Individuals previously infected with the hepatitis B virus (HBV) who
receive chemotherapy or immunosuppressive treatment may be at risk of
reactivating the disease according to a summary of report from the
Emerging Trends Conference, “Reactivation of Hepatitis B,” and published
in Hepatology,
a journal of the American Association for the Study of Liver Diseases.
Reactivation of HBV can be fatal and the study authors suggest routine
screening of HBV in all patients prior to the start of treatment with
immunosuppressives or anti-cancer drugs.
HBV is transmitted by contact with body fluids,
such as blood, from an infected individual, causing acute or chronic
disease that attacks the liver. While vaccination helps to control the
spread of HBV, medical evidence estimates that up to 10% of the global
population is infected with chronic HBV. In the U.S. nearly 3,000 acute
cases of HBV were reported to the Centers for Disease Control and
Prevention (CDC) in 2012.
The Food and Drug Administration (FDA) issued a
Drug Safety Communication in September 2013 that read, “Boxed warning
and new recommendations to decrease risk of hepatitis B reactivation
with the immune-suppressing and anti-cancer drugs Arzerra
(ofatumumab) and Rituxan (rituximab).” Ofatumumab and rituximab are
monoclonal antibody therapy medications that target the protein CD20,
which is found on immune system B cells. These anti-CD20 drugs are used
to treat autoimmune diseases, leukemia, lymphoma and transplant
rejection.
“While the FDA urged clinicians to screen
patients for HBV prior to starting treatments with ofatumumab and
rituximab to prevent the reoccurrence of the virus, this may be just the
tip of the iceberg,” said lead author Dr. Adrian Di Bisceglie with
Saint Louis University School of Medicine in Missouri.
To detect HBV infection, doctors are looking for
the hepatitis B surface antigen (HBsAg) circulating in patients’ blood.
Antibodies to the hepatitis B core antigen develop in all patients and
remains after the HBsAg clearance, indicating a potential for
reactivation of the disease. HBV reactivation can be severe causing
acute liver failure and even death, with one prior study reporting a 25%
mortal rate.
After a systematic literature review, researchers
identified 504 studies pertaining to reactivation of HBV. While it
remains unclear how HBV reactivation occurs, experts believe a loss of
immune control over viral replication may trigger the process.
Reactivation of HBV may occur with chemotherapy,
organ and tissue transplantation, High dose corticosteroids, and
biologicals targeting tumor necrosis factor-alpha (TNF-α), Anti-TNF
medications are used in treating rheumatic diseases, such as rheumatoid
arthritis, digestive conditions that include Crohn’s and colitis, and
dermatologic conditions, such as psoriasis.
“Our research suggests that the issue of HBV
reactivation may be an under-appreciated clinical challenge that extends
well beyond the use of just two anti-CD20 medications,” concludes Dr.
Di Bisceglie. “Further study and cooperation between various medical
disciplines will help broaden understanding of HBV reactivation.”
Access the full study on the Wiley Press Room here. (To access PDFs and embargoed stories you must be logged in to the Press Room before clicking the link. Request a login here.)
Full citation: “Recent FDA Warnings on
Hepatitis B Reactivation with Immune-Suppressing and Anti-Cancer Drugs:
Just the tip of the iceberg?” Adrian M. Di Bisceglie, Anna S. Lok, Paul
Martin, Norah Terrault, Robert P. Perrillo and Jay H. Hoofnagle. Hepatology; (DOI: 10.1002/hep.27609).
URL: http://doi.wiley.com/10.1002/hep.27609
Author Contact: Media wishing to speak with Dr. Di Bisceglie may contact Carrie Bebermeyer with Saint Louis University bebermcl@slu.edu .
About the Journal
Hepatology is the premier publication in the field of liver
disease, publishing original, peer-reviewed articles concerning all
aspects of liver structure, function and disease. Each month, the
distinguished Editorial Board monitors and selects only the best
articles on subjects such as immunology, chronic hepatitis, viral
hepatitis, cirrhosis, genetic and metabolic liver diseases and their
complications, liver cancer, and drug metabolism. Hepatology is published on is published by Wiley on behalf of the American Association for the Study of Liver Diseases (AASLD). For more information, please visit http://wileyonlinelibrary.com/journal/hep.
Labels: FDA Warning, HBV Reactivation, immunosuppressives