Department of Paediatrics and Child Health, School of Medicine, Muhimbili University of Health and Allied Sciences, P.O. BOX 65001, Dar-Es-Salaam, Tanzania.
BMC Pediatr. 2013 Jun 15;13:95. doi: 10.1186/1471-2431-13-95.
Adherence to antiretroviral drugs in the treatment of paediatric HIV infection is complicated because of many factors including stigma and drug intake logistics. It is therefore important to identify children with non-adherence in order to intervene before they become at risk of developing treatment failure or drug resistance. The aim of this study was to determine the level of adherence to antiretroviral therapy (ART), measured by caretaker report, medication return and nevirapine plasma concentration. In addition, the association between level of adherence and patient's immune status was compared across the three methods of measuring adherence.
This was a descriptive cross-sectional study involving HIV infected children aged 2-14 years, on nevirapine- based antiretroviral treatment for at least six months, attending care and treatment clinic in three municipal hospitals in Dar- Es- Salaam City. Eligible patients and their accompanying caretakers were consecutively enrolled after obtaining written informed consent. Structured questionnaires were administered to caretakers to assess patient's adherence by caretaker report and medication return whereas a single blood sample for CD4 cell count/percent and determination of nevirapine plasma concentration was taken from patients on the day of assessment.
A total of 300 patients and accompanying caretakers were enrolled and the mean patient age (SD) was 8 (3) years. Caretakers' report and medication return showed good adherence (98% and 97%) respectively. However, the level of adherence assessed by nevirapine plasma concentration (85%) was significantly lower than caretaker report and medication return (p < 0.001). The agreement between nevirapine plasma concentration and medication return and between nevirapine plasma concentration and caretaker report was weak (k = 0. 131) (k = 0. 09) respectively. Nevirapine plasma concentration below 3 μg/ml was associated with immunosuppression (p = 0. 021) whereas medication return (>5% of prescribed doses) and caretaker reported missing more than one dose within 72 hours prior to interview were not associated with immunosuppression (p = 0. 474), (p = 0. 569) respectively.
Lower adherence level observed using nevirapine plasma concentration and its association with immunological response supports the validity of the method and indicates that adherence data obtained from caretaker report and medication return may overestimate the true adherence in paediatric antiretroviral therapy.
由于污名化和药物摄入等诸多因素，儿童抗逆转录病毒药物治疗的依从性较为复杂。因此，识别不依从的儿童并在他们面临治疗失败或耐药的风险之前进行干预非常重要。本研究旨在通过看护人报告、药物返还和奈韦拉平血浆浓度来确定抗逆转录病毒治疗（ART）的依从程度。此外，还比较了三种依从性测量方法中，依从性水平与患者免疫状态之间的关系。
这是一项描述性的横断面研究，纳入了年龄在 2-14 岁之间、接受基于奈韦拉平的抗逆转录病毒治疗至少 6 个月、在坦桑尼亚达累斯萨拉姆市的三家市立医院接受护理和治疗的 HIV 感染儿童。在获得书面知情同意后，连续纳入符合条件的患者及其陪同的照顾者。对照顾者进行结构化问卷调查，通过照顾者报告和药物返还来评估患者的依从性，而在评估当天，从患者身上采集一份用于 CD4 细胞计数/百分比和奈韦拉平血浆浓度检测的单一血样。
共纳入 300 名患者及其陪同的照顾者，患者的平均年龄（标准差）为 8（3）岁。照顾者报告和药物返还均显示出较高的依从性（分别为 98%和 97%）。然而，奈韦拉平血浆浓度评估的依从性水平（85%）明显低于照顾者报告和药物返还（p<0.001）。奈韦拉平血浆浓度与药物返还和奈韦拉平血浆浓度与照顾者报告之间的一致性较弱（k=0.131）（k=0.09）。奈韦拉平血浆浓度低于 3μg/ml 与免疫抑制有关（p=0.021），而药物返还（超过规定剂量的 5%）和照顾者报告在接受采访前 72 小时内漏服超过一剂与免疫抑制无关（p=0.474）（p=0.569）。
使用奈韦拉平血浆浓度观察到的依从性水平较低及其与免疫反应的关系支持该方法的有效性，并表明从照顾者报告和药物返还中获得的依从性数据可能高估了儿科抗逆转录病毒治疗的真实依从性。
