This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Chronic hepatitis C virus (HCV) is the most common cause for liver cirrhosis and a major etiology for primary hepatocellular carcinoma (HCC) in the United States. HCV is 2 times more prevalent in African Americans (AA) than in Caucasian Americans (CA), and appear to be an important cause for the higher incidence of HCC among AA. Pegylated interferon (PEGIFN) plus ribavirin treatments is the most effective treatment for chronic hepatitis C virus (HCV) infections. HCV is eradicated in 55% of treated patients. For unclear reasons, AA have a lower probability of clearing HCV than CA during treatment. There were no major differences in the pharmacokinetics of PEGIFN between AA and CA in Virahep-C study. Others have found a significant correlation between ribavirin serum concentrations and both virologic responses and ribavirin toxicity in patients receiving PEGIFN combination therapy. Concerning ribavirin pharmacokinetics, a pilot study found a significantly lower maximum ribavirin concentrations (Cmax) after the first-dose in AA compared to CA. There was trend toward lower ribavirin exposure measured by the area-under-the concentration by time curve (AUC) and higher apparent ribavirin clearance in AA. Thus, we hypothesize that ribavirin pharmacokinetics differ between AA and CA HCV genotype 1 patients and that this difference contributes to the lower efficacy of PEGIFN and ribavirin in AA. This project has two components: 1) a retrospective study to compare ribavirin pharmacokinetic (PK) (ribavirin plasma concentrations, area under the concentration time curve, and clearance) and HCV eradication in 75 AA and 75 CA who participated in the NIDDK VIRAHEP-C study (2001-2006);and 2) a prospective comparison of ribavirin pharamcokinetics after the first dose and at steady state (6 weeks) in 70 AA and 70 CA patients during pegylated interferon and ribavirin treatment for chronic HCV.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR016500-08
Application #
7951172
Study Section
Special Emphasis Panel (ZRR1-CR-3 (02))
Project Start
2009-03-01
Project End
2010-06-30
Budget Start
2009-03-01
Budget End
2010-06-30
Support Year
8
Fiscal Year
2009
Total Cost
$31,511
Indirect Cost
Name
University of Maryland Baltimore
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
188435911
City
Baltimore
State
MD
Country
United States
Zip Code
21201
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Wrobleski, Margaret M; Parker, Elizabeth A; Hurley, Kristen M et al. (2018) Comparison of the HEI and HEI-2010 Diet Quality Measures in Association with Chronic Disease Risk among Low-Income, African American Urban Youth in Baltimore, Maryland. J Am Coll Nutr 37:201-208
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Harhay, Meera N; Xie, Dawei; Zhang, Xiaoming et al. (2018) Cognitive Impairment in Non-Dialysis-Dependent CKD and the Transition to Dialysis: Findings From the Chronic Renal Insufficiency Cohort (CRIC) Study. Am J Kidney Dis 72:499-508
Bansal, Nisha; Roy, Jason; Chen, Hsiang-Yu et al. (2018) Evolution of Echocardiographic Measures of Cardiac Disease From CKD to ESRD and Risk of All-Cause Mortality: Findings From the CRIC Study. Am J Kidney Dis 72:390-399
Cedillo-Couvert, Esteban A; Ricardo, Ana C; Chen, Jinsong et al. (2018) Self-reported Medication Adherence and CKD Progression. Kidney Int Rep 3:645-651

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