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艾尔巴韦/格拉瑞韦在沙特阿拉伯卡西姆地区丙型肝炎病毒4型感染患者中的安全性和疗效。

Safety and efficacy of elbasvir/grazoprevir in patients infected with hepatitis C virus genotype 4 in Qassim region of Saudi Arabia.

作者信息

Murgod Shivananda E, Ahmed Sumaira, Almutairi Nawaf, Alqifari Abdullah, Alharbi Majed, Shoqueer Ahmed

机构信息

Department of Gastroenterology and Hepatology, King Fahad Specialist Hospital, General Directorate of Health Affairs, Buraydah, Qassim, Saudi Arabia.

出版信息

Int J Health Sci (Qassim). 2023 Mar-Apr;17(2):22-27.

PMID:36891044
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9986884/
Abstract

OBJECTIVE

Untreated hepatitis C virus (HCV) infection can lead to cirrhosis, hepatocellular cancer, and even death and also increases liver diseases. The elbasvir/grazoprevir (EBR-GZR) treatment regimen when given in HCV genotype (GT) 1 and GT4 infection for 8 or 12 weeks showed a high sustained virolgical response (SVR) rates in different populations. This study was assessed the effectiveness as well as safety of EBR-GZR in 12 week treatment regimen in HCV GT4-infected treatment-naïve Saudi patients.

METHODS

This study conducted from June 2017 and December 2020 on Saudi HCV patients infected with GT4. Treatment protocol was given for 12 weeks in treatment-naive HCV GT4 infected cirrhotic and non-cirrhotic participants which were later followed for a total of 24 weeks for safety and efficacy of EBR-GZR.

RESULTS

We analyzed data of 54 participants with HCV GT 4 infection. Mean age was (53.46 ± 14.94) Treatment regimen was given to 14 cirrhotic (F4) and 40 non-cirrhotic (F0-F3). SVR was seen in 98.1% of participants with tolerable side effects and improved model for end stage liver disease (MELD) scores as fall in percentage seen from 18.5% to 14.8% in participants with MELD > 10.

CONCLUSION

This retrospective study confirms that EBR-GZR for 12 weeks is a safe and effective treatment regimen in HCV GT4 patients in studied Saudi population. Treatment completion was followed by high SVR12 rates with improvement in prognostic markers of liver disease in participants with compensated cirrhosis. In short, the EBR-GZR combination showed efficacy in achieving the SVR12 in Child-Pugh B cirrhotic and non-cirrhotic population with a favorable safety profile.

摘要

目的

未经治疗的丙型肝炎病毒(HCV)感染可导致肝硬化、肝细胞癌,甚至死亡,还会增加肝脏疾病的发生。艾尔巴韦/格拉瑞韦(EBR-GZR)治疗方案用于HCV基因1型(GT1)和GT4感染患者,治疗8周或12周时,在不同人群中显示出较高的持续病毒学应答(SVR)率。本研究评估了EBR-GZR在未接受过治疗的HCV GT4感染沙特患者中进行12周治疗方案的有效性和安全性。

方法

本研究于2017年6月至2020年12月对感染GT4的沙特HCV患者开展。对未接受过治疗的HCV GT4感染的肝硬化和非肝硬化参与者给予12周的治疗方案,随后对EBR-GZR的安全性和有效性进行总共24周的随访。

结果

我们分析了54例HCV GT4感染参与者的数据。平均年龄为(53.46±14.94)。治疗方案给予了14例肝硬化(F4)和40例非肝硬化(F0-F3)患者。98.1%的参与者出现SVR,副作用可耐受,终末期肝病模型(MELD)评分有所改善,MELD>10的参与者中该评分下降百分比从18.5%降至14.8%。

结论

这项回顾性研究证实,在研究的沙特人群中,EBR-GZR治疗12周对于HCV GT4患者是一种安全有效的治疗方案。治疗完成后SVR12率较高,代偿期肝硬化参与者的肝病预后标志物有所改善。简而言之,EBR-GZR组合在Child-Pugh B级肝硬化和非肝硬化人群中实现SVR12方面显示出疗效,且安全性良好。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/24c9/9986884/c8f172908576/IJHS-17-22-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/24c9/9986884/c8f172908576/IJHS-17-22-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/24c9/9986884/c8f172908576/IJHS-17-22-g004.jpg

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本文引用的文献

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Efficacy of Elbasvir/Grazoprevir in Early Chronic G1/G4 Hepatitis C infection in HIV/HCV co-infected patients with mild fibrosis.Elbasvir/Grazoprevir 在伴有轻度纤维化的 HIV/HCV 合并感染的慢性 G1/G4 型丙型肝炎早期感染患者中的疗效。
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Efficacy and safety of elbasvir/grazoprevir for 8 or 12 weeks for hepatitis C virus genotype 4 infection: A randomized study.艾尔巴韦/格拉瑞韦治疗丙型肝炎病毒4型感染8周或12周的疗效与安全性:一项随机研究。
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