Department of Global Health, University of Washington, Seattle, WA, USA.
Department of Decision Sciences, University of South Africa, Pretoria, South Africa.
Lancet HIV. 2021 Apr;8(4):e216-e224. doi: 10.1016/S2352-3018(20)30279-4. Epub 2020 Dec 18.
BACKGROUND: The number of people on antiretroviral therapy (ART) requiring treatment monitoring in low-resource settings is rapidly increasing. Point-of-care (POC) testing for ART monitoring might alleviate burden on centralised laboratories and improve clinical outcomes, but its cost-effectiveness is unknown. METHODS: We used cost and effectiveness data from the STREAM trial in South Africa (February, 2017-October, 2018), which evaluated POC testing for viral load, CD4 count, and creatinine, with task shifting from professional to lower-cadre registered nurses compared with laboratory-based testing without task shifting (standard of care). We parameterised an agent-based network model, EMOD-HIV, to project the impact of implementing this intervention in South Africa over 20 years, simulating approximately 175 000 individuals per run. We assumed POC monitoring increased viral suppression by 9 percentage points, enrolment into community-based ART delivery by 25 percentage points, and switching to second-line ART by 1 percentage point compared with standard of care, as reported in the STREAM trial. We evaluated POC implementation in varying clinic sizes (10-50 patient initiating ART per month). We calculated incremental cost-effectiveness ratios (ICERs) and report the mean and 90% model variability of 250 runs, using a cost-effectiveness threshold of US$500 per disability-adjusted life-year (DALY) averted for our main analysis. FINDINGS: POC testing at 70% coverage of patients on ART was projected to reduce HIV infections by 4·5% (90% model variability 1·6 to 7·6) and HIV-related deaths by 3·9% (2·0 to 6·0). In clinics with 30 ART initiations per month, the intervention had an ICER of $197 (90% model variability -27 to 863) per DALY averted; results remained cost-effective when varying background viral suppression, ART dropout, intervention effectiveness, and reduction in HIV transmissibility. At higher clinic volumes (≥40 ART initiations per month), POC testing was cost-saving and at lower clinic volumes (20 ART initiations per month) the ICER was $734 (93 to 2569). A scenario that assumed POC testing did not increase enrolment into community ART delivery produced ICERs that exceeded the cost-effectiveness threshold for all clinic volumes. INTERPRETATION: POC testing is a promising strategy to cost-effectively improve patient outcomes in moderately sized clinics in South Africa. Results are most sensitive to changes in intervention impact on enrolment into community-based ART delivery. FUNDING: National Institutes of Health.
背景：在资源匮乏的环境中，接受抗逆转录病毒疗法（ART）治疗的人数迅速增加，对其进行治疗监测的人数也在迅速增加。即时检测（POC）可能会减轻中央实验室的负担并改善临床结果，但这种方法的成本效益尚不清楚。
方法：我们使用了南非 STREAM 试验（2017 年 2 月至 2018 年 10 月）的成本和效果数据，该试验评估了即时检测在病毒载量、CD4 计数和肌酸酐方面的应用，与不进行任务转移的实验室检测（标准护理）相比，该检测将专业人员的任务转移到了级别较低的注册护士手中。我们使用基于代理的网络模型 EMOD-HIV 来预测在南非实施这项干预措施在 20 年内的影响，模拟了每个运行过程中大约 175000 人。我们假设即时检测使病毒抑制率提高了 9 个百分点，使 25%的人进入社区提供的 ART 治疗，使 1%的人转为二线 ART，这与 STREAM 试验中的报告结果一致。我们在不同的诊所规模（每月 10-50 名患者开始接受 ART）下评估了即时检测的实施情况。我们使用了 500 美元的成本效益阈值（每避免一个残疾调整生命年（DALY）的成本）来计算增量成本效益比（ICER），并报告了 250 次运行的平均值和 90%模型的变异性。
结果：即时检测在接受 ART 治疗的患者中覆盖率达到 70%，预计可使 HIV 感染率降低 4.5%（90%模型变异性 1.6%至 7.6%），使 HIV 相关死亡率降低 3.9%（2.0%至 6.0%）。在每月有 30 名患者开始接受 ART 的诊所中，该干预措施的 ICER 为 197 美元（90%模型变异性 -27 至 863），每避免一个 DALY 成本效益比；当改变背景下的病毒抑制率、ART 脱落率、干预效果和 HIV 传播率降低时，结果仍然具有成本效益。在更高的诊所容量（每月≥40 名患者开始接受 ART）下，即时检测是节省成本的，而在更低的诊所容量（每月 20 名患者开始接受 ART）下，ICER 为 734 美元（93 至 2569）。一个假设即时检测不会增加社区 ART 治疗人数的方案，其 ICER 对所有诊所容量都超过了成本效益阈值。
结论：即时检测是一种很有前途的策略，可以在南非中等规模的诊所中以具有成本效益的方式改善患者的治疗效果。结果对干预措施对社区提供的 ART 治疗的影响的变化最为敏感。
资金来源：美国国立卫生研究院。
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