Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada.
Division of Infectious Diseases/Chronic Viral Illness Service, Department of Medicine, Glen Site, McGill University Health Centre, Montreal, Quebec, Canada.
J Viral Hepat. 2018 Dec;25(12):1507-1514. doi: 10.1111/jvh.12985. Epub 2018 Sep 27.
Clinical trial results of direct acting antivirals (DAAs) for the treatment of hepatitis C virus (HCV) have shown improvements in health-related quality of life (HR-QoL). However, the extent to which these results are broadly generalizable to real-world settings is unknown. We investigated the real-world impact of oral DAA therapy on HR-QoL among individuals coinfected with HIV/HCV. We used data from the Canadian HIV/HCV Co-Infection Cohort Study that prospectively follows 1795 participants from 18 centres. Since 2007, clinical, lifestyle, and HR-QoL data have been collected biannually through self-administered questionnaires and chart review. HR-QoL was measured using the EQ-5D instrument. Participants initiating oral DAAs, having at least one visit before treatment initiation and at least one visit after DAA treatment response was ascertained, were included. Successful treatment response was defined as a sustained viral response (SVR). Segmented multivariate linear mixed models were used to evaluate the impact of SVR on HR-QoL, controlling for pretreatment trends. 227 participants met our eligibility criteria, 93% of whom achieved SVR. Before treatment, the EQ-5D utility index decreased 0.6 percentage-point/y (95% CI, -0.9, -0.3) and health state was constant over time. The immediate effect of SVR resulted in an increase of 2.3-units (-0.1, 4.7) in patients' health state and 2.0 percentage-point increase (-0.2, 4.0) in utility index. Health state continued to increase post-SVR by 1.4 units/y (-0.9, 3.7), while utility trends post-SVR plateaued over the observation period. Overall using real-world data, we found modest improvements in HR-QoL following SVR, compared to previously published clinical trials.
直接作用抗病毒药物（DAAs）治疗丙型肝炎病毒（HCV）的临床试验结果显示，健康相关生活质量（HR-QoL）得到改善。然而，这些结果在多大程度上可以广泛推广到真实世界环境中尚不清楚。我们调查了口服 DAA 治疗对 HIV/HCV 合并感染个体 HR-QoL 的真实世界影响。我们使用了加拿大 HIV/HCV 合并感染队列研究的数据，该研究前瞻性地随访了来自 18 个中心的 1795 名参与者。自 2007 年以来，通过自我管理问卷和图表审查每两年收集一次临床、生活方式和 HR-QoL 数据。使用 EQ-5D 工具测量 HR-QoL。纳入了开始口服 DAA 治疗、在治疗开始前至少有一次就诊且在 DAA 治疗反应后至少有一次就诊的参与者。成功的治疗反应定义为持续病毒学应答（SVR）。使用分段多变量线性混合模型评估 SVR 对 HR-QoL 的影响，同时控制治疗前的趋势。227 名参与者符合我们的入选标准，其中 93%达到了 SVR。治疗前，EQ-5D 效用指数每年下降 0.6 个百分点（95%CI，-0.9，-0.3），健康状况随时间保持不变。SVR 的即时效应导致患者健康状况增加 2.3 个单位（-0.1，4.7），效用指数增加 2.0 个百分点（-0.2，4.0）。SVR 后健康状况继续每年增加 1.4 个单位（-0.9，3.7），而 SVR 后效用趋势在观察期间趋于平稳。总体而言，使用真实世界数据，我们发现与以前的临床试验相比，SVR 后 HR-QoL 有适度改善。
