FDA approved class labeling revisions regarding the risk of hepatitis B virus reactivation in patients coinfected with hepatitis C virus (HCV) and hepatitis B virus (HBV)
Subject: FDA approved class labeling revisions regarding the risk of hepatitis B virus reactivation in patients coinfected with hepatitis C virus (HCV) and hepatitis B virus (HBV)
From: "U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>
Date: Tue, 14 Feb 2017 13:57:11 -0600
Title: FDA approved class labeling revisions regarding the risk of hepatitis B virus reactivation in patients coinfected with hepatitis C virus (HCV) and hepatitis B virus (HBV)
Informationabout FDA Hepatitis product approvals, safety warnings, medical product labeling changes, notices of upcoming public meetings, and notices about proposed regulatory guidances.
On February 14, 2017FDA approved class labeling revisions regarding the risk of hepatitis B
virus reactivation in patients coinfected with hepatitis C virus (HCV) and hepatitis
B virus (HBV). The class labeling applies to the following HCV direct acting antiviral
(DAA) agents:
Daklinza (daclatasvir)
Epclusa (sofosbuvir/velpatasvir)
Harvoni
(ledipasvir/sofosbuvir)
Olysio (simeprevir)
Sovaldi (sofosbuvir)
Technivie
(ombitasvir/paritaprevir/ritonavir)
Viekira Pak
(ombitasvir/paritaprevir/ritonavir tablets; dasabuvir tablets)
The key messages from the class labeling revisions
include:
Test
all patients for evidence of current or prior HBV infection by measuring
hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (anti-HBc)
before initiating treatment with HCV DAAs.
In
patients with serologic evidence of HBV infection, monitor for clinical and
laboratory signs of hepatitis flare or HBV reactivation during HCV treatment
and during post-treatment follow-up.
Initiate
appropriate patient management for HBV infection as clinically indicated.
Below is the new class labeling information included for
the HCV DAAs labels. Note [Drug X] applies to each of the HCV DAAs listed
above.
FULL PRESCRIBING INFORMATION
2DOSAGE
AND ADMINISTRATION
2.1Testing Prior to the Initiation of
Therapy
Test all patients for evidence of current or prior HBV
infection by measuring hepatitis B surface antigen (HBsAg) and hepatitis B core
antibody (anti-HBc) before initiating HCV treatment with [DRUG X] [see Warnings and Precautions (5.1)].
5 WARNINGS AND PRECAUTIONS
5.1Risk of Hepatitis B Virus Reactivation
in Patients Coinfected with HCV and HBV
Hepatitis B virus (HBV) reactivation has been reported in
HCV/HBV coinfected patients who were undergoing or had completed treatment with
HCV direct acting antivirals, and who were not receiving HBV antiviral therapy.
Some cases have resulted in fulminant hepatitis, hepatic failure, and death.
Cases have been reported in patients who are HBsAg positive and also in
patients with serologic evidence of resolved HBV infection (i.e., HBsAg
negative and anti-HBc positive).HBV
reactivation has also been reported in patients receiving certain
immunosuppressant or chemotherapeutic agents; the risk of HBV reactivation
associated with treatment with HCV direct-acting antivirals may be increased in
these patients.
HBV reactivation is characterized as an abrupt increase
in HBV replication manifesting as a rapid increase in serum HBV DNA level. In
patients with resolved HBV infection, reappearance of HBsAg can occur.
Reactivation of HBV replication may be accompanied by hepatitis, i.e.,
increases in aminotransferase levels and, in severe cases, increases in
bilirubin levels, liver failure, and death can occur.
Test all patients for evidence of current or prior HBV
infection by measuring HBsAg and anti-HBc before initiating HCV treatment with [DRUG
X]. In patients with serologic evidence of HBV infection, monitor for clinical
and laboratory signs of hepatitis flare or HBV reactivation during HCV
treatment with [DRUG X] and during post-treatment follow-up. Initiate
appropriate patient management for HBV infection as clinically indicated.
17 PATIENT COUNSELING INFORMATION
Risk of Hepatitis B Virus Reactivation in
Patients Coinfected with HCV and HBV
Inform patients that HBV reactivation can occur in
patients coinfected with HBV during or after treatment of HCV infection. Advise
patients to tell their healthcare provider if they have a history of HBV
infection [see Warnings and Precautions (5.1)].
Patient
Information
What
is the most important information I should know about [DRUG X]?
[DRUG X] can cause serious side effects, including,
Hepatitis
B virus reactivation: Before starting treatment with [DRUG X],
your healthcare provider will do blood tests to check for hepatitis B virus
infection. If you have ever had hepatitis B virus infection, the hepatitis B
virus could become active again during or after treatment of hepatitis C virus
with [DRUG X]. Hepatitis B virus becoming active again (called reactivation)
may cause serious liver problems including liver failure and death. Your
healthcare provider will monitor you if you are at risk for hepatitis B virus
reactivation during treatment and after you stop taking [DRUG X].
Before
taking [DRUG X], tell your healthcare provider about all of your medical
conditions, including if you:
have
ever had hepatitis B virus infection
What
are the possible side effects of [DRUG X]?
[DRUG X] can cause serious side effects, including:
Hepatitis
B virus reactivation. See “What is the most important information I should know
about [DRUG X]?”
You will be able to view the updated labels at drugs@fda or dailymed.
Steve Morin Office of Health and Constituent Affairs Food and Drug Administration
Richard Klein Office of Health and Constituent Affairs Food and Drug Administration
Kimberly Struble Division of Antiviral Products Food and Drug Administration
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