相关实验视频
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A Protocol for Analyzing Hepatitis C Virus Replication
Published on: June 26, 2014
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全口服达克拉塔斯维尔加阿苏纳普雷维尔治疗C型肝炎病毒基因型1b:一项跨国,第三阶段,多队列研究
Michael Manns1, Stanislas Pol2, Ira M Jacobson3
1Hannover Medical School, Hannover, Germany; German Center for Infection Research (DZIF), Hannover-Braunschweig, Germany.
Lancet (London, England)
|August 1, 2014
概括
这项研究表明,达克拉塔斯维尔加上阿苏纳普雷维尔是一种有效的全口服,无干扰素和无瑞巴维林治疗慢性型肝炎病毒 (HCV) 基因型1b感染的疗法. 在未接受治疗和经过治疗的患者中观察到高持续病毒学反应率,包括肝硬化患者.
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:
- 慢性型肝炎病毒 (HCV) 感染需要新的治疗策略.
- 现有疗法通常涉及干扰素和利巴维林,但它们有局限性.
- 对于无干扰素和无瑞巴维林治疗方案存在未满足的需求.
研究的目的:
- 评估使用达克拉塔斯维尔加阿苏纳普雷维尔全口服治疗的疗效和安全性.
- 为了评估患有慢性HCV基因型1b感染的患者的这种治疗方案.
- 包括患有高未满足需求的患者群体,如肝硬化患者.
主要方法:
- 第三期,多队列,随机,双盲,安慰剂对照研究 (HALLMARK-DUAL).
- 参与者包括以前没有接受过治疗的患者,没有反应的患者,以及那些不符合条件/不耐受以前治疗的患者.
- 主要终点:在治疗后第12周持续的病毒学反应.
主要成果:
- 持续病毒学反应 (SVR) 率高:未接受治疗的患者中有90%,未反应者中有82%,不符合条件/不耐受组中有82%.
- 达克拉塔斯维尔和阿苏纳普雷维尔的组合耐受性很好.
- 严重的不良事件和停止治疗的发生很少.
结论:
- 达克拉塔斯维尔加上阿苏纳普雷维尔在HCV基因型1b感染的患者中显示出高疗效.
- 这种全口服,无干扰素和无瑞巴维林的治疗方案是不同患者群体的可行选择.
- 治疗耐受性良好,支持其在临床实践中的使用.
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