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Prenatal Exposure to Zidovudine and Risk for Ventricular Septal Defects and Congenital Heart Defects: Data From the Antiretroviral Pregnancy Registry (APR). V Vannappagari, 1,2 J Albano, 3 N Koram, 1 H Tilson, 2 AE Scheuerle , 4 M Napier 2.
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Prenatal Exposure to Zidovudine and Risk for Ventricular Septal Defects and Congenital Heart Defects: Data From the Antiretroviral Pregnancy Registry (APR) V Vannappagari,1,2 J Albano,3 N Koram,1 H Tilson,2AE Scheuerle,4 M Napier2 1Worldwide Epidemiology, GlaxoSmithKline, RTP, NC, USA; 2Gillings School of Global Public Health, University of North Carolina-Chapel Hill, NC, USA; 3INC Research, Post Approval and Strategic Services, Raleigh, USA; 4Tesserae Genetics, Dallas, TX, USA
Methods Results 16,304 Prospectively reported pregnancies in the APR • Rate and Relative Risk analyses by: • Presence of VSDs: isolated; with CHD only; Multisystem defects • Type and timing of antiretroviral therapy exposure • Particularly differentiation regimens with/without ZDV and with/without NRTIs • Excludes: Chromosome anomalies and/or terminated before 20 wks
Results Conclusions • Prevalence of and risk for VSD and CHD among infants exposed to ZDV-containing regimens is no different from infants exposed to non-ZDV ARV regimens • Among those exposed to ZDV-containing regimens there is no difference in rate of VSD or CHD by trimester of earliest exposure.