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Evaluation of hepatitis C treatment-as-prevention within Australian prisons (SToP-C): a prospective cohort study
The Lancet Gastroenterology & Hepatology ( IF 35.7 ) Pub Date : 2021-05-07 , DOI: 10.1016/s2468-1253(21)00077-7
Behzad Hajarizadeh 1 , Jason Grebely 1 , Marianne Byrne 1 , Pip Marks 1 , Janaki Amin 2 , Hamish McManus 1 , Tony Butler 1 , Evan B Cunningham 1 , Peter Vickerman 3 , Natasha K Martin 4 , John G McHutchison 5 , Diana M Brainard 6 , Carla Treloar 7 , Georgina M Chambers 8 , Luke Grant 9 , Colette Mcgrath 10 , Andrew R Lloyd 1 , Gregory J Dore 1 ,
Affiliation  

Background

Limited empirical evidence exists for the effectiveness of hepatitis C virus (HCV) treatment-as-prevention. The Surveillance and Treatment of Prisoners with hepatitis C (SToP-C) study aimed to assess the effect of HCV treatment-as-prevention in the prison setting.

Methods

SToP-C was a prospective study, including a before-and-after analysis, within a cohort of people incarcerated in two maximum-security prisons (male) and two medium-security prisons (one male, one female) in New South Wales, Australia. All prison inmates aged at least 18 years were eligible for enrolment. After HCV testing, participants were monitored for risk behaviours and HCV infection, among three sub-populations: uninfected (HCV antibody-negative); previously infected (HCV antibody-positive, HCV RNA-negative); and infected (HCV antibody and HCV RNA-positive). Uninfected participants were followed up every 3–6 months to detect HCV primary infection and previously infected participants were followed up every 3–6 months to detect re-infection. Participants with HCV infection were assessed for treatment, initially standard-of-care treatment (administered by prison health services) from 2014 to mid-2017, then direct-acting antiviral (DAA) treatment scale-up from mid-2017 onwards (12 weeks of sofosbuvir plus velpatasvir, administered through SToP-C). Participants were followed up until study closure in November, 2019. The primary study outcome was HCV incidence before and after DAA treatment scale-up among participants at risk of HCV primary infection or re-infection. This study is registered with ClinicalTrials.gov, NCT02064049.

Findings

Between Oct 30, 2014, and Sept 30, 2019, 3691 participants were enrolled in the SToP-C study. 719 (19%) participants had detectable HCV RNA, 2240 (61%) were at risk of primary HCV infection, and 725 (20%) were at risk of re-infection at baseline. DAA treatment was initiated in 349 (70%) of 499 eligible participants during the treatment scale-up period. The HCV incidence analysis comprised 1643 participants at risk of HCV infection or re-infection during longitudinal follow-up (median age 33 years [IQR 27–42]; 1350 [82%] male). 487 (30%) of 1643 participants reported injecting drugs in prison. HCV incidence decreased from 8·31 per 100 person-years in the pre-treatment scale-up period to 4·35 per 100 person-years in the post-treatment scale-up period (incidence rate ratio [IRR] 0·52 [95% CI 0·36–0·78]; p=0·0007). The incidence of primary infection decreased from 6·64 per 100 person-years in the pre-treatment scale-up period to 2·85 per 100 person-years in the post-treatment scale-up period (IRR 0·43 [95% CI 0·25–0·74]; p=0·0019), whereas the incidence of re-infection decreased from 12·36 per 100 person-years to 7·27 per 100 person-years (0·59 [0·35–1·00]; p=0·050). Among participants reporting injecting drugs during their current imprisonment, the incidence of primary infection decreased from 39·08 per 100 person-years in the pre-treatment scale-up period to 14·03 per 100 person-years in the post-treatment scale-up period (IRR 0·36 [95% CI 0·16–0·80]; p=0·0091), and the incidence of re-infection decreased from 15·26 per 100 person-years to 9·34 per 100 person-years (0·61 [0·34–1·09]; p=0·093). The adjusted analysis (adjusted for age, Indigenous Australian ethnicity, duration of stay in prison, previous imprisonment, injecting drug use status, and prison site) indicated a significant reduction in the risk of HCV infection between the pre-DAA treatment scale-up and post-DAA treatment scale-up periods (adjusted hazard ratio 0·50 [95% CI 0·33–0·76]; p=0·0014).

Interpretation

DAA treatment scale-up was associated with reduced HCV incidence in prison, indicative of a beneficial effect of HCV treatment-as-prevention in this setting. These findings support broad DAA treatment scale-up within incarcerated populations.

Funding

Australian National Health and Medical Research Council Partnership Project Grant and Gilead Sciences.



中文翻译:

澳大利亚监狱中丙型肝炎治疗作为预防的评估 (SToP-C):一项前瞻性队列研究

背景

丙型肝炎病毒 (HCV) 治疗作为预防的有效性存在有限的经验证据。丙型肝炎囚犯的监测和治疗 (SToP-C) 研究旨在评估监狱环境中 HCV 治疗作为预防的效果。

方法

SToP-C 是一项前瞻性研究,包括一项前后分析,对象是新南威尔士州两所最高安全监狱(男性)和两所中等安全监狱(一男一女)的一群人,澳大利亚。所有年满 18 岁的监狱囚犯都有资格入学。HCV 检测后,参与者在三个亚群中接受危险行为和 HCV 感染监测:未感染(HCV 抗体阴性);既往感染(HCV 抗体阳性,HCV RNA 阴性);和感染(HCV 抗体和 HCV RNA 阳性)。未感染的参与者每 3-6 个月随访一次以检测 HCV 原发感染,以前感染的参与者每 3-6 个月随访一次以检测再感染。对感染 HCV 的参与者进行了治疗评估,最初从 2014 年到 2017 年年中采用标准护理治疗(由监狱卫生服务机构管理),然后从 2017 年年中开始扩大直接作用抗病毒 (DAA) 治疗(12 周的 sofosbuvir 加 velpatasvir,通过 SToP 给药- C)。对参与者进行随访,直到 2019 年 11 月研究结束。主要研究结果是有 HCV 原发感染或再感染风险的参与者在 DAA 治疗扩大之前和之后的 HCV 发病率。本研究已在 ClinicalTrials.gov 注册,NCT02064049。主要研究结果是有 HCV 原发感染或再感染风险的参与者在 DAA 治疗扩大之前和之后的 HCV 发病率。本研究已在 ClinicalTrials.gov 注册,NCT02064049。主要研究结果是有 HCV 原发感染或再感染风险的参与者在 DAA 治疗扩大之前和之后的 HCV 发病率。本研究已在 ClinicalTrials.gov 注册,NCT02064049。

发现

2014 年 10 月 30 日至 2019 年 9 月 30 日期间,共有 3691 名参与者参加了 SToP-C 研究。719 (19%) 名参与者有可检测的 HCV RNA,2240 (61%) 名参与者有原发性 HCV 感染的风险,725 (20%) 名参与者在基线时有再次感染的风险。在治疗扩大期间,499 名符合条件的参与者中有 349 人(70%)开始了 DAA 治疗。HCV 发病率分析包括 1643 名在纵向随访期间有 HCV 感染或再次感染风险的参与者(中位年龄 33 岁 [IQR 27-42];1350 名 [82%] 男性)。1643 名参与者中有 487 人(30%)报告在监狱中注射毒品。HCV 发病率从治疗前扩大期的每 100 人年 8·31 下降到治疗后扩大期的每 100 人年 4·35(发病率比 [IRR] 0·52 [ 95% CI 0·36–0·78];p=0·0007)。原发感染发生率从治疗前扩大期的每 100 人年 6·64 人下降到治疗后扩大期的每 100 人年 2·85 人(IRR 0·43 [95% CI 0·25–0·74];p=0·0019),而再感染的发生率从每 100 人年 12·36 例降至每 100 人年 7·27 例 (0·59 [0· 35–1·00];p=0·050)。在目前监禁期间报告注射毒品的参与者中,原发性感染的发生率从治疗前扩大期的每 100 人年 39·08 例下降到治疗后扩大期的每 100 人年 14·03 例——上升期(IRR 0·36 [95% CI 0·16–0·80];p=0·0091),再感染的发生率从每 100 人年 15·26 下降到每 100 人年 9·34人年(0·61 [0·34–1·09];p=0·093)。调整后的分析(根据年龄、

解释

DAA 治疗规模扩大与监狱中 HCV 发病率的降低有关,表明在这种情况下 HCV 治疗作为预防的有益效果。这些发现支持在被监禁人群中扩大 DAA 治疗规模。

资金

澳大利亚国家健康和医学研究委员会合作项目拨款和吉利德科学。

更新日期:2021-06-11
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