1. Vannappagari et al, 20th International AIDS Conference; July 20-25, 2014; Melbourne, Australia. Poster #5647 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 1 Worldwide Epidemiology, GlaxoSmithKline, RTP, NC, USA; 2 Gillings School of Global Public Health, University of North Carolina-Chapel Hill, NC, USA; 3 INC Research, Post Approval and Strategic Services, Raleigh, USA; 4 Tesserae Genetics, Dallas, TX, USA

2. Vannappagari et al, 20th International AIDS Conference; July 20-25, 2014; Melbourne, Australia. Poster #5647 Methods 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 Live Births VSDCHD Cases Prevalence (%) (95% CI) Relative Risk (95% CI) P- value Cases Prevalence (%) (95% CI) Relative Risk (95% CI) P- value Exposures Resulting in VSD/CHD or Live Birth 1545136 90 Regimens Containing ZDV 13073310.24 (0.16, 0.34) 1.13 (0.44,2.90) 1.00 780.60 (0.47, 0.74) 1.18 (0.64,2.17) 0.66 Regimens Excluding ZDV 237850.21 (0.07, 0.49) 120.50 (0.26, 0.88) Results

3. Vannappagari et al, 20th International AIDS Conference; July 20-25, 2014; Melbourne, Australia. Poster #5647 Results  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. Overall Total Exposed Live Births First Trimester Earliest Exposure Second/Third Trimester Earliest Exposure VSD [CHD] Cases Total Exposed (Live Births)Rate VSD [CHD] Cases Total Exposed (Live Births)Rate P- value Regimens Containing ZDV 130739 [26] 40000.23 [0.65] 22 [52] 90470.24 [0.57] 1.00 [0.62] Regimens Excluding ZDV 23782 [6] 18390.11 [0.33] 3 [6] 5380.56 [1.12] 0.08 [0.03] Conclusions