1 HIV-NAT, Thai Red Cross AIDS Research Center , Bangkok, Thailand .
AIDS Patient Care STDS. 2014 Jun;28(6):296-302. doi: 10.1089/apc.2013.0276.
There is no consensus on a gold standard for monitoring adherence to antiretroviral therapy (ART). We compared different adherence monitoring tools in predicting virologic failure as part of a clinical trial. HIV-infected Thai and Cambodian children aged 1-12 years (N=207) were randomized to immediate-ART or deferred-ART until CD4% <15%. Virologic failure (VF) was defined as HIV-RNA >1000 copies/mL after ≥6 months of ART. Adherence monitoring tools were: (1) announced pill count, (2) PACTG adherence questionnaire (form completed by caregivers), and (3) child self-report (self-reporting from children or caregivers to direct questioning by investigators during the clinic visit) of any missed doses in the last 3 days and in the period since the last visit. The Kappa statistic was used to describe agreement between each tool. The median age at ART initiation was 7 years with median CD4% 17% and HIV-RNA 5.0 log(10)copies/mL and 92% received zidovudine/lamivudine/nevirapine. Over 144 weeks, 13% had VF. Mean adherence by announced pill count before VF in VF children was 92% compared to 98% in children without VF (p=0.03). Kappa statistics indicated slight to fair agreement between tools. In multivariate analysis adjusting for gender, treatment arm ethnicity and caregiver education, significant predictors of VF were poor adherence by announced pill count (OR 4.56; 95%CI 1.78-11.69), reporting any barrier to adherence in the PACTG adherence questionnaire (OR 7.08; 95%CI 2.42-20.73), and reporting a missed dose in the 24 weeks since the last HIV-RNA assessment (OR 8.64; 95%CI 1.96-38.04). In conclusion, we recommend the child self-report of any missed doses since last visit for use in HIV research and in routine care settings, because it is easy and quick to administer and a strong association with development of VF.
对于抗逆转录病毒疗法（ART）依从性的监测，目前尚无金标准。我们比较了不同的依从性监测工具，以预测作为临床试验一部分的病毒学失败。将年龄在 1-12 岁的泰国和柬埔寨感染 HIV 的儿童（N=207）随机分为立即开始 ART 或延迟到 CD4%＜15%时开始 ART。病毒学失败（VF）定义为开始 ART 治疗≥6 个月后 HIV-RNA＞1000 拷贝/mL。依从性监测工具包括：（1）报药法，（2）PACTG 依从性问卷（由照料者填写），以及（3）儿童自我报告（儿童或照料者在就诊期间直接向调查员报告最近 3 天和上次就诊以来错过的任何剂量）。使用 Kappa 统计量描述每种工具之间的一致性。ART 开始时的中位年龄为 7 岁，中位 CD4%为 17%，HIV-RNA 为 5.0log10 拷贝/mL，92%接受齐多夫定/拉米夫定/奈韦拉平治疗。在 144 周的时间里，有 13%的儿童出现 VF。VF 儿童在 VF 发生前通过报药法的平均依从率为 92%，而未发生 VF 的儿童为 98%（p=0.03）。Kappa 统计量表明，工具之间的一致性为轻度到中度。在调整性别、治疗臂种族和照料者教育的多变量分析中，VF 的显著预测因素是报药法显示的依从性差（OR 4.56；95%CI 1.78-11.69）、PACTG 依从性问卷报告任何依从障碍（OR 7.08；95%CI 2.42-20.73）以及在最后一次 HIV-RNA 评估后 24 周报告漏服（OR 8.64；95%CI 1.96-38.04）。总之，我们建议在 HIV 研究和常规护理环境中使用儿童自我报告最近一次就诊以来漏服的任何药物，因为它易于实施且快速，与 VF 的发生有很强的关联。
