Tuesday, 17 January 2017 12:59

Public Alert Direct-Acting Antivirals For Hepatitis C

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The Agency is warning about the risk of hepatitis B virus (HBV) becoming an active infection again in any patient who has a current or previous infection with HBV and is treated with certain direct-acting antiviral (DAA) medicines for hepatitis C virus. In a few cases, HBV reactivation in patients treated with DAA medicines resulted in serious liver problems or death. It is currently unknown why the reactivation occurs.

Direct-acting antiviral medicines are used to treat chronic hepatitis C virus (HCV) infection, an infection that can last a lifetime. These medicines reduce the amount of HCV in the body by preventing HCV from multiplying, and i most cases, they cure HCV. Without treatment, HCV can lead to serious liver problems cirrhosis, liver cancer, and death.

The FDA has identified 24 cases of HBV reactivation reported to FDA and from the published literature in HCV/HBV co-infected patients treated with DAAs during the 31 months from November 22, 2013 to July 18, 2016. As a result, the FDA is requiring a Boxed Warning, about the risk of HBV reactivation to be added to the drug labels of these DAAs directing health care professionals to screen and monitor for HBV in all patients receiving DAA treatment. This warning will also be included in the patient information leaflet or Medication Guides for these medicines.

 

Healthcare provider’s action

 

  • Healthcare providers 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 follow-up.
  • Healthcare providers and patients should report adverse events associated with the use of these products to the nearest NAFDAC office, NAFDAC PRASOR (20543 TOLL FREE from all networks) or via This email address is being protected from spambots. You need JavaScript enabled to view it.

NAFDAC.........Safeguarding the Health of the Nation!!!

Read 1413 times Last modified on Tuesday, 17 January 2017 13:23

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