Increasing Access to Hepatitis C Treatment in Opioid Endemic Rural Areas: the Kentucky Viral Hepatitis Treatment (KeY Treat) Study

摘要 肯塔基州病毒性肝炎治疗项目（KeY Treat）的总体目标是增加获得 在阿片类药物/HCV中间的阿巴拉契亚农村社区治疗丙型肝炎病毒（HCV） 共病的本研究旨在探讨是否消除障碍与获得直接作用 治疗HCV的抗病毒药物（DAA）（自付费用高，保险限制要求 专家，禁欲，和严重的肝损伤）将显着降低佩里的HCV负担 县，肯塔基州。这项拟议的研究是由吉利德科学公司捐赠的大量药物促成的 对于索非布韦/维帕他韦，为期12周，每天一次，泛基因型DAA。KeY Treat提出了一个多管齐下的 使用中级提供者模式治疗HCV的方法。除了DAA治疗，参与者将 提供获得补贴的药物辅助治疗、注射器服务和病例管理的机会。我们将 利用目标社区（公共卫生、监狱、医院）的现有资源以及正在进行的项目 致力于增加受影响社区获得HCV护理的机会（ECHO，FOCUS），以回答是否 消除影响获得HCV治疗的主要障碍，以及仍然存在的障碍。所有RNA阳性 肯塔基州佩里县的居民将有资格/招募参加研究（N = 900），以及以下人员 具体目标将被解决：1）确定慢性丙型肝炎的农村居民中的HCV治疗吸收 HCV; 2）在参加KeY Treat的患者中检查治疗完成的预测因素; 3） 检查达到持续病毒学应答（SVR或治愈）的参与者的特征; 4） 在达到SVR的患者中确定长期再感染率; 5）检查5年减少率 干预社区与农村对照县HCV感染率和流行率的比较 肯塔基州;以及6）使用数学建模评估KeY Treat的影响和成本效益。的 拟议的研究有巨大的潜力影响美国农村的公共卫生。大多数 在CDC最近的HCV/HIV热点分析中确定的县是农村，并且有真实的需要改善 获得DAA，以防止进一步的HCV传播，减轻晚期肝病的负担， 和肝细胞癌的风险。来自KeY Treat的数据将为政策提供信息， DAA的医疗补助/保险限制，并将提供急需的HCV提供蓝图 在资源匮乏的农村地区的治疗。

ABSTRACT The overarching goal of the Kentucky Viral Hepatitis Treatment Project (KeY Treat) is to increase access to treatment for the hepatitis C virus (HCV) in a rural Appalachian community in the midst of the opioid/HCV syndemic. This study seeks to examine whether removing barriers associated with accessing direct-acting antivirals (DAAs) for the treatment of HCV (high out-of-pocket costs, insurance restrictions requiring a specialist, abstinence, and significant liver damage) will significantly reduce the burden of HCV in Perry County, Kentucky. The proposed study is made possible by a significant drug donation from Gilead Sciences for sofosbuvir/velpatasvir, a 12-week, once per day, pan-genotypic DAA. KeY Treat proposes a multi-pronged approach to treating HCV using a mid-level provider model. In addition to DAA treatment, participants will be offered access to subsidized medication-assisted treatment, syringe services, and case management. We will leverage existing resources in the target community (public health, jail, hospital), as well as ongoing projects dedicated to increasing access to HCV care in affected communities (ECHO, FOCUS) to answer whether removing the major barriers to HCV treatment affect access, and what barriers remain. All RNA-positive residents of Perry County, Kentucky will be eligible/recruited for study participation (N≈900), and the following specific aims will be addressed: 1) determination of HCV treatment uptake among rural residents with chronic HCV; 2) examination of the predictors of treatment completion among those enrolled in KeY Treat; 3) examination of the characteristics of participants achieving sustained virologic response (SVR, or cure); 4) establishment of long-term re-infection rates among those achieving SVR; 5) examination of 5-year reductions in incidence and prevalence of HCV in the intervention community compared with a control county in rural Kentucky; and 6) evaluate the impact and cost-effectiveness of KeY Treat using mathematical modeling. The proposed research has tremendous potential to impact public health in the rural United States. The majority of counties identified in CDC’s recent HCV/HIV hotspot analysis were rural, and there is a real need to improve access to DAAs in order to prevent further HCV transmission, reduce the burden of advanced liver disease, and hepatocellular carcinoma in generations to come. Data from KeY Treat will inform policies around Medicaid/insurance restrictions for DAAs, and will deliver a much needed blueprint for the provision of HCV treatment in resource-deprived rural areas.