IMPACT HCV I mprove M edicine: P atient A t C en T er of HCV

1. IMPACT HCVImprove Medicine: Patient At CenTer of HCV By Jeffrey J. Weiss, PhD, MS & Ponni V. Perumalswami, MD

2. Institute of Medicine Viral Hepatitis Report, 2010 • 2.7-3.9 million Americans are living with HCV • 75% are unaware that they are infected • Complications of untreated HCV—such as chronic liver disease, cirrhosis, liver cancer, and transplantation—result in over $30 billion health care costs annually. • The burden of disease from HCV is projected to increase over the next several decades

3. Prevalence of HCV Ab in the Third National Health and Nutrition Examination Survey (NHANES III, 1988–1994) and the current NHANES (1999–2002) By Age Persons born 1945 - 1964 By Year of Birth Armstrong G L et al. Ann Intern Med 2006;144:705-714

4. Candidates for Screening for HCV Birth Cohort Screening Adults born during 1945–1965 should receive one-time testing for HCV without prior ascertainment of HCV risk Persons who have injected illicit drugs in the recent and remote past Persons with conditions associated with a high prevalence of HCV infection Prior recipients of transfusions or organ transplants prior to July 1992 Children born to HCV-infected mothers Health care, emergency medical and public safety workers after a needle stick injury or mucosal exposure to HCV-positive blood Current sexual partners of HCV-infected persons 2012 Additional Recommendations1 1998 Recommendations2 • Centers for Disease Control and Prevention. Recommendations for the identification of chronic hepatitis C virus infection among persons born during 1945-1965. MMWR Recomm Rep 2012;61 (RR-4):1-32. • Centers for Disease Control and Prevention. Recommendations for prevention and control of hepatitis C virus (HCV) infection and HCVrelated chronic disease. MMWR Recomm Rep 1998;47:1-39.

5. Primary Care Providers (PCPs) are Key to Screening Patients at risk for HCV • PCPs play a critical role in hepatitis C virus (HCV) screening, early diagnosis, and referral for treatment • Ferrante JM, Winston DG, Chen PH, de la Torre AN. Family physicians' knowledge and screening of chronic hepatitis and liver cancer. Fam Med. 2008;40(5):345-351. • Chak E, Talal AH, Sherman KE, Schiff ER, Saab S. Hepatitis C infection in USA: an estimate of true prevalence. Liver Int. 2011 Mar 16 [Epub ahead of print]. • Institute of Medicine. Hepatitis and Liver Cancer: A National Strategy for Prevention and Control of Hepatitis B and C. Washington, DC: The National Academies Press; 2010. • Ghany MG, Strader DB, Thomas DL, Seeff LB. Diagnosis, management, and treatment of hepatitis C: an update. Hepatology. 2009;49(4):1335-1374.

6. The Majority of HCV-Infected Individuals Remain Untreated • Shatin D, Schech SD, Patel K, McHutchison JG. Population-based hepatitis C surveillance and treatment in a national managed care organization. Am J Manag Care. 2004;10:250-256. • Institute of Medicine. Hepatitis and Liver Cancer: A National Strategy for Prevention and Control of Hepatitis B and C. Washington, DC: The National Academies Press; 2010. • United States Department of Health and Human Services. Combating the Silent Epidemic of Viral Hepatitis: Action Plan for the Prevention, Care & Treatment of Viral Hepatitis. 2011. • Ferrante JM, Winston DG, Chen PH, de la Torre AN. Family physicians' knowledge and screening of chronic hepatitis and liver cancer. Fam Med. 2008;40(5):345-351.

7. Unmet Need • HCV infection is preventable and curable • The complexity of new treatments for HCV is increasing and the expertise of providers and quality of treatment provided impacts the number of patients cured • There will be a shortage of providers to treat HCV unless a new cadre of treaters is trained • New antiviral therapies for HCV are associated with serious side effects that require specialty care services, such as pre-treatment medical and psychosocial optimization, and aggressive on-treatment management • At the same time, new HCV treatments have dramatically increased rates of cure and consequently have the potential to significantly decrease downstream health care costs

8. Our Aims: IMPACT HCV • To create a state-of-the-art innovative web application (IMPACT HCV app) that will improve access to quality health care for persons infected with hepatitis C, expand the workforce, and lead to cost savings • To provide outreach to at-risk communities, train primary care providers in rural areas and prison system through an app and optimizing treatment evaluations and strategies for patients with HCV • To create and implement innovative strategies to centralize the pre-treatment work-up through the app in order to reduce the burden of treatment on PCPs • To demonstrate how a partnership of academic medicine, public health and community health centers can foster the capacity of rural and community physician partners to diagnose and provide safe and effective treatment for HCV infection in any population, consistent with accepted standard of care

9. IMPACT HCV • IMPACT HCV, is a partnership of: • An academic medical center (Icahn School of Medicine at Mount Sinai) • The New York State Department of Health AIDS Institute (Colleen Flanigan, RN, MS, Director, Viral Hepatitis Section) • The leading primary care association in New York(Community Health Care Association of New York State – CHCANYS; Kameron Wells, ND, RN, Vice President, Clinical Affairs) • CHCANYS currently has a collaborative demonstration pilot project in partnership with the NYS DOH AIDS Institute to increase the capacity within federally qualified health centers (FQHCs) to expand and improve HCV prevention, screening, diagnosis and linkage to treatment using a tele-consultation model • IMPACT HCV project will collaborate with and build upon the work being done in this demonstration project.

10. IMPACT HCV • By linking health-care providers from community practices with specialists experienced in treating hepatitis C • provide case conferencing • create knowledge networks • web based support groups • training modules • The app will incorporate several modalities of distance learning, including audio and video teleconferencing, Internet-based assessment tools, best practices, online presentations and telephone, text and email communications • At weekly virtual clinics, partners will present and discuss patients with hepatitis C with specialists

11. IMPACT HCV • Expand the workforce • Train primary care providers to screen, evaluate and treat patients with HCV • Engage patients • Patients are primary stakeholders in their health • IMPACT HCV app will be HCV patient centered • Building and implementing an app • Build content for patients and providers • Navigate both patients and providers through the spectrum of HCV diagnosis and management

12. Evaluation of IMPACT HCV • The app will be internally evaluated using web analytics captured from the app • Provider assessments (pre and post intervention) • Quantitative and qualitative data • Variables assessed will include HCV knowledge, number of pre treatment evaluations completed, number of patients initiated on HCV treatment, treatment outcomes including early treatment discontinuation and SVR, and provider satisfaction • Patients assessments (pre and post intervention) • Quantitative and qualitative data • Variables assessed will include HCV knowledge, patient ease and experience of using the app as well as data on patient engagement in and adherence to care • Track both volume and user experience

13. Sustainability of IMPACT HCV • The app complements work being carried out in a program entitled, “Building a Hepatitis C Demonstration Project” -- funded by the NYS DOH AIDS Institute in collaboration with CHCANYS • The app builds upon our experience providing web based tools to increase HCV provider skills (Psychosocial Readiness Evaluation and Preparation for Hepatitis C Treatment; PrepC; www. PrepC.org) • The dynamic nature of the app will allow for continual updating of practice and treatment guidelines as new HCV treatments continue to evolve • The project is expected to yield long-term benefits by reducing the cost burden of end state liver disease (ESLD), which is rising dramatically

14. Replication of IMPACT HCV • This app will be piloted and scaled up to expand efforts to reach additional PCPs and patients with HCV • We aim to replicate IMPACT HCV app in the following three ways: • Begin with a pilot in four selected FQHCs in year one of the grant period. The second year of the grant period will be used to scale up the app to make accessible to all PCPs • Expand to target other providers and care team members involved with education, screening and care of patients with HCV • Serve as a multiplier to expand the primary care workforce capacity to manage other common, chronic, but complex diseases outside of HCV