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首页> 外文期刊>The New England journal of medicine >Extended antiretroviral prophylaxis to reduce breast-milk HIV-1 transmission.
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Extended antiretroviral prophylaxis to reduce breast-milk HIV-1 transmission.

机译:扩大抗逆转录病毒预防措施以减少母乳中HIV-1的传播。

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摘要

BACKGROUND: 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. METHODS: 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. RESULTS: 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 (theprimary 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. CONCLUSIONS: 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.)
机译:背景:迫切需要有效的策略,以在资源有限的环境中通过母乳喂养减少1型人类免疫缺陷病毒(HIV-1)的母婴传播。方法:在马拉维的布兰太尔参加了一项以HIV-1感染为母乳喂养的婴儿的妇女的3期随机试验。婴儿出生时被随机分配到以下三种方案中的一种:单剂量奈韦拉平加1周齐多夫定(对照方案)或对照方案加上每日延长预防性使用奈韦拉平(扩大奈韦拉平)或奈韦拉平联合齐多夫定(延长双重用药)预防)直到14周龄。使用Kaplan-Meier分析,我们通过出生时的DNA聚合酶链反应分析评估了HIV-1阴性婴儿的HIV-1感染风险。结果:在该研究的3016名婴儿中,对照组从6周到18个月的年龄一直都有较高的HIV-1感染率。在第9个月时,对照组的HIV-1感染率(主要终点)估计为10.6%,而延长的奈韦拉平组为5.2%(P <0.001),而延长的双用药为6.4%。预防组(P = 0.002)。两个扩展预防组之间没有显着差异。研究组之间的母乳喂养频率没有显着差异。接受长期双重预防的婴儿被认为可能与研究药物有关的不良事件(主要是中性粒细胞减少症)的数量显着增加。结论:在出生后的头14周内使用奈韦拉平或奈韦拉平和齐多夫定进行预防可显着降低9个月大婴儿的出生后HIV-1感染。 (ClinicalTrials.gov编号,NCT00115648。)

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