their infants received one dose within three days of birth. A second group of women received AZT one or more times during labor, while their infants received doses twice daily throughout the first week. This regimen was followed because of AZT's shorter half-life. A third, much smaller group of women and their infants received a placebo. (The placebo was discontinued early in the study when there was evidence that AZT was superior to the placebo.) Approximately 99 percent of the study participants breastfed their children. After 18 months, most of the women had completed breastfeeding, with the average duration lasting 9 months.
"Our study was driven by the need to find an inexpensive, safe and effective method of preventing HIV transmission in countries where it may not be practical to administer AZT," says J. Brooks Jackson, M.D., of the Johns Hopkins University School of Medicine, who co-directed the study with Professor Francis Mmiro, MBChB, of Makerere University in Kampala, Uganda.
After 18 months, infants enrolled in the NVP regimen sustained a 41 percent reduction in risk for HIV infection when compared with infants taking in the AZT regimen. (At 18 months, 25.8 percent of children in the AZT group were infected with HIV, while 15.7 percent of those in the NVP group were HIV-infected, yielding a difference of 41 percent when a time variable is considered.) These data are consistent with the 42 percent risk reduction for the NVP group when the babies were 6 to 8 weeks of age. The cost savings of using nevirapine in the study were substantial, approximately 70 times less than the AZT treatment.
The researchers speculate that the long-lasting benefits of NVP are not due to any persistently protective role provided by the drug itself since it is metabolized within 10 days; rather, infants receiving NVP, as with some other effective antiretroviral regimens, gain a protective advantage during the first few weeks of life, the time of great
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Contact: Jennifer Wenger
jwenger@niaid.nih.gov
301-402-1663
NIH/National Institute of Allergy and Infectious Diseases
11-Sep-2003
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