Clinical and Epidemiology Core

随着丙型肝炎病毒(丙型肝炎病毒)治疗抗病毒方案的不断改进，以及根除病毒的好处变得更加明显，提高治疗成功率的必要性变得越来越重要。包括聚乙二醇化干扰素(聚乙二醇化干扰素)和利巴韦林的标准护理(SOC)治疗方案都很长，有显著的副作用，而且并不是所有患者都受益。最近完成的第二阶段试验证明，新药物的疗效有所改善，如丙型肝炎病毒蛋白酶抑制剂和聚合酶抑制剂。3期试验正在进行中，FDA可能很快就会批准新的联合疗法，包括蛋白酶抑制剂telapvir或bocprevir与聚乙二醇干扰素和利巴韦林联合使用。尽管最近取得了这些进展，但仍有必要了解人类对丙型肝炎病毒感染的免疫反应的基本机制，以最大限度地发挥现有治疗方法的好处，并为开发更有效的治疗方法提供必要的知识库。 临床流行病学中心的使命是支持和促进该中心关于先天免疫和适应性免疫的两个综合研究项目。该核心中心将：(A)从2005-2009年丙型肝炎病毒1型(GT-1)聚乙二醇化干扰素/利巴韦林治疗的回顾定义结果的200名患者中识别、登记并获取血液样本；(B)从2011-2014年期间开始丙型肝炎病毒GT-1联合抗病毒治疗的80名未接受治疗的不同预期队列中登记并连续获取血液样本；(C)为中心的总体目标提供肝病学和临床研究专业知识，包括制定与患者相关的方案和管理人类受试者保护的方方面面。此外，中心将开发和维护中心的生物仓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)为中心的项目开发分析数据库，以及(B)对抗病毒治疗反应的免疫学相关性进行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. Recently completed phase 2 trials have demonstrated improved efficacy of new agents, such as HCV protease inhibitors and polymerase inhibitors. Phase 3 trials are underway and there may soon be FDA approval of new combination therapies, including the protease inhibitors telaprevir or boceprevir combined with peg-IFN and ribavirin. Despite these recent advances, there remains an underlying need to understand the fundamental mechanisms of the human immune response to HCV infection, 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 protection. In addition, 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.