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Real World Experience of Chronic Hepatitis C Retreatment with Genotype Specific Regimens in Nonresponders to Previous Interferon-Free Therapy

机译:慢性丙型肝炎的真实世界经验与非反应者基因型特异性方案对先前干扰素治疗的慢性丙型肝炎

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摘要

Background and Aim. The development of interferon- (IFN-) free regimens substantially improved efficacy of treatment for HCV, but despite excellent effectiveness the failures still occur. The aim of our study was to evaluate the efficacy of retreatment with genotype specific direct acting antivirals- (DAA-) based regimens in nonresponders to previous IFN-free therapy. Materials and Methods. Analysed population consisted of 31 nonresponders to IFN-free regimen, which received second IFN-free rescue therapy, selected from 6228 patients included in a national database EpiTer-2. Results. Age and gender distribution were similar, whereas proportion of genotype 1b was slightly higher and genotype 4 lower in the whole population compared to studied one. Patients included in the study demonstrated much more advanced fibrosis. Primary therapy was discontinued in 12 patients, which were recognized as failures due to nonvirologic reason, whereas virologic reason of therapeutic failure was recognized in 19 patients which completed therapy. Overall sustained virologic response (SVR) rate was 81% and 86% in intent-to-treat (ITT) and modified ITT analysis, respectively (74% and 78% in virologic failures, 92% and 100% in nonvirologic failures). Resistance-associated substitutions (RAS) testing was carried out in 8 patients from the group of completed primary therapy and three of them had potential risk for failure of rescue therapy due to NS5A association, while two of them achieved SVR. Conclusions. We demonstrated moderate effectiveness of genotype specific rescue therapy in failures due to virologic reason and high in those who discontinued primary therapy. Therefore rescue therapy with genotype specific regimens should be considered always if more potent regimens are not available.
机译:背景和目标。干扰素(IFN-)免疫方案的发展显着提高了治疗HCV的疗效,但尽管仍然发生了良好的效果。我们的研究目的是评估撤退与基于基于基于非反应者的基因型特异性直接作用抗病毒 - (DAA-)的非反应方案的疗效。材料和方法。分析的人口由31种无应答者组成,无反应于无反应的IFN-救援治疗,选自国家数据库Eniter-2中包括的6228名患者。结果。年龄和性别分布类似,而基因型1B的比例略高,与研究相比,整个人群中略低,基因型4降低。该研究中纳入的患者表现出更先进的纤维化。初级治疗在12名患者中停止,这被认为是由于非疾病原因导致的失败,而治疗失败的病毒学原因在19例完成治疗的19名患者中得到认可。总体持续的病毒学反应(SVR)率为81%和86%,分别修饰ITT分析(病毒学故障的74%和78%,非病毒故障的92%和100%)。抗性相关的取代(RAS)测试在已完成的初级治疗组中进行,其中三名患者,由于NS5A协会,其中三种救助治疗失败的风险,而其中两位达到了SVR。结论。由于病毒原因,我们证明了基因型特异性救援治疗的中等有效性,并且在那些终止疗法的人中高。因此,如果不可用的更有效的方案,应始终考虑使用基因型特异性方案的救援治疗。

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