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
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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