FDA: Monitor Hep C Patients for Hep B Reactiviation

The US Food and Drug Administration (FDA) is now requiring a Boxed Warning be added to the drug labels of certain direct-acting antiviral (DAA) medicines used for the treatment of the hepatitis C virus (HCV). The warnings concern the reactivation of hepatitis B virus (HBV) in patients with previous HBV infection taking the drugs to treat HCV.
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The warning recommends that health care professionals screen and monitor all HCV patients taking DAAs for HBV. It is based on 24 identified cases of HBV reactivation reported to the FDA and from the published literature in HCV/HBV coinfected patients treated with DAA between November 2013 and July 2016.

The FDA noted that HBV reactivation was not reported as an adverse event in clinical trials submitted for DAA approvals because coinfected patients were excluded from those trials in order to specifically evaluate the safety of these drugs in patients infected with HCV only.

—Michael Potts

Reference:

FDA. FDA Drug Safety Communication: FDA warns about the risk of hepatitis B reactivating in some patients treated with direct-acting antivirals for hepatitis C [press release]. http://www.fda.gov/Drugs/DrugSafety/ucm522932.htm. October 4, 2016.