Click Here for November 1, 2022 Meeting Materials
Overview:
Viral hepatitis B is a blood-borne infection, which primarily occurs in early childhood through unsafe injections and medical procedures, as well as rarely through sexual contact and birth related infections [1]. Although HBV can be prevented by vaccination, about 240- 350 million people are chronically infected with HBV throughout the world, including approximately 2.2 million people living in the United States [2] . Hepatitis B and C represent a significant burden worldwide, leading to a million deaths a year, 78% of world's hepatocellular carcinoma (HCC), and greater than 50% of the world’s fatal cirrhosis [3]. The 2016 WHO report, which focused on global health strategies to end viral hepatitis, indicated that each country should identify its most affected population and adjust their response accordingly [4][2]. Vaccines are a critical component to ending the epidemic of hepatitis B and are identified as a core intervention strategy. Approximately 90% of children in the United States were fully immunized against HBV in 2013; however, only about a 25% of adults over 19 were vaccinated against HBV in 2014 [2].
To tackle the issue of HBV elimination in the United States, it is important to refocus vaccination efforts on the adult population. The Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) recommends that all adults aged 19 through 59 years, and adults aged 60 years or older with risk factors for hepatitis B infection should receive the Hepatitis B vaccine [5]. Specifically, those who are injection-drug users, have multiple sexual partners including men who have sex with men (MSM), live with others who have chronic HBV infection, are developmentally disabled in long-term-care facilities, in correctional facilities, at risk for occupational exposure to HBV, hemodialysis patients, persons with HCV infection, persons with chronic liver disease, traveling to countries where HBV is endemic, persons with HIV, and persons with diabetes, [4] are populations we plan to target as they are more at continued risk of HBV infection and transmission to others. Although the new recommendations are clear in calling for universal hepatitis B vaccination for adults, access to the vaccines will require strategic implementation programs, which should include focused efforts in vaccinating these particular groups.
Although HBV prevention strategies have been implemented successfully in the United States for children, many challenges remain for implementing vaccination in adult populations as a means of eliminating this virus. To address the response in the United States (US) and discuss the various issues related to national planning and policy, the Forum is organizing --the Elimination of Hepatitis B in the US by 2030 Symposium-- as part of its Policy Series under the education area of impact. The Elimination of Hepatitis B in the US by 2030 Symposium is led by a steering committee (SC) and managed by Forum staff. The SC is co-chaired by Drs. Arthur Reingold and Veronica Miller. Additional Scientific Planning Committee Members include:
• John Ward, Coalition for Global Hepatitis Elimination at the Task Force for Global Health
• Chari Cohen, Hepatitis B Foundation
• Judith Feinberg, West Virginia University Medicine
• Kelly Moore, Immunize.org
• Kevin Ault, University of Kansas, School of Medicine
Format:
This symposium will take place on November 1, 2022 in Atlanta Georgia, and will feature comprehensive discussions with high level experts from industry, government, patient advocacy, and academia to produce recommendations regarding how to improve the national adult vaccination strategy. The symposium program will be developed through the guidance of the Scientific Planning Committee, and include representation of experts from local health departments and the following organizations: University of California Berkeley School of Public Health (UCB SPH), the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP); the Coalition for Global Hepatitis Elimination at the Task Force for Global Health; the CDC Division of Viral Hepatitis; HBV vaccine manufacturing companies; and policy advocates from among the National Viral Hepatitis Roundtable (NVHR), HepB United, Hepatitis B Foundation and the National Alliance of State & Territorial AIDS Directors (NASTAD) among others. This event will feature in-depth discussions regarding national goals, prevention, screening and treatment, and vaccination strategies. One major output, among others, of this event will be a manuscript for peer-reviewed publication.• Overview on recommendations:
implementation for different populations
centers, All healthcare facilities, Pop up and mobile clinics/health centers
Scientific Planning Committee Co-Chairs
About the Forum:
The Forum for Collaborative Research (Forum) at the University of California Berkeley (UCB) School of Public Health (UCB SPH), founded in 1997, is a public/private partnership that addresses cutting edge science and policy issues through a process of stakeholder engagement. Its impetus was a request from Vice President Al Gore to convene all stakeholder groups to discuss and discover opportunities for cross-sector dialogue and collaboration. The hallmark of the Forum is inclusion of all stakeholder groups, including academia, industry, professional societies, patient representatives, payors, regulatory agencies and other relevant entities.
The Forum focuses on three areas of impact: 1) Practice - to address gaps and unmet needs in each disease area by convening disease specific forums; 2) Research -to sponsor research collaborations across multiple disciplinesincorporating science into the policymaking and regulatory processes for emerging therapeutics and technologies; and 3) Education - to train the next generation of leaders in drug development and health policy and help inform health policy via its Policy Series.
Practice: The Forum has and continues to address specific hurdles in drug development for human immunodeficiency virus (HIV), hepatitis B (HBV), transplantation associated virus infections (TAVI), primary sclerosing cholangitis (PSC), non-alcoholic fatty liver disease (NAFLD)/non-alcoholic steatohepatitis (NASH), genetically based rare diseases, and ocular diseases. We addressed an 8th disease area, HCV infection, through the HCV Forum, initiated in 2007 and completed in 2017. To carry out the work of the drug development-oriented disease specific Forums, we work closely with the Food and Drug Administration (FDA) and the European Medicines Agency (EMA), among other regulatory agencies in the world providing a trans-Atlantic regulatory scope and breadth to scientific based deliberations. Collaborating experts are individuals with significant experience and expertise in understanding the science, disease process, clinical research from one of the stakeholder group’s perspectives and in senior positions within their organizations.
Research: Building on its extensive knowledge base, stakeholder network and strong UC Berkeley faculty connections, the Forum fosters research collaborations across multiple disciplines via its Data center for collaborative Data Analyses by: 1) promoting Innovation in Regulatory Science toaid in the development and use of new tools, standards, and approaches to more efficiently evaluate product safety, efficacy and quality; and 2) establishing Standards for Science in Regulation by exploring multi-disciplinary approaches to regulatory decision making, and impact of regulatory decisions on individuals and societies. The Forum’s interdisciplinary data center facilitates data analyses from housed placebo arm databases across different disease areas and a network of information sharing among stakeholders including FDA, EMA, other national regulatory agencies, NIH and other federal health agencies, academic content experts, Academy of Medicine, professional organizations, patient representatives and industry participants.
Education: The Forum’s commitment to teaching and training aims to ensure that the next generation of experts and leaders in health policy and drug/diagnostic development can meet the public health needs of the nation and the world. The Forum offers educational and training opportunities in an environment of hands-on experience and exposure to current experts, issues, and solutions through formal classroom and online coursework and internships and fellowships. Forum students range from undergraduates to senior post-doctoral fellows.
Students learn to identify and examine innovative approaches to incorporating science into the policymaking and regulatory processes for emerging technologies and recommend agile adaptive regulatory approaches for assessing critical applications of innovative healthcare technologies.
The Policy Series, brings together the brightest minds of experts from relevant local, regional, national, and international public health organizations, including governmental and non-for profits, industry, and patient organizations. Our hallmark policy projects include the National Summit series, [sharing of best practices – collectively of organizations working in HIV (states had policies preventing them from following CDC universal guidelines for testing for HIV, which led to the recommendations on HIV screening and testing algorithms; [7] and guidance on HCV screening and testing algorithms. Impact in terms of advancing the national HIV policy [7].
Bay area health disparity offshoot from the national summit efforts - program on overcoming health disparities in the bay area – led to CA HIV research program which provides major grant to UCSF and UCLA (CFARs) to work in the US inequities across the bay area– bridging academia to community.
Co-located at the University of California campus in Washington, DC and at the UC Berkeley School of Public Health in California, the Forum is well positioned to stimulate joint research, crystallize new approaches to regulate and train the next generation of scientifically fluent policymakers and regulators.
About University of California Berkeley School of Public Health:
The University of California Berkeley School of Public Health (BPH) is at the forefront of solving complex public health problems through groundbreaking research, world-class education and community-engaged action.For more than 75 years, its faculty, students, and more than 18,000 alumni have put their education and skills into practice to improve the health and welfare of countless communities, the state and the world.The Center for Disease Control and Prevention recognizes BPH as one of nine health promotion and disease prevention research centers around the nation. BPH’s mission is to improve population health, especially for the most vulnerable, through:
In the area of infectious diseases BPH’s division of Infectious Disease and Vaccinology promotes public health through better understanding of infectious diseases and human immunology based on the interaction of basic and translational research that contributes to the development of new diagnostics, treatment, prevention, and the control of human infectious diseases.
The Forum’s presence at BPH provides its stakeholders access to the deep, innovative and multi-disciplinary contributions that the Berkeley faculty, centers, and schools can offer. Across the Berkeley campus, researchers work in the cutting edge of bioscience and related disciplines in foundational research in molecular and cell biology, bioengineering, informatics, and statistics, and on the most critical matters in policy, law, and economics. There is no university better situated to bring the consideration of regulatory science and policy together.
HBV can be prevented through vaccinations, making it possible to not only eliminate, but prevent unnecessary disease development in vulnerable populations. The Forum’s Elimination of Hepatitis B in the US by 2030 Symposium, will bring together Berkeley’s expertise along with national experts and key opinion leaders to inform on what is the best strategy for a robust and efficient national adult vaccination needed to ensurethe elimination of HBV in the US.
Sponsors and Partners:
References:
(1) Buckley, G. J., & Strom, B. L. (Eds.). (2017). A National Strategy for the Elimination of Hepatitis B and C. National Academies Press. https://doi.org/10.17226/24731
(2) CDC. (2015). Epidemiology and Prevention of Vaccine-Preventable Diseases (E. J. Hamborsky, A. Kroger, and S. Wolfe (Ed.). CDC.
(3) WHO. (2016). Global health sector strategy on viral hepatitis, 2016-2021: Towards ending viral hepatitis.
(4) Kowdley, K. V., Wang, C. C., Welch, S., Roberts, H., & Brosgart, C. L. (2012). Prevalence of chronic hepatitis B among foreign-born persons living in the United States by country of origin. Hepatology, 56(2), 422–433. https://doi.org/10.1002/hep.24804
(5) Schillie S, Vellozzi C, Reingold A, et al. Prevention of Hepatitis B Virus Infection in the United States: Recommendations of the Advisory Committee on Immunization Practices. MMWR Recomm Rep 2018;67(No. RR-1):1–31.
(6) Ott, J. J., Stevens, G. A., Groeger, J., & Wiersma, S. T. (2012). Global epidemiology of hepatitis B virus infection: New estimates of age-specific HBsAg seroprevalence and endemicity. Vaccine, 30(12), 2212–2219. https://doi.org/10.1016/j.vaccine.2011.12.116
(7) Panneer N, Lontok E, Branson BM, Teo CG, Dan C, Parker M, Stekler JD, et al. HIV and hepatitis C virus infection in the United States: whom and how to test. Clin Infect Dis 2014;59:875-882.
