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一项多中心EpiTer-2研究的结果:8周格卡瑞韦/哌仑他韦方案治疗儿童和青少年慢性丙型肝炎的真实世界疗效和安全性

Real-World Efficacy and Safety of an 8-Week Glecaprevir/Pibrentasvir Regimen in Children and Adolescents with Chronic Hepatitis C-Results of a Multicenter EpiTer-2 Study.

作者信息

Pawlowska Malgorzata, Dobrowolska Krystyna, Moppert Justyna, Pokorska-Śpiewak Maria, Purzynska Mariola, Marczynska Magdalena, Zarebska-Michaluk Dorota, Flisiak Robert

机构信息

Department of Infectious Diseases and Hepatology, Faculty of Medicine, Collegium Medicum Bydgoszcz, Nicolaus Copernicus University, 87-100 Torun, Poland.

Department of Paediatrics, Infectious Diseases and Hepatology, Voivodeship Infectious Observation Hospital in Bydgoszcz, 85-030 Bydgoszcz, Poland.

出版信息

J Clin Med. 2023 Nov 6;12(21):6949. doi: 10.3390/jcm12216949.

DOI:10.3390/jcm12216949
PMID:37959413
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10647729/
Abstract

The aim of the study was to analyze the effectiveness and safety of anti-HCV treatment based on a pangenotypic direct-acting antiviral (DAA) regimen with glecaprevir/pibrentasvir (GLE/PIB) in children. The multi-center study was conducted in HCV-infected children who were treated in the period from November 2022 to January 2023. The analysis included 23 pediatric patients with a mean (SD) age of 9.61 (3.68) years. The cohort included 13 girls and 10 boys. The most common HCV genotypes were GT1b ( = 9, 39.1%), GT1a ( = 6, 26.1%) and GT3 ( = 5, 21.7%). The SVR was assessed at 12 weeks after the end of treatment and was 100% for both girls and boys. The conducted study showed a very good tolerance of the treatment in the entire analyzed group and confirmed a very high efficacy and safety for 8-week treatment with GLE/PIB in children over three years of age. It seems that our study is the first on the real-world use of an 8-week GLE/PIB pangenotypic therapy in a group of children aged 3-12 years and the first in Europe for adolescents aged 12-17.

摘要

本研究的目的是分析基于泛基因型直接抗病毒药物(DAA)glecaprevir/pibrentasvir(GLE/PIB)方案治疗儿童丙型肝炎病毒(HCV)的有效性和安全性。这项多中心研究在2022年11月至2023年1月期间接受治疗的HCV感染儿童中进行。分析纳入了23例儿科患者,平均(标准差)年龄为9.61(3.68)岁。该队列包括13名女孩和10名男孩。最常见的HCV基因型为GT1b(n = 9,39.1%)、GT1a(n = 6,26.1%)和GT3(n = 5,21.7%)。在治疗结束后12周评估持续病毒学应答(SVR),女孩和男孩的SVR均为100%。所进行的研究表明,在整个分析组中该治疗耐受性良好,并证实GLE/PIB对3岁以上儿童进行8周治疗具有很高的疗效和安全性。我们的研究似乎是首次针对3至12岁儿童群体实际应用8周GLE/PIB泛基因型疗法的研究,也是欧洲首次针对12至17岁青少年的此类研究。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9484/10647729/5336112c2534/jcm-12-06949-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9484/10647729/539f686a48c2/jcm-12-06949-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9484/10647729/5336112c2534/jcm-12-06949-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9484/10647729/539f686a48c2/jcm-12-06949-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9484/10647729/5336112c2534/jcm-12-06949-g002.jpg

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The impact of treatment on the psychological burden of mothers of children with chronic hepatitis C virus infection: a multicenter, questionnaire survey.
治疗对慢性丙型肝炎病毒感染患儿母亲心理负担的影响:一项多中心、问卷调查研究。
Sci Rep. 2022 Dec 21;12(1):22116. doi: 10.1038/s41598-022-25519-1.
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Adolescents with chronic hepatitis C might be good candidates for direct-acting antiviral therapy.患有慢性丙型肝炎的青少年可能是直接抗病毒治疗的合适人选。
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Global change in hepatitis C virus prevalence and cascade of care between 2015 and 2020: a modelling study.全球丙型肝炎病毒流行率的变化和 2015 年至 2020 年期间的治疗流程:建模研究。
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