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    Liver and Bile

    Clin Gastroenterol Hepatol. 2022;20(4):898–907

    Yoo S, Lee D, Shim JH, Kim KM, Lim YS, Lee HC, Yoo C, Ryoo BY, Choi J

    Risk of hepatitis B virus reactivation in patients treated with immunotherapy for anti-cancer treatment


    Background and 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, the authors 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, hepatitis B virus (HBV) reactivation was rarely observed in patients with antiviral prophylaxis while undergoing treatment with immune checkpoint inhibitors. However, HBV reactivation may occur in hepatitis B surface antigen-positive patients without antiviral prophylaxis or noncompliant with antiviral prophylaxis.

    Prof. Dr. J. Choi, Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea,
    E-Mail: j.choi@amc.seoul.kr

    DOI: DOI: 10.1016/j.cgh.2021.06.019

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