Kumwenda Newton I, Hoover Donald R, Mofenson Lynne M, Thigpen Michael C, Kafulafula George, Li Qing, Mipando Linda, Nkanaunena Kondwani, Mebrahtu Tsedal, Bulterys Marc, Fowler Mary Glenn, Taha Taha E
Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD 21205, USA.
N Engl J Med. 2008 Jul 10;359(2):119-29. doi: 10.1056/NEJMoa0801941. Epub 2008 Jun 4.
Effective strategies are urgently needed to reduce mother-to-child transmission of human immunodeficiency virus type 1 (HIV-1) through breast-feeding in resource-limited settings.
Women with HIV-1 infection who were breast-feeding infants were enrolled in a randomized, phase 3 trial in Blantyre, Malawi. At birth, the infants were randomly assigned to one of three regimens: single-dose nevirapine plus 1 week of zidovudine (control regimen) or the control regimen plus daily extended prophylaxis either with nevirapine (extended nevirapine) or with nevirapine plus zidovudine (extended dual prophylaxis) until the age of 14 weeks. Using Kaplan-Meier analyses, we assessed the risk of HIV-1 infection among infants who were HIV-1-negative on DNA polymerase-chain-reaction assay at birth.
Among 3016 infants in the study, the control group had consistently higher rates of HIV-1 infection from the age of 6 weeks through 18 months. At 9 months, the estimated rate of HIV-1 infection (the primary end point) was 10.6% in the control group, as compared with 5.2% in the extended-nevirapine group (P<0.001) and 6.4% in the extended-dual-prophylaxis group (P=0.002). There were no significant differences between the two extended-prophylaxis groups. The frequency of breast-feeding did not differ significantly among the study groups. Infants receiving extended dual prophylaxis had a significant increase in the number of adverse events (primarily neutropenia) that were deemed to be possibly related to a study drug.
Extended prophylaxis with nevirapine or with nevirapine and zidovudine for the first 14 weeks of life significantly reduced postnatal HIV-1 infection in 9-month-old infants. (ClinicalTrials.gov number, NCT00115648.)
在资源有限的环境中，迫切需要有效的策略来减少人类免疫缺陷病毒1型（HIV-1）通过母乳喂养的母婴传播。
对正在母乳喂养婴儿的HIV-1感染女性进行了一项在马拉维布兰太尔开展的随机3期试验。婴儿出生时被随机分配至三种方案之一：单剂量奈韦拉平加1周齐多夫定（对照方案），或对照方案加每日延长预防用药，即使用奈韦拉平（延长奈韦拉平方案）或奈韦拉平加齐多夫定（延长双药预防方案），直至14周龄。我们使用Kaplan-Meier分析评估了出生时DNA聚合酶链反应检测HIV-1阴性的婴儿中HIV-1感染风险。
在该研究的3016名婴儿中，对照组从6周龄至18个月龄的HIV-1感染率始终较高。在9个月时，对照组的HIV-1感染估计率（主要终点）为10.6%，而延长奈韦拉平组为5.2%（P<0.001），延长双药预防组为6.4%（P=0.002）。两个延长预防组之间无显著差异。各研究组之间的母乳喂养频率无显著差异。接受延长双药预防的婴儿中，被认为可能与研究药物相关的不良事件（主要是中性粒细胞减少）数量显著增加。
在出生后的前14周使用奈韦拉平或奈韦拉平与齐多夫定进行延长预防，可显著降低9月龄婴儿的产后HIV-1感染率。（ClinicalTrials.gov编号，NCT00115648。）
