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Home > Press Releases Translations

可负担丙型肝炎新联合疗法 治愈率达97%

Home > Press Releases Translations

可负担丙型肝炎新联合疗法 治愈率达97%

Healthcare worker examines liver of hepatitis C patient in Thailand
12 Apr 2018
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巴黎,2018年4月12日

试验结果支持从公共卫生角度着手施用丙型肝炎疗程

非营利研发组织DNDi,也即是‘被忽视疾病药物研发倡议组织’(Drugs for Neglected Diseases initiative)在巴黎国际肝病大会上发表第II/III期STORM-C-1试验中期结果,显示一种包含新药ravidasvir的丙型肝炎联合疗法不仅安全有效,而且费用可负担得起。此联合疗法可达到极高治愈率,其中包括难治的个案。

DNDi执行总监Bernard Pécoul表示:“试验结果显示sofosbuvir和ravidasvir联合疗法与目前可得的最佳丙型肝炎疗法不相上下,但是前者价格可负担得起,对于不属于制药公司试用计划的国家而言,它可成为另一种治疗选择。”

在马来西亚卫生局的联合赞助下,DNDi采用埃及药物制造商Pharco Pharmaceuticals生产的药物在马来西亚和泰国十个地点展开此试验。2016和2017年签订的协议批准在马来西亚展开试验和按比例增加病人。在此协议下,长达12周的疗程的目标价格为300美元,比马来西亚现有疗程费用减少几乎100%。

马来西亚卫生部总监拿督Noor Hisham Abdullah医生指出:“丙型肝炎在马来西亚已成为一大公共卫生问题,为国家利益着想,确有必要提升人们获得治疗的机会。”马来西亚政府于2017年9月就sofosbuvir专利权发出一项“政府使用”准证,让国内40万名丙型肝炎患者可以在公共医院获得非专利丙型肝炎病毒疗程。

DNDi 展开STORM-C-1开放标签试验以评估候选药物ravidasvir与sofosbuvir联用的疗效、安全性、耐药性和药物动力学。301名慢性感染成人患者接受ravidasvir/sofosbuvir联合疗法,无肝硬化者疗程长达12周,有代偿性肝硬化者则接受24周的疗程。根据丙型肝炎病毒疗法的国际标准治愈定义,12周疗程完毕后,97%登记者已治愈(95% 置信区间:94.4-98.6)。即使在最难治的病人群中,其治愈率也十分高:肝硬化者(96%治愈)、接受例常疗法的人体免疫缺陷病毒患者(97%)、感染基因型3(97%)病毒包括有肝硬化者(96%),以及曾接受以往的丙型肝炎病毒疗法者(96%)。重要的是,身具多种风险因素的病人被治愈,同时无检测到意料之外的安全警讯。

Figure: STORM-C-1 : SVR12 rates overall and per pre-defined sub groups-Intend to treat analysis
整体STORM-C-1 : SVR12率以及按预定次子群-意向治疗分析

无国界医生 (Médecins Sans Frontières,简称MSF)副营运总监 Pierre Mendiharat 指出:“从治疗提供者角度而言,这是令人振奋的事,因为我们等待一种简单、廉价、强效而且为可所有病人群组所耐受的疗法已久,包括目前治疗效果较差的病人,譬如接受抗逆转录酶病毒疗法者。若要使更多发展中国家最弱势病人群体获得治疗,这是关键因素。”通过无国界医生组织转型投资能力(Transformational Investment Capacity ,简称TIC)方案资助的 STORM-C 项目,无国界医生得以和 DNDi 联手提高主要低收入和中等收入国家的丙型肝炎病人获得护理和治疗的机会。

全世界共有超过7100万人患丙型肝炎,此病每年造成40万人死亡。虽然高效疗法已存在多年,仅有不到300万人正接受治疗,每年死亡的感染人数比获得治疗者多。世界卫生组织锁定目标争取在2030年前让八成感染丙型肝炎病毒者获得治疗。

Ravidasvir是Presidio Pharmaceuticals向DNDi授予特许权的口服NS5A抑制剂。大多数在马来西亚和泰国登记参加DNDi试验者所感染的病毒属于基因型1(42% 参加者)或基因型3(53%),从而确定此联合疗法对另两种基因型病毒的功效。进一步试验已在计划中,目的是记录联合疗法对其他基因型丙型肝炎病毒感染者,尤其是脆弱群体的疗效和安全性,以便可以从公共卫生角度着手施用丙型肝炎疗程。

Pharco总裁Sherine Helmy博士说:“Pharco很荣幸能够提供可负担价格的疗法,以便可以从公共卫生角度着手施用丙型肝炎疗程。我们期盼可以进一步携手合作,在其他临床试验中确定ravidasvir的安全性和疗效。”

媒体联络处

  • DNDi: Ilan Moss, +1 646 266 5216, imoss@dndi.org / media@dndi.org

海报参考文献

I. Andrieux-Meyer, S.S.Tan, N. Salvadori, F. Simon, T.R. Cressey, MS Rosaida, Abu Hassan MR, H. Omar, H. P. Tee, W.K. Chan, Suresh K., S. Thongsawat, K. Thetket, A. Avihingsanon, S. Khemnark, S. Thanprasertsuk, J-M. Piedagnel, Sasikala S., Nur Asimah Z.A, N. Da Silva, J. Brenner, B. Pécoul, M. Lallemant and Shahnaz M. Safety and efficacy of ravidasvir plus sofosbuvir 12 weeks in non-cirrhotic and 24 weeks in cirrhotic patients with hepatitis C virus genotypes 1, 2, 3 and 6: the STORM-C-1 phase II/III trial. International Liver Congress, Paris, April 11-15 2018,  France. Poster LBP-032.

关于 DNDi

‘被忽视疾病药物研发倡议组织’(Drugs for Neglected Diseases initiative,简称DNDi)是一个非营利研发组织,致力为被忽视的病人提供新治疗法,尤其是针对非洲人类锥虫病、南美锥虫病、利什曼病、丝虫病、儿童人体免疫缺陷病毒/爱滋病以及丙型肝炎。 www.dndi.org

Photo credit: Suriyan Tanasri-DNDi

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