A NATIONAL STRATEGY
FOR THE ELIMINATION
OF HEPATITIS B AND C
PHASE TWO REPORT
Gillian J. Buckley and Brian L. Strom, Editors
Committee on a National Strategy for the Elimination of
Hepatitis B and C
Board on Population Health and Public Health Practice
Health and Medicine Division
A Report of
THE NATIONAL ACADEMIES PRESS
Washington, DC
www.nap.edu
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This activity was supported by the American Association for the Study of Liver Diseases, the Infectious Diseases Society of America, the National Viral Hepatitis Roundtable, and the U.S. Department of Health and Human Services/Centers for Disease Control and Prevention (Contract No. 200-2011-38807, Task Order #44). Any opinions, findings, conclusions, or recommendations expressed in this publication do not necessarily reflect the views of any organization or agency that provided support for the project.
International Standard Book Number-13: 978-0-309-45729-3
International Standard Book Number-10: 0-309-45729-7
Digital Object Identifier: https://doi.org/10.17226/24731
Library of Congress Control Number: 2017942500
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Copyright 2017 by the National Academy of Sciences. All rights reserved.
Printed in the United States of America
Suggested citation: National Academies of Sciences, Engineering, and Medicine. 2017. A national strategy for the elimination of hepatitis B and C: Phase two report. Washington, DC: The National Academies Press. doi: https://doi.org/10.17226/24731.
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COMMITTEE ON A NATIONAL STRATEGY FOR THE ELIMINATION OF HEPATITIS B AND C
BRIAN L. STROM (Chair), Chancellor, Biomedical and Health Sciences, Rutgers University, The State University of New Jersey
JON KIM ANDRUS, Adjoint Professor and Senior Investigator, Division of Vaccines and Immunization, Center for Global Health, University of Colorado Denver
ANDREW ARONSOHN, Associate Professor of Medicine, University of Chicago
DANIEL CHURCH, Senior Epidemiologist, Bureau of Infectious Disease and Laboratory Sciences, Massachusetts Department of Public Health
SEYMOUR S. COHEN, American Cancer Society Research Professor, retired
ALISON EVANS, Associate Professor, Dornsife School of Public Health, Drexel University
PAUL KUEHNERT, Assistant Vice President, Program, Robert Wood Johnson Foundation
VINCENT LO RE III, Assistant Professor of Medicine (Infectious Diseases) and Epidemiology, University of Pennsylvania
KATHLEEN MAURER, Director, Health and Addiction Services, Connecticut Department of Correction
RANDALL MAYER, Chief, Bureau of HIV, STD, and Hepatitis, Division of Behavioral Health, Iowa Department of Public Health
SHRUTI MEHTA, Professor of Epidemiology, Bloomberg School of Public Health, Johns Hopkins University
STUART C. RAY, Professor of Medicine, Center for Viral Hepatitis Research, Division of Infectious Diseases, Johns Hopkins University
ARTHUR REINGOLD, Edward Penhoet Distinguished Professor of Global Health and Infectious Diseases, School of Public Health, University of California, Berkeley
SAMUEL SO, Lui Hac Minh Professor, School of Medicine, Stanford University
NEERAJ SOOD, Professor and Vice Dean for Research, Sol Price School of Public Policy and Schaeffer Center for Health Policy & Economics, University of Southern California
GRACE WANG, Family Physician, International Community Health Services
LUCY WILSON, Chief, Center for Surveillance, Infection Prevention, and Outbreak Response, Maryland Department of Health and Mental Hygiene
Study Staff
GILLIAN J. BUCKLEY, Study Director
AIMEE MEAD, Research Associate
SOPHIE YANG, Research Assistant
MARJORIE PICHON, Senior Program Assistant
DORIS ROMERO, Financial Associate
ROSE MARIE MARTINEZ, Director, Board on Population Health and Public Health Practice
James C. Puffer, M.D./American Board of Family Medicine (ABFM) Fellow
GERARDO MORENO, University of California, Los Angeles
Consultants
HOMIE RAZAVI, Center for Disease Analysis
MEHLIKA TOY, Stanford University School of Medicine
TIMOTHY WESTMORELAND, Georgetown University Law Center
Reviewers
This report has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making 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:
HARVEY ALTER, National Institutes of Health Clinical Center
SANJAY BASU, Stanford Prevention Research Center
JOHN BIRGE, The University of Chicago Booth School of Business
JULES DIENSTAG, Harvard Medical School
SHELLY F. GREENFIELD, McLean Hospital
RUTH KATZ, The Aspen Institute
ANNA LOK, University of Michigan Medical School
DAVID MENDEZ, University of Michigan School of Public Health
WALTER O. ORENSTEIN, Emory University School of Medicine
ROBIN POLLINI, Pacific Institute for Research
CHARLES RICE, The Rockefeller University
JOSHUA M. SHARFSTEIN, Johns Hopkins Bloomberg School of Public Health
DAVID THOMAS, John Hopkins Bloomberg School of Public Health
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 this report was overseen by Robert B. Wallace, University of Iowa, and Robert F. Sproull, University of Massachusetts Amherst. They were responsible for making certain that an independent examination of this report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this report rests entirely with the authoring committee and the institution.
Acknowledgments
The Committee on a National Strategy for the Elimination of Hepatitis B and C wishes to acknowledge the many people whose contributions and support made this report possible. The committee benefited from presentations made by a number of experts. The following individuals shared their research, experience, and perspectives with the committee: Jerome Adams, Sabrina Assoumou, Ryan Clary, John Coster, Ben Cowie, Jeff Duchin, Michael Fried, Nadine Gracia, Tim Gronniger, Jennifer Havens, Alicia Ifkovic-Mau, Michael Klompas, Kimberley Lenz, Steve Miller, Robin Pollini, Joshua Sharfstein, William Stauffer, Coy Stout, David Thomas, Chia Wang, John Ward, Stefan Wiktor, and Robert Zavoski.
The following individuals were important sources of information, generously giving their time and knowledge to further the committee’s efforts: Anne Burns, James Kachadoorian, Dima Qato, Homie Razavi, Mitch Rothholz, Mehlika Toy, and Timothy Westmoreland.
The committee acknowledges the support of the National Academies of Sciences, Engineering, and Medicine staff, especially Daniel Bearss, Clyde Behney, Iliana Espinal, Chelsea Frakes, Greta Gorman, Hope Hare, Nicole Joy, Sarah Kelley, Ellen Kimmel, Rebecca Morgan, Tina Ritter, Doris Romero, Barbara Schlein, Lauren Shern, Elizabeth Tyson, Jennifer Walsh, Annalyn Welp, and Taryn Young. The committee and staff thank Rebekah Hutton for designing the cover art.
The committee also benefited from the work of committees of the Institute of Medicine that conducted studies relevant to this report, particularly the Committee on a National Strategy for Prevention and Control of Viral Hepatitis Infections in the United States.
Finally, funding for this project was provided by the American Association for the Study of Liver Diseases, the Centers for Disease Control and Prevention Divisions of Viral Hepatitis and Cancer Prevention and Control, the Infectious Diseases Society of America, the National Viral Hepatitis Roundtable, and the Department of Health and Human Services Office of Minority Health. The committee extends special thanks for that support.
Preface
Viral hepatitis can be a devastating disease, causing over one and a half million deaths a year. Recent developments in prevention and treatment have engendered a change in the way the world views this problem. Increasingly, we ask if there is a better, feasible alternative to the suffering and untimely mortality caused by hepatitis B and C. The National Academies of Sciences, Engineering, and Medicine’s Committee on a National Strategy for the Elimination of Hepatitis B and C was charged with determining if these diseases might be eliminated in the United States and, if so, how that goal might be met. My fellow committee members and I were humbled by the philosophical and practical challenge these questions posed.
In our first report, the committee concluded that these infections could be eliminated as public health problems in the United States. (For purposes of brevity, the material in the first report is not repeated in this second one.) At the same time, the report emphasized the multiple barriers that stand in the way of this goal, all of which could be seen as consequences of another, more basic problem: viral hepatitis is simply not a sufficient priority in the United States.
The time is right for this to change. This report, which the committee hopes will be a vehicle for such change, lays out a strategy through which morbidity and mortality from viral hepatitis could be reduced by 2030 to the point that neither hepatitis B nor C commands attention as a major public health threat in the United States.
The committee’s deliberations necessarily touched on other pressing topics of public health significance, such as the opioid epidemic and the
problem of unaffordable medicines. Ultimately, this study deals with these topics only as they relate to viral hepatitis. I refer readers seeking a broader analysis of either question to two other committees currently convened by the National Academies: the Committee on Ensuring Patient Access to Affordable Drug Therapies and the Committee on Pain Management and Regulatory Strategies to Address Prescription Opioid Abuse.
The committee met three times to prepare this report. In closed session, the group evaluated the evidence and deliberated on the best strategy to eliminate hepatitis B and C as public health problems in the United States. Based on expert opinion and review of the evidence, the committee came to conclusions about a suitable strategy, recommending action for specific organizations to reach this goal. The committee drew on published literature and presentations from expert speakers in its deliberations. Members of the public were free to submit written testimony to the committee.
The committee is greatly appreciative of the strong and constant support provided by the study staff, who worked diligently over the many months of our deliberations and report preparation. Without their excellent and unending support we would never have been able to complete our task. We specifically wish to thank Gillian Buckley, who served as Study Director, and provided us enormous assistance and direction as the committee work proceeded, and without whom this report would not have existed. Other members of the National Academies staff who aided the study include Aimee Mead, Marjorie Pichon, Annalyn Welp, and Sophie Yang. Finally, as committee chair, I would like to thank my colleagues who served as committee members, who not only taught me an enormous amount about viral hepatitis, but served as a tremendous team, sharing expertise and (usually!) coming to an easy consensus. They also put in enormous work, providing the initial drafts of the report text.
Brian L. Strom, Chair
Committee on a National Strategy for the Elimination of Hepatitis B and C
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 |
AHN |
acute hepatic necrosis |
ALT |
alanine transaminase |
anti-HBc |
antibody to hepatitis B core antigen |
anti-HBe |
antibody to hepatitis B e antigen |
anti-HBs |
antibody to hepatitis B surface antigen |
CDC |
Centers for Disease Control and Prevention |
CHB |
chronic hepatitis B |
CHeCS |
Chronic Hepatitis Cohort Study |
CI |
confidence interval |
CMS |
Centers for Medicaid & Medicare Services |
CT |
computed tomography |
DAA |
direct-acting antiviral |
DEA |
Drug Enforcement Agency |
ECHO |
Extension for Community Healthcare Outcomes |
FDA |
Food and Drug Administration |
FQHC |
federally qualified health center |
HBeAg |
hepatitis B e antigen |
HBsAg |
hepatitis B surface antigen |
HBV |
hepatitis B virus |
HCC |
hepatocellular carcinoma |
HCV |
hepatitis C virus |
HEDIS |
Healthcare Effectiveness Data and Information Set |
HHS |
Department of Health and Human Services |
HRSA |
Health Resources and Services Administration |
ICER |
incremental cost-effectiveness ratio |
IDSA |
Infectious Diseases Society of America |
IMPACT |
Improving Mood–Promoting Access to Collaborative Treatment |
MRI |
magnetic resonance imaging |
NCQA |
National Committee for Quality Assurance |
NHANES |
National Health and Nutrition Examination Survey |
NIH |
National Institutes of Health |
OPTN |
Organ Procurement and Transplantation Network |
PWID |
people who inject drugs |
QALY |
quality-adjusted life year |
SAMHSA |
Substance Abuse and Mental Health Services Administration |
SEER |
Surveillance, Epidemiology, and End Results |
SMR |
standardized mortality ratio |
SVR |
sustained virologic response |
UI |
uncertainty interval |
UN |
United Nations |
UNAIDS |
Joint United Nations Programme on HIV/AIDS |
USPSTF |
U.S. Preventive Services Task Force |
VA |
Department of Veterans Affairs |
WHO |
World Health Organization |