Infectious Diseases, Azienda Ospedaliera Universitaria Careggi, Florence, Italy.
HIV Med. 2010 Jan;11(1):40-5. doi: 10.1111/j.1468-1293.2009.00740.x. Epub 2009 Aug 3.
Atazanavir (ATV) has demonstrated high efficacy and safety in both treatment-naïve and treatment-experienced patients. Some comparative data are available on the durability of ritonavir-boosted (ATV/r) and unboosted formulations, but there are no data on clinicians' motivations for choosing one or another in everyday practice. The aim of this study was to evaluate the long-term efficacy of boosted and unboosted ATV in a cohort of treatment-experienced patients.
All patients included in the study were enrolled in an observational cohort within the Surveillance Cohort Long-Term Toxicity Antiretrovirals (SCOLTA) Project. Data on CD4 cell count, HIV viral load, metabolic parameters and adverse events of grade 3-4 are collected through an on-line system every six months. The duration of treatment with ATV was evaluated using the Kaplan-Meier curve and boosted and unboosted regimens were compared using the log-rank test.
A total of 509 patients starting ATV as a component of their antiretroviral therapy were enrolled in the SCOLTA Project at the time of the study. Boosted ATV was received by 379 patients (74.5%) while 130 (25.5%) were treated with the unboosted formulation. The last therapeutic regimen did not influence the choice of ATV formulation. The mean observational time was 23.9 months. At the end of follow-up, 58.5% of patients on unboosted ATV and 58.1% of patients on ATV/r continued the treatment and no statistically significant differences were observed for ATV durability between the formulations or among the single causes of therapy interruption.
Our results suggest that, in unselected clinical settings, ATV-containing antiretroviral therapy is durable and safe in both its formulations.
阿扎那韦（ATV）在初治和经治患者中均显示出高效且安全。有一些关于利托那韦增强（ATV/r）和未增强制剂的耐久性的比较数据，但在日常实践中，临床医生选择一种或另一种制剂的动机尚无数据。本研究旨在评估经治患者中增强和未增强 ATV 的长期疗效。
本研究中所有纳入的患者均来自于长期毒性抗逆转录病毒药物监测队列（SCOLTA）项目的观察性队列。通过在线系统每六个月收集一次 CD4 细胞计数、HIV 病毒载量、代谢参数和 3-4 级不良事件的数据。采用 Kaplan-Meier 曲线评估 ATV 的治疗时间，采用对数秩检验比较增强和未增强方案。
在研究时，共有 509 名开始使用 ATV 作为其抗逆转录病毒治疗一部分的患者入组 SCOLTA 项目。379 名患者（74.5%）接受了增强型 ATV，130 名（25.5%）接受了未增强型 ATV。最后一次治疗方案并未影响 ATV 制剂的选择。平均观察时间为 23.9 个月。随访结束时，未增强 ATV 组和增强 ATV/r 组分别有 58.5%和 58.1%的患者继续治疗，两种制剂之间以及治疗中断的单一原因之间均未观察到 ATV 耐久性的统计学显著差异。
我们的结果表明，在未选择的临床环境中，含 ATV 的抗逆转录病毒治疗在两种制剂中均具有持久性和安全性。
