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

istock_000004180692largeThe 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.

Of the cases reported, two patients died and one required a liver transplant, though FDA cautions that this number includes only cases submitted to FDA, so there are likely additional cases.

As a result, FDA is now requiring a boxed warning to be added to nine DAAs, including Gilead’s blockbusters Harvoni and Sovaldi, as well as Abbvie’s Viekra Pak and Bristol-Myers Squibb’s Daklinza.

– See more at: 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/#sthash.upHoT1bH.dpuf


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