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FDA Drug Safety Podcast: FDA warns about the risk of hepatitis B reactivating in some patients treated with direct-acting antivirals for hepatitis C

FDA Drug Safety Podcast: FDA warns about the risk of hepatitis B reactivating in some patients treated with direct-acting antivirals for hepatitis C

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Welcome to FDA Drug Safety Podcasts for health care professionals. This is Lesley Navin, Advanced Practice Nurse from the Division of Drug Information.

On October 4, 2016, FDA announced it 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.

We are requiring a Boxed Warning, our most prominent 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.

DAA medicines are used to treat chronic hepatitis C virus (HCV) infection by reducing the amount of HCV in the body, preventing it from multiplying and in most cases curing HCV.

Health care professionals should screen all patients for 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. It is currently unknown why the reactivation occurs.

We identified 24 cases of HBV reactivation reported to FDA and from the published literature in HCV/HBV co-infected patients treated with DAAs between November 2013 and July 2016. This number includes only cases submitted to FDA, so there are likely additional cases. Of the cases reported, two patients died and one required a liver transplant. HBV reactivation was not reported as an adverse event in the clinical trials submitted for the DAA approvals because patients with HBV co-infection were excluded from the trials. The trials excluded these patients in order to specifically evaluate the safety of DAAs in patients infected with only HCV and without the presence of another virus which affects the liver.

We urge health care professionals and patients to report side effects involving DAAs and other medicines to the FDA MedWatch program at www.fda.gov/medwatch.

A link to the full communication detailing specific information for health care professionals, a list of DAAs, and the complete Data Summary can be found at www.fda.gov/DrugSafetyCommunications. If you have drug questions, you can reach us at druginfo@fda.hhs.gov

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