South African Department of Science and Technology/National Research Foundation Centre of Excellence in Epidemiological Modelling and Analysis (SACEMA), Stellenbosch University, Stellenbosch, South Africa.
Centre for Health Economics, University of York, York, UK.
Lancet Glob Health. 2014 Jan;2(1):e35-43. doi: 10.1016/S2214-109X(13)70048-2. Epub 2013 Dec 10.
BACKGROUND: WHO's 2013 revisions to its Consolidated Guidelines on antiretroviral drugs recommend routine viral load monitoring, rather than clinical or immunological monitoring, as the preferred monitoring approach on the basis of clinical evidence. However, HIV programmes in resource-limited settings require guidance on the most cost-effective use of resources in view of other competing priorities such as expansion of antiretroviral therapy coverage. We assessed the cost-effectiveness of alternative patient monitoring strategies. METHODS: We evaluated a range of monitoring strategies, including clinical, CD4 cell count, and viral load monitoring, alone and together, at different frequencies and with different criteria for switching to second-line therapies. We used three independently constructed and validated models simultaneously. We estimated costs on the basis of resource use projected in the models and associated unit costs; we quantified impact as disability-adjusted life years (DALYs) averted. We compared alternatives using incremental cost-effectiveness analysis. FINDINGS: All models show that clinical monitoring delivers significant benefit compared with a hypothetical baseline scenario with no monitoring or switching. Regular CD4 cell count monitoring confers a benefit over clinical monitoring alone, at an incremental cost that makes it affordable in more settings than viral load monitoring, which is currently more expensive. Viral load monitoring without CD4 cell count every 6-12 months provides the greatest reductions in morbidity and mortality, but incurs a high cost per DALY averted, resulting in lost opportunities to generate health gains if implemented instead of increasing antiretroviral therapy coverage or expanding antiretroviral therapy eligibility. INTERPRETATION: The priority for HIV programmes should be to expand antiretroviral therapy coverage, firstly at CD4 cell count lower than 350 cells per μL, and then at a CD4 cell count lower than 500 cells per μL, using lower-cost clinical or CD4 monitoring. At current costs, viral load monitoring should be considered only after high antiretroviral therapy coverage has been achieved. Point-of-care technologies and other factors reducing costs might make viral load monitoring more affordable in future. FUNDING: Bill & Melinda Gates Foundation, WHO.
背景：世界卫生组织（WHO）在 2013 年对其抗逆转录病毒药物综合指南进行了修订，建议以临床证据为基础，常规进行病毒载量监测，而不是临床或免疫监测，作为首选监测方法。然而，资源有限的环境下的 HIV 规划需要考虑到其他竞争优先事项（如扩大抗逆转录病毒治疗的覆盖范围），指导如何最有效地利用资源。我们评估了替代患者监测策略的成本效益。
方法：我们评估了一系列监测策略，包括临床、CD4 细胞计数和病毒载量监测，单独和联合使用，不同的频率，以及切换到二线治疗的不同标准。我们同时使用了三个独立构建和验证的模型。我们根据模型中预测的资源使用情况和相关单位成本估算成本；我们将效益量化为避免的残疾调整生命年（DALY）。我们使用增量成本效益分析比较了替代方案。
结果：所有模型都表明，与没有监测或切换的假设基线情况相比，临床监测可带来显著效益。与单独的临床监测相比，定期的 CD4 细胞计数监测提供了效益，其增量成本在比病毒载量监测更广泛的环境中是可承受的，而病毒载量监测目前更昂贵。每 6-12 个月不进行 CD4 细胞计数的病毒载量监测可最大程度地降低发病率和死亡率，但每避免一个 DALY 的成本很高，如果实施该方案而不是增加抗逆转录病毒治疗的覆盖范围或扩大抗逆转录病毒治疗的资格，将会错失产生健康收益的机会。
解释：HIV 规划的重点应该是首先在 CD4 细胞计数低于 350 个细胞/μL 时，然后在 CD4 细胞计数低于 500 个细胞/μL 时，使用成本较低的临床或 CD4 监测扩大抗逆转录病毒治疗的覆盖范围。在目前的成本下，只有在实现高抗逆转录病毒治疗覆盖范围后，才应考虑病毒载量监测。即时检测技术和其他降低成本的因素可能会使病毒载量监测在未来变得更加经济实惠。
资金来源：比尔及梅琳达·盖茨基金会，世界卫生组织。
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