Real-life Data of Glecaprevir/Pibrentasvir in Chronic Hepatitis C Patients: A Single-center Study

IF 0.3 4区医学 Q4 GASTROENTEROLOGY & HEPATOLOGY

Hepatitis Monthly Pub Date : 2023-04-15 DOI:10.5812/hepatmon-134406

M. Çabalak, Tayibe Bal, S. Ocak, İsa Ahmet Bal, Y. Onlen

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引用次数: 0

Abstract

Background: Glecaprevir/pibrentasvir (G/P) is a pangenotypic direct-acting antiviral (DAA) drug with a high resistance barrier. It has been used in patients with chronic hepatitis C in Turkey since March 2019. This drug's efficacy and safety data in Turkey are very limited, and there are not enough studies on real-life data. Objectives: In this study, we aim to present real-life data, efficacy, and safety for our patients. Methods: In this retrospective, observational, single-center study, 116 patients who were started on G/P (100mg/40mg) oral therapy at the infectious diseases clinic between March 2019 and December 2021 due to HCV were included. Of the 116 patients included in the study, 92 were analyzed. Demographic data of the patients, previous treatment experience, drug use, viral load (HCV RNA levels at the 4th week of treatment and 12th week after treatment), and viral genotype data were obtained retrospectively from the automation system. Statistical analysis IBM SPSS version 21.0 statistical package program was used. Results: Seventy-one (77.2%) of the patients were male, and 21 (22.8%) were female, with a mean age of 47.4 (18 - 89). Genotype distribution of patients 8.7% (n = 8) type 1a, 31.5% (n = 29) type 1b, 26.1% (n = 24) type 2, 22.9% (n = 21) type 3, 10.9% (n = 10) were type 4, 8.7% (n = 8) of the patients were treatment-experienced. In our study, there were no patients with cirrhosis. SVR-12 could not be obtained from a patient infected with only genotype 1a. In addition, this patient was co-infected with Hepatitis B. No side effects were observed in any of the patients that required treatment discontinuation. The SVR-12 rate was 98.6% with patients per protocol analysis (PP), but the SVR-12 rate was 77.2% with intention to treat analysis (ITT). Conclusions: In conclusion, this study suggested that G/P therapy in Turkey is used in real life with very high efficacy and tolerability. In addition, a significant change was observed in the genotype distribution previously reported in Turkey in the patient group we treated.

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Glecaprevir/Pibrentasvir在慢性丙型肝炎患者中的真实生活数据：一项单中心研究

背景:Glecaprevir/pibrentasvir (G/P)是一种具有高耐药屏障的泛型直接作用抗病毒(DAA)药物。自2019年3月以来，它已在土耳其用于慢性丙型肝炎患者。这种药物在土耳其的疗效和安全性数据非常有限，并且没有足够的真实数据研究。目的:在这项研究中，我们的目标是为我们的患者提供真实的数据、疗效和安全性。方法:在这项回顾性、观察性、单中心研究中，纳入了2019年3月至2021年12月因HCV在传染病诊所开始服用G/P (100mg/40mg)口服治疗的116例患者。在纳入研究的116例患者中，有92例进行了分析。从自动化系统中回顾性获取患者的人口学资料、既往治疗经历、药物使用情况、病毒载量(治疗第4周和治疗后第12周的HCV RNA水平)和病毒基因型数据。统计分析采用IBM SPSS 21.0版统计软件包程序。结果:男性71例(77.2%)，女性21例(22.8%)，平均年龄47.4岁(18 ~ 89岁)。基因型分布:8.7% (n = 8)为1a型，31.5% (n = 29)为1b型，26.1% (n = 24)为2型，22.9% (n = 21)为3型，10.9% (n = 10)为4型，8.7% (n = 8)为治疗经历型。在我们的研究中，没有肝硬化患者。仅基因型为1a的患者无法获得SVR-12。此外，该患者同时感染了乙型肝炎。没有观察到任何需要停药的患者出现副作用。每个方案分析(PP)患者的SVR-12率为98.6%，但意向治疗分析(ITT)患者的SVR-12率为77.2%。结论:本研究表明，土耳其的G/P治疗在现实生活中使用，具有非常高的疗效和耐受性。此外，在我们治疗的患者组中，在土耳其先前报道的基因型分布中观察到显着变化。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Hepatitis Monthly 医学-胃肠肝病学

CiteScore

1.50

自引率

0.00%

发文量

审稿时长

3 months

期刊介绍： Hepatitis Monthly is a clinical journal which is informative to all practitioners like gastroenterologists, hepatologists and infectious disease specialists and internists. This authoritative clinical journal was founded by Professor Seyed-Moayed Alavian in 2002. The Journal context is devoted to the particular compilation of the latest worldwide and interdisciplinary approach and findings including original manuscripts, meta-analyses and reviews, health economic papers, debates and consensus statements of the clinical relevance of hepatological field especially liver diseases. In addition, consensus evidential reports not only highlight the new observations, original research, and results accompanied by innovative treatments and all the other relevant topics but also include highlighting disease mechanisms or important clinical observations and letters on articles published in the journal.