Exposure
to Antiretroviral Drugs during Pregnancy Does Not Impair HIV Negative Children's
Mental Development
By
Liz Highleyman  | Giving
babies a single dose of nevirapine (Viramune) plus AZT (Retrovir) after birth
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Antiretroviral
therapy -- including prophylactic use of zidovudine
(AZT; Retrovir) and nevirapine
(Viramune) -- has dramatically reduced the risk of mother-to-child
HIV transmission to less than 2%, but many women remain concerned about the
immediate and long-term effects of these drugs on children exposed during pregnancy.
In
a study presented at the XVII International AIDS Conference
this month in Mexico City, investigators examined neurodevelopmental function
in 1840 HIV-exposed but uninfected children enrolled in PACTG 219/219C, a prospective
cohort study conducted at more than 80 U.S. sites. Half the children were female,
55% were black, 32% were Latino/Hispanic, and about 16% had low birth weight (<
2500 grams).
Antiretroviral drug exposure information was collected during
pregnancy or within the first year of life. Cognitive and motor function were
assessed using the Bayley Scales of Infant Development. Linear regression methods
were used to evaluate the effect of in utero antiretroviral exposure on
Mental Development Index (MDI) and Psychomotor Development Index (PDI) at 2 years
of age, controlling for potential confounders including age, birth year, sex,
race/ethnicity, birth weight, primary caregiver, caregiver education level, primary
language, geographical and urban/rural location, and maternal substance use.
Results
•
Among the 1840
infants born between 1993 and 2006, a total of 1694 (92%) were exposed and 146
(8%) were unexposed to antiretroviral drugs during gestation.
•
After controlling
for confounding factors, MDI scores of children exposed to any antiretroviral
therapy in utero were marginally higher than those of unexposed children:
•
Adjusted mean
MDI: 94.8 for exposed children vs 92.2 for unexposed (P = 0.07).
•
PDI scores
were similar in the antiretroviral exposed and unexposed groups.
•
Adjusted mean
PDI: 93.9 vs 93.5, respectively (P = 0.82).
•
However, MDI
and PDI scores of the study population as a whole (antiretroviral exposed and
unexposed) were significantly lower than those of the U.S. population.
•
Among the subset
of children with low birth weight, MDI and PDI scores were significantly higher
for antiretroviral-exposed compared with unexposed children (P = 0.01 for MDI;
P < 0.01 for PDI).
•
Maternal substance
use during pregnancy was reported for 17% of mothers, but was not significantly
associated with differences in MDI or PDI scores.
•
There was a
slight decreasing trend in scores associated with increasing maternal viral load,
but no significant effect of maternal antiretroviral therapy use after controlling
for viral load.
•
All other covariates
showed significant associations with MDI scores except primary caregiver, and
with PDI scores except race/ethnicity and primary language.
In
conclusion, the researchers stated, "No decline in cognitive or motor function
was observed for infants with in utero antiretroviral exposure compared
to unexposed [children]."
They also found that "those with prenatal
antiretroviral exposure did not have higher rates of severe cognitive impairment
or motor impairment" (13% with MDI < 70; 10% with PDI < 70).
They
added, "While these results are reassuring, continued evaluation of uninfected
infants with in utero antiretroviral exposure for late outcomes is important,"
since this analysis lasted only until 2 years of age.
They also noted that,
"Overall, the HIV-uninfected children in our study scored significantly below
U.S. norms, and thus may require continued follow-up."
Harvard
School of Public Health, Center for Biostatistics in AIDS Research and Department
of Biostatistics, Boston, MA; Children's Memorial Hospital, Northwestern University,
Chicago, IL; National Institute of Child Health and Human Development, Pediatric,
Adolescent and Maternal AIDS Branch, Rockville, MD.
8/22/08
Reference
P
Williams, M Marino, K Malee, and others. Neurodevelopmental status and prenatal
antiretroviral exposure in HIV-exposed uninfected infants. XVII International
AIDS Conference (AIDS 2008). Mexico City. August 3-8, 2008. Abstract
MOAB0102.
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