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April 22, 2002


Rapid HIV Test For At-Risk Pregnant Women To Help Reduce Infection to Newborns

Pregnant women who receive little or no prenatal care and who are at risk for contracting the human immunodeficiency virus (HIV) that causes AIDS will soon be offered a rapid HIV test aimed at reducing the rate of HIV transmission to their newborns, in a study being conducted by Emory University and Morehouse Schools of Medicine obstetricians at Grady Memorial Hospital in Atlanta, Ga. The study began April 8.

The Maternal Infant Rapid Intervention At Delivery (MIRIAD) study will evaluate innovative approaches to counseling and voluntary rapid HIV testing for women in labor with unknown HIV status. The primary objective is to assess the feasibility of obtaining informed consent for HIV testing during labor or soon after birth. MIRIAD, which is being funded by the Centers for Disease Control and Prevention (CDC), also aims to discover barriers to HIV testing and reasons for lack of prenatal care, and to evaluate neonatal adherence and receipt of post-natal care for women identified as HIV-infected. Other study sites include New York, Miami, New Orleans and Chicago.

"Women will be able to get test results in a matter of hours, which will enable physicians to offer treatment as soon as possible," said Michael K. Lindsay, M.D., co-principal investigator, associate professor with the Emory University School of Medicine, and director of the Maternal-Fetal Medicine Division. Steven Nesheim, M.D., associate professor of infectious diseases, is principal investigator. "This will help identify two specific populations -- new mothers and their newborn children -- and offer the option of being treated." Obstetricians at Grady deliver more than 4,000 babies each year. Dr. Lindsay estimates that 20 percent, or 800, or those women receive little or no prenatal care. Of the women who delivered at Grady Hospital in 2001, 65 were HIV-infected. HIV is passed from one person to another through blood-to-blood and sexual contact. A history of intravenous drug abuse and having multiple sexual partners are the primary risk factors. Infected women, in turn, can pass HIV to their babies during pregnancy or delivery, or after delivery through breast-feeding. Without taking preventive measures, the chances are about one in four that HIV will pass from an HIV-positive mother to her baby before or during birth.

The MIRIAD study, using the new, rapid test known as Determine, will draw the expectant mother's blood and test for the presence of antibodies. All results from the rapid test will then be confirmed with conventional antibody testing known as the ELISA and the Western blot test. If the blood contains antibodies, there will be an immediate reaction, indicating that the mother-to-be is possibly infected. Results are available within a matter of hours, compared to one to three days with the traditional ELISA and Western blot HIV testing.

Lindsay said rapid testing should help determine if Determine is just as effective as traditional tests.

"That's the big debate: If you do a rapid test on someone, is that as good as the traditional test?" Lindsay says. "And that's one of the problems. Some of the tests are not as good as the traditional tests, and that's going to be one of the things we will actually be able to examine, because everyone who has a positive rapid test, we'll do a traditional test on them, and we'll go back and look and see what the correlation is."

Lindsay said women in the study who test positive for HIV will receive anti-retroviral therapy such as nevirapine, ZDV and 3TC intravenously or orally while they're pregnant - and while they're in labor. Following delivery, their newborns will receive the medication four times a day for the first six weeks of life. This scenario of antiretroviral therapy reduces the HIV transmission rate to the baby by approximately 70 percent from 25 percent to 8 percent. If a woman does not take medication while she is pregnant but is identified as being HIV-positive when she enters labor, she can be offered antiretroviral therapy. In this scenario, the HIV transmission rate to the baby is lowered by approximately 50 percent from 25 percent to 12 percent. Finally, if antiretroviral medication is given only to the newborn because the mother did not receive prenatal care and received no medication in labor, the transmission rate to the infant is reduced approximately 50 percent.

"The best scenario is for the mother to receive antiretroviral medication while she's pregnant, in labor, and postdelivery. That's when she receives the maximum benefit," Lindsay said. "When a woman doesn't come in for prenatal care, she's not going to receive antiretrovirals during pregnancy, but she can still receive medication while she's in labor, and then administer medication to her newborn. Although not as effective in reducing HIV transmission as the full antiretroviral regimen, the partial regimen still reduces perinatal HIV."

At this time, three antiretroviral drugs, ZDV, nevirapine, and ZDV/3TC, are recommended by the Public Health Service for administration to HIV-infected pregnant women during labor to prevent perinatal transmission of HIV. There has been great progress made in the last decade in reducing the risk of perinatal HIV transmission. HIV transmission rates as low as 1 percent to 2 percent have been achieved in women receiving antiretroviral treatment who undergo elective cesarean section prior to onset of labor or rupture of membranes, or in women on antiretrovirals with a low viral load (<1,000 copies/ml) whether they deliver vaginally or by elective cesarean.

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