在HIV检测和治疗的背景下,BIC/F/TAF与DRV/c/F/TAF的随机对照试验,BicTnT
Gary Whitlock1,2, Sarah Fidler2, Amanda Clarke3,4
1Chelsea and Westminster Hospital, London, UK.
HIV research & clinical practice
|September 8, 2024
概括
在迅速启动抗逆转录病毒疗法时,比特格拉维尔/emtricitabine/tenofovir alafenamide (BIC/F/TAF) 与达鲁纳维尔/cobicistat/emtricitabine/tenofovir alafenamide (DRV/c/F/TAF) 相比显示出显著更快的HIVRNA下降. 在BIC-T&T研究中,这两种疗法都表现出良好的耐受性.
科学领域:
- 传染性疾病 传染性疾病
- 病毒学 病毒学
- 药理学 药理学是指药理学的学科.
背景情况:
- 在快速ART启动中,BIC/F/TAF和DRV/c/F/TAF的对比数据有限.
- 该BIC-T&T研究通过在英国的试验和治疗环境中比较这两种疗法来弥补这一差距.
研究的目的:
- 评估BIC/F/TAF与DRV/c/F/TAF的疗效和耐受性,以快速启动抗逆转录病毒治疗 (ART).
- 为了比较两个治疗手臂在第12周的病毒学反应.
主要方法:
- 随机,开放标签,多中心研究设计.
- 在HIV-1确诊后14天内启动ART.
- 主要终点:在第12周的病毒学反应 (HIV RNA <50拷贝/毫升),通过log10HIV RNA的时间加权平均变化来评估.
主要成果:
- 36名参与者被随机分配,平均年龄为35岁.
- 从诊断到ART启动的平均时间为7.9天.
- 与DRV/c/F/TAF (2.6 log10 copies/mL) (p < 0.001) 相比,BIC/F/TAF显示了log10HIVRNA (3.1 log10副本/mL) 的时间加权平均下降显著更大 (p < 0.001).
- 两种疗法均表现出良好的耐受性,没有3级或4级不良事件.
结论:
- 在快速ART启动的背景下,与DRV/c/F/TAF相比,BIC/F/TAF促进了显著更快的HIVRNA下降.
- 这项对比研究为早期艾滋病毒管理中治疗选择提供了关键证据.
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