723
DREAM Program: 6-month Follow-up of the Prevention of Mother-to-Child Transmission Service
Leonardo Palombi*1, P Germano2, G Liotta1, G Guidotti3, P Narciso4, C F Perno1, S Ceffa5, M Bartolo6, S Mancinelli1, and M Marazzi7
1Univ of Tor Vergata, Rome, Italy; 2Community of Sant'Egidio, Rome, Italy; 3Inst Superiore di Sanità, Rome, Italy; 4IRCCS L Spallanzani, Rome, Italy; 5Univ of Pisa, Italy; 6San Giovanni Hosp, Rome, Italy; and 7LUMSA Univ, Rome, Italy
Background: Prevention of HIV vertical transmission is a
burning issue in resource-limited settings. The biggest difficulty is to
translate the results of clinical trials into reality in public health
programs; focusing prevention of mother-to-child transmission (PMTCT)
strategies around the time of delivery could limit the impact of programs
offered to <60% of pregnant women.
Methods: The DREAM protocol offered free access to
triple therapy (zidovudine/stavudine + lamivudine + nevirapine [AZT/d4T+LMV+NVP])
from the 24th week of pregnancy to all HIV-positive pregnant women as well as
nutritional supplementation and formula milk. The protocol ended when the baby
had been weaned, usually by the time it reached 6 months. Infant HIV-1 testing
was undertaken at the ages of one and six months (b-DNA Versant 3.0). Children
were re-called to undergo the antibody test at 18 months. A retrospective
analysis of the clinical files of 351 children born to pregnant women (mean age
25.2 years ±5.2) who entered the program from May 2002 and delivered before 31
December 2004 was carried out. All the women were attended to at the Matola II Health Center, Maputo Province, Mozambique.
Results: At the beginning, the median of viral load, CD4
cells count and hemoglobin was 11,300 copies/mL (IQR
25 to 75, 1750 to 39,500), 484 cells/μL (310 to 663),
and 9.7 g/100 cm3 (8.9 to 10.7), respectively. ART was administered
for a median time of 78 days (IQR 25 to 75, 48 to 101) before delivery. The
newborns’ HIV infection rate was 1.4% (5 of 351; 95%CI 0.2 to 2.6) and 1.3% (4
of 306; 0.1 to 2.5) by the age of 1 month and between the first and sixth month
respectively. The cumulative lost-to-follow up rate was 13.1% (46 of 351). Reported
cases of anemia (hematocrit <8 g/100 cm3)
before delivery amounted to 33 (9.4%). Pre-delivery hepatic adverse reactions
(elevation of at least one of liver enzymes 5 times higher of the UPL) have
been recorded in 27 cases (7.7%) without jaundice. Skin adverse reactions have
been observed in 33 cases (9.4%). Children were traced when they reached 18
months of age. Seven children had died and 249 underwent rapid testing; three
tested positive for HIV infection (1.2%).
Conclusions: Triple therapy could decrease HIV MTCT below of
4% by age 18 months in a public health setting with a low lost-to-follow up
rate. The lost-to-follow up rate could be further reduced through improving
prevention strategies during breastfeeding time. Toxicity of HAART-containing
Nevirapine seems easily manageable even if women have a high CD4 count.
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