FDA is warning about the risk of reactivation of hepatitis B virus (HBV) among patients who have had the disease and are taking certain direct-acting antiviral (DAA) medicines for hepatitis C virus (HCV). The agency noted that in a few cases, HBV reactivation in patients treated with the drugs led to serious liver problems or death. HBV reactivation generally occurred within 4–8 weeks. FDA is now requiring a boxed warning about the risk of HBV reactivation on the labels of the DAAs, directing health care professionals to screen and monitor for HBV in all patients receiving DAA treatment. Additionally, the warning will be included in the patient information leaflet or Medication Guides for the drugs. FDA said it identified two dozen cases of HBV reactivation, either reported to it or from published literature, in people coinfected with HBV and HCV who were treated with DAAs from November 22, 2013 to July 18, 2016. Of these cases, two patients died and one required a liver transplant. HBV reactivation was not reported as an adverse event in the clinical trials for DAA approvals, as patients coinfected with HBV were not included in the trial. Read More
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