Risk of Hepatitis B Virus Reactivation in Patients Treated With Immunotherapy for Anti-cancer Treatment
Abstract
Background & aims Hepatitis B virus (HBV) reactivation is a well-known complication in patients with chronic hepatitis B treated with cytotoxic chemotherapy. However, the risk of HBV reactivation through use of immune checkpoint inhibitors (ICIs) is not well understood. Therefore, we aimed to evaluate the risk of HBV reactivation and hepatic adverse events in patients with cancer receiving ICIs according to cancer type and virologic serology. Methods This historical cohort study included 3465 patients with cancer treated with ICIs between January 2015 and September 2020. The primary outcome was the occurrence of HBV reactivation, and the secondary outcome was presence of hepatic adverse events during ICI treatment. Results The mean patient age was 62.2 years, and 68.8% of patients were men. Of the 3465 eligible patients, 511 (14.7%) showed hepatitis B surface antigen (HBsAg) positivity. The incidence rates of HBV reactivation of the total patients, HBsAg-positive patients, and HBsAg-negative patients were 0.14% (5/3465), 1.0% (5/511), and 0.0% (0/2954), respectively. Among HBsAg-positive patients, HBV reactivation occurred at a rate of 0.5% (2/409) and 2.9% (3/102) in patients with and without hepatocellular carcinoma, respectively. The HBV reactivation rates were 0.4% (2/464) and 6.4% (3/47) in patients with and without antiviral prophylaxis, respectively. Grade 3-4 hepatitis occurred in 23 (4.5%) HBsAg-positive, and 218 (7.4%) HBsAg-negative patients. No HBV-related fatality occurred. Only 2 patients (0.4%) experienced HBsAg seroclearance after ICI treatment among HBsAg-positive patients. Conclusions In general, HBV reactivation was rarely observed in patients with antiviral prophylaxis while undergoing ICI treatment. However, HBV reactivation may occur in HBsAg-positive patients without antiviral prophylaxis or noncompliant with antiviral prophylaxis.
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Early studies have demonstrated that in patients with chronic HBV infection undergoing ICI therapy, the addition of intensified antiviral treatment can significantly reduce the risk of viral reactivation.
“Early studies have demonstrated that in patients with chronic HBV infection undergoing ICI therapy, the addition of intensified antiviral treatment can significantly reduce the risk of viral reactivation150,151.”
From Microbiome meets immunotherapy: unlocking the hidden predictors of immune checkpoint inhibitors (2025) · cites this paper as [150]
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- Authors
- Yoo, S., Lee, D., Shim, J. H., Kim, K. M., Lim, Y.-S., Lee, H. C., Yoo, C., Ryoo, B.-Y., & Choi, J.
- Affiliations
- Asan Medical Center (KR)
- Corresponding author
- Choi, Jonggi
- ORCID
- Venue
- Clinical Gastroenterology and Hepatology
- Publisher
- Elsevier BV
- Published
- 2022-04
- Volume
- 20
- Issue
- 4
- Pages
- 898-907
- ISSN
- 1542-3565 (ISSN-L)
- OpenAlex
- W3176511332
- Cited by
- 73
- References
- 29
- Citations by year
- 2026: 8 · 2025: 14 · 2024: 22 · 2023: 16 · 2022: 12 · 2021: 1
- FWCI
- 9.23
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Clinical Gastroenterology and Hepatology (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Epidemiology › Hepatitis B Virus Studies
- Health Sciences › Medicine › Hepatology › Hepatitis C virus research
- Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
- Keywords
- HBV reactivation, immune checkpoint inhibitors, cancer immunotherapy, HBsAg seropositivity, antiviral prophylaxis, hepatocellular carcinoma, hepatic adverse events, HBsAg loss
- MeSH terms
- Antiviral Agents, Hepatitis B, Hepatitis B Surface Antigens, Hepatitis B virus, Carcinoma, Hepatocellular, Humans, Immunotherapy, Liver Neoplasms, Male, Middle Aged, Virus Activation, Cohort Studies
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