In a previous trial of antiretroviral therapy (ART) involving pregnant women with human immunodeficiency virus (HIV) infection, those randomly assigned to receive tenofovir, emtricitabine, and ritonavir-boosted lopinavir (TDF–FTC–LPV/r) had infants at greater risk for very premature birth and death within 14 days after delivery than those assigned to receive zidovudine, lamivudine, and ritonavir-boosted lopinavir (ZDV–3TC–LPV/r). METHODS Using data from two U.S.-based cohort studies, we compared the risk of adverse birth outcomes among infants with in utero exposure to ZDV–3TC–LPV/r, TDF–FTC–LPV/r, or TDF–FTC with ritonavir-boosted atazanavir (ATV/r). We evaluated the risk of preterm birth (<37 completed weeks of gestation), very preterm birth (<34 completed weeks), low birth weight (<2500 g), and very low birth weight (<1500 g). Risk ratios with 95% confidence intervals were estimated with the use of modified Poisson models to adjust for confounding. RESULTS There were 4646 birth outcomes. Few infants or fetuses were exposed to TDF–FTC–LPV/r (128 [2.8%]) as the initial ART regimen during gestation, in contrast with TDF–FTC–ATV/r (539 [11.6%]) and ZDV–3TC–LPV/r (954 [20.5%]). As compared with women receiving ZDV–3TC–LPV/r, women receiving TDF–FTC–LPV/r had a similar risk of preterm birth (risk ratio, 0.90; 95% confidence interval [CI], 0.60 to 1.33) and low birth weight (risk ratio, 1.13; 95% CI, 0.78 to 1.64). As compared to women receiving TDF–FTC–ATV/r, women receiving TDF–FTC–LPV/r had a similar or slightly higher risk of preterm birth (risk ratio, 1.14; 95% CI, 0.75 to 1.72) and low birth weight (risk ratio, 1.45; 95% CI, 0.96 to 2.17). There were no significant differences between regimens in the risk of very preterm birth or very low birth weight. CONCLUSIONS The risk of adverse birth outcomes was not higher with TDF–FTC–LPV/r than with ZDV–3TC–LPV/r or TDF–FTC–ATV/r among HIV-infected women and their infants in the United States, although power was limited for some comparisons. (Funded by the National Institutes of Health and others).
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