Del Rio-Valencia J C, Asensi-Diez R, Villalobos-Torres L, Muñoz Castillo I
Juan Carlos del Rio-Valencia, Hospital Regional Universitario de Málaga. Avenida de Carlos Haya s/n. CP.29010. Málaga. Spain.
Rev Esp Quimioter. 2018 Jun;31(3):226-236. Epub 2018 May 16.
Hepatitis C virus (HCV) infection is a major cause of chronic liver disease. Six different genotypes (GT) of HCV (genotypes 1-6) have been identified. The genotype is clinically relevant since the majority of current direct antiviral agents (DAA´s) do not have pangenotypic efficacy. The purpose of this study was to describe the clinical characteristics of real world patients and evaluate the effectiveness of different treatment regimens.
Retrospective and observational study carried out in a third level hospital. Study period: January 2015-January 2016. Inclusion criteria: HCV patients of any genotype treated with either DAAs ± rivabirin (RBV) or DAAs + RBV + pegilated interferon (Peg-IFN) regimens for 12 weeks. Exclusion criteria: patients without adequate clinical or analytical information available for further analysis. Patients treated for 24 weeks were excluded. The main endpoint was sustained virologic response 12 weeks after the end of treatment (SVR12), and secondary endpoint was SVR24.
A total of 515 patients were included (aged 55.52±8.97 years). GT1: patients treated with simeprevir + sofosbuvir (SIM + SOF), ledipavir (LDV)/SOF and paritaprevir/ritonavir/ombitasvir + dasabuvir (PTV/r/OBV + DSV) ± RBV had a SVR12 of 93.59% (190/203), 98.82% (N=84/85), 94.28% (66/70), respectively. Regarding daclatasvir (DCV) + SOF and SIM + DCV, everybody (19/19) and 87.5% (7/8) got SVR12, respectively. GT2: 71.42% (N=10/14) of patients achieved SVR12, concretely, SOF + RBV had a SVR12 75% (N=6/8). GT3: 43.75% (N=7/16), 90% (N=9/10) and 95% (N=19/20) of patients treated with LDV/SOF, LDV/SOF + RBV and SOF + DCV obtained SVR12, respectively. GT4: patients treated with LDV/SOF, SIM + SOF and PTV/r/OBV ± RBV had a SVR12 rate of 100% (21/21), 91.67% (22/24) and 92% (23/25), respectively. All patients that got SVR12 achieved SVR24.
Our study confirmed the efficacy data reported in clinical trials in a cohort of patients with GT1-4 and a wide range of basal characteristics.
丙型肝炎病毒（HCV）感染是慢性肝病的主要病因。已鉴定出HCV的六种不同基因型（GT）（1-6型）。由于大多数当前的直接抗病毒药物（DAA）不具有泛基因型疗效，因此基因型具有临床相关性。本研究的目的是描述真实世界患者的临床特征并评估不同治疗方案的有效性。
在一家三级医院进行回顾性观察研究。研究期间：2015年1月至2016年1月。纳入标准：接受DAA±利巴韦林（RBV）或DAA + RBV +聚乙二醇干扰素（Peg-IFN）方案治疗12周的任何基因型的HCV患者。排除标准：没有足够临床或分析信息可供进一步分析的患者。接受24周治疗的患者被排除。主要终点是治疗结束后12周的持续病毒学应答（SVR12），次要终点是SVR24。
共纳入515例患者（年龄55.5±8.97岁）。GT1：接受西米普明+索非布韦（SIM + SOF）、来迪帕司韦（LDV）/索非布韦和帕利瑞韦/利托那韦/奥比他韦+达沙布韦（PTV/r/OBV + DSV）±RBV治疗的患者的SVR12分别为93.59%（190/203）、98.82%（N = 84/85）、94.28%（66/70）。对于达卡他韦（DCV）+索非布韦和SIM + DCV，分别有100%（19/19）和87.5%（7/8）的患者获得SVR12。GT2：71.42%（N = 10/14）的患者实现了SVR12，具体而言，索非布韦+ RBV的SVR12为75%（N = 6/8）。GT3：接受LDV/索非布韦、LDV/索非布韦+ RBV和索非布韦+ DCV治疗的患者分别有43.75%（N = 7/16）、90%（N = 9/10）和95%（N = 19/20）获得SVR12。GT4：接受LDV/索非布韦、SIM +索非布韦和PTV/r/OBV±RBV治疗的患者的SVR12率分别为100%（21/21）、91.67%（22/24）和92%（23/25）。所有获得SVR12的患者均实现了SVR24。
我们的研究在一组具有GT1-4和广泛基础特征的患者中证实了临床试验中报告的疗效数据。
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