Znoyko O O, Klimova E A, Maevskaya M V, Shuldyakov А A, Linkova Yu N, Morozova M A
A.I. Evdokimov Moscow State University of Medicine and Dentistry, Moscow, Russia.
Research Institute of Innovative Therapy, I.M. Sechenov First Moscow State Medical University, Ministry of Health of Russia, Moscow, Russia.
Ter Arkh. 2016;88(11):156-162. doi: 10.17116/terarkh20168811156-162.
Since the incidence of chronic hepatitis C (CHC) increases steadily, the priority of national health care is to provide antiviral therapy (AVT) for the maximum number of patients infected with hepatitis C virus (HCV). The regimens including pegylated interferons (PEG-IFN) are still in demand in the Russian Federation. A number of clinical trials have been conducted to evaluate the efficacy and safety of cepeginterferon alpha-2b (cePEG-IFN alpha-2b), an original PEG-IFN-α developed in the Russian Federation. Their results have shown that cePEG-IFN alpha-2b in the two-component AVT regimen has at least no less clinical efficacy than PEG-IFN alpha-2b and PEG-INF alpha-2a in HCV monoinfected and HCV/HIV co-infected patients. The pooled analysis of data has indicated that the use of cePEG-IFN alpha-b in combination with ribavirin allows an average of 80% of the patients with HCV genotypes 2 and 3 and 62% of those with HCV genotype 1 to achieve a sustained virological response (SVR). In clinical practice when the two-component AVT regimen (cePEG-IFN alpha-b and ribavirin) was used in patients with early-stage CHC and mild fibrosis, SVR was recorded in 90.7% of the patients with HCV genotype 2/3 and in 75% of those with HCV genotype 1. The experience in using cePEG-IFN alpha-2b as a component of the three-component AVT regimen (simeprevir, cePEG IFN alfa-2b, and ribavirin) has been published. The observational program manly covered young patients with mild or moderate fibrosis. SVR was observed in 94% of the patients. Another paper describes the experience with the triple AVT therapy (simeprevir, cePEG-IFN alfa-2b, and ribavirin) in 22 patients, the majority of whom had advanced fibrosis. SVR was recorded in 71.4% of those who had completed treatment. Thus, an individual approach and assessment of predictive response factors to two- or three-component AVT regimens including cePEG-IFN alpha 2b can achieve successful treatment outcomes in most patients with CHC, which is, in some cases, more economically sound than interferon-free regimens used as first-line therapy.
由于慢性丙型肝炎（CHC）的发病率稳步上升，国家医疗保健的首要任务是为尽可能多的丙型肝炎病毒（HCV）感染者提供抗病毒治疗（AVT）。在俄罗斯联邦，包括聚乙二醇化干扰素（PEG-IFN）的治疗方案仍有需求。已经进行了多项临床试验来评估俄罗斯研发的原创聚乙二醇化干扰素α-2b（cePEG-IFNα-2b）的疗效和安全性。试验结果表明，在HCV单一感染和HCV/HIV合并感染患者中，双组分AVT方案中的cePEG-IFNα-2b至少具有与PEG-IFNα-2b和PEG-INFα-2a相同的临床疗效。数据汇总分析表明，cePEG-IFNα-b与利巴韦林联合使用时，平均80%的HCV基因2型和3型患者以及62%的HCV基因1型患者可实现持续病毒学应答（SVR）。在临床实践中，当双组分AVT方案（cePEG-IFNα-b和利巴韦林）用于早期CHC和轻度纤维化患者时，90.7%的HCV基因2/3型患者和75%的HCV基因1型患者实现了SVR。使用cePEG-IFNα-2b作为三组分AVT方案（simeprevir、cePEG IFN alfa-2b和利巴韦林）组成部分的经验已发表。观察项目主要涵盖轻度或中度纤维化的年轻患者。94%的患者实现了SVR。另一篇论文描述了22例患者接受三联AVT治疗（simeprevir、cePEG-IFN alfa-2b和利巴韦林）的经验，其中大多数患者有晚期纤维化。完成治疗的患者中71.4%实现了SVR。因此，对包括cePEG-IFNα 2b在内的双组分或三组分AVT方案的预测反应因素进行个体化处理和评估，可使大多数CHC患者获得成功的治疗结果，在某些情况下，这比用作一线治疗的无干扰素方案更具经济合理性。
