AGA urges antiviral prophylaxis for patients at high risk for hepatitis B reactivation
Key takeaways:
- AGA guidance strongly recommends antiviral prophylaxis for patients at high risk for hepatitis B reactivation.
- At-risk patients not recommended for antiviral prophylaxis should be actively monitored.
In a new clinical practice guideline, the AGA provided evidence-based recommendations for either antiviral prophylaxis or continued surveillance to manage hepatitis B virus reactivation in patients receiving immunosuppressive therapy.
“HBV reactivation is generally a consequence of chronic immunosuppression, induced either by drug therapy or by pathologic immunosuppression,” Faisal S. Ali, MD, from the division of gastroenterology and hepatology at Beth Israel Deaconess Medical Center, and colleagues wrote in Gastroenterology. “The incidence of HBV reactivation varies by the degree and mechanism of immunosuppression.”
They continued, “This guideline update aims to address the wide range of exposures that are suspected to increase the risk of HBV reactivation, and for which guideline recommendations currently do not exist.”
Since the last AGA guidance on HBV reactivation was published in 2014, immunosuppressive therapies have proliferated with a considerable uptick in immune checkpoint inhibitors, anti-interleukin therapies, Janus kinase (JAK) inhibitors, anti-tumor necrosis factor therapies, chimeric antigen receptor T-cell (CAR T-cell) therapies, cytokine/integrin inhibitor therapies and tyrosine kinase inhibitors (TKIs).
Using the evidence-to-decision framework, Ali and colleagues developed recommendations based on patient HBV infection status — hepatitis B surface antigen positive vs. HBsAg negative/anti-HB core antibody (HBc)-positive — and risk for reactivation based on the specific immunosuppressive therapies they received.
For patients at high risk (>10%) for HBV reactivation, the AGA strongly recommends antiviral prophylaxis vs. monitoring alone. Exposures include:
- HBsAg-positive group: Anthracycline derivatives, anti-TNF agents, anti-IL-6 agents, B-cell-depleting agents, CAR T-cell therapy, cytokine/integrin inhibitors, transcatheter arterial chemoembolization (TACE), TKIs, JAK inhibitors, HCV coinfection undergoing direct-acting antiviral therapy and moderate/high-dose corticosteroids for at least 4 weeks.
- HBsAg-negative/anti-HBc-positive group: B-cell-depleting agents
Among patients at moderate risk (1%-10%) for HBV reactivation, the AGA conditionally recommends antiviral prophylaxis vs. monitoring alone. Exposures include:
- HBsAg-positive group: Anti-T-cell therapy and low-dose corticosteroids for at least 4 weeks.
- HBsAg-negative/anti-HBc-positive group: Anthracycline derivatives, anti-IL-6 therapy, anti-T-cell therapy, CAR T-cell therapy, cytokine/integrin inhibitors, TACE, TKIs, JAK inhibitors and moderate/high-dose corticosteroids for at least 4 weeks.
Among patients at low risk (<1%) for HBV reactivation, the AGA conditionally recommends monitoring alone vs. antiviral prophylaxis. Exposures include:
- HBsAg-positive group: Low/moderate/high-dose corticosteroids for no more than 1 week and intra-articular corticosteroids.
- HBsAg-negative/anti-HBc-positive group: Low-dose corticosteroids for at least 4 weeks, immune checkpoint inhibitors, anti-TNF therapy, HCV coinfection undergoing DAA therapy, intra-articular corticosteroids and low/moderate/high-dose corticosteroids for no more than 1 week.
Lastly, among patients with only a potential risk for HBV reactivation, the AGA strongly recommends testing the patient for HBV, first for serologic markers alone to determine whether the patient is HBsAg or anti-HBc positive and then by viral load.
“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 HBV reactivation; and enroll a large, nonselective cohort that can guide categorization of risk of HBV reactivation,” Ali and colleagues wrote. “Although we were able to generate updated guidance and include new therapies in our risk categories, there remains uncertainty in certain risk categorizations.”
The researchers noted that “technological innovation may enable the establishment and maintenance of an online repository that is updated periodically to provide accurate estimates of baseline risk of HBV reactivation for different exposures of interest; this should be an area of future research.”
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