Clinical and Epidemiology Core

临床和流行病学核心

• 批准号: 8376382
• 负责人: NORAH A. TERRAULT
• 金额: $ 23.11万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-06-01 至 2015-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8376382
• 关键词: Adverse effects; Antiviral Agents; Antiviral Therapy; Area; Blood specimen; Caring; Chronic Hepatitis C; Clinical; Clinical Research; Combined Modality Therapy; Data Analyses; Databases; Development; Enrollment; Epidemiology; Genotype; Goals; Hepatitis C; Hepatitis C virus; Hepatology; Human; Immune response; Immune system; Immunologic Factors; Immunology; Interferons; Laboratories; Laboratory Research; Maintenance; Mission; Natural Immunity; New Agents; Outcome; Participant; Patients; Pharmaceutical Preparations; Phase II Clinical Trials; Phase III Clinical Trials; Polymerase; Process; Protease Inhibitor; Protocols documentation; Regimen; Research; Research Personnel; Research Project Grants; Ribavirin; Specimen; Therapeutic; Time Study; Treatment Protocols; Viral; adaptive immunity; biobank; clinical epidemiology; cohort; design; effective therapy; human subject; human subject protection; improved; inhibitor/antagonist; knowledge base; programs; prospective; response; success; treatment response

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.

随着丙型肝炎病毒（HCV）治疗抗病毒方案的不断改进和随着病毒的益处