重磅!单片双药HIV治疗药物多伟托®扩大适应症获批,延展至稳定转换HIV感染者

2022-05-11 梅斯医学 梅斯医学

HIV

艾滋病仍是中国面临的严重公共卫生问题,目前“简化疗法”是当下HIV治疗新趋势。

2022511日,葛兰素史克(GSK)宣布创新单片双药HIV治疗方案多伟托®(通用名:拉米夫定多替拉韦片)扩大适应症已正式获得中国国家药品监督管理局批准,作为一种完整方案,用于治疗已实现病毒学抑制的HIV-1成人及12岁以上青少年感染者。多伟托®20213月获批用于初治HIV成人感染者此次适应症扩大到稳定转换的成人和青少年感染者,将为更广泛的、不同治疗阶段的HIV感染者带来更多优化治疗选择。

多伟托®是《中国艾滋病诊疗指南(2021年版)》一线推荐药物,由固定剂量的多替拉韦(50mg)和拉米夫定(300mg)组成。其中,多替拉韦是第二代HIV整合酶链转移抑制剂,通过阻止病毒DNA整合至人体免疫细胞(T细胞)的遗传物质来阻断HIV的复制;拉米夫定则是一种核苷类逆转录酶抑制剂,常与其他抗逆转录病毒药物联合使用,用于HIV感染的治疗。

中国医学科学院北京协和医院感染内科主任、中华医学会感染性疾病分会主任委员和艾滋病学组组长李太生教授表示:“HIV感染者目前仍需终身服药,因此不仅需要考虑药物有效性,还要考虑药物的安全性、长期治疗的依从性等问题。此次多伟托®扩大适应症获批,让临床医生在不同治疗阶段有了更多、更简、更优的治疗选择。《中国艾滋病诊疗指南(2021年版)》指出,双药治疗方案在初治和经治HIV感染者中的疗效和安全性已经得到证实,也被国际指南推荐用于艾滋病优选的抗病毒方案。随着简化双药治疗方案适应症范围的扩大,将帮助更广泛的HIV感染者提高用药依从性,建立长期治疗的意愿和信心。

GSK中国处方药和疫苗总经理齐欣女士表示:“‘不放弃任何一位HIV感染者是我们一贯坚持的初心和使命。此次多伟托®扩大适应症获批,是继去年其获批上市及纳入医保目录之后,GSKHIV治疗领域的又一重磅喜讯。受益于国家加快创新药物审批的相关政策,创新单片双药HIV治疗方案能快速惠及更广泛、不同治疗阶段的HIV感染者,对此我们深感振奋。未来,我们将继续推动药物的创新与可及,让更多HIV感染者从中受益,全面助推中国HIV防治事业。

目前,艾滋病仍是中国面临的严重公共卫生问题。截至2020年底,我国共有105.3万人感染艾滋病毒,其报告死亡数位居传染病病种第一位。简化疗法是当下HIV治疗新趋势,多伟托®作为中国首个完整的、每日一次、单一片剂的艾滋病双药治疗方案,与传统三联治疗方案相比,既能减少HIV感染者服用抗逆转录病毒药物种类,也能达到经科学验证的病毒学抑制疗效。2019年,多伟托®获得了欧盟广泛HIV治疗适应症批准;2020年,美国FDA也批准了多伟托®扩大适应症,作为一种完整方案,用于治疗已实现病毒学抑制的HIV-1成人感染者。

一项大型3SALSA临床研究48周结果显示:在已实现病毒学抑制且先前没有经历过病毒学失败的多样化HIV-1成人感染者中,转换至拉米夫定多替拉韦片方案后,与继续接受至少3种药物组成的广泛治疗方案相比,在疗效方面具有非劣效性、安全性相当。这也是继TANGO研究144周数据公布之后,又一证明多伟托®疗效非劣效性和高抗药性屏障的转换治疗研究。

参考资料

1.获批新适应症:作为完整治疗方案用于以下两类对本品任一成分无已知耐药相关突变的1型人类免疫缺陷病毒(HIV-1)感染成人及12岁以上青少年(体重至少40公斤)患者:(1)无抗逆转录病毒治疗史的患者;(2)作为替代治疗方案,用于接受稳定抗逆转录治疗达到病毒学抑制(HIV-1 RNA50拷贝/mL)且无治疗失败史的患者。

2.中华医学会感染病学分会艾滋病丙型肝炎学组,中国疾病预防控制中心,中国艾滋病诊疗指南(2021年版)[J].中国艾滋病性病,20212711):1182-1201.

3.拉米夫定多替拉韦片产品说明书

4.中华医学会感染病学分会艾滋病丙型肝炎学组,中国疾病预防控制中心,中国艾滋病诊疗指南(2021年版)[J].中国艾滋病性病,20212711):1182-1201.

5.我国HIV/AIDS流行病学研究进展,中国疾控中心 https://baijiahao.baidu.com/s?id=1717561617758656559&wfr=spider&for=pc

6.2020年我国卫生健康事业发展统计公报,国家卫健委规划发展与信息化司.https://baijiahao.baidu.com/s?id=1705177485254050752&wfr=spider&for=pc

7.CahnP, MaderoJS, ArribasJR, et al. Dolutegravir plus lamivudine versus dolutegravir plus tenofovir disoproxil fumarate and emtricitabine in antiretroviral-naive adults with HIV-1 infection (GEMINI-1 and GEMINI-2): week 48 results from two multicentre, double-blind, randomised, non-inferiority, phase 3 trials. Lancet. 2019 Jan 12;393(10167):143–155.

8.https://www.fda.gov/drugs/human-immunodeficiency-virus-hiv/fda-approved-changes-dovato-dolutegravirlamivudine-product-labeling

9.https://news.bioon.com/article/6fb9e1568972.htmlHIV新药!GSK二合一药物Dovato(多伟托®)疗效媲美多药方案且无病毒学失败,今年6月在中国上市!

10.https://pubmed.ncbi.nlm.nih.gov/35079789/

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=1921872, encodeId=0fc019218e2ee, content=<a href='/topic/show?id=4f0a6469837' target=_blank style='color:#2F92EE;'>#治疗药物#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=64698, encryptionId=4f0a6469837, topicName=治疗药物)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c9d3459, createdName=周虎, createdTime=Wed Jan 18 18:30:05 CST 2023, time=2023-01-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1290246, encodeId=737e12902468e, content=<a href='/topic/show?id=f774890827' target=_blank style='color:#2F92EE;'>#HIV感染者#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=8908, encryptionId=f774890827, topicName=HIV感染者)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=f65b226, createdName=circumcision, createdTime=Thu May 12 05:30:05 CST 2022, time=2022-05-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1336874, encodeId=a08613368e400, content=<a href='/topic/show?id=554d94e13ae' target=_blank style='color:#2F92EE;'>#适应症#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=94713, encryptionId=554d94e13ae, topicName=适应症)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3dd32500118, createdName=644982816_68283321, createdTime=Thu May 12 05:30:05 CST 2022, time=2022-05-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1549818, encodeId=f1e4154981890, content=<a href='/topic/show?id=f7879600061' target=_blank style='color:#2F92EE;'>#重磅#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=96000, encryptionId=f7879600061, topicName=重磅)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=3acc14121561, createdName=xxxx1054, createdTime=Thu May 12 05:30:05 CST 2022, time=2022-05-12, status=1, ipAttribution=)]
  2. [GetPortalCommentsPageByObjectIdResponse(id=1921872, encodeId=0fc019218e2ee, content=<a href='/topic/show?id=4f0a6469837' target=_blank style='color:#2F92EE;'>#治疗药物#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=64698, encryptionId=4f0a6469837, topicName=治疗药物)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c9d3459, createdName=周虎, createdTime=Wed Jan 18 18:30:05 CST 2023, time=2023-01-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1290246, encodeId=737e12902468e, content=<a href='/topic/show?id=f774890827' target=_blank style='color:#2F92EE;'>#HIV感染者#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=8908, encryptionId=f774890827, topicName=HIV感染者)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=f65b226, createdName=circumcision, createdTime=Thu May 12 05:30:05 CST 2022, time=2022-05-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1336874, encodeId=a08613368e400, content=<a href='/topic/show?id=554d94e13ae' target=_blank style='color:#2F92EE;'>#适应症#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=94713, encryptionId=554d94e13ae, topicName=适应症)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3dd32500118, createdName=644982816_68283321, createdTime=Thu May 12 05:30:05 CST 2022, time=2022-05-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1549818, encodeId=f1e4154981890, content=<a href='/topic/show?id=f7879600061' target=_blank style='color:#2F92EE;'>#重磅#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=96000, encryptionId=f7879600061, topicName=重磅)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=3acc14121561, createdName=xxxx1054, createdTime=Thu May 12 05:30:05 CST 2022, time=2022-05-12, status=1, ipAttribution=)]
  3. [GetPortalCommentsPageByObjectIdResponse(id=1921872, encodeId=0fc019218e2ee, content=<a href='/topic/show?id=4f0a6469837' target=_blank style='color:#2F92EE;'>#治疗药物#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=64698, encryptionId=4f0a6469837, topicName=治疗药物)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c9d3459, createdName=周虎, createdTime=Wed Jan 18 18:30:05 CST 2023, time=2023-01-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1290246, encodeId=737e12902468e, content=<a href='/topic/show?id=f774890827' target=_blank style='color:#2F92EE;'>#HIV感染者#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=8908, encryptionId=f774890827, topicName=HIV感染者)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=f65b226, createdName=circumcision, createdTime=Thu May 12 05:30:05 CST 2022, time=2022-05-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1336874, encodeId=a08613368e400, content=<a href='/topic/show?id=554d94e13ae' target=_blank style='color:#2F92EE;'>#适应症#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=94713, encryptionId=554d94e13ae, topicName=适应症)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3dd32500118, createdName=644982816_68283321, createdTime=Thu May 12 05:30:05 CST 2022, time=2022-05-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1549818, encodeId=f1e4154981890, content=<a href='/topic/show?id=f7879600061' target=_blank style='color:#2F92EE;'>#重磅#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=96000, encryptionId=f7879600061, topicName=重磅)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=3acc14121561, createdName=xxxx1054, createdTime=Thu May 12 05:30:05 CST 2022, time=2022-05-12, status=1, ipAttribution=)]
  4. [GetPortalCommentsPageByObjectIdResponse(id=1921872, encodeId=0fc019218e2ee, content=<a href='/topic/show?id=4f0a6469837' target=_blank style='color:#2F92EE;'>#治疗药物#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=64698, encryptionId=4f0a6469837, topicName=治疗药物)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c9d3459, createdName=周虎, createdTime=Wed Jan 18 18:30:05 CST 2023, time=2023-01-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1290246, encodeId=737e12902468e, content=<a href='/topic/show?id=f774890827' target=_blank style='color:#2F92EE;'>#HIV感染者#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=8908, encryptionId=f774890827, topicName=HIV感染者)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=f65b226, createdName=circumcision, createdTime=Thu May 12 05:30:05 CST 2022, time=2022-05-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1336874, encodeId=a08613368e400, content=<a href='/topic/show?id=554d94e13ae' target=_blank style='color:#2F92EE;'>#适应症#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=94713, encryptionId=554d94e13ae, topicName=适应症)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3dd32500118, createdName=644982816_68283321, createdTime=Thu May 12 05:30:05 CST 2022, time=2022-05-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1549818, encodeId=f1e4154981890, content=<a href='/topic/show?id=f7879600061' target=_blank style='color:#2F92EE;'>#重磅#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=96000, encryptionId=f7879600061, topicName=重磅)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=3acc14121561, createdName=xxxx1054, createdTime=Thu May 12 05:30:05 CST 2022, time=2022-05-12, status=1, ipAttribution=)]
    2022-05-12 xxxx1054

相关资讯

NEJM:单次高剂量两性霉素B脂质体方案治疗HIV相关隐球菌性脑膜炎

单剂量脂质体两性霉素B-氟胞嘧啶-氟康唑联合治疗方案治疗HIV相关隐球菌性脑膜炎的效果与现行WHO推荐方案相当,且不良事件率更低

Science:HIV变异毒株已出现,毒力更强、更具传染性...

该研究发现了一种更具侵袭性的HIV变异毒株,与HIV-1原始毒株相比,它能使感染者以两倍的速度发展成艾滋病。

Nat Commun:在HIV-1治疗后控制者中,短暂的病毒暴露驱动体液免疫反应

研究发现,HIV治疗后,控制者的体液免疫反应既有效又强劲,这可能有助于在没有治疗的情况下控制HIV-1感染。

Science:HIV病毒超强变异,为艾滋病进程开倍速

多年来,人们一直担心HIV-1会出现变异的情况,而一项新研究似乎证实了这种可能性。

Nat Med:两名HIV感染者在中断治疗后,为何能实现长期病毒控制?

最近,研究人员对两名HIV感染者(04号和30号)进行了长期研究,他们之前参加了包括ATI在内的随机、对照治疗性疫苗试验的安慰剂组(ClinicalTrials.gov标识符:NCT01859325)