Sperling R S, Shapiro D E, Coombs R W, Todd J A, Herman S A, McSherry G D, O'Sullivan M J, Van Dyke R B, Jimenez E, Rouzioux C, Flynn P M, Sullivan J L
Department of Obstetrics, Gynecology, and Reproductive Science, Mount Sinai School of Medicine, New York, NY 10029, USA.
N Engl J Med. 1996 Nov 28;335(22):1621-9. doi: 10.1056/NEJM199611283352201.
A placebo-controlled trial has shown that treatment with zidovudine reduces the rate at which human immunodeficiency virus type 1 (HIV-1) is transmitted from mother to infant. We present data from that trial showing the number of infected infants at 18 months of age and the relation between the maternal viral load, the risk of HIV-1 transmission, and the efficacy of zidovudine treatment. Viral cultures were obtained, and HIV-1 RNA was measured by two assays in samples of maternal blood obtained at study entry and at delivery.
In 402 mother-infant pairs, the rate of transmission of HIV-1 was 7.6 percent (95 percent confidence interval, 4.3 to 12.3 percent) with zidovudine treatment and 22.6 percent (95 percent confidence interval, 17.0 to 29.0 percent) with placebo (P<0.001). In the placebo group, a large viral burden at entry or delivery or a positive culture was associated with an increased risk of transmission (the transmission rate was greater than 40 percent in the highest quartile of the RNA level). In both groups, transmission occurred at a wide range of maternal plasma HIV-1 RNA levels. Zidovudine reduced plasma RNA levels somewhat (median reduction, 0.24 log). Zidovudine was effective regardless of the HIV-1 RNA level or the CD4+ count at entry. In the zidovudine group, however, after we adjusted for the base-line HIV-1 RNA level and CD4+ count, the reduction in viral RNA from base line to delivery was not significantly associated with the risk of transmission of HIV-1.
A high maternal plasma concentration of virus is a risk factor for the transmission of HIV-1 from an untreated mother to her infant. The reduction in such transmission after zidovudine treatment is only partly explained by the reduction in plasma levels of viral RNA. To prevent HIV-1 transmission, initiating maternal treatment with zidovudine is recommended regardless of the plasma level of HIV-1 RNA or the CD4+ count.
一项安慰剂对照试验表明，齐多夫定治疗可降低人类免疫缺陷病毒1型（HIV-1）母婴传播率。我们展示了该试验的数据，包括18个月龄时感染婴儿的数量，以及母体病毒载量、HIV-1传播风险和齐多夫定治疗效果之间的关系。采集了病毒培养样本，并通过两种检测方法对研究入组时和分娩时采集的母体血液样本中的HIV-1 RNA进行了测量。
在402对母婴中，接受齐多夫定治疗的HIV-1传播率为7.6%（95%置信区间为4.3%至12.3%），接受安慰剂治疗的传播率为22.6%（95%置信区间为17.0%至29.0%）（P<0.001）。在安慰剂组中，入组时或分娩时病毒载量高或培养结果呈阳性与传播风险增加相关（RNA水平最高四分位数组的传播率大于40%）。在两组中，HIV-1母婴传播均发生在母体血浆HIV-1 RNA水平的广泛范围内。齐多夫定使血浆RNA水平有所降低（中位数降低0.24对数）。无论入组时HIV-1 RNA水平或CD4+细胞计数如何，齐多夫定均有效。然而，在齐多夫定组中，在对基线HIV-1 RNA水平和CD4+细胞计数进行校正后，从基线到分娩时病毒RNA的降低与HIV-1传播风险无显著关联。
母体血浆中高病毒浓度是未经治疗的母亲将HIV-1传播给婴儿的危险因素。齐多夫定治疗后此类传播的减少仅部分归因于血浆病毒RNA水平的降低。为预防HIV-1传播，建议无论HIV-1 RNA血浆水平或CD4+细胞计数如何，均对母亲启动齐多夫定治疗。
