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凯力唯（60mg）联合赛波唯（0.4g）III期临床试验SVR12（FAS）

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凯力唯（60mg）联合赛波唯（0.4g）III期临床试验SVR12（FAS）_第4页

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凯力唯（60mg）联合赛波唯（0.4g）III期临床试验SVR12（FAS）_第5页

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所属报告：

凯因科技-公司研究报告-丙肝新药快速放量乙肝在研新药进展可期-240630（21页）.pdf

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凯力唯为首个国产丙肝高治愈率泛基因型全口服药物，获《丙型肝炎防治指南（2022年版）》推荐。凯力唯（盐酸可洛派韦胶囊）是一种全新的针对 HCV（丙肝病毒）的泛基因型 NS5A 复制复合子抑制剂，可抑制 HCV 的组装和复制。凯力唯是公司具有自主知识产权的化学 1 类新药，获得了“十三五”国家科技重大专项 -重大新药创制专项（2017ZX09201006-003）及中关村高精尖培育项目支持，通过优先审评审批程序于 2020年 2 月获批上市。赛波唯（索磷布韦片）是国产首家上市的 NS5B 聚合酶抑制剂，是治疗慢性丙肝的一线临床用药，主要与其他抗 HCV 药物联用，具有治愈率高、安全性高、不易产生耐药的优点，获得国家“十三五”国家科技重大专项-重大新药创制专项（2019ZX09302-028）支持，于 2020 年 3 月获批上市。凯力唯（盐酸可洛派韦胶囊）联用赛波唯（索磷布韦片）（联用方案简称“凯因方案”）是首个国产丙肝高治愈率泛基因型全口服药物组合，可治疗初治或干扰素经治的基因 1 型、2 型、3 型、6 型成人慢性丙型肝炎病毒（HCV）感染，覆盖中国所有主要基因型，可合并或不合并代偿性肝硬化。III期临床试验结果显示：基因 1 型、2 型、3 型和 6 型丙肝患者每天口服 1 次凯力唯（60mg）和赛波唯（0.4g），连续用药 12 周后的安全耐受性良好，总体受试者的 SVR12（按照治疗方案完成治疗后 12 周时的持续病毒学应答）为 97%，其中基因 1 型受试者 SVR12 为99%，基因 2 型受试者 SVR12 为 96%，基因 3 型受试者 SVR12 为 90%，基因 6 型受试者 SVR12 为 98%；合并进展性肝纤维化或代偿性肝硬化者 SVR12 为 97%；干扰素经治者 SVR12 为 100%。“凯因方案”的临床疗效与国际已上市同类药物丙通沙效果相当，获得《丙型肝炎防治指南（2022 年版）》推荐。

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