Le Nicole K, Riggi Emilia, Marrone Gaetano, Vu Tam Van, Izurieta Ricardo O, Nguyen Chuc Kim Thi, Larsson Mattias, Do Cuong Duy
Morsani College of Medicine, University of South Florida, Tampa, FL, United States of America.
Department of Brain and Behavioural Sciences, Medical Statistics Unit, University of Pavia, Pavia, Italy.
PLoS One. 2017 Sep 6;12(9):e0182688. doi: 10.1371/journal.pone.0182688. eCollection 2017.
We evaluated the sensitivity and specificity of the WHO immunological criteria for detecting antiretroviral therapy (ART) treatment failure in a cohort of Vietnamese patients. We conducted a stratified analysis to determine the effects of BMI, peer support, adherence to antiretroviral (ARV) drugs, age, and gender on the sensitivity and specificity of the WHO criteria.
We conducted a retrospective cohort study of 605 HIV-infected patients using data previously collected from a cluster randomized control trial study. We compared the sensitivity and specificity of CD4+ counts to the gold standard of virologic testing as a diagnostic test for ART failure at different time points of 12, 18, and 24 months.
The sensitivity [95% confidence interval (CI)] of the WHO immunological criteria based on a viral load ≥ 1000 copies/mL was 12% (5%-23%), 14% (2%-43%), and 12.5% (2%-38%) at 12, 18, and 24 months, respectively. In the same order, the specificity was 93% (90%-96%), 98% (96%-99%), and 98% (96%-100%). The positive predictive values (PPV) at 12, 18, and 24 months were 22% (9%-40%), 20% (3%-56%), and 29% (4%-71%); the negative predictive values (NPV) at the same time points were 87% (84%-90%), 97% (95%-98%), and 96% (93%-98%). The stratified analysis revealed similar sensitivities and specificities.
The sensitivity of the WHO immunological criteria is poor, but the specificity is high. Although testing costs may increase, we recommend that Vietnam and other similar settings adopt viral load testing as the principal method for determining ART failure.
我们评估了世界卫生组织（WHO）免疫标准在越南患者队列中检测抗逆转录病毒疗法（ART）治疗失败的敏感性和特异性。我们进行了分层分析，以确定体重指数（BMI）、同伴支持、抗逆转录病毒（ARV）药物依从性、年龄和性别对WHO标准敏感性和特异性的影响。
我们利用先前从一项整群随机对照试验研究中收集的数据，对605例HIV感染患者进行了回顾性队列研究。我们将CD4+细胞计数的敏感性和特异性与病毒学检测的金标准进行比较，作为在12、18和24个月不同时间点ART失败的诊断测试。
基于病毒载量≥1000拷贝/mL的WHO免疫标准的敏感性[95%置信区间（CI）]在12、18和24个月时分别为12%（5%-23%）、14%（2%-43%）和12.5%（2%-38%）。按相同顺序，特异性分别为93%（90%-96%）、98%（96%-99%）和98%（96%-100%）。12、18和24个月时的阳性预测值（PPV）分别为22%（9%-40%）、20%（3%-56%）和29%（4%-71%）；同一时间点的阴性预测值（NPV）分别为87%（84%-90%）、97%（95%-98%）和96%（93%-98%）。分层分析显示了相似的敏感性和特异性。
WHO免疫标准的敏感性较差，但特异性较高。尽管检测成本可能会增加，但我们建议越南和其他类似情况采用病毒载量检测作为确定ART失败的主要方法。
