Benito José M, Sánchez-Parra Clara, Maida Ivana, Aguilera Antonio, Rallón Norma I, Rick Fernanda, Labarga Pablo, Fernández-Montero José V, Barreiro Pablo, Soriano Vincent
Department of Infectious Diseases, Hospital Carlos III, Madrid, Spain.
Antivir Ther. 2013;18(5):709-15. doi: 10.3851/IMP2614. Epub 2013 May 3.
Achievement of early viral suppression is important in patients with chronic HCV infection treated with telaprevir (TLV) or boceprevir (BOC) to avoid selection of drug resistance and attain cure. No head-to-head studies comparing TLV and BOC have been performed so far.
All consecutive individuals who initiated triple HCV therapy with TLV or BOC outside clinical trials at three European clinics were evaluated. Rapid virological response (RVR) was defined as unquantifiable HCV RNA (<25 IU/ml) at week 4 for TLV and at week 8 for BOC (4 weeks after lead-in).
A total of 106 patients were evaluated, 33 treated with BOC and 73 with TLV. Median age, gender, body mass index, baseline HCV RNA, HCV subtype 1a (45% versus 42%) and IL28B-CC alleles (29% versus 23%) did not differ significantly in BOC and TLV groups, respectively. HIV coinfection was more prevalent in patients on TLV than BOC (24% versus 44%). Conversely, more patients on BOC than TLV had previously failed pegylated interferon plus ribavirin (82% versus 64%). RVR was achieved by 82% of patients on TLV versus 59% on BOC (P=0.001). Multivariate logistic regression analysis confirmed that TLV use was the strongest predictor of RVR (OR 3.54 [95% CI 1.23, 10.24]; P=0.02), others being HCV subtype 1b versus 1a (OR 3.26 [95% CI 1.17, 9.09]; P=0.02) and low baseline HCV RNA (OR 0.41 [95% CI 0.16, 1.03]; P=0.06). Prior interferon exposure, HIV coinfection or absence of advanced liver fibrosis did not influence the likelihood of RVR.
Compared to BOC, triple therapy with TLV produces greater RVR rates. TLV might be a better option in more difficult-to-cure patients, such as those with high baseline HCV RNA and/or HCV 1a subtype. HIV coinfection does not influence early HCV RNA responses.
对于接受特拉匹韦(TLV)或博赛匹韦(BOC)治疗的慢性丙型肝炎病毒(HCV)感染患者,实现早期病毒抑制对于避免产生耐药性并获得治愈至关重要。目前尚未进行比较TLV和BOC的直接对比研究。
对在欧洲三家诊所接受非临床试验的TLV或BOC三联HCV治疗的所有连续患者进行评估。快速病毒学应答(RVR)定义为TLV治疗第4周时HCV RNA不可定量(<25 IU/ml),BOC治疗导入期后第8周时HCV RNA不可定量。
共评估了106例患者,33例接受BOC治疗,73例接受TLV治疗。BOC组和TLV组的年龄中位数、性别、体重指数、基线HCV RNA、HCV 1a亚型(分别为45%对42%)和IL28B - CC等位基因(分别为29%对23%)无显著差异。TLV治疗患者的HIV合并感染比BOC治疗患者更常见(分别为24%对44%)。相反,BOC治疗患者中先前聚乙二醇化干扰素加利巴韦林治疗失败的比例高于TLV治疗患者(分别为82%对64%)。TLV治疗患者的RVR实现率为82%,BOC治疗患者为59%(P = 0.001)。多因素逻辑回归分析证实,使用TLV是RVR的最强预测因素(比值比[OR] 3.54 [95%置信区间1.23, 10.24];P = 0.02),其他因素包括HCV 1b亚型与1a亚型(OR 3.26 [95%置信区间1.17, 9.09];P = 0.02)以及低基线HCV RNA(OR 0.41 [95%置信区间0.16, 1.03];P = 0.06)。既往干扰素暴露、HIV合并感染或无晚期肝纤维化并不影响RVR的可能性。
与BOC相比,TLV三联疗法产生更高的RVR率。对于更难治愈的患者,如基线HCV RNA高和/或HCV 1a亚型患者,TLV可能是更好的选择。HIV合并感染不影响早期HCV RNA应答。