索磷布韦维帕他韦治疗慢性丙型肝炎患者疗效和安全性观察:一项单中心真实世界回顾性分析

目的 回顾性分析索磷布韦维帕他韦(SOF/VEL)联合利巴韦林(RBV)治疗慢性丙型肝炎(CHC)患者真实世界研究(RWS)的疗效和安全。方法 2018年5月～2020年4月初治/PR经治的CHC患者32例和代偿期丙型肝炎肝硬化(CHC-CLC)患者36例,接受SOF/VEL治疗12 w,失代偿期丙型肝炎肝硬化(CHC-DLC)或合并肝细胞癌(HCC)患者31例,接受SOF/VEL联合利巴韦林(RBV)治疗12 w。部分患者合并存在高血压、糖尿病、肿瘤和慢性乙型肝炎。采用RT-PCR法检测HCV基因型(GTs)。结果 本组HCV 感染患者以GT 2a(55.6%)和GT1b(34.3%)为主;CHC、CHC-CLC和CHC-DLC患者早期病毒学应答(EVR4)分别为90.6%、86.1%、83.9%,治疗结束病毒学应答(EOT)均为100.0%,CHC组和CHC-CLC组SVR12和SVR24均为100.0%,CHC-DLC组 SVR12和SVR24均为93.5%,三组间EVR4、EOT、SVR12、SVR24均无显著性差异(P>0.05);所有患者SVR12和SVR24均为97.8%,除GT3b型外其他GTs感染患者SVR12和SVR24均为100.0%;三组血生化学应答率分别为87.5%、83.3%和74.2%;本组总体不良反应(AE)发生率为12.1%,无严重AE或因AE停药和死亡事件发生。结论 应用SOF/VEL或联合RBV治疗CHC或相关的肝硬化患者,无论何种基因型感染,均有良好的效果,且安全。

Real-world study of efficacy and safety of sofosbuvir/velpatasvir in treatment of patients with hepatitis C and hepatitis C precipitated liver cirrhosis in a single centre of western-north China

Objective The aim of this study was to investigate the efficacy and safety of sofosbuvir/velpatasvir(SOF/VEL) in treatment of patients with chronic hepatitis C(CHC) and hepatitis C precipitated liver cirrhosis in real-world study(RWS) in a single centre.Method This RWS included naive or PR-treated patients with CHC, some concomitant with blood hypertension, diabetes, tumor or hepatitis, between May 2018 and April 2020. 32 patients with CHC and 36 patients with compensated hepatitis C – induced liver cirrhosis( CHC-CLC) received SOF/VEL for 12 weeks, and 31 patients with decompensated hepatitis C liver cirrhosis(CHC-DLC) or hepatocellular carcinoma received SOF/VEL and ribavirin(RBV) for 12 weeks. The HCV genotypes( GTs) were determined by RT-PCR.Results The prevalence of GT 2a(55. 6%) and GT1b(34. 3%) was dominant in our series;the early virological response(EVR4) in patients with CHC, CHC-CLC and CHC-DLC were 90. 6%, 86. 1% and 83. 9%, the end of treatment(EOT) virologic response were 100. 0% in the three groups, the sustained virological response(SVR) 12 and SVR24 in patients with CHC and CHC-CLC were 100. 0% and 100. 0% and both the SVR12 and SVR24 in patients with CHC-DLC were 93. 5%, not significantly different among the three groups(P>0. 05);both the SVR12 and SVR24 in our series was 97. 8%, and they reached 100. 0% when the patients with GT3b infection were excluded;the biochemical responses rates in the three groups were 87. 5%, 83. 3% and 74. 2%, and the incidence of adverse event(AE) in our series was 12. 1%, no severe AE or discontinuation of therapy owning to AE occurred.Conclusion The efficacy of SOF/VEL and/or with RBV in treating patients with CHC and CHC-precipitated liver diseases is good and promising, without severe untoward effects.