Maternal or Infant Antiretroviral Drugs to Reduce HIV-1 Transmission

作者：Chasela Charles S; Hudgens Michael G; Jamieson Denise J; Kayira Dumbani; Hosseinipour Mina C; Kourtis Athena P; Martinson Francis; Tegha Gerald; Knight Rodney J; Ahmed Yusuf I; Kamwendo Deborah D; Hoffman Irving F; Ellington Sascha R; Kacheche Zebrone; Soko Alice; Wiener Jeffrey B; Fiscus Susan A; Kazembe Peter; Mofolo Innocent A; Chigwenembe Maggie; Sichali Dorothy S; van der Horst Charles M^*

来源：New England Journal of Medicine, 2010, 362(24): 2271-2281.

DOI：10.1056/NEJMoa0911486

Background
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.
Methods
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.
Results
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.
Conclusions
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.)

• 出版日期2010-6-17