The FDA has approved Retrovir for HIV-infected pregnant woman less than two weeks after its Antiviral Drugs Advisory Committee recommended use of the AZT therapy to reduce the risk of transmitting the disease to infants. Lisa Behrens, public affairs specialist for Burroughs Wellcome Co., said the treatment is available immediately. The FDA approval was based on results from an AIDS Clinical Trial Group 076 study sponsored by the National Institute of Allergy and Infectious Diseases. The Phase III trial results, reported in February, showed that the estimated rate of HIV transmission from infected mothers to their children was 8.3 percent when both were treated with Retrovir, compared with a rate of 25.5 percent for those trial participants who received no therapy. Burroughs Wellcome, of Research Triangle Park, N.C., said the women received 500 mg of Retrovir each day during pregnancy and a continuous infusion during labor. Infants received the drug within 24 hours of birth and for another six weeks. Treatments for women began between the 14th and 34th week of pregnancy and the majority of the patients had not received Retrovir prior to participating in the study. Behrens said the cost of the treatments will vary depending on such factors as the number of weeks a pregnant woman received Retrovir prior to labor. In general, she said, the estimated wholesale price of the drug for treatment of the mother during pregnancy, labor and delivery and of the child following birth will be less than $900. In the Phase III trials, the company reported no birth defects were associated with Retrovir and the drug was "well tolerated" by women and their children. Some infants experienced "reversible mild anemia." But Burroughs Wellcome researchers said follow-up studies will be conducted for side-effects as more pregnant women are exposed to the drug. According to U.S. health officials, 6,000 to 7,000 HIV-infected women give birth each year and about 1,500 to 2,000 of their children are infected with the virus. n
-- Charles Craig Staff Writer
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