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慢性HDV患者的bulevirtide单疗法:从III期随机试验的96周的有效性和安全性结果

Heiner Wedemeyer¹, Soo Aleman², Maurizia Brunetto³

¹Medizinische Hochschule Hannover, Klinik für Gastroenterologie, Hepatologie, Infektiologie und Endokrinologie, Hannover, Germany.

Journal of hepatology

|May 11, 2024

概括

持续治疗慢性三角型肝炎 (CHD) 的布莱维 (BLV) 治疗长达96周,改善了病毒学和生化反应,即使在早期结果不足最佳的患者中也是如此. 在这项长期研究中,BLV证明了持续的安全性和有效性.

科学领域:

肝病学肝病学是一种肝病学.
病毒学病毒学
药理学药理学是指药理学的学科.

背景情况:

布列维 (BLV) 是一种新型的进入抑制剂,已批准用于慢性型肝炎 (CHD).
以前的研究表明,BLV单一治疗优于48周的延迟治疗.
长期疗效和安全性数据对于临床实践至关重要.

研究的目的:

评估持续BLV治疗到96周对病毒学和生化反应率的影响.
为了评估24周未达到最佳病毒反应的患者的疗效.
确认BLV.LV的长期安全性和耐受性.

主要方法:

一项正在进行的,开放的,随机的III期研究 (NCT03852719),涉及150名心脏病患者.
患者接受了BLV 2 mg/天,10 mg/天或延迟治疗 (48周),随后接受了BLV 10 mg/天.
组合反应:无法检测到的HDVRNA或≥2 log10 IU/ml降低加上ALT正常化.

主要成果:

在48周到96周之间,有效性反应得到维持和改善.
在24周早期反应不足的患者中,43%的非响应者和82%的部分响应者在96周内实现了病毒学反应.
生物化学改善通常独立于病毒学反应发生;BLV是安全的和耐受良好的.

结论:

长期的BLV治疗 (96周) 维持并增加了冠心病患者的病毒学和生化反应.
持续BLV对未达到最佳早期病毒学反应的患者有益.
在心血管疾病治疗中,BLV单一治疗是安全的,并且可以耐受长达96周的时间.

关键词:

在 HDV RNA 中.这是一种NTCP抑制剂.布莱维尔提德 (Bulevirtide) 是一种蛋白质的化合物.慢性肝炎的三角形肝炎乙型肝炎病毒的感染.乙型肝炎病毒D型肝炎肝炎不包括肝炎不包括米尔克卢德克斯 B B 第三期临床试验临床试验病毒性肝炎病毒性肝炎病毒性肝炎病毒抑制病毒抑制病毒进入抑制抑制病毒的进入.

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