Comparison of HBV reactivation between patients with high HBV-DNA and low HBV-DNA loads undergoing PD-1 inhibitor and concurrent antiviral prophylaxis
Min-Ke He # 1 , Chuan Peng # 2 , Yang Zhao # 1 , Run-Bin Liang # 1 , Zhi-Cheng Lai 1 , Anna Kan 1 , Qi-Jiong Li 1 , Wei Wei 1 , Yao-Jun Zhang 1 , Min-Shan Chen 1 , Rong-Ping Guo 1 , Ming Shi 3
Affiliations
Affiliations
1
Department of Hepatobiliary Oncology, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, 510060, People's Republic of China.
2
Department of Ultrasonography, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.
3
Department of Hepatobiliary Oncology, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, 510060, People's Republic of China. [email protected].
#
Contributed equally.
PMID: 33813646 DOI: 10.1007/s00262-021-02911-w
Abstract
Background: Programmed cell death protein-1 (PD-1) inhibitor is recommended to treat advanced hepatocellular carcinoma (HCC). However, the safety of PD-1 inhibitor in patients with high HBV-DNA load is unknown because of the potential risk of hepatitis B virus (HBV) reactivation. This study was to compare the HBV reactivation between patients with low HBV-DNA loads and high HBV-DNA loads undergoing antiviral prophylaxis and PD-1 inhibitor.
Methods: This was a retrospective study including consecutive hepatitis B surface antigen-positive HCC patients who received PD-1 inhibitor and concurrent antiviral prophylaxis for prevention of clinical hepatitis. Patients were divided into low HBV-DNA group (low group, ≤ 500 IU/ml) and high HBV-DNA group (high group, > 500 IU/ml) according to the baseline HBV-DNA level. The incidences of HBV reactivation, HBV-associated hepatitis, and PD-1 inhibitor disruption were compared between the two groups.
Results: Two hundred two eligible patients were included: 94 in the low group and 108 in the high group. Seven patients (5 in the low group and 2 in the high group) developed HBV reactivation, and all recovered from HBV reactivation and HBV-associated hepatitis. The incidence of HBV reactivation in the two groups was low (5.3% vs 1.9%, P = 0.34). There was also no difference in the incidence of HBV-associated hepatitis (P = 0.56), or PD-1 inhibitor disruption (P = 0.82). The multivariable analysis showed PD-1 inhibitor with hepatic arterial infusion chemotherapy was the only significant risk factor for HBV reactivation (P = 0.04) and hepatitis (P = 0.002).
Conclusion: With concurrent antiviral prophylaxis, HBV-DNA load higher than 500 IU/ml should not be a contraindication for PD-1 inhibitor.
方法：這是一項回顧性研究，包括連續接受PD-1抑製劑的乙型肝炎表面抗原陽性的HCC患者，同時進行了抗病毒藥物的預防，以預防臨床肝炎。根據基線HBV-DNA水平，將患者分為低HBV-DNA組（低組，≤500 IU / ml）和高HBV-DNA組（高組，> 500 IU / ml）。比較了兩組的HBV激活，HBV相關肝炎和PD-1抑製劑破壞的發生率。