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微消除丙型肝炎病毒在人类免疫缺陷病毒合并感染中的应用:随着多中心治疗扩大试验的开展,发病率和患病率呈下降趋势。

Microelimination of Hepatitis C Among People With Human Immunodeficiency Virus Coinfection: Declining Incidence and Prevalence Accompanying a Multicenter Treatment Scale-up Trial.

机构信息

Burnet Institute, Melbourne, Victoria, Australia.

Department of Infectious Diseases, The Alfred and Monash University, Melbourne, Victoria, Australia.

出版信息

Clin Infect Dis. 2021 Oct 5;73(7):e2164-e2172. doi: 10.1093/cid/ciaa1500.

DOI:10.1093/cid/ciaa1500
PMID:33010149
Abstract

BACKGROUND

Gay and bisexual men (GBM) are a key population affected by human immunodeficiency virus (HIV) and hepatitis C virus (HCV) coinfection. We aimed to measure HCV treatment effectiveness and to determine the population impact of treatment scale-up on HCV prevalence and incidence longitudinally among GBM.

METHODS

The co-EC Study (Enhancing Care and Treatment Among HCV/HIV Coinfected Individuals to Eliminate Hepatitis C Transmission) was an implementation trial providing HCV direct-acting antiviral treatment in Melbourne, Australia, during 2016-2018. Individuals with HCV/HIV coinfection were prospectively enrolled from primary and tertiary care services. HCV viremic prevalence and HCV antibody/viremic incidence were measured using a statewide, linked, surveillance system.

RESULTS

Among 200 participants recruited, 186 initiated treatment during the study period. Sustained virological response in primary care (98% [95% confidence interval {CI}, 93%-100%]) was not different to tertiary care (98% [95% CI, 86%-100%]). From 2012 to 2019, between 2434 and 3476 GBM with HIV infection attended our primary care sites annually, providing 13 801 person-years of follow-up; 50%-60% received an HCV test annually, and 10%-14% were anti-HCV positive. Among those anti-HCV positive, viremic prevalence declined 83% during the study (54% in 2016 to 9% in 2019). HCV incidence decreased 25% annually from 1.7/100 person-years in 2012 to 0.5/100 person-years in 2019 (incidence rate ratio, 0.75 [95% CI, .68-.83]; P < .001).

CONCLUSIONS

High treatment effectiveness by nonspecialists demonstrates the feasibility of treatment scale-up in this population. Substantial declines in HCV incidence and prevalence among GBM provides proof-of-concept for HCV microelimination.

CLINICAL TRIALS REGISTRATION

NCT02786758.

摘要

背景

男同性恋和双性恋者(GBM)是受人类免疫缺陷病毒(HIV)和丙型肝炎病毒(HCV)合并感染影响的关键人群。我们旨在衡量 HCV 治疗效果,并确定治疗规模扩大对 GBM 中 HCV 流行率和发病率的纵向人群影响。

方法

共同 EC 研究(加强 HCV/HIV 合并感染者的护理和治疗以消除丙型肝炎传播)是一项实施性试验,在 2016 年至 2018 年期间在澳大利亚墨尔本提供 HCV 直接作用抗病毒治疗。从初级和三级保健服务中前瞻性招募 HCV/HIV 合并感染者。使用全州范围的、链接的监测系统测量 HCV 病毒血症流行率和 HCV 抗体/病毒血症发病率。

结果

在招募的 200 名参与者中,186 名在研究期间开始接受治疗。初级保健中的持续病毒学应答率(98%[95%置信区间{CI},93%-100%])与三级保健(98%[95%CI,86%-100%])无差异。从 2012 年到 2019 年,每年有 2434 至 3476 名感染 HIV 的 GBM 在我们的初级保健场所就诊,提供了 13801 人年的随访;每年有 50%-60%接受 HCV 检测,10%-14%抗 HCV 阳性。在抗 HCV 阳性者中,研究期间病毒血症流行率下降了 83%(2016 年为 54%,2019 年为 9%)。HCV 发病率每年下降 25%,从 2012 年的 1.7/100 人年降至 2019 年的 0.5/100 人年(发病率比,0.75[95%CI,0.68-0.83];P<0.001)。

结论

非专家的高治疗效果证明了在该人群中扩大治疗规模的可行性。GBM 中 HCV 发病率和流行率的大幅下降为 HCV 微消除提供了概念验证。

临床试验注册

NCT02786758。

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