IN VITRO TESTING FOR AGENTS THAT INHIBIT HBV REPLICATION

在第一阶段，开发了定量分析来筛选治疗性的 在慢性乙型肝炎患者中阻断B型肝炎病毒（HBV）复制的药物 被感染的细胞 II期研究的第一个目标是简化 体外测试系统，以降低成本和劳动力，并提高 可靠性和准确性。 II期研究的第二个目标是 利用改进的测定法来检测5至10种模型化合物， HBV或其他嗜肝DNA病毒。 这些研究将比较 体外组织培养试验中的抗HBV活性与观察到的 in vivo. 在第二阶段的第二年，第三个目标是筛选 至少100种抗病毒化合物， 与加速试验相关的潜在技术问题 时间表，证明测试程序的有效性， 未来III期研究的合作伙伴， 鉴定可以被修饰以提高功效的母体化合物。 在 第三阶段，预计将测试300至1000种化合物 每年一次。 测试的速度将取决于流媒体的成功与否 第二阶段试验和合作伙伴的财政支持。

In Phase I, quantitative assays were developed to screen for therapeutic agents that block the replication of hepatitis B virus (HBV) in chronically infected cells. The first objective of Phase II studies is to simplify the in vitro testing system, to reduce costs and labor, and to enhance reliability and accuracy. The second objective of Phase II studies is to utilize the improved assays to examine 5 to 10 model compounds that inhibit HBV or other hepadnaviruses in animal models. These studies will compare the anti-HBV activity in the in vitro tissue culture assay to that observed in vivo. In the second year of Phase II, the third objective is to screen at least 100 antiviral compounds in collaborative programs to identify potential technical problems associated with an accelerated testing schedule, demonstrate the validity of the testing procedures to collaborating partners for future Phase III studies, and potentially identify parental compounds which may be modified to improve efficacy. In Phase III, it is anticipated that 300 to 1000 compounds will be tested yearly. The pace of testing will be determined by the success in streaming the Phase II assays and by financial support from collaborative partners.