Marotta P, Bailey R, Elkashab M, Farley J, Feinman S V, Peltekian K, Poliquin M, Witt-Sullivan H, Rampakakis E, Drolet M, Cooper C
London Health Sciences Center, London, ON, Canada.
University of Alberta, Edmonton, AB, Canada.
Eur J Clin Microbiol Infect Dis. 2016 Apr;35(4):597-609. doi: 10.1007/s10096-016-2576-1. Epub 2016 Feb 6.
The purpose of this investigation was to assess the real-life effectiveness of pegylated interferon (peg-IFN) α-2b with ribavirin (RBV) in a cohort of treatment-naïve patients with chronic genotypes 2 (G2) or 3 (G3) hepatitis C virus (HCV) infection. A post-hoc pooled analysis of two Canadian multicenter, observational studies, RediPEN and PoWer, was carried out. A total of 1242 G2- or G3-infected patients were included. The primary outcome was sustained virologic response (SVR). Secondary endpoints included early virologic response (EVR), end-of-treatment (EOT) response, and relapse. Multivariate logistic regression was used to identify independent predictors of treatment response. SVR in G2 and G3 was 74.4 % and 63.6 %, respectively. Relapse occurred in 12.7 % and 19.1 % of G2- and G3-infected patients achieving EOT response, respectively. Overall, G3 was found to independently predict reduced SVR [odds ratio (OR) = 0.20; p = 0.007] and increased relapse (OR = 6.84; p = 0.022). Among G3-infected patients, increasing fibrosis score was the most important factor predicting reduced SVR [F2 vs. F0/F1 (OR = 0.41; p = 0.009); F3 vs. F0/F1 (OR = 0.72; p = 0.338); F4 vs. F0/F1 (OR = 0.27; p = 0.001)]. Male gender (OR = 13.16; p = 0.020) and higher fibrosis score [F2 vs. F0/F1 (OR = 9.72; p = 0.016); F3/F4 vs. F0/F1 (OR = 4.23; p = 0.113)] were associated with increased relapse in G3 patients. These results support the real-life effectiveness of peg-IFN α-2b plus ribavirin in HCV G2- and G3-infected patients. Overall, genotype was identified as the most significant predictor of treatment outcome. Fibrosis score and gender were key outcome predictors in the G3-infected population. In clinical settings, peg-INF/RBV offers an alternative for patients without access to all oral direct-acting antivirals.
本研究旨在评估聚乙二醇干扰素(peg-IFN)α-2b联合利巴韦林(RBV)在初治的慢性2型(G2)或3型(G3)丙型肝炎病毒(HCV)感染患者队列中的实际疗效。对加拿大两项多中心观察性研究RediPEN和PoWer进行了事后汇总分析。共纳入1242例G2或G3感染患者。主要结局为持续病毒学应答(SVR)。次要终点包括早期病毒学应答(EVR)、治疗结束时(EOT)应答和复发。采用多因素逻辑回归分析确定治疗应答的独立预测因素。G2和G3患者的SVR分别为74.4%和63.6%。达到EOT应答的G2和G3感染患者中,复发率分别为12.7%和19.1%。总体而言,发现G3是SVR降低[比值比(OR)=0.20;p=0.007]和复发增加(OR=6.84;p=0.022)的独立预测因素。在G3感染患者中,纤维化评分增加是预测SVR降低的最重要因素[F2与F0/F1相比(OR=0.41;p=0.009);F3与F0/F1相比(OR=0.72;p=0.338);F4与F0/F1相比(OR=0.27;p=0.001)]。男性(OR=13.16;p=0.020)和较高的纤维化评分[F2与F0/F1相比(OR=9.72;p=0.016);F3/F4与F0/F1相比(OR=4.23;p=0.113)]与G3患者复发增加相关。这些结果支持peg-IFNα-2b联合利巴韦林在HCV G2和G3感染患者中的实际疗效。总体而言,基因型被确定为治疗结局的最重要预测因素。纤维化评分和性别是G3感染人群的关键结局预测因素。在临床环境中,peg-INF/RBV为无法使用所有口服直接抗病毒药物的患者提供了一种替代方案。