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Antiretroviral Drugs Seem Safe During Pregnancy

Pregnancy outcomes among women with HIV infections were similar whether or not they received antiretroviral therapy.

Although treating HIV-infected pregnant women with antiretroviral drugs has been the standard of care for almost a decade, doubts linger as to the complete safety of these drugs during pregnancy. A large meta-analysis incorporated data from 2 completed and 5 ongoing observational studies of 2123 treated and 1143 untreated pregnant women who delivered from 1990 through 1998.

Overall unadjusted rates of premature delivery actually were lower in treated women. Rates of very premature delivery (at <32 weeks' gestation) and adverse neonatal outcomes such as stillbirth, low birth weight, and low Apgar scores did not differ between groups. When results were adjusted for maternal drug, alcohol, and tobacco use and low antenatal CD4 cell counts, rates of adverse outcomes remained similar in the 2 groups.

When outcomes among 137 women whose antiretroviral regimens included protease inhibitors were compared with outcomes among those whose regimens did not include protease inhibitors, only very premature delivery and very low neonatal weight emerged as significant risks associated with protease-inhibitor use. However, the confidence intervals for these calculations were wide, and the more frequent incidence of advanced HIV disease among women who were treated with protease inhibitors may have influenced the results.

Comment: The rapidity with which HIV therapeutics have changed in the last decade magnifies all the usual problems with meta-analyses. Still, these findings provide some reassurance that, if pregnancy-related risks associated with antiretroviral drugs exist, they are quite difficult to find.

— Abigail Zuger, MD

Published in Journal Watch General Medicine June 25, 2002

Citation(s):

Tuomala RE et al. Antiretroviral therapy during pregnancy and the risk of an adverse outcome. N Engl J Med 2002 Jun 13; 346:1863-70.

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