Li Juan, Li Guangming, Wang Juanxia, Zhao Rui, He Jingjing, Wang Liang, Zhang Lingyi
Department of Hepatology, Lanzhou University Second Hospital No. 82 Cuiying Gate, Chengguan District, Lanzhou 730000, Gansu, China.
Am J Transl Res. 2022 Jun 15;14(6):3995-4005. eCollection 2022.
To determine the efficacy and safety of elbasvir/grazoprevir (EBR/GZR) treatment in Chinese patients with GT1b chronic hepatitis virus C (HCV) infections.
In this retrospective study, 49 treatment-naive patients with chronic GT1b HCV infection were treated with GZR (100 mg) plus EBR (50 mg) for 12 weeks. The viral response was the primary endpoint and fibrosis stage changes during and after treatment, as well as the incidence of treatment-emergent adverse events (TEAE) were secondary endpoints.
After 2-week EBR/GZR treatment, the virologic response rate was 85.1% (80/94) and reached 100% (94/94) after 8 and 12 weeks of therapy. Sustained virologic response (SVR) rates were 100% at the 12, 24 and 48-week follow-ups. Multivariate analysis revealed that the baseline viral load of HCV RNA may affect the rapid 2-week virologic response (OR: 0.36, 95% CI: 0.14-0.92, P=0.034), but did not influence efficacy during further treatment or follow-ups. Fifteen patients with ≥1 TEAE (16.0%) were observed and 7 (7.4%) and 8 (8.5%) patients had mild ALT or AST elevations (1.1-2.5× BL), but no serious drug-related AEs occurred. Liver stiffness measurement (LSM), the AST to platelet ratio index (APRI) and the fibrosis index based on 4 factor (FIB4) scores were consistently reduced, especially in patients with high baseline assessments after 12 weeks' treatment and during follow-ups.
A 12-week EBR/GZR regimen shows high efficacy and safety in Chinese patients with GT1b HCV infections.
确定艾尔巴韦/格拉瑞韦（EBR/GZR）治疗中国基因1b型慢性丙型肝炎病毒（HCV）感染患者的疗效和安全性。
在这项回顾性研究中，49例初治的慢性基因1b型HCV感染患者接受格拉瑞韦（100毫克）加艾尔巴韦（50毫克）治疗12周。病毒反应是主要终点，治疗期间及之后的纤维化阶段变化以及治疗中出现的不良事件（TEAE）发生率是次要终点。
EBR/GZR治疗2周后，病毒学应答率为85.1%（80/94），治疗8周和12周后达到100%（94/94）。在12周、24周和48周随访时持续病毒学应答（SVR）率均为100%。多变量分析显示，HCV RNA的基线病毒载量可能影响2周时的快速病毒学应答（OR：0.36，95%CI：0.14 - 0.92，P = 0.034），但不影响后续治疗及随访期间的疗效。观察到15例患者发生≥1次TEAE（占16.0%），7例（7.4%）和8例（8.5%）患者出现轻度ALT或AST升高（为基线值的1.1 - 2.5倍），但未发生严重的药物相关不良事件。肝脏硬度测量（LSM）、AST与血小板比值指数（APRI）以及基于4项指标的纤维化指数（FIB4）评分持续降低，尤其是在基线评估较高的患者中，在治疗12周后及随访期间均如此。
12周的EBR/GZR治疗方案对中国基因1b型HCV感染患者显示出高疗效和安全性。
