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在初治抗逆转录病毒治疗患者中,利托那韦增强和未增强的阿扎那韦的疗效与安全性。

Efficacy and safety of ritonavir-boosted and unboosted atazanavir among antiretroviral-naïve patients.

作者信息

Horberg Michael, Klein Daniel, Hurley Leo, Silverberg Michael, Towner William, Antoniskis Diana, Kovach Drew, Mogyoros Miguel, Blake William, Dobrinich Robert, Dodge Wayne

机构信息

HIV Initiative, Kaiser Permanente, Oakland, California 94612, USA.

出版信息

HIV Clin Trials. 2008 Nov-Dec;9(6):367-74. doi: 10.1310/hct0906-367.

DOI:10.1310/hct0906-367
PMID:19203902
Abstract

PURPOSE

Evaluate responses and safety of ritonavir-boosted atazanavir ("boosted atazanavir") compared to unboosted atazanavir among antiretroviral-naïve patients in the clinical managed care setting.

METHOD

Observational cohort analysis of atazanavir use (comparing ritonavir-boosted to non-boosted) at Kaiser Permanente and Group Health Cooperative from 2003 to 2006. Antiretroviral-naïve patients initiating atazanavir were followed through 52 weeks of treatment.

RESULTS

443 patients were prescribed atazanavir (69 non-boosted; 15.5%). Boosted and non-boosted atazanavir groups were similar with respect to gender and age. Boosted atazanavir use was associated with greater odds achieving HIV RNA <400 c/mL (odds ratio [OR] = 3.24, p = .008), greater decrease in HIV RNA (-0.37 log10/mL, p = .03), greater increase in CD4 T-cell count (+59 cells/microL, p = .01), and greater increase in total bilirubin (+1.21 mg/dL as opposed to +0.56 mg/dL, p .001). There were no statistically significant differences for glucose, liver transaminases, total cholesterol, or LDL cholesterol elevations. There were greater odds of maximal viral control when atazanavir was combined with tenofovir or zidovudine in combination with lamivudine (or emtricitabine).

CONCLUSIONS

Ritonavir-boosted atazanavir is associated with greater virologic control and immune response through 52 weeks compared to non-boosted atazanavir, without greater risk of adverse events except elevated bilirubin. Thus, ritonavir-boosted atazanavir is the preferred method of prescribing atazanavir.

摘要

目的

在临床管理式医疗环境中,评估初治抗逆转录病毒治疗患者中,利托那韦增强的阿扎那韦(“增强型阿扎那韦”)与未增强的阿扎那韦相比的疗效和安全性。

方法

对2003年至2006年在凯撒医疗集团和健康合作组织中使用阿扎那韦的情况(比较利托那韦增强型与未增强型)进行观察性队列分析。对初治抗逆转录病毒治疗且开始使用阿扎那韦的患者进行为期52周的治疗随访。

结果

443例患者接受了阿扎那韦治疗(69例未增强,占15.5%)。增强型和未增强型阿扎那韦组在性别和年龄方面相似。使用增强型阿扎那韦实现HIV RNA<400拷贝/mL的几率更高(优势比[OR]=3.24,p=0.008),HIV RNA下降幅度更大(-0.37 log10/mL,p=0.03),CD4 T细胞计数增加幅度更大(+59个细胞/微升,p=0.01),总胆红素升高幅度更大(+1.21mg/dL,而未增强型为+0.56mg/dL,p<0.001)。在血糖、肝转氨酶、总胆固醇或低密度脂蛋白胆固醇升高方面无统计学显著差异。当阿扎那韦与替诺福韦或齐多夫定联合拉米夫定(或恩曲他滨)联合使用时,实现最大病毒控制的几率更高。

结论

与未增强的阿扎那韦相比,利托那韦增强的阿扎那韦在52周内与更好的病毒学控制和免疫反应相关,除了胆红素升高外,不良事件风险并未增加。因此,利托那韦增强的阿扎那韦是阿扎那韦的首选给药方法。

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