionals should screen all patients for evidence of current or prior HBV infection before starting treatment with [direct-acting antivirals], and monitor patients using blood tests for HBV flare-ups or reactivation during treatment and post-treatment follow-up,” agency officials said in a drug safety communication. “It is currently unknown why the reactivation occurs.”