Extended antiretroviral prophylaxis to reduce breast-milk HIV-1 transmission.
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.)
Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD 21205, USA.
Newton I
NI
Kumwenda
Donald R
DR
Hoover
Lynne M
LM
Mofenson
Michael C
MC
Thigpen
George
G
Kafulafula
Qing
Q
Li
Linda
L
Mipando
Kondwani
K
Nkanaunena
Tsedal
T
Mebrahtu
Marc
M
Bulterys
Mary Glenn
MG
Fowler
Taha E
TE
Taha
D019380:Anti-HIV Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001942:Breast Feeding; D003906:Developing Countries; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D015658:HIV Infections / Q000453:epidemiology / Q000517:prevention & control / Q000635:transmission*; D015497:HIV-1; D006801:Humans; D007223:Infant; D007226:Infant Mortality; D007231:Infant, Newborn; D018445:Infectious Disease Transmission, Vertical / Q000517:prevention & control*; D053208:Kaplan-Meier Estimate; D008295:Malawi / Q000453:epidemiology; D008297:Male; D008895:Milk, Human / Q000821:virology*; D009503:Neutropenia / Q000139:chemically induced; D019829:Nevirapine / Q000008:administration & dosage* / Q000009:adverse effects; D016016:Proportional Hazards Models; D012307:Risk Factors; D015215:Zidovudine / Q000008:administration & dosage* / Q000009:adverse effects
D019380:Anti-HIV Agents; D015215:Zidovudine; D019829:Nevirapine