关键词: 慢性丙型肝炎, 基因1型, Boceprevir, 持续病毒学应答率, 随机对照试验, Meta分析

Abstract: Objective To evaluate the efficacy and safety of boceprevir in combination with peginterferon alfa and ribavirin for treatment of hepatitis C patients with hepatitis C viral genotype 1 infection. Methods MEDLINE,CENTRAL,EMBASE were searched for randomized controlled trial articles published from January 2006 to October 2015 on subject of patients with HCV-G1 infection receiving triple-therapy regimens with boceprevir and peginterferon alfa plus ribavirin. According to the predefined inclusion and exclusion criteria,the included studies were evaluated and analyzed by meta-analysis with RevMan 5.3 software. The primary outcomes was sustained virological response（SVR） and adverse events,and the secondary outcomes included rapid virological response （RVR） and relapse. Results Four RCTs involving 2211 patients were included in this study. The results of meta-analysis showed that the triple-therapy regimens increased SVR [naive:64.08% （737/1150） vs.42.20% （176/417）,OR=0.34,95% CI （0.27,0.42）,P<0.00001;and retreatment:63.02% （288/457） vs.21.09% （31/147）,OR=0.16,95%CI （0.10,0.24）,P<0.00001],and the triple-therapy regimens reduced the risk of relapse in both naive and retreatment patients [11.33% （115/1015） vs.24.00% （66/275）,OR=2.69,95% CI （1.90,3.81）,P<0.00001],as to the RVR,there was no statistical difference between the two groups [72.11% （843/1169） vs.51.861% （265/511）,OR=0.48,95% CI（0.19,1.78）,P=0.28];the incidence of severe anaemia in triple-therapy regimens was obviously higher than in control group [3.98% （64/1607） vs.1.46% （9/614）,OR=0.33,95% CI（0.16,0.68）,P=0.003],and the same phenomena was found as to serious adverse events [10.45% （168/1607） vs.7.33% （45/614）,OR=0.66,95% CI （0.48,0.90）,P=0.01] or the discontinuation because of adverse events [12.49% （109/873） vs.5.18% （13/251）,OR=0.37,95% CI（0.20,0.67）,P=0.001]. Conclusion Boceprevir in combination with peginterferon and ribavirin might increase SVR significantly in patients with hepatitis C and hepatitis C viral genotype one infection,reduce the rate of relapse,but increase the rates of severe anaemia,serious adverse events and the discontinuation because of adverse events. As for the quantity of the included studies is limited,this conclusion still needs to be further proved by more RCT studies.

Key words: Hepatitis C, Genotype 1, Boceprevir, Sustained virological response, RCT, Meta-analysis