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NEJM:HCV基因型2或3患者——sofosbuvir/velpatasvir优于标准治疗方案

2015-11-19 崔倩 译 MedSci原创

在第2阶段的试验中,用核苷酸聚合酶抑制剂sofosbuvir和NS5A抑制剂velpatasvir的组合治疗导致在慢性感染丙型肝炎病毒(HCV)基因型2或3的患者持续病毒学反应的比例很高。研究人员进行了两次随机,3阶段,开放性研究,涉及到的患者为HCV基因型2或3并且接受过治疗的,还有那些没有接受过治疗的,包括代偿性肝硬化患者。在一项试验中,HCV基因型2的患者被随机以1:1的比例分配接受sofo

在第2阶段的试验中,用核苷酸聚合酶抑制剂sofosbuvir和NS5A抑制剂velpatasvir的组合治疗导致在慢性感染丙型肝炎病毒(HCV)基因型2或3的患者持续病毒学反应的比例很高。

研究人员进行了两次随机、3阶段、开放性研究,涉及到的患者为HCV基因型2或3,接受过治疗或者没有接受过治疗的,包括代偿性肝硬化在内的患者。在一项试验中,HCV基因型2的患者被随机以1:1的比例分配接受sofosbuvir-velpatasvir,每日一次,固定剂量组合的片剂(134例患者),或sofosbuvir加上基于重量的ribavirin(132例患者),为期12周。在第二个试验中,HCV基因型3的患者被随机以1:1的比例分配接受sofosbuvir-velpatasvir为期12周(277例患者)或sofosbuvir-ribavirin为期24周(275例患者)。两个试验的主要终点是在12周的治疗结束后的持续病毒学应答。

在HCV基因型为2的患者中,sofosbuvir-velpatasvir组中持续的病毒学反应率是99%(95%置信区间[Cl],96至100),优于sofosbuvir-ribavirin组94%的比率(95%Cl 88至97)(P=0.02)。在HCV基因型为3的患者中,sofosbuvir-velpatasvir组的持续病毒学应答率为95%(95%Cl,92至98),优于sofosbuvir-ribavirin组80%的比率(95%Cl,75至85)(P<0.001)。在两项研究中最常见的副作用是疲劳、头痛、恶心、失眠等。

在HCV基因型2或3患者中,不论有或没有先前的治疗,其中包括那些代偿性肝硬化患者,12周sofosbuvir--velpatasvir治疗的持续病毒学反应率均优于sofosbuvir-ribavirin的标准治疗。

原始出处:

Graham R. Foster,Nezam Afdhal,Stuart K. Roberts,et al.Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection,NEJM,2015.11.16

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    2016-01-02 xyfg98

    值得关注

    0

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    2015-11-21 ymljack
  7. [GetPortalCommentsPageByObjectIdResponse(id=1904961, encodeId=0263190496158, content=<a href='/topic/show?id=21f66464823' target=_blank style='color:#2F92EE;'>#治疗方案#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=64648, encryptionId=21f66464823, topicName=治疗方案)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=5ee4187, createdName=zhangjiqing, createdTime=Sun Jul 24 18:08:00 CST 2016, time=2016-07-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1890801, encodeId=43e71890801b5, content=<a href='/topic/show?id=742341e1782' target=_blank style='color:#2F92EE;'>#基因型#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=77, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=41717, encryptionId=742341e1782, topicName=基因型)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=f984116, createdName=kzlchina, createdTime=Thu Apr 07 06:08:00 CST 2016, time=2016-04-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2020025, encodeId=a74a202002512, content=<a href='/topic/show?id=5cdd18368d7' target=_blank style='color:#2F92EE;'>#Velpatasvir#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=61, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=18368, encryptionId=5cdd18368d7, topicName=Velpatasvir)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=9de22500104, createdName=1249894fm73暂无昵称, createdTime=Sat Mar 05 22:08:00 CST 2016, time=2016-03-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1948243, encodeId=a5a8194824305, content=<a href='/topic/show?id=c04b6193ee0' target=_blank style='color:#2F92EE;'>#标准治疗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=68, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=61937, encryptionId=c04b6193ee0, topicName=标准治疗)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=72bf2500198, createdName=小小小向日葵, createdTime=Tue Jan 19 05:08:00 CST 2016, time=2016-01-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=51062, encodeId=5c2e5106290, content=值得关注, beContent=null, objectType=article, channel=null, level=null, likeNumber=152, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=fe261399236, createdName=xyfg98, createdTime=Sat Jan 02 00:21:00 CST 2016, time=2016-01-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1257616, encodeId=65e8125e616ad, content=<a href='/topic/show?id=774e856e22' target=_blank style='color:#2F92EE;'>#HCV#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=69, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=8567, encryptionId=774e856e22, topicName=HCV)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=460849, createdName=ymljack, createdTime=Sat Nov 21 12:08:00 CST 2015, time=2015-11-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1466006, encodeId=7341146600638, content=<a href='/topic/show?id=217c292009' target=_blank style='color:#2F92EE;'>#ATA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2920, encryptionId=217c292009, topicName=ATA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=387a6772119, createdName=bbjsj_1981, createdTime=Sat Nov 21 12:08:00 CST 2015, time=2015-11-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1500775, encodeId=5c0c1500e75ea, content=<a href='/topic/show?id=4a27165246a' target=_blank style='color:#2F92EE;'>#Sofosbuvir#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=73, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=16524, encryptionId=4a27165246a, topicName=Sofosbuvir)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=50d29462111, createdName=Tommy1952, createdTime=Sat Nov 21 12:08:00 CST 2015, time=2015-11-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1581404, encodeId=fd141581404c1, content=<a href='/topic/show?id=c0c9110333d' target=_blank style='color:#2F92EE;'>#LPA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=91, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11033, encryptionId=c0c9110333d, topicName=LPA)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=9a7b16794085, createdName=ms9474365431325850, createdTime=Sat Nov 21 12:08:00 CST 2015, time=2015-11-21, status=1, ipAttribution=)]
    2015-11-21 bbjsj_1981
  8. [GetPortalCommentsPageByObjectIdResponse(id=1904961, encodeId=0263190496158, content=<a href='/topic/show?id=21f66464823' target=_blank style='color:#2F92EE;'>#治疗方案#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=64648, encryptionId=21f66464823, topicName=治疗方案)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=5ee4187, createdName=zhangjiqing, createdTime=Sun Jul 24 18:08:00 CST 2016, time=2016-07-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1890801, encodeId=43e71890801b5, content=<a href='/topic/show?id=742341e1782' target=_blank style='color:#2F92EE;'>#基因型#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=77, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=41717, encryptionId=742341e1782, topicName=基因型)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=f984116, createdName=kzlchina, createdTime=Thu Apr 07 06:08:00 CST 2016, time=2016-04-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2020025, encodeId=a74a202002512, content=<a href='/topic/show?id=5cdd18368d7' target=_blank style='color:#2F92EE;'>#Velpatasvir#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=61, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=18368, encryptionId=5cdd18368d7, topicName=Velpatasvir)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=9de22500104, createdName=1249894fm73暂无昵称, createdTime=Sat Mar 05 22:08:00 CST 2016, time=2016-03-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1948243, encodeId=a5a8194824305, content=<a href='/topic/show?id=c04b6193ee0' target=_blank style='color:#2F92EE;'>#标准治疗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=68, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=61937, encryptionId=c04b6193ee0, topicName=标准治疗)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=72bf2500198, createdName=小小小向日葵, createdTime=Tue Jan 19 05:08:00 CST 2016, time=2016-01-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=51062, encodeId=5c2e5106290, content=值得关注, beContent=null, objectType=article, channel=null, level=null, likeNumber=152, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=fe261399236, createdName=xyfg98, createdTime=Sat Jan 02 00:21:00 CST 2016, time=2016-01-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1257616, encodeId=65e8125e616ad, content=<a href='/topic/show?id=774e856e22' target=_blank style='color:#2F92EE;'>#HCV#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=69, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=8567, encryptionId=774e856e22, topicName=HCV)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=460849, createdName=ymljack, createdTime=Sat Nov 21 12:08:00 CST 2015, time=2015-11-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1466006, encodeId=7341146600638, content=<a href='/topic/show?id=217c292009' target=_blank style='color:#2F92EE;'>#ATA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2920, encryptionId=217c292009, topicName=ATA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=387a6772119, createdName=bbjsj_1981, createdTime=Sat Nov 21 12:08:00 CST 2015, time=2015-11-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1500775, encodeId=5c0c1500e75ea, content=<a href='/topic/show?id=4a27165246a' target=_blank style='color:#2F92EE;'>#Sofosbuvir#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=73, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=16524, encryptionId=4a27165246a, topicName=Sofosbuvir)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=50d29462111, createdName=Tommy1952, createdTime=Sat Nov 21 12:08:00 CST 2015, time=2015-11-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1581404, encodeId=fd141581404c1, content=<a href='/topic/show?id=c0c9110333d' target=_blank style='color:#2F92EE;'>#LPA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=91, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11033, encryptionId=c0c9110333d, topicName=LPA)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=9a7b16794085, createdName=ms9474365431325850, createdTime=Sat Nov 21 12:08:00 CST 2015, time=2015-11-21, status=1, ipAttribution=)]
  9. [GetPortalCommentsPageByObjectIdResponse(id=1904961, encodeId=0263190496158, content=<a href='/topic/show?id=21f66464823' target=_blank style='color:#2F92EE;'>#治疗方案#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=64648, encryptionId=21f66464823, topicName=治疗方案)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=5ee4187, createdName=zhangjiqing, createdTime=Sun Jul 24 18:08:00 CST 2016, time=2016-07-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1890801, encodeId=43e71890801b5, content=<a href='/topic/show?id=742341e1782' target=_blank style='color:#2F92EE;'>#基因型#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=77, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=41717, encryptionId=742341e1782, topicName=基因型)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=f984116, createdName=kzlchina, createdTime=Thu Apr 07 06:08:00 CST 2016, time=2016-04-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2020025, encodeId=a74a202002512, content=<a href='/topic/show?id=5cdd18368d7' target=_blank style='color:#2F92EE;'>#Velpatasvir#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=61, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=18368, encryptionId=5cdd18368d7, topicName=Velpatasvir)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=9de22500104, createdName=1249894fm73暂无昵称, createdTime=Sat Mar 05 22:08:00 CST 2016, time=2016-03-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1948243, encodeId=a5a8194824305, content=<a href='/topic/show?id=c04b6193ee0' target=_blank style='color:#2F92EE;'>#标准治疗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=68, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=61937, encryptionId=c04b6193ee0, topicName=标准治疗)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=72bf2500198, createdName=小小小向日葵, createdTime=Tue Jan 19 05:08:00 CST 2016, time=2016-01-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=51062, encodeId=5c2e5106290, content=值得关注, beContent=null, objectType=article, channel=null, level=null, likeNumber=152, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=fe261399236, createdName=xyfg98, createdTime=Sat Jan 02 00:21:00 CST 2016, time=2016-01-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1257616, encodeId=65e8125e616ad, content=<a href='/topic/show?id=774e856e22' target=_blank style='color:#2F92EE;'>#HCV#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=69, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=8567, encryptionId=774e856e22, topicName=HCV)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=460849, createdName=ymljack, createdTime=Sat Nov 21 12:08:00 CST 2015, time=2015-11-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1466006, encodeId=7341146600638, content=<a href='/topic/show?id=217c292009' target=_blank style='color:#2F92EE;'>#ATA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2920, encryptionId=217c292009, topicName=ATA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=387a6772119, createdName=bbjsj_1981, createdTime=Sat Nov 21 12:08:00 CST 2015, time=2015-11-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1500775, encodeId=5c0c1500e75ea, content=<a href='/topic/show?id=4a27165246a' target=_blank style='color:#2F92EE;'>#Sofosbuvir#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=73, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=16524, encryptionId=4a27165246a, topicName=Sofosbuvir)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=50d29462111, createdName=Tommy1952, createdTime=Sat Nov 21 12:08:00 CST 2015, time=2015-11-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1581404, encodeId=fd141581404c1, content=<a href='/topic/show?id=c0c9110333d' target=_blank style='color:#2F92EE;'>#LPA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=91, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11033, encryptionId=c0c9110333d, topicName=LPA)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=9a7b16794085, createdName=ms9474365431325850, createdTime=Sat Nov 21 12:08:00 CST 2015, time=2015-11-21, status=1, ipAttribution=)]
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