644 
Infectious Morbidity and Mortality in Formula-fed Infants Born to Women Infected by HIV
Karin Nielsen-Saines*1, H Watts2, J Pilotto3, E Joao4, G Gray5, J McIntyre6, J Bethel7, L Mofenson2, M Camarca7, J Moye2, and The NICHD HPTN 040 Study Team
1David Geffen Sch of Med, Univ of California, Los Angeles, US; 2Natl Inst of Child Hlth and Human Devt, NIH, Bethesda, MD, US; 3Hosp Geral de Nova Iguacu, Rio de Janeiro, Brazil; 4Hosp dos Servidores do Estado, Rio de Janeiro, Brazil; 5Soweto Clinical Trials Unit, Johannesburg, South Africa; 6Univ of the Witwatersrand, Johannesburg, South Africa; and 7Westat, Rockville, MD, US
Background: Formula feeding is associated with
significant infectious morbidity and mortality in HIV-1-exposed infants in
resource-limited settings. We evaluated infectious morbidity and mortality in the
National Institute of Child Health and Human Development (NICHD)/HIV Prevention
Trials Network (HPTN) 040/P1043, a randomized perinatal clinical trial
comparing 3 neonatal antiretroviral regimens for prevention of mother-to-child
transmission (PMTCT) in formula-fed infants born to women who do not receive prenatal
antiretrovirals, ongoing in Brazil, South Africa, Argentina, and the United States.
Methods: We evaluated frequency of severe,
life-threatening, or fatal adverse experiences within a proportional subcohort
of 500 HIV-1-exposed infants enrolled from April 2004 to February 2007 in Brazil and South Africa. Analysis included HIV-1-uninfected infants who completed 6 months of
follow-up, and a representative proportion of uninfected infants who died
before 6 months.
Results: We included 412 infants from Brazil and 88 from South Africa. Half were female. There were 71 severe adverse events, including 6
deaths (2 in Brazil, 4 in South Africa); 2 deaths were associated with
gastroenteritis, 2 with respiratory infections. Otherwise, 15 events (6 of 100
infant-years) were associated with gastroenteritis, 25 (10 of 100 infant-years)
with respiratory infections, 24 (9.6 of 100 infant-years) with severe
infections, 5 (2 of 100 infant-years) with congenital infections, and 2 (0.8 of
100 infant-years) with other infections. Maternal CD4 levels or virus load at
delivery did not correlate with infant mortality or other severe adverse
events. The table below compares 6-month mortality per 1000 live births, using for
reference the 2000 World Health Organization (WHO) 6-country Collaborative
Study on the Role of Breastfeeding on the Prevention of Infant Mortality. In
comparison, 2005 UNICEF country-specific 12-month infant mortality rates are 31
per 1000 for Brazil, 55 per 1000 for South Africa.
|
Population
|
n
|
Deaths
|
Rate/1000
|
p value
|
|
NICHD/HPTN 040 overall
|
500
|
6
|
12
|
0.022
|
|
Brazil NICHD/HPTN 040
|
412
|
2
|
5
|
0.003
|
|
South Africa NICHD/HPTN 040
|
88
|
4
|
45
|
0.53
|
|
2000 WHO Collaborative Study
|
17,992
|
553
|
31
|
—
|
Conclusions: Estimated 6-month mortality in our
study of formula-fed infants in Brazil and South Africa was not elevated
compared with representative, pooled WHO rates for breastfed infants. Rates of
serious infectious complications in HIV-1-exposed infants from disenfranchised
populations whose mothers had poor to no prenatal care were low overall. Our
results suggest that formula feeding for HIV exposed infants should not be
dismissed on the basis of increased infectious morbidity and mortality risk in
all settings.
|
