Hepatitis B (HBV) affects over 1.25 million Americans, and hepatitis C (HCV) over 3.2 million Americans. In the decades to come, more than 150,000 Americans are expected to die from these conditions unless steps are taken to increase awareness, diagnosis, and access to necessary care and treatment. Emerging interferon-free, direct-acting all-oral antiviral (DAA) treatments have changed the landscape of HCV treatment and care. These treatments appear to be safer than interferon-based treatments and provide exceptionally high rates of sustained virological response (SVR). Both HBV and HCV treatment guidelines have been updated to reflect evidence regarding initiation of new therapies; however, the evidence for those recommendations is largely based on clinical trials conducted under highly controlled conditions in restricted patient populations with limited data collection. Significant health disparities?across race, sex, age, and co-infection (with HIV or dual hepatitis)?may limit the generalizability of these populations. Data from longitudinal cohorts of ?real world? hepatitis patients are needed to assess the population impact of rapidly evolving antiviral therapies, to understand the spectrum of disease and its natural history, and to evaluate the public health impact of chronic viral hepatitis. The Chronic Hepatitis Cohort Study (CHeCS) is the first comprehensive longitudinal cohort study of chronic viral hepatitis in the US, and has served as a model platform for observational data collection in this population. Since 2010, CHeCS has reported valuable information and expanded knowledge on many facets of hepatitis disease and policy. We propose to build upon CHeCS to develop ?CHeCS-II,? in order to achieve the long-term goal of applying this rich data and infrastructure resource to inform public health planning, policy decisions, and clinical management of HBV and HCV. To achieve this, we will leverage the established CHeCS infrastructure, which has: (1) a diverse, real-world, non-veteran-based US cohort of >3,000 HBV, >11000 HCV, and >500 HIV co-infected patients receiving care through four U.S. health systems; (2) an experienced multidisciplinary team; (3) an efficient system for patient identification and data collection. We will provide scientific leadership to identify research findings and priorities by: (1) Offering seamless collaboration across study sites and with the Centers for Disease Control (Aim 1); (2) Expanding our HCV cohort to over 14,000 patients with >2 years' follow-up; (3) Increasing follow-up of HBV patients to >5 years; (4) Collecting additional data regarding social determinants of health, including access to and uptake of care (Aim 2); (5) Applying rigorous analytical approaches to develop an in-depth understanding of health disparities and comorbidities, as well as investigating how these differences impact access to and uptake of antiviral therapy; (6) Advancing translation of this research to inform hepatitis-related policy and practice (Aim 3).

Public Health Relevance

This study will improve understanding of viral hepatitis-related health disparities and comorbidities, especially with regard to how these differences impact access to and uptake of antiviral therapy. This data to will be used to enhance and advance translation of hepatitis research into evidence-based policy and practice.

Agency
National Institute of Health (NIH)
Institute
National Center for HIV, Viral Hepatitis, STDS and Tb Prevention (NCHHSTP)
Type
Research Demonstration--Cooperative Agreements (U18)
Project #
5U18PS005154-02
Application #
9331359
Study Section
Special Emphasis Panel (ZPS1)
Program Officer
Loveys, Deborah
Project Start
2016-09-01
Project End
2020-08-31
Budget Start
2017-09-01
Budget End
2018-08-31
Support Year
2
Fiscal Year
2017
Total Cost
Indirect Cost
Name
Henry Ford Health System
Department
Type
DUNS #
073134603
City
Detroit
State
MI
Country
United States
Zip Code
48202
Moorman, Anne C; Rupp, Loralee B; Gordon, Stuart C et al. (2018) Long-Term Liver Disease, Treatment, and Mortality Outcomes Among 17,000 Persons Diagnosed with Chronic Hepatitis C Virus Infection: Current Chronic Hepatitis Cohort Study Status and Review of Findings. Infect Dis Clin North Am 32:253-268
Li, J; Zhang, T; Gordon, S C et al. (2018) Impact of sustained virologic response on risk of type 2 diabetes among hepatitis C patients in the United States. J Viral Hepat 25:952-958
Spradling, Philip R; Xing, Jian; Rupp, Loralee B et al. (2018) Uptake of and Factors Associated With Direct-acting Antiviral Therapy Among Patients in the Chronic Hepatitis Cohort Study, 2014 to 2015. J Clin Gastroenterol 52:641-647
Lu, Mei; Li, Jia; Rupp, Loralee B et al. (2018) Changing trends in complications of chronic hepatitis C. Liver Int 38:239-247
Moorman, Anne C; Xing, Jian; Rupp, Loralee B et al. (2018) Hepatitis B Virus Infection and Hepatitis C Virus Treatment in a Large Cohort of Hepatitis C-Infected Patients in the United States. Gastroenterology 154:754-758
Moorman, Anne C; Xing, Jian; Nelson, Noele P et al. (2018) Need for Increasing Hepatitis A Virus Vaccination Among Patients Infected With Hepatitis B Virus and Hepatitis C Virus. Gastroenterology 154:2015-2017
Lu, Mei; Chacra, Wadih; Rabin, David et al. (2017) Validity of an automated algorithm using diagnosis and procedure codes to identify decompensated cirrhosis using electronic health records. Clin Epidemiol 9:369-376
Gordon, Stuart C; Trudeau, Sheri; Li, Jia et al. (2017) Race, Age, and Geography Impact Hepatitis C Genotype Distribution in the United States. J Clin Gastroenterol :
Xing, Jian; Spradling, Philip R; Moorman, Anne C et al. (2017) A Point System to Forecast Hepatocellular Carcinoma Risk Before and After Treatment Among Persons with Chronic Hepatitis C. Dig Dis Sci 62:3221-3234
Boscarino, Joseph A; Moorman, Anne C; Rupp, Loralee B et al. (2017) Comparison of ICD-9 Codes for Depression and Alcohol Misuse to Survey Instruments Suggests These Codes Should Be Used with Caution. Dig Dis Sci 62:2704-2712

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