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病毒学抑制患者从恩夫韦肽转换为拉替拉韦的疗效和安全性。

Efficacy and safety of switching from enfuvirtide to raltegravir in patients with virological suppression.

作者信息

Santos José R, Llibre Josep M, Ferrer Elena, Domingo Pere, Imaz Arkaitz, Moltó José, Martin-Iguacel Raquel, Caum Carme, Podzamczer Daniel, Clotet Bonaventura

机构信息

Lluita contra la SIDA, Hospital Universitari Germans Trias i Pujol, Badalona, Barcelona, Spain Universitat Autònoma de Barcelona, Barcelona, Spain.

出版信息

HIV Clin Trials. 2009 Nov-Dec;10(6):432-8. doi: 10.1310/hct1006-432.

DOI:10.1310/hct1006-432
PMID:20133273
Abstract

OBJECTIVE

To assess the Efficacy and safety of switching from HAART containing enfuvirtide to raltegravir as a simplification strategy in patients with viral suppression and intolerance to enfuvirtide.

METHODS

Thirty-six patients with sustained plasma HIV RNA levels <50 copies/mL for at least 3 months with injection site reactions and/or injection fatigue while receiving an enfuvirtide-containing optimized background regimen switched from enfuvirtide to raltegravir (400 mg bid).

RESULTS

Patientshad received enfuvirtide for a median of 96 weeks and had sustained HIV RNA <50 copies/ mL for a median of 95 weeks. One patient discontinued raltegravir due to the appearance of cutaneous rash (grade 2) unresponsive to antihistamines after 19 days of starting raltegravir. The remaining 35 patients were followed for 24 weeks and 18 of them for 48 weeks. All patients maintained virological suppression <50 copies/mL at Weeks 24 and 48. No patient had blips in their viral load after switching to raltegravir. There were no grade 3 or 4 adverse events related to raltegravir.

CONCLUSIONS

A switch from enfuvirtide to raltegravir in virologically suppressed patients who are highly treatment-experienced maintained both virologic and immunologic efficacy up to 48 weeks.

摘要

目的

评估在病毒得到抑制且对恩夫韦肽不耐受的患者中,将含恩夫韦肽的高效抗逆转录病毒治疗(HAART)转换为拉替拉韦作为简化治疗策略的疗效和安全性。

方法

36例患者在接受含恩夫韦肽的优化背景方案治疗时,出现注射部位反应和/或注射疲劳,且血浆HIV RNA水平持续<50拷贝/mL至少3个月,这些患者从恩夫韦肽转换为拉替拉韦(400mg,每日两次)。

结果

患者接受恩夫韦肽治疗的中位时间为96周,HIV RNA持续<50拷贝/mL的中位时间为95周。1例患者在开始使用拉替拉韦19天后因出现皮疹(2级)且对组胺药无反应而停用拉替拉韦。其余35例患者随访24周,其中18例随访48周。所有患者在第24周和第48周时病毒学抑制均维持在<50拷贝/mL。转换为拉替拉韦后,没有患者出现病毒载量波动。没有与拉替拉韦相关的3级或4级不良事件。

结论

在病毒学得到抑制且治疗经验丰富的患者中,从恩夫韦肽转换为拉替拉韦,在长达48周的时间内维持了病毒学和免疫学疗效。

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