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索磷布韦在巴基斯坦人群中的疗效和安全性初步结果:一项真实生活试验——索磷布韦肝炎根除准确性试验(HEATS)

Initial results of efficacy and safety of Sofosbuvir among Pakistani Population: A real life trial - Hepatitis Eradication Accuracy Trial of Sofosbuvir (HEATS).

作者信息

Azam Zahid, Shoaib Muhammad, Javed Masood, Sarwar Muhammad Adnan, Shaikh Hafeezullah, Khokhar Nasir

机构信息

Prof. Zahid Azam, FCPS (Gastro); FCPS (Med); M.Sc (Clinical Research). Professor of Medicine & Gastroenterology, Gastroinstinal and Liver Practice (GILP) and Dow University of Health Sciences, Karachi, Pakistan.

Dr. Muhammad Shoaib, FCPS (Gastroenterology). Consultant Gastroenterologist, Memom Medical Institute Hospital, Karachi, Pakistan.

出版信息

Pak J Med Sci. 2017 Jan-Feb;33(1):48-52. doi: 10.12669/pjms.331.12352.

DOI:10.12669/pjms.331.12352
PMID:28367171
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5368328/
Abstract

OBJECTIVE

The uridine nucleotide analogue sofosbuvir is a selective inhibitor of hepatitis C virus (HCV) NS5B polymerase approved for the treatment of chronic HCV infection with genotypes 1 - 4. The objective of the study was to evaluate the interim results of efficacy and safety of regimens containing Sofosbuvir (Zoval) among Pakistani population with the rapid virologic response (RVR2/4 weeks) with HCV infections.

METHODS

This is a multicenter open label prospective observational study. Patients suffering from chronic Hepatitis C infection received Sofosbuvir (Zoval) 400 mg plus ribavirin (with or without peg interferon) for 12/24 weeks. The interim results of this study were rapid virological response on week 4. Data was analyzed using SPSS version 21 for descriptive statistics.

RESULTS

A total of 573 patients with HCV infection were included in the study. The mean age of patients was 46.07 ± 11.41 years. Out of 573 patients 535 (93.3%) were treatment naive, 26 (4.5%) were relapser, 7 (1.2%) were non-responders and 5 (1.0%) were partial responders. A rapid virologic response was reported in 563(98.2%) of patients with HCV infection after four weeks of treatment. The treatment was generally well tolerated.

CONCLUSION

Sofosbuvir (Zoval) is effective and well tolerated in combination with ribavirin in HCV infected patients.

摘要

目的

尿苷核苷酸类似物索磷布韦是一种丙型肝炎病毒(HCV)NS5B聚合酶的选择性抑制剂,已被批准用于治疗1 - 4型慢性HCV感染。本研究的目的是评估在巴基斯坦感染HCV且具有快速病毒学应答(2/4周)的人群中,含索磷布韦(Zoval)方案的疗效和安全性的中期结果。

方法

这是一项多中心开放标签前瞻性观察性研究。慢性丙型肝炎感染患者接受索磷布韦(Zoval)400毫克加利巴韦林(有或无聚乙二醇干扰素)治疗12/24周。本研究的中期结果是第4周时的快速病毒学应答。使用SPSS 21版进行数据分析以进行描述性统计。

结果

共有573例HCV感染患者纳入研究。患者的平均年龄为46.07±11.41岁。在573例患者中,535例(93.3%)为初治患者,26例(4.5%)为复发患者,7例(1.2%)为无应答者,5例(1.0%)为部分应答者。治疗4周后,563例(98.2%)HCV感染患者报告有快速病毒学应答。该治疗总体耐受性良好。

结论

在HCV感染患者中,索磷布韦(Zoval)与利巴韦林联合使用有效且耐受性良好。

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本文引用的文献

1
Hepatitis C virus prevalence and genotype distribution in Pakistan: Comprehensive review of recent data.巴基斯坦丙型肝炎病毒流行率及基因型分布:近期数据的综合综述
World J Gastroenterol. 2016 Jan 28;22(4):1684-700. doi: 10.3748/wjg.v22.i4.1684.
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EASL Recommendations on Treatment of Hepatitis C 2015.2015年欧洲肝脏研究学会丙型肝炎治疗指南
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Simeprevir plus sofosbuvir, with or without ribavirin, to treat chronic infection with hepatitis C virus genotype 1 in non-responders to pegylated interferon and ribavirin and treatment-naive patients: the COSMOS randomised study.simeprevir 联合索非布韦,无论是否联合利巴韦林,治疗对聚乙二醇干扰素和利巴韦林无应答且未经治疗的慢性丙型肝炎病毒 1 型感染者:COSMOS 随机研究。
Lancet. 2014 Nov 15;384(9956):1756-65. doi: 10.1016/S0140-6736(14)61036-9. Epub 2014 Jul 28.
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Epidemiology and natural history of HCV infection.丙型肝炎病毒感染的流行病学和自然史。
Nat Rev Gastroenterol Hepatol. 2013 Sep;10(9):553-62. doi: 10.1038/nrgastro.2013.107. Epub 2013 Jul 2.
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Sofosbuvir for previously untreated chronic hepatitis C infection.索磷布韦片治疗未经治疗的慢性丙型肝炎感染。
N Engl J Med. 2013 May 16;368(20):1878-87. doi: 10.1056/NEJMoa1214853. Epub 2013 Apr 23.
6
Sofosbuvir for hepatitis C genotype 2 or 3 in patients without treatment options.索磷布韦用于无治疗选择的 2 或 3 型丙型肝炎病毒感染患者。
N Engl J Med. 2013 May 16;368(20):1867-77. doi: 10.1056/NEJMoa1214854. Epub 2013 Apr 23.
7
Sofosbuvir with pegylated interferon alfa-2a and ribavirin for treatment-naive patients with hepatitis C genotype-1 infection (ATOMIC): an open-label, randomised, multicentre phase 2 trial.索磷布韦联合聚乙二醇干扰素 α-2a 和利巴韦林治疗初治慢性丙型肝炎病毒基因型 1 感染患者(ATOMIC):一项开放标签、随机、多中心 2 期临床试验。
Lancet. 2013 Jun 15;381(9883):2100-7. doi: 10.1016/S0140-6736(13)60247-0. Epub 2013 Mar 15.
8
Sofosbuvir in combination with peginterferon alfa-2a and ribavirin for non-cirrhotic, treatment-naive patients with genotypes 1, 2, and 3 hepatitis C infection: a randomised, double-blind, phase 2 trial.索磷布韦联合聚乙二醇干扰素α-2a 和利巴韦林治疗非肝硬化、初治基因型 1、2 和 3 型丙型肝炎感染患者的随机、双盲、2 期临床试验。
Lancet Infect Dis. 2013 May;13(5):401-8. doi: 10.1016/S1473-3099(13)70033-1. Epub 2013 Mar 15.
9
Nucleotide polymerase inhibitor sofosbuvir plus ribavirin for hepatitis C.核苷酸聚合酶抑制剂索非布韦联合利巴韦林治疗丙型肝炎。
N Engl J Med. 2013 Jan 3;368(1):34-44. doi: 10.1056/NEJMoa1208953.
10
Sofosbuvir (GS-7977) plus peginterferon/ribavirin in treatment-naïve patients with HCV genotype 1: a randomized, 28-day, dose-ranging trial.索非布韦(GS-7977)联合聚乙二醇干扰素/利巴韦林治疗初治 HCV 基因型 1 患者:一项随机、28 天、剂量范围研究。
J Hepatol. 2013 Apr;58(4):663-8. doi: 10.1016/j.jhep.2012.11.018. Epub 2012 Nov 23.