NEJM:Ibalizumab可有效治疗多重耐药型艾滋病

2018-08-23 高原(北京佑安医院) 信诺医讯

抗逆转录病毒药物的联合使用可有效治疗人类免疫缺陷病毒1型(HIV-1)引起的艾滋病感染并提高患者存活,但部分患者因感染多重耐药型病毒(MDR HIV-1)导致传统治疗对病毒抑制不足,治疗失败以及病情恶化。

抗逆转录病毒药物的联合使用可有效治疗人类免疫缺陷病毒1型(HIV-1)引起的艾滋病感染并提高患者存活,但部分患者因感染多重耐药型病毒(MDR HIV-1)导致传统治疗对病毒抑制不足,治疗失败以及病情恶化。

Ibalizumab是一种人源化IgG4单克隆抗体,通过与CD4的非竞争性结合阻断HIV-1进入细胞,但不干扰CD4相关的免疫传导。前期研究显示Ibalizumab可降低病毒载量,且和其他抗逆转录病毒药物无交叉耐药。

此项单组、开放标签、3期研究纳入40例联合药物治疗失败的MDR HIV-1成人患者。入组时病毒载量均超过1,000拷贝HIV-1 RNA/ml。患者在对照期(0-7天)接受现有治疗;单药期(7-13天)第7天接受静脉推注2,000 mg Ibalizumab, 后继续现有治疗;维持期(14天-25周)每14天接受一次800 mg Ibalizumab,同时联用优化背景治疗。

31/40例患者完成研究,83%的患者达到主要终点,在14天时病毒载量较基线(7天)降低至少0.5 log10拷贝/ml(P<0.001),平均降低1.1 log10拷贝/ml,25周时平均降低1.6 log10拷贝/ml。10例患者出现抗病毒失败或反弹,其中9例对Ibalizumab敏感性较基线降低。常见不良事件为腹泻(20%的患者)。4例患者死于潜在疾病;1例死于与Ibalizumab治疗相关的不良事件(免疫重建炎症综合征)。

本研究发现每两周一次Ibalizumab联合优化背景治疗对多重耐药型艾滋病具有肯定的抗病毒活性。

原始出处:Brinda Emu, M.D., Jeffrey Fessel, M.D., Shannon Schrader, M.D., et al. Phase 3 Study of Ibalizumab for Multidrug-Resistant HIV-1. N Engl J Med. 2018 Aug 16;379(7):645-654. 

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    2019-05-26 snf701207
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    2018-08-27 huangshang9812

    哈哈哈,学习了

    0

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    2018-08-24 kafei

    学习了谢谢

    0

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    2018-08-23 329523732

    不错

    0

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