PLATINUM C 平台在治疗慢性丙型肝炎中的应用：一项针对丙型肝炎真实世界结局的前瞻性治疗登记研究方案。

A platform in the use of medicines to treat chronic hepatitis C (PLATINUM C): protocol for a prospective treatment registry of real-world outcomes for hepatitis C.

机构信息

Wesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids Institute, The University of Western Australia, Perth, Australia.

Disease Elimination Program, Burnet Institute, Melbourne, Australia.

出版信息

BMC Infect Dis. 2020 Oct 29;20(1):802. doi: 10.1186/s12879-020-05531-4.

DOI:10.1186/s12879-020-05531-4

PMID:33121439

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7596998/

Abstract

BACKGROUND

Safe, highly curative, short course, direct acting antiviral (DAA) therapies are now available to treat chronic hepatitis C. DAA therapy is freely available to all adults chronically infected with the hepatitis C virus (HCV) in Australia. If left untreated, hepatitis C may lead to progressive hepatic fibrosis, cirrhosis and hepatocellular carcinoma. Australia is committed to eliminating hepatitis as a public health threat by 2030 set by the World Health Organization. However, since the introduction of funded DAA treatment, uptake has been suboptimal. Australia needs improved strategies for testing, treatment uptake and treatment completion to address the persisting hepatitis C public health problem. PLATINUM C is a HCV treatment registry and research platform for assessing the comparative effectiveness of alternative interventions for achieving virological cure.

METHODS

PLATINUM C will prospectively enrol people with active HCV infection confirmed by recent detection of HCV ribonucleic acid (RNA) in blood. Those enrolled will agree to allow standardised collection of demographic, lifestyle, treatment, virological outcome and other relevant clinical data to better inform the future management of HCV infection. The primary outcome is virological cure evidenced by sustained virological response (SVR), which is defined as a negative HCV PCR result 6 to 18 months after initial prescription of DAA therapy and no less than 12 weeks after the completion of treatment. Study participants will be invited to opt-in to medication adherence monitoring and quality of life assessments using validated self-reported instruments (EQ-5D-5L).

DISCUSSION

PLATINUM C is a treatment registry and platform for nesting pragmatic trials. Data collected will inform the design, development and implementation of pragmatic trials. The digital infrastructure, study procedures and governing systems established by the registry will allow PLATINUM C to support a wider research platform in the management of hepatitis C in primary care.

TRIAL REGISTRATION

The trial is registered with the Australia and New Zealand Clinical Trials Register ( ACTRN12619000023156 ). Date of registration: 10/01/2019.

摘要

背景

安全、高效、疗程短的直接作用抗病毒（DAA）疗法现已可用于治疗慢性丙型肝炎。澳大利亚为所有慢性感染丙型肝炎病毒（HCV）的成年人免费提供 DAA 治疗。如果不进行治疗，丙型肝炎可能导致进行性肝纤维化、肝硬化和肝细胞癌。澳大利亚致力于到 2030 年实现世界卫生组织设定的消除丙型肝炎这一公共卫生威胁的目标。然而，自引入资金支持的 DAA 治疗以来，接受治疗的人数仍不理想。澳大利亚需要改进检测、治疗接受和治疗完成的策略，以解决持续存在的丙型肝炎公共卫生问题。PLATINUM C 是一个丙型肝炎治疗登记处和研究平台，用于评估实现病毒学治愈的替代干预措施的相对有效性。

方法

PLATINUM C 将前瞻性招募近期血液中检测到丙型肝炎核糖核酸（RNA）证实患有丙型肝炎活动感染的人群。招募的参与者将同意允许标准化收集人口统计学、生活方式、治疗、病毒学结果和其他相关临床数据，以更好地为丙型肝炎感染的未来管理提供信息。主要结局是通过持续病毒学应答（SVR）证明的病毒学治愈，这定义为在开始 DAA 治疗后 6 至 18 个月和治疗完成后至少 12 周时 HCV PCR 结果阴性。研究参与者将被邀请选择使用经过验证的自我报告工具（EQ-5D-5L）进行药物依从性监测和生活质量评估。