HEPATITIS AND LIVER CANCER

A National Strategy for Prevention and Control of Hepatitis B and C

Heather M. Colvin and Abigail E. Mitchell, Editors

Committee on the Prevention and Control of Viral Hepatitis Infections

Board on Population Health and Public Health Practice

INSTITUTE OF MEDICINE
OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS

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H E P AT I T I S A N D LIVER CANCER A National Strate gy for Prev ention and C ontrol of Hepatitis B and C Heather M. Colvin and Abigail E. Mitchell, Editors Committee on the Prevention and Control of Viral Hepatitis Infections Board on Population Health and Public Health Practice

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THE NATIONAL ACADEMIES PRESS 500 Fifth Street, N.W. Washington, DC 20001 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 study was supported by Contract 200-2005-13434, TO#16, between the National Acad- emy of Sciences and the Department of Health and Human Services (with support from the Centers for Disease Control and Prevention, the Office of Minority Health, and the Depart- ment of Veterans Affairs) and by the Task Force for Child Survival and Development on behalf of the National Viral Hepatitis Roundtable. Any opinions, findings, conclusions, or recommen- dations expressed in this publication are those of the author(s) and do not necessarily reflect the view of the organizations or agencies that provided support for this project. Library of Congress Cataloging-in-Publication Data Hepatitis and liver cancer : a national strategy for prevention and control of hepatitis B and C / Heather M. Colvin and Abigail E. Mitchell, editors ; Committee on the Prevention and Control of Viral Hepatitis Infections, Board on Population Health and Public Health Practice. p. ; cm. Includes bibliographical references and index. ISBN 978-0-309-14628-9 1. Hepatitis B—United States. 2. Hepatitis C—United States. 3. Liver—Cancer—United States. I. Colvin, Heather M. II. Mitchell, Abigail E. III. Institute of Medicine (U.S.). Committee on the Prevention and Control of Viral Hepatitis Infections. IV. Institute of Medicine (U.S.). Board on Population Health and Public Health Practice. V. National Academies Press (U.S.) [DNLM: 1. Hepatitis B—complications—United States. 2. Hepatitis B—prevention & control—United States. 3. Hepatitis C—complications—United States. 4. Hepatitis C— prevention & control—United States. 5. Liver Neoplasms—prevention & control—United States. 6. Viral Hepatitis Vaccines—therapeutic use—United States. WC 536 H5322 2010] RA644.H4H37 2010 616.99'436—dc22 2010003194 Additional copies of this report are available from the National Academies Press, 500 Fifth Street, N.W., Lockbox 285, Washington, DC 20055; (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area); Internet, http://www.nap.edu. For more information about the Institute of Medicine, visit the IOM home page at www. iom.edu. Copyright 2010 by the National Academy of Sciences. All rights reserved. Printed in the United States of America The serpent has been a symbol of long life, healing, and knowledge among almost all cultures and religions since the beginning of recorded history. The serpent adopted as a logotype by the Institute of Medicine is a relief carving from ancient Greece, now held by the Staatliche Museen in Berlin. Suggested citation: IOM (Institute of Medicine). 2010. Hepatitis and Liver Cancer: A National Strategy for Prevention and Control of Hepatitis B and C. Washington, DC: The National Academies Press.

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“Knowing is not enough; we must apply. Willing is not enough; we must do.” — Goethe Advising the Nation. Improving Health.

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The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Acad- emy has a mandate that requires it to advise the federal government on scientific and technical matters. Dr. Ralph J. Cicerone is president of the National Academy of Sciences. The National Academy of Engineering was established in 1964, under the charter of the National Academy of Sciences, as a parallel organization of outstanding en- gineers. It is autonomous in its administration and in the selection of its members, sharing with the National Academy of Sciences the responsibility for advising the federal government. The National Academy of Engineering also sponsors engineer- ing programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. Charles M. Vest is presi- dent of the National Academy of Engineering. The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions in the examination of policy matters pertaining to the health of the public. The Insti- tute acts under the responsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Harvey V. Fineberg is president of the Institute of Medicine. The National Research Council was organized by the National Academy of Sci- ences in 1916 to associate the broad community of science and technology with the Academy’s purposes of furthering knowledge and advising the federal government. Functioning in accordance with general policies determined by the Academy, the Council has become the principal operating agency of both the National Academy of Sciences and the National Academy of Engineering in providing services to the government, the public, and the scientific and engineering communities. The Coun- cil is administered jointly by both Academies and the Institute of Medicine. Dr. Ralph J. Cicerone and Dr. Charles M. Vest are chair and vice chair, respectively, of the National Research Council. www.national-academies.org

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COMMITTEE ON THE PREvENTION AND CONTROL OF vIRAL HEPATITIS INFECTIONS R. Palmer Beasley (Chair), Ashbel Smith Professor and Dean Emeritus, University of Texas, School of Public Health, Houston, Texas Harvey J. Alter, Chief, Infectious Diseases Section, Department of Transfusion Medicine, National Institutes of Health, Bethesda, Maryland Margaret L. Brandeau, Professor, Department of Management Science and Engineering, Stanford University, Stanford, California Daniel R. Church, Epidemiologist and Adult Viral Hepatitis Coordinator, Bureau of Infectious Disease Prevention, Response, and Services, Massachusetts Department of Health, Jamaica Plain, Massachusetts Alison A. Evans, Assistant Professor, Department of Epidemiology and Biostatistics, Drexel University School of Public Health, Drexel Institute of Biotechnology and Viral Research, Doylestown, Pennsylvania Holly Hagan, Senior Research Scientist, College of Nursing, New York University, New York Sandral Hullett, CEO and Medical Director, Cooper Green Hospital, Birmingham, Alabama Stacene R. Maroushek, Staff Pediatrician, Department of Pediatrics, Hennepin County Medical Center, Minneapolis, Minnesota Randall R. Mayer, Chief, Bureau of HIV, STD, and Hepatitis, Iowa Department of Public Health, Des Moines, Iowa Brian J. McMahon, Medical Director, Liver Disease and Hepatitis Program, Alaska Native Tribal Health Consortium, Anchorage, Alaska Martín Jose Sepúlveda, Vice President, Integrated Health Services, International Business Machines Corporation, Somers, New York Samuel So, Lui Hac Minh Professor, Asian Liver Center, Stanford University School of Medicine, Stanford, California David L. Thomas, Chief, Division of Infectious Diseases, Department of Medicine, Johns Hopkins School of Medicine, Baltimore, Maryland Lester N. Wright, Deputy Commissioner and Chief Medical Officer, New York Department of Correctional Services, Albany, New York Study Staff Abigail E. Mitchell, Study Director Heather M. Colvin, Program Officer Kathleen M. McGraw, Senior Program Assistant Norman Grossblatt, Senior Editor Rose Marie Martinez, Director, Board on Population Health and Public Health Practice v

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Reviewers T his report has been reviewed in draft form by persons chosen for their diverse perspectives and technical expertise, in accordance with procedures approved by the National Research Council’s (NRC’s) Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the institution in mak- ing its published report as sound as possible and to ensure that the report meets institutional standards for objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process. We wish to thank the following individuals for their review of this report: Scott Allen, Brown University Medical School Jeffrey Caballero, Association of Asian Pacific Community Health Organizations Colleen Flanigan, New York State Department of Health James Jerry Gibson, South Carolina Department of Health and Environmental Control Fernando A. Guerra, San Antonio Metropolitan Health District Theodore Hammett, Abt Associates Inc. Jay Hoofnagle, National Institute of Diabetes and Digestive and Kidney Diseases Charles D. Howell, University of Maryland School of Medicine Walter A. Orenstein, Bill & Melinda Gates Foundation Philip E. Reichert, Florida Department of Health Charles M. Rice III, The Rockefeller University vii

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viii REVIEWERS Tracy Swan, Treatment Action Group Su Wang, Charles B. Wang Community Health Center John B. Wong, Tufts Medical Center Although the reviewers listed above have provided many constructive comments and suggestions, they were not asked to endorse the conclusions or recommendations, nor did they see the final draft of the report before its release. The review of the report was overseen by Bradford H. Gray, Senior Fellow, The Urban Institute, and Elena O. Nightingale, Scholar-in- Residence, Institute of Medicine. Appointed by the Institute of Medicine and the National Research Council, they were responsible for making cer- tain that an independent examination of the report was carried out in ac- cordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of the report rests entirely with the author committee and the institution.

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Acknowledgments T he committee acknowledges the valuable contributions made by the many persons who shared their experience and knowledge with the committee. The committee appreciates the time and insight of the pre- senters during the public sessions: John Ward, Dale Hu, Cindy Weinbaum, and David Bell, Centers for Disease Control and Prevention; Chris Taylor and Martha Saly, National Viral Hepatitis Roundtable; Lorren Sandt, Car- ing Ambassadors Program; Joan Block, Hepatitis B Foundation; Gary Heseltine, Council of State and Territorial Epidemiologists; William Rogers, Centers for Medicare and Medicaid Services; Tanya Pagán Raggio Ashley, Health Resources Services Administration; Carol Craig, National Associa- tion of Community Health Centers; Daniel Raymond, Harm Reduction Coalition; and Mark Kane, formerly of the Children’s Vaccine Program, PATH. We are also grateful for the thoughtful written and verbal testimony provided by members of the public affected by hepatitis B or hepatitis C. Several persons contributed their expertise for this report. The com- mittee thanks David Hutton, of the Department of Management Science and Engineering at Stanford University; victor Toy, Beverly David, and Kathleen Tarleton, of IBM; Shiela Strauss, of the New York University College of Nursing; Ellen Chang and Stephanie Chao, of the Asian Liver Center at Stanford University; Gillian Haney, of the Massachusetts Depart- ment of Public Health; and all the State Adult Viral Hepatitis Prevention Coordinators that provided information to the committee. This report would not have been possible without the diligent assistance of Jeffrey Efird and Daniel Riedford, of the Centers for Disease Control and ix

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x ACKNOWLEDGMENTS Prevention. We appreciate the assistance of Ronald valdiserri, of the De- partment of Veterans Affairs, for providing literature for the report. The committee thanks the staff members of the Institute of Medicine, the National Research Council, and the National Academies Press who contributed to the development, production, and dissemination of this report. The committee thanks the study director, Abigail Mitchell, and program officer Heather Colvin for their work in navigating this complex topic and Kathleen McGraw for her diligent management of the committee logistics. This report was made possible by the support of the Division of Viral Hepatitis and Division of Cancer Prevention and Control of the Centers for Disease Control and Prevention, the Department of Health and Human Services Office of Minority Health, the Department of Veterans Affairs, and the National Viral Hepatitis Roundtable.

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Contents ACRONYMS AND ABBREVIATIONS xvii SUMMARY 1 The Charge to the Committee, 2 Findings and Recommendations, 2 Surveillance, 3 Knowledge and Awareness, 8 Immunization, 9 Viral Hepatitis Services, 12 Recommendation Outcomes, 17 1 INTRODUCTION 19 Prevalence and Incidence of Hepatitis B and Hepatitis C Worldwide, 22 Prevalence and Incidence of Hepatitis B and Hepatitis C in the United States, 25 Hepatitis B, 25 Hepatitis C, 28 Liver Cancer and Liver Disease from Chronic Hepatitis B Virus and Hepatitis C Virus Infections, 29 The Committee’s Task, 30 The Committee’s Approach to Its Task, 32 References, 35 xi

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xii CONTENTS 2 SURVEILLANCE 41 Applications of Surveillance Data, 43 Outbreak Detection and Control, 44 Resource Allocation, 45 Programmatic Design and Evaluation, 45 Linking Patients to Care, 45 Disease-Specific Issues Related to Viral-Hepatitis Surveillance, 46 Identifying Acute Infections, 47 Identifying Chronic Infections, 51 Identifying Perinatal Hepatitis B, 54 Other Challenges for Hepatitis B and Hepatitis C Surveillance Systems, 56 Infrastructure and Process-Specific Issues with Surveillance, 57 Funding Sources, 58 Program Design, 59 Reporting Systems and Requirements, 59 Capturing Data on At-Risk Populations, 61 Case Evaluation, Followup, and Partner Services, 62 Recommendations, 63 Model for Surveillance, 66 Core Surveillance, 67 Targeted Surveillance, 71 References, 72 3 KNOWLEDGE AND AWARENESS ABOUT CHRONIC HEPATITIS B AND HEPATITIS C 79 Knowledge and Awareness Among Health-Care and Social-Service Providers, 80 Hepatitis B, 81 Hepatitis C, 83 Recommendation, 85 Community Knowledge and Awareness, 89 Hepatitis B, 89 Hepatitis C, 93 Recommendation, 96 References, 101 4 IMMUNIZATION 109 Hepatitis B Vaccine, 109 Current Vaccination Recommendations, Requirements, and Rates, 110 Immunization-Information Systems, 126

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xiii CONTENTS Barriers to Hepatitis B Vaccination, 127 Hepatitis C Vaccine, 136 Feasibility of Preventing Chronic Hepatitis C, 136 Need for a Vaccine to Prevent Chronic Hepatitis C, 137 Cost Effectiveness of a Hepatitis C Vaccine, 137 References, 138 5 VIRAL HEPATITIS SERVICES 147 Current Status, 148 Components of Viral Hepatitis Services, 154 Identification of Infected Persons, 154 Prevention, 166 Medical Management, 166 Major Gaps in Services, 170 General Population, 170 Foreign-Born People, 173 Illicit-Drug Users, 175 Pregnant Women, 181 Correctional Settings, 184 Community Health Facilities, 186 Targeting Settings That Serve At-Risk Populations, 189 References, 192 A COMMITTEE BIOGRAPHIES 209 B PUBLIC MEETING AGENDAS 215 BOxES, FIGuRES, AND TABLES Boxes S-1 Recommendations, 4 2-1 Role of Disease Surveillance, 42 2-2 CDC Acute Hepatitis B Case Definition, 48 2-3 CDC Acute Hepatitis C Case Definition, 49 2-4 CDC Chronic Hepatitis B Case Definition, 52 2-5 CDC Hepatitis C Virus Infection Case Definition (Past or Present), 53 2-6 CDC Perinatal Hepatitis B Virus Infection Case Definition, 55 3-1 Geographic Regions That Have Intermediate and High Hepatitis B Virus Endemicity, 81

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xiv CONTENTS 4-1 Summary of ACIP Hepatitis B Vaccination Recommendations, 112 5-1 Summary of Recommendations Regarding Viral Hepatitis Services, 148 5-2 Mission Statement of Centers for Disease Control and Prevention Division of Viral Hepatitis, 150 5-3 Components of Comprehensive Viral Hepatitis Services, 155 5-4 Summary of CDC At-Risk Populations for Hepatitis B Virus Infection, 156 5-5 Summary of CDC At-Risk Populations for Hepatitis C Virus Infection, 158 5-6 Hepatitis B Virus-Specific Antigens and Antibodies Used for Testing, 160 Figures 1-1 Approximate global preventable death rate from selected infectious diseases and other causes, 2003, 20 1-2 The committee’s approach to its task, 34 2-1 Natural progression of hepatitis B infection, 46 2-2 Natural progression of hepatitis C infection, 47 4-1 Estimated cost of adult hepatitis B vaccination per quality adjusted life year (QALY) gained for different age groups and different rates of acute hepatitis B virus (HBV) infection incidence, 119 4-2 Trends in private health-insurance coverage, 133 5-1 Hepatitis B services model, 157 5-2 Essential viral hepatitis services for illicit-drug users, 180 Tables 1-1 Key Characteristics of Hepatitis B and Hepatitis C, 21 1-2 Burden of Selected Serious Chronic Viral Infections in the United States, 26 4-1 Hepatitis B Vaccine Schedules for Newborns, by Maternal HBsAg Status—ACIP Recommendations, 114 4-2 Hepatitis B Immunization Management of Preterm Infants Who Weigh Less Than 2,000 g, by Maternal HBsAg Status—ACIP Recommendations, 115

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xv CONTENTS 4-3 Estimated Chance That an Acute Hepatitis B Infection Becomes Chronic with Age, 118 4-4 Studies of Hepatitis B Vaccination Rates in Injection-Drug Users, 122 4-5 Public Health-Insurance Plans, 130 5-1 Summary of Adult Viral Hepatitis Prevention Coordinators Survey, 153 5-2 Interpretation of Hepatitis B Serologic Diagnostic Test Results, 161 5-3 Interpretation of Hepatitis C Virus Diagnostic Test Results, 164 5-4 Studies of Association Between Opiate Substitution Treatment and Hepatitis C Virus Seroconversion, 178

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Acronyms and Abbreviations AASLD American Association for the Study of Liver Diseases ACIP Advisory Committee on Immunization Practices ACOG American College of Obstetricians and Gynecologists AHRQ Agency for Healthcare Research and Quality AIDS acquired immunodeficiency syndrome ALT alanine aminotransferase anti-HBc Hepatitis B core antibody anti-HBs Hepatitis B surface antibody anti-HCV Hepatitis C antibody API Asian and Pacific Islander AST aspartate transaminase AVHPC adult viral hepatitis prevention coordinators CDC Centers for Disease Control and Prevention CHIP Children’s Health Insurance Program CI confidence interval CIA enhanced chemiluminescence CMS Centers for Medicare and Medicaid Services DIS disease intervention specialist DTaP diptheria and tetanus toxoids and acellular pertussis adsorbed vaccine DUIT drug user intervention trial DVH Division of Viral Hepatitis xvii

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xviii ACRONYMS AND ABBREVIATIONS EIA enzyme immunoassay EIP Emerging Infections Program EPSDT early periodic screening diagnosis and treatment program FDA Food and Drug Administration FEHBP Federal Employee Health Benefit Program FQHC federally qualified health center HAV Hepatitis A virus HBIG Hepatitis B immunoglobulin HBsAg Hepatitis B surface antigen HBV Hepatitis B virus HCC hepatocellular carcinoma HCV Hepatitis C virus HCW health-care workers HDHP high deductable health plan HIAA Health Insurance Association of America HIB haemophilus influenzae type B HIV human immunodeficiency virus HMO health maintenance organization HPV human papilloma virus HRSA Health Resources and Services Administration IDU injection-drug user IIS immunization information systems IOM Institute of Medicine IPV inactivated polio virus MMTP methadone maintenance treatment program NASTAD National Alliance of State and Territorial AIDS Directors NAT nucleic acid test NCHHSTP National Center for HIV/AIDS, Viral Hepatitis, Sexually Transmitted Diseases, and Tuberculosis Prevention NEDSS National Electronic Disease Surveillance System NETSS National Electronic Telecommunications System for Surveillance NGO nongovernmental organization NHANES National Health and Nutrition Examination Survey NIDU non-injection-drug user NVAC National Vaccine Advisory Committee

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xix ACRONYMS AND ABBREVIATIONS OB/GYN obstetrician/gynecologist OMH Office of Minority Health OR odds ratio PEI peer education intervention PHIN Public Health Information Network POS point of service PPO preferred provider organization PY person year QALY quality adjusted life year RCT randomized clinical trial RIBA recombinant immunoblot assay RNA ribonucleic acid RSV respiratory syncytial virus SAMHSA Substance Abuse and Mental Health Services Administration SARS severe acute respiratory syndrome SEP syringe exchange program STD sexually transmitted disease STRIVE Study To Reduce Intravenous Exposures TB tuberculosis TCM traditional Chinese medicine USPHS US Public Health Service USPSTF US Preventive Services Task Force VA Department of Veterans Affairs vCJD variant Creutzfeldt-Jakob disease VFC Vaccines for Children WHO World Health Organization

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