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微环境清除丙型肝炎:一种新的治疗模式。

Microenvironment Eradication of Hepatitis C: A Novel Treatment Paradigm.

机构信息

Department of Gastroenterology and Hepatology, Marqués de Valdecilla University Hospital, School of Medicine, University of Cantabria, Cantabria, Spain. Marqués de Valdecilla Research Institute (IDIVAL, initials in Spanish), Santoña, Spain. Medical Service. El Dueso Penitentiary Centre, Santoña, Spain. Radiology Department, Marqués de Valdecilla University Hospital, School of Medicine, University of Cantabria, Cantabria, Spain. Internal Medicine and Infectious Diseases Department, Marqués de Valdecilla University Hospital, School of Medicine, University of Cantabria, Cantabria, Spain. Centro de investigación en red de Salud Mental (CIBERSAM), Santander, Spain. Department of Medicine and Psychiatry, Marqués de Valdecilla University Hospital, School of Medicine, University of Cantabria, Cantabria, Spain. Immunology Department, Marqués de Valdecilla University Hospital, School of Medicine, University of Cantabria, Cantabria, Spain. Department of Microbiology, Marqués de Valdecilla University Hospital, School of Medicine, University of Cantabria, Cantabria, Spain. Department of Microbiology, Complejo Hospitalario Universitario Granada-Hospital San Cecilio, Instituto de Investigación Biosanitaria (IBS), Granada, Spain. Department of Gastroenterology and Hepatology, Hospital Universitario Puerta de Hierro. Majadahonda. School of Medicine, Universidad Autónoma Madrid, Madrid, Spain.

出版信息

Am J Gastroenterol. 2018 Nov;113(11):1639-1648. doi: 10.1038/s41395-018-0157-x. Epub 2018 Jun 27.

Abstract

OBJECTIVES

Prisons are major reservoirs of hepatitis C virus (HCV) in which a therapeutic approach has been particularly difficult so far. Our aim was to create a permanent program of HCV elimination in a prison based on a "test and treat" strategy.

METHODS

This open-label clinical trial was conducted in the Spanish prison "El Dueso" between May 2016 and July 2017. Viremic patients were treated with a ledipasvir-sofosbuvir regimen (8-12 weeks) according to the 2015 Spanish Guidelines. A teleconsultation program was established to follow-up patients from the hospital. Non-responders were submitted for a phylogenetic analysis and offered retreatment. An evaluation of new cases of HCV infection was performed every 6 months and upon release in all inmates.

RESULTS

847 (99.5%) inmates accepted to participate. HCV antibodies were present in 110 (13.0%) and 86 (10.2%) had detectable viremia. Most of them were genotype 1 or 3 (82.6%) and had <F2 fibrosis (52.2%). Treatment was started in the 69 inmates whose stay in prison was longer than 30 days. Sustained virological response was achieved in 64 out of 66 patients (96.9%), three of whom were successfully rescued with a salvage regimen after treatment failure. Two patients were lost to follow-up and three are currently on treatment without viremia. As a result, by July 2017 none of the 409 imprisoned was viremic, and neither reinfections nor de novo infections were detected.

CONCLUSIONS

A sustained "test-and-treat" strategy against HCV in prisons is feasible and beneficial. Spreading this strategy should entail a public health impact.

摘要

目的

监狱是丙型肝炎病毒(HCV)的主要储库,到目前为止,针对该病毒的治疗方法一直特别困难。我们的目标是在监狱中创建一个基于“检测和治疗”策略的HCV 消除永久性计划。

方法

本开放性临床试验于 2016 年 5 月至 2017 年 7 月在西班牙“El Dueso”监狱进行。对病毒血症患者采用 ledipasvir-sofosbuvir 方案(8-12 周)进行治疗,方案依据 2015 年西班牙指南制定。建立远程会诊计划以对来自医院的患者进行随访。对无应答者进行系统进化分析,并提供补救治疗。对所有囚犯每 6 个月进行 HCV 新感染病例评估,并在释放时进行评估。

结果

847 名(99.5%)囚犯同意参与。110 名(13.0%)和 86 名(10.2%)囚犯的 HCV 抗体呈阳性,且存在可检测到的病毒血症。他们中的大多数为基因型 1 或 3(82.6%),且纤维化程度<F2(52.2%)。在监狱停留时间超过 30 天的 69 名囚犯中开始进行治疗。在 66 名接受治疗的患者中,有 64 名(96.9%)获得持续病毒学应答,其中 3 名治疗失败后通过挽救方案成功获救。2 名患者失去随访,3 名目前正在治疗中且无病毒血症。因此,截至 2017 年 7 月,409 名被监禁的囚犯中没有一名出现病毒血症,也没有发现再感染或新感染。

结论

在监狱中实施持续的 HCV“检测和治疗”策略是可行且有益的。推广这种策略应该会产生重大的公共卫生影响。

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