Mukherjee Aparna, Singla Mohit, Velpandian T, Sirohiwal Anju, Vajpayee M, Singh Ravinder, Kabra S K, Lodha Rakesh
Departments of Pediatrics, *Ocular Pharmacology and #Microbiology, All India Institute of Medical Sciences, New Delhi, India. Correspondence to: Dr Rakesh Lodha, Additional Professor, Department of Pediatrics, AIIMS, New Delhi, India.
Indian Pediatr. 2014 Mar;51(3):191-7. doi: 10.1007/s13312-014-0382-3.
To determine the trough and two hour plasma levels of nevirapine, stavudine, and lamivudine when administered in fixed dose combinations (FDC).
Cross sectional.
Tertiary care hospital in Northern India.
79 HIV-infected children receiving antiretroviral therapy with FDCs for more than month.
Two-point sampling (0 and 2 hours after the morning dose).
Plasma concentrations of all three drugs were simultaneously assayed by liquid chromatography/mass spectroscopy.
Majority (77%) of children were receiving fixed dose combination of stavudine, lamivudine, nevirapine in the ratio of 6:30:50 mg. The median (IQR) trough and 2-hour plasma levels (µg/mL) of nevirapine, stavudine and lamivudine were 5.2 (4.0, 6.3) and 7.9 (6.0, 9.7); 0.1 (0.06, 0.16) and 1.1 (0.59, 1.6); 0.1 (0.02, 0.2) and 2.5 (1.4, 3.1), respectively. Very few children had sub-therapeutic plasma drug levels of stavudine (2.5%), lamivudine (7.6%) and nevirapine (10%). Inadequate viral suppression at 6 months follow up was significantly associated with initial high viral load, low CD4 percentage at the time of enrolment in study, and lower doses of lamivudine and stavudine.
The currently available generic pediatric fixed dose antiretroviral combinations in India provide adequate drug exposure in majority of children.
确定以固定剂量组合（FDC）形式给药时，奈韦拉平、司他夫定和拉米夫定的谷浓度及服药两小时后的血药浓度。
横断面研究。
印度北部的三级护理医院。
79名接受抗逆转录病毒治疗且使用FDC超过一个月的HIV感染儿童。
两点取样（早晨服药后0小时和2小时）。
采用液相色谱/质谱联用技术同时检测三种药物的血药浓度。
大多数（77%）儿童接受的是司他夫定、拉米夫定、奈韦拉平按6:30:50毫克比例的固定剂量组合。奈韦拉平、司他夫定和拉米夫定的中位数（四分位间距）谷浓度及服药两小时后的血药浓度（微克/毫升）分别为5.2（4.0，6.3）和7.9（6.0，9.7）；0.1（0.06，0.16）和1.1（0.59，1.6）；0.1（0.02，0.2）和2.5（1.4，3.1）。极少儿童的司他夫定（2.5%）、拉米夫定（7.6%）和奈韦拉平（10%）血药浓度低于治疗水平。随访6个月时病毒抑制效果不佳与初始病毒载量高、入组研究时CD4百分比低以及拉米夫定和司他夫定剂量较低显著相关。
印度目前可用的通用儿科固定剂量抗逆转录病毒组合在大多数儿童中能提供足够的药物暴露。
