Analysis of hepatitis B reactivation risk warning label in drug instructions based on livertox database

Abstract

Abstract: Objective To investigate and analyze the record of 996 drugs associated with hepatitis B reactivation (HBVr) documented in the livertox database, and to compare this information with the HBVr medication warnings provided in the drug instructions. Methods The HBVr prompt information of drugs in the Livertox database was counted and compared with the HBVr medication warning information in the drug instructions included in the DRUGS.dxy.cn. Results The Livertox database contained information on 47 drugs and 1 drug class, all of which had HBVr risk information prompts and were marketed in China. It was concerning to note that glucocorticoid drugs and 10 drug instructions did not mention HBVr risk information, while 2 drug instructions only partially mentioned the risk. Conclusion Drug manufacturer should promptly update drug descriptions and add warning labels based on the latest HBVr risk information. Clinicians and pharmacists need to enhance medication monitoring for patients with viral infection to promote safe drug use.

Key words: Livertox, Drug-induced liver injury, HBV reactivation, Hepatitis B

WU Ling, WEI Long, SU Qiong-li. Analysis of hepatitis B reactivation risk warning label in drug instructions based on livertox database[J]. Chinese Hepatolgy, 2024, 29(1): 81-84.

References

[1] 钟霄,周鹏程,范学工.乙型肝炎病毒再激活概述[J].中国感染控制杂志,2017,16(11):1089-1094.
[2] 蔡庆贤,罗芳,夏章,等.常见抗肿瘤药物所致乙型肝炎病毒再激活的诊疗进展[J].临床内科杂志,2022,39(07):439-444.
[3] Liver Tox:Clinical and Research Information on Drug-Induced Liver Injury[M].Bethesda (MD): National Institute of Diabetes and Digestive and Kidney Diseases; 2012-.https://www.ncbi.nlm.nih.gov/books/NBK547852/
[4] 唐婧,宋微微,艾超.药品说明书中肝功能不全患者用药警示信息标注情况调查分析[J].中国现代应用药学,2020,37(07):873-876.
[5] 尤红,王福生,李太生等.慢性乙型肝炎防治指南(2022年版)[J].实用肝脏病杂志,2023,26(03):457-478.
[6] Papalopoulos I, Fanouriakis A, Kougkas N, et al. Liver safety of non-tumour necrosis factor inhibitors in rheumatic patients with past hepatitis B virus infection: an observational, controlled, long-term study[J]. Clin Exp Rheumatol, 2018,36:102-109.
[7] ZHANG S,JI D,CHEN GF.An excerpt of APASL clinical practice guideline on hepatitis B reactivation related to the use of immunosuppressive therapy ( 2021) [J]. J Clin Hepatol,2021,37( 12) : 2782-2786.
[8] 陈宛丽,姚金晓,杨莹,王舒,刘冰.弥漫大B细胞淋巴瘤患者化疗后HBV再激活的影响因素[J].中华医院感染学杂志,2022,32(18):2803-2807.
[9] 王汇敏,包俊豪,何美芝,等.恩替卡韦和拉米夫定防治血液肿瘤化疗后乙型肝炎病毒再激活的临床研究[J].中国实用内科杂志,2020,40(08):668-670.
[10] Moneva-Leniz LM,Sahuquillo-Torralba A,Vila-Payeras A,et al.Risk of hepatitis B virus reactivation in patientson secukinumab for psoriasis:a series of 4 cases[J].Acta sDermosifiliogr(EnglEd),2020,111(7):613-614.
[11] Chiu HY, Hui RC, Huang YH, et al.Safety profile of secukinumab in treatment of patients with psoriasisand concurrent hepatitis B or C:a multicentric prospective cohort study[J].Acta Derm Venereol,2018,98(9):829-834.
[12] 王惠,凌青霞,庄一心.非小细胞肺癌患者表皮生长因子受体酪氨酸激酶抑制剂治疗中乙肝再激活发生率[J].中国肿瘤临床与康复,2022,29(02):134-137.
[13] Carr A,Cooper DA. Restoration of immunity to chronic hepatitis B infection in HIV-infected patienton protease inhibitor[J].Lancet,1997,349:995-6.
[14] 雷定佳,秦波.免疫检查点抑制剂相关乙型肝炎病毒再激活研究进展[J].肝脏,2022,27(10):1135-1138.
[15] Zhang X, Zhou Y, Chen C, et al. Hepatitis B virus reactivation in cancer patients with positive hepatitis B surface antigen undergoing PD-1 inhibition[J]. J Immunother Cancer, 2019, 7(1):322.
[16] 何林蓉,葛勇鹏,李嗣钊,等.风湿病患者发生传统免疫抑制剂相关乙肝病毒再激活的认识[J].中日友好医院学报,2019,33(05):303-305.
[17] Mo YQ, Liang AQ, Ma JD, et al. Discontinuation of antiviral prophylaxis correlates with high prevalence of hepatitis B virus (HBV) reactivation in rheumatoid arthritis patients with HBV carrier state: a real-world clinical practice[J]. BMC Musculoskelet Disord, 2014, 15: 449.
[18] Roth GS, Decaens T. Liver immunotolerance and hepatocellular carcinoma: Patho-physiological mechanisms and therapeutic perspectives[J]. Eur J Cancer, 2017 Dec;87:101-112.
[19] 耿研,谢希,王昱,等.类风湿关节炎诊疗规范[J].中华内科杂志,2022,61(01):51-59.