FDA requires black box warning on HCV drugs regarding potential HBV reactivation
The FDA issues a warning about the risk of hepatitis B virus reactivation among patients taking direct-acting antivirals to treat hepatitis C infections.
The FDA has issued a warning regarding the risk of reactivating hepatitis B virus (HBV) among patients with a prior history of HBV who are receiving treatment with direct-acting antiviral (DAA) medicines for hepatitis C virus (HCV).
The FDA noted that some patients treated with DAA medicines experienced HBV reactivation, which resulted in serious liver problems or death within 4 to 8 weeks. The agency will now require a Boxed Warning to be included on drug labels for DAA medications, patient information leaflets, and medication guides to help clinicians screen and monitor HBV in patients receiving these medications.
Twenty-four cases of HBV reactivation were identified in co-infected patients treated with DAAs between November 2013 and July 2016. Two patients died and one required a liver transplant.
The FDA states in their recommendation that “health care professionals should screen all patients for evidence of current or prior HBV infection before starting treatment with DAAs, and monitor patients using blood tests for HBV flare-ups or reactivation during treatment and post-treatment follow-up.”
In addition, they advise patients to tell a healthcare professional about any history of HBV infection or other liver problems before receiving treatment for HCV. Signs of serious liver problems may include fatigue, weakness, loss of appetite, nausea, light-colored stools, or yellow eyes or skin. Patients should not stop taking DAAs without talking to a clinician and are encouraged to read the medicine guide that is included in each new prescription.
- U.S. Food and Drug Administration. Direct-acting antivirals for hepatitis C: drug safety communication—Risk of hepatitis B reactivating [press release]. Accessed October 12, 2016.