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儿童慢性丙型肝炎病毒感染的治疗:欧洲儿科胃肠病学、肝病学和营养学会肝病委员会立场文件

Treatment of Chronic Hepatitis C Virus Infection in Children: A Position Paper by the Hepatology Committee of European Society of Paediatric Gastroenterology, Hepatology and Nutrition.

作者信息

Indolfi Giuseppe, Hierro Loreto, Dezsofi Antal, Jahnel Jörg, Debray Dominique, Hadzic Nedim, Czubkowski Piotr, Gupte Girish, Mozer-Glassberg Yael, van der Woerd Wendy, Smets Françoise, Verkade Henkjan J, Fischler Björn

机构信息

Paediatric and Liver Unit, Meyer Children's University Hospital of Florence, Firenze, Italy.

Pediatric Liver Service Hospital Infantil Universitario La Paz, Madrid, Spain.

出版信息

J Pediatr Gastroenterol Nutr. 2018 Mar;66(3):505-515. doi: 10.1097/MPG.0000000000001872.

Abstract

OBJECTIVES

In 2017, the European Medicines Agency and the Food and Drug Administration approved the use of the fixed-dose combination of ledipasvir/sofosbuvir and of the combination of sofosbuvir and ribavirin for treatment of adolescents (12-17 years or weighing >35 kg) with chronic hepatitis C virus (HCV) genotype 1, 4, 5, and 6 and genotype 2 and 3 infections, respectively. Although trials with direct-acting antivirals are ongoing for younger children, the only available treatment in the United States and Europe for those <12 years is still the dual therapy of pegylated interferon and ribavirin. There is currently a lack of a systematic approach to the care of these patients. The Hepatology Committee of the European Society of Pediatric Gastroenterology, Hepatology and Nutrition developed an evidence-based position paper for the management of chronic HCV infection in children.

METHODS

A systematic literature search and meta-analysis were performed using MEDLINE and Embase from June 1, 2007 to June 1, 2017. The approach of the Grading of Recommendations Assessment, Development and Evaluation was applied to evaluate outcomes. European Society of Pediatric Gastroenterology, Hepatology and Nutrition Committee members voted on each recommendation, using the nominal voting technique.

RESULTS

The efficacy of the different direct-acting antivirals combinations tested was higher, the relapse and the treatment discontinuation rates lower when compared to pegylated interferon and ribavirin.

CONCLUSIONS

This position paper addresses therapeutic management issues including goals, endpoints, indications, contraindications, and the optimal treatment regimen in children with chronic HCV infection.

摘要

目的

2017年,欧洲药品管理局和美国食品药品监督管理局分别批准使用固定剂量组合的来迪派韦/索磷布韦以及索磷布韦与利巴韦林的组合,用于治疗12至17岁或体重超过35千克、分别感染慢性丙型肝炎病毒(HCV)1、4、5和6型以及2和3型的青少年。尽管针对年幼儿童使用直接抗病毒药物的试验正在进行,但在美国和欧洲,12岁以下儿童唯一可用的治疗方法仍然是聚乙二醇化干扰素与利巴韦林的联合疗法。目前缺乏针对这些患者的系统性护理方法。欧洲儿科胃肠病学、肝病学和营养学会肝病学委员会制定了一份关于儿童慢性HCV感染管理的循证立场文件。

方法

使用MEDLINE和Embase对2007年6月1日至2017年6月1日期间的文献进行了系统检索和荟萃分析。应用推荐分级评估、制定和评价方法来评估结果。欧洲儿科胃肠病学、肝病学和营养学会委员会成员采用记名投票技术对每项建议进行投票。

结果

与聚乙二醇化干扰素和利巴韦林相比,所测试的不同直接抗病毒药物组合的疗效更高,复发率和治疗中断率更低。

结论

本立场文件阐述了慢性HCV感染儿童的治疗管理问题,包括目标、终点、适应症、禁忌症和最佳治疗方案。

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