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Title: Antiretrovirals Appear Safe During Pregnancy: Presented at ACOG

"Antiretrovirals Appear Safe During Pregnancy: Presented at ACOG"

By Maggie Schwarz WASHINGTON, D.C. -- May 11, 2006 -- The safety of 28 antiretrovirals in HIV-positive pregnant women has been assessed in nearly 6000 pregnancies and only 1 agent was identified as being associated with a risk for birth defects, according to research presented here at the 54[^th Annual Clinical Meeting of the American College of Obstetricians and Gynecologists (ACOG).

Brenda Ross, MD, assistant professor of maternal-fetal medicine, Johns Hopkins Medical Center, Baltimore, Maryland, presented the research on a population of 5829 pregnancies registered in the multinational, voluntary, collaborative Antiretroviral Pregnancy Registry, which monitors pregnancy exposures for signals of a possible increase in the incidence of birth defects.

Most women in the registry are taking 3 medications but they can be on just 1 to be enrolled. The median age of women whose pregnancies are registered is 28 years (range 13-48 years). Ninety percent of reports originated in the United States. Also included in the registry are the United Kingdom, France, Germany, Australia, Brazil, and South Africa, among others.

Of 5829 evaluable pregnancies to date, 5560 resulted in live births. Of these, 2.6% involved at least 1 birth defect. The rate of birth defects reported in the general population is 3.1%, according to the Centers for Disease Control and Prevention.

Among first-trimester antiretroviral exposures, 2.9% of 2117 of pregnancies involved a birth defect.

The only agent to present a problem was efavirenz (Sustiva' Stocrin). Teratogenicity risk for this agent was noted and a warning included in the labeling several years ago.

Dr. Ross concluded, "Antiretrovirals are generally safe. It's important to register patients so we can continue to determine teratogenic potential. All patients are enrolled anonymously."

[Presentation title: The Antiretroviral Pregnancy Registry: 15 Years of Progress and 15 Years of Data. Abstract p. 41S]

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