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• the Public Health Problem • the National Academies Response 3/8/2018 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., Amgen, 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., Pfizer 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 Upjohn Company, US Pharmacopeia, and Wyeth-Ayerst Research Executive Vice President for Health Affairs • Pharmacoepidemiology training program support: NIH, Abbott Laboratories, Alza Corp., Amgen, Aventis March 16, 2018 Pharmaceuticals, Inc., Bayer Corp., Berlex Laboratories, Inc., Ciba-Geigy Corp., Genentech, 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, Biogen Idec, Boehringer Ingelheim, Bracco Diagnostics, Inc., Bristol-Myers Squibb Company, Centocor, Inc., Cephalon, Inc., Churchill Communications, Ciba-Geigy, Inc., Connaught Laboratories, CV Therapeutics, Cygnus Corp., Inc. , National Strategy studies supported by: Daiichi Pharmaceuticals UK, Ltd., Dupont-Merck, Eli Lilly and Company, Ethicon, 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 1 3/8/2018 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 2 3/8/2018 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 3 3/8/2018 Information Information (2) • The CDC, in partnership with state and
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