Is antiretroviral therapy during pregnancy associated with an increased risk of preterm delivery, low birth weight, or stillbirth?

Background. Data on complications of pregnancy associated with antiretroviral therapy are limited. Some small studies have demonstrated an increased preterm delivery rate, but a recent retrospective United States multisite study did not concur with these findings. Our objective was to investigate whether antiretroviral therapy was associated with adverse pregnancy outcome at a single site. Methods. Using prospectively gathered data, women were identified who were determined to be human immunodeficiency virus positive before or during pregnancy who sought care at our prenatal clinic and who gave birth at the University of Miami/Jackson Memorial Medical Center from 1990 through 2002. The outcome measures were preterm delivery, low birth weight, and stillbirth. Results. The cohort included 999 women who received antiretroviral therapy during pregnancy (monotherapy in 492, combination therapy without a protease inhibitor [PI] in 373, and combination therapy with a PI in 134) and 338 women who did not receive therapy. After adjustment for possible confounders, only combination therapy with a PI was associated with an increased risk of preterm delivery, compared with any other combination (odds ratio, 1.8 [95% confidence interval, 1.1-3.0]). There were no differences in rates of low birth weight and stillbirth, regardless of therapy. Conclusion. Compared with monotherapy and combination therapy without a PI, only combination therapy with a PI was associated with an increased risk of preterm delivery.