Breast milk HIV-1 suppression and decreased transmission: a randomized trial comparing HIVNET 012 nevirapine versus short-course zidovudine.
OBJECTIVE
To compare the effect of perinatal regimens of short-course nevirapine (HIVNET 012) and zidovudine [Thai-Centers for Disease Control and Prevention (CDC) regimen] on breast milk viral shedding and perinatal transmission during the first 6 weeks postpartum in a randomized clinical trial.


METHODS
Randomized clinical trial.


METHODS
Pregnant HIV-1 seropositive women in Nairobi, Kenya who planned to breastfeed were randomized to HIVNET 012 or Thai-CDC regimens. Two to four breast milk samples were collected each week between delivery and 6 weeks postpartum. Breast milk HIV-1 RNA was quantified using the Gen-Probe TMA assay. Infants were tested for HIV-1 DNA at birth and 6 weeks.


RESULTS
From March to October 2003, 76 women were enrolled and 795 breast milk samples were collected from 60 women who were randomized and followed after delivery. Between 3 and 21 days postpartum, nevirapine was associated with significantly greater suppression of breast milk log10 HIV-1 RNA: days 3 to 7 (1.98 versus 2.42, P = 0.1); days 8 to 14 (1.78 versus 2.48, P = 0.005); days 15 to 21 (1.90 versus 2.97, P = 0.003). At 6 weeks, the HIV-1 perinatal transmission rate was significantly lower among those who took nevirapine than zidovudine (6.8% versus 30.3%, P = 0.02).


CONCLUSIONS
Compared to a peripartum zidovudine regimen, nevirapine was significantly more likely to decrease HIV-1 RNA in breast milk during the first week and through the third week postpartum following single-dose administration, and corresponded with decreased transmission risk at 6 weeks. Sustained breast milk HIV-1 suppression may contribute to the ability of nevirapine to decrease perinatal transmission of HIV-1.
Chung
Michael H
MH
Department of Medicine, University of Washington, Seattle, Washington 98104, USA. mhchung@u.washington.edu
Kiarie
James N
JN
Richardson
Barbra A
BA
Lehman
Dara A
DA
Overbaugh
Julie
J
John-Stewart
Grace C
GC
D000328:Adult; D019380:Anti-HIV Agents / Q000627:therapeutic use*; D004279:DNA, Viral / Q000032:analysis; D005260:Female; D005500:Follow-Up Studies; D015658:HIV Infections / Q000517:prevention & control* / Q000635:transmission; D015497:HIV-1 / Q000187:drug effects / Q000302:isolation & purification*; D006801:Humans; D007231:Infant, Newborn; D018445:Infectious Disease Transmission, Vertical / Q000517:prevention & control*; D008895:Milk, Human / Q000821:virology*; D019829:Nevirapine / Q000627:therapeutic use; D011181:Postnatal Care / Q000379:methods; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000188:drug therapy; D011295:Prenatal Care / Q000379:methods; D012367:RNA, Viral / Q000032:analysis; D015215:Zidovudine / Q000627:therapeutic use
D019380:Anti-HIV Agents; D004279:DNA, Viral; D012367:RNA, Viral; D015215:Zidovudine; D019829:Nevirapine