在一项单臂、开放标签、多中心研究中，治疗初治、APRI≤1 的 HCV 感染患者，接受 8 周格卡瑞韦哌仑他韦治疗的疗效和安全性。
Efficacy and Safety of 8 Weeks of Glecaprevir/Pibrentasvir in Treatment-Naïve, HCV-Infected Patients with APRI ≤ 1 in a Single-Arm, Open-Label, Multicenter Study.
机构信息
Division of Gastroenterology and Hepatology, University of Michigan, Ann Arbor, MI, USA.
Liver Unit, Hospital Clinic, IDIBAPS and CIBERehd, University of Barcelona, Barcelona, Spain.
出版信息
Adv Ther. 2019 Dec;36(12):3458-3470. doi: 10.1007/s12325-019-01123-0. Epub 2019 Oct 23.
INTRODUCTION
The presence or absence of cirrhosis in patients with chronic hepatitis C virus (HCV) infection influences the type and duration of antiviral therapy. Non-invasive markers, like serum aspartate aminotransferase (AST) to platelet ratio index (APRI), may help identify appropriate HCV treatment-naive patients for 8-week treatment with the pangenotypic regimen of glecaprevir/pibrentasvir.
METHODS
This single-arm, open-label, international, prospective study (NCT03212521) evaluated the efficacy and safety of 8-week glecaprevir/pibrentasvir regimen in HCV treatment-naïve adults with chronic HCV genotypes 1-6 infection, APRI ≤ 1, and no prior evidence of cirrhosis. The primary and secondary outcomes were sustained virologic response at 12 weeks post-treatment (SVR12) by modified intent-to-treat (mITT) and intent-to-treat (ITT) analyses, respectively. Additional endpoints included virologic failures, treatment adherence, and genotype-specific SVR12 rates.
RESULTS
Among the 230 patients enrolled, most were less than 65 years old (90%); 37% and 43% had a history of injection drug use or psychiatric disorders, respectively. SVR12 rates were 100% (222/222; 95% CI 98.3-100%) and 96.5% (222/230; 95% CI 94.2-98.9%) by mITT and ITT analyses, respectively. There were no virologic failures. ITT SVR12 rates were greater than 94% for all HCV genotypes. In patients with available data, treatment adherence was 99% (202/204). There were no grade 3 or higher laboratory abnormalities in alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total bilirubin, and low rates of serious adverse events (2%).
CONCLUSIONS
Glecaprevir/pibrentasvir was highly efficacious and well tolerated in HCV treatment-naïve patients with APRI ≤ 1 and no prior evidence of cirrhosis.
TRIAL REGISTRATION
ClinicalTrials.gov number, NCT03212521.
FUNDING
AbbVie. Plain language summary available for this article.
简介
慢性丙型肝炎病毒（HCV）感染患者是否存在肝硬化会影响抗病毒治疗的类型和持续时间。非侵入性标志物，如血清天冬氨酸氨基转移酶（AST）与血小板比值指数（APRI），可能有助于识别适当的 HCV 初治患者，进行 8 周的泛基因型 glecaprevir/pibrentasvir 治疗。
方法
这项单臂、开放标签、国际、前瞻性研究（NCT03212521）评估了 8 周 glecaprevir/pibrentasvir 方案在慢性 HCV 基因型 1-6 感染、APRI≤1 和无肝硬化既往证据的 HCV 初治成人中的疗效和安全性。主要和次要终点分别为治疗后 12 周时的持续病毒学应答（SVR12），采用改良意向治疗（mITT）和意向治疗（ITT）分析。其他终点包括病毒学失败、治疗依从性和基因型特异性 SVR12 率。
结果
在 230 名入组患者中，大多数患者年龄小于 65 岁（90%）；37%和 43%分别有静脉注射药物使用史或精神疾病史。mITT 和 ITT 分析的 SVR12 率分别为 100%（222/222；95%CI 98.3-100%）和 96.5%（222/230；95%CI 94.2-98.9%）。无病毒学失败。所有 HCV 基因型的 ITT SVR12 率均大于 94%。在有可用数据的患者中，治疗依从性为 99%（202/204）。丙氨酸氨基转移酶（ALT）、天冬氨酸氨基转移酶（AST）和总胆红素的实验室异常发生率为 3 级或更高的比例为 0%，严重不良事件的发生率较低（2%）。
结论
glecaprevir/pibrentasvir 在 APRI≤1 和无肝硬化既往证据的 HCV 初治患者中疗效显著，耐受性良好。
试验注册
ClinicalTrials.gov 编号，NCT03212521。
资金
艾伯维。本文提供通俗易懂的摘要。
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