Innovations in Management of Chronic Hepatitis C: Cost-effectiveness Analyses and Overcoming Barriers to Treatment Uptake Open Access

Abstract

Cost-effectiveness of interferon-free treatment for chronic hepatitis C. At least 3.2 million people in the United States (US) live with chronic hepatitis C infection (CHC), which progresses largely asymptomatically toward cirrhosis, liver cancer, and premature death when untreated. Interferon-free treatments approved by the FDA in 2013 improve cure rates, eliminate most side effects and eligibility barriers, and simplify treatment administration compared to older interferon-based regimens. However, their added expense will contribute to access challenges. This analysis uses a decision-analytic Markov model with a lifetime horizon and societal perspective to investigate cost-effectiveness of interferon-free treatment compared to the previous standard of care. Results indicate that level of treatment uptake will be an important driver of cost-effectiveness.

Race/ethnicity as a barrier to CHC treatment: NHANES and the Grady Liver Clinic. Although interferon-free regimens will reduce many CHC treatment barriers, additional strategies are needed to overcome those related to socioeconomic status. Black race and Hispanic ethnicity are consistently associated with lack of CHC treatment in the US, and with socioeconomic variables known to impede access to care. A 2013 study of HCV-infected individuals from the National Health and Nutrition Examination Survey (NHANES) found no association between race and treatment, but because NHANES excludes several groups with high CHC prevalence, its generalizability to the overall US HCV-infected population is questionable. This analysis compares the NHANES results to CHC treatment data from the Grady Memorial Hospital Liver Clinic in Atlanta, Georgia, which serves a predominantly black and uninsured population. Grady's CHC treatment prevalence was equivalent to NHANES', even though the Grady sample included an overrepresentation of racial and socioeconomic groups historically difficult to engage and retain in care. In logistic regression analyses, likelihood of treatment was higher among Hispanics than non-Hispanics. Treatment uptake among blacks was mediated by presence of hypertension. These findings indicate that the Grady Liver Clinic is a successful model for treating underserved racial minorities for CHC. Combined with enhanced screening and access to interferon-free regimens that simplify treatment, innovative models like Grady's targeting high-risk, high-prevalence populations can make significant contributions toward reducing CHC-related morbidity and mortality in the US.

Table of Contents

INTRODUCTION........................................................................................................................... 1

Chronic hepatitis C: Global disease burden and natural history........................................................... 1

HCV transmission......................................................................................................................... 2 Treatment................................................................................................................................... 2 Cost of treatment......................................................................................................................... 3

PART 1: Cost-effectiveness of Novel CHC Treatments........................................................................ 4

LITERATURE REVIEW: Factors Associated with CHC Treatment Uptake................................................ 15

Importance of treatment uptake.................................................................................................... 15

Literature review methods............................................................................................................ 16 Overview.................................................................................................................................... 16

Healthcare access and insurance status.......................................................................................... 17

Substance abuse......................................................................................................................... 18 Injection drug use....................................................................................................................... 18 Other drug use............................................................................................................................ 20 Alcohol....................................................................................................................................... 20 Demographic variables................................................................................................................. 21 Age............................................................................................................................................ 21 Gender....................................................................................................................................... 23 Race/Ethnicity............................................................................................................................. 23 Socioeconomic status................................................................................................................... 25 Education................................................................................................................................... 25 Employment............................................................................................................................... 25 Income...................................................................................................................................... 26 Housing..................................................................................................................................... 26 Social support............................................................................................................................. 27

Sexual identity/Sexual history....................................................................................................... 27

Incarceration history.................................................................................................................... 28 HCV-specific variables.................................................................................................................. 28 Genotype................................................................................................................................... 28 Liver biopsy................................................................................................................................ 29

Measures of HCV disease severity.................................................................................................. 29

Fibrosis stage and cirrhosis........................................................................................................... 29 Asymptomatic disease.................................................................................................................. 30 Infection length........................................................................................................................... 30 ALT and AST levels...................................................................................................................... 30 HCV viral load............................................................................................................................. 31 Co-morbidities............................................................................................................................. 32 Medical comorbidities................................................................................................................... 32 Weight/Obesity............................................................................................................................ 32 HIV and HBV co-infection.............................................................................................................. 32 Serological markers...................................................................................................................... 33 Miscellaneous.............................................................................................................................. 33

Mental health/Psychiatric comorbidities........................................................................................... 34

PART 2: Is race as a barrier to CHC treatment? A Comparison of NHANES and the Grady Liver Clinic....... 36

Racial and socioeconomic barriers to CHC treatment......................................................................... 36

Race, ethnicity and CHC treatment in NHANES................................................................................. 36

Race/ethnicity as a treatment barrier in clinical models...................................................................... 37

Methods...................................................................................................................................... 38 Data Sources............................................................................................................................... 38 NHANES...................................................................................................................................... 38 Grady Liver Clinic..........................................................................................................................39 Variable definitions....................................................................................................................... 39 Statistical analysis........................................................................................................................ 39 Results........................................................................................................................................ 40 Descriptive statistics...................................................................................................................... 40 Univariate analyses....................................................................................................................... 41 Treatment uptake......................................................................................................................... 41 Race........................................................................................................................................... 41 Other associations......................................................................................................................... 41

Multivariate logistic regression (race/ethnicity-treatment associations)................................................. 42

Discussion.................................................................................................................................... 42 General findings............................................................................................................................ 42

Associations between race and treatment......................................................................................... 43

Study limitations........................................................................................................................... 44 Cross-sectional study design........................................................................................................... 44 Population differences.................................................................................................................... 44 Variable definitions........................................................................................................................ 45 Data limitations............................................................................................................................. 45 Conclusions................................................................................................................................... 45 REFERENCES................................................................................................................................. 47 TABLES AND FIGURES.................................................................................................................... 55 APPENDIX..................................................................................................................................... 69 IRB Exemption Letter...................................................................................................................... 69

About this Master's Thesis

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School	Rollins School of Public Health
Department	Career Masters of Public Health
Degree	MPH
Submission	Master's Thesis
Language	English
Research Field	Health Sciences, Public Health Health Sciences, Epidemiology
Keyword	hepatitis C virus cost-effectiveness chronic hepatitis C treatment barrier treatment uptake Grady Liver Clinic interferon-free direct-acting antiviral NHANES
Committee Chair / Thesis Advisor	Spaulding, Anne C, Emory University
Committee Members	Miller, Lesley, Emory University Sullivan, Kevin Paul, Emory University
Partnering Agencies	Hospital or other health care provider CDC

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