一个Tobevibart加Elebsiran在D型肝炎的第二阶段试验
Tarik Asselah1, Michael A Chattergoon2, Alina Jucov3,4
1Université Paris-Cité, Hôpital Beaujon, Assistance Publique-Hôpitaux de Paris, INSERM Unité Mixte de Recherche 1149, Paris.
The New England journal of medicine
|November 10, 2025
概括
托贝维巴特和埃莱布西兰的联合治疗和托贝维巴特单一治疗都有效地降低了D型肝炎病毒 (HDV) RNA和氨酸转移酶 (ALT) 水平. 托贝维巴特加上埃勒布西兰显示出高水平的无法检测的HDVRNA和降低的乙型肝炎病毒表面抗原 (HBsAg) 水平.
科学领域:
- 肝病学 肝病学是一种肝病学.
- 病毒学 病毒学
- 免疫治疗是一种免疫疗法.
背景情况:
- 慢性肝炎D病毒 (HDV) 感染仍然是一个重要的未满足的医疗需求.
- 托贝维巴特 (单克隆抗体) 和埃勒布西兰 (小干扰RNA) 向乙型肝炎病毒表面抗原 (HBsAg),但它们对高强度病毒的疗效尚不清楚.
研究的目的:
- 评估tobevibart加elebsiran与tobevibart单一治疗在慢性HDV感染患者中的疗效和安全性.
- 评估病毒载量减少和肝酶正常化作为主要终点.
主要方法:
- 一个正在进行的,第二阶段,开放标签,随机试验.
- 参与者每4周接受tobevibart加elebsiran或每2周接受tobevibart单一治疗.
- 主要终点:在第24周结合病毒学和生化反应.
主要成果:
- 在第24周,综合反应率为47% (托贝维巴特+埃勒布西兰) 和70% (托贝维巴特单一治疗).
- 在第48周,66% (托贝维巴特+埃尔布西兰) 和48% (托贝维巴特单疗法) 的患者获得了无法检测的HDVRNA.
- 在组合治疗中,B型肝炎病毒表面抗原 (HBsAg) 水平显著下降 (91%对比48周的21%). 没有观察到ALT火焰.
结论:
- 这两种治疗策略在48周内都有效降低了HDVRNA和ALT水平.
- 托贝维巴特加上埃勒布西兰显示出高频率的不可检测的HDVRNA和显著的HBsAg降低.
- 综合疗法一般耐受良好,主要报告流感样症状和寒.
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