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奈韦拉平与依非韦伦治疗方案对泰国HIV感染儿童的疗效和耐受性比较

Efficacy and tolerability of nevirapine- versus efavirenz-containing regimens in HIV-infected Thai children.

作者信息

Lapphra Keswadee, Vanprapar Nirun, Chearskul Sanay, Phongsamart Wanatpreeya, Chearskul Pimpanada, Prasitsuebsai Wasana, Chokephaibulkit Kulkanya

机构信息

Department of Pediatrics, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand.

出版信息

Int J Infect Dis. 2008 Nov;12(6):e33-8. doi: 10.1016/j.ijid.2007.10.008. Epub 2008 Jun 24.

Abstract

BACKGROUND

Non-nucleoside reverse transcriptase inhibitor (NNRTI)-based highly active antiretroviral therapy (HAART) has been the most affordable regimen for the HIV-infected in developing countries. There are limited data comparing nevirapine (NVP) to efavirenz (EFV) in HIV-infected children. This study aimed to assess the efficacy and tolerability of NVP-based regimens compared to EFV-based regimens in HIV-infected children in Thailand.

METHODS

The medical records of HIV-infected children who had received NNRTI-based regimens for more than 6 months at the Department of Pediatrics, Siriraj Hospital, Mahidol University, Thailand, were reviewed.

RESULTS

Of the 139 HIV-infected children studied, 70 were male, and the median age at treatment initiation was 6.08 years (range 0.32-14.56 years); the median duration of follow-up was 36 months (range 6-66 months). The median baseline CD4 cell count was 185cells/mm(3) (range 2-3482cells/mm(3)) and the median baseline CD4 percentage was 7.20% (range 0.11-36.57%). An NVP-based regimen was initiated in 61 (44%): 38 antiretroviral (ARV)-naïve and 23 ARV-experienced. An EFV-based regimen was initiated in 78 (56%): 34 ARV-naïve and 44 ARV-experienced. The CD4 cell count and percentage gains were not different between the NVP and EFV groups in both the ARV-naïve and the ARV-experienced. However, ARV-naïve children who received an EFV regimen had significantly lower baseline CD4 levels than those who received an NVP regimen. ARV-naïve children had a better CD4 response than the ARV-experienced. The survival rates of children in the NVP groups were not different from those in the EFV groups for both the ARV-naïve and the ARV-experienced. Treatment failure occurred in one ARV-naïve NVP case (2.6%), two ARV-naïve EFV cases (5.8%), and nine ARV-experienced NVP cases (39%) at 24 months of treatment, and 11 ARV-experienced EFV cases (25%) at 18 months of treatment. Seven (10%) children had adverse effects from treatment with NVP. The main side effects were rash and hepatitis; six had to switch to EFV. Four (5%) children had adverse effects from treatment with EFV; two had to switch to NVP.

CONCLUSIONS

Both NVP- and EFV-based HAART regimens were effective in children in Thailand for at least 3 years. HIV-infected Thai children generally tolerated NNRTI well.

摘要

背景

基于非核苷类逆转录酶抑制剂(NNRTI)的高效抗逆转录病毒疗法(HAART)一直是发展中国家艾滋病毒感染者最经济实惠的治疗方案。关于艾滋病毒感染儿童中奈韦拉平(NVP)与依非韦伦(EFV)对比的数据有限。本研究旨在评估在泰国艾滋病毒感染儿童中,基于NVP的治疗方案与基于EFV的治疗方案的疗效和耐受性。

方法

回顾了泰国玛希隆大学诗里拉吉医院儿科接受基于NNRTI治疗方案超过6个月的艾滋病毒感染儿童的病历。

结果

在研究的139名艾滋病毒感染儿童中,70名是男性,开始治疗时的中位年龄为6.08岁(范围0.32 - 14.56岁);中位随访时间为36个月(范围6 - 66个月)。基线CD4细胞计数中位数为185个细胞/mm³(范围2 - 3482个细胞/mm³),基线CD4百分比中位数为7.20%(范围0.11 - 36.57%)。61名(44%)儿童开始采用基于NVP的治疗方案:38名初治抗逆转录病毒(ARV)儿童和23名经治ARV儿童。78名(56%)儿童开始采用基于EFV的治疗方案:34名初治ARV儿童和44名经治ARV儿童。在初治和经治的ARV儿童中,NVP组和EFV组的CD4细胞计数和百分比增加情况无差异。然而,接受EFV治疗方案的初治儿童基线CD4水平显著低于接受NVP治疗方案的儿童。初治儿童的CD4反应优于经治儿童。对于初治和经治儿童,NVP组儿童的生存率与EFV组儿童无差异。在治疗24个月时,1例初治NVP病例(2.6%)、2例初治EFV病例(5.8%)以及9例经治NVP病例(39%)出现治疗失败;在治疗18个月时,11例经治EFV病例(25%)出现治疗失败。7名(10%)儿童在接受NVP治疗时有不良反应。主要副作用是皮疹和肝炎;6名儿童不得不改用EFV。4名(5%)儿童在接受EFV治疗时有不良反应;2名儿童不得不改用NVP。

结论

基于NVP和EFV的HAART治疗方案在泰国儿童中至少3年有效。泰国艾滋病毒感染儿童对NNRTI总体耐受性良好。

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