积极使用毒品和酒精人群对直接抗病毒治疗的依从性：INCLUD研究。
Adherence to Direct-Acting Antiviral Therapy in People Actively Using Drugs and Alcohol: The INCLUD Study.
作者信息
Brooks Kristina M, Castillo-Mancilla Jose R, Morrow Mary, MaWhinney Samantha, Rowan Sarah E, Wyles David, Blum Joshua, Huntley Ryan, Salah Lana M, Tehrani Arya, Bushman Lane R, Anderson Peter L, Kiser Jennifer J
机构信息
Department of Pharmaceutical Sciences, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.
Division of Infectious Diseases, School of Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.
出版信息
Open Forum Infect Dis. 2020 Nov 19;8(1):ofaa564. doi: 10.1093/ofid/ofaa564. eCollection 2021 Jan.
BACKGROUND
Hepatitis C virus treatment in persons who use drugs (PWUD) is often withheld due to adherence and reinfection concerns. In this study, we report treatment outcomes, technology-based adherence data, and adherence predictors in PWUD and/or alcohol.
METHODS
INCLUD was a prospective, open-label study of ledipasvir/sofosbuvir for 12 weeks in PWUD aged 18-70 years. Participants were randomized to wireless (wirelessly observed therapy) or video-based directly observed therapy (vDOT). Drug use was assessed every 2 weeks. Sustained virologic response (SVR) was examined by intention-to-treat and as-treated. Factors associated with missing ≥1 dose(s) between visits were examined using generalized linear models.
RESULTS
Sixty participants received ≥1 ledipasvir/sofosbuvir dose (47 human immunodeficiency virus [HIV]/hepatitis C virus [HCV], 13 HCV only; 78% male; 22% black; 25% cirrhotic). Substance use occurred at 94% of person-visits: 60% marijuana, 56% alcohol, 37% methamphetamine, 22% opioids, 17% cocaine, and 20% injection drug use. The SVR by intention-to-treat was 86.7% (52 of 60) and as-treated was 94.5% (52 of 55). Confirmed failures included 1 relapse, 1 reinfection, and 1 unknown (suspected reinfection). Median total adherence was 96% (interquartile range [IQR], 85%-100%; range, 30%-101%), and between-visit adherence was 100% (IQR, 86%-100%; range, 0%-107%). The odds of missing ≥1 dose between visits increased with HIV coinfection (2.94; 95% confidence interval [CI], 1.37-6.32; = .006), black race (4.09; 95% CI, 1.42-11.74; = .009), methamphetamine use (2.51; 95% CI, 1.44-4.37; = .0.001), and cocaine use (2.12; 95% CI, 1.08-4.18; = .03) and decreased with marijuana use (0.34; 95% CI, 0.17-0.70; = .003) and vDOT (0.43; 95% CI, 0.21-0.87; = .02).
CONCLUSIONS
Persons who use drugs achieved high SVR rates with high, but variable, ledipasvir/sofosbuvir adherence using technology-based methods. These findings support efforts to expand HCV treatment in PWUD.
背景
由于对依从性和再感染的担忧，吸毒者（PWUD）的丙型肝炎病毒治疗常常被推迟。在本研究中，我们报告了PWUD和/或酗酒者的治疗结果、基于技术的依从性数据以及依从性预测因素。
方法
INCLUD是一项针对18至70岁PWUD进行的前瞻性、开放标签研究，使用来迪派韦/索磷布韦治疗12周。参与者被随机分为无线组（无线观察治疗）或基于视频的直接观察治疗（vDOT）。每2周评估一次药物使用情况。通过意向性分析和实际治疗情况来检查持续病毒学应答（SVR）。使用广义线性模型检查与访视期间漏服≥1剂药物相关的因素。
结果
60名参与者接受了≥1剂来迪派韦/索磷布韦治疗（47名人类免疫缺陷病毒[HIV]/丙型肝炎病毒[HCV]感染者，13名仅感染HCV者；78%为男性；22%为黑人；25%为肝硬化患者）。94%的人次访视中出现物质使用情况：60%使用大麻，56%饮酒，37%使用甲基苯丙胺，22%使用阿片类药物，17%使用可卡因，20%注射吸毒。意向性分析的SVR为86.7%（60例中的52例），实际治疗情况的SVR为94.5%（55例中的52例）。确诊的治疗失败包括1例复发、1例再感染和1例不明原因（疑似再感染）。总体依从性中位数为96%（四分位间距[IQR]，85%-100%；范围，30%-101%），访视期间的依从性为100%（IQR，86%-100%；范围，0%-107%）。访视期间漏服≥1剂药物的几率随着HIV合并感染（2.94；95%置信区间[CI]，1.37-6.32；P = 0.006）、黑人种族（4.09；95% CI，1.42-11.74；P = 0.009）、甲基苯丙胺使用（2.51；95% CI，1.44-4.37；P = 0.001）和可卡因使用（2.12；95% CI，1.08-4.18；P = 0.03）而增加，随着大麻使用（0.34；95% CI，0.17-0.70；P = 0.003）和vDOT（0.43；95% CI，0.21-0.87；P = 0.02）而降低。
结论
吸毒者使用基于技术的方法来迪派韦/索磷布韦依从性较高但存在差异，SVR率也较高。这些发现支持在PWUD中扩大HCV治疗的努力。
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