Outcomes from monitoring of patients on antiretroviral therapy in resource-limited settings with viral load, CD4 cell count, or clinical observation alone: a computer simulation model
Outcomes from monitoring of patients on antiretroviral therapy in resource-limited settings with viral load, CD4 cell count, or clinical observation alone: a computer simulation model
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DOI：
10.1016/s0140-6736(08)60624-8
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发表时间：
2008-04-01
期刊：
影响因子：
168.9
通讯作者：
Lundgren, Jens D.
中科院分区：
文献类型：
--
作者：
Phillips, Andrew N.;Pillay, Deenan;Lundgren, Jens D.
在低收入国家，世卫组织建议采用以人群为基础的抗逆转录病毒治疗方法，采用标准化方案，并根据临床状况和可用的CD 4细胞计数而不是病毒载量做出临床决策。我们的目的是研究这种监测策略的潜在后果，特别是在生存和耐药性development.Methods方面的HIV感染和抗逆转录病毒治疗的效果的验证计算机模拟模型被用来比较生存，使用二线方案，和耐药性的发展，结果从不同的策略-基于病毒载量，CD 4细胞计数，或仅临床观察-用于确定何时将开始使用世卫组织推荐的司他夫定、拉米夫定和奈韦拉平一线方案进行抗逆转录病毒治疗的患者转换为二线抗逆转录病毒治疗。通过病毒载量监测，预测的潜在存活生命年比例为83（当病毒载量>500拷贝/mL时转换），82%，CD 4细胞计数监测（从峰值下降50%时转换），82%在临床监测下转换（当发生两起新的WHO 3级事件或1起WHO 4级事件时转换）。20年后的相应值分别为67%、64%和64%。在广泛的单变量和多变量敏感性分析中，结果对模型规格的变化具有鲁棒性。虽然生存期稍长，病毒载量监测，这种策略是不是最具成本效益的。解释司他夫定，拉米夫定，奈韦拉平的一线方案的病毒载量或CD 4细胞计数监测的好处是温和的临床监测。开发这些检测方法的廉价和可靠的版本是重要的，但扩大抗逆转录病毒药物的使用范围（无论是否有实验室监测）是目前的最高优先事项。
Background In lower-income countries, WHO recommends a population-based approach to antiretroviral treatment with standardised regimens and clinical decision making based on clinical status and, where available CD4 cell count, rather than viral load. Our aim was to study the potential consequences of such monitoring strategies, especially in terms of survival and resistance development.Methods A validated computer simulation model of HIV infection and the effect of antiretroviral therapy was used to compare survival, use of second-line regimens, and development of resistance that result from different strategies-based on viral load, CD4 cell count, or clinical observation alone-for determining when to switch people starting antiretroviral treatment with the WHO-recommended first-line regimen of stavudine, lamivudine, and nevirapine to second-line antiretroviral treatment.Findings Over 5 years, the predicted proportion of potential life-years survived was 83% with viral load monitoring (switch when viral load >500 copies per mL), 82% with CD4 cell count monitoring (switch at 50% drop from peak), and 82% with clinical monitoring (switch when two new WHO stage 3 events or a WHO stage 4 event occur). Corresponding values over 20 years were 67%, 64%, and 64%. Findings were robust to variations in model specification in extensive univariable and multivariable sensitivity analyses. Although survival was slightly longer with viral load monitoring, this strategy was not the most cost effective.Interpretation For patients on the first-line regimen of stavudine, lamivudine, and nevirapine the benefits of viral load or CD4 cell count monitoring over clinical monitoring alone are modest. Development of cheap and robust versions of these assays is important, but widening access to antiretrovirals-with or without laboratory monitoring-is currently the highest priority.