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FDA Now Requires Boxed Warning on HCV Drugs: Harvoni, Sovaldi, Daklinza and More

October 5, 2016

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FDA warns that the use of direct-acting antiviral medicines for Hepatitis C may lead to the reactivation of Hepatitis B.

FDA Adds Boxed Warning to Hepatitis C Drugs, Warns of Hepatitis B Reactivation Risk

By Zachary Brennan on October 4, 2016

The US Food and Drug Administration (FDA) on Tuesday warned of serious risks for some patients who have been infected with the hepatitis B virus (HBV) and are being treated with certain direct-acting antiviral (DAA) medicines for hepatitis C virus (HCV).

FDA identified 24 cases of HBV reactivation reported to FDA and from the published literature in HCV/HBV co-infected patients treated with DAAs between 22 November 2013 and 18 July 2016.

Continue reading this entire article:
http://www.raps.org/Regulatory-Focus/News/2016/10/04/25946/FDA-Adds-Boxed-Warning-to-Hepatitis-C-Drugs-Warns-of-Hepatitis-B-Reactivation-Risk/

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