Genotype assays and third-line ART in resource-limited settings: a simulation and cost-effectiveness analysis of a planned clinical trial.
Genotype assays and third-line ART in resource-limited settings: a simulation and cost-effectiveness analysis of a planned clinical trial.
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DOI：
10.1097/qad.0b013e32835221eb
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发表时间：
2012-06-01
期刊：
影响因子：
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通讯作者：
Walensky RP
中科院分区：
文献类型：
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作者：
Lorenzana SB;Hughes MD;Grinsztejn B;Collier AC;Luz PM;Freedberg KA;Wood R;Levison JH;Mugyenyi PN;Salata R;Wallis CL;Weinstein MC;Schooley RT;Walensky RP
根据计划的国际A5288试验（MULTI-OCTAVE），预测在资源有限的环境中选择三线抗逆转录病毒治疗（ART）的基因型检测的临床和经济结局。我们使用预防艾滋病并发症的成本效益（CEPAC）-国际模型，比较了南非二线抗逆转录病毒治疗失败的受试者的三种策略：（1）持续二线：无基因型检测，所有受试者继续接受二线抗逆转录病毒治疗;（2）A5288：基因型，以确定耐药谱并分配适当的治疗方案;或（3）基于人群的三线：没有基因型，所有受试者都转换到有效的三线方案。模型输入来自南非公布的数据。耐药谱、ART方案和疗效数据是用于试验计划的数据。持续二线、A5288和基于人群的三线的预期寿命分别为61.1、103.8和104.2个月。与持续的二线战略（12 460美元）相比，A5288战略（39 250美元）和基于人口的战略（44 120美元）的人均终身费用增加。与持续二线相比，A5288的增量成本效益比为7，500美元/年挽救生命（YLS），与A5288相比，基于人群的三线为154，500美元/年挽救生命。在A5288策略中，很晚才开始治疗，加上获得基因型的漫长延迟，大大降低了5年生存率，使基于人群的三线策略更具吸引力。我们预计，虽然公共卫生的三线治疗方法是负担不起的，基因型检测和三线ART在资源有限的设置将增加生存率和成本效益相比，以人口为基础的方法，支持疗效研究的价值。
To project the clinical and economic outcomes of a genotype assay for selection of third-line antiretroviral therapy (ART) in resource-limited settings, as per the planned international A5288 trial (MULTI-OCTAVE). We used the Cost-effectiveness of Preventing AIDS Complications (CEPAC)-International Model to compare three strategies for subjects who have failed second-line ART in South Africa: (1) Sustained second-line: no genotype assay, all subjects remain on second-line ART; (2) A5288: genotype to determine the resistance profile and assign an appropriate regimen; or (3) Population-based third-line: no genotype, all subjects switch to a potent third-line regimen. Model inputs are from published data in South Africa. Resistance profiles, ART regimens, and efficacy data were those used for trial planning. Projected life expectancy for sustained second-line, A5288, and population-based third-line are 61.1, 103.8, and 104.2 months. Compared to sustained second-line ($12,460), per person lifetime costs increase for the A5288 ($39,250) and population-based ($44,120) strategies. The incremental cost-effectiveness ratio of A5288, compared to sustained second-line, is $7,500/year of life saved (YLS), and for population-based third-line, compared to A5288, is $154,500/YLS. In the A5288 strategy, very late presentation to care, coupled with lengthy delays to obtain the genotype, dramatically reduces 5-yr survival, making the population-based third-line strategy more attractive. We project that, while the public health approach to third-line therapy is unaffordable, genotype assays and third-line ART in resource-limited settings will increase survival and be cost-effective compared to the population-based approach, supporting the value of an efficacy study.