Maternal or infant antiretroviral drugs to reduce HIV-1 transmission.
Maternal or infant antiretroviral drugs to reduce HIV-1 transmission.
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DOI：
10.1056/nejmoa0911486
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发表时间：
2010-06-17
期刊：
影响因子：
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通讯作者：
BAN Study Group
中科院分区：
文献类型：
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作者：
Chasela CS;Hudgens MG;Jamieson DJ;Kayira D;Hosseinipour MC;Kourtis AP;Martinson F;Tegha G;Knight RJ;Ahmed YI;Kamwendo DD;Hoffman IF;Ellington SR;Kacheche Z;Soko A;Wiener JB;Fiscus SA;Kazembe P;Mofolo IA;Chigwenembe M;Sichali DS;van der Horst CM;BAN Study Group
我们评估了马拉维母乳喂养期间母亲三联抗逆转录病毒治疗方案或婴儿奈韦拉平预防治疗28周以减少人类免疫缺陷病毒1型（HIV-1）产后传播的疗效。我们将2369名HIV-1阳性、哺乳期母亲（CD 4+淋巴细胞计数至少为250个细胞/mm 3）及其婴儿随机分配至接受母体抗逆转录病毒治疗方案、婴儿奈韦拉平或不接受延长的产后抗逆转录病毒治疗方案（对照组）。所有母亲和婴儿均接受单剂量奈韦拉平和1周齐多夫定加拉米夫定的围产期预防。我们使用Kaplan-Meier方法来估计出生后2周HIV-1阴性的婴儿在28周内HIV-1传播或死亡的累积风险。使用对数秩检验比较发生率。在母婴配对中，5.0%的婴儿在出生2周时HIV-1呈阳性。对照组在2 - 28周之间HIV-1传播的估计风险（5.7%）高于母亲方案组（2.9%，P = 0.009）或婴儿方案组（1.7%，P<0.001）。2 ~ 28周婴儿HIV-1感染或死亡的估计风险在对照组为7.0%，在母体方案组为4.1%（P = 0.02），在婴儿方案组为2.6%（P<0.001）。在接受抗逆转录病毒治疗的患者中，中性粒细胞减少症的女性比例（6.2%）高于奈韦拉平组（2.6%）或对照组（2.3%）。在接受奈韦拉平治疗的婴儿中，1.9%发生超敏反应。无论是母亲使用抗逆转录病毒治疗方案或婴儿奈韦拉平28周是有效的，在减少HIV-1的传播母乳喂养。（ClinicalTrials.gov编号，NCT 00164736。）
We evaluated the efficacy of a maternal triple-drug antiretroviral regimen or infant nevirapine prophylaxis for 28 weeks during breast-feeding to reduce postnatal transmission of human immunodeficiency virus type 1 (HIV-1) in Malawi. We randomly assigned 2369 HIV-1–positive, breast-feeding mothers with a CD4+ lymphocyte count of at least 250 cells per cubic millimeter and their infants to receive a maternal antiretroviral regimen, infant nevirapine, or no extended postnatal antiretroviral regimen (control group). All mothers and infants received perinatal prophylaxis with single-dose nevirapine and 1 week of zidovudine plus lamivudine. We used the Kaplan–Meier method to estimate the cumulative risk of HIV-1 transmission or death by 28 weeks among infants who were HIV-1–negative 2 weeks after birth. Rates were compared with the use of the log-rank test. Among mother–infant pairs, 5.0% of infants were HIV-1–positive at 2 weeks of life. The estimated risk of HIV-1 transmission between 2 and 28 weeks was higher in the control group (5.7%) than in either the maternal-regimen group (2.9%, P = 0.009) or the infant-regimen group (1.7%, P<0.001). The estimated risk of infant HIV-1 infection or death between 2 and 28 weeks was 7.0% in the control group, 4.1% in the maternal-regimen group (P = 0.02), and 2.6% in the infant-regimen group (P<0.001). The proportion of women with neutropenia was higher among those receiving the antiretroviral regimen (6.2%) than among those in either the nevirapine group (2.6%) or the control group (2.3%). Among infants receiving nevirapine, 1.9% had a hypersensitivity reaction. The use of either a maternal antiretroviral regimen or infant nevirapine for 28 weeks was effective in reducing HIV-1 transmission during breast-feeding. (ClinicalTrials.gov number, NCT00164736.)