HIV口服“疫苗”时代到来!默沙东口服长效新药开展III期临床

2020-11-26 medsci medsci

美国默沙东公司于近日宣布了一项与比尔及梅琳达·盖茨基金会(Bill & Melinda Gates Foundation)的合作。该合作将在撒哈拉以南非洲,存在HIV-1感染高风险的妇女和青春期女孩中

美国默沙东公司于近日宣布了一项与比尔及梅琳达·盖茨基金会(Bill & Melinda Gates Foundation)的合作。该合作将在撒哈拉以南非洲,存在HIV-1感染高风险的妇女和青春期女孩中,开展一项代号为IMPOWER 22的III期关键性、随机、多中心、双盲、活性药物对照的临床研究,评估默沙东新型口服核苷类逆转录酶易位抑制剂(NRTTI)- islatravir(前称MK-8591)作为每月一次的口服暴露前预防性用药(PrEP)的疗效和安全性。该研究将于2021年初启动。

 
IMPOWER 22研究中的活性对照药物为恩曲他滨/富马酸替诺福韦酯(FTC/TDF),每天口服一次。在研究期间,大约4500名年龄在16岁-45岁之间的顺性别女性和青春期女孩将被随机(按地点和年龄分层)分配,接受islatravir或FTC/TDF治疗。
 
默沙东研究实验室高级副总裁兼全球临床开发主管、首席医学官Roy D. Baynes博士表示:“与比尔及梅琳达·盖茨基金会的合作体现了我们共同的使命,即通过在HIV预防方面进行有意义的创新,来结束全球HIV的流行。已有多项临床研究证实,islatravir作为一款一月一次的口服PrEP候选药物前景光明。通过此次合作,我们可以进一步探索islatravir的潜力,助力实现全球公共卫生共同目标之一,减少新发HIV感染者人数。”

比尔及梅琳达·盖茨基金会结核病和艾滋病项目主任Emilio Emini博士表示:“除非我们能有效地防止高危人群感染HIV,否则HIV流行将无法在世界范围内结束。这项合作将有助于推动HIV科学的发展,并有可能为撒哈拉以南非洲地区和全球的高危女性预防HIV感染提供新的选择。”
 
除IMPOWER 22外,默沙东还计划在HIV预防方面开展更多研究。这些研究将包括IMPOWER 24,一项全球III期临床试验,评估islatravir作为每月一次的PrEP用药在包括男男性行为人群和变性女性在内的受HIV流行病影响的其他关键人群中的疗效和安全性。
 
在HIV治疗方面,islatravir也有望发挥更大作用。在2020年世界AIDS大会上,有研究披露,islatravir的疗效远远高于其他已批准的抗逆转录病毒药物,对具有耐药性突变的HIV病毒具有活性,并且在体内半衰期很长。同时研究人员对islatravir+doravirine(多拉韦林)的安全性和有效性做了相关评估,目前临床研究中在各种剂量下均表现出良好的耐受性。
 
islatravir未来将有不同剂型的可能性,针对PrEP和HIV治疗的更多研究均在进行中。

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    2021-08-28 juliusluan78
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    2020-11-11 yese
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