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Mom's HIV Drugs Not Linked to Premature Birth

Originally published by Reuters Health, June 13, 2002

NEW YORK (Reuters Health) — Despite some concerns arising from past studies, treating a pregnant woman's HIV with combination-drug therapy does not appear to raise the risk of premature birth or other newborn health threats, US researchers reported Wednesday.

They say the findings "provide reassurance" that the risks of antiretroviral drugs during pregnancy are "low" and are probably outweighed by the benefits—namely, guarding the mother's health while cutting the odds that she will transmit HIV to her baby.

The study of nearly 3,300 pregnant women with HIV found that combination-drug therapy was not linked to higher rates of premature birth, low birth weight, stillbirth or poor newborn health. The findings are published in the June 13th issue of The New England Journal of Medicine.

According to the study authors, led by Dr. Ruth E. Tuomala of Brigham and Women's Hospital in Boston, Massachusetts, some research from Europe and the US has suggested that multiple-drug regimens for HIV may raise the risk of premature delivery.

However, the HIV drug zidovudine—also known as AZT—has been shown to significantly cut the risk of mother-to-child HIV transmission. And US public health recommendations support giving pregnant women combination-drug therapy to protect their own health while lowering transmission risk.

To look at whether doing so might increase prematurity and other birth risks, Tuomala's team reviewed seven US clinical trials. Some of the women in these studies delivered in the early 1990s, before zidovudine was widely used to cut mother-to-child HIV transmission. The rest, who delivered between 1994 and 1998, were on HIV drugs during pregnancy.

The researchers found no clear differences in pregnancy outcomes among women who received no HIV drugs, one drug or multiple drugs. For example, 16% of women on antiretroviral therapy delivered prematurely, compared with 17% of untreated women. And the odds of premature delivery were similar with one-drug or multiple-drug regimens, according to the report.

There was, however, an association between very low birth weight and multi-drug regimens containing protease inhibitor medications, the report indicates.

The reason for this finding is unclear, according to the authors. They point out that it is "likely" that women on protease inhibitors had more-advanced HIV, which could explain the connection.

"Our data," Tuomala's team concludes, "provide reassurance that the risks of adverse outcomes of pregnancy that are attributable to antiretroviral therapy are low and are likely to be outweighed by the recognized benefits of such therapy during pregnancy."