Clinical and Epidemiology Core

随着丙型肝炎病毒（HCV）治疗性抗病毒方案的不断改进，以及病毒治疗的益处， 根除变得更加明显，提高治疗成功率的必要性变得越来越大。 重要.标准治疗（SOC）治疗方案，包括聚乙二醇化干扰素（peg-IFN）和 利巴韦林是长时间的，具有显著的副作用，并且不能使所有患者受益。最近完成的阶段 2项试验证明了新药物的疗效改善，如HCV蛋白酶抑制剂和 聚合酶抑制剂3期试验正在进行中，FDA可能很快会批准新的 组合疗法，包括蛋白酶抑制剂特拉匹韦或博赛匹韦与聚乙二醇-IFN的组合， 利巴韦林。尽管最近取得了这些进展，但仍然需要了解基本的 HCV感染的人体免疫应答机制，既要最大限度地发挥目前的好处， 我们的目标是提供现有的治疗方法，并为开发更有效的治疗方法所需的知识库做出贡献。 临床流行病学核心的使命是支持和促进中心的两个综合 先天免疫和适应性免疫的研究项目。核心研究将（a）从2005-2009年期间接受聚乙二醇干扰素/利巴韦林治疗的HCV基因型1（GT-1）患者中，对200例患者的血液样本进行鉴定、招募和采集;（B）从80名开始HCV GT-1联合抗病毒治疗的初治患者的多样化前瞻性队列中招募并获得连续血液样品，在2011年至2014年期间，该中心将提供1项研究;以及（c）为该中心的总体目标提供肝病学和临床研究专业知识，包括制定患者相关方案和管理人类受试者保护的所有方面。此外，核心将开发和维护中心的生物储存库和综合研究数据库，并提供流行病学、生物统计学和数据分析专业知识，以（a）开发中心项目的分析数据库，（B）进行抗病毒治疗反应免疫学相关性的项目内和项目间分析。

As hepatitis C virus (HCV) therapeutic antiviral regimens continue to improve and as the benefits of viral eradication become more apparent, the need to increase treatment success rates becomes ever more important. Standard-of-care (SOC) treatment regimens that include pegylated interferon (peg-IFN) and ribavirin are lengthy, have significant side effects, and do not benefit all patients. Recenfiy completed phase 2 trials have demonstrated improved efficacy of new agents, such as HCV protease inhibitors and polymerase inhibitors. Phase 3 trials are undenway and there may soon be FDA approval of new combinafion therapies, including the protease inhibitors telaprevir or boceprevir combined with peg-IFN and ribavirin. Despite these recent advances, there remains'an underiying need to understand the fundamental mechanisms of the human immune response to HCV infecfion, both to maximize the benefits of currently available treatments and to contribute to the knowledge base necessary to develop more effective therapies. The mission of the Clinical Epidemiology Core is to support and facilitate the Center's two integrated research Projects on innate and adaptive immunity. The Core will (a) identify, enroll, and obtain a blood sample from a diverse group of 200 patients with retrospectively defined outcomes of peg-IFN/ribavirin treatment in the years 2005-2009 for HCV genotype 1 (GT-1); (b) enroll and obtain consecutive blood samples from a diverse prospective cohort of 80 treatment-naive patients initiating combination antiviral therapy for HCV GT-1 in the years 2011-2014; and (c) provide hepatology and clinical research expertise to the Center's overall goals, including the development of patient-related protocols and the administration of all aspects of human subjects protecfion. In addifion, the Core will develop and maintain the Center's biorepository and comprehensive study databases and provide epidemiological, biostatistical, and data analysis expertise to (a) develop analytic databases for the Center's projects and (b) conduct the intra- and inter-project analyses of the immunological correlates of antiviral treatment responses.