Clinical Trials Unit, Aviation House, 125 Kingsway, London, WC2B 6NH, UK.
AIDS. 2011 Nov 28;25(18):2279-87. doi: 10.1097/QAD.0b013e32834d614c.
To investigate virological and immunological response to antiretroviral therapy (ART), and predictors of switching and interrupting treatment among infants starting ART across Europe.
Cohort study.
Nine cohorts from 13 European countries contributed data on HIV-infected infants born 1996-2008 and starting ART before age 12 months. Logistic and linear regression, and competing risks methods were used to assess predictors of virological (viral load <400 copies/ml) and immunological (change in CD4 Z-score) response, switching to second-line ART and treatment interruptions with viral load less than 400 copies/ml.
A total of 437 infants were followed for median 5.9 (interquartile range 2.3-7.6) years after starting ART; 30% had an AIDS diagnosis prior to ART initiation. 53% had suppressed viral load <400 copies/ml at 12 months in 1996-1999, increasing to 77% in 2004-2008. Virological and immunological responses at 12 months varied by initial ART type (P < 0.001 and P = 0.03, respectively), with four-drug nonnucleoside reverse transcriptase inhibitor (NNRTI)-based regimens being superior [virological response <400 copies/ml adjusted odds ratio = 3.00, 95% confidence interval (CI) 1.24-7.23; mean increase in CD4 Z-score coefficient = 0.64, 95% CI 0.10-1.17] to both three-drug NNRTI-based (reference) and boosted protease inhibitor regimens which were similar. Rates of switching to second-line ART were lower among children starting four-drug NNRTI-based and boosted protease inhibitor-based regimens compared with three-drug NNRTI regimens (P = 0.03). Sixty five percent of infants remained on first-line ART without treatment interruption after 5 years.
Effective and prolonged responses to first-line ART can now be achieved in infants starting early ART outside trial settings. Superior responses to four-drug NNRTI compared with boosted protease inhibitor or three-drug NNRTI regimens need further evaluation, as does treatment interruption following early ART.
研究在欧洲，开始抗逆转录病毒治疗（ART）的婴儿的病毒学和免疫学反应，以及切换和中断治疗的预测因素。
队列研究。
来自欧洲 13 个国家的 9 个队列提供了 1996 年至 2008 年出生且在 12 个月之前开始 ART 的 HIV 感染婴儿的数据。使用逻辑回归和线性回归以及竞争风险方法来评估病毒学（病毒载量<400 拷贝/ml）和免疫学（CD4 Z 分数变化）反应、切换至二线 ART 和治疗中断的预测因素。
共有 437 名婴儿在开始 ART 后中位数 5.9 年（四分位距 2.3-7.6 年）进行了随访；30%在开始 ART 前已被诊断为艾滋病。1996 年至 1999 年，有 53%的婴儿在 12 个月时病毒载量抑制到<400 拷贝/ml，到 2004 年至 2008 年增加到 77%。12 个月时的病毒学和免疫学反应因初始 ART 类型而异（P<0.001 和 P=0.03），四药非核苷逆转录酶抑制剂（NNRTI）为基础的方案更优[病毒学反应<400 拷贝/ml 的调整优势比为 3.00，95%置信区间（CI）为 1.24-7.23；CD4 Z 分数增加的平均系数为 0.64，95%CI 为 0.10-1.17]，与三药 NNRTI 为基础（参照）和强化蛋白酶抑制剂方案相似。与三药 NNRTI 方案相比，开始使用四药 NNRTI 为基础和强化蛋白酶抑制剂方案的儿童切换到二线 ART 的比例较低（P=0.03）。5 年后，65%的婴儿在没有中断治疗的情况下继续使用一线 ART。
现在可以在试验环境之外开始早期 ART 的婴儿中实现有效的长期 ART 反应。与强化蛋白酶抑制剂或三药 NNRTI 方案相比，四药 NNRTI 方案的优越反应需要进一步评估，早期 ART 后中断治疗也需要进一步评估。
