Clinical effect and cost-effectiveness of incorporation of point-of-care assays into early infant HIV diagnosis programmes in Zimbabwe: a modelling study
Clinical effect and cost-effectiveness of incorporation of point-of-care assays into early infant HIV diagnosis programmes in Zimbabwe: a modelling study
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DOI：
10.1016/s2352-3018(18)30328-x
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发表时间：
2019-03-01
期刊：
影响因子：
16.1
通讯作者：
Ciaranello, Andrea L.
中科院分区：
文献类型：
--
作者：
Frank, Simone C.;Cohn, Jennifer;Ciaranello, Andrea L.
背景：用于早期婴儿HIV诊断的新的护理点(POC)检测方法比传统的总核酸检测方法更昂贵，但可以增加检测的机会，缩短结果的时间，并加快抗逆转录病毒治疗的开始。我们的目的是评估在津巴布韦将这些POC检测纳入婴儿早期诊断项目的临床好处和成本效益。方法我们使用预防艾滋病并发症的成本效益(CEPAC)-儿科模型来检验在津巴布韦6周时用POC检测取代传统的婴儿HIV早期诊断方法的临床好处、成本和成本效益。我们模拟了两种婴儿HIV早期诊断策略：常规策略和POC策略。模型化分析在灵敏度、特异度、返回结果的时间和概率以及成本方面有所不同。模型结果包括存活率、预期寿命和人均终生治疗费用，这是针对所有感染艾滋病毒的婴儿和所有感染艾滋病毒的婴儿分别报告的。我们从卫生保健系统的角度计算了所有感染艾滋病毒的婴儿的增量成本-效果比，并计算了折扣(每年3%)的成本和预期寿命。我们判断每一年节省的生命增加1010美元(津巴布韦每年的国内生产总值)或更少的成本-效果比是具有成本效益的。当使用传统检测方法进行婴儿早期诊断时，预计未贴现的预期寿命为22.7岁，所有感染艾滋病毒的婴儿为62.5岁，每个感染艾滋病毒的婴儿的成本为610美元。在感染艾滋病毒的婴儿中，使用POC检测进行早期艾滋病毒诊断将预期未折扣预期寿命提高到25.5岁，在感染艾滋病毒的婴儿中，预期寿命为62.6岁，每个感染艾滋病毒的婴儿的成本为690美元。在12周时，所有感染艾滋病毒的婴儿在常规检测策略下的存活率为76.1%，而在POC检测策略下的存活率为83.5%。对于早期婴儿诊断，POC检测与传统检测相比，每挽救一年生命，增加的成本-效果比为680美元。当常规检测特性保持不变时，只要POC检测的特异性和敏感性分别大于92%和65%，这一比率就保持在成本-效果阈值以下。我们的结果对POC检测成本、启动抗逆转录病毒治疗的概率和POC检测结果的返回概率的合理变化具有很强的稳健性。与传统检测方法相比，津巴布韦的POC检测用于婴儿早期艾滋病毒诊断将提高存活率，延长预期寿命，并对感染艾滋病毒的婴儿具有成本效益。
Background New point-of-care (POC) assays for early infant HIV diagnosis are costlier than conventional total nucleic acid assays, but could increase access to testing, shorten time to results, and expedite initiation of antiretroviral therapy. We aimed to assess the clinical benefits and cost-effectiveness of incorporating these POC assays into early infant diagnosis programmes in Zimbabwe.Methods We used the Cost Effectiveness of Preventing AIDS Complications (CEPAC)-Pediatric model to examine the clinical benefits, costs, and cost-effectiveness of replacing conventional assays for early infant HIV diagnosis with POC assays at age 6 weeks in Zimbabwe. We simulated two strategies for early infant HIV diagnosis: conventional and POC. Modelled assays differed in sensitivity; specificity; time to, and probability of, return of results; and cost. Model outcomes included survival, life expectancy, and mean lifetime per-person treatment cost, which were reported separately for all HIV-exposed infants and all infants with HIV. We calculated incremental cost-effectiveness ratios with discounted (3% per year) costs and life expectancy from a health-care system perspective for all HIV-exposed infants. We judged incremental cost-effectiveness ratios of $1010 (Zimbabwe's annual gross domestic product per person) or less per year of life saved to be cost-effective.Findings When conventional assays were used for early infant diagnosis, projected undiscounted life expectancy was 22.7 years for infants with HIV and 62.5 years for all HIV-exposed infants, at a cost of $610 per HIV-exposed infant. Use of POC assays for early infant HIV diagnosis improved projected undiscounted life expectancy to 25.5 years among infants with HIV and 62.6 years among HIV-exposed infants at a cost of $690 per HIV-exposed infant. At age 12 weeks, survival among all infants with HIV was 76.1% with the conventional testing strategy and 83.5% with the POC testing strategy. The incremental cost-effectiveness ratio of POC assays versus conventional assays for early infant diagnosis was $680 per year of life saved. When conventional assay characteristics remained constant, this ratio remained under the cost-effectiveness threshold as long as the specificity and sensitivity of the POC assay were greater than 92% and 65%, respectively. Our results were robust to plausible variations in POC assay cost, the probability of ART initiation, and probability of return of the results of POC testing.Interpretation Compared with conventional assays, POC assays for early infant HIV diagnosis in Zimbabwe will improve survival, extend life expectancy, and be cost-effective for HIV-exposed infants.