基于索磷布韦的药物治疗中国海南地区基因6型丙型肝炎病毒感染的真实世界研究  

A real-world study of sofosbuvir-based drug treatment for hepatitis C virus genotype 6 infection in Hainan region of China

作　　者：王姣[1] 刘明 张艳茹 邢慧芸 李晖[1] 林锋[1] 吴涛[1] Wang Jiao;Liu Ming;Zhang Yanru;Xing Huiyun;Li Hui;Lin Feng;Wu Tao(Department of Infectious Diseases,Hainan General Hospital,Hainan Affiliated Hospital of Hainan Medical University,Haikou 570311,China;NHC Key Laboratory of Control of Tropical Diseases,Hainan Medical University,Haikou 570311,China)

机构地区：[1]海南省人民医院,海南医学院附属海南医院感染科,国家卫生健康委员会热带病防治重点实验室,海口570311

出　　处：《中华肝脏病杂志》2021年第7期679-684,共6页Chinese Journal of Hepatology

基　　金：海南省"南海名家"培养高层次人才项目。

摘　　要：目的在真实世界中,探讨基于索磷布韦为基础的方案对海南岛丙型肝炎病毒(HCV)基因6型慢性感染者的有效性和安全性。方法选择2018年1月至2020年3月期间的53例初治基因6型HCV感染的慢性丙型肝炎患者,以索磷布韦(SOF)为基础的方案治疗[索磷布韦维帕他韦(SOF/VEL)12周或索磷布韦联合利巴韦林(SOF+RBV)24周],停药后随访24周。主要疗效指标为治疗结束停药随访12周时获得持续病毒应答(SVR12)发生率。次要指标为治疗结束时、治疗结束后24周病毒学应答情况。并观察治疗期间不良事件发生情况。组间比较用t检验,持续病毒学应答用意向治疗及改良性的意向治疗分析。结果53例HCV基因6型的慢性丙型肝炎患者亚型分布情况:6a型22例,6w型5例,6xa型5例,6v型3例,6e型2例,6r型2例,6xh型1例,13例为不能确定基因亚型的特殊病毒株。停药12周总体持续病毒应答率为100%,且治疗期间(4周)、治疗结束时、治疗结束后(24周)均未检测到HCV RNA。共有7例报告了不良事件,主要为疲乏、纳差、轻度贫血,未见严重不良事件发生。结论基于索磷布韦为基础联合利巴韦林或者维帕他韦的治疗方案不仅对HCV 6a亚型可获得较高应答率,对于HCV基因6型中的少见流行基因亚型及特殊病毒株均可获得良好的病毒学应答,不良反应轻微,安全性可接受。Objective To explore the real-world effectiveness and safety of sofosbuvir-based regimen for patients with chronic hepatitis C virus(HCV)genotype 6 infection in Hainan Island.Methods Fifty-three cases with chronic hepatitis C virus(HCV)genotype 6 infection who were initially treated with a sofosbuvir(SOF)-based regimen[sofosbuvir/velpatasvir(SOF/VEL)for 12 weeks or sofosbuvir combined with ribavirin(SOF+RBV)for 24 weeks],followed by 24 weeks of follow-up after discontinuation of the drug from January 2018 to March 2020 were selected.The primary outcome measures were incidence of sustained virological response at 12 weeks(SVR12)after the drug withdrawal.The secondary outcome measures were adverse drug events with sustained virological response at the end of treatment and 24 weeks after the end of treatment.The occurrence of adverse events was observed during the treatment.An intragroup comparison was performed by t-test.Intention-to-treat and modified intention-to-treat analysis was used for sustained virological respons.Results The subtype distribution of chronic hepatitis C virus(HCV)genotype 6 in 53 cases of chronic hepatitis C infection were as follows:22 cases of type 6a,5 cases of type 6w,5 cases of type 6xa,3 cases of type 6v,2 cases of type 6e,2 cases of type 6r,1 case of type 6xh,and 13 cases of special virus strains with undetermined genotype.The overall sustained virological response rate at 12 weeks after the drug withdrawal was 100%.Furthermore,HCV RNA was undetectable during the treatment period(4 weeks),at the end of treatment and after the treatment(24 weeks).There were seven cases of adverse events,mainly including fatigue,anorexia,and mild anemia;however,no serious adverse events were reported.Conclusion Sofosbuvir-based regimen combined with ribavirin or velpatasvir cannot only achieve high response rate to HCV subtype 6a,but also obtain a good sustained virological response to the rare prevalent sub-genotypes and special virus strains of HCV genotype 6,with mild adverse reactions and acceptable

关 键 词：丙型肝炎病毒 基因型 索磷布韦 中国海南岛 

分 类 号：R512.63[医药卫生—内科学]