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Chronic Hepatitis C Viral Infection: Natural History and Treatment Outcomes in Substance Abusers

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Chronic Hepatitis C Viral Infection: Natural History and Treatment Outcomes in Substance Abusers Chronic Hepatitis C Viral Infection: Natural History and Treatment Outcomes in Substance Abusers by Ava Ayana John-Baptiste A thesis submitted in conformity with the requirements for the degree of Doctor of Philosophy Graduate Department of Health Policy, Management and Evaluation University of Toronto © Copyright by Ava Ayana John-Baptiste, 2010 Chronic Hepatitis C Viral Infection: Natural History and Treatment Outcomes in Substance Abusers Ava Ayana John-Baptiste Doctor of Philosophy Graduate Department of Health Policy, Management and Evaluation University of Toronto 2010 Abstract Hepatitis C is the most common blood-borne viral illness in the North America. Chronic hepatitis C infection may lead to cirrhosis of the liver, liver failure and liver cancer. In North America, injection drug use is the most important risk factor for infection and substance abusing populations are disproportionately affected by the disease. Antiviral therapy exists and approximately 50% of infected individuals can be cured. The aim of this thesis was to provide information to help clinicians and policy-makers minimize the impact of hepatitis C in substance abusers. The thesis is comprised of three studies. The first assessed the rate of progression to cirrhosis for those acquiring infection through injection drug use, using a meta-analysis of 44 studies from the published literature. We estimated that fibrosis progression occurs at a rate of 8.1 per 1000 person-years (95% Credible Region (CR), 3.9 to 14.7) corresponding to a 20-year cirrhosis prevalence of 14.8% (95% CR, 7.5 to 25.5). The second study measured the association between successful antiviral therapy and quality of life. We demonstrated that sustained responders to therapy had higher scores on the hepatitis-specific Medical Outcomes Survey Short-Form-36 (SF-36), Health Utilities Index Mark 2/3 (HUI2/3), and time-tradeoff (TTO) than treatment failures, an average of 3.7 years following antiviral therapy. The third study assessed rates of adherence to antiviral therapy and rates of sustained response in current or former ii substance abusers on methadone maintenance. We demonstrated that while use of illicit substances prior to therapy negatively affected adherence, rates of sustained response were comparable to non-substance abusing populations. Our work indicates the future burden of disease in current and former substance abusers, demonstrates that antiviral therapy can be successful in this population, and indicates that the benefits of successful therapy may extend beyond decreased disease burden to improved quality of life. iii Acknowledgments My family: I would like to thank my husband Samuel for enthusiastic encouragement and loving support. I am continually amazed by his positive attitude in the face of difficulty. I would like to thank my son Jed for making life worthwhile with his laughter. I would like to thank my mother for always being there. I know that I am lifted up on the wings of her prayers. I would like to thank my father Arthur Eugene Nelson. When he was alive, he expected me to achieve academically and I am still marching to his drum. (The drum is a steel pan and it plays calypso music.) I would like to thank my brother Atiba for theoretical discussions about research and about life. He helped me keep everything in perspective. I would like to thank Alexis and Atiba for babysitting bus and train runs that allowed me to work just that much longer. My committee and collaborators: I would like to thank Dr. Murray Krahn for encouraging personal and intellectual expansion each step of the way along this journey. He provided me with everything I needed and stretched my imagination by asking difficult questions. I am eternally grateful for his mentorship and his support. I would like to thank Jenny Heathcote for her example. She demonstrated that passion and intellect can combine to move mountains. I would like to also thank Audrey Laporte for modeling the academic who juggles everything – life, love and the pursuit of knowledge. I would like to thank each committee member for their comments and insights to my thesis. I would like to thank George Tomlinson for introducing me to Thomas Bayes (posthumously) and helping me to learn Winbugs! I would like to thank my external reviewers for helpful comments and stimulating conversation during my defense. My friends: I would like to thank the best office-mate ever, Beate Sander, for discussions that provided relief on the days when the demands of academia seemed overwhelming. I would like to thank Gloria Woo for promising to fund my future research projects. I would like to thank Karen Bremner for interesting conversations and thoughtful insights – her passion for research is infectious. I would like to thank Karen Liu for taking care of administrative “stuff” efficiently and cheerfully, even when I made requests at the last minute. I would like to thank Tracey Hamilton, Vondell Burke and Soyini Chadderton-Downes for uplifting my spirits by never forgetting a birthday. iv My funding sources: The Canadian Institutes of Health Research (CIHR) funded this work in several ways. I received a Canada Graduate Scholarship Doctoral Fellowship. Project funding for Study 3 was provided by the CIHR Interdisciplinary Health Research Team (IHRT) on Illicit Opiate Addiction Research, Treatment and Policy. A CIHR operating grant (FRN-#74661) was instrumental in completing Study 2. The National Canadian Research Training Program in Hepatitis C Research funded me through a doctoral fellowship. The Canadian Liver Foundation co-sponsored my doctoral fellowship. Finally, I would like to thank Jesus who stood by me and strengthened me. Although you are invisible, your love and care have been very real to me. “The eternal God is your refuge, and underneath are the everlasting arms…” Deuteronomy 33:27 (Bible, New International Version Copyright © 1984) v Published work derived from this thesis John-Baptiste A et al. The natural history of hepatitis C infection acquired through injection drug use: Meta-analysis and meta-regression. J Hepatol (2010), doi:10.1016/j.jhep.2010.03.015 John-Baptiste A, Tomlinson G, Hsu P, Krajden M, Heathcote J, Laporte A, Yoshida E, Anderson F, Krahn M. Sustained responders have better quality of life and productivity compared to treatment failures long after antiviral therapy for hepatitis C. American Journal of Gastroenterology. 2009 Oct;104(10):2439-48. John-Baptiste A, Varenbut M, Lingley M, Teplin D, Daiter J, Krahn M. Treatment of Hepatitis C infection in patients on methadone maintenance in a community setting. Journal of Viral Hepatitis. 2009 Aug;16(8):557-67. vi Table of Contents Acknowledgments .......................................................................................................................... iv Published work derived from this thesis ........................................................................................ vi Table of Contents .......................................................................................................................... vii List of Tables .................................................................................................................................. x List of Figures ................................................................................................................................ xi List of Appendices ........................................................................................................................ xii Chapter 1 Introduction and Overview ........................................................................................... 13 1 Introduction ................................................................................................................................ 13 2 Overview and organization of the thesis ................................................................................... 14 Chapter 2 Background .................................................................................................................. 16 3 Hepatitis C Virology .................................................................................................................. 16 4 Epidemiology ............................................................................................................................. 18 5 Natural History of HCV Infection ............................................................................................. 20 6 Treatment ................................................................................................................................... 28 7 Substance abuse ......................................................................................................................... 31 8 Quality of life ............................................................................................................................. 36 9 Cost-effectiveness analysis ........................................................................................................ 43 10 Research questions and rationale ............................................................................................. 45 Chapter 3 Methods ........................................................................................................................ 47 11 Methods - Study 1 ................................................................................................................... 47 11.1 Methods for estimating the rate of progression to cirrhosis ............................................
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