Bethesda, MD (Feb. 6, 2015) -- Long-term immunosuppressive therapy can cause the hepatitis B virus (HBV) to become active, even in patients who are not aware that they are infected with the virus. A new guideline from the American Gastroenterological Association (AGA) provides guidance to physicians and patients who use immunosuppressive agents for the treatment of a variety of disorders, including gastrointestinal, dermatologic, neurologic and rheumatologic, among others. The new guideline1 and accompanying technical review2 and clinical decision support tool3 have been published in Gastroenterology, the official journal of the AGA Institute.
"Many specialists are unaware that they should conduct hepatitis B screening on their patients prior to beginning long-term immunosuppressive therapy," according to K. Rajender Reddy, MD, lead author of the guidelines, from the division of gastroenterology and hepatology, University of Pennsylvania, Philadelphia. "Preventing HBV reactivation in these patients involves screening those at risk, identifying patients for risk based on HBV serologic status and the type of immunosuppression, and consideration of prophylaxis with anti-hepatitis B therapeutics."
Several aspects of HBVr prevention remain unclear, including which patients to screen, in whom to use which HBV preventive therapies and for how long, and how to monitor those at risk but not on preventive therapy.
AGA developed the guideline using Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology and best practices as outlined by the Institute of Medicine. Despite a large number of published studies, in most cases the recommendations for prophylaxis are weak because either the quality of the available data and/or the baseline risk of HBVr is low or uncertain, and/or risks and benefits for a particular strategy do not overwhelmingly support its use.
Recognizing these and other limitations, the recommendations included here represent a rigorous, evidence-based summary of extensive literature describing the prevention of HBVr. Review of this guideline, plus the associated technical review, will facilitate effective shared decision making with patients at risk for HBVr.
1& 2. Is antiviral prophylaxis needed for hepatitis B surface antigen-positive patients who will undergo immunosuppressive drug therapy? Is antiviral prophylaxis needed for hepatitis B surface antigen-negative, antibody to hepatitis B core antigen-positive patients who will undergo immunosuppressive drug therapy?
- AGA recommends antiviral prophylaxis over no prophylaxis for patients at high risk (>10 percent risk of reactivation) undergoing immunosuppressive drug therapy. (Strong recommendation; moderate-quality evidence)
- AGA suggests antiviral prophylaxis over monitoring for patients at moderate risk (1 to 10 percent risk of reactivation) undergoing immunosuppressive drug therapy. (Weak recommendation; moderate-quality evidence)
- AGA suggests against routinely using antiviral prophylaxis in patients undergoing immunosuppressive drug therapy who are at low risk (<1 percent risk of reactivation) for HBVr. (Weak recommendation; moderate-quality evidence)
Read the guideline to review the complete definition for each risk group.
3. Does the presence of antibody to hepatitis B surface antigen in addition to anti-HBc in HBsAg-negative patients confer additional protection against HBVr?
- AGA suggests against using anti-HBs status to guide antiviral prophylaxis for all risk groups. (Weak recommendation; very low-quality evidence)
4. Is prophylactic treatment with third-generation nucleos(t)ide analogues more effective than first- or second-generation nucleos(t)ide agents?
- >AGA suggests use of antiviral drugs with a high barrier to resistance over lamivudine for prophylaxis in patients undergoing immunosuppressive drug therapy. (Weak recommendation; moderate-quality evidence)
5. Is HBV DNA monitoring followed by on-demand antiviral therapy as effective as prophylactic antiviral therapy?
- AGA makes no recommendation for a strategy of HBV DNA monitoring followed by rescue treatment as an alternative to antiviral prophylaxis. (No recommendation - knowledge gap)
6. Is treatment of established HBVr with third-generation nucleos(t)ide agents more effective than first- or second-generation drugs?
- AGA recommends antiviral drugs with a high barrier to resistance over lamivudine for established HBVr in patients undergoing immunosuppressive drug therapy. (Strong recommendation; moderate-quality evidence)
7. Should patients who will undergo long-term immunosuppressive drug therapy be screened for HBV before starting treatment?
- AGA recommends screening for HBV (HBsAg and anti-HBc, followed by a sensitive HBV DNA test if positive) in patients at moderate or high risk who will undergo immunosuppressive drug therapy. (Strong recommendation; moderate-quality evidence)
- AGA suggests against routinely screening for HBV in patients who will undergo immunosuppressive drug therapy and are at low risk. (Weak recommendation; moderate-quality evidence)
###
Read the "American Gastroenterological Association Institute Guideline on the Prevention and Treatment of Hepatitis B Virus Reactivation During Immunosuppressive Drug Therapy" to review the prevention and treatment recommendations in its entirety.
To learn more about hepatitis, read the AGA patient brochure.
AGA's guidelines are created using a process that employs the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology. GRADE has been adopted by several national and international societies, including AGA, and is becoming the common methodology for the streamlined and rigorous development of clear, transparent and actionable guidelines.
1 Reddy KR et al. American Gastroenterological Association Institute Guideline on the Prevention and Treatment of Hepatitis B Virus Reactivation During Immunosuppressive Drug Therapy. Gastroenterology 2015;148(1): 215-219.
2 Perrillo RP et al. American Gastroenterological Association Institute Technical Review on Prevention and Treatment of Hepatitis B Virus Reactivation During Immunosuppressive Drug Therapy. Gastroenterology 2015;148(1): 221-244.e3.
3 AGA Institute Guidelines on Hepatitis B Reactivation (HBVr): Clinical Decision Support Tool. Gastroenterology 2015;148(1): 220.
About the AGA Institute
The American Gastroenterological Association is the trusted voice of the GI community. Founded in 1897, the AGA has grown to include more than 16,000 members from around the globe who are involved in all aspects of the science, practice and advancement of gastroenterology. The AGA Institute administers the practice, research and educational programs of the organization. http://www.gastro.org.
About Gastroenterology
Like AGA and Gastroenterology on Facebook.
Join AGA on LinkedIn.
Follow us on Twitter @AmerGastroAssn.
Check out our videos on YouTube.
Journal
GASTROENTEROLOGY