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Adv Ther. 2018 Jul;35(7):1087-1102. doi: 10.1007/s12325-018-0721-1. Epub 2018 Jun 9.
Chronic infection with hepatitis C virus (HCV) is a leading cause of liver disease and infectious disease deaths. While recent and emerging treatment options for HCV patients have enabled higher rates of sustained virologic response (SVR), the demographic, clinical, geographic, and payer characteristics of the estimated 3.4 million chronic HCV patients in the USA are poorly understood. The goal of this study was to create a dataset describing the current HCV patient landscape in the USA.
Data from two large national laboratory companies representing the majority of US patients screened for HCV antibody and/or tested for HCV RNA from 2013 through 2016 were organized into the present study dataset. Age, gender, payer channel, 3-digit ZIP code and ordering physician specialty, and 3-digit ZIP code information were available for all patients. Among RNA-positive patients, additional clinical characteristics included HCV genotype, fibrosis stage, renal function, and HIV status. Initiating treatment and attaining cure were imputed using data-driven algorithms based on successive RNA viral load measurements.
The number of RNA-positive HCV patients increased from 200,066 patients in 2013 to 469,550 in 2016. The availability of clinical data measurements and rates of treatment initiation increased over the study period, indicating improved care engagement for HCV patients. Treatment and cure rates varied by age, disease severity, geographic location, and payer channel. Sensitivity and specificity of the cure prediction algorithms were consistently above 0.90, validating the robustness of the data imputation approach.
This is the largest, most comprehensive dataset available to describe the current US HCV patient landscape. Our results highlight that the epidemiology of HCV is evolving with an increasing number of patients who are younger and have milder disease than described in previous years. Results of this study should help guide efforts toward the elimination of HCV in this country. Future work will focus on factors associated with varying treatment and cure patterns and describing recent changes in the HCV patient landscape.
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慢性丙型肝炎病毒（HCV）感染是导致肝病和传染病死亡的主要原因。虽然最近和新兴的 HCV 患者治疗方案能够提高持续病毒学应答（SVR）的比率，但美国估计有 340 万慢性 HCV 患者的人口统计学、临床、地理和支付方特征仍知之甚少。本研究的目的是创建一个描述美国目前 HCV 患者情况的数据集。
从两家大型全国性实验室公司收集的数据，这些公司代表了 2013 年至 2016 年期间筛查 HCV 抗体和/或检测 HCV RNA 的大多数美国患者，将这些数据组织到本研究的数据集中。所有患者均提供年龄、性别、支付方渠道、3 位邮政编码和开单医生专业，以及 3 位邮政编码信息。在 RNA 阳性患者中，其他临床特征包括 HCV 基因型、纤维化分期、肾功能和 HIV 状态。根据连续 RNA 病毒载量测量数据驱动的算法，推断出开始治疗和达到治愈的情况。
2013 年 RNA 阳性 HCV 患者数量为 200066 例，到 2016 年增加到 469550 例。在研究期间，临床数据测量和治疗开始的可用性增加，表明 HCV 患者的治疗参与度有所提高。治疗和治愈率因年龄、疾病严重程度、地理位置和支付方渠道而异。治愈预测算法的灵敏度和特异性始终高于 0.90，验证了数据推断方法的稳健性。
这是目前描述美国 HCV 患者情况的最大、最全面的数据集。我们的研究结果表明，HCV 的流行病学正在发生变化，越来越多的患者比前几年描述的更年轻，疾病更轻。本研究的结果应有助于指导在该国消除 HCV 的努力。未来的工作将集中于与不同治疗和治愈模式相关的因素，并描述 HCV 患者情况的最新变化。
艾伯维。本文提供了通俗易懂的摘要。
