Clinicians face two major challenges in managing patients with chronic hepatitis C. First, the natural history of chronic hepatitis C remains poorly understood so that predicting the course for an individual patient for whom we are caring remains imprecise. Epidemiologic studies have implicated a number of host factors, such as gender, alcohol consumption, and HIV co-infection, as being associated with rapidly progressive disease. However, the mechanisms by which these interact to alter disease pathogenesis remain unknown. The second challenge is trying to optimize therapy for a diverse population of patients infected with hepatitis C. Although newer therapies for HCV are increasingly effective, there is a large body of evidence to suggest that certain patient populations respond less well to antiviral therapy than others. To date, there have been no prospective studies addressing these issues or the mechanisms by which this may occur. The UNC Liver Diseases Program, under my direction, is currently active in pursuing various studies that focus on these two important themes in hepatitis C. These studies provide the backbone of my mentoring program for junior faculty and fellows who are actively involved in their design, execution, and analysis. For the purposes of this application, I will focus on one ongoing study involving special populations, funded by NIDDK, that investigates antiviral response and resistance in African Americans with chronic hepatitis C (UO1-DK60327- 01, VIRAHEP-C). I will also provide a synopsis of other ongoing studies that form the core of our HCV research program. My immediate career goal is to maintain the trajectory of patient-oriented research at UNC. In the long-term, I would like to direct a multi-disciplinary team of clinical investigators and basic scientists who can work together closely on translational studies of the pathogenesis of chronic viral hepatitis. Finally, my experiences working within the General Clinical Research Center (GCRC) have been very favorable and I would like to become more actively involved in that program. The K-24 award will allow me to attain my goals by relieving me of some of my clinical commitments, thus allowing me to concentrate further on patient-oriented research. It will provide me with additional time to mentor junior faculty and fellows and continue to foster their development within the context of a burgeoning patient-oriented research program.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Midcareer Investigator Award in Patient-Oriented Research (K24)
Project #
1K24DK066144-01
Application #
6712400
Study Section
Diabetes, Endocrinology and Metabolic Diseases B Subcommittee (DDK)
Program Officer
Podskalny, Judith M,
Project Start
2004-07-01
Project End
2009-06-30
Budget Start
2004-07-01
Budget End
2005-06-30
Support Year
1
Fiscal Year
2004
Total Cost
$139,317
Indirect Cost
Name
University of North Carolina Chapel Hill
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
608195277
City
Chapel Hill
State
NC
Country
United States
Zip Code
27599
Evon, Donna M; Golin, Carol E; Ruffin, Rachel et al. (2018) Novel patient-reported outcomes (PROs) used in a pilot and feasibility study of a Cognitive Behavioral Coping Skills (CBCS) group intervention for patients with chronic hepatitis C. Pilot Feasibility Stud 4:92
Lim, Joseph K; Liapakis, Ann Marie; Shiffman, Mitchell L et al. (2018) Safety and Effectiveness of Ledipasvir and Sofosbuvir, With or Without Ribavirin, in Treatment-Experienced Patients With Genotype 1 Hepatitis C Virus Infection and Cirrhosis. Clin Gastroenterol Hepatol 16:1811-1819.e4
Welzel, Tania M; Nelson, David R; Morelli, Giuseppe et al. (2017) Effectiveness and safety of sofosbuvir plus ribavirin for the treatment of HCV genotype 2 infection: results of the real-world, clinical practice HCV-TARGET study. Gut 66:1844-1852
Evon, Donna M; Golin, Carol E; Ruffin, Rachel et al. (2017) Development and Pilot-Testing of a Cognitive Behavioral Coping Skills Group Intervention for Patients with Chronic Hepatitis C. Contemp Clin Trials Commun 6:85-96
Saxena, Varun; Khungar, Vandana; Verna, Elizabeth C et al. (2017) Safety and efficacy of current direct-acting antiviral regimens in kidney and liver transplant recipients with hepatitis C: Results from the HCV-TARGET study. Hepatology 66:1090-1101
Evon, Donna M; Golin, Carol E; Stoica, Teodora et al. (2017) What's Important to the Patient? Informational Needs of Patients Making Decisions About Hepatitis C Treatment. Patient 10:335-344
Terrault, Norah A; Zeuzem, Stefan; Di Bisceglie, Adrian M et al. (2016) Effectiveness of Ledipasvir-Sofosbuvir Combination in Patients With Hepatitis C Virus Infection and Factors Associated With Sustained Virologic Response. Gastroenterology 151:1131-1140.e5
Feld, Jordan J; Maan, Raoel; Zeuzem, Stefan et al. (2016) Effectiveness and Safety of Sofosbuvir-Based Regimens for Chronic HCV Genotype 3 Infection: Results of the HCV-TARGET Study. Clin Infect Dis 63:776-783
Brown Jr, Robert S; O'Leary, Jacqueline G; Reddy, K Rajender et al. (2016) Interferon-free therapy for genotype 1 hepatitis C in liver transplant recipients: Real-world experience from the hepatitis C therapeutic registry and research network. Liver Transpl 22:24-33
Johansson, Susanne; Talloen, Willem; Tuefferd, Marianne et al. (2016) High MIG (CXCL9) plasma levels favours response to peginterferon and ribavirin in HCV-infected patients regardless of DPP4 activity. Liver Int 36:344-52

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