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Zidovudine use in pregnancy and congenital malformations.

Zidovudine use in pregnancy and congenital malformations.
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Rough K, Sun JW, Seage GR, Williams PL, Huybrechts KF, Bateman BT, Hernandez-Diaz S,


Rough K, Sun JW, Seage GR, Williams PL, Huybrechts KF, Bateman BT, Hernandez-Diaz S, (click to view)

Rough K, Sun JW, Seage GR, Williams PL, Huybrechts KF, Bateman BT, Hernandez-Diaz S,

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AIDS (London, England) 31(12) 1733-1743 doi 10.1097/QAD.0000000000001549

Abstract
OBJECTIVE
There is inconsistent evidence that zidovudine use during pregnancy increases overall, cardiac, and male genital malformations.

DESIGN
We conducted a systematic review and meta-analysis of zidovudine use and malformations and, using Bayesian methods, combined it with data from a cohort study of mother-infant pairs in the nationwide Medicaid Analytic eXtract (MAX).

METHODS
Using MAX data (2000-2010), we identified pregnant women with HIV treated with antiretroviral therapy (ART). Women with at least one zidovudine dispensing during the first trimester were compared to women receiving ART without zidovudine in the first trimester. Malformation outcomes were defined using diagnosis/procedure codes. To adjust for confounding, we performed 1 : 1 propensity score matching. Bayesian methods require specification of a prior, which we developed in the meta-analysis. Logistic regression models combined MAX data with the prior, estimating odds ratios (ORs) and 95% credible intervals.

RESULTS
Fourteen articles contributed information on overall malformations, seven on cardiac malformations, and five on male genital malformations. In MAX, matching led to a sample of 735 women each in the zidovudine and comparator groups. When comparing first trimester zidovudine use to other ART, the Bayesian procedure yielded OR estimates slightly above the null for overall [OR = 1.11, 95% credible interval (0.80-1.55)] and cardiac [OR = 1.30 (0.63-2.71)] malformations. There were no zidovudine-exposed cases of male genital malformations in MAX, but the meta-analysis yielded elevated OR estimates [OR = 2.57 (1.26-5.24)].

CONCLUSION
For most malformations, first-trimester zidovudine was not associated with increased risk. The potential increase in male genital malformations was small in absolute terms, and should be evaluated further.

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