Association between in utero zidovudine exposure and nondefect adverse birth outcomes: analysis of prospectively collected data from the Antiretroviral Pregnancy Registry

V Vannappagari, N Koram, J Albano, H Tilson, C Gee, V Vannappagari, N Koram, J Albano, H Tilson, C Gee

Abstract

Objective: To examine the association between nondefect adverse birth outcomes and in utero exposure to zidovudine (ZDV)-containing regimens versus non-ZDV antiretroviral (ARV) regimens.

Design: Analysis of prospectively-collected data.

Setting: Global.

Population: HIV-infected pregnant women prenatally exposed to antiretrovirals.

Methods: Estimation of prevalence of and risk for nondefect adverse birth outcomes among HIV-infected women.

Main outcome measures: Prevalence of and risk for nondefect adverse birth outcomes.

Results: Among 12 780 singleton birth outcomes with in utero ZDV exposure, 96.1% were live births; 3.9% were spontaneous abortions, induced abortions or stillbirths. Among live births, 16.4% were low birthweight (LBW); 12.3% were premature. Among 1904 outcomes with in utero exposure to non-ZDV ARV regimens, 85.8% were live births; 14.2% were spontaneous abortions, induced abortions or stillbirths. Among live births, 14.1% were LBW; 12.4% were premature. Relative risk comparing exposure to ZDV-containing ARV regimens to non-ZDV ARV regimens for spontaneous abortions was 0.18 (95% confidence interval [95% CI] 0.14-0.22); induced abortions 0.28 (95% CI 0.22-0.36); stillbirths 0.76 (95% CI 0.51-1.12); premature births 1.00 (95% CI 0.87-1.15) and LBW 1.17 (95% CI 1.02-1.33).

Conclusion: Prevalence of nondefect adverse birth outcomes is lower among outcomes with in utero ZDV exposure versus in utero non-ZDV ARV exposure. The risks for spontaneous and induced abortions were no different for ZDV-containing regimens versus non-ZDV ARV regimens. For premature births and stillbirths, there was no significant difference in risk between the two regimens. The risk of LBW was statistically significantly higher among ZDV-containing regimens versus non-ZDV ARV regimens.

Tweetable abstract: ZDV-containing regimens do not increase the risk for nondefect adverse birth outcomes.

Trial registration: ClinicalTrials.gov NCT01137981.

Keywords: Epidemiology HIV; pregnancy outcomes; zidovudine.

© 2015 The Authors BJOG An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd on behalf of Royal College of Obstetricians and Gynaecologists.

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