STUDY OF VIRAL RESISTANCE TO ANTIVIRAL THERAPY FOR CHRONIC HEPATITIS C (VIRAHEP)

慢性丙型肝炎 (VIRAHEP) 病毒抗病毒治疗的研究

• 批准号: 7376926
• 负责人: CHARLES D HOWELL
• 金额: $ 2.38万
• 依托单位: UNIVERSITY OF MARYLAND BALTIMORE
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-03-01 至 2007-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7376926
• 关键词: STUDY; VIRAL; RESISTANCE; ANTIVIRAL; THERAPY

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. VIRAHEP-C is a multicenter, collaborative clinical trial, sponsored by NIDDK-NIH, designed to test the hypothesis that African Americans respond less well to antiviral therapy than Caucasian patients. A total of 400 patients, equally divided between African American and Caucasians, will be enrolled at eight clinical centers throughout the United States. All participants will be HCV genotype 1. Participants will be treated for 48 weeks with pegylated interferon alfa-2a 180 mcg/week plus ribaviirin 1000-1200 mg/day. Participants will be followed for an additional 48 weeks after cessation of therapy. Sustained virological response rates (undetectable HCV RNA in serum 24 weeks post-treatment) and durable sustained virological response rates (undetectable HCV RNA in serum 48 weeks post-treatment) between the two cohorts will be compared to determine differences in treatment response between the two racial graoups. Clinical and virological data from these treatment cohorts will be used to evaluate factors associated with resistance to antiviral therapy in African Americans and Caucasians with chronic hepatitis C. Ancillary virology, immunology, genetics, and interferon signaling studies will be performed on samples obtained from participants will investigate potential mechanisms of antiviral resistance. Thus, viral kinetics (the rate at which HCV RNA is cleared from serum during therapy), immunological responses, measures of, and host and viral genetics will be evaluated in releationship to treatment respo

该子项目是利用 NIH/NCRR 资助的中心拨款提供的资源的众多研究子项目之一。子项目和研究者 (PI) 可能已从另一个 NIH 来源获得主要资金，因此可以在其他 CRISP 条目中出现。列出的机构是中心的机构，不一定是研究者的机构。 VIRAHEP-C 是一项由 NIDDK-NIH 赞助的多中心协作临床试验，旨在检验非裔美国人对抗病毒治疗的反应不如白人患者的假设。总共 400 名患者将在美国各地的 8 个临床中心入组，其中非洲裔美国人和白种人各占一半。所有参与者均为 HCV 基因型 1。参与者将接受为期 48 周的聚乙二醇化干扰素 α-2a 180 微克/周加利巴韦林 1000-1200 毫克/天的治疗。治疗停止后，参与者将被额外随访 48 周。将比较两组之间的持续病毒学缓解率（治疗后 24 周血清中检测不到 HCV RNA）和持久持续病毒学缓解率（治疗后 48 周血清中检测不到 HCV RNA），以确定两组之间治疗反应的差异种族群体。这些治疗队列的临床和病毒学数据将用于评估与患有慢性丙型肝炎的非裔美国人和白种人抗病毒治疗耐药相关的因素。将从参与者获得的样本进行辅助病毒学、免疫学、遗传学和干扰素信号研究研究抗病毒耐药的潜在机制。因此，将评估病毒动力学（治疗期间从血清中清除 HCV RNA 的速率）、免疫反应、宿主和病毒遗传学的测量以及与治疗反应的关系。