在临床环境中，基于恩夫韦肽的抗逆转录病毒疗法对有治疗经验的HIV感染患者的病毒学和免疫学影响及持久性。

Virologic and immunologic impact and durability of enfuvirtide-based antiretroviral therapy in HIV-infected treatment-experienced patients in a clinical setting.

作者信息

Loutfy M R, Antoniou T, Shen S, Diong C, Vlaicu M, Halpenny R, Kovacs C, Fletcher D, Raboud J M

机构信息

Department of Medicine, University of Toronto, Toronto, Ontario Maple Leaf Medical Clinical, Toronto, Ontario, Canada.

出版信息

HIV Clin Trials. 2007 Jan-Feb;8(1):36-44. doi: 10.1310/hct0801-36.

DOI:10.1310/hct0801-36

PMID:17434847

Abstract

OBJECTIVE

To evaluate the effectiveness and safety of enfuvirtide-based therapy in treatment-experienced patients in a clinical setting.

METHOD

Retrospective study of treatment-experienced patients receiving enfuvirtide-based therapy for a minimum of 2 months. Endpoints included virologic suppression, virologic rebound, immunologic response, and adverse events.

RESULTS

Sixty-four patients were eligible for inclusion in the analysis. Median baseline viral load and CD4+ count were 4.7 log10 copies/mL (interquartile range [IQR], 4.0-5.2) and 150 cells/mm3 (IQR, 60-250), respectively. At month 12, viral load declined by a median of 2.53 log10 copies/mL (IQR, 0.97-3.12). The unadjusted median time to virologic suppression was 7.7 months (95% CI 4.1-10.4 months). Baseline viral load and number of protease inhibitors in the current regimen were significantly associated with virologic suppression following multivariate analysis (hazard ratio [HR] 0.45, 95% CI 0.31-0.63, p < .0001, and HR 0.51, 95% CI 0.27-0.94, p = .03, respectively). Among the 42 patients who attained sustained virologic suppression, 10 experienced virologic rebound during a median follow-up of 13.3 months (IQR, 7.0-19.1). Injection site reactions were reported in 33 (52%) patients, resulting in treatment discontinuation in nine patients.

CONCLUSION

Enfuvirtide-based therapy provides durable antiretroviral activity for treatment-experienced patients in a clinical setting.

摘要

目的

评估在临床环境中，基于恩夫韦肽的疗法对经治患者的有效性和安全性。

方法

对接受基于恩夫韦肽的疗法至少2个月的经治患者进行回顾性研究。观察指标包括病毒学抑制、病毒学反弹、免疫反应和不良事件。

结果

64例患者符合纳入分析标准。基线病毒载量中位数和CD4+细胞计数分别为4.7 log10拷贝/毫升（四分位间距[IQR]，4.0 - 5.2）和150个细胞/立方毫米（IQR，60 - 250）。在第12个月时，病毒载量中位数下降了2.53 log10拷贝/毫升（IQR，0.97 - 3.12）。未经调整的病毒学抑制中位时间为7.7个月（95%置信区间4.1 - 10.4个月）。多因素分析后，基线病毒载量和当前治疗方案中蛋白酶抑制剂的数量与病毒学抑制显著相关（风险比[HR]分别为0.45，95%置信区间0.31 - 0.63，p < 0.0001；以及HR 0.51，95%置信区间0.27 - 0.94，p = 0.03）。在42例实现持续病毒学抑制的患者中，10例在中位随访13.3个月（IQR，7.0 - 19.1）期间出现病毒学反弹。33例（52%）患者报告有注射部位反应，其中9例患者因此停药。