艾滋病治疗革命:FDA批准长效HIV药物,每月仅需一次治疗

2021-01-25 生物探索 生物探索

这是FDA批准的首个针对HIV成年患者的完整注射方案。

当地时间1月21日,由全球制药巨头强生公司旗下杨森制药与知名艾滋病治疗企业ViiV Healthcare合作开发的Cabenuva获得美国食品和药品监督管理局(FDA)批准,以取代传统的抗逆转录病毒方案,用于治疗感染了人类免疫缺陷病毒1型(HIV-1)的成人患者。

据悉,这是FDA批准的首个针对HIV成年患者的完整注射方案,患者仅需每月接受一次治疗,就能达到抑制病毒的效果。这也是HIV治疗史上的里程碑事件,意味着一种全新的、更便利的疗法的诞生。

在HIV被发现的16年后,中国工程院外籍院士、华裔艾滋病研究专家何大一提出了抗逆转录病毒疗法(鸡尾酒疗法),为HIV患者带来了生存的希望。然而,该疗法需要患者每日服药以抑制体内的HIV病毒。此次Cabenuva获批上市,意味着患者将由365天全天接受治疗转变为每月一次、全年共12次治疗,大大提高了该疗法的依从性。

除Cabenuva外,FDA还批准了cabotegravir的片剂配方Vocabria,在接受Cabenuva治疗前与rilpivirine口服联用一个月,以确保由片剂转换为缓释注射配方前的耐受性良好。

Cabenuva是由ViiV Healthcare公司的cabotegravir(CAB)和强生公司的rilpivirine(RPV)组成的联合疗法,前者是一种长效HIV-1整合酶链转移抑制剂,后者则是一种长效非核苷逆转录酶抑制剂。

此次Cabenuva获批是基于抗逆转录病毒治疗作为长效抑制的ATLAS和第一个长效注射方案FLAIR这两项关键的3期临床研究结果,涵盖全球16个国家共计1182例HIV成年患者。在48周的研究期内,Cabenuva在维持病毒抑制方面与传统疗法,即每天口服三种抗逆转录病毒药物的作用一样有效,研究结束接受该疗法的患者均表现出持续的病毒学抑制,并且在CD4+细胞计数方面没有观察到与基线水平相关的临床变化。

在不良反应方面,Cabenuva患者最常感到注射部位不适、发热、疲劳、头痛、肌肉骨骼疼痛、恶心、睡眠障碍、头晕和皮疹等。

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    2021-10-19 bugit
  2. [GetPortalCommentsPageByObjectIdResponse(id=1839909, encodeId=1782183990954, content=<a href='/topic/show?id=341ae311ea' target=_blank style='color:#2F92EE;'>#FDA批准#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7311, encryptionId=341ae311ea, topicName=FDA批准)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=30bd35, createdName=bugit, createdTime=Tue Oct 19 02:34:31 CST 2021, time=2021-10-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=920863, encodeId=f327920863bc, content=<a href='/topic/show?id=a48786e89c1' target=_blank style='color:#2F92EE;'>#艾滋病#</a>基本是临门一脚了,相信未来5年内可以实现真正治愈!, beContent=null, objectType=article, channel=null, level=null, likeNumber=129, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=86789, encryptionId=a48786e89c1, topicName=艾滋病)], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20211210/ede9c51184aa4f54ae6c1164cfb8eeac/967dbf3eff2943c7bf3ccfec3a776ab0.JPG, createdBy=a33789389, createdName=病毒猎手, createdTime=Thu Jan 28 22:36:27 CST 2021, time=2021-01-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=919782, encodeId=bea3919e8281, content=把握源头是根本, beContent=null, objectType=article, channel=null, level=null, likeNumber=85, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210125/94e1be22587742c0b2fab4c78f243cd4/3dd739ef915e43e7849f25de4555d7cf.jpg, createdBy=68ab5455388, createdName=ms9000001876908053, createdTime=Mon Jan 25 17:56:25 CST 2021, time=2021-01-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=919626, encodeId=4bc191962612, content=赞, beContent=null, objectType=article, channel=null, level=null, likeNumber=82, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20201110/2d55d24dc5fd419d994b7b920c79731b/d3c8bdca983c4af1b90220a8192e353a.jpg, createdBy=e14e5296465, createdName=飞翔的乌龟, createdTime=Mon Jan 25 09:42:55 CST 2021, time=2021-01-25, status=1, ipAttribution=)]
    2021-01-28 病毒猎手

    #艾滋病#基本是临门一脚了,相信未来5年内可以实现真正治愈!

    0

  3. [GetPortalCommentsPageByObjectIdResponse(id=1839909, encodeId=1782183990954, content=<a href='/topic/show?id=341ae311ea' target=_blank style='color:#2F92EE;'>#FDA批准#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7311, encryptionId=341ae311ea, topicName=FDA批准)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=30bd35, createdName=bugit, createdTime=Tue Oct 19 02:34:31 CST 2021, time=2021-10-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=920863, encodeId=f327920863bc, content=<a href='/topic/show?id=a48786e89c1' target=_blank style='color:#2F92EE;'>#艾滋病#</a>基本是临门一脚了,相信未来5年内可以实现真正治愈!, beContent=null, objectType=article, channel=null, level=null, likeNumber=129, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=86789, encryptionId=a48786e89c1, topicName=艾滋病)], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20211210/ede9c51184aa4f54ae6c1164cfb8eeac/967dbf3eff2943c7bf3ccfec3a776ab0.JPG, createdBy=a33789389, createdName=病毒猎手, createdTime=Thu Jan 28 22:36:27 CST 2021, time=2021-01-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=919782, encodeId=bea3919e8281, content=把握源头是根本, beContent=null, objectType=article, channel=null, level=null, likeNumber=85, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210125/94e1be22587742c0b2fab4c78f243cd4/3dd739ef915e43e7849f25de4555d7cf.jpg, createdBy=68ab5455388, createdName=ms9000001876908053, createdTime=Mon Jan 25 17:56:25 CST 2021, time=2021-01-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=919626, encodeId=4bc191962612, content=赞, beContent=null, objectType=article, channel=null, level=null, likeNumber=82, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20201110/2d55d24dc5fd419d994b7b920c79731b/d3c8bdca983c4af1b90220a8192e353a.jpg, createdBy=e14e5296465, createdName=飞翔的乌龟, createdTime=Mon Jan 25 09:42:55 CST 2021, time=2021-01-25, status=1, ipAttribution=)]
    2021-01-25 ms9000001876908053

    把握源头是根本

    0

  4. [GetPortalCommentsPageByObjectIdResponse(id=1839909, encodeId=1782183990954, content=<a href='/topic/show?id=341ae311ea' target=_blank style='color:#2F92EE;'>#FDA批准#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7311, encryptionId=341ae311ea, topicName=FDA批准)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=30bd35, createdName=bugit, createdTime=Tue Oct 19 02:34:31 CST 2021, time=2021-10-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=920863, encodeId=f327920863bc, content=<a href='/topic/show?id=a48786e89c1' target=_blank style='color:#2F92EE;'>#艾滋病#</a>基本是临门一脚了,相信未来5年内可以实现真正治愈!, beContent=null, objectType=article, channel=null, level=null, likeNumber=129, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=86789, encryptionId=a48786e89c1, topicName=艾滋病)], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20211210/ede9c51184aa4f54ae6c1164cfb8eeac/967dbf3eff2943c7bf3ccfec3a776ab0.JPG, createdBy=a33789389, createdName=病毒猎手, createdTime=Thu Jan 28 22:36:27 CST 2021, time=2021-01-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=919782, encodeId=bea3919e8281, content=把握源头是根本, beContent=null, objectType=article, channel=null, level=null, likeNumber=85, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210125/94e1be22587742c0b2fab4c78f243cd4/3dd739ef915e43e7849f25de4555d7cf.jpg, createdBy=68ab5455388, createdName=ms9000001876908053, createdTime=Mon Jan 25 17:56:25 CST 2021, time=2021-01-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=919626, encodeId=4bc191962612, content=赞, beContent=null, objectType=article, channel=null, level=null, likeNumber=82, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20201110/2d55d24dc5fd419d994b7b920c79731b/d3c8bdca983c4af1b90220a8192e353a.jpg, createdBy=e14e5296465, createdName=飞翔的乌龟, createdTime=Mon Jan 25 09:42:55 CST 2021, time=2021-01-25, status=1, ipAttribution=)]
    2021-01-25 飞翔的乌龟

    0

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