艾滋病复方新药F/TAF在III期临床达主要终点，有望成为标准治疗方案

2015-09-09 佚名不详

评估实验性HIV复方新药F/TAF（恩曲他滨/替诺福韦艾拉酚胺富马酸，200/10mg，200/25mg）治疗HIV-1感染者的一项III期研究达到了主要终点。在美国，吉利德已于2015年4月向FDA提交了F/TAF（200/10mg，200/25mg）的新药申请，FDA将于2016年4月7日作出审查决定。在欧盟，EMA已在2015年5月28日受理F/TAF的上市申请。该研究是一项随机双盲II

评估实验性HIV复方新药F/TAF（恩曲他滨/替诺福韦艾拉酚胺富马酸，200/10mg，200/25mg）治疗HIV-1感染者的一项III期研究达到了主要终点。在美国，吉利德已于2015年4月向FDA提交了F/TAF（200/10mg，200/25mg）的新药申请，FDA将于2016年4月7日作出审查决定。在欧盟，EMA已在2015年5月28日受理F/TAF的上市申请。

该研究是一项随机双盲III期研究，涉及663例接受含Truvada（恩曲他滨/替诺福韦酯，FTC/TDF）的稳定方案连续治疗≥6个月并实现病毒学抑制（HIV-1 RNA水平＜50拷贝/毫升）的艾滋病患者。研究中，患者以1:1的比例随机分配至维持其基于Truvada的稳定方案（Truvada+安慰剂+第三种制剂）或切换至基于F/TAF的方案（F/TAF+安慰剂+第三种制剂）。在随机分配后，患者将随访96周。研究中，F/TAF每日剂量为200/25mg；若与一种蛋白酶抑制剂（利托那韦或cobicistat）联合用药，则每日剂量为200mg/10mg。

目前，该项研究正在进行中。主要目的是评估由FTC/TDF转向F/TAF相对于维持FTC/TDF的疗效，采用48周时HIV-1 RNA水平＜50拷贝/毫升的患者比例进行评价。次要终点是评估48周和96周时2种方案的肾脏安全性（包括肾小球滤过率，eGFR）以及2种方案在髋关节和脊柱骨密度（BMD）方面的骨骼安全性。关于该研究的更多信息，可查询网站www.clinicaltrials.gov。

此次公布的数据显示，在研究的48周，基于F/TAF的方案组与基于TDF的方案组取得了相似的病毒学抑制率，2个组实现HIV-1 RNA水平＜50拷贝/毫升的患者比例相当（F/TAF方案组 vs TDF方案组：94.3% vs 93.0；百分比差异1.3%；95%Cl：-2.5% - 5.1%）。与基于TDF的方案组相比，F/TAF方案组在髋关节和脊柱平均骨密度（BMD，p＜0.001）以及估算的肾小球滤过率中位数变化（eGFR，p＜0.001）方面均具有统计学显著差异。因不良事件导致的一般安全性及停药率在2个组相当。研究中，最常见的不良事件包括上呼吸道感染、腹泻、头痛、鼻咽炎、支气管炎。这2种方案的一般耐受性良好。

吉利德计划在2016年的科学会议上公布该研究的详细数据。吉利德研发副总裁及首席科学官 Norber Bischofberger表示，在过去的十多年来，Truvada（FTC/TDF）已成为艾滋病临床治疗的基石，来自此次研究及其他近期研究的数据显示，F/TAF兼具高疗效及改善的安全性，有望取代FTC/TDF成为下一代基石，为新一代HIV治疗方案提供一种改善的背景配方，将进一步优化HIV患者的临床治疗。

TAF：吉利德捍卫传染病领导者地位的有力利器

TAF（tenofovir alafenamide fumarate，替诺福韦艾拉酚胺富马酸）是一种新型核苷类逆转录酶抑制剂（NRTI），在临床试验中已被证明在低于吉利德已上市药物Viread（替诺福韦酯，TDF）十分之一剂量时，就具有非常高的抗病毒疗效，同时可改善肾功能和骨骼方面参数。TDF也是一种新型NRTI药物，目前被广泛用于HIV（艾滋）和HBV（乙肝）的治疗，该药在2014年的销售额达到了11亿美元。而TAF有望取代TDF，成为吉利德巩固其感染性疾病治疗领域领导者地位的又一利器。

除了F/TAF之外，吉利德另外2款基于TAF的复方产品也正在接受FDA的审查，分别为三合一复方产品R/F/TAF和四合一复方产品E/C/F/TAF；FDA将分别于2016年3月和2015年11月作出审查决定。在欧洲，EMA已受理E/C/F/TAF和R/F/TAF的上市申请。除此之外，吉利德还在研发另一款四合一HIV复发产品D/C/F/TAF。

原始出处：

Gilead’s Investigational Fixed-Dose Combination of Emtricitabine/Tenofovir Alafenamide (F/TAF) Meets Primary 48-Week Objective in Phase 3 Study

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2016-01-18 小小小向日葵

#标准治疗#

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2015-09-09 医生2402

#I期临床#

21 0
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2015-10-04 juliusluan78

#III#

20 0
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2016-01-14 medsic

对社会来说也是好消息！

116 0
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2016-01-14 medsic

对社会来说也是好消息！

122 0
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2016-01-14 medsic

感谢分享…

82 0
[GetPortalCommentsPageByObjectIdResponse(id=1948242, encodeId=f2a019482428a, 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=23, 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=Mon Jan 18 19:13:00 CST 2016, time=2016-01-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1652732, encodeId=25681652e32c5, content=<a href='/topic/show?id=5b011018e07' target=_blank style='color:#2F92EE;'>#I期临床#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=21, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10187, encryptionId=5b011018e07, topicName=I期临床)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=fc1f24335670, createdName=医生2402, createdTime=Wed Sep 09 18:13:00 CST 2015, time=2015-09-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1915875, encodeId=8ea919158e5a8, content=<a href='/topic/show?id=c5a89550ff' target=_blank style='color:#2F92EE;'>#III#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=20, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9550, encryptionId=c5a89550ff, topicName=III)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e68e415, createdName=juliusluan78, createdTime=Sun Oct 04 09:13:00 CST 2015, time=2015-10-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=57286, encodeId=28ed5e2868a, content=对社会来说也是好消息！, beContent=null, objectType=article, channel=null, level=null, likeNumber=116, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=32ba1611217, createdName=medsic, createdTime=Thu Jan 14 13:05:00 CST 2016, time=2016-01-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=57287, encodeId=fe1b5e28721, content=对社会来说也是好消息！, beContent=null, objectType=article, channel=null, level=null, likeNumber=122, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=32ba1611217, createdName=medsic, createdTime=Thu Jan 14 13:05:00 CST 2016, time=2016-01-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=57288, encodeId=636d5e2888c, content=感谢分享…, beContent=null, objectType=article, channel=null, level=null, likeNumber=82, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=32ba1611217, createdName=medsic, createdTime=Thu Jan 14 13:05:00 CST 2016, time=2016-01-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=57289, encodeId=730f5e289eb, content=感谢分享…, beContent=null, objectType=article, channel=null, level=null, likeNumber=88, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=32ba1611217, createdName=medsic, createdTime=Thu Jan 14 13:05:00 CST 2016, time=2016-01-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=57284, encodeId=a3055e284bf, content=对艾滋病患者是好消息……, beContent=null, objectType=article, channel=null, level=null, likeNumber=102, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=32ba1611217, createdName=medsic, createdTime=Thu Jan 14 13:04:00 CST 2016, time=2016-01-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=57285, encodeId=f9a55e2856c, content=对艾滋病患者是好消息……, beContent=null, objectType=article, channel=null, level=null, likeNumber=89, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=32ba1611217, createdName=medsic, createdTime=Thu Jan 14 13:04:00 CST 2016, time=2016-01-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1904958, encodeId=d617190495881, 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=21, 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=Wed Mar 23 22:13:00 CST 2016, time=2016-03-23, status=1, ipAttribution=)]
2016-01-14 medsic

感谢分享…

88 0
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2016-01-14 medsic

对艾滋病患者是好消息……

102 0
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2016-01-14 medsic

对艾滋病患者是好消息……

89 0
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2016-03-23 zhangjiqing

#治疗方案#

21 0

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数字化学术传播解决方案

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感染

艾滋病复方新药F/TAF在III期临床达主要终点，有望成为标准治疗方案

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