Intrapartum and neonatal single-dose nevirapine compared with zidovudine for prevention of mother-to-child transmission of HIV-1 in Kampala, Uganda: 18-month follow up of the HIVNET 012 randomized trial
Intrapartum and neonatal single-dose nevirapine compared with zidovudine for prevention of mother-to-child transmission of HIV-1 in Kampala, Uganda: 18-month follow up of the HIVNET 012 randomized trial
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乌干达坎帕拉产时和新生儿单剂量奈韦拉平与齐多夫定预防 HIV-1 母婴传播的比较：HIVNET 012 随机试验的 18 个月随访
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发表时间：
2004
期刊：
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通讯作者：
F. Mmiro
中科院分区：
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作者：
J. Jackson;P. Musoke;T. Fleming;L. Guay;D. Bagenda;M. Allen;C. Nakabiito;J. Sherman;P. Bakaki;M. Owor;Contance Ducar;M. Deseyve;A. Mwatha;L. Emel;C. Duefield;M. Mirochnick;M. Fowler;Lynne M. Mofenson;P. Miotti;Maria Gigllottl;D. Bray;F. Mmiro
在分娩初期向感染人类免疫缺陷病毒1型（HIV-1）的妇女提供抗逆转录病毒治疗可以提供一种相对简单和负担得起的预防垂直传播的手段。1999年，HIVNET 012研究小组报告称，与短暂的齐多夫定治疗方案相比，单剂量的产时/新生儿奈韦拉平治疗方案显著降低了47%的母婴传播风险。对496名婴儿进行了14至16周的随访。现在可获得这些婴儿直至18个月的数据。参与研究的母亲被分配在分娩开始时接受200毫克奈韦拉平，出生后72小时内婴儿服用2毫克/公斤（方案A），或在分娩开始时接受600毫克齐多夫定，随后每3小时服用300毫克，直到分娩，然后每天口服两次4毫克/公斤，持续7天（方案B）。HIV-1检测估计1岁前的HIV-1 RNA和18个月大时的HIV-1抗体。出生时齐多夫定组HIV-1传播的估计风险为10.3%，奈韦拉平组为8.1%；6 ~ 8周龄分别为20%和11.8%；14至16周龄22.1%和13.5%；18个月时分别为25.8%和15.7%。总的来说，在最后的随访中，奈韦拉平与HIV-1传播相对风险降低41%相关（95%置信区间，16-59%）。多因素分析显示，除治疗效果外，母体基线病毒载量和CD4细胞计数也具有高度显著性。调整母乳喂养状态并没有改变治疗效果。在两个治疗组中，大约10%的婴儿在出生后的头2个月内发生了严重的不良事件，在18个月时事件也相当频繁。在欠发达国家，产时/新生儿奈韦拉平似乎是一种简单、廉价且耐受性良好的治疗方案，可显著减少HIV-1的围产期传播。
Providing antiretroviral therapy to human immunodeficiency virus type 1 (HIV-1)-infected women at the onset of labor could offer a relatively simple and affordable means of preventing vertical transmission. The HIVNET 012 study team reported, in 1999, that a single-dose intrapartum/neonatal regimen of nevirapine significantly lowered the risk of mother-child transmission by 47% compared with a brief regimen of zidovudine. The 496 infants had been followed up for 14 to 16 weeks. Data now are available for these infants up to age 18 months. Participating mothers had been assigned to receive either 200 mg nevirapine at the onset of labor, with 2 mg/kg for the infant within 72 hours after birth (regimen A), or 600 mg zidovudine at the onset of labor, followed by 300 mg every 3 hours until delivery and then 4 mg/kg orally twice a day for 7 days for the infant (regimen B). Testing for HIV-1 estimated HIV-1 RNA up to age 1 year and HIV-1 antibody at age 18 months. The estimated risk of HIV-1 transmission was 10.3% with zidovudine and 8.1% in the nevirapine group at birth; 20% and 11.8%, respectively, by age 6 to 8 weeks; 22.1% and 13.5% by age 14 to 16 weeks; and 25.8% and 15.7% by age 18 months. In all, nevirapine was associated with a 41% reduction in the relative risk of HIV-1 transmission at last follow up (95% confidence interval, 16-59%). Multivariate analysis showed that highly significant factors, besides the treatment effect, included the baseline maternal viral load and CD4 cell count. Adjusting for breastfeeding status did not alter the treatment effect. Serious adverse infant events in the first 2 months after birth occurred in approximately 10% of both treatment groups, and events also were comparably frequent at age 18 months. Intrapartum/neonatal nevirapine appears to be a simple, inexpensive, and well-tolerated regimen for significantly reducing perinatal transmission of HIV-1 in less developed countries.