Background:  The DREAM program has treated 25,000 HIV⁺ patients in 6 African countries since 2002. As part of prevention of mother-to-child transmission (PMTCT) efforts, HAART to all pregnant HIV⁺ women and formula to their infants for the first 6 months were offered, with significant reduction in transmission and good adherence. The cost of formula, however, has precluded its continued administration.

Methods:  As of August 2005, a cohort of HIV-1-infected pregnant women in Mozambique enrolled into the program. Patients received HAART antenatally and opted for exclusive breastfeeding, continuing HAART for the first 6 months of lactation with early weaning thereafter. Infants were followed prospectively and tested for HIV-1 at 1 and 6 months of age using DNA.

Results:  We enrolled 341 women with the following baseline median parameters:  age 26.0 years, pre-treatment absolute CD4 cell counts 422 cells/mm³, HIV-1 RNA 8850 copies/mL, and pre-delivery HAART duration of 87 days. Of all the women, 6% were WHO clinical stages 3 or 4; 49 (14.4%) were in their second pregnancy and 3 (0.9%) in their third. At 1 month of age, 337 infants (98.8%) were HIV uninfected and 4 (1.2%) were positive by intention-to-treat analysis. Mean virus load of non-transmitting mothers was 38,089 copies/mL vs 158,697 copies/mL in 4 transmitting women (p = 0.37). Mean maternal pre-HAART CD4 cell counts were 457 and 389 cells/mm³, respectively (p = 0.62). Mean duration of therapy pre-delivery was different:  129 days for non-transmitters and 79 days for transmitters (p = 0.58). Median infant parameters included birth weight of 3.3 kg with a z-score of –0.64, and a median hemoglobin value of 10.3 at 1 month of age, higher than that of the local population. At 6 months, an additional 2 of 251 (0.8%) infants had detectable HIV-1 results. We recorded 7 infant deaths between the 2 time points, all tested negative at 1 month with a mortality rate of 28.5/1000 child-years (significantly less than the background infant mortality rate of 100/1000 child-years). Including 6 HIV-uninfected children, 8 (2.3%) were lost to follow-up in the first month. The remaining children are younger than 6 months.

Conclusions:  The provision of HAART antenatally and during lactation to African women is safe, feasible, and highly effective in prevention of perinatal transmission. Late postnatal HIV transmission appears to be preventable with maternal use of HAART during lactation and should be strongly considered as a public health approach to PMTCT efforts.