Recommendations of the U.S. Public Health Service Task Force on the Use of Zidovudine to Reduce Perinatal Transmission of Human Immunodeficiency Virus' was published in the Centers for Disease Control and Prevention (CDC) Morbidity and Mortality Weekly Report (MMWR) August 5, 1994. These recommendations update interim guidance issued in the April 29, 1994 MMWR and were developed following the recently reported results from AIDS Clinical Trials Group (ACTG) Protocol 076, which demonstrated that zidovudine (ZDV) administered to a selected group of HIV-infected pregnant women and their infants can reduce the risk of perinatal HIV infection by approximately two-thirds. This clinical trial is a collaborative effort between the National Institutes of Health in the United States and the National Institute of Health and Medical Research and the National Agency of Research on AIDS in France. The regimen used in this trial included antenatal oral administration of ZDV beginning at 14-34 weeks of gestation and continuing throughout pregnancy, followed by intrapartum intravenous ZDV and postnatal oral administration of ZDV to the infant for 6 weeks after delivery.
This document summarizes the results of the trial, discusses limitations in the interpretation of the results, reviews the potential long-term adverse effects of this ZDV regimen for infants and women, and provides recommendations for the use of ZDV to reduce perinatal transmission and for medical monitoring of pregnant women and infants receiving this therapy. For more information, contact Dr. Jack Moye at the National Institutes of Health, (301)496-7339, or Dr. Harold Jaffe at CDC, (404)639-2000.
What are the recommendations for treating HIV-infected pregnant women?
The U.S. Public Health Service task force recommendations are designed to provide a basis for discussion between an HIV-infected pregnant woman and her health-care provider about the use of ZDV to reduce perinatal HIV transmission.
HIV-infected women should be informed of the substantial benefit and short-term safety of ZDV administered during pregnancy and the neonatal period observed in the ACTG Protocol 076. However, they must also be informed that the long-term risks of ZDV therapy to themselves and their children are unknown. A woman's decision to use ZDV to reduce the risk for HIV transmission to her infant should be based on a balance of the benefits and potential risks of the regimen to herself and her child.
The document provides recommendations regarding the use of ZDV to reduce the risk of perinatal HIV transmission for women whose clinical situation meets the entry criteria for ACTG Protocol 076 as well as for HIV-infected pregnant women with differing clinical situations.
Are additional recommendations being formulated?
PHS is developing further recommendations to prevent perinatal HIV transmission. Following development of the draft document, these recommendations will be circulated widely for public comment.
How are the recommendations being distributed?
In addition to the usual MMWR distribution (approximately 47,400 copies of each issue are routinely mailed out), copies of the PHS task force recommendations are being mailed to appropriate national organizations and other government agencies and distributed through electronic bulletin boards.