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丙型肝炎病毒(HCV)治疗疗程个体化在HIV/HCV合并感染个体中的作用。

Role of individualization of hepatitis C virus (HCV) therapy duration in HIV/HCV-coinfected individuals.

作者信息

Hopkins S, Lambourne J, Farrell G, McCullagh L, Hennessy M, Clarke S, Mulcahy F, Bergin C

机构信息

Department of Genitourinary Medicine & Infectious Disease, St James's Hospital, Dublin, Ireland.

出版信息

HIV Med. 2006 May;7(4):248-54. doi: 10.1111/j.1468-1293.2006.00365.x.

Abstract

OBJECTIVE

The aim of this study was to assess the efficacy, safety and tolerability of pegylated interferon and ribavirin in HIV/hepatitis C virus (HCV)-coinfected patients, prescribed for the same duration and at the same dosage as that used in HCV monoinfection studies.

DESIGN

It was an open-label, single-centre, prospective study.

METHODS

Forty-five patients coinfected with HIV and HCV with CD4 counts >200 cells/microL were treated with pegylated interferon-alpha2b 1.5 microg/kg/week and ribavirin 1000-1200 mg/day for 24-48 weeks depending on HCV genotype. Safety and tolerability were assessed weekly for the first month and monthly thereafter. Virological response was assessed at weeks 4, 12 and 24 and at the end of treatment and 12 and 24 weeks post completion of treatment. The primary endpoint was defined as undetectable HCV RNA at 24 weeks post completion of treatment [sustained virological response (SVR)].

RESULTS

The majority of patients were male and had been injecting drug users. Sixty per cent were on antiretroviral therapy. In an intention-to-treat analysis, 53% had an SVR (genotype 1, 19% and genotype 2/3, 75%). All patients who had undetectable HCV RNA at week 4 of HCV treatment [very early virological response (VEVR)] had a SVR. On multivariate analysis only HCV genotype predicted SVR. Adverse events occurred frequently.

CONCLUSIONS

These results indicate that 24 weeks of HCV treatment may be adequate for HIV-infected individuals coinfected with HCV genotype 2 or 3. VEVR can predict SVR in this group and may be used to guide the subgroup of genotype 2/3 individuals who will respond to 24 weeks of treatment.

摘要

目的

本研究旨在评估聚乙二醇化干扰素和利巴韦林在人类免疫缺陷病毒(HIV)/丙型肝炎病毒(HCV)合并感染患者中的疗效、安全性和耐受性,给药持续时间和剂量与HCV单一感染研究中使用的相同。

设计

这是一项开放标签、单中心的前瞻性研究。

方法

45例HIV和HCV合并感染且CD4细胞计数>200个/微升的患者,根据HCV基因型,接受聚乙二醇化干扰素-α2b 1.5微克/千克/周和利巴韦林1000 - 1200毫克/天治疗24 - 48周。第一个月每周评估安全性和耐受性,之后每月评估一次。在第4、12和24周、治疗结束时以及治疗完成后12和24周评估病毒学反应。主要终点定义为治疗完成后24周时HCV RNA检测不到[持续病毒学应答(SVR)]。

结果

大多数患者为男性,曾是注射吸毒者。60%的患者正在接受抗逆转录病毒治疗。在意向性分析中,53%的患者获得SVR(基因型1为19%,基因型2/3为75%)。所有在HCV治疗第4周时HCV RNA检测不到的患者[非常早期病毒学应答(VEVR)]均获得SVR。多因素分析显示只有HCV基因型可预测SVR。不良事件频繁发生。

结论

这些结果表明,对于合并感染HCV基因型2或3的HIV感染个体,24周的HCV治疗可能足够。VEVR可预测该组患者的SVR,并可用于指导对24周治疗有反应的基因型2/3个体亚组。

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