The American Gastroenterological Association (AGA) has unveiled an updated clinical practice guideline focusing on the prevention of hepatitis B virus reactivation (HBVr) in individuals at risk. This comprehensive guideline, published in Gastroenterology, aims to provide healthcare providers with a framework to balance desirable and undesirable effects, patient values and preferences, costs, and health equity considerations. The guideline replaces a previous version issued in 2014 concerning prophylaxis for immunosuppressed patients.
The panel, which was solely funded by the AGA, meticulously analyzed 11 studies to compile data necessary for understanding the baseline risk of HBVr in hepatitis C virus (HCV) coinfection cohorts undergoing direct-acting antiviral (DAA) therapy. One notable recommendation is the strong endorsement for hepatitis B testing among at-risk individuals, backed by moderate-certainty evidence.
Key Recommendations and Findings
The guideline's cornerstone recommendation is antiviral prophylaxis over mere monitoring for individuals classified as high risk for HBVr. This preventive strategy should commence before introducing medications that pose a risk for HBVr and should continue for no less than six months after such treatments have concluded. In addition, the guideline places a high value on testing for hepatitis B in patients who prioritize evading even a small risk of reactivation.
"Not every at-risk individual needs pharmacologic treatment, but some certainly do, and this guideline was designed to try to better identify who needs treatment, based on those important drug- and virus-specific factors." – Simon
Individuals who prefer to avoid long-term antiviral therapy due to associated costs may opt for active monitoring instead of prophylaxis. Despite this flexibility, the guideline acknowledges some uncertainty in patient risk categorizations, especially concerning standard immunosuppressive therapies used in autoimmune, rheumatologic, and posttransplant regimens.
Insights into Risk Assessment
The pooled baseline risk for HBVr in patients who were hepatitis B surface antigen (HBsAg)-positive was found to be 240 per 1000, placing them at high risk for reactivation. This finding underscores the importance of prophylactic antiviral therapy for patients who highly value avoiding the reactivation risk. However, the guideline recognizes the necessity for more data to accurately estimate HBVr risk in various contexts, particularly with newly approved immunosuppressive drugs and combination treatments.
"As the armamentarium of immunotherapeutics evolves, it will be crucial to search for, use, and maintain studies that provide baseline HBV serologies; include a clear definition of HBVr; and enroll a large, nonselective cohort that can guide categorization of risk of HBVr," – The panelists
The guideline also highlights changes in the perceived risk levels of certain treatments. For instance, earlier guidance considered anti-TNF therapy as moderate risk for patients who are only hepatitis B core-positive. This has now been reassessed and downgraded to low risk.
"For example, the prior guidance had put anti-TNF as of moderate risk for hepatitis B core–positive-only patients and is now downgraded to low risk." – Kilaru
Addressing Uncertainties and Future Directions
There remain areas of uncertainty that require further clarification. The guideline emphasizes that while some questions were resolved with satisfactory certainty, data scarcity continues to hinder definitive guidance in other areas. This lack of data is particularly evident in estimating HBVr risk with newer immunosuppressive drug therapies.
“For some of the questions, the panel was satisfied with the level of certainty. However, for other questions, the data are still very sparse, and so we have tried to ensure that these areas of uncertainty are highlighted clearly for providers and patients.” – Simon
Adoption of these recommendations may encounter delays, particularly among physicians who have witnessed severe or fatal HBV reactivations recently.
“It may take some time for these recommendations to be adopted, especially for physicians in the community who have seen fatal or severe reactivations in the past few years.” – Kilaru
Leave a Reply