Pharmaceutical care of a case of hepatitis B virus reactivation induced by iparomlimab and tuvonralimab

LI Duohui; XU Jingyu; LI Lin; ZHANG Qian; TANG Liqin; WU Yingqi

doi:10.6039/j.issn.1001-0408.2025.24.17

您当前的位置：

首页 >

文章列表页 >

Pharmaceutical care of a case of hepatitis B virus reactivation induced by iparomlimab and tuvonralimab

更新时间：2025-12-26

- Pharmaceutical care of a case of hepatitis B virus reactivation induced by iparomlimab and tuvonralimab
- ZHONGGUO YAOFANG Vol. 36, Issue 24, Pages: 3113-3117(2025)
- 作者机构：
  
  1.安庆市立医院药事管理科，安徽安庆;246003
  2.淮北市人民医院药学部，安徽淮北　235000
  3.中国科学技术大学附属第一医院（安徽省立医院）药学部，合肥　230001
- 作者简介：
- 基金信息：
- DOI：10.6039/j.issn.1001-0408.2025.24.17
  CLC： R969.3;R979.1
- Received：15 July 2025，
  
  Revised：2025-10-30，
  
  Accepted：10 November 2025，
  
  Published：30 December 2025
- 稿件说明：
移动端阅览
李多慧,许静语,李林,等.艾帕洛利托沃瑞利单抗致乙肝病毒再激活1例的药学监护 ^Δ[J].中国药房,2025,36(24):3113-3117.

LI Duohui,XU Jingyu,LI Lin,et al.Pharmaceutical care of a case of hepatitis B virus reactivation induced by iparomlimab and tuvonralimab[J].ZHONGGUO YAOFANG,2025,36(24):3113-3117.
李多慧,许静语,李林,等.艾帕洛利托沃瑞利单抗致乙肝病毒再激活1例的药学监护 ^Δ[J].中国药房,2025,36(24):3113-3117. DOI： 10.6039/j.issn.1001-0408.2025.24.17.

LI Duohui,XU Jingyu,LI Lin,et al.Pharmaceutical care of a case of hepatitis B virus reactivation induced by iparomlimab and tuvonralimab[J].ZHONGGUO YAOFANG,2025,36(24):3113-3117. DOI： 10.6039/j.issn.1001-0408.2025.24.17.

摘要

目的

介绍1例艾帕洛利托沃瑞利单抗致乙肝病毒（HBV）再激活的病例，汇总分析免疫检查点抑制剂（ICIs）致该不良反应的临床特点及潜在机制，为该药的临床使用提供参考。

方法

从临床药师角度出发，回顾性分析1例转移性宫颈癌患者使用艾帕洛利托沃瑞利单抗后出现HBV再激活的治疗过程，并进行不良反应相关性分析，总结ICIs致HBV再激活的临床特点、危险因素、潜在机制、治疗及药学监护要点。结果与

结论

该患者在使用艾帕洛利托沃瑞利单抗后出现HBV再激活及严重肝损伤，经停药、予甲泼尼龙等对症治疗后病情好转。经诺氏药物不良反应评估量表和我国《药品不良反应报告和监测管理办法》判断，艾帕洛利托沃瑞利单抗与HBV再激活的关联性为“很可能”，且为新的不良反应；艾帕洛利托沃瑞利单抗、紫杉醇与肝损伤的关联性均为“很可能”。接受抗病毒药物规范治疗的乙肝患者在接受ICIs治疗后出现HBV再激活实属罕见；HBV再激活与ICIs致免疫过度激活、破坏免疫平衡有关；临床可予糖皮质激素进行治疗，并行用药前风险评估、治疗期间相关指标监测等药学监护。

Abstract

OBJECTIVE

To report a case of hepatitis B virus （HBV） reactivation induced by iparomlimab and tuvonralimab， summarize the clinical characteristics and potential mechanisms of such adverse reactions induced by immune-checkpoint inhibitors （ICIs）， and provide references for clinical application.

METHODS

From the perspective of a clinical pharmacist， a retrospective analysis was conducted on the treatment course of a patient with metastatic cervical cancer who experienced HBV reactivation after receiving iparomlimab and tuvonralimab. Additionally， an analysis of the correlation with adverse reactions was performed， and the clinical characteristics， risk factors， potential mechanisms， key points of treatment approaches and pharmaceutical care associated with HBV reactivation induced by ICIs were summarized.

RESULTS&CONCLUSIONS

The patient developed HBV reactivation and severe liver injury after using iparomlimab and tuvonralimab. The condition improved following drug discontinuation， and symptomatic treatment such as glucocorticoids. According to Naranjo’s Assessment Scale and China’s

Measures for the Reporting and Monitoring of Adverse Drug Reactions

， the association between iparomlimab and tuvonralimab and HBV reactivation was judged as “highly probable”， and it was identified as a new adverse reaction； the correlation between iparomlimab and tuvonralimab， paclitaxel and liver injury was “highly probable”. HBV reactivation in hepatitis B patients receiving standardized antiviral therapy is very rare after ICIs treatment； HBV reactivation is related to the overactivation of the immune system and disruption of immune balance induced by ICIs. For such patients， glucocorticoids should be administered for treatment， accompanied by pharmaceutical care， including pre-medication risk assessment and monitoring of relevant indicators during treatment.

关键词

Keywords

references

郑荣寿，陈茹，韩冰峰，等 . 2022年中国恶性肿瘤流行情况分析 [J ] . 中华肿瘤杂志， 2024 ， 46 （ 3 ）： 221 - 231 .

FERRALL L ， LIN K Y ， RODEN R B S ， et al . Cervical cancer immunotherapy：facts and hopes [J ] . Clin Cancer Res ， 2021 ， 27 （ 18 ）： 4953 - 4973 .

龙行涛，周琦，林仲秋 . 子宫颈癌免疫检查点抑制剂临床应用指南：2024年版 [J ] . 中国实用妇科与产科杂志， 2024 ， 40 （ 7 ）： 712 - 719 .

PANDEY A ， EZEMENARI S ， LIAUKOVICH M ， et al . A rare case of pembrolizumab-induced reactivation of hepatitis B [J ] . Case Rep Oncol Med ， 2018 ， 2018 ： 5985131.0 .

郑飞跃，吴燕，饶跃峰，等 . 诺氏评估量表在药物不良反应评价中的作用及实例分析 [J ] . 中国药学杂志， 2012 ， 47 （ 8 ）： 650 - 652 .

国家卫生健康委 . 药品不良反应报告和监测管理办法 [EB/OL ] .（ 2011-05-24 ）[ 2025-07-01 ] . https：//www.nhc.gov.cn/fzs/c100048/201105/bc23deb4ba-ae4a39a63e6dc0-94b1c3e4.shtml https://www.nhc.gov.cn/fzs/c100048/201105/bc23deb4ba-ae4a39a63e6dc0-94b1c3e4.shtml .

MUSTAFAYEV K ， TORRES H . Hepatitis B virus and hepatitis C virus reactivation in cancer patients receiving novel anticancer therapies [J ] . Clin Microbiol Infect ， 2022 ， 28 （ 10 ）： 1321 - 1327 .

YOO S ， LEE D B ， SHIM J H ， et al . Risk of hepatitis B virus reactivation in patients treated with immunotherapy for anti-cancer treatment [J ] . Clin Gastroenterol Hepatol ， 2022 ， 20 （ 4 ）： 898 - 907 .

WONG G L ， WONG V W ， HUI V W ， et al . Hepatitis flare during immunotherapy in patients with current or past hepatitis B virus infection [J ] . Am J Gastroenterol ， 2021 ， 116 （ 6 ）： 1274 - 1283 .

ZHANG X Y ， ZHOU Y X ， CHEN C ， et al . Hepatitis B virus reactivation in cancer patients with positive hepatitis B surface antigen undergoing PD-1 inhibition [J ] . J Immu-nother Cancer ， 2019 ， 7 （ 1 ）： 322 .

HUNG Y P ， LEE P C ， CHANG Y H ， et al . Hepatic events during immune checkpoint inhibitor treatment between liver and non-liver malignancies in hepatitis B endemic areas [J ] . Aliment Pharmacol Ther ， 2025 ， 61 （ 3 ）： 501 - 512 .

SZNOL M ， FERRUCCI P F ， HOGG D ， et al . Pooled analysis safety profile of nivolumab and ipilimumab combination therapy in patients with advanced melanoma [J ] . J Clin Oncol ， 2017 ， 35 （ 34 ）： 3815 - 3822 .

ZHAO Y Y ， MA Y X ， ZANG A M ， et al . First-in-human phase Ⅰ/Ⅰb study of QL1706（PSB205），a bifunctional PD1/CTLA-4 dual blocker，in patients with advanced solid tumors [J ] . J Hematol Oncol ， 2023 ， 16 （ 1 ）： 50 .

KEAM S J . Iparomlimab and tuvonralimab：first approval [J ] . Drugs ， 2025 ， 85 （ 5 ）： 699 - 706 .

CHO H ， KANG H ， KIM C W ， et al . Phenotypic characte-ristics of PD-1 and CTLA-4 expression in symptomatic acute hepatitis A [J ] . Gut Liver ， 2016 ， 10 （ 2 ）： 288 - 294 .

KNOLLE P A ， THIMME R . Hepatic immune regulation and its involvement in viral hepatitis infection [J ] . Gastroenterology ， 2014 ， 146 （ 5 ）： 1193 - 1207 .

FRANCESCHINI D ， PAROLI M ， FRANCAVILLA V ， et al . PD-L1 negatively regulates CD4 + CD25 + Foxp3 + Tregs by limiting STAT-5 phosphorylation in patients chronically infected with HCV [J ] . J Clin Invest ， 2009 ， 119 （ 3 ）： 551 - 564 .

ASANO T ， KISHI Y ， MEGURI Y ， et al . PD-1 signaling has a critical role in maintaining regulatory T cell homeo-stasis；implication for Treg depletion therapy by PD-1 blockade [J ] . Blood ， 2015 ， 126 （ 23 ）： 848 .

YI M ， ZHENG X L ， NIU M K ， et al . Combination strategies with PD-1/PD-L1 blockade：current advances and future directions [J ] . Mol Cancer ， 2022 ， 21 （ 1 ）： 28 .

邹海，杨云松，陈臻瑶，等 . CSCO和NCCN及ASCO指南对免疫检查点抑制剂相关肝毒性管理的比较 [J ] . 医药导报， 2025 ， 44 （ 6 ）： 841 - 846 .

中华医学会，中华医学会杂志社，中华医学会肝病分会药物性肝病学组，等 . 中国药物性肝损伤基层诊疗与管理指南：2024年 [J ] . 中华全科医师杂志， 2024 ， 23 （ 8 ）： 813 - 830 .

DEEPAN N ， MAUNG S T ， DECHARATANACHART P ， et al . Hepatitis B virus reactivation in cancer patients receiving chemotherapy：a systematic review and meta-analysis [J ] . Semin Oncol ， 2024 ， 51 （ 5/6 ）： 123 - 134 .

Views

下载量

CSCD

Alert me when the article has been cited

提交

Tools

Publicity Resources

Pharmaceutical care for a patient with visual abnormalities induced by oxaliplatin by clinical pharmacists

Pharmaceutical care for the HIV-negative patient with disseminated Talaromyces marneffei osteomyelitis complicated by pulmonary tuberculosis

Expert consensus on rational medication management of targeted PI3K/Akt/mTOR inhibitors in breast cancer

Individualized treatment and pharmaceutical care for breast cancer complicated with chronic kidney disease

Pharmaceutical care of anti-infective treatment for a case of pulmonary infection due to Alternaria alternata after renal transplantation

Related Author

ZHANG Yang

CHEN Shuhe

GAO Yue

ZHANG Qinghua

HE Liting

Writing Group of Expert Consensus on Rational Medication Management of Targeted PI3K/Akt/mTOR Inhibitors in Breast Cancer

任天舒

赵庆春

Related Institution

Hubei Academy of Traditional Chinese Medicine

Dept. of Pharmacy， the Affiliated Hospital of Hubei University of Chinese Medicine

Dept. of Pharmacy， Hubei Provincial Hospital of TCM

Dept. of Pharmacy， Jiangmen Central Hospital

Dept. of Internal Medicine， Zhonggongmiao Community Hospital of Ningbo Yinzhou District No.2 Hospital Medical Community

⁰