January 30, 1998 / Vol. 47 / No. RR-2 TM Recommendations and Reports Public Health Service Task Force Recommendations for the Use of Antiretroviral Drugs in Pregnant Women Infected with HIV-1 for Maternal Health and for Reducing Perinatal HIV-1 Transmission in the United States U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention (CDC) Atlanta, Georgia 30333 The MMWR series of publications is published by the Epidemiology Program Office, Centers for Disease Control and Prevention (CDC), U.S. Department of Health and Hu- man Services, Atlanta, GA 30333. SUGGESTED CITATION Centers for Disease Control and Prevention. Public Health Service task force rec- ommendations for the use of antiretroviral drugs in pregnant women infected with HIV-1 for maternal health and for reducing perinatal HIV-1 transmission in the United States. MMWR 1998;47(No. RR-2):[inclusive page numbers]. Centers for Disease Control and Prevention.......................... David Satcher, M.D., Ph.D. Director The production of this report as an MMWR serial publication was coordinated in: Epidemiology Program Office.................................... Stephen B. Thacker, M.D., M.Sc. Director Richard A. Goodman, M.D., M.P.H. Editor, MMWR Series Office of Scientific and Health Communications (proposed) Recommendations and Reports................................... Suzanne M. Hewitt, M.P.A. Managing Editor Rachel J. Wilson Project Editor Morie M. Higgins Peter M. Jenkins Visual Information Specialists Use of trade names and commercial sources is for identification only and does not imply endorsement by the U.S. Department of Health and Human Services. Copies can be purchased from Superintendent of Documents, U.S. Government Printing Office, Washington, DC 20402-9325. Telephone: (202) 512-1800. Vol. 47 / No. RR-2 MMWR i Contents Introduction...........................................................................................................2 Background ...........................................................................................................3 General Principles Regarding the Use of Antiretrovirals in Pregnancy .........12 Recommendations for Antiretroviral Chemoprophylaxis to Reduce Perinatal HIV Transmission............................................................................14 Clinical Scenarios ..............................................................................................15 Recommendations for the Monitoring of Women and Their Infants .............23 Future Research Needs ......................................................................................25 References...........................................................................................................26 Single copies of this document are available from the Centers for Disease Control and Prevention, National AIDS Clearinghouse, P.O. Box 6003, Rockville, MD 20850. Telephone: (800) 458-5231. ii MMWR January 30, 1998 Executive Committee and Consultants to the Public Health Service Task Force On May 9, 1997, the Public Health Service convened a workshop to review a) the 1994 U.S. Public Health Service Task Force recommendations on use of zidovudine to reduce perinatal HIV-1 transmission; b) advances in understanding the pathogenesis of HIV-1 infection and the treatment of HIV-1 disease; and c) specific considerations regarding use of antiretroviral drugs in pregnant HIV-1–infected women and their in- fants. The workshop provided updated recommendations to the Public Health Service on the use of antiretroviral drugs for treatment of HIV-1 infection in pregnant women and for chemoprophylaxis to reduce perinatal HIV-1 transmission. The following persons participated in the workshop and either served as the execu- tive committee writing group that developed the recommendations or as consultants to the Public Health Service task force: Executive Committee Howard L. Minkoff, M.D. (Co-Chair) Nancy Kass, Sc.D. State University of New York Johns Hopkins School of Public Health Health Science Center at Brooklyn Baltimore, MD Brooklyn, NY Michael K. Lindsay, M.D., M.P.H. Wade Parks, M.D., Ph.D. (Co-Chair) Emory University School of Medicine New York University School of Medicine Atlanta, GA New York, NY Kenneth McIntosh, M.D. Arlene D. Bardeguez, M.D. Children’s Hospital of Boston University of Medicine and Boston, MA Dentistry of New Jersey Hermann Mendez, M.D. New Jersey Medical School State University of New York Health Newark, NJ Science Center at Brooklyn Ronald Bayer, Ph.D. Brooklyn, NY Columbia University School Angus Nicoll, M.D. of Public Health PHLS Communicable Disease New York, NY Surveillance Centre Charles C. J. Carpenter, M.D. London, England The Miriam Hospital Mary Jo O’Sullivan, M.D. Providence, RI University of Miami School of Medicine Jacqueline Clements Miami, FL Lincoln Community Health Center Sallie Marie Perryman Durham, NC New York State Department I. Celine Hanson, M.D. of Health AIDS Institute Baylor College of Medicine New York, NY Houston, TX Vol. 47 / No. RR-2 MMWR iii Executive Committee (Continued) Gwendolyn Scott, M.D. Catherine M. Wilfert, M.D. University of Miami School of Medicine Duke University Medical Center Miami, FL Durham, NC Ruth Tuomala, M.D. Carmen Zorrilla, M.D. Brigham and Women’s Hospital University of Puerto Rico Medical School Boston, MA San Juan, PR D. Heather Watts, M.D. University of Washington Seattle, WA Consultants to the Public Health Service Task Force Jean Anderson, M.D. Paul Krogstad, M.D. Johns Hopkins University School University of California, of Medicine Los Angeles School of Medicine Baltimore, MD Los Angeles, CA Isaac Delke, M.D. Laurent Mandelbrot, M.D. University of Florida Maternite Port Royal Health Science Center Paris, France Jacksonville, FL Theresa McGovern, J.D. Dianne Donovan HIV Law Project Positively Kids, Inc. New York, NY Queensbury, NY Janet Mitchell, M.D., M.P.H. Wafaa El-Sadr, M.D., M.P.H., M.A. Interfaith Medical Center Harlem Hospital Brooklyn, NY New York, NY Eileen Monagham Patricia S. Fleming Pediatric Community Bethesda, MD Constituency Group Spencerport, NY Donna Futterman, M.D. Montefiore Medical Center Joseph Perriens, M.D. Bronx, NY UNAIDS Geneva, Switzerland Cheryl Healton, Dr.P.H. Columbia University School Kenneth Rich, M.D. of Public Health University of Illinois at Chicago New York, NY Chicago, IL Saundra D. Johnson Pauline Thomas, M.D. Gay Men’s Health Crisis, Inc. New York City Department of Health New York, NY New York, NY iv MMWR January 30, 1998 Public Health Service Task Force Lynne M. Mofenson, M.D. (Chair) Elaine Daniels, M.D., Ph.D. National Institutes of Health Office of HIV/AIDS Policy Bethesda, MD Washington, DC James McNamara, M.D. Deborah von Zinkernagel, R.N., M.S., National Institutes of Health S.M. Bethesda, MD Office of HIV/AIDS Policy Washington, DC Mary Glenn Fowler, M.D., M.P.H. National Institutes of Health Michael Kaiser, M.D. Bethesda, MD Health Resources and Services Administration Ellen Cooper, M.D. Rockville, MD National Institutes of Health Bethesda, MD Karen Hench, R.N. Health Resources and Martha Rogers, M.D. Services Administration Centers for Disease Control Rockville, MD and Prevention Atlanta, GA Steven Gitterman, M.D., Ph.D. Food and Drug Administration R.J. Simonds, M.D. Rockville, MD Centers for Disease Control and Prevention David Lanier, M.D. Atlanta, GA Agency for Health Care Policy and Research Eric Goosby, M.D. Rockville, MD Office of HIV/AIDS Policy Washington, DC Frances Page, R.N., M.P.H. Office on Women’s Health Washington, DC Vol. 47 / No. RR-2 MMWR v The material in this report was prepared for publication by: Lynne M. Mofenson, M.D. Center for Research for Mothers and Children National Institute of Child Health and Human Development National Institutes of Health in collaboration with Robert J. Simonds, M.D. Division of HIV/AIDS Prevention—Surveillance and Epidemiology National Center for HIV, STD, and TB Prevention Robin R. Moseley, M.A.T. Division of AIDS, STD, and TB Laboratory Research National Center for Infectious Diseases vi MMWR January 30, 1998 Vol. 47 / No. RR-2 MMWR 1 Public Health Service Task Force Recommendations for the Use of Antiretroviral Drugs in Pregnant Women Infected with HIV-1 for Maternal Health and for Reducing Perinatal HIV-1 Transmission in the United States Summary These recommendations update the 1994 guidelines developed by the Public Health Service for the use of zidovudine (ZDV) to reduce the risk for perinatal human immunodeficiency virus type 1 (HIV-1) transmission.* This report pro- vides health-care providers with information for discussion with HIV-1–infected pregnant women to enable such women to make an informed decision regard- ing the use of antiretroviral drugs during pregnancy. Various circumstances that commonly occur in clinical practice are presented as scenarios and the factors influencing treatment considerations are highlighted in this report. In February 1994, the results of Pediatric AIDS Clinical Trials Group (PACTG) Protocol 076 documented that ZDV chemoprophylaxis could reduce perinatal HIV-1 transmission by nearly 70%. Epidemiologic data have since confirmed the efficacy of ZDV for reduction of perinatal transmission and have extended this efficacy to children of women with advanced disease, low CD4+ T-lymphocyte counts, and prior ZDV therapy. Additionally, substantial advances have been made in the understanding of the pathogenesis of HIV-1 infection and in the treatment and monitoring of HIV-1 disease. These advances