默沙东多拉韦林在中国获批上市

2020-11-30 医谷网 医谷网

今日(11月27日),据国家药监局的药品批准证明文件待领取信息显示,默沙东公司开发的艾滋病病毒(HIV)感染治疗药物多拉韦林(doravirine)新药上市申请获得批准,用于治疗与其他抗反转录病毒药物

今日(11月27日),据国家药监局的药品批准证明文件待领取信息显示,默沙东公司开发的艾滋病病毒(HIV)感染治疗药物多拉韦林(doravirine)新药上市申请获得批准,用于治疗与其他抗反转录病毒药物联合治疗HIV-1感染且无NNRTI(非核苷逆转录酶抑制剂)类耐药的既往或现有证据的成年患者。此前,多拉韦林已被国家药监局药审中心纳入优先审评。

据了解,多拉韦林是每日一次的口服固定剂量三合一复方片剂,由doravirine(100mg)、拉米夫定(lamivudine,3TC,300mg)和替诺福韦地索普西富马酸盐(tenofovir disoproxil fumarate,TDF,300mg)组成。2018年8月,多拉韦林获得美国FDA和欧盟批准,用于治疗无抗逆转录病毒治疗史的HIV-1感染成年患者。

在此前一项名为DRIVE-AHEAD的三期临床研究中,多拉韦林抗HIV感染中的临床效果就已得到验证,该试验中,有728名未接受过抗病毒疗法的HIV-1患者参与,随机接受多拉韦林或依非韦伦/恩曲他滨/TDF(EFV/FTC/TDF)组合疗法的治疗。多拉韦林表现出持续48周的病毒抑制,与对照组相比,达到了非劣效性的主要终点。84%的多拉韦林组患者将HIV-1病毒RNA拷贝数抑制到<50拷贝/mg,对照组比例为81%。对于那些基线病毒载量高的患者,多拉韦林组患者达到病毒抑制的比例为77%,对照组为74%。

艾滋病已成为一个全球性关注的公共卫生问题,再过几日,就是第33个“世界艾滋病日”,多拉韦林的获批,无疑为国内的HIV患者治疗带来了一种新选择。

据国家卫健委此前发布的数据显示,截至2019年10月底,全国报告存活艾滋病感染者95.8万例,性传播成为当前主要传播途径。数据显示,2019年1月至10月,全国共检测2.3亿人次,新报告发现感染者13.1万例,新增加抗病毒治疗12.7万例,全国符合治疗条件的感染者接受抗病毒治疗比例为86.6%,治疗成功率为93.5%。整体疫情持续处于低流行水平。

当前,艾滋病经输血传播基本阻断,经静脉吸毒传播和母婴传播得到有效控制,性传播成为主要传播途径。2019年1月至10月的新报告感染者中,异性性传播占73.7%,男性同性性传播占23.0%。疫情分布不平衡,波及范围广泛,影响因素复杂多样,防治形势仍然严峻。

在国内,抗HIV药物以政府统一采购、免费发放为主。根据前瞻产业研究院数据,我国抗HIV药物以外资企业为主,包括吉利德、默沙东、葛兰素史克、强生等,其中吉利德居市场统治地位。2018年7月,由我国首个自主研发的抗HIV新药艾可宁(艾博韦泰长效注射剂)获批上市。该药是全球首个抗HIV长效融合抑制剂,把用药频率改为一周一针,该给药方式是目前口服药治疗方案的一个重要补充和提升。

版权声明:
本网站所有内容来源注明为“梅斯医学”或“MedSci原创”的文字、图片和音视频资料,版权均属于梅斯医学所有。非经授权,任何媒体、网站或个人不得转载,授权转载时须注明来源为“梅斯医学”。其它来源的文章系转载文章,或“梅斯号”自媒体发布的文章,仅系出于传递更多信息之目的,本站仅负责审核内容合规,其内容不代表本站立场,本站不负责内容的准确性和版权。如果存在侵权、或不希望被转载的媒体或个人可与我们联系,我们将立即进行删除处理。
在此留言
评论区 (4)
#插入话题
  1. [GetPortalCommentsPageByObjectIdResponse(id=1632601, encodeId=56b91632601c1, content=<a href='/topic/show?id=aa0488034a0' target=_blank style='color:#2F92EE;'>#获批上市#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=88034, encryptionId=aa0488034a0, topicName=获批上市)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=820f21933891, createdName=weiz, createdTime=Fri May 28 20:40:33 CST 2021, time=2021-05-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1259979, encodeId=d1d812599e93a, content=<a href='/topic/show?id=6ff910336054' target=_blank style='color:#2F92EE;'>#默沙东#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=103360, encryptionId=6ff910336054, topicName=默沙东)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=28d456, createdName=yese, createdTime=Wed Dec 02 07:40:33 CST 2020, time=2020-12-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=903658, encodeId=f3219036582e, content=学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=64, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=571d5428601, createdName=ms2000000493371593, createdTime=Mon Nov 30 21:20:38 CST 2020, time=2020-11-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=903613, encodeId=c0ad9036138a, content=认真学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=62, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6EF3hKja8nER8RMzxQdria9eCYFhgLTLsDOeqnvIYdeLDz5eP6EnicLuE5gibiawgno4zUA0jAR7Nbtp2llQ9fs3Mk/0, createdBy=278f1986883, createdName=医鸣惊人, createdTime=Mon Nov 30 17:27:56 CST 2020, time=2020-11-30, status=1, ipAttribution=)]
    2021-05-28 weiz
  2. [GetPortalCommentsPageByObjectIdResponse(id=1632601, encodeId=56b91632601c1, content=<a href='/topic/show?id=aa0488034a0' target=_blank style='color:#2F92EE;'>#获批上市#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=88034, encryptionId=aa0488034a0, topicName=获批上市)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=820f21933891, createdName=weiz, createdTime=Fri May 28 20:40:33 CST 2021, time=2021-05-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1259979, encodeId=d1d812599e93a, content=<a href='/topic/show?id=6ff910336054' target=_blank style='color:#2F92EE;'>#默沙东#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=103360, encryptionId=6ff910336054, topicName=默沙东)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=28d456, createdName=yese, createdTime=Wed Dec 02 07:40:33 CST 2020, time=2020-12-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=903658, encodeId=f3219036582e, content=学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=64, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=571d5428601, createdName=ms2000000493371593, createdTime=Mon Nov 30 21:20:38 CST 2020, time=2020-11-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=903613, encodeId=c0ad9036138a, content=认真学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=62, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6EF3hKja8nER8RMzxQdria9eCYFhgLTLsDOeqnvIYdeLDz5eP6EnicLuE5gibiawgno4zUA0jAR7Nbtp2llQ9fs3Mk/0, createdBy=278f1986883, createdName=医鸣惊人, createdTime=Mon Nov 30 17:27:56 CST 2020, time=2020-11-30, status=1, ipAttribution=)]
    2020-12-02 yese
  3. [GetPortalCommentsPageByObjectIdResponse(id=1632601, encodeId=56b91632601c1, content=<a href='/topic/show?id=aa0488034a0' target=_blank style='color:#2F92EE;'>#获批上市#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=88034, encryptionId=aa0488034a0, topicName=获批上市)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=820f21933891, createdName=weiz, createdTime=Fri May 28 20:40:33 CST 2021, time=2021-05-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1259979, encodeId=d1d812599e93a, content=<a href='/topic/show?id=6ff910336054' target=_blank style='color:#2F92EE;'>#默沙东#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=103360, encryptionId=6ff910336054, topicName=默沙东)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=28d456, createdName=yese, createdTime=Wed Dec 02 07:40:33 CST 2020, time=2020-12-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=903658, encodeId=f3219036582e, content=学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=64, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=571d5428601, createdName=ms2000000493371593, createdTime=Mon Nov 30 21:20:38 CST 2020, time=2020-11-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=903613, encodeId=c0ad9036138a, content=认真学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=62, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6EF3hKja8nER8RMzxQdria9eCYFhgLTLsDOeqnvIYdeLDz5eP6EnicLuE5gibiawgno4zUA0jAR7Nbtp2llQ9fs3Mk/0, createdBy=278f1986883, createdName=医鸣惊人, createdTime=Mon Nov 30 17:27:56 CST 2020, time=2020-11-30, status=1, ipAttribution=)]
    2020-11-30 ms2000000493371593

    学习了

    0

  4. [GetPortalCommentsPageByObjectIdResponse(id=1632601, encodeId=56b91632601c1, content=<a href='/topic/show?id=aa0488034a0' target=_blank style='color:#2F92EE;'>#获批上市#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=88034, encryptionId=aa0488034a0, topicName=获批上市)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=820f21933891, createdName=weiz, createdTime=Fri May 28 20:40:33 CST 2021, time=2021-05-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1259979, encodeId=d1d812599e93a, content=<a href='/topic/show?id=6ff910336054' target=_blank style='color:#2F92EE;'>#默沙东#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=103360, encryptionId=6ff910336054, topicName=默沙东)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=28d456, createdName=yese, createdTime=Wed Dec 02 07:40:33 CST 2020, time=2020-12-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=903658, encodeId=f3219036582e, content=学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=64, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=571d5428601, createdName=ms2000000493371593, createdTime=Mon Nov 30 21:20:38 CST 2020, time=2020-11-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=903613, encodeId=c0ad9036138a, content=认真学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=62, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6EF3hKja8nER8RMzxQdria9eCYFhgLTLsDOeqnvIYdeLDz5eP6EnicLuE5gibiawgno4zUA0jAR7Nbtp2llQ9fs3Mk/0, createdBy=278f1986883, createdName=医鸣惊人, createdTime=Mon Nov 30 17:27:56 CST 2020, time=2020-11-30, status=1, ipAttribution=)]
    2020-11-30 医鸣惊人

    认真学习了

    0