Being Alive; March 1994
Study Design
Participants were HIV+ pregnant women who had received no antiretroviral treatment during the current pregnancy and had no clear clinical indication to do so and had a CD4 less than 200. They were randomized to receive AZT or placebo beginning between 14 and 34 weeks of pregnancy. The AZT regimen consisted of 500 mg/day until the start of labor, then IV AZT during labor, then a syrup form given to the newborn for six weeks. The infants were evaluated at 12, 24 and 78 weeks after birth to see if HIV could be cultured from their blood.
Results
Of the 364 babies with sufficient data to be evaluated, 13 (8.3%) in the AZT group vs. 40 (25.5%) in the placebo arm were HIV infected. Thus, the use of AZT in this particular group reduced the risk of mother-to-infant transmission by 67.5%. Side effects were equal in both groups, except that the babies in the AZT group had a higher incidence of a mild anemia at birth, which disappeared gradually without requiring transfusion. The rate of congenital malformations was also equal and the same as the normal rate in the population, and there were no adverse effects on the mothers in either group.
Conclusions
The typical risk of mother-to-infant HIV transmission in the US is from 20-25%. The potential reduction to about 8% is obviously exciting news.
We must be careful to remember that the results are directly applicable only to women similar to those in this trial. In particular, the long term risks of the AZT use, including in the HIV negative infants, remains to be assessed. It is important that everyone be followed for a long time.There is also danger that these results will be taken as evidence for mandatory HIV antibody testing of all pregnant women, and even the mandatory use of AZT. We must be vigilant to fight any such proposals.
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