Department of Infectious Diseases, Akershus University Hospital, Lørenskog, Norway; Department of Gastroenterology, Oslo University Hospital, Oslo, Norway.
Agency for Social and Welfare Services, City of Oslo, Oslo, Norway.
Int J Drug Policy. 2021 Oct;96:103165. doi: 10.1016/j.drugpo.2021.103165. Epub 2021 Feb 26.
The aims were to evaluate HCV treatment effectiveness, estimate reinfection rates, and demonstrate the feasibility of reinfection surveillance and retreatment among marginalized people who inject drugs (PWID).
Prospective observational study including consecutive HCV RNA positive individuals attending a low-threshold clinic in Oslo, Norway, between 2013 and 2020. Participants were offered individually tailored HCV treatment and post-treatment HCV RNA surveillance at three months intervals.
Of 488 HCV RNA positive individuals, 363 initiated treatment (median age 48.7 years, 72.5% male, 17.2% liver cirrhosis, 54.3% unstable housing). All participants had a history of injecting drug use, 71.1% received opioid agonist treatment, and 70.1% reported recent (past 3 months) injecting. In intention-to-treat analysis, excluding those with HCV RNA results pending, virologic response was achieved in 306 of 340 (90.0%) participants. In modified intention-to-treat analysis, also excluding those with loss to follow-up during treatment, virologic response was achieved in 306 of 323 (94.7%). Virologic response was not associated with recent injecting drug use or socio-demographic factors. Reinfection surveillance was accomplished in 297 individuals (308.2 PY of follow-up; median 0.50 years). Eight cases of reinfection were detected for an incidence of 2.60/100 PY (95% CI 1.12-5.11) overall, and 3.74/100 PY (95% CI 1.62-7.37) among those with injecting drug use during follow-up (n = 205). Reinfection was associated with younger age (IRR 0.37; 95% CI 0.18-0.74), and all cases occurred in participants aged below 49 years with ongoing injecting drug use who reported mixed heroin/amphetamine injecting. Successful retreatment was provided in all cases and no second reinfections were observed.
The findings consolidate previous evidence supporting the effectiveness of HCV treatment among PWID, provide novel data on reinfection rates and associated factors, and demonstrate the feasibility of reinfection surveillance and retreatment in a real-world setting.
本研究旨在评估 HCV 治疗效果，估计再感染率，并证明对边缘化的吸毒者（PWID）进行再感染监测和再治疗的可行性。
这是一项前瞻性观察性研究，纳入了 2013 年至 2020 年期间在挪威奥斯陆一家低门槛诊所就诊的连续 HCV RNA 阳性个体。为参与者提供个体化的 HCV 治疗，并在三个月的间隔内进行治疗后 HCV RNA 监测。
488 例 HCV RNA 阳性个体中，363 例接受了治疗（中位年龄 48.7 岁，72.5%为男性，17.2%有肝硬化，54.3%住房不稳定）。所有参与者均有吸毒史，71.1%接受阿片类药物激动剂治疗，70.1%报告最近（过去 3 个月）有注射吸毒行为。在意向治疗分析中，排除 HCV RNA 结果待定的患者，340 例患者中有 306 例（90.0%）达到病毒学应答。在修改后的意向治疗分析中，排除治疗期间失访的患者，323 例患者中有 306 例（94.7%）达到病毒学应答。病毒学应答与近期吸毒或社会人口学因素无关。在 297 例患者中完成了再感染监测（297 例患者共 308.2 人年的随访；中位随访时间 0.50 年）。总体上，共发现 8 例再感染病例，发病率为 2.60/100 人年（95%CI 1.12-5.11），在随访期间有吸毒行为的 205 例患者中发病率为 3.74/100 人年（95%CI 1.62-7.37）。再感染与年龄较小有关（IRR 0.37；95%CI 0.18-0.74），所有病例均发生在年龄在 49 岁以下、持续吸毒且报告混合使用海洛因/苯丙胺的患者中。所有病例均提供了成功的再治疗，未观察到第二次再感染。
这些发现巩固了之前支持 PWID 中 HCV 治疗有效性的证据，提供了再感染率和相关因素的新数据，并证明了在真实环境中进行再感染监测和再治疗的可行性。
