注射吸毒人群丙型肝炎病毒感染的综合治疗：一项随机对照试验的研究方案（INTRO-HCV）。

Integrated treatment of hepatitis C virus infection among people who inject drugs: study protocol for a randomised controlled trial (INTRO-HCV).

机构信息

Bergen Addiction Research Group, Department of Addiction Medicine, Haukeland University Hospital, Bergen, Norway.

Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway.

出版信息

BMC Infect Dis. 2019 Nov 8;19(1):943. doi: 10.1186/s12879-019-4598-7.

DOI:10.1186/s12879-019-4598-7

PMID:31703669

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6839172/

Abstract

BACKGROUND

A large proportion of people who inject drugs (PWID) living with hepatitis C virus (HCV) infection have not been treated. It is unknown whether inclusion of HCV diagnostics and treatment into integrated substance use disorder treatment and care clinics will improve uptake and outcome of HCV treatment in PWID. The aim is to assess the efficacy of integrating HCV treatment to PWID and this paper will present the protocol for an ongoing trial.

METHODS

INTRO-HCV is a multicentre, randomised controlled clinical trial that will compare the efficacy of integrated treatment of HCV in PWID with the current standard treatment. Integrated treatment includes testing for HCV, assessing liver fibrosis with transient elastography, counselling, treatment delivery, follow-up and evaluation provided by integrated substance use disorder treatment and care clinics. Most of these clinics for PWID provide opioid agonist therapy while some clinics provide low-threshold care without opioid agonist therapy. Standard care involves referral to further diagnostics, treatment and treatment follow-up given in a hospital outpatient clinic with equivalent medications. The differences between the delivery platforms in the two trial arms involve use of a drop-in approach rather than specific appointment times, no need for additional travelling, less blood samples taken during treatment, and treatment given from already known clinicians. The trial will recruit approximately 200 HCV infected individuals in Bergen and Stavanger, Norway. The primary outcomes are time to treatment initiation and sustained virologic response, defined as undetectable HCV RNA 12 weeks after end of treatment. Secondary outcomes are cost-effectiveness, treatment adherence, changes in quality of life, fatigue and psychological well-being, changes in drug use, infection related risk behaviour, and risk of reinfection. The target group is PWID with HCV diagnosed receiving treatment and care within clinics for PWID.

DISCUSSION

This study will inform on the effects of an integrated treatment program for HCV in clinics for PWID compared to standard care aiming to increase access to treatment and improving treatment adherence. If the integrated treatment model is found to be safe and efficacious, it can be considered for further scale-up.

TRIAL REGISTRATION

ClinicalTrials.gov.no. NCT03155906.

摘要

背景

很大一部分患有丙型肝炎病毒 (HCV) 感染的吸毒者（PWID）尚未接受治疗。目前尚不清楚将 HCV 诊断和治疗纳入综合物质使用障碍治疗和护理诊所是否会提高 PWID 接受 HCV 治疗的比例和治疗效果。本研究旨在评估将 HCV 治疗纳入 PWID 的效果，本文将介绍正在进行的试验方案。

方法

INTRO-HCV 是一项多中心、随机对照临床试验，将比较综合治疗与目前标准治疗对 PWID 中 HCV 治疗的疗效。综合治疗包括 HCV 检测、使用瞬时弹性成像评估肝纤维化、咨询、治疗实施、随访和评估，均由综合物质使用障碍治疗和护理诊所提供。这些为 PWID 提供的诊所大多数提供阿片类药物激动剂治疗，而一些诊所提供无需阿片类药物激动剂治疗的低门槛护理。标准护理包括在医院门诊进行进一步的诊断、治疗和治疗随访，提供相同的药物。在这两个试验组的治疗平台之间存在差异，即采用了即到即治疗的方式，而非特定预约时间；无需额外出行；在治疗过程中抽取的血样更少；以及由已经熟知患者情况的医生进行治疗。该试验将在挪威卑尔根和斯塔万格招募约 200 名 HCV 感染个体。主要结局是治疗开始时间和持续病毒学应答，定义为治疗结束后 12 周 HCV RNA 不可检测。次要结局是成本效益、治疗依从性、生活质量、疲劳和心理健康、药物使用变化、感染相关风险行为以及再感染风险的变化。目标人群是在为 PWID 提供治疗和护理的诊所中接受 HCV 诊断和治疗的 PWID。