AEGiS-AP: Premature Births Prompt New Scrutiny of AIDS Drug Studies

Important note: Information in this article was accurate in 1998. The state of the art may have changed since the publication date.

Premature Births Prompt New Scrutiny of AIDS Drug Studies

The Associated Press; Saturday, August 1, 1998; Page A07
Lauran Neergaard, Associated Press

Government researchers have temporarily halted the enrollment of pregnant women into studies of the potent anti-AIDS protease inhibitors, as they try to determine whether the drugs might increase the risk of premature birth.

The National Institutes of Health stressed yesterday that the safety concerns are very preliminary, and there is no reason for pregnant women taking drug "cocktails" containing protease inhibitors to stop. But doctors should carefully monitor HIV-infected women who have higher risks of premature birth, the agency's scientists said. "Our view is the great majority of women on these drugs do very well," said NIH's Betsy Smith, who monitors the safety findings. But "with increased risk factors that might lead to prematurity, we should be cautious."

Taking a protease inhibitor plus two other AIDS drugs has become the gold standard treatment for HIV, the AIDS virus, dramatically improving patients' health. Doctors have been prescribing these cocktails to HIV-infected pregnant women, but their use in pregnancy is only now being studied. Scientists are studying if protease inhibitors are safe during pregnancy, and if they help protect the fetus from HIV.

Women already can take one AIDS drug, AZT, that cuts their baby's risk of infection in half, but doctors hope to further reduce that chance.

NIH temporarily halted the enrollment in these early protease studies last week, citing "an unexpected number" of premature births. The results so far are tiny: Of 10 U.S. babies studied so far, three were premature and one died in utero. One full-term baby also died, but of infection.

A Swiss study found nine premature babies out of 30 born. But that study suggests an equal risk between mothers who took a protease combination and mothers who just took two older AIDS drugs. That means that taking more drugs in total might be the explanation for the premature births.

NIH will discuss the findings at a meeting of AIDS specialists Sunday, and plans to continue the protease studies just with women at low risk of premature labor.

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