School of Health Research, Clemson University, Clemson, South Carolina.
Department of Medicine, University of South Carolina School of Medicine, Greenville.
JAMA Netw Open. 2024 Aug 1;7(8):e2430024. doi: 10.1001/jamanetworkopen.2024.30024.
Hepatitis C virus (HCV) reinfection after curative treatment remains a concern for people who inject drugs.
To assess the incidence of HCV reinfection and associated risk factors.
DESIGN, SETTING, AND PARTICIPANTS: This cohort study is a secondary analysis of a randomized clinical trial that was conducted across opioid treatment programs and community health centers in the US between September 2016 and August 2018. The current analyses were performed in March 2022. People who inject drugs who achieved sustained virologic response (SVR) were followed for up to 42 months.
Patients were randomly assigned to receive modified directly observed therapy or patient navigation.
The primary outcome was rate of HCV reinfection. Change in reinfection rates over time was assessed using a Poisson regression model.
A total of 415 participants (mean [SD] age, 44.7 [11.5] years; 302 male [72.8%]) achieved a SVR and had 1 or more post-SVR assessments for HCV RNA. Overall, 302 (72.8%) reported recent injection drug use, 192 (46.3%) were living in unstable housing, and 313 (75.4%) had received recent methadone or buprenorphine for opioid use disorder. The overall reinfection rate was 11.4 per 100 person-years at risk (95% CI, 8.7-14.7 per 100 person-years at risk) over 518 person-years of follow-up. Reinfection rates varied significantly across sites, ranging from 2.9 per 100 person-years at risk (95% CI, 0.1-16.3 per 100 person-years) to 25.2 per 100 person-years at risk (95% CI, 15.6-38.5 per 100 person-years at risk) (P = .006). There was a significant decrease in incident reinfection with increasing post-SVR follow-up (weeks 0-24, 15.5 per 100 person-years; 95% CI, 10.3-22.3 per 100 person-years; weeks 73-144, 4.3 per 100 person-years; 95% CI, 0.9-12.5 per 100 person-years; P = .008). Reinfection rates were lower for participants aged 40 years or older than for younger participants (adjusted incidence rate ratio, 0.32; 95% CI, 0.18-0.57) and for participants for whom methamphetamine was not detected in urinary drug screening compared with participants for whom methamphetamine was detected (adjusted incidence rate ratio, 0.41; 95% CI, 0.21-0.82). Participants who reported injection drug use within the preceding 3 months had higher risk of reinfection than those who did not have recent injection drug use (adjusted incidence rate ratio, 3.33; 95% CI, 1.86-5.97).
In this cohort study of people who injected drugs and were treated for HCV infection in community settings, reinfection was high in the period immediately after SVR but decreased significantly over time. These findings highlight the importance of early intervention to prevent reinfection.
ClinicalTrials.gov Identifier: NCT02824640.
经治疗后丙型肝炎病毒 (HCV) 再感染仍然是注射吸毒者关注的问题。
评估 HCV 再感染的发生率和相关危险因素。
设计、地点和参与者:这是一项在美国阿片类药物治疗计划和社区卫生中心进行的随机临床试验的二次分析,研究时间为 2016 年 9 月至 2018 年 8 月。目前的分析于 2022 年 3 月进行。达到持续病毒学应答 (SVR) 的注射吸毒者在最长 42 个月的时间内接受随访。
患者被随机分配接受改良直接观察治疗或患者导航。
主要结局是 HCV 再感染率。使用泊松回归模型评估再感染率随时间的变化。
共有 415 名参与者(平均 [标准差] 年龄,44.7 [11.5] 岁;302 名男性 [72.8%])达到 SVR 并在 HCV RNA 检测后进行了 1 次或多次评估。总体而言,302 名(72.8%)报告最近有注射吸毒史,192 名(46.3%)居住在不稳定的住房中,313 名(75.4%)最近接受美沙酮或丁丙诺啡治疗阿片类药物使用障碍。在 518 人年的随访中,总再感染率为每 100 人年 11.4 例(95%CI,每 100 人年 8.7-14.7 例)。再感染率在不同地点差异显著,范围从每 100 人年 2.9 例(95%CI,每 100 人年 0.1-16.3 例)到每 100 人年 25.2 例(95%CI,每 100 人年 15.6-38.5 例)(P=0.006)。随着 SVR 随访时间的增加,新发再感染的发生率显著下降(0-24 周时为 15.5 例/100 人年;95%CI,每 100 人年 10.3-22.3 例;73-144 周时为 4.3 例/100 人年;95%CI,每 100 人年 0.9-12.5 例;P=0.008)。40 岁及以上参与者的再感染率低于年轻参与者(调整后的发病率比,0.32;95%CI,0.18-0.57),尿液药物筛查未检测到甲基苯丙胺的参与者的再感染率低于检测到甲基苯丙胺的参与者(调整后的发病率比,0.41;95%CI,0.21-0.82)。在过去 3 个月内报告有注射吸毒史的参与者再感染风险高于没有最近注射吸毒史的参与者(调整后的发病率比,3.33;95%CI,1.86-5.97)。
在这项针对社区环境中接受 HCV 感染治疗的注射吸毒者的队列研究中,SVR 后立即发生的再感染率较高,但随着时间的推移显著下降。这些发现强调了早期干预以预防再感染的重要性。
ClinicalTrials.gov 标识符:NCT02824640。