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最近感染HCV的人群中4周的glecaprevir-pibrentasvir:TARGET3D研究

Marianne Martinello^1,2, Sanjay Bhagani³, David Shaw⁴

¹Kirby Institute, UNSW, Sydney, Australia.

JHEP reports : innovation in hepatology

|September 29, 2023

概括

对最近的C型肝炎病毒 (HCV) 感染进行了为期4周的glecaprevir-pibrentasvir治疗,其疗效低于最佳 (78% SVR12). 较低的基线病毒载量改善了结局,但总体而言,较短的治疗持续时间比较长的疗程效果较低.

科学领域:

肝病学和病毒性胃肠道学
传染病与公共卫生问题
药物治疗和临床试验

背景情况:

在关键人群中,正在探索短期的型肝炎病毒 (HCV) 治疗以消除HCV.
最近的HCV感染,通过特定的血清学和临床标志物在定义的时间范围内定义,是新治疗策略的目标.

研究的目的:

评估最近感染HCV的成年人4周glecaprevir-pibrentasvir疗法的疗效.
评估持续的病毒学反应 (SVR12) 作为意图治疗 (ITT) 和每协议 (PP) 种群的主要终点.

主要方法:

一个单臂,多中心的国际试验,涉及23名最近感染HCV的成年人 (持续时间<12个月).
参与者每天接受glecaprevir-pibrentasvir (300毫克-120毫克) 在4周内.
在治疗后12周确定了SVR12;初级和再感染病例是基于HCVRNA和临床/血清学数据定义的.

主要成果:

78% (ITT) 和82% (PP) 的参与者在12周内实现了持续的病毒学反应 (SVR12).
在基线HCVRNA ≤6 log10 IU/ml的参与者中观察到更高的疗效 (100% SVR12).
发生了四例病毒学失败 (复发);两例对更长时间的治疗方案进行重复治疗有反应.

结论:

4周的glecaprevir-pibrentasvir疗法在较长时间 (≥6周) 的治疗相比,在最近的HCV感染中显示出低于最佳的疗效.
基线病毒载量是影响治疗反应的潜在因素.
虽然通常是安全的,但4周的疗程的有效性可能会限制其在这个人群中用于HCV消除策略的实用性.

关键词:

在C型肝炎患者中,C型肝炎是最常见的.这种情况是急性急性.直接作用的抗病毒药物.最近的最近的最近的最近治疗治疗治疗治疗治疗治疗

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