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RESEARCH HIGHLIGHTS IMPORTANCE OF VIRAL LOAD AS PREDICTOR OF MATERNAL/FETAL HIV TRANSMISSION

 ORLANDO, Fla., Oct. 5 /PRNewswire/ -- The amount of human immunodeficiency virus (HIV), or viral load, in a woman's blood during pregnancy appears to be a significant determinant of the risk of transmitting HIV to her infant, according to a new study presented today.
 Dr. Barbara Weiser of the New York State Department of Health reported that women with greater amounts of HIV in their blood were found to be more likely to transmit the virus to their babies than those with low levels of HIV. Weiser presented her data today at the 34th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC). The study was funded by the Pediatric AIDS Foundation and the National Institutes of Health.
 "The identification of high maternal virus level as a major determinant of this mode of transmission provides the scientific rationale for using strategies to interrupt transmission by reducing levels of virus," said Weiser. "These findings also help explain the observation that only about 25 percent of babies born to HIV-infected mothers become infected with the virus."
 In a related study presented here today, researchers suggested that treatment of HIV-infected pregnant women, and their newborns, with Retrovir brand zidovudine (AZT) could prevent as many as 1,200 babies from being infected with the virus each year.
 This analysis, presented by Dr. Susan Davis of the Centers for Disease Control and Prevention (CDC) in Atlanta, was based on the preliminary findings of a government-sponsored study announced earlier this year. That study, AIDS Clinical Trial Group (ACTG) 076, was designed to evaluate the efficacy and safety of treating HIV-infected pregnant women after at least 13 weeks of pregnancy, and their babies, with Retrovir to prevent maternal-fetal transmission of HIV. The study was stopped when an interim analysis of the study data showed that therapy with Retrovir reduced the risk of transmission by 67 percent.
 Calculations for today's reported analysis were based on a survey of childbearing women by the CDC. Based on that survey, researchers estimated that in 1993, approximately 6,600 babies were born to women infected with HIV.
 At that time, the rate of transmission of HIV from mother to infant was approximately 26 percent, meaning that roughly 1,700 of those infants were born infected with HIV. By assuming similar rates and applying the preliminary finding from ACTG 076 of a two-thirds reduced risk of transmission when both the pregnant women and their babies received therapy with Retrovir, the researchers concluded that this intervention could potentially prevent an estimated 1,200 babies from becoming infected at birth.
 The finding earlier this year that Retrovir could help prevent transmission of HIV to newborns prompted swift action by government officials. In August, the U.S. Food and Drug Administration cleared Retrovir for marketing to reduce the risk of maternal-fetal transmission of HIV after the first trimester of pregnancy.
 In the ACTG 076 study, Retrovir was very well-tolerated by both mothers and infants with no significant reports of adverse events other that reversible mild anemia in some infants. Also, the data showed no significant difference in congenital birth defects in infants whose mothers received Retrovir over those whose mothers received placebo. No defects were attributed to Retrovir. However, while the safety data to date are reassuring, researchers noted that the number of mother-infant exposures to Retrovir is still relatively small, and stressed that further follow-up will be needed, particularly for any long-term effects, if any.
 In March of 1987, Retrovir became the first antiretroviral drug indicated for the treatment of HIV infection and AIDS, and continues to be the most extensively studied anti-HIV therapy. The use of Retrovir as a therapy for HIV infection and AIDS was discovered by scientists at Burroughs Wellcome Co. of Research Triangle Park, N.C., a research-based pharmaceutical company which also developed and manufactures Retrovir.
 -0- 10/5/94
 /CONTACT: Doug Stokke, 919-315-8611, or Kathy Bartlett, 919-315-4302, both of Burroughs Wellcome/
 (BW)


CO: Burroughs Wellcome ST: North Carolina IN: MTC SU: PDT

MM -- CH011 -- 1542 10/05/94 17:11 EDT
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Date:Oct 5, 1994
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