DTIC ADA346817: 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. Vol. 47, No. RR-2

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A . Report Title: 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
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January 30, 1998 / Vol. 47 / No. RR-2
Recommendations
and
Reports
MORBIDITY AND MORTALITY WEEKLY REPORT
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( 4
Centers for Disease Control and Prevention (CDC) ^StRv,Ct
Atlanta, Georgia 30333
The MMWRseries 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: [phone].
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: [phone].
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 Mclntosh, 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
MaryJoO'Sullivan, M.D.
Providence, Rl
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 in
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
RuthTuomala, 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
MMWR January 30,1998
IV
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
RJ. 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
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
MMWR January 30,1998
VI
Vol. 47 / No. RR-2 MMWR
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%. Epidemiologie 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 have resulted in
changes in standard antiretroviral therapy for HIV- 1-infected adults. More ag-
gressive combination drug regimens that maximally suppress viral replication
are now recommended. Although considerations associated with pregnancy
may affect decisions regarding timing and choice of therapy, pregnancy is not a
reason to defer standard therapy. The use of antiretroviral drugs in pregnancy
requires unique considerations, including the potential need to alter dosing as a
result of physiologic changes associated with pregnancy, the potential for
adverse short- or long-term effects on the fetus and newborn, and the effective-
ness for reducing the risk for perinatal transmission. Data to address many of
these considerations are not yet available. Therefore, offering antiretroviral ther-
apy to HIV- 1-infected women during pregnancy, whether primarily to treat HIV-1
infection, to reduce perinatal transmission, or for both purposes, should be ac-
companied by a discussion of the known and unknown short- and long-term
benefits and risks of such therapy for infected women and their infants. Stand-
ard antiretroviral therapy should be discussed with and offered to HIV- 1-infected
pregnant women. Additionally, to prevent perinatal transmission, ZDV chemo-
prophylaxis should be incorporated into the antiretroviral regimen.
* Information included in these guidelines may not represent approval by the Food and Drug
Administration (FDA) or approved labeling for the particular product or indications in question.
Specifically, the terms "safe" and "effective" may not be synonymous with the FDA-defined
legal standards for product approval.