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澳大利亚真实世界队列研究:广泛获得直接作用抗病毒治疗丙型肝炎的高疗效:REACH-C 研究。

High Effectiveness of Broad Access Direct-Acting Antiviral Therapy for Hepatitis C in an Australian Real-World Cohort: The REACH-C Study.

机构信息

The Kirby InstituteUNSW AustraliaSydneyNSWAustralia.

Cairns HospitalCairnsQLDAustralia.

出版信息

Hepatol Commun. 2022 Mar;6(3):496-512. doi: 10.1002/hep4.1826. Epub 2021 Nov 2.

Abstract

Australia was one of the first countries with unrestricted access to government subsidized direct-acting antiviral (DAA) therapy for adults with chronic hepatitis C virus. This study assessed real-world DAA treatment outcomes across a diverse range of Australian clinical services and evaluated factors associated with successful treatment and loss to follow-up. Real-world Effectiveness of Antiviral therapy in Chronic Hepatitis C (REACH-C) consisted a national observational cohort of 96 clinical services including specialist clinics and less traditional settings such as general practice. Data were obtained on consecutive individuals who commenced DAAs from March 2016 to June 2019. Effectiveness was assessed by sustained virological response ≥12 weeks following treatment (SVR) using intention-to-treat (ITT) and per-protocol (PP) analyses. Within REACH-C, 10,843 individuals initiated DAAs (male 69%; ≥50 years 52%; cirrhosis 22%). SVR data were available in 85% (9,174 of 10,843). SVR was 81% (8,750 of 10,843) by ITT and 95% (8,750 of 9,174) by PP. High SVR (≥92%) was observed across all service types and participant characteristics. Male gender (adjusted odds ratio [aOR] 0.56, 95% confidence interval [CI] 0.43-0.72), cirrhosis (aOR 0.52, 95% CI 0.41-0.64), recent injecting drug use (IDU; aOR 0.64, 95% CI 0.46-0.91) and previous DAA treatment (aOR 0.50, 95% CI 0.28-0.90) decreased the likelihood of achieving SVR. Multiple factors modified the likelihood of loss to follow-up including IDU ± opioid agonist therapy (OAT; IDU only: aOR 1.75, 95% CI 1.44-2.11; IDU + OAT: aOR 1.39, 95% CI 1.11-1.74; OAT only, aOR 1.36; 95% CI 1.13-1.68) and age (aOR 0.97, 95% CI 0.97-0.98). Conclusion: Treatment response was high in a diverse population and through a broad range of services following universal access to DAA therapy. Loss to follow-up presents a real-world challenge. Younger people who inject drugs were more likely to disengage from care, requiring innovative strategies to retain them in follow-up.

摘要

澳大利亚是最早允许成年人不受限制地获得政府补贴的直接作用抗病毒 (DAA) 治疗慢性丙型肝炎病毒的国家之一。本研究评估了澳大利亚各种临床服务中 DAA 治疗的实际效果,并评估了与成功治疗和失访相关的因素。真实世界丙型肝炎抗病毒治疗效果(REACH-C)是一项全国性观察队列研究,包括 96 个临床服务,包括专科诊所和不太传统的服务,如全科医生。数据来自于 2016 年 3 月至 2019 年 6 月期间开始使用 DAA 的连续个体。采用意向治疗(ITT)和按方案(PP)分析,通过治疗后 12 周持续病毒学应答(SVR)评估疗效。在 REACH-C 中,10843 人开始使用 DAA(男性 69%;≥50 岁 52%;肝硬化 22%)。85%(9174/10843)可获得 SVR 数据。ITT 为 81%(8750/10843),PP 为 95%(8750/9174)。所有服务类型和参与者特征均观察到高 SVR(≥92%)。男性(调整比值比[OR]0.56,95%置信区间[CI]0.43-0.72)、肝硬化(OR0.52,95%CI0.41-0.64)、最近使用注射毒品(OR0.64,95%CI0.46-0.91)和以前的 DAA 治疗(OR0.50,95%CI0.28-0.90)降低了 SVR 的可能性。多种因素改变了失访的可能性,包括使用注射毒品和阿片类药物激动剂治疗(IDU+OAT;仅 IDU:OR1.75,95%CI1.44-2.11;IDU+OAT:OR1.39,95%CI1.11-1.74;仅 OAT:OR1.36;95%CI1.13-1.68)和年龄(OR0.97,95%CI0.97-0.98)。结论:在广泛的服务范围内,对多种人群进行了普遍的 DAA 治疗后,治疗反应良好。失访是一个现实世界的挑战。年轻的注射吸毒者更有可能脱离治疗,需要创新的策略来保持他们的随访。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7925/8870316/91921d6954c5/HEP4-6-496-g002.jpg

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