Hepatology, Department of BioMedical Research, University of Bern, Bern, Switzerland.
Division of Gastroenterology and Hepatology, University Hospital Zürich, Zürich, Switzerland.
PLoS One. 2020 Nov 4;15(11):e0241267. doi: 10.1371/journal.pone.0241267. eCollection 2020.
Fatigue is the most commonly reported symptom of Hepatitis C Virus (HCV) infected patients and severely impacts their quality of life. The aim of this study was to measure the impact of 3D regimen treatment on the fatigue, daytime physical activity and sleep efficiency of HCV infected patients with fatigue.
HEMATITE was an observational, prospective, open-label, single-arm, Swiss multi-centric study in mono-infected HCV genotype 1 patients. The 28 week observation period comprised of 4 weeks preparation, 12 weeks treatment and 12 weeks follow-up. Fatigue was assessed using the fatigue severity scale (FSS) questionnaire. Patients with FSS ≥ 4 (clinically significant fatigue) were included. The activity tracker, ActiGraph GT9X Link®, was used to measure daytime physical activity and sleep efficiency. Outcome analysis was performed on a scaled down intention to treat (sdITT) population, which excluded patients with insufficient tracker data at all study visits and a modified ITT (mITT) population, which consisted of patients with complete tracker data at all study visits.
Forty of 41 patients in the ITT population had a sustained virologic response 12 weeks post-treatment (SVR12). Mean baseline FSS score was 6.0 for the sdITT population and 5.9 for the mITT population and decreased from baseline to 12 weeks post-treatment by 2.6 (95% confidence interval [CI]: 2.1, 3.1) for the sdITT (n = 37) population and 2.8 (95% CI: 2.2, 3.4) for the mITT (n = 24) population. Mean daytime physical activity or sleep efficiency did not change considerably over the course of the study.
Measurement by the activity tracker of mean day time physical activity did not show a considerable change from baseline to SVR12 upon treatment with 3D regimen. Nevertheless, a reduction of fatigue as assessed with the validated fatigue severity scale (FSS) was observed, suggesting a causative role of HCV in this extrahepatic manifestation.
ClinicalTrials.gov identifier: NCT03002818.
疲劳是丙型肝炎病毒（HCV）感染患者最常报告的症状，严重影响其生活质量。本研究旨在测量 3D 方案治疗对伴有疲劳的 HCV 感染患者的疲劳、白天体力活动和睡眠效率的影响。
HEMATITE 是一项在瑞士多中心进行的观察性、前瞻性、开放标签、单臂 HCV 基因 1 型单感染患者的研究。28 周的观察期包括 4 周准备期、12 周治疗期和 12 周随访期。疲劳使用疲劳严重程度量表（FSS）问卷进行评估。纳入 FSS≥4（有临床意义的疲劳）的患者。使用活动追踪器 ActiGraph GT9X Link®测量白天体力活动和睡眠效率。对规模缩小的意向治疗（sdITT）人群进行结果分析，该人群排除了所有研究访视时跟踪器数据不足的患者，对完整跟踪器数据的患者进行修改后的意向治疗（mITT）人群进行分析。
41 例意向治疗（ITT）人群中的 40 例患者在治疗后 12 周时获得持续病毒学应答（SVR12）。sdITT 人群的基线 FSS 评分平均为 6.0，mITT 人群的基线 FSS 评分平均为 5.9，sdITT（n=37）人群从基线到治疗后 12 周下降了 2.6（95%置信区间[CI]：2.1，3.1），mITT（n=24）人群下降了 2.8（95%置信区间[CI]：2.2，3.4）。在研究过程中，白天体力活动或睡眠效率的平均值没有明显变化。
使用活动追踪器测量的白天体力活动平均值在接受 3D 方案治疗后从基线到 SVR12 时没有明显变化。然而，用经过验证的疲劳严重程度量表（FSS）评估的疲劳减轻表明 HCV 在这种肝外表现中起因果作用。
ClinicalTrials.gov 标识符：NCT03002818。
