Potentially Fatal HBV Infection Reactivation Associated with Direct-Acting Antiviral Drugs

​The U.S. Food and Drug Administration (FDA) is warning clinicians about the risk of hepatitis B virus (HBV) becoming an active infection in patients with a previous HBV infection who received treatment with certain direct-acting antiviral (DAA) medications for hepatitis C virus (HCV). FDA received reports of patients who suffered serious liver problems or death as a result of HBV reactivation related to these drugs. Of the 24 such cases reported to FDA from November 22, 2013 to July 18, 2016, two resulted in death, and an additional patient required a liver transplant.