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一家葡萄牙中心的经验:丙型肝炎直接抗病毒治疗的有效性

Experience of a Portuguese Center: Effectiveness of Direct-Acting Antiviral Therapy for Hepatitis C.

作者信息

Falcão Fátima, Lopes Carla, Viegas Erica, Perez Rita, Aldir Isabel, Farinha Helena, Carvalho António, Mirco Ana, Marques Susana, Bana E Costa Tiago, Miranda Ana Cláudia, Lebre Luís, Peixe Paula, Chagas Cristina, Mansinho Kamal, Correia José Manuel

机构信息

Pharmacy and Therapeutics Committee. Centro Hospitalar de Lisboa Ocidental. Lisboa; Pharmacy Department. Centro Hospitalar de Lisboa Ocidental. Lisboa; Department of Pharmacy Practice. Faculty of Pharmacy. University of Lisbon. Lisboa. Portugal.

Pharmacy Department. Centro Hospitalar de Lisboa Ocidental. Lisboa. Portugal.

出版信息

Acta Med Port. 2019 Mar 29;32(3):189-194. doi: 10.20344/amp.10655.

Abstract

INTRODUCTION

In late 2014, Portugal implemented a national program for the treatment of patients with chronic hepatitis C with directacting antiviral agents. This program has made Portugal one of the first European countries to implement a structured measure of treatment to eliminate this serious public health problem. The aim of this study was to assess the effectiveness of direct-acting antiviral therapy in the treatment of patients with chronic hepatitis C virus infection.

MATERIAL AND METHODS

A retrospective observational study was conducted at Centro Hospitalar de Lisboa Ocidental on the national online platform from December 2014 until February 2017 and included patients with hepatitis C virus infection who underwent treatment. The primary endpoint was sustained virologic response at least 12 weeks post treatment. Data was analyzed with the SPSS 17.0 program.

RESULTS

During the study period, 820 patients completed therapy and achieved sufficient follow-up time to assess sustained virologic response with an overall response rate of 97.2% (n = 797) and a response rate of 98.0%, 99.5%, 90.9%, 95.1% and 94.2% for genotypes 1a, 1b, 2, 3 and 4, respectively. Data suggested that advanced fibrosis (F3/F4), human immunodeficiency virus co-infection and treatment failure with interferon and ribavirin were not negatively related with sustained virologic response in our population. Most patients (80.1%) completed treatment with ledipasvir/sofosbuvir ± ribavirin. The most common adverse events were fatigue and insomnia followed by headache and weight loss.

DISCUSSION

Patients predominantly had genotype 1 infection which correlates with HCV distribution in Europe, but we found a major proportion in genotype 4 which can be explained by immigration from African countries. Our patients' ages ranging from 22 to 90 years, reflected a new approach with no upper age limit. Direct-acting antivirals regimens resulted in remarkably high SVR rates compared to interferon-based regimens, which were consistent with clinical trials data.

CONCLUSION

Our data showed that direct-acting antiviral-based regimens are safe and have a high success rate in the treatment of patients with hepatitis C virus infection in a real-world setting.

摘要

引言

2014年末,葡萄牙实施了一项使用直接抗病毒药物治疗慢性丙型肝炎患者的国家计划。该计划使葡萄牙成为最早实施结构化治疗措施以消除这一严重公共卫生问题的欧洲国家之一。本研究的目的是评估直接抗病毒疗法治疗慢性丙型肝炎病毒感染患者的有效性。

材料与方法

2014年12月至2017年2月,在里斯本西部中心医院的国家在线平台上进行了一项回顾性观察研究,纳入接受治疗的丙型肝炎病毒感染患者。主要终点是治疗后至少12周的持续病毒学应答。使用SPSS 17.0程序进行数据分析。

结果

在研究期间,820例患者完成治疗并获得足够的随访时间以评估持续病毒学应答,总体应答率为97.2%(n = 797),1a、1b、2、3和4型的应答率分别为98.0%、99.5%、90.9%、95.1%和94.2%。数据表明,在我们的研究人群中,重度肝纤维化(F3/F4)、人类免疫缺陷病毒合并感染以及干扰素和利巴韦林治疗失败与持续病毒学应答无负相关。大多数患者(80.1%)使用来迪派韦/索磷布韦±利巴韦林完成治疗。最常见的不良事件是疲劳和失眠,其次是头痛和体重减轻。

讨论

患者主要感染1型,这与欧洲丙型肝炎病毒的分布相关,但我们发现4型占很大比例,这可以用来自非洲国家的移民来解释。我们患者的年龄在22岁至90岁之间,反映了一种无年龄上限的新方法。与基于干扰素的方案相比,直接抗病毒方案导致了非常高的持续病毒学应答率,这与临床试验数据一致。

结论

我们的数据表明,在现实环境中,基于直接抗病毒药物的方案在治疗丙型肝炎病毒感染患者方面是安全的,并且成功率很高。

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