慢性丙型肝炎患者对直接抗病毒药物无应答的简单预测指标

Simple predictors of nonresponse to direct-acting antivirals in chronic hepatitis C patients.

作者信息

Shousha Hend Ibrahim, Saad Yasmin, Saleh Doa'a A, Dabes Hosam, Alserafy Magdy, ElShazly Yehia, Said Mohamed

机构信息

Department of Endemic Medicine and Hepato-gastroenterology.

Department of Public Health and Community Medicine, Faculty of Medicine, Cairo University, Cairo.

出版信息

Eur J Gastroenterol Hepatol. 2020 Aug;32(8):1017-1022. doi: 10.1097/MEG.0000000000001612.

DOI:10.1097/MEG.0000000000001612

PMID:31789947

Abstract

OBJECTIVES

The introduction of direct acting antivirals (DAAs) has resulted in very high sustained virological response rates (SVR) in patients with chronic hepatitis-C (CHC). There are still a minority who fails to achieve SVR. This study aims to identify simple factors associated with nonresponse to DAAs using routine pretreatment workup.

METHODS

A retrospective study included 10 655 CHC patients who were candidates for anti-viral therapy. Pretreatment demographics, laboratory results, ultrasonography and FIB-4were obtained.

RESULTS

At post-treatment week 4, 10 495 patients (98.5%) were responders and 160 (1.5%) were non-responders. About 50.6% of non-responders were males and 61.3% were cirrhotic. Non-responders had significantly higher baseline BMI, liver enzymes, AFP and a significantly lower albumin, platelet count by univariate analysis ((P < 0.001). Sex, previous treatment, BMI, liver cirrhosis, AST, Albumin and platelet counts were the independent predictors of non-response. At post-treatment week 12, HCV-PCR results were available only for 7259 patients and 210 (2.9%) were non-responders. 54.8% of non-responders were cirrhotic and 51.4% were males. Non-responders had significantly higher AST, AFP and INR and a significantly lower albumin level, platelet count by univariate analysis (P < 0.05). Sex, previous treatment, AST, Albumin, WBC and platelet counts were the independent predictors of non-response. SVR-4 among treatment naive patients was 98.6% while among treatment experienced was 96.8%. SVR-12 among treatment naive patients was 97.9% while among treatment experienced was 87.9%.Cirrhotics had SVR-4 rate 97.7% and SVR-12 rate 96.21%.

CONCLUSION

Routine pre-treatment work up for HCV G4 patients receiving DAAs can help in prediction of non-response.

摘要

目的

直接抗病毒药物（DAA）的引入使慢性丙型肝炎（CHC）患者的持续病毒学应答率（SVR）非常高。仍有少数患者未能实现SVR。本研究旨在通过常规治疗前检查确定与DAA无应答相关的简单因素。

方法

一项回顾性研究纳入了10655例适合抗病毒治疗的CHC患者。获取了治疗前的人口统计学数据、实验室检查结果、超声检查和FIB-4。

结果

治疗后第4周，10495例患者（98.5%）有应答，160例（1.5%）无应答。约50.6%的无应答者为男性，61.3%为肝硬化患者。单因素分析显示，无应答者的基线BMI、肝酶、甲胎蛋白水平显著更高，白蛋白、血小板计数显著更低（P<0.001）。性别、既往治疗、BMI、肝硬化、谷草转氨酶、白蛋白和血小板计数是无应答的独立预测因素。治疗后第12周，仅7259例患者有丙型肝炎病毒聚合酶链反应（HCV-PCR）结果，210例（2.9%）无应答。54.8%的无应答者为肝硬化患者，51.4%为男性。单因素分析显示，无应答者的谷草转氨酶、甲胎蛋白和国际标准化比值显著更高，白蛋白水平、血小板计数显著更低（P<0.05）。性别、既往治疗、谷草转氨酶、白蛋白、白细胞和血小板计数是无应答的独立预测因素。初治患者的SVR-4为98.6%，经治患者为96.8%。初治患者的SVR-12为97.9%；经治患者为87.9%。肝硬化患者的SVR-4率为97.7%，SVR-12率为96.21%。