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“3D方案”大幅提升丙肝临床治愈率

2018-01-10 李惠钰 科学网

丙肝是与艾滋病毒、结核病、疟疾并立的全球公共卫生领域难题及重大威胁。全球丙肝感染率1%,约有7100万人,目前中国约有1000万丙肝病毒感染者。


丙肝是与艾滋病毒、结核病、疟疾并立的全球公共卫生领域难题及重大威胁。全球丙肝感染率1%,约有7100万人,目前中国约有1000万丙肝病毒感染者。全球某研究型生物制药企业1月6日在北京宣布,旗下被称之为“3D方案”的、用于治疗成人基因1型慢性丙型肝炎的直接抗病毒治疗方案——维建乐(奥比帕利片)联合易奇瑞(达塞布韦钠片)正式登陆中国市场。

“3D方案”包含3种直接抗病毒药物,即NS5A抑制剂、NS3/4A蛋白酶抑制剂和NS5B聚合酶非核苷类似物抑制剂,可以从丙肝病毒生命周期的3个主要靶点抑制丙肝病毒的复制。针对基因1b型的亚洲慢性丙肝患者的两项3期临床研究数据表现卓越。北京大学第一医院感染疾病科主任、肝病中心主任王贵强教授介绍,“从基因分型上看,我国丙肝患者以基因1b型比重最大,约占56.8%。奥比帕利联合达塞布韦方案对于基因1b型丙肝患者具有稳定的高治愈率和安全性。”

长期以来,我国丙肝治疗一直以干扰素与利巴韦林联合用药为主,其治愈率约为44%-70%,且副作用较多。“3D方案”是全口服的、无干扰素、可联合或不联合利巴韦林,可用于治疗成人基因1型慢性丙型肝炎,包括无肝硬化或伴代偿期肝硬化的患者,疗程可短至12周,持续病毒学应答率(SVR12)为99.5%-100%,大幅提高了丙肝的临床治愈率。

“3D方案”目前已在全球70多个国家和地区获批用于临床治疗基因1型慢性丙肝患者,包括美国以及所有28个欧盟成员国。该方案已先后得到包括欧洲肝病研究学会(EASL)、美国肝病研究学会(AASLD)及感染性疾病学会(IDSA)等机构发布的多个丙肝治疗指南推荐,作为基因1型丙肝患者有效的治疗选择。

中国工程院院士、中华医学会肝病学分会名誉主任委员庄辉教授说:“希望丙肝创新药物能够尽快纳入国家医保目录,使更多丙肝患者能够接受治疗,以尽早实现‘2030年消除病毒性肝炎这一严重公共卫生威胁’的伟大目标。”艾伯维中国总经理欧思朗表示,“艾伯维一直致力于为尽可能多的中国丙肝患者提供创新有效的治疗方案,期待能继续作为可信赖的合作伙伴,积极推进多方合作,共同推进中国尽早迈入‘无丙肝社会’。”(

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