The FDA has approved Retrovir for HIV-infected pregnant woman lessthan two weeks after its Antiviral Drugs Advisory Committeerecommended use of the AZT therapy to reduce the risk of transmittingthe 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 TrialGroup 076 study sponsored by the National Institute of Allergy andInfectious Diseases. The Phase III trial results, reported in February,showed that the estimated rate of HIV transmission from infectedmothers to their children was 8.3 percent when both were treated withRetrovir, compared with a rate of 25.5 percent for those trialparticipants who received no therapy.Burroughs Wellcome, of Research Triangle Park, N.C., said the womenreceived 500 mg of Retrovir each day during pregnancy and acontinuous infusion during labor. Infants received the drug within 24hours of birth and for another six weeks.Treatments for women began between the 14th and 34th week ofpregnancy and the majority of the patients had not received Retrovirprior to participating in the study.Behrens said the cost of the treatments will vary depending on suchfactors as the number of weeks a pregnant woman received Retrovirprior to labor. In general, she said, the estimated wholesale price of thedrug for treatment of the mother during pregnancy, labor and deliveryand of the child following birth will be less than $900.In the Phase III trials, the company reported no birth defects wereassociated with Retrovir and the drug was "well tolerated" by womenand their children. Some infants experienced "reversible mild anemia."But Burroughs Wellcome researchers said follow-up studies will beconducted for side-effects as more pregnant women are exposed to thedrug.According to U.S. health officials, 6,000 to 7,000 HIV-infected womengive birth each year and about 1,500 to 2,000 of their children areinfected with the virus. n
-- Charles Craig
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