Poerksen Goenke, Pollock Louisa, Moons Peter, Chesshyre Emily, Burger David, Khoo Saye, Molyneux Elizabeth
General Paediatrics, Royal Hospital for Sick Children, Edinburgh, UK.
Antivir Ther. 2010;15(3):343-50. doi: 10.3851/IMP1544.
Children remain under-represented in national antiretroviral treatment (ART) programmes in settings with limited resources and high HIV prevalence. In Malawi, an increasing number of HIV-infected children have been started on ART with split tablets of an adult fixed-dose combination drug in the past few years. In 2006, the national paediatric ART regime was changed from Triomune 40 (T40) to Triomune 30 (T30).
This was a cross-sectional study conducted at the paediatric ART clinic in Blantyre (Malawi) from September 2006 to July 2007. Children taking T30 for > 6 weeks from each dosing weight band (<5, 5-<8, 8-<12, 12-<14, 14-<19, 19-<26, 26-<30 and > or = 30 kg) were recruited. Plasma drug concentration, CD4+ T-cell count and HIV viral load were measured.
A total of 74 children were analysed. The median nevirapine (NVP) concentration was 7.35 mg/l. A therapeutic NVP plasma level > 3 mg/l was found in 62 (87.8%) children. A subtherapeutic NVP level (< 3 mg/l) occurred significantly more often in children treated with T30 doses between one-quarter tablet once daily and one-half tablet twice daily (P=0.035). Median prescribed NVP dose was 342 mg/m(2)/day, but 13 (17.6%) children received a dose below the recommended dose of 300 mg/m(2)/day. Compared with a historical control, the median prescribed NVP dose was increased (from 243 to 342 mg/m(2)/day).
Our findings indicate that with the Malawian T30-based ART regime, the majority (87.8%) of children in the study group achieved a therapeutic NVP level. However, treatment remains suboptimal especially for young children receiving T30 dosages less than or equal to one-half tablets twice daily and child appropriate formulations are warranted.
在资源有限且艾滋病毒感染率高的地区，儿童在国家抗逆转录病毒治疗（ART）项目中的代表性仍然不足。在马拉维，过去几年越来越多感染艾滋病毒的儿童开始使用成人固定剂量复方药物的分割片进行抗逆转录病毒治疗。2006年，该国的儿科抗逆转录病毒治疗方案从三联片40（T40）改为三联片30（T30）。
这是一项于2006年9月至2007年7月在马拉维布兰太尔的儿科抗逆转录病毒治疗诊所进行的横断面研究。从每个给药体重范围（<5、5 - <8、8 - <12、12 - <14、14 - <19、19 - <26、26 - <30以及≥30千克）中选取服用T30超过6周的儿童。测量血浆药物浓度、CD4 + T细胞计数和艾滋病毒病毒载量。
共分析了74名儿童。奈韦拉平（NVP）的中位浓度为7.35毫克/升。62名（87.8%）儿童的NVP血浆水平达到治疗水平（>3毫克/升）。在每天服用四分之一片至每天服用半片两次的T30剂量治疗的儿童中，NVP水平低于治疗水平（<3毫克/升）的情况明显更常见（P = 0.035）。规定的NVP中位剂量为342毫克/平方米/天，但13名（17.6%）儿童接受的剂量低于300毫克/平方米/天的推荐剂量。与历史对照相比，规定的NVP中位剂量有所增加（从243毫克/平方米/天增至342毫克/平方米/天）。
我们的研究结果表明，基于马拉维T30的抗逆转录病毒治疗方案，研究组中的大多数儿童（87.8%）达到了NVP的治疗水平。然而，治疗仍未达到最佳效果，特别是对于每天服用T30剂量小于或等于半片两次的幼儿，因此需要适合儿童的制剂。
