Risk of Hepatitis B Reactivation Prompts Hepatitis C Medication Warning in Europe

Published on December 6, 2016 by Sandy Liebhard

Health regulators in Europe have issued a new warning regarding the potential for direct-acting antiviral Hepatitis C medications to reactivate a latent Hepatitis B virus. According to December 2nd communication issued by the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC), at least 30 cases of Hepatitis B reactivation have been reported in Europe among patients treated with these drugs.

Direct-acting antivirals reduce the amount of Hepatitis C virus in the body by preventing its replication. In many patients, treatment results in a complete cure.  Hepatitis C medications cited by PRAC include:

  • Daklinza
  • Exviera
  • Harvoni
  • Olysio
  • Sovaldi
  • Viekirax

The Committee has recommended that Hepatitis C infected patients be screened for the Hepatitis B virus prior to starting treatment with any direct-acting antivirals. Patients infected with both viruses should be monitored and current medical guidelines should be followed.

FDA Orders Black Box Warning for Direct-Acting Antivirals

In October, the U.S. Food & Drug Administration (FDA) mandated that all medications in this class carry a Black Box Warning regarding the risk of Hepatitis B reactivation. Drugs subject to the FDA mandate include:

  • Daklinza
  • Epclusa
  • Harvoni
  • Olysio
  • Sovaldi
  • Technivie
  • Viekira Pak
  • Viekira Pak XR
  • Zepatier

According to the FDA, 24 cases of Hepatitis B reactivation were reported in patients treated with direct-acting antivirals during the 31-month period running from November 22, 2013 to July 18, 2016. Two patients died and one required a liver transplant.  The FDA has advised direct-acting antiviral patients co-infected with Hepatitis C and B to contact their doctor immediately if they develop any of the following symptoms:

  • Fatigue
  • Weakness
  • Loss of appetite
  • Nausea and vomiting
  • Yellow eyes or skin

Patients should not stop taking their Hepatitis C medication without first talking to their health care professional, as doing so could result in the virus becoming less responsive to certain drugs.

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