慢性 HCV 感染且近期有注射吸毒史人群对索磷布韦和维帕他韦的依从性：SIMPLIFY 研究。
Adherence to sofosbuvir and velpatasvir among people with chronic HCV infection and recent injection drug use: The SIMPLIFY study.
机构信息
The Kirby Institute, UNSW Sydney, Sydney, Australia.
The Kirby Institute, UNSW Sydney, Sydney, Australia; Faculty of Medicine and Health Sciences, Macquarie University, Sydney, Australia.
出版信息
Int J Drug Policy. 2018 Dec;62:14-23. doi: 10.1016/j.drugpo.2018.08.013. Epub 2018 Oct 22.
BACKGROUND
This study investigated treatment adherence among people with recent injecting drug use in a study of sofosbuvir/velpatasvir therapy for HCV infection.
METHODS
SIMPLIFY is an international open-label, single-arm multicentre study that recruited participants with recent injecting drug use (previous six months) and chronic HCV genotype (G) 1-6 infection between March and October 2016 in seven countries (19 sites). Participants received sofosbuvir/velpatasvir once-daily for 12 weeks administered in a one-week electronic blister pack (records the time and date of each dose) for 12 weeks. We evaluated non-adherence (<90% adherent) as measured by electronic blister-pack assessed using logistic regression and generalised estimating equations (continuous) with detailed analyses of dosing dynamics.
RESULTS
Among 103 participants, 97% (n = 100) completed treatment. Median adherence to therapy was 94%. Overall, 32% (n = 33) were considered non-adherent (<90% adherence). Adherence significantly decreased over the course of therapy. Recent stimulant injecting (cocaine and/or amphetamines) at treatment initiation and during treatment was independently associated with non-adherence. Inconsistent dose timing (standard deviation of daily dose timing of ≥240 min) was also independently associated with non-adherence to therapy. Factors associated with inconsistent dose timing included lower levels of education and recent stimulant injecting. SVR was similar among adherent and non-adherent populations (94% vs. 94%, P = 0.944).
CONCLUSION
This study demonstrated high adherence to once-daily sofosbuvir/velpatasvir therapy among a population of people with recent injecting drug use. Recent stimulant injecting prior to and during DAA therapy and inconsistent dose-timing during treatment was associated with non-adherence. However, there was no impact of non-adherence on response to therapy, suggesting that adherence is not a significant barrier to successful DAA therapy in people with recent injecting drug use.
背景
本研究调查了近期有注射吸毒史的 HCV 感染者接受索磷布韦/维帕他韦治疗的治疗依从性。
方法
SIMPLIFY 是一项国际性、开放性、单臂、多中心研究，于 2016 年 3 月至 10 月在 7 个国家（19 个地点）招募了近期有注射吸毒史（过去 6 个月内）和慢性 HCV 基因型（G）1-6 感染的参与者。参与者接受索磷布韦/维帕他韦每日一次治疗 12 周，药物由一周电子泡罩包装（记录每次剂量的时间和日期）给药 12 周。我们使用电子泡罩包装评估的非依从性（<90%依从性），并使用逻辑回归和广义估计方程（连续）进行评估，并对给药动态进行了详细分析。
结果
在 103 名参与者中，97%（n=100）完成了治疗。治疗依从性中位数为 94%。总体而言，32%（n=33）被认为是非依从者（<90%依从性）。治疗过程中，依从性显著下降。治疗开始时和治疗期间最近使用兴奋剂（可卡因和/或安非他命）与不依从相关。剂量时间不一致（每日剂量时间的标准差≥240 分钟）也与治疗不依从独立相关。与剂量时间不一致相关的因素包括教育程度较低和最近使用兴奋剂。依从人群和不依从人群的 SVR 相似（94%与 94%，P=0.944）。
结论
本研究表明，近期有注射吸毒史的人群对每日一次的索磷布韦/维帕他韦治疗依从性较高。在 DAA 治疗前和治疗期间最近使用兴奋剂以及治疗期间剂量时间不一致与不依从相关。然而，不依从对治疗反应没有影响，表明在近期有注射吸毒史的人群中，依从性不是成功进行 DAA 治疗的显著障碍。
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