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 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

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

VSD CHD

Cases

Prevalence (%) (95% CI)

Relative Risk

(95% CI)P-

value

Cases

Prevalence (%) (95% CI)

Relative Risk

(95% CI)P-

valueExposures Resulting in VSD/CHD orLive Birth

15451 36 90

Regimens Containing ZDV

13073 31 0.24 (0.16, 0.34)

1.13 (0.44,2.90) 1.00

78 0.60 (0.47,

0.74) 1.18 (0.64,2.17) 0.66

Regimens Excluding ZDV

2378 5 0.21(0.07, 0.49)

12 0.50(0.26, 0.88)

Results

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.

OverallTotal 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

13073 9

[26]

4000 0.23

[0.65]

22

[52]

9047 0.24

[0.57]

1.00

[0.62]

Regimens Excluding ZDV

2378 2

[6]

1839 0.11

[0.33]

3

[6]

538 0.56

[1.12]

0.08

[0.03]

Conclusions