VIRAHEP-C Clinical Center

描述(由申请人提供)： 慢性丙型肝炎是慢性肝病和肝硬变的主要原因 在美国，现在是肝移植的主要原因 到终末期肝病。约占美国人口(400万)的1.8% 美国有丙型肝炎病毒抗体(抗丙型肝炎病毒)，大约 270万美国人有慢性感染的证据。疾病的流行 非洲裔美国人的丙型肝炎病毒抗体(3.2%)高于非裔美国人 非西班牙裔白人(1.8%)。慢性丙型肝炎残存的治疗 有问题，不令人满意。干扰素(干扰素)单用三联疗法 每周一次的注射已被证明具有生化、病毒学和 对组织学有益的影响。然而，持续病毒学应答(SVR) 仅见于少数患者(6%-16%)。联合用药治疗 干扰素+和利巴韦林治疗24或48周可导致高达35%至43%的SVR 分别进行了分析。目前关于这一影响的公开数据非常有限。 种族对慢性丙型肝炎患者抗病毒治疗反应的影响 大多数可用的报告显示，非裔美国人的 与接受所有治疗方案的非西班牙裔白人相比，SVR。我们是 建议进行一项多中心、对照的综合疗法临床试验。 聚乙二醇化干扰素+利巴韦林用于非裔美国人和非西班牙裔白人 慢性感染丙型肝炎病毒1型。将进行治疗 总持续时间为48周，完成后跟踪48周 心理治疗。共有400名高加索人和非洲人人数相等的患者 美国人(每组200人)将参加这项研究。初级阶段 这项试验的终点是确定非裔美国人和 非西班牙裔白人。此外，预测有利反应的因素 病毒学反应的模式也将在两个种族中进行评估 组。本试验的目的是评估：(A)SVR的比率 在患有慢性丙型肝炎的非洲裔美国人和非西班牙裔白人中 聚乙二醇化干扰素联合利巴韦林治疗慢性粒细胞白血病 48周；(B)预测SVR转为联合治疗的因素 在两个种族群体中的每一个中，以及与较差的反应相关的因素 非裔美国人和(C)病毒学反应的模式(包括病毒反应 动力学)，并确定不同的反应是否可以预测 最终结果(持续反应、复发或缺乏反应) 这两个种族中的每一个。这项研究的结果将使我们能够 开发特定的算法来预测非洲人中SVR的治疗率 美国人基于他们的治疗前的特点和模式 治疗期间的病毒学反应。

DESCRIPTION (provided by applicant): Chronic hepatitis C is the leading cause of chronic liver disease and cirrhosis in the United States and is now the leading cause for liver transplantation due to end-stage liver disease. Approximately 1.8% of population (4 million) in the United States have antibody to hepatitis C virus (anti-HCV) and approximately 2.7 million Americans have evidence of chronic infection. The prevalence of antibody to HCV is higher among African Americans (3.2%) than among the non-Hispanic whites (1.8%). Treatment of chronic hepatitis C remains problematical and unsatisfactory. Interferon (IFN) monotherapy given as three times weekly injections has been shown to have biochemical, virological and histological beneficial effects. However, sustained virological response (SVR) is seen in only a minority of patients (6-16%). Treatment with combination of IFN + and ribavirin for 24 or 48 weeks results in SVR rates of up to 35 to 43% respectively. Very limited published data is currently available on the impact of race on response to antiviral therapy in patients with chronic hepatitis C. Most available reports show that African Americans have a significantly lower SVR when compared to non-Hispanic whites with all treatment regimens. We are proposing a multicenter, controlled clinical trial of combination therapy of pegylated interferon + ribavirin for African Americans and non-Hispanic whites chronically infected with HCV genotype 1 virus. Treatment will be administered for a total duration of 48 weeks with a 48-week follow-up post completion of therapy. A total of 400 patients with equal numbers of Caucasians and African Americans (200 in each group) will be enrolled into this study. The primary end-point of this trial is to determine rate of SVR among African Americans and non-Hispanic whites. In addition, factors predictive for a favorable response and patterns of virological response will also be assessed in the two racial groups. The objectives of this trial are to evaluate: (a) the rates of SVR among African Americans and non-Hispanic Whites with chronic hepatitis C after treatment with combination therapy using pegylated interferon and ribavirin for 48 weeks; (b) the factors that are predictive of a SVR to combination therapy in each of the two racial groups and factors associated with poorer response in African Americans and (c) the patterns of virological response (including viral kinetics) early during treatment and determine if different responses predict the ultimate outcome (sustained response, relapse or a lack of response) in each of the two racial groups. The findings of this study will allow us to develop specific algorithms to predict rates of SVR to therapy among African Americans based on their pre-treatment characteristics and patterns of virological response during therapy.