Reuse of Nevirapine in Exposed HIV-Infected Children After Protease Inhibitor-Based Viral Suppression A Randomized Controlled Trial
Reuse of Nevirapine in Exposed HIV-Infected Children After Protease Inhibitor-Based Viral Suppression A Randomized Controlled Trial
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DOI：
10.1001/jama.2010.1278
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发表时间：
2010-09-08
影响因子：
120.7
通讯作者：
Kuhn, Louise
中科院分区：
文献类型：
--
作者：
Coovadia, Ashraf;Abrams, Elaine J.;Kuhn, Louise
背景：建议对感染人类免疫缺陷病毒(HIV)的婴儿使用奈韦拉平，以预防母婴传播。然而，无限期地继续基于PI的治疗是有局限性的，重复使用奈韦拉平有许多好处。目的测试最初通过基于PI的治疗实现病毒抑制的奈韦拉平暴露的婴儿在切换到基于奈韦拉平的治疗时是否能够保持病毒抑制。设计、设置和患者随机试验于2005年4月至2009年5月在南非约翰内斯堡的一家医院进行，从323名在24个月前开始基于PI治疗的接触奈韦拉平的儿童中选取195名在3个月或更长时间内实现病毒抑制低于400拷贝/毫升。干预对照组儿童继续接受利托那韦强化的洛普韦、司他夫定和拉米夫定(n=99)。转换组儿童用奈韦拉平替代利托那韦增强型洛匹那韦(n=96)。主要观察指标随机分组后对儿童进行52周的随访。血浆HIV-1RNA>50拷贝/毫升为主要终点。结果血浆病毒血症>50拷贝/毫升的发生率(Kaplan-Meier概率，0.438；95%CI，0.334~0.537)明显低于对照组(0.576；95%CI，0.470~0.668)(P=0.02)。转换组确诊病毒血症的发生率(0.201；95%CI，0.125~0.289)明显高于对照组(0.022；95%CI，0.004~0.069)(P
Context Protease inhibitor (PI)-based therapy is recommended for infants infected with human immunodeficiency virus (HIV) who were exposed to nevirapine for prevention of mother-to-child HIV transmission. However, there are limitations of continuing PI-based therapy indefinitely and reuse of nevirapine has many advantages.Objective To test whether nevirapine-exposed infants who initially achieve viral suppression with PI-based therapy can maintain viral suppression when switched to nevirapine-based therapy.Design, Setting, and Patients Randomized trial conducted between April 2005 and May 2009 at a hospital in Johannesburg, South Africa, among 195 children who achieved viral suppression less than 400 copies/mL for 3 or more months from a cohort of 323 nevirapine exposed children who initiated PI-based therapy before 24 months of age.Interventions Control group children continued to receive ritonavir-boosted lopinavir, stavudine, and lamivudine (n=99). Switch group children substituted nevirapine for ritonavir-boosted lopinavir (n=96).Main Outcome Measures Children were followed up for 52 weeks after randomization. Plasma HIV-1 RNA of greater than 50 copies/mL was the primary end point. Confirmed viremia greater than 1000 copies/mL was used as a criterion to consider regimen changes for children in either group (safety end point).Results Plasma viremia greater than 50 copies/mL occurred less frequently in the switch group (Kaplan-Meier probability, 0.438; 95% CI, 0.334-0.537) than in the control group (0.576; 95% CI, 0.470-0.668) (P=.02). Confirmed viremia greater than 1000 copies/mL occurred more frequently in the switch group (0.201; 95% CI, 0.125-0.289) than in the control group (0.022; 95% CI, 0.004-0.069) (P