Incidence of Hepatitis B Virus Reactivation in Patients Treated With Immunosuppressive and Chemotherapeutic Agents

Journal article

Background: Data on the incidence of hepatitis B virus reactivation (HBVr) remain limited. In Japan, patients who are HBsAg‐negative and anti‐HBc‐positive with undetectable HBV DNA are monitored without antiviral prophylaxis, allowing the estimation of HBVr incidence. Methods: Using administrative claims data from Japan (2008–2022), we included patients receiving immunosuppressive or chemotherapeutic agents who were HBV DNA‐negative at baseline, underwent at least two HBV DNA tests, and did not receive antiviral therapy. HBVr incidence was estimated and stratified according to AGA guideline–based risk categories. Results: We analysed 9422 patients. In the high‐risk category, HBVr incidence was 52.3 per 1000 person‐years (PY) (95% CI: 37.7–70.7) after anti‐CD20 therapy and 46.5 per 1000 PY (95% CI: 15.1–108.5) after other high‐risk agents. In the moderate‐risk category, incidence was 21.0 per 1000 PY (95% CI: 8.4–43.2) after anthracycline derivatives, 12.1 per 1000 PY (95% CI: 4.9–25.0) after tyrosine kinase inhibitors, and 21.0 per 1000 PY (95% CI: 11.5–35.2) after moderate‐ to high‐dose corticosteroids for ≥ 4 weeks. Low‐dose or short‐term corticosteroids were also associated with HBVr (12.4 per 1000 PY; 95% CI: 9.0–16.6). HBVr also occurred at 12.5 per 1000 PY (95% CI: 2.6–36.6) following other uncertain‐risk immunosuppressive agents, including calcineurin inhibitors. Conclusions: HBVr incidence was quantified across a broad range of immunosuppressive and chemotherapeutic therapies, including those with previously limited incidence data. The observed incidence patterns were broadly consistent with current guideline‐based risk stratification, while also highlighting measurable risk in some therapies traditionally considered lower risk.

Authors: Ikeuchi, K; Saito, M; Okushin, K; Kishida, T; Kado, A

• Publication status: Published
• Peer review status: Peer reviewed
• Publisher: Wiley
• Journal: Alimentary Pharmacology and Therapeutics
• Article number: apt.70749
• Publication date: 2026-05-26
• Acceptance date: 2026-05-19
• DOI: 10.1111/apt.70749
• EISSN: 1365-2036
• ISSN: 0269-2813
• Language: English
• Keywords: chemotherapies; corticosteroids; administrative claims database; risk stratification