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中国自主开发出艾滋病病毒膜融合抑制剂 已完成Ⅱb期临床试验，效果显著
http://www.stdaily.com 2010年08月02日 来源： 科技日报 作者： 冯国梧
本报天津8月1日电（记者冯国梧）记者从今天召开的西夫韦肽研讨会上了解到，我国自主开发的艾滋病病毒膜融合抑制剂——西夫韦肽已顺利完成Ⅱb期临床试验，其疗效十分显著。
西夫韦肽属于国家一类创新专利药物，由天津扶素生物公司自主开发。扶素生物公司依据艾滋病病毒膜融合蛋白gp41的空间结构，全新设计和合成的新一代膜融合抑制剂，已经获得中国、美国及欧洲等专利授权，并已在国际杂志上发表10余篇相关专业文章。
据介绍，目前扶素生物公司已完成了西夫韦肽临床前以及Ⅰa、Ⅰb、Ⅱa和Ⅱb期临床研究，所有临床研究均按照国家药品临床试验管理规范（GCP）的要求进行，共有200余例志愿者和感染者参加了临床研究。研究结果显示，西夫韦肽的安全性和耐受性良好；每日一次20mg西夫韦肽的单药治疗效果等同于每日两次、每次100mg的美国同类上市药物T20。Ⅱb期试验结果显示，在联合治疗24周后，西夫韦肽能够显著提升抗病毒治疗效果，与使用传统抗病毒药物治疗相比，西夫韦肽可使艾滋病病毒载量降至检测不到的水平提升59%，并使CD4细胞计数的增加率提升89%。西夫韦肽的注射位点反应的发生率为7%，远低于T20的98%。
在今天的研讨会上，来自纽约血液研究中心、葡萄牙里斯本大学等多个国内外知名艾滋病研究单位以及北京佑安医院、北京地坛医院等多家艾滋病诊疗机构的专家对西夫韦肽给予了很高的评价。他们均表示，西夫韦肽的疗效大大超过人们的预期，其问世将为艾滋病人带来福音。
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China independently developed the AIDS virus membrane fusion inhibitors have completed clinical trials Ⅱ b, the effect was significantly
http://www.stdaily.com 2010 年 08 月 02 First Stage: Journal of Science and Technology: Fung Wu
Newspaper in Tianjin on August 1 (Xinhua Wu Fung), held from today's seminar Sifuvirtide know, China has independently developed the AIDS virus membrane fusion inhibitors - Sifuvirtide has successfully completed clinical trials Ⅱ b , its effect is very significant.
Sifuvirtide state innovation patent for a class of drug, by the Tianjin company supporting the independent development of biological factors. Helping the company based on biological factors of HIV gp41 membrane fusion protein spatial structure, new design and synthesis of a new generation of membrane fusion inhibitor, has received the Chinese, American and European patents and has published more than 10 international journal articles professional articles.
Recent statistics show that supporting the prime biological company has completed Sifuvirtide pre-clinical and Ⅰ a, Ⅰ b, Ⅱ a 和 Ⅱ b clinical study, all clinical research according to the national Pharmaceutical Clinical Practice (GCP) requirements, a total of 200 volunteers and infected patients participated in clinical research. The results show that Sifuvirtide the safety and well tolerated; Sifuvirtide 20mg once a day single-drug treatment is equivalent to twice daily 100mg of the United States listed the same drugs T20. Ⅱ b on the test results show that after 24 weeks of combination therapy, Sifuvirtide can significantly enhance the anti-viral treatment, and compared with conventional antiviral treatment, AIDS can Sifuvirtide fell to undetectable viral load raise the level of 59%, and to enhance the rate of increase of CD4 cell count of 89%. Sifuvirtide injection site reaction rate was 7%, well below the 98% of T20.
At today's seminar, from the New York Blood Center, University of Lisbon, Portugal and many other well-known AIDS research units as well as Beijing You'an Hospital, Beijing Ditan Hospital and a number of bodies of AIDS treatment experts gave Sifuvirtide highly. They said the effect Sifuvirtide greatly exceeded expectations, the advent of AIDS will bring good news.
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