Subject: FDA warns about the risk of hepatitis B reactivating in some patients treated with direct-acting antivirals for hepatitis C
From: "U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>
Date: Tue, 04 Oct 2016 15:09:48 -0500
Title: FDA warns about the risk of hepatitis B reactivating in some patients treated with direct-acting antivirals for hepatitis C
Informationabout FDA Hepatitis product approvals, safety warnings, medical product labeling changes, notices of upcoming public meetings, and notices about proposed regulatory guidances.
October 4, 2016
FDA 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.
As a result, 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.
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
in most cases, they cure HCV. Without treatment, HCV can lead to serious
liver problems including cirrhosis, liver cancer, and death (see List
of Direct-Acting Antivirals).
Patients should tell your health care
professional if you have a history of hepatitis B infection or other
liver problems before being treated for hepatitis C. Do not stop taking
your DAA medicine without first talking to your health care
professional. Stopping treatment early could result in your virus
becoming less responsive to certain hepatitis C medicines. Read the
patient information leaflet or Medication Guide
that comes with each new prescription because the information may have
changed. Contact your health care professional immediately if you
develop fatigue, weakness, loss of appetite, nausea and vomiting, yellow
eyes or skin, or light-colored stools, as these may be signs of serious
liver problems.
We identified 24 cases of HBV reactivation reported to FDA1
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, 2016.2-7 This number includes only cases submitted to
FDA, so there are likely additional cases about which we are unaware. 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,
including their effects on the liver, in patients infected with only HCV
and without the presence of another virus which affects the liver (see
Data Summary).
We urge health care professionals and patients to
report side effects involving DAAs and other medicines to the FDA
MedWatch program, using the information in the “Contact FDA” box at the
bottom of the page.
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