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(关键治疗)的首要目标是增加获得 在阿片类药物/丙型肝炎病毒中间的阿巴拉契亚农村社区丙型肝炎病毒的治疗 合并症。这项研究试图检查是否消除与获得直接作用相关的障碍 用于治疗丙型肝炎病毒的抗病毒药物(高额自付费用，保险限制要求 专家、禁欲和严重的肝脏损害)将显著减少佩里的丙型肝炎病毒负担 肯塔基州的县。这项拟议的研究是通过吉利德科学公司的一笔重大药物捐赠而成为可能的 对于Sofosbuvir/velpatasvir，12周，每天一次，泛基因DAA。Key Treat提出了多管齐下的建议 使用中层提供者模型治疗丙型肝炎病毒的方法。除了DAA治疗外，参与者还将 提供获得补贴的药物辅助治疗、注射器服务和病例管理。我们会 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 致力于在受影响的社区(ECHO，FOCUS)增加获得丙型肝炎病毒护理的机会，以回答是否 消除影响获取丙型肝炎病毒治疗的主要障碍，以及仍然存在哪些障碍。全部为RNA阳性 肯塔基州佩里县的居民将有资格/被招募参加研究(N≈900)，以及以下 具体目标将涉及：1)确定慢性丙型肝炎农村居民的丙型肝炎治疗接受率 丙型肝炎病毒；2)在参加关键治疗的患者中检查治疗完成的预测因素；3) 检查实现持续病毒学应答(SVR或治愈)的参与者的特征；4) 建立达到SVR的人的长期再感染率；5)检查5年减少率 农村干预社区与对照县丙型肝炎病毒感染率比较 肯塔基州；6)使用数学模型评估关键治疗的影响和成本效益。这个 拟议中的研究具有巨大的潜力，可以影响美国农村的公共健康。大多数人 在疾控中心最近的丙型肝炎/艾滋病毒热点分析中确定的县是农村，确实需要改进 获得DAA，以防止进一步的丙型肝炎传播，减轻晚期肝病的负担， 以及子孙后代的肝细胞癌。Key Treat的数据将为各地政策提供信息 对DAA的医疗补助/保险限制，并将为提供丙型肝炎病毒提供急需的蓝图 资源匮乏的农村地区的待遇。

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.