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Real-world Experience with Sofosbuvir-based Regimens for Chronic Hepatitis C, Including Patients with Factors Previously Associated with Inferior Treatment Response

机译:基于Sofosbuvir的慢性丙型肝炎治疗方案的实际经验,包括先前与治疗反应较差相关的因素的患者

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The introduction of sofosbuvir, a direct acting antiviral, has revolutionized the treatment of chronic hepatitis C virus (HCV). Phase 3 clinical trials have demonstrated the efficacy, simplicity, and tolerability of sofosbuvir-based regimens and report high rates of sustained virological response (SVR) rates. The purpose of this study was to assess whether clinical trial findings translate into a real-world setting, particularly with treatment of chronic HCV in our diverse, multiethnic population of Hawai‘i. Retrospective analysis was performed for 113 patients with genotype 1–6 HCV infection being treated at the Queen's Liver Center between January 2014 and March 2015. SVR rates for our cohort were slightly lower than the rates published by the clinical trials. Data analysis also suggested that most baseline characteristics previously associated with inferior response might not be as significant for sofosbuvir-based regimens; in our cohort, male gender was the only factor significantly related to increased risk of virologic relapse. Pacific Islanders also had higher rate of relapse compared to other ethnic groups, but the small number of patients treated in this subgroup make it difficult to validate this finding. While newer all-oral treatment regimens have been introduced since this study, we highlight the importance of comparing real-world versus clinical trial results for new treatments, and provide data analyses for treatment of chronic HCV in Hawai‘i.
机译:直接作用抗病毒药物索非布韦的引入彻底改变了慢性丙型肝炎病毒(HCV)的治疗方法。 3期临床试验已经证明了基于sofosbuvir的治疗方案的有效性,简便性和耐受性,并且报告了较高的持续病毒学应答(SVR)率。这项研究的目的是评估临床试验结果是否可转化为现实世界,尤其是在我们夏威夷各族不同种族的人群中,对慢性HCV的治疗尤其如此。在2014年1月至2015年3月期间,对女王肝病中心治疗的113例1-6型HCV基因型患者进行了回顾性分析。我们队列的SVR率略低于临床试验公布的率。数据分析还表明,以前与不良反应相关的大多数基线特征对于基于索非布韦的治疗方案可能并不那么重要。在我们的队列中,男性是与病毒学复发风险增加显着相关的唯一因素。与其他种族相比,太平洋岛民的复发率也更高,但是在该亚组中接受治疗的患者数量很少,因此难以证实这一发现。尽管自这项研究以来已引入了更新的全口服治疗方案,但我们强调了将现实与临床试验结果进行新治疗进行比较的重要性,并提供了用于夏威夷慢性HCV治疗的数据分析。

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