摘要
目的探讨艾尔巴韦/格拉瑞韦(elbasvir/grazoprevir,EBR/GZR)治疗中国基因1b型(genotype 1b,GT1b)慢性丙型肝炎病毒(hepatitis C virus,HCV)感染患者中的疗效和安全性。方法在这项回顾性研究中,49例HCV GT1b初治慢丙肝患者接受12周GZR(100 mg)+EBR(50 mg)治疗。主要终点是病毒学应答,次要终点是治疗前后肝纤维化分期变化,以及治疗期间不良事件(treatment-emergent adverse event,TEAE)的发生率。结果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%。12周、24周和48周随访时,持续病毒学应答率均为100%。多因素分析显示,基线HCV RNA病毒载量可能影响EBR/GZR治疗2周时的快速病毒学应答(OR:0.36,95%,CI:0.14~0.92,P=0.034),但不影响后续治疗或随访阶段的疗效。15例(16.0%)患者发生过≥1次TEAE,7例(7.4%)和8例(8.5%)患者出现丙氨酸转氨酶(alanine aminotransferase,ALT)或天冬氨酸转氨酶(aspartate aminotransferase,AST)轻度升高(1.1~2.5×BL),但未发生严重的药物相关不良事件。肝脏硬度值、AST与血小板比值指数和基于年龄、ALT、AST及血小板4项指标的纤维化指数持续降低,其中基线指数高的患者在治疗12周后以及随访期间下降尤为明显。结论12周EBR/GZR方案对中国HCV GT1b患者具有较高的疗效和安全性。
Objective To determine the efficacy and safety of elbasvir/grazoprevir(EBR/GZR)treatment in Chinese patients with genotype 1b(GT1b)chronic hepatitis virus C(HCV)infections.Methods 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.Results After 2-week EBR/GZR treatment,the virologic response rate was 85.1%(80/94)and reached 100%after 8 and 12 weeks of therapy.Sustained virologic response 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 alanine aminotransferase(ALT)or aspartate aminotransferase(AST)elevations(1.1-2.5×BL),but no serious drug-related adverse events occurred.Liver stiffness measurement,the AST to platelet ratio index and the fibrosis index based on age,ALT,AST and platelet 4 factor scores were consistently reduced,especially in patients with high baseline assessments after 12 weeks’treatment and during follow-ups.Conclusions A 12-week EBR/GZR regimen shows high efficacy and safety in Chinese patients with GT1b HCV infections.
作者
肖琳(译)
张岭漪
Xiao Lin;Zhang Lingyi(MSD China,Shanghai 200233,China;Lanzhou University Second Hospital,Lanzhou 730000,China)
出处
《国际病毒学杂志》
2023年第5期423-428,共6页
International Journal of Virology
