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Conflict of Interest Disclosure (1)

• Research grants provided by the US government, especially multiple different branches of the National Institutes of Health (NIH), the Agency for Healthcare Research and Quality, Food and Drug Administration, the Department of Veterans Affairs, and the US Agency for International Development • Research grants provided by foundations: American Cancer Society, American College of Cardiology, American College of Clinical Pharmacy Foundation, Asia Foundation, Charles A. Dana Foundation, Institute of Medicine of the National Academy of Sciences, Joint Commission on Prescription Drug Use, Pennsylvania Department of Health, Rockefeller Foundation, Andrew W. Mellon Foundation, and A National Strategy International Clinical Epidemiology Network, Inc. • Research grants provided by private industry: Aetna, Alza Corp., , AstraZeneca, Bayer Corp., for the Elimination of Hepatitis B and C Bayer Consumer Care, Berlex Laboratories, Boran Pharmaceuticals, Bristol-Myers Squibb, the Burroughs Wellcome Company, Ciba-Geigy Corp., COR Therapeutics Inc., GlaxoSmithKline, Glaxo- SmithKline Beecham, Glaxo Wellcome, Health Information Designs, Inc., Hoechst-Roussel Pharmaceuticals, Hoffman-La Roche, Inc., Integrated Therapeutics, Inc., a subsidiary of Schering-Plough Corporation, International Formula Council, Key Pharmaceuticals Inc., Marion Merrell Dow, Inc., McNeil Consumer Products, McNeil Pharmaceuticals, Mead Johnson Pharmaceuticals, Merck and Company, Novartis Pharmaceuticals Corp., Inc., Pfizer Pharmaceuticals, Pharming, PharMark Corp., A.H. Robins Company, Rowell Laboratories, Sandoz Pharmaceuticals, Schering Corp., Searle Brian L. Strom, MD, MPH Pharmaceutical, Shire, Smith Kline and French Laboratories, Sterling Winthrop Inc., Syntex, Inc., Takeda RBHS Chancellor Pharmaceuticals North America, the Company, US Pharmacopeia, and -Ayerst Research Executive Vice President for Health Affairs • Pharmacoepidemiology training program support: NIH, , Alza Corp., Amgen, Aventis March 16, 2018 Pharmaceuticals, Inc., Bayer Corp., Berlex Laboratories, Inc., Ciba-Geigy Corp., , Inc., Hoechst-Marion-Roussel, Inc., Hoffman LaRoche, Integrated Therapeutics Group, Inc., Johnson and Johnson, Mary E Groff Charitable Trust, Merck and Company, Inc., McNeil Consumer Product Company, McNeil Consumer Healthcare, Novartis Pharmaceuticals Corp., Pfizer Inc., Sanofi Aventis, Sanofi Pasteur, SmithKline Beecham Pharmaceuticals, Whitehall-Robins Healthcare, and Wyeth-Ayerst Rutgers, The State University of New Jersey Research

Conflict of Interest Disclosure (2) A National Strategy • Consultant: Abbott Laboratories, AbbVie, Aetna, Alza Corp., Amgen, Astra-Merck, AstraZeneca LP, for the Elimination of Hepatitis B and C Aventis Pharmaceuticals, Bayer Corp., Berlex Laboratories, Idec, Boehringer Ingelheim, Bracco Diagnostics, Inc., Bristol-Myers Squibb Company, Centocor, Inc., , Inc., Churchill Communications, Ciba-Geigy, Inc., Connaught Laboratories, CV Therapeutics, Cygnus Corp., Inc. , National Strategy studies supported by: Daiichi Pharmaceuticals UK, Ltd., Dupont-Merck, , , Endo Pharmaceuticals, Food and Drug Administration, GlaxoSmithKline, Hoechst-Roussel Pharmaceuticals, Inc., Hoffman • Centers for Disease Control and Prevention (CDC) LaRoche, IBEX Technologies Corp., IMS Health, Inflexxion, Inc., Inveresk Research North Carolina, Inc., IOM/National Academies of Science, Janssen Pharmaceuticals, John Wiley & Sons, Inc., LA-SER • US Department of Health and Human Services (HHS) Europe Limited, Lexicon Pharmaceutical, Lundbeck LLC, McNeil Consumer Products Company, Mikalix and Company, Novartis, Omnicare, Inc., Orchid Bioscience, Inc., Oscient Pharmaceutical Corp., Otsuka, • American Association for the Study of Liver Disease (AASLD) Pfizer, Inc., PharMark Corp., Pierre Fabre Dermatologie, Quintiles Strategic Research and Safety/The Lewin Group, Inc., Rhone Poulenc Rorer Pharmaceuticals, Inc., Roche Laboratories, Inc., RW Johnson • Infectious Diseases Society of America (IDSA) Pharmaceutical Research Institute, Sanofi Pasteur, Inc., Schering-Plough Research Institute, Science, Toxicology, and Technology Consultants, Searle, Shire Pharmaceuticals, Syntex, USA, Inc., Takeda, • National Viral Hepatitis Roundtable TAP Pharmaceuticals, Teva Branded Pharmaceutical Products R&D, Inc., UCB Biosciences, Inc., Value Health Sciences, ViiV HealthCare, VIVUS, Inc., Warner Lambert, Wyeth Consumer Healthcare Division, • National Academies of Sciences, Engineering, and Medicine and numerous law firms • Prior member of the Board of Directors of Medco Health Solutions, Inc.

A National Strategy A National Strategy for the Elimination of Hepatitis B and C for the Elimination of Hepatitis B and C • The Public Health Problem • The Public Health Problem • The National Academies Response • The National Academies Response • The Solution – A Fivefold Approach • The Solution – A Fivefold Approach

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The Public Health Problem The Public Health Problem (2) • Hepatitis B (HBV) and Hepatitis C (HCV) viruses cause nearly 1.5 million deaths worldwide • HBV and HCV account for approximately 80% of the world’s liver cancer • 20,000 deaths in the United States alone • Chronic HBV increases odds of liver cancer 50 – – 1.3 Million Americans have HBV 100 x – 2.7 Million Americans have HCV • Viral hepatitis causes more deaths each year than • Chronic HCV increases the odds 15 – 20 x HIV, tuberculosis, malaria, traffic fatalities, or • Viral hepatitis drove a 38% increase in liver diabetes cancer in the US between 2003 and 2012 • The 7th leading cause of death in the world receives less that 1% of NIH funding • Worsening opioid crisis increasing HCV infections

The Public Health Problem (3) The Public Health Problem (4) • HBV has an effective vaccine • 20,000 Americans die from HCV every year • Current treatments can cure most incidences of HCV • This exceeds the death rate for the other 60 other – costly but cost effective in comparison to other most deadly infectious diseases combined interventions • Treatment costs in the $10,000’s per patient making it unaffordable for most patients and public/private • Eliminating HBV and HCV would avert 90,000 insurers deaths in the United States by 2030 • Of the approximately 700,000 people enrolled in state Medicaid programs eligible for treatment, only 20,000 (less than 3%) receive treatment every year

A National Strategy NAM Committee – Statement of Tasks for the Elimination of Hepatitis B and C • In 2016, the National Academies of Science, • The Public Health Problem Engineering, and Medicine (NAM, previously IOM) convened an expert committee to eliminate viral • The National Academies Response hepatitis as a public health problem by 2030 • The Solution – A Fivefold Approach • Phase One Report (2016) – Question: Is it feasible to eliminate hepatitis B and C from the United States? What are the obstacles? • Phase Two Report (2017) – Question: What is the strategy to eliminate viral hepatitis from the United States? 12

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Phase One and Two Reports Phase One Report Conclusions • Phase 1 Report – concluded that HBV and HCV could • The world has the tools to prevent Hepatitis B (HBV) and be eliminated as public health problems in the United cure Hepatitis C (HCV) States by overcoming substantial obstacles – HBV vaccine confers 95% immunity in 3 doses • Phase 2 – recommends a national action plan – Direct-acting antiviral treatments cure infection in 95% of patients to hasten the end of HBV and HCV through: • Ending transmission of HBV is highly feasible in • Information children/perinatal • Essential Interventions • Ending transmission of HBV and HCV in adults, reducing • Service Delivery morbidity and mortality attributable to ongoing infection, and • Financing eliminating chronic infection are all feasible • Conclusion: it is feasible to control the public health • Research problem of HBV and HCV in the United States in the short term, and eliminate it in the long term – although cross- cutting barriers exist

A National Strategy Phase Two Report: for the Elimination of Hepatitis B and C A National Action Plan • The Public Health Problem • Information • The National Academies Response • Essential Interventions • The Solution – A Fivefold Approach • Service Delivery • Financing • Research

Hepatitis B Targets Hepatitis C Targets • By 2030, a 50 percent reduction in mortality from • By 2030, a 90 percent reduction in incidence of HCV chronic HBV is possible - averting over 60,000 deaths is possible in the US • To meet this goal: • To meet this goal requires treatment without – 90 percent of chronic HBV cases must be diagnosed restrictions on severity of disease and a consistent – 90 percent brought to care ability to diagnose new cases, even as prevalence – 80 percent of those treated for whom treatment is indicated decreases • Also reduces new cases of HBV-related hepatocellular • Reduces mortality by 65 percent relative to 2015 with carcinoma by about 1/3 and HBV-related cirrhosis by 28,800 deaths averted approximately 45 percent • To meet these targets requires: • The elimination of HBV infection in neonates and – At least 110,000 diagnoses per year until 2020 children under 5 is possible, as demonstrated in – Approx. 89,000 diagnoses per year 2020 - 2024 Alaska Native population – Over 70,000 diagnoses each year 2025 - 2030 17 18

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Information Information (2) • The CDC, in partnership with state and local health departments, should support standard hepatitis case • The CDC should support cross-sectional and finding measures, and the follow-up, monitoring, and cohort studies to measure HBV and HCV infection linkage to care of all viral hepatitis cases reported incidence and prevalence in high-risk populations through public health surveillance • Research in high-risk populations will create a better • CDC should work with the National Cancer Institute to understanding of the epidemiology of viral hepatitis attach viral etiology to reports of liver cancer in its periodic • Population-based research can clarify the true national reports on cancer incidence and prevalence of HBV and HCV infection • Not all state and local health departments are in a position to measure hepatitis disease burden • Integrated, highly-automated, electronic surveillance systems would generate a more accurate understanding of viral hepatitis disease burden 19 20

Essential Interventions Essential Interventions (2) • The CDC, AASLD, IDSA, and ACOG should • States should expand access to adult HBV recommend that all HBsAg+ pregnant women have vaccination, removing barriers to free early prenatal HBV DNA and liver enzyme tests to immunization in pharmacies and other easily evaluate whether antiviral therapy is indicated for accessible settings prophylaxis to eliminate mother-to-child • HBV is vaccine-preventable, but only about 25% of transmission or for treatment of chronic active adults older than 19 are fully immunized hepatitis • Early testing for HBV viremia can help determine the best course of treatment for HBsAg+ pregnant women, balancing questions of drug resistance and hepatitis flare against the risk of mother-to-child transmission 21 22

Essential Interventions (3) Essential Interventions (4) • The CDC should collaborate with states to identify • States and federal agencies should expand access appropriate settings for enhanced viral hepatitis to syringe exchanges and opioid agonist therapy testing based on expected prevalence • People who inject drugs account for approximately • Any measures that shed light on the subclinical 75% of new HCV infections burden of HBV and HCV infection will benefit society • The most effective way to prevent hepatitis C among • Screenings can be a burden on providers and the people who inject drugs is to combine strategies to: health system but there are settings where increased – Improve the safety of injections; screenings could yield significant benefits – Treat underlying addictions

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Essential Interventions (5) Service Delivery • Public and private health plans should • NCQA should establish measures to monitor remove restrictions that are not medically compliance with viral hepatitis screening indicated and offer direct-acting antivirals to guidelines and HBV vaccine birth dose coverage all chronic HCV patients and include the new measures in HEDIS • Treating everyone with HCV, regardless of • Gaps exists between the practice of medicine as disease stage, would prevent considerable recommended by experts and what really happens suffering in patients; and • NCQA is interested in closing those gaps and HEDIS • Protect the public by reducing the population indicators draw attention from providers and health reservoir for infection plan managers • Curing HCV has a demonstrable clinical benefit, • Inclusion of viral hepatitis in HEDIS would increase including reduction in cirrhosis and restoration of attention to these services

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Service Delivery (2) Service Delivery (3)

• AASLD and IDSA should partner with primary care • The Department of Health and Human Services providers and their professional organizations to should work with the states to build a build capacity to treat HBV and HCV in primary comprehensive system of care and support for care settings and establish referral systems for special populations with HBV and HCV on the medically complex patients scale of the Ryan White system • The need for specialist treatment is a critical • The patients most affected by viral hepatitis can be the bottleneck in hepatitis care hardest to reach and require more support services • Viral hepatitis care remains out of reach for people in • These populations include: rural and underserved areas – Uninsured and underserved – People with behavioral health problems

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Service Delivery (4) Financing • The criminal justice system should screen, • The federal government, on behalf of HHS, vaccinate, and treat HBV and HCV in correctional should purchase the rights to a direct-acting facilities according to national clinical practice antiviral for use in neglected market segments guidelines (Medicaid, Indian Health Service, prisons) by • Incarcerated populations bear a disproportionate licensing/ assigning a patent in a voluntary burden of viral hepatitis transaction with an innovator pharmaceutical • This is an opportunity however; the correctional health company system in our jails and prisons are an ideal place to vaccinate against HBV and implement HCV treatment

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Financing (2) Research • To eliminate gaps in hepatitis research key questions • Eliminating HCV depends on treating at least 260,000 must be addressed: patients a year with direct-acting antivirals • Basic research: • None of these drugs will come off patent before 2029, – Curative therapy for chronic HBV infection just one year before the target date – HCV vaccine development • Delaying mass treatment will result in millions of deaths and $ billions in wasted medical costs • Implementation research: – Stigma alleviation – Curative therapy for chronic HBV infection – Understanding networks of drug users; and – Health in incarcerated populations

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NAM Committee and Staff

Brian L. Strom, M.D., M.P.H, Chair Vincent Lo Re III, M.D., M.S.C.E. Neeraj Sood, Ph. D. Chancellor Associate Professor, Medicine & Epidemiology Professor and Vice Dean for Research Rutgers Biomedical & Health Sciences Perelman School of Medicine, Sol Price School of Public Policy Rutgers University, University of Pennsylvania University of Southern California The State University of New Jersey Kathleen Maurer, M.D., M.P.H., M.B.A. Grace Wang, M.D. Jon Kim Andrus, M.D. Director, Health and Addiction Services Family Physician Adjunct Professor and Senior Investigator, Connecticut Department of Correction International Community Health Services Division of Vaccines and Immunization, Center for Global Health, Randall Mayer, M.P.H. Lucy Wilson, M.D., Sc.M. University of Colorado Denver Interim Director, Chief, Center for Surveillance, Division of Behavioral Health Infection Prevention, and Outbreak Response Andrew Aronsohn, M.D. Iowa Department of Public Health Maryland Department of Health & Mental Hygiene Assistant Professor of Medicine Gastroenterology Shruti Mehta, Ph.D., M.P.H. Gillian Buckley, Ph.D. University of Chicago Professor of Epidemiology Study Director Bloomberg School of Public Health, Board on Population Health Daniel Church, M.P.H. Johns Hopkins University Epidemiologist and Viral Hepatitis Aimee Mead, MPH Prevention Coordinator Stuart C. Ray, M.D. Research Associate Massachusetts Department of Public Health Professor of Medicine Board on Population Health Center for Viral Hepatitis Research, Seymour Cohen, Ph.D. Johns Hopkins University Sophie Yang Instructor Emeritus Research Assistant Marine Biological Laboratory Arthur Reingold, M.D. Board on Population Health Edward Penhoet Distinguished Professor Alison Evans, Sc. D. Global Health and Infectious Diseases Marjorie Pichon Senior Program Assistant Associate Professor School of Public Health, Dornsife School of Public Health University of California, Berkley Board on Population Health Drexel University Samuel So, M.B.B.S. Rose Marie Martinez, ScD Senior Board Director Paul Kuehnert, DNP, RN Lui Hac Minh Professor Assistant Vice President, Program School of Medicine, Stanford University Board on Population Health 33 Robert Wood Johnson Foundation

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