Qu Yundong, Li Tao, Wang Lei, Liu Feng, Ye Qian
Department of Infectious Diseases and Hepatology, the Second Hospital of Shandong University, 247, Beiyuan Road, 250033 Jinan, PR China.
Department of Infectious Diseases and Hepatology, the Second Hospital of Shandong University, 247, Beiyuan Road, 250033 Jinan, PR China.
Clin Res Hepatol Gastroenterol. 2016 Apr;40(2):203-12. doi: 10.1016/j.clinre.2015.06.021. Epub 2015 Jul 26.
To gain a profile of the efficacy and safety of simeprevir-based triple therapy in chronic hepatitis virus C (HCV) genotype 1 infected patients.
We searched in Medline, Embase, Cochrane database of systematic reviews and CINAHL for randomized controlled trials (RCTs) without year or language restriction. Eligible studies should evaluate simeprevir plus peginterferon and ribavirin combination therapy for chronic hepatitis C genotype 1 patients, while the standard peginterferon and ribavirin therapy as control group. Results must include the data of achieving sustained virological response (SVR), rapid virological response (RVR), incidence of discontinuation and severe adverse events (SAE).
Six RCTs (2209 patients) were included. The proportion of achieving SVR at 12 weeks after planned end of treatment (SVR12) was significantly higher in the simeprevir group than in the control group (RR=1.69, 95%CI: 1.37-2.08, P<0.001). The results also showed that the RVR rate was significantly higher in the simeprevir group (RR=9.57, 95%CI: 5.82-15.73, P<0.001). The addition of simeprevir was not accompanied with the increased risks of SAE (RR=0.67, 95%CI: 0.47-0.94, P=0.023). The incidence of discontinuation due to adverse events seems a little higher in simeprevir group than in the control group (3.0% vs. 1.1%), though there was no statistical difference (RR=1.26, 95%CI: 0.58-2.74, P=0.566).
Simeprevir-based triple therapy significantly increase the SVR12 rate and RVR rate without increasing the incidences of SAE and treatment discontinuation due to adverse events. However, further inquiries on the long-term safety of simeprevir are required in future.
了解基于西米普明的三联疗法在慢性丙型肝炎病毒（HCV）1型感染患者中的疗效和安全性概况。
我们在Medline、Embase、Cochrane系统评价数据库和CINAHL中检索了无年份或语言限制的随机对照试验（RCT）。符合条件的研究应评估西米普明联合聚乙二醇干扰素和利巴韦林对慢性丙型肝炎1型患者的联合治疗，而标准聚乙二醇干扰素和利巴韦林治疗作为对照组。结果必须包括实现持续病毒学应答（SVR）、快速病毒学应答（RVR）、停药发生率和严重不良事件（SAE）的数据。
纳入6项RCT（2209例患者）。西米普明组治疗计划结束后12周时实现SVR（SVR12）的比例显著高于对照组（RR = 1.69，95%CI：1.37 - 2.08，P < 0.001）。结果还显示，西米普明组的RVR率显著更高（RR = 9.57，95%CI：5.82 - 15.73，P < 0.001）。添加西米普明并未伴随着SAE风险的增加（RR = 0.67，95%CI：0.47 - 0.94，P = 0.023）。尽管没有统计学差异（RR = 1.26，9%CI：0.58 - 2.74，P = 0.566），但西米普明组因不良事件停药的发生率似乎略高于对照组（3.0%对1.1%）。
基于西米普明的三联疗法显著提高了SVR12率和RVR率，且未增加SAE发生率和因不良事件导致的治疗停药率。然而，未来需要进一步探究西米普明的长期安全性。
