Risk of Hepatitis B Virus Reactivation in Patients Treated with Immunotherapy for Anti-cancer Treatment.

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Hepatitis B virus (HBV) reactivation is a well-known complication in patients with chronic hepatitis B (CHB) 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.This historical cohort study included 3,465 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.The mean patient age was 62.2 years and 68.8% of patients were men. Of the 3,465 eligible patients, 511 (14.7%) showed HBsAg positivity. The incidence rates of HBV reactivation of the total patients, HBsAg-positive patients, and HBsAg-negative patients were 0.14% (5/3,465), 1.0% (5/511), and 0.0% (0/2,954), 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 HCC, 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 two patients (0.4%) experienced HBsAg seroclearance after ICI treatment among HBsAg-positive patients.In general, HBV reactivation was rarely observed in patients with antiviral prophylaxis while undergoing ICIs treatment. However, HBV reactivation may occur in HBsAg-positive patients without antiviral prophylaxis or non-compliant with antiviral prophylaxis.

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Authors: Sun Yoo, Danbi Lee, Ju Hyun Shim, Kang Mo Kim, Young-Suk Lim, Han Chu Lee, Changhoon Yoo, Baek-Yeol Ryoo, Jonggi Choi