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Cal A Institute of Medicine Nadona1 Academy of Sciences NATIONAL ACADB~Y PRESS Washington, D.C. 1988

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National Academy Press ~ 2101 Constitution Avenue, NW ~ Washington, DC 20418 NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance. This report has been reviewed by a group other than the authors according to procedures approved by a Report Review Committee consisting of members of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The National Academy of Sciences was established in 1863 by Act of Congress as a private, nonprofit, self-governing membership corporation for the furtherance of science and technology, required to advise the federal government upon request within its fields of competence. Under its corporate charter the Academy established the National Research Council in 1916 and the National Academy of Engineering in 1964. The Institute of Medicine was chartered in 1970 by the National Academy of Sciences to enlist distinguished members of the appropriate professions in the examination of policy matters pertaining to the health of the public. In this, the Institute acts under both the Academy's 1863 congressional charter responsibility to be an adviser to the federal government and its own initiative in identifying issues of medical care, research, and education. Support for this project was provided in part by the National Research Council (NRC) Fund, a pool of private, discretionary, nonfederal funds that is used to support a program of Academy-initiated studies of national issues in which science and technology figure significantly. The NRC Fund consists of contributions from several sources: a consortium of private foundations, including the Carnegie Corporation of New York, the Charles E. Culpeper Foundation, the William and Flora Hewlett Foundation, the John D. and Catherine T. MacArthur Foundation, the Andrew W. Mellon Foundation, the Rockefeller Foundation, and the Alfred P. Sloan Foundation; the Academy Industry Program, which seeks annual contributions from companies that are concerned with the health of U.S. science and technology and with public policy issues with technological content; and the National Academy of Sciences and the National Academy of Engineering endowments. Additional funds were provided by The Merck Company Foundation and by the U.S. Public Health Service and Health Care Financing Administration (contract number ASU-000001-07-S). Library of Congress Catalogue Card Number 88-61558 ISBN 0-309-03879-0 First Printing, June 1988 Second Printing, November 1988 Third Printing, June 1989 Copyright ~ 1988 by the National Academy of Sciences No part of this book may be reproduced by any mechanical, photographic, or electronic process, or in the form of a phonographic recording, nor may it be stored in a retrieval system, transmitted, or otherwise copied for public or private use, without written permission from the publisher, except for the purposes of official use by the U.S. government. Printed in the United States of America

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Committee for the Oversight of AIDS Activities THEODORE COOPER (Chair), The Upjohn Company, Kalamazoo, Michigan STUART ALTMAN, Brandeis University, Waltham, Massachusetts DAVID BALTIMORE, Whitehead Institute for Biomedical Research and Massachusetts Institute of Technology, Cambridge KRISTINE GEBBIE, Oregon Health Division, Portland DONALD R. HOPKINS, The Carter Presidential Center, Atlanta KENNETH PREWITT, The Rockefeller Foundation, New York HOWARD M. TEMIN, University of Wisconsin School of Medicine, Madison PAUL VOLBERDING, San Francisco General Hospital STAFF ROBIN WEISS, Project Director and Director, AIDS Activities LESLIE HARDY, Project Officer MARY JANE POTASH, Project Officer GAIL SPEARS, Administrative Assistant KATHLEEN ACHOR, Senior Secretary HOLLY DAWKINS, Secretary JOANNE INNIS, Secretary APRIL POWERS, Secretary CONSULTANTS MARK FEINBERG, Whitehead Institute for Biomedical Research, Cambridge, Massachusetts LYNN I. LEVIN, Institute of Medicine LEAH MAZADE, National Academy Press JEFF STRYKER, University of Michigan School of Public Health, Ann Arbor ROY WIDDUS, Global Programme on AIDS, World Health Organization . . . 111

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Preface Twenty months ago, in October 1986, the Institute of Medicine/National Academy of Sciences (IOM/ NAS) issued Confronting AIDS: Directions for Public Health, Health Care, and Research. That report described what was known then about the acquired immune deficiency syndrome (AIDS). It contained the information on which the IOM/ NAS Committee on a National Strategy for AIDS based its conclusions and recommendations. Appendix A in this volume is the summary and recommendations from that report. In March 1987, IOM/ NAS created a new committee, the AIDS Activities Oversight Committee, and charged it to monitor and assess the nation's response to the problems raised by AIDS in matters of public health, health care, and research. The committee was also asked to coordinate and oversee studies and activities concerning AIDS through- out the National Academy of Sciences complex. One of the committee's first undertakings was to review Confronting AIDS, a year and a half later, with an eye toward assessing the nation's progress against AIDS and appraising the quality and extent of its responses. To supplement its expertise, the committee identified approximately 60 correspondents; these included experts in the fields of molecular biology, immunology, virology, drug and vaccine development, clinical medicine, epidemiology, public health, international health, infectious diseases, ethics, law, education, social sciences, the history of science, and other disciplines, as well as administrators of the major federal agencies concerned with AIDS and some state and local officials. These correspondents were asked to prepare papers for the committee describing progress and events in their

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V1 PREFACE fields since the fall of 1986. Appendix C is a list of the correspondents from whom material was received. This report presents the committee's findings and the recommendations that arose from them. It should be viewed as an update of and a supplement to Confronting AIDS; it makes no attempt to duplicate the breadth and depth of information available in the original report. The preponderance of the factual material in Confronting AIDS remains accurate as of May 1988. For a basic understanding of the scientific knowledge that underlies both recent advances and the current recom- mendations, the committee refers the reader to that volume. This update highlights new information or events that have given rise to the need for new directions; it also focuses on recommendations from the earlier report that deserve reemphasis. Chapters tend to vary in length and in the depth of their analysis, reflecting the reality that more or less progress has occurred in different areas and also the committee's intent to provide useful information to a varied audience of laypersons, scientists, and policymakers. The committee plans to address some areas more fully in the future; the U.S. role in combating the global epidemic, for example, awaits further study. It is now clear that the "AIDS epidemic" is really an epidemic of HIV infection, and when referring to the epidemic in general, we use the terms interchangeably. When we discuss target populations for intervention, however, we distinguish among asymptomatic infected persons, sympto- matic individuals, or people with AIDS as defined for surveillance purposes by the Centers for Disease Control (see Appendix B). As is true for any new disease, we expect that terminology will continue to evolve as our understanding increases. Finally, like its predecessor body, the AIDS Oversight Committee was continually aware that it was assessing a "moving target." As new developments occur and new knowledge is acquired, the committee will pause again for reflection and evaluation. ACKNOWLEDGMENTS The committee wishes to thank the many persons who took time from their activities to assess the current status of their fields for the purposes of this report. Thanks are also due to the members of the AIDS Oversight Committee, all of whom made exceptional efforts to fulfill the requirements of the update. Finally, I wish to acknowledge the remarkable contribution and tireless assistance of the IOM/ NAS staff headed by Robin Weiss. THEODORE COOPER Chairman of the Board and Chief Executive Officer The Upjohn Company

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Contents EXECUTIVE SUMMARY Introduction, ~ HIV Infection and Its Epidemiology, 2 The Spectrum of HIV Infection, 2; Modes and Efficiencies of HIV Transmission, 3; Prevalence and Incidence of Infection in the United States, 4 Understanding the Epidemic's Course, 5 Altering the Epidemic's Course, 5 Antidiscrimination Protections, 6; Education, 6; Screening and Testing for HIV Antibody, 8; Other Public Health Measures, 11; AIDS and IV Drug Abuse, 12; Resources for Public Health Measures, 13 Care of Persons Infected with HIV, 13 Care Needs of Special Patients, 13; Health Care Providers, 14; Costs of Health Care for Persons with AIDS, 16; Financing Health Care for Persons with AIDS and Other HIV-Infected Individuals, 16; Possible Financing Mechanisms, 17 The Biology of HIV and Biomedical Research Needs, 17 HIV Biology, 18; Drug Development and Testing, 18; Vaccine Development and Testing, 20; Roundtable on vat

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~ Vlll CONTENTS Drugs and Vaccines, 20; Animal Models of AIDS, 21; Resources for the Campaign, 21 international Aspects of AIDS and HIV Infection, 22 A National Commission on HIV Infection and AIDS, 24 INTRODUCTION References, 31 2 HIV INFECTION AND ITS EPIDEMIOLOGY HIV: The Etiologic Agent of AIDS, 33 Proportion of Infected Individuals Who Will Develop AIDS, 35 The Spectrum of HIV Infection, 36 Modes and Efficiencies of HIV Transmission, 38 Heterosexual Transmission, 39; Efficiencies of Transmission, 42; Relative Efficiencies of HIV Transmission, 45 Prevalence and Incidence of HIV Infection in the United States, 46 HIV Prevalence in Groups at Recognized Risk, 46; HIV Prevalence Among Selected Segments of the General Population, 47; Incidence of New Infections, 49; National Estimates of HIV Infection, 49; The Program of HIV Surveys and Studies, 50 AIDS Cases in the United States, 51 The Demographic Impact of AIDS, 52 Future Research Needs, 52 References, 53 l . 27 .. 33 3 UNDERSTANDING THE COURSE OF THE EPIDEMIC ................ The Uses of Models, 58 Data Needs, 59 References, 60 4 ALTERING THE COURSE OF THE EPIDEMIC Features of Public Health Programs, 61 Antidiscrimination Protections, 62 . 57 . 61

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CONTENTS iX Education, 64 Content of the Message, 65; School-Based Education, 66; Effect of Educational Programs, 67; Gay and Bisexual Men, 68; AIDS and Condoms, 68 HIV Antibody Screening and Testing, 69 Technical Considerations, 71; Informed Consent and Confidentiality, 71; Voluntary Testing, 74; Mandatory Screening, 75; Home-Based Testing, 79 Other Public Health Measures, 80 Duty to Warn, 80; Contact Notification, 81; Reporting of HIV-Seropositive Cases, 82; Personal Control Measures, 83 AIDS and {V Drug Abuse, 84 Intervention Innovations, 85; Distribution of Sterile Needles and Syringes, 86 Resources, 87 References, 89 5 CARE OF PERSONS INFECTED WITH HIV Care Needs of Special Patient Groups, 94 IV Drug Abusers, 94; Infants and Children, 95; Patients with Dementia or Other Neuropsychological Deficits, 96 Health Care Providers, 96 Ethical Aspects of Providing Care, 97; Health Care Provider Training, 101; The Psychological Burden of AIDS Patient Care, 103 Health Care Costs for HIV-Related Conditions, 104 Direct Costs of Care for AIDS Patients, 104; Indirect Costs of HIV-Related Conditions, 106; Cost Implications of Projected AIDS Cases, 107; Research on Health Care Costs, 109 Financing Health Care for HIV-Related Conditions, ~10 Sources of Financing, 111; Alternative Financing Mechanisms to Improve Health Care Coverage, 113; Development of a Financing Strategy, 117 References, IlS 6 THE BlOI~OGY OF HIV AND BIOMEDICAL' RESEARCH NEEDS .................. HIV Biology, 123 . 93 . 123

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X CONTENTS Viral Taxonomy and Disease, 123; Control of Viral Gene Expression, 127; Regulation and Production of HIV, 127; Interrupting Infection by HIV, 130; Natural History of HIV Infection, 132; The Importance of Basic Research, 135 Drug Development and Testing, 136 Vaccine Development and Testing, 141 Roundtable on Drugs and Vaccines, 146 Animal Models of AIDS, 147 Resources, 149 Facilities, 149; Reagent Distribution Center, 150 Funding for Research, 151 References, 151 7 INTERNATIONAL ASPECTS OF AIDS AND HIV INFECTION ............................ The WHO Global Programme on AIDS, 160 Rationale for U.S. International Involvement, 161 The U.S. Contribution to International Efforts, 161 References, 164 A NATIONAL COMMISSION ON HIV INFECTION AND AIDS APPENDIXES .. 159 165 A. Summary and Recommendations from Confronting AIDS: Directions for Public Health, Health Care, and Research 171 B. CDC Classification System for HIV Infections and Revised Case Definition for AIDS 202 C. Correspondents D. Biographical Notes on Committee Members INDEX . . . 218 .. 221 227

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Confronting A one ~ L _ ~ Update 1988

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