Sofosbuvir-Based Therapies for Patients with Hepatitis C Virus Infection: Real-World Experience in China
Sofosbuvir-Based Therapies for Patients with Hepatitis C Virus Infection: Real-World Experience in China
复制标题
基于索非布韦的丙型肝炎病毒感染患者治疗：中国的真实经验
DOI：
10.1155/2018/3908767
复制
发表时间：
2018-01-01
影响因子：
2.7
通讯作者：
Zhou, Yuanping
中科院分区：
文献类型：
--
作者：
Hu, Chengguang;Yuan, Guosheng;Zhou, Yuanping
背景和目的：关于中国慢性丙型肝炎病毒（HCV）感染患者对索非布韦（SOF）治疗反应的文献资料很少。本研究的目的是在中国大陆的现实环境中评估基于Sofs的治疗方案对无肝硬化的慢性丙型肝炎（CHC）患者的有效性和安全性。方法从2014年12月至2017年6月，共招募了226例接受SOF联合达卡他韦（DCV），雷迪帕韦（LDV）或维帕他韦（VEL）的患者。主要观察点为治疗后12周（SVR 12）持续病毒学应答（SVR）的患者百分比，并在治疗和随访期间监测所有不良事件。结果总的SVR 12率为96%（216/226），不同治疗组的SVR 12率为93%~ 100%。基因型1b和6a之间的疗效差异无统计学意义（GT 1b为98%，GT 6a为100%，P=0.322）。与GT 1b和6a患者的高成功率相比，GT 3a和3b患者的SVR 12相对较低。GT 3和非GT 3患者的疗效有显著差异（分别为77%和98%，P<0.001）。不同治疗方案（分别为93%、97%、100%，P=0.153）、性别（男性95%、女性96%，P=0.655）、基线HCV RNA水平（分别为96%、95%，P=0.614）之间的疗效无显著差异。初治和既往治疗患者的SVR率也相似（分别为98%和93%，P=0.100）。结论NS 5 B聚合酶抑制剂SOF联合NS 5A抑制剂DCV、LDV或VEL治疗12周与高SVR 12发生率相关，且无肝硬化的HCV感染患者耐受性良好。此外，DAA失败的患者应重新接受更有效的方案，如SOF/VEL。
Background and Aims There is scarcity of data in literature regarding the treatment response to sofosbuvir- (SOF-) based therapies in Chinese patients with chronic Hepatitis C Virus (HCV) infection. The aim of this study was to evaluate the efficacy and safety of SOF-based regimens for chronic hepatitis C (CHC) patients without cirrhosis in a real-world setting in mainland China. Methods A total of 226 patients receiving SOF plus daclatasvir (DCV), ledipasvir (LDV), or velpatasvir (VEL) were enrolled from December 2014 to June 2017. The primary observation point was the percentage of patients with a sustained virologic response (SVR) at posttreatment week 12 (SVR12), and all adverse events were monitored during treatment and follow-up period. Results The overall SVR12 rate was 96% (216/226), and individual SVR12 ranged from 93% to 100% in different treatment groups. No significant differences of efficacy were detected between genotypes 1b and 6a (98% for GT 1b versus 100% for GT 6a, P=0.322). Comparing the high success rates in GT 1b and 6a patients, SVR12 was relatively low in GT 3a and 3b patients. A significant difference in efficacy was observed between GT 3 and not GT 3 patients (77% versus 98%, respectively, P<0.001). No significant differences in efficacy were detected among different regimens (93% versus 97% versus 100%, respectively, P=0.153), gender (95% for male versus 96% for female, P=0.655), or baseline HCV RNA lever (96% versus 95%, respectively, P=0.614). Similar SVR rates were also obtained in naïve and previously treated patients (98% versus 93%, respectively, P=0.100). Conclusions NS5B polymerase inhibitor SOF plus one of the NS5A inhibitors, such as DCV, LDV, or VEL for 12 weeks was associated with high SVR12 rates and well tolerated in HCV-infected patients without cirrhosis. Moreover, patients with DAAs failure should be retreated with more effective regimens like SOF/VEL.