The Pharmaceutical Journal
Vol 268 No 7203 p861-867
22 June 2002

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New England Journal of Medicine (content.nejm.org)

Benefits of HIV therapy in pregnancy outweigh risks

Treatment of women with antiretrovirals during pregnancy carries only a small risk of adverse outcomes, say American researchers.

Dr Ruth Tuomala, Brigham and Women's Hospital, Boston, and colleagues looked at data from seven studies to assess whether antiretroviral therapy during pregnancy is associated with an increased risk of premature delivery and other adverse outcomes. They found that rates of premature delivery, low birth weight and stillbirth were similar whether or not the women received antiretroviral therapy and whether the treated women received combination or monotherapy.

"Our data provide reassurance that the risks of adverse outcomes of pregnancy are low and are likely to be outweighed by the recognised benefits of such therapy during pregnancy," they say.

The studies involved 2,123 HIV-1 infected women who had received antiretroviral therapy during pregnancy and 1,143 women who had not. Of those treated with antiretrovirals, 1,590 women received monotherapy, 396 received combination therapy without protease inhibitors and 137 received combination therapy that included protease inhibitors.

Overall, combination therapy was not associated with an increased risk of premature delivery, as compared with monotherapy, or with delivery of an infant with low birth weight. The researchers found that the risk of low birth weight was lower among infants born to women who received combination therapy without protease inhibitors than among infants born to women who received no therapy, despite the treated women having lower CD4+ cell counts.

The inclusion of protease inhibitors in combination therapy appeared to increase the risk of very low birth weight. However, this increased risk might reflect the disease stage of the mother. "It is likely that women who received combination therapy with protease inhibitors had more advanced disease than those who received combination therapy without protease inhibitors," the researchers comment. They also point out that any small increase in the risk of low birth weight is likely to be outweighed by the benefits of treatment with protease inhibitors for both the mother and the infant (New England Journal of Medicine 2002;346:1863).