Journal Article

Birth Outcomes for Pregnant Women with HIV Using Tenofovir–Emtricitabine

Seage, George R, Hernandez-Diaz, Sonia, Chadwick, Ellen G, Hoffman, Risa M, Huo, Yanling, Patel, Kunjal, Rough, Kathryn, Williams, Paige L, Currier, Judith S, Barr, Emily, Shapiro, David E

2018

Overview

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). 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. 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. 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.).

• Publisher: Massachusetts Medical Society
• Subject: Acquired immune deficiency syndrome / Adult / AIDS / Anti-HIV Agents - adverse effects / Anti-HIV Agents - therapeutic use / Antiretroviral drugs / Antiretroviral therapy / Antiviral drugs / Clinical outcomes / Cohort Studies / Disease Transmission, Infectious - prevention & control / Drug Administration Schedule / Drug Therapy, Combination - adverse effects / Emtricitabine / Emtricitabine - adverse effects / Emtricitabine - therapeutic use / Female / Fetuses / Gestation / HIV / HIV Infections - drug therapy / Human immunodeficiency virus / Humans / Infant, Low Birth Weight / Infant, Newborn / Infants / Intrauterine exposure / Lamivudine / Lamivudine - therapeutic use / Lopinavir / Lopinavir - adverse effects / Lopinavir - therapeutic use / Low birth weight / Maternal & child health / Pregnancy / Pregnancy Complications, Infectious - drug therapy / Pregnancy Outcome / Premature birth / Premature Birth - epidemiology / Risk / Ritonavir / Ritonavir - therapeutic use / Tenofovir / Tenofovir - adverse effects / Tenofovir - therapeutic use / Womens health / Zidovudine / Zidovudine - therapeutic use