CCO_Amsterdam2013_CC_2013_Phase_III_and_Approved分析课件.pptVIP

下载本文档

6
0
约14万字
约 43页
2017-09-01 发布于广东
举报
版权申诉

CCO_Amsterdam2013_CC_2013_Phase_III_and_Approved分析课件.ppt

1、本文档共43页，可阅读全部内容。
2、原创力文档（book118）网站文档一经付费（服务费），不意味着购买了该文档的版权，仅供个人/单位学习、研究之用，不得用于商业用途，未经授权，严禁复制、发行、汇编、翻译或者网络传播等，侵权必究。
3、本站所有内容均由合作方或网友上传，本站不对文档的完整性、权威性及其观点立场正确性做任何保证或承诺！文档内容仅供研究参考，付费前请自行鉴别。如您付费，意味着您自己接受本站规则且自行承担风险，本站不退款、不进行额外附加服务；查看《如何避免下载的几个坑》。如果您已付费下载过本站文档，您可以点击这里二次下载。
4、如文档侵犯商业秘密、侵犯著作权、侵犯人身权等，请点击“版权申诉”（推荐），也可以打举报电话：400-050-0827(电话支持时间：9:00-18:30)。
5、该文档为VIP文档，如果想要下载，成为VIP会员后，下载免费。
6、成为VIP后，下载本文档将扣除1次下载权益。下载后，不支持退款、换文档。如有疑问请联系我们。
7、成为VIP后，您将拥有八大权益，权益包括：VIP文档下载权益、阅读免打扰、文档格式转换、高级专利检索、专属身份标志、高级客服、多端互通、版权登记。
8、VIP文档为合作方或网友上传，每下载1次，网站将根据用户上传文档的质量评分、类型等，对文档贡献者给予高额补贴、流量扶持。如果你也想贡献VIP文档。上传文档

P/R, peginterferon alfa-2a + ribavirin; RGT, response-guided therapy; SMV, simeprevir; SVR, sustained virologic response. Stefan Zeuzem, MD: This slide shows the virologic outcomes of the QUEST-1 trial. The majority of patients achieved undetectable HCV RNA at Week 4, and the overall SVR rate at 12 weeks posttreatment was superior in the simeprevir-containing treatment arm: 80% vs 50% with the peginterferon/ribavirin control arm. ? The slide also shows how many patients met the response-guided therapy criteria and how this affected the SVR outcomes. In this trial, 85% of patients met the criteria for shortened therapy and were allowed to discontinue treatment after an overall treatment duration of 24 weeks. Only 15% of patients in the simeprevir arm underwent the full 48-week treatment. Patients who qualified for 24 weeks of therapy achieved an SVR rate of 91% compared with 21% for those patients who underwent 48 weeks of treatment. ? Paul Y. Kwo, MD: One important take-home point from QUEST-1 is that extending therapy to 48 weeks in patients who did not have an RVR was associated with poor SVR rates. For all practical purposes, I think this may be considered a futility endpoint. * CI, confidence interval; GT, genotype; HCV, hepatitis C virus; Pbo, placebo; P/R, peginterferon alfa-2a + ribavirin; SMV, simeprevir; SVR, sustained virologic response. Stefan Zeuzem, MD: The left-hand figure on this slide continues the common theme that patients with cirrhosis tend to have lower SVR rates than noncirrhotic patients. Although SVR rates were higher with triple therapy vs peginterferon/ribavirin in both cirrhotic and noncirrhotic patients, the response to triple therapy was also attenuated in patient with cirrhosis vs noncirrhotic patients. ? The lower figure highlights an important challenge for genotype 1 HCV–infected patients during simeprevir therapy—the presence of a naturally occurring HCV polymorphism, Q80K, may lower the response to therapy in patients with ge