Schulte Bernd, Schmidt Christiane S, Manthey Jakob, Strada Lisa, Christensen Stefan, Cimander Konrad, Görne Herbert, Khaykin Pavel, Scherbaum Norbert, Walcher Stefan, Mauss Stefan, Schäfer Ingo, Verthein Uwe, Rehm Jürgen, Reimer Jens
Centre for Interdisciplinary Addiction Research, Department of Psychiatry, Medical Centre Hamburg-Eppendorf, Hamburg, Germany.
Institute of Clinical Psychology and Psychotherapy & Center of Clinical Epidemiology and Longitudinal Studies, Technische Universität Dresden, Dresden, Germany.
Open Forum Infect Dis. 2020 Aug 13;7(8):ofaa317. doi: 10.1093/ofid/ofaa317. eCollection 2020 Aug.
Patient-reported outcomes (PROs) can help to reduce uncertainties about hepatitis C virus (HCV) treatment with direct-acting antivirals (DAAs) among people who inject drugs and increase treatment uptake in this high-risk group. Besides clinical data, this study analyzed for the first time PROs in a real-world sample of patients on opioid agonist treatment (OAT) and HCV treatment with DAAs.
HCV treatment data including virological response, adherence, safety, and PROs of 328 German patients on OAT were analyzed in a pragmatic prospective cohort study conducted from 2016 to 2018. Clinical effectiveness was defined as sustained virological response (SVR) at week 12 after end of treatment and calculated in per-protocol (PP) and intention-to-treat (ITT) analyses. Changes over time in PROs on health-related quality of life, physical and mental health, functioning, medication tolerability, fatigue, concentration, and memory were analyzed by repeated-measures analyses of variances (ANOVAs).
We found high adherence and treatment completion rates, a low number of mainly mild adverse events, and high SVR rates (PP: 97.5% [n = 285]; ITT: 84.5% [n = 328]). Missing SVR data in the ITT sample were mainly caused by patients lost to follow-up after treatment completion. Most PROs showed statistically significant but modest improvements over time, with more pronounced improvements in highly impaired patients.
This real-world study confirms that DAA treatment among OAT patients is feasible, safe, and effective. PROs show that all patients, but particularly those with higher somatic, mental, and social burden, benefit from DAA treatment.
患者报告结局（PROs）有助于减少注射吸毒者中使用直接抗病毒药物（DAAs）治疗丙型肝炎病毒（HCV）的不确定性，并提高这一高危人群的治疗接受率。除临床数据外，本研究首次分析了接受阿片类激动剂治疗（OAT）并使用DAAs治疗HCV的真实世界患者样本中的PROs。
在一项于2016年至2018年进行的务实前瞻性队列研究中，分析了328例接受OAT的德国患者的HCV治疗数据，包括病毒学应答、依从性、安全性和PROs。临床疗效定义为治疗结束后第12周的持续病毒学应答（SVR），并在符合方案（PP）分析和意向性分析（ITT）中进行计算。通过重复测量方差分析（ANOVA）分析了PROs在健康相关生活质量、身心健康、功能、药物耐受性、疲劳、注意力和记忆力方面随时间的变化。
我们发现依从性和治疗完成率较高，主要为轻度不良事件的数量较少，SVR率较高（PP：97.5%[n = 285]；ITT：84.5%[n = 328]）。ITT样本中缺失的SVR数据主要是由于患者在治疗完成后失访所致。大多数PROs随时间显示出具有统计学意义但适度的改善，在受损严重的患者中改善更为明显。
这项真实世界研究证实，OAT患者使用DAA治疗是可行、安全且有效的。PROs表明，所有患者，尤其是那些躯体、心理和社会负担较重的患者，都能从DAA治疗中获益。
