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FDA Issues Warning New Hepatitis C Drugs Could Reactivate Hepatitis B Virus

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The following is excerpted from an FDA news release. To read the release in its entirety, click here.

The U.S. Food and Drug Administration is warning about the risk that some of the new direct-acting antiviral medicines for hepatitis C (HCV) can reactivate the hepatitis B virus (HBV) among patients who have had HBV. “In a few cases, HBV reactivation in patients treated with DAA medicines resulted in serious liver problems or death.”

Accordingly, the FDA is requiring that drug manufacturers add a Boxed Warning about the risk of HBV reactivation to the drug labels and medication guides of at least nine brand-name direct-acting antiviral drugs, including Daklinza, Epclusa, Harvoni, Olysio, Sovaldi, Technivie, Viekira Pak, and Zepatier.

The FDA said that it had identified 24 cases of HBV reactivation, from November 22, 2013, through July 18, 2016. (HBV reactivation was not identified as an adverse event during the approval of the HCV drugs, because HBV patients had been excluded from the clinical trials.)

The FDA recommends that patients tell their doctors if they have a history of HBV infection or other liver problems before being treated for HCV. The FDA also advises that patients should not stop taking their HCV medication without first consulting their doctors. The agency further urges patients to contact their doctors if they experience symptoms of liver problems: fatigue, weakness, loss of appetite, nausea and vomiting, yellow eyes or skin, or light-colored stools.

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