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http://www.nytimes.com/2002/06/13/health/13IMMU.html

AIDS Drugs During Pregnancy Don't Harm Fetus, Study Finds

By SHERYL GAY STOLBERG

ASHINGTON, June 12 — American doctors routinely prescribe antiretroviral drug cocktails to pregnant women infected with the AIDS virus despite nagging fears that the medicines might result in premature or low birth-weight babies. But those fears are largely unfounded, according to a study made public today.

The study, involving 3,266 expectant mothers infected with the virus, H.I.V., found that those who took the drug cocktails were no more likely to give birth to premature or low birth-weight babies than those who did not.

The research was started by the National Institutes of Health after studies in Europe suggested that the medicines might pose a risk. Experts said the findings, which appear in the current issue of The New England Journal of Medicine, should reassure women and their doctors.

"There was always this little back-of-the-mind concern," said Dr. Anthony Fauci, director of the National Institute for Allergy and Infectious Diseases, one of two branches at the N.I.H. that paid for the research. "A chance was taken in treating those women. This study shows that, in retrospect, it was a good decision."

The study did, however, suggest an association between a certain class of AIDS medicines, protease inhibitors and very low birth-weight babies. But the authors said that finding, based on data on a small subset of women in the study, was not solid and required further study.

"The numbers were quite small," said Dr. Ruth E. Tuomala, the lead author of the study and an obstetrician-gynecologist at Brigham and Women's Hospital in Boston.

It is possible, Dr. Tuomala said, that only the sickest women were treated with protease inhibitors, and that "the severity of the illness is responsible for the lower birth weight, as opposed to the drug itself."

The Centers for Disease Control and Prevention estimates that 6,000 H.I.V.-infected women give birth every year and that 300 to 400 babies are born with the virus. One of the biggest public health successes of the AIDS epidemic has been the use of antiretroviral medicines to reduce the spread of the virus from mothers to infants.

The move toward treatment began in 1994, with publication of a landmark study showing that the antiretroviral drug AZT sharply reduced mother-to-infant transmission, by as much as 70 percent. More recently, studies have shown that the drug cocktails can reduce transmission even further.

The National Institutes of Health study analyzed data from seven large studies involving pregnant women with H.I.V. to assess the risk of such complications as premature delivery, low birth weight, stillbirth and low scores on the Apgar test to determine a newborn's state of health.

The analysis compared 2,123 women who received antiretroviral therapy with 1,143 who did not. Among the treated women, 16 percent gave birth prematurely — defined as prior to the 37th week of the standard 40-week pregnancy — compared with 17 percent of the untreated women.

The percentage of low birth-weight babies, those born weighing less than 2,500 grams, was the same in both groups, 16 percent. The Apgar scores and rates of stillbirth were also nearly identical.

As a result, experts say, the study is not likely to change medical practice, which has been to treat H.I.V.-infected expectant mothers as if they were not pregnant, on the theory that taking care of the disease is best for both mother and child.

"The goal is to treat the woman and to do it as safely as you can for the fetus," said Dr. Mary Young, who treats patients with H.I.V. at Georgetown University Medical Center.

Dr. Young said she avoided one popular protease inhibitor, Sustiva, because it was known to cause birth defects in animals, and another, Crixivan, because it caused kidney stones in adults and, she reasoned, might do the same in a fetus.

Dr. Young said research on the medicine in pregnant women had been scant, however, and "we are kind of flying blind."

But there have been some studies that suggest the antiretrovirals might cause harm.

In 1998, Swiss researchers published a study of 30 women that found that those who received so-called combination therapy had a higher risk of premature delivery. A larger European study also suggested that protease inhibitors increased the risk of prematurity. Those studies prompted the institutes' research.

"They were very small, uncontrolled studies, and everybody knew that," Dr. Tuomala said. "But nonetheless, you couldn't erase this."

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