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在真实世界的经验中,格卡瑞韦哌仑他韦 8 周疗程是否足以治疗所有丙型肝炎病毒感染患者?

Is an 8-week regimen of glecaprevir/pibrentasvir sufficient for all hepatitis C virus infected patients in the real-world experience?

机构信息

Department of Infectious Diseases, Voivodeship Hospital, Jan Kochanowski University, Kielce, Poland.

Department of Infectious Diseases and Hepatology, Medical University of Silesia, Katowice, Poland.

出版信息

J Gastroenterol Hepatol. 2021 Jul;36(7):1944-1952. doi: 10.1111/jgh.15337. Epub 2020 Nov 23.

Abstract

BACKGROUND AND AIMS

The revolution of the antiviral treatment of hepatitis C virus (HCV) infection resulting in higher effectiveness came with the introduction of direct-acting antivirals with pangenotypic regimens as a final touch. Among them, the combination of glecaprevir (GLE) and pibrentasvir (PIB) provides the opportunity for shortening therapy to 8 weeks in the majority of patients. Because of still insufficient evaluation of this regimen in the real-world experience, our study aimed to assess the efficacy and safety of 8-week GLE/PIB in chronic hepatitis C patients depending on liver fibrosis and genotype (GT).

METHODS

The analysis included patients who received GLE/PIB for 8 weeks selected from the EpiTer-2 database, large retrospective national real-world study evaluating antiviral treatment in 12 584 individuals in 22 Polish hepatology centers.

RESULTS

A total of 1034 patients with female predominance (52%) were enrolled in the analysis. The majority of them were treatment naïve (94%), presented liver fibrosis (F) of F0-F3 (92%), with the most common GT1b, followed by GT3. The overall sustained virologic response after exclusion of nonvirologic failures was achieved in 95.8% and 98%, respectively (P = 0.19). In multivariate logistic regression HCV GT-3 (beta = 0.07, P = 0.02) and HIV infection (beta = -0.14, P < 0.001) were independent predictors of nonresponse.

CONCLUSIONS

We demonstrated high effectiveness of 8-week GLE/PIB treatment in a non-GT3 population irrespective of liver fibrosis stage. Comparable efficacy was achieved in non-cirrhotic patients regardless of the genotype, including GT3 HCV.

摘要

背景与目的

丙型肝炎病毒 (HCV) 感染抗病毒治疗的革命带来了更高的疗效,这得益于泛基因型方案的直接作用抗病毒药物的引入。其中,格卡瑞韦(GLE)和哌仑他韦(PIB)联合治疗为大多数患者提供了将治疗时间缩短至 8 周的机会。由于该方案在真实世界经验中的评估仍不充分,我们的研究旨在评估 8 周 GLE/PIB 在慢性丙型肝炎患者中的疗效和安全性,取决于肝纤维化和基因型 (GT)。

方法

该分析包括从 EpiTer-2 数据库中选择的接受 8 周 GLE/PIB 治疗的患者,这是一项大型回顾性全国真实世界研究,评估了 22 个波兰肝病中心的 12584 名个体的抗病毒治疗情况。

结果

共纳入 1034 名女性为主的患者(52%)进行分析。其中大多数为初治患者(94%),纤维化程度为 F0-F3(92%),最常见的 GT1b,其次是 GT3。排除非病毒学失败后,总体持续病毒学应答率分别为 95.8%和 98%(P=0.19)。在多变量逻辑回归中,HCV GT-3(beta=0.07,P=0.02)和 HIV 感染(beta=-0.14,P<0.001)是无应答的独立预测因素。

结论

我们证明了在非 GT3 人群中,8 周 GLE/PIB 治疗具有很高的疗效,无论肝纤维化阶段如何。在非肝硬化患者中,无论基因型如何,包括 GT3 HCV,都取得了相当的疗效。

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