Comparison of peg-interferon, ribavirin plus telaprevir vs simeprevir by propensity score matching.
Comparison of peg-interferon, ribavirin plus telaprevir vs simeprevir by propensity score matching.
复制标题
通过倾向评分匹配比较聚乙二醇干扰素、利巴韦林加特拉匹韦与西美匹韦。
作者：
H. Fujii;Takeshi Nishimura;Atsushi Umemura;Taichiro Nishikawa;K. Yamaguchi;M. Moriguchi;Y. Sumida;H. Mitsuyoshi;Chihiro Yokomizo;Saiyu Tanaka;H. Ishikawa;K. Nishioji;H. Kimura;S. Takami;Y. Nagao;Takayuki Takeuchi;T. Shima;Y. Sawa;M. Minami;K. Yasui;Y. Itoh
目的
目的比较特拉匹韦（TVR）和西米匹韦（SMV）联合聚乙二醇干扰素（PEG-IFN）和利巴韦林（RBV）治疗慢性丙型肝炎（CHC）的疗效。
方法
共有306例CHC患者纳入本研究。TVR联合治疗组有159例患者，SMV联合治疗组有147例患者。为了评价导致12周持续病毒学应答（SVR 12）的治疗前因素，对TVR和SMV组进行了单变量和多变量分析。为了调整TVR和SMV组之间的患者背景，进行了倾向评分匹配。评价治疗期间的病毒学应答和SVR 12。
结果
TVR组和SMV组中SVR 12 [不可检测的血清丙型肝炎病毒（HCV）RNA水平]的总体发生率分别为79.2%和69.4%。SMV组患者年龄较大，血清HCV RNA水平较高，血红蛋白较低，白细胞介素28 B（IL 28 B）基因型（rs 8099917）的患病率较高，对既往PEG-IFN和RBV治疗的反应较差。进行倾向评分匹配以调整背景（n = 104），并证明TVR和SMV组的SVR 12率分别为74.0%和73.1%。在TVR组中，由于不良事件而导致的停药率更高;然而，SMV组中的突破和无应答更常见。多因素分析显示，IL 28 B基因型（rs 8099917）是两组中SVR 12的唯一独立预测因素。
结论
在倾向评分匹配后，SVR 12率几乎相同。
AIM
To compare efficacy of telaprevir (TVR) and simeprevir (SMV) combined with pegylated interferon (PEG-IFN) and ribavirin (RBV) while treating chronic hepatitis C (CHC).
METHODS
In all, 306 CHC patients were included in this study. There were 159 patients in the TVR combination therapy group and 147 patients in the SMV combination therapy group. To evaluate pretreatment factors contributing to sustained virological response at 12 wk (SVR12), univariate and multivariate analyses were performed in TVR and SMV groups. To adjust for patient background between TVR and SMV groups, propensity score matching was performed. Virological response during treatment and SVR12 were evaluated.
RESULTS
Overall rates of SVR12 [undetectable serum hepatitis C virus (HCV) RNA levels] were 79.2% and 69.4% in TVR and SMV groups, respectively. Patients in the SMV group were older, had higher serum HCV RNA levels, lower hemoglobin, higher prevalence of unfavorable interleukin-28B (IL28B) genotype (rs8099917), and poorer response to previous PEG-IFN and RBV treatment. Propensity score matching was performed to adjust for backgrounds (n = 104) and demonstrated SVR12 rates of 74.0% and 73.1% in the TVR and SMV groups, respectively. In the TVR group, discontinuation rates were higher because of adverse events; however, breakthrough and nonresponse was more frequent in the in SMV group. Multivariate analysis revealed IL28B genotype (rs8099917) as the only independent predictive factor of SVR12 in both groups.
CONCLUSION
SVR12 rates were almost identical following propensity score matching.