Tuesday, October 4, 2016

Sovaldi cured my Hep C but killed me by reactivating Hep B

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

Posted 04 October 2016By Zachary Brennan
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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. 
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.
- 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.BVELqNYl.dpuf

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