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基于聚乙二醇干扰素治疗慢性丙型肝炎持续病毒学应答的预测:来自巴西南里奥格兰德州队列的回归分析

Prediction of Sustained Virological Response to Peginterferon-based Therapy for Chronic Hepatitis C: Regression Analysis of a Cohort from Rio Grande do Sul, Brazil.

作者信息

V Picon Rafael, Fendt Lúcia, Amaral Karine, D Picon Paulo

机构信息

Department of Gastroenterology, Hospital Nossa Senhora da Conceição, Porto Alegre, Rio Grande do Sul, Brazil.

Department of Critical Care, Hospital de Clínicas de Porto Alegre, Porto Alegre, Rio Grande do Sul, Brazil.

出版信息

Euroasian J Hepatogastroenterol. 2017 Jan-Jun;7(1):27-33. doi: 10.5005/jp-journals-10018-1207. Epub 2017 May 5.

DOI:10.5005/jp-journals-10018-1207
PMID:29201768
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5663770/
Abstract

AIM

Peginterferon plus ribavirin (peg-IFN/RBV) is still the standard of care for treatment of hepatitis C virus (HCV) in many countries. Given the high toxicity of this regimen, our study aimed to develop a prediction tool that can identify which patients are unlikely to benefit from peg-IFN/RBV and could thus postpone treatment in favor of new-generation direct-acting antivirals.

MATERIALS AND METHODS

Binary regression was performed using demographic, clinical, and laboratory covariates and sustained virological response (SVR) outcomes from a prospective cohort of individuals referred for therapy from 2003 to 2008 in a public HCV treatment center in Rio Grande do Sul, Brazil.

RESULTS

Of the 743 participants analyzed, 489 completed 48 weeks of treatment (65.8%). A total of 202 of those who completed peg-IFN/RBV therapy achieved SVR (27.2% responders), 196 did not (26.4%), and 91 had missing viral load (VL) at week 72 (12.2% loss to follow-up). The remainder discontinued therapy (n = 254 [34.2%]), 78 (30.7%) doing so due to adverse effects. Baseline covariates included in the regression model were sex, age, human immunodeficiency virus, infection status, aspartate transaminase, alanine transaminase, hemoglobin, platelets, serum creatinine, prothrombin time, pretreatment VL, cirrhosis on liver biopsy, and treatment naivety. A predicted SVR of 17.9% had 90.0% sensitivity for detecting true nonresponders. The negative likelihood ratio at a predicted SVR of 17.9% was 0.16, and the negative predictive value was 92.6%.

CONCLUSION

Easily obtainable variables can identify patients that will likely not benefit from peg-IFN-based therapy. This prediction model might be useful to clinicians.

CLINICAL SIGNIFICANCE

To our knowledge, this is the only prediction tool that can reliably help clinicians to postpone peg-IFN/RBV therapy for HCV genotype 1 patients. Picon RV, Fendt L, Amaral K, Picon PD. Prediction of Sustained Virological Response to Peginterferon-based Therapy for Chronic Hepatitis C: Regression Analysis of a Cohort from Rio Grande do Sul, Brazil. Euroasian J Hepato-Gastroenterol 2017;7(1):27-33.

摘要

目的

在许多国家,聚乙二醇干扰素联合利巴韦林(peg-IFN/RBV)仍是丙型肝炎病毒(HCV)治疗的标准方案。鉴于该方案毒性较高,我们的研究旨在开发一种预测工具,以识别哪些患者不太可能从peg-IFN/RBV治疗中获益,从而推迟治疗,转而采用新一代直接抗病毒药物。

材料与方法

使用人口统计学、临床和实验室协变量以及2003年至2008年在巴西南里奥格兰德州一家公共HCV治疗中心接受治疗的前瞻性队列个体的持续病毒学应答(SVR)结果进行二元回归分析。

结果

在分析的743名参与者中,489人完成了48周的治疗(65.8%)。在完成peg-IFN/RBV治疗的患者中,共有202人实现了SVR(应答者占27.2%),196人未实现(占26.4%),91人在第72周时病毒载量(VL)缺失(随访失访率为12.2%)。其余患者中断治疗(n = 254 [34.2%]),其中78人(30.7%)因不良反应中断治疗。回归模型中纳入的基线协变量包括性别、年龄、人类免疫缺陷病毒感染状态、天冬氨酸转氨酶、丙氨酸转氨酶、血红蛋白、血小板、血清肌酐、凝血酶原时间、治疗前VL、肝活检显示的肝硬化以及未接受过治疗。预测SVR为17.9%时,检测真正无应答者的敏感性为90.0%。预测SVR为17.9%时的阴性似然比为0.16,阴性预测值为92.6%。

结论

易于获取的变量可识别可能无法从基于peg-IFN的治疗中获益的患者。该预测模型可能对临床医生有用。

临床意义

据我们所知,这是唯一一种能够可靠地帮助临床医生为HCV 1型患者推迟peg-IFN/RBV治疗的预测工具。皮康·RV、芬特·L、阿马拉尔·K、皮康·PD。慢性丙型肝炎基于聚乙二醇干扰素治疗的持续病毒学应答预测:来自巴西南里奥格兰德州队列的回归分析。《欧亚肝脏胃肠病学杂志》2017;7(1):27 - 33。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/30e9/5663770/8fa47f8d7722/ejohg-07-027-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/30e9/5663770/35f4998c0da5/ejohg-07-027-g001.jpg
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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/30e9/5663770/8fa47f8d7722/ejohg-07-027-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/30e9/5663770/35f4998c0da5/ejohg-07-027-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/30e9/5663770/47816861359a/ejohg-07-027-i001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/30e9/5663770/54de6ed0ee69/ejohg-07-027-i002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/30e9/5663770/7ac78ab42275/ejohg-07-027-i003.jpg
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