达拉他韦联合阿舒瑞韦治疗26例慢性丙型肝炎患者的临床观察  

The efficacy and safety of daclatasvir combined with asunprevir in the treatment of 26 cases with chronic hepatitis C

作　　者：刘俊平[1] 靳慧鸣 宁会彬 刘翠平[1] 张乾 肖二辉[1] 李宽[1] 尚佳[1] Liu Junping;Jin Huiming;Ning Huibin;Liu Cuiping;Zhang Qian;Xiao Erhui;Li Kuan;Shang Jia(Department of Infectious Diseases, Henan Provincial People′s Hospital, Zhengzhou 450003, China)

机构地区：[1]河南省人民医院感染科,郑州450003

出　　处：《中华传染病杂志》2018年第10期611-615,共5页Chinese Journal of Infectious Diseases

基　　金：河南省医学科技攻关计划省部共建项目 (20140101015);河南省科技攻关项目 (172102310068).

摘　　要：目的了解达拉他韦(daclatasvir,DCV)+阿舒瑞韦(asunprevir,ASV)治疗基因1型慢性丙型肝炎患者的有效性和安全性。方法收集2017年9月至2017年11月就诊于河南省人民医院的慢性丙型肝炎患者,且同意使用DCV+ASV抗病毒治疗。分别于治疗前以及治疗后1、2、4、8、12、24周和结束后12周检测HCVRNA水平;记录患者合并症、合并用药和临床不良事件。正态分布的计量资料采用t检验,非正态分布的计量资料以M(P25,P75)表示。结果共纳入29例基因1b型患者。治疗前评估确诊肝硬化4例,非肝硬化患者25例。7例患者既往有干扰素联合利巴韦林治疗病史。9例患者合并其他疾病,7例患者有合并用药。25例完成24周抗病毒治疗疗程,3例患者失访,1例患者因在治疗中出现病毒反弹完成16周抗病毒治疗。1例患者在治疗失败后检测HCVRNANS5A耐药位点,提示L31V联合Y93H突变。在26例随访患者中,25例实现结束后12周持续病毒学应答(sustainedvirologicresponse,SVR)。1例患者因为发生耐药相关突变(resistance-associatedvariants,RAV)导致治疗失败。在26例患者中无严重不良反应。结论DCV联合ASV治疗基因1b型慢性丙型肝炎患者具有较好的临床有效率,安全性良好。选用该方案需要关注RAV对治疗疗效的影响。Objective To explore the efficacy and safety of daclatasvir (DCV) combined with asunprevir (ASV) for chronic genotype 1b (GT1b) hepatitis C. Methods Twenty-nine GT1b hepatitis C patients who were treated with DCV combined ASV in Henan Provincial People′s Hospital from September 2017 to November 2017 were included. Hepatitis C virus (HCV) RNA levels were tested before treatment, 1 week, 2 weeks, 3 weeks, 4 weeks, 8 weeks, 12 weeks and 24 weeks after treatment, and 12 weeks after the end of the treatment. The comorbidities, combined use of drugs and adverse clinical events were registered. T test was used to compare the measurement data with normal distribution and M (P25, P75) was used for measurement data with non-normal distribution. Results A total of 29 patients with GT1b were included, with 4 cirrhosis cases and 25 non cirrhotic cases. Seven patients had history of previous interferon and ribavirin combination treatment. There were 9 patients with comorbidity and 7 patients with combined medication. Finally, 25 patients completed a 24-week course of antiviral treatment; 3 patients were lost to follow-up, and 1 patient withdrew after 16weeks of antiviral treatment because of a virus rebound. Of the 26 followed up patients, 25 achieved sustained virological response at 12-week (SVR12), and one patient failed. And the HCV RNA NS5A resistance-associated variants (RAV) were detected in the patients with treatment failure. No severe adverse clinical events occurred in 26 patients. Conclusions DCV combined with ASV is effective and safe in the treatment of GT1b chronic hepatitis C. However, the effect of RAV on therapeutic efficacy should be concerned during the treatment.

关 键 词：肝炎 丙型 慢性 达拉他韦 阿舒瑞韦 

分 类 号：R512.63[医药卫生—内科学]