思想散步分享 http://blog.sciencenet.cn/u/fqng1008 前三十年写日记,后三十年写博客

博文

从丙肝药sofosbuvirIII期临床成功看新药竞争势态

已有 3495 次阅读 2013-2-22 11:10 |个人分类:肝病手记|系统分类:科研笔记| 杂谈, 丙型肝炎, 干扰素治疗, sofosbuvir

    刚刚写完“复方中药的尴尬”,就又看到《生物谷》(BIOON)2013年2月21日的短讯:19日,Gilead宣布sofosbuvir的第4个也是最后一个III期临床获得成功,这个被称为 FUSION 的三期研究评价了为期12周和16周的 sofosbuvir(之前名为GS-7977)+ 免疫增强剂利巴韦林(ribavirin)组合疗法,对于之前治疗失败的2型或3型丙型肝炎患者来说,治疗之后73%达到SVR。如果获批,sofosbuvir将成为用于丙型肝炎治疗的首个全口服组合治疗方案中的重要组成部分,并有望消除传统注射药物的需求

    曾几何时,我们还在跟患者宣称“干扰素(后来进展为聚乙二醇干扰素)+ 利巴韦林”是丙型肝炎的唯一疗法,虽然副作用较大,但疗效不错。不想时过境迁,新的口服药横空出世为干扰素退出丙型肝炎一线治疗打下坚实基础。新药竞争的主要趋势是高效低毒,这是人类健康的必然选择,而且是不可动摇的选择。面对如此竞争激烈的新药开发市场,难道低水平重复的复方中药没有紧迫感,真的可以以不变应万变?难道不能从“辨证论治”的特色套路里走出来?

    我看,还是“变亦变,不变亦变”,积极寻找应对策略和措施,不要继续在“复方药理学”的诠释中(不以疗效为首要目标)自鸣得意了。

 

附英文报道

Gilead Sciences (GILD) today announced topline results from the Phase 3 FUSION study evaluating 12- and 16-week courses of therapy with the once-daily nucleotide sofosbuvir plus ribavirin (RBV) in treatment-experienced patients with genotype 2 or 3 chronic hepatitis C virus (HCV) infection who failed prior treatment. The study met its primary efficacy endpoint of superiority compared to a predefined historic control sustained virologic response (SVR) rate of 25 percent. In FUSION, 50 percent of patients (n=50/100) in the 12-week arm and 73 percent of patients (n=69/95) in the 16-week arm achieved SVR12 (p<0.001 for both arms).

"This study demonstrates that all-oral therapy with sofosbuvir provides significant efficacy among difficult-to-treat hepatitis C patients who could not be cured by prior regimens containing pegylated interferon and now have limited treatment options," said Norbert Bischofberger, PhD, Executive Vice President of Research and Development and Chief Scientific Officer. "With positive results from all four Phase 3 trials now in hand, Gilead is on track to meet its goal of filing regulatory applications in the United States and Europe in the second quarter."

In the FUSION study, HCV genotype 2 or 3 patients who failed prior interferon-based therapy were randomized (1:1) to receive either a 12-week (n=103) or 16-week (n=98) course of sofosbuvir 400 mg once daily plus RBV (1,000 or 1,200 mg/day). Sixty-three percent of patients were infected with genotype 3. In the 12-week arm, SVR12 rates were 86 percent among genotype 2 and 30 percent among genotype 3 patients. In the 16-week arm, SVR12 rates were 94 percent among genotype 2 and 62 percent among genotype 3 patients. Among the 34 percent of FUSION participants who had compensated cirrhosis at baseline, 31 percent achieved SVR12 in the 12-week arm, and 66 percent achieved SVR12 in the 16-week arm. All patients in the study became HCV negative on treatment, and relapse accounted for all virologic failures.

No patients discontinued sofosbuvir or RBV due to adverse events. The most common adverse events reported in ≥15 percent of patients in the study were fatigue, headache, insomnia and nausea.

Results from all four pivotal Phase 3 studies of sofosbuvir – FUSION, POSITRON, FISSION and NEUTRINO – will support the initial regulatory filing for sofosbuvir as part of all-oral therapy with RBV among genotype 2 and 3 treatment-na?ve, treatment-experienced and interferon-intolerant HCV patients, and for sofosbuvir in combination with RBV and pegylated interferon among treatment-na?ve patients with genotypes 1, 4, 5 and 6.



https://wap.sciencenet.cn/blog-279293-664079.html

上一篇:复方中药的尴尬
下一篇:疗效竞争是真刀真枪,花拳绣腿上不了战场——感王进博文
收藏 IP: 119.8.184.*| 热度|

1 许培扬

该博文允许注册用户评论 请点击登录 评论 (5 个评论)

数据加载中...
扫一扫,分享此博文

Archiver|手机版|科学网 ( 京ICP备07017567号-12 )

GMT+8, 2024-2-22 13:25

Powered by ScienceNet.cn

Copyright © 2007- 中国科学报社

返回顶部