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Study Shows Immunosuppressives, Chemotherapy May Reactivate Hepatitis B

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Key Points

  • The FDA issued a Drug Safety Communication in 2013 about the risk of hepatitis B reactivation from use of the anti-CD20 monoclonal antibodies ofatumumab and rituximab.
  • Researchers suspect loss of immune control over viral replication may trigger reactivation of HBV.
  • Routine screening of HBV is suggested in all patients prior to the start of treatment with immunosuppressives or anticancer drugs.

Individuals previously infected with the hepatitis B virus (HBV) that receive chemotherapy or immunosuppressive treatment may be at risk of reactivating the virus, according to a report published by Di Bisceglie et al in Hepatology. Reactivation of HBV can be fatal, and researchers suggest routine screening of HBV in all patients prior to the start of treatment with immunosuppressives or anticancer drugs.

FDA Drug Safety Communication

The U.S. Food and Drug Administration (FDA) issued a Drug Safety Communication in September 2013 detailing a new Boxed Warning and recommendations to decrease risk of hepatitis B reactivation with the immune-suppressing and anticancer drugs ofatumumab (Arzerra) and rituximab (Rituxan). Ofatumumab and rituximab are CD20-targeting monoclonal antibody therapies 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 Adrian Di Bisceglie, MD, FACP, Professor of Internal Medicine and Chief of Hepatology at Saint Louis University School of Medicine.

To detect HBV infection, doctors look for hepatitis B surface antigen (HBsAg) circulating in patients’ blood. Antibodies to the hepatitis B core antigen develop in all patients, and remain after the HBsAg clearance, indicating a potential for reactivation of the disease. HBV reactivation can be severe, causing acute liver failure and even death.

Literature Review

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 medications targeting tumor necrosis factor-alpha (TNF-α). Anti-TNF medications are used in treating rheumatic diseases, such as rheumatoid arthritis; digestive conditions, such as Crohn's disease and colitis; and dermatologic conditions, such as psoriasis.

“Our research suggests that the issue of HBV reactivation may be an underappreciated clinical challenge that extends well beyond the use of just two anti-CD20 medications,” concluded Dr. Di Bisceglie. “Further study and cooperation between various medical disciplines will help broaden understanding of HBV reactivation.”

About HBV

HBV is transmitted by contact with body fluids 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 a chronic form of the disease. In the United States, nearly 3,000 acute cases of HBV were reported to the Centers for Disease Control and Prevention (CDC) in 2012.

Dr. Di Bisceglie is the corresponding author for the Hepatology article.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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