Special announcement: On September 25th 2013, the U.S. Food and Drug Administration issued a warning and new recommendations to decrease risk of hepatitis B reactivation that can occur with use of the drugs oftatumumab (Arzerra) and rituximab (Rituxan). ASCO now recommends that doctors may consider screening patients for Hepatitis B virus if they have higher risk of the disease or if they are receiving treatments that are very likely lower the immune system, such as stem cell transplantation and the drugs ofatumumab and rituximab.
ASCO has issued a provisional clinical opinion recommending that selected patients at high risk for infection with hepatitis B virus (HBV) be screened before receiving treatment with chemotherapy since there is a chance that an inactive infection could become active again with treatment that suppresses the immune system. A provisional clinical opinion offers direction to doctors and others who treat people with cancer after the publication or presentation of potentially practice-changing information.
“This new provisional clinical opinion is a useful tool for practicing oncologists who are facing the decision of whether and how to test their patients about to undergo chemotherapy for hepatitis B. Based on the best available evidence, it provides practical guidance on the issue of routine screening in this setting,” said Michael Neuss, MD, Chair, ASCO Clinical Practice Committee.
The Centers for Disease Control (CDC) issued updated recommendations for hepatitis B screening to include anyone who is receiving chemotherapy for cancer. Hepatitis B is a viral infection caused by HBV and can be detected with a blood test. Long-term infection with HBV damages the liver and can lead to liver cancer, cirrhosis (scarring of the liver), and liver failure, which can cause death. HBV is spread by coming onto contact with body fluids (such as blood or semen) of a person who is infected. HBV infection can be prevented with a vaccine. Those at high risk for hepatitis B infection include:
- People who use injection drugs
- People with multiple sex partners or those diagnosed with a sexually transmitted disease
- Men who have sex with men
- People who have sexual contact with or live in the same household as someone who is already infected with HBV
- Infants who are born to mothers infected with HBV
- Infants and children of immigrants from areas with high rates of HBV infection, such as Eastern Europe, Asia, Africa, the Middle East, and the Pacific Islands
- Health care workers or other employees that come into contact with human blood
- Patients who are receiving hemodialysis for kidney disease
Infection with HBV can be treated with drugs called antiviral medication.
HBV and Cancer
For people with cancer and HBV who require chemotherapy or another treatment that suppresses the immune system, there is a slight risk that a latent (inactive) infection with hepatitis B can become active again (called reactivation). This is because chemotherapy can weaken the immune system that helps fight infection. It is not known how a latent HBV infection becomes active or causes problems for specific cancers or specific chemotherapy. Some examples of treatment that appear more likely to overwhelm the immune system and lead to reactivation of the infection are the high doses of chemotherapy given before bone marrow/stem cell transplantation and rituximab (Rituxan), a treatment for lymphoma.
In the provisional clinical opinion, ASCO recommends the following:
- Right now, there is not enough scientific evidence about the benefits and risks of screening every patient with cancer for HBV who is receiving, or about to receive, chemotherapy.
- People who are infected with HBV or at higher risk of having HBV (based on the risk factors listed above) may have an increased risk of liver failure if the virus reactivates once chemotherapy begins. For this reason, it is important to tell your doctor if you believe you are infected with HBV or have been exposed to HBV.
- The decision to test for HBV should be made with your doctor, discussing the risks and benefits of having the test (see the special announcement above).
- If you are tested, and the results are positive for HBV infection, then the doctor can consider giving antiviral medication before and throughout the course of chemotherapy.
- A patient's treatment should not be delayed because of screening or treating HBV.
“The issue of routine screening for hepatitis in patients about to under chemotherapy has been unresolved for some time. This new provisional clinical opinion from ASCO summarizes the existing evidence and provides practicing oncologists with the practical guidance needed to engage their patients in shared decision-making,” said Charles Penley, MD, Immediate Past Chair, ASCO Clinical Practice Committee.
Talk with your doctor about how to proceed with HBV testing given your current health, current or past HBV infection or exposure, and cancer treatment plan. Preventing reactivation with HBV, which could result in liver failure, is a potential benefit of the HBV test. Some potential harms of this test are that it may result in a delay of beginning chemotherapy, the possibility that antiviral medication could interfere with chemotherapy, and any costs to the patient and doctors from performing the test and evaluating the results.
For More Information
The information in this guide is not intended as medical or legal advice, or as a substitute for consultation with a physician or other licensed health care provider. Patients with health care-related questions should call or see their physician or other health care provider promptly and should not disregard professional medical advice, or delay seeking it, because of information encountered in this guide. The mention of any product, service, or treatment in this guide should not be construed as an ASCO endorsement. ASCO is not responsible for any injury or damage to persons or property arising out of or related to any use of this patient guide, or to any errors or omissions.
ASCO's provisional clinical opinions (PCOs) reflect expert consensus based on clinical evidence and literature available at the time they are written, and are intended to assist physicians in clinical decision-making and identify questions and settings for further research. Due to the rapid flow of scientific information in oncology, new evidence may have emerged since the time a PCO was submitted for publication. PCOs are not continually updated and may not reflect the most recent evidence. PCOs cannot account for individual variation among patients, and cannot be considered inclusive of all proper methods of care or exclusive of other treatments. It is the responsibility of the treating physician or other health care provider, relying on independent experience and knowledge of the patient, to determine the best course of treatment for the patient. Accordingly, adherence to any PCO is voluntary, with the ultimate determination regarding its application to be made by the physician in light of each patient's individual circumstances. ASCO PCOs describe the use of procedures and therapies in clinical practice and cannot be assumed to apply to the use of these interventions in the context of clinical trials. ASCO assumes no responsibility for any injury or damage to persons or property arising out of or related to any use of ASCO's PCOs, or for any errors or omissions.