【作者】 任姗； 金怡； 黄燕翔； 马丽娜； 何智敏； 谢立； 陈新月；

【Author】 Shan Ren;Yi Jin;Yanxiang Huang;Lina Ma;Li Xie;Xinyue Chen;Beijing You’an Hospital,Capital Medical University;Beijing Municipal Liver Diseases Institute;

【机构】 首都医科大学附属北京佑安医院肝病综合科； 北京市肝炎研究所；

【摘要】 目的随着聚乙二醇干扰素及利巴韦林(PR)联合丙型肝炎病毒(HCV)蛋白酶抑制剂三联(Triple)方案抗病毒治疗开始应用于基因1b亚型的慢性丙型肝炎(CHC)患者以来,关于HCV非结构蛋白3抗原(NS3Ag)检测联合HCV RNA用于预测其治疗应答的研究逐渐用于临床。我们拟探讨HCV NS3Ag预测基因1b亚型CHC患者予以PR及Triple方案抗病毒治疗疗效分析。方法我们入组300例基因1b亚型CHC患者,28例进行Triple治疗,272例进行PR治疗,治疗基线、2周、4周、12周、24周、48周及72周同时进行HCV RNA及NS3Ag检测,比较HCVRNA与NS3Ag之间的相关性,分析NS3Ag变化对治疗应答的预测价值。结果在全部患者中HCV RNA与HCV NS3Ag存在较好的线性相关性(r=0.67),这种相关性在Triple治疗组中更为显著(r=0.89)。PR方案中获得RVR且4周HCV NS3Ag下降(dHCV NS3Ag)大于0.775患者获得SVR的阳性预测值(PPV)及阴性预测值(NPV)分别为96.31%和67.19%,12周获得c EVR且dHCV NS3Ag大于0.832患者获得SVR的PPV及NPV分别为94.16%,和87.26%。最为有趣的是,HCV RNA转阴后dHCV NS3Ag不足0.525患者出现复发及病毒学反弹的PPV为90.6%,NV76.7%。结论 NS3Ag检测可作为一种有效检测方案,与HCV RNA共同早期预测PR或是Triple治疗的应答率,以及复发和病毒学反弹的几率,避免不良反应的增加以及过度医疗的产生。更多还原

【Abstract】 Since hepatitis C virus(HCV) non-structural 3(NS3) protease inhibitor(PI) combined with pegylated interferon/ribavirin(PR) has been approved for chronic HCV genotype(GT)1 b infection,a more reliable and clinically useful predictor combined with HCV RNA detection to predict earlier virologic response and breakthrough or relapse is therefore required in clinical practice.We evaluated early predictive efficacy of serum HCV NS3 antigen(Ag) kinetics on virologic response in patients with GT1 b HCV during PR or PR/Simeprevir(Triple) therapy.For 300 patients recruited,HCV RNA and HCV NS3 Ag were detected at baseline,and at weeks 2,4,12,24,48,and 72.Correlation of HCV RNA and HCV NS3 Ag in all patients was pretty good(r=0.67).HCV RNA and HCV NS3 Ag kinetics were similar during follow-up of Triple therapy,correlation of two marker was excellent(r=0.89).For patients with PR therapy at week4,the positive and negative predictive values(PPV and NPV) of decrease in total of NS3 Ag(dHCV NS3 Ag) more than 0.775 combined with HCV RNA undetective(RVR) for SVR were 96.31% and 67.19%,respectively,while at week 12(dHCV NS3 Ag more than 0.832 and cEVR) they were 94.16%,87.26%,respectively.Especially for relapse and breakthrough,we found that PPV and NPV of dHCV NS3 Ag less than 0.525 were 90.6% and 76.7%.HCV NS3 Ag assay appears a useful,valuable test,could be a supplementary predictor to HCV RNA in PR and Triple treatment,and differentiate breakthrough or relapse,thus,could avoid side effects and expense for these patients.更多还原