长期开放标签vebicorvir慢性HBV感染:安全性和治疗结束后的反应
Man-Fung Yuen1, Scott Fung2, Xiaoli Ma3
1Department of Medicine and State Key Laboratory of Liver Research, School of Clinical Medicine, Queen Mary Hospital, The University of Hong Kong, Hong Kong.
长期使用韦比科维尔 (VBR) 和核胺逆转录酶抑制剂 (NRTIs) 的治疗对于慢性乙型肝炎病毒 (HBV) 感染是安全的. 然而,所有患者在停止治疗后都经历了病毒反弹,这表明VBR不足以治愈HBV.
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:
- 第一代核心抑制剂韦比科尔维尔 (VBR) 在慢性乙型肝炎病毒 (HBV) 感染的IIa期研究中显示出安全性和抗病毒活性.
- 核酸逆转录酶抑制剂 (NRTIs) 是标准的治疗方法,但在停止治疗后发生病毒反弹,表明对有限疗法的未满足需求.
研究的目的:
- 评估慢性HBV感染患者的开放性VBR与NRTI结合的长期安全性和有效性.
- 评估VBR + NrtI治疗停止后病毒学反应的持久性.
主要方法:
- 在此长期扩展研究 (NCT03780543) 中,以前参加IIa期研究的患者接受了VBR + NrtI.
- 在VBR + NrtI治疗≥52周后,应用了停止标准,患者要么停止VBR + NrtI,仅VBR,要么继续两者.
- 主要疗效终点是患者在治疗停止后24周内达到HBV DNA<20 IU/ml的比例.
主要成果:
- 长期的VBR + NrtI治疗维持了HBV核酸和抗原的抑制.
- 没有患者达到治疗后持续病毒学反应的初级终点;大多数患者在停止治疗后≥4周经历了病毒学反弹.
- 治疗一般耐受良好,很少出现导致停止治疗的不良事件. 没有报告死亡或药物相互作用.
结论:
- 长期VBR + NrtI是安全的,并抑制HBV复制,但不会导致持续治愈.
- 在停止治疗后,所有患者都出现了病毒性复发,这凸显了对慢性HBV更有效的有限治疗策略的需求.
- 对下一代核心抑制剂的进一步研究可能是必要的,以实现HBV治愈的持久反应.
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