Kline Mark W, Rugina Sorin, Ilie Margareta, Matusa Rodica F, Schweitzer Ana-Maria, Calles Nancy R, Schwarzwald Heidi L
Baylor College of Medicine International Pediatric AIDS Initiative, Texas Children's Hospital, Houston, Texas, USA.
Pediatrics. 2007 May;119(5):e1116-20. doi: 10.1542/peds.2006-2802. Epub 2007 Apr 9.
There are no published reports of the long-term safety and effectiveness of highly active antiretroviral therapy for children and adolescents living in resource-limited settings or of large cohorts of HIV-infected children and adolescents treated long-term (>48 weeks) with lopinavir/ritonavir-containing highly active antiretroviral therapy.
The purpose of this work was to evaluate the long-term outcomes of treatment of HIV-infected children and adolescents with lopinavir/ritonavir-containing highly active antiretroviral therapy in a resource-limited setting.
We studied an inception cohort of 414 HIV-infected children receiving lopinavir/ritonavir-containing highly active antiretroviral therapy between November 2001 and August 2006 at the Romanian-American Children's Center in Constanta, Romania. The center provides comprehensive primary and HIV specialty care and treatment to all known HIV-infected children and adolescents living in Constanta. We measured safety and effectiveness by the percentage of children remaining on treatment, rates of mortality, and changes in plasma HIV RNA concentrations and CD4+ lymphocyte counts.
The study population consisted predominantly of antiretroviral drug-experienced older children and adolescents with advanced HIV disease. Treatment was well tolerated, with 337 children (81%) remaining on therapy after a median duration of >4 years. Thirty-seven deaths occurred; the death rate compared favorably to prospectively collected historical data. The most recent on-treatment plasma HIV RNA concentration was <400 copies per milliliter in 192 of 265 children tested. The mean baseline CD4+ lymphocyte count was 292 cells per microliter (n = 299); the mean change from baseline was +266 (n = 284), +317 (n = 260), +343 (n = 176), and +270 cells per microliter (n = 121) after 1, 2, 3, and 4 years of treatment, respectively.
Highly active antiretroviral therapy can be administered safely and effectively to children and adolescents in resource-limited settings. Lopinavir/ritonavir-containing highly active antiretroviral therapy is a safe, effective, and durable treatment option for antiretroviral drug-experienced older children and adolescents with advanced HIV disease.
对于生活在资源有限环境中的儿童和青少年，尚无关于高效抗逆转录病毒疗法长期安全性和有效性的公开报告，也没有关于接受含洛匹那韦/利托那韦的高效抗逆转录病毒疗法长期治疗（超过48周）的大量HIV感染儿童和青少年队列的公开报告。
这项工作的目的是评估在资源有限的环境中，用含洛匹那韦/利托那韦的高效抗逆转录病毒疗法治疗HIV感染儿童和青少年的长期结果。
我们研究了2001年11月至2006年8月期间在罗马尼亚康斯坦察的罗马尼亚 - 美国儿童中心接受含洛匹那韦/利托那韦的高效抗逆转录病毒疗法的414名HIV感染儿童的起始队列。该中心为所有已知的生活在康斯坦察的HIV感染儿童和青少年提供全面的初级和HIV专科护理及治疗。我们通过继续接受治疗的儿童百分比、死亡率以及血浆HIV RNA浓度和CD4 +淋巴细胞计数的变化来衡量安全性和有效性。
研究人群主要由有抗逆转录病毒药物治疗经验的大龄儿童和患有晚期HIV疾病的青少年组成。治疗耐受性良好，中位治疗时间超过4年后，有337名儿童（81%）仍在接受治疗。发生了37例死亡；死亡率与前瞻性收集的历史数据相比情况较好。在接受检测的265名儿童中，有192名儿童最近一次治疗时的血浆HIV RNA浓度低于每毫升400拷贝。基线时CD4 +淋巴细胞的平均计数为每微升292个细胞（n = 299）；治疗1、2、3和4年后，与基线相比的平均变化分别为每微升+266（n = 284）、+317（n = 260）、+343（n = 176）和+270个细胞（n = 121）。
在资源有限的环境中，可以安全有效地对儿童和青少年实施高效抗逆转录病毒疗法。对于有抗逆转录病毒药物治疗经验、患有晚期HIV疾病的大龄儿童和青少年，含洛匹那韦/利托那韦的高效抗逆转录病毒疗法是一种安全、有效且持久的治疗选择。
