Lack of effect on prematurity, birth weight, and infant growth from exposure to protease inhibitors in utero and after birth.

STUDY OBJECTIVE: To determine whether an association exists between exposure in utero and after birth to highly active antiretroviral therapy (HAART) containing protease inhibitors and prematurity, birth weight, and infant growth parameters.

DESIGN: Retrospective cohort study.

SETTING: Tertiary, university-affiliated hospital in Montreal, Canada.

PATIENTS: Cohort of 206 pairs of mothers who had human immunodeficiency virus (HIV) and had been treated with HAART between 1997 and 2005, of whom 176 had regimens containing protease inhibitors, and their infants, as well as a control group of 206 infants born to non-HIV-infected mothers and thus not exposed to HAART.

MEASUREMENTS AND MAIN RESULTS: Demographic and clinical characteristics were retrieved from patients' medical records and the hospital's HIV database. Duration of HAART use, rates of prematurity and low birth weight, and infant growth parameters during the first 2 years of the child's life were evaluated. Median duration of HAART use for the women before delivery was 18 weeks (range 4-36 wks) and for infants, started within the first 8-12 hours of life, was 6 weeks (range 2-6 wks). In infants exposed to HAART, the 10.6% rate of prematurity (11.1% with and 7.1% without protease inhibitors) was not significantly higher than that in the control group (7.8%). Moreover, the 9.9% rate for small for gestational age (9.8% with and 10.3% without protease inhibitors) was also not significantly higher than that in the control group (5.3%). The 176 mothers and infants exposed to protease inhibitors had a median follow-up of 5 years. Stillbirth or death was not observed. At delivery, the weight, length, and head circumference of the 176 infants exposed to protease inhibitors were similar to those of the control group. During the first 2 years of life, premature infants were in the lower percentiles of growth; however, they followed normal Centers for Disease Control and Prevention growth curves matched for age and sex.

CONCLUSION: Significantly higher rates of prematurity and low birth weight were not demonstrated in infants exposed in utero to HAART with protease inhibitors. Moreover, these children reached normal growth percentiles during the first 2 years of life.