This project is aimed at developing practical, safe and effective means of preventing the progression of liver disease in patients with chronic hepatitis C virus infection. Approximately 800 patients with chronic hepatitis C who have failed to respond to therapy with alpha interferon (with or without ribavirin) and who have significant fibrosis on liver biopsy will be enrolled in a study of the efficacy and safety of a continuous long-term antiviral therapy (for as long as four years). The objective of the study is to evaluate whether continuous long-term antiviral therapy can slow the progression of liver disease, preventing cirrhosis or preventing worsening of cirrhosis, decompensation, development of hepatocellular carcinoma (HCC) and death from liver disease. The study will also evaluate the natural history of hepatitis C and the facts that predict or correlate with disease progression. The major focus will be to evaluate whether an antiviral therapy, despite not leading to eradication of HCV, can suppress hepatocellular injury, necrosis and fibrosis. Patients with chronic hepatitis C who have previously been treated with alpha interferon without a sustained virological and biochemical response will be eligible to enter this study. This contract is for the central data coordinating center (DCC). The study also includes nine (9) clinical centers (CCs) and a central virological testing laboratory (VL), which will be contracted for under separate agreements.

Project Start
Project End
Budget Start
Budget End
Support Year
Fiscal Year
2004
Total Cost
Indirect Cost
Name
New England Research Institute
Department
Type
DUNS #
City
State
Country
Zip Code
Snow, Kristin K; Bell, Margaret C; Stoddard, Anne M et al. (2014) Processes to manage analyses and publications in a phase III multicenter randomized clinical trial. Trials 15:159
Wang, Weihua; Zhang, Xiaoan; Xu, Yanjuan et al. (2014) High-resolution quantification of hepatitis C virus genome-wide mutation load and its correlation with the outcome of peginterferon-alpha2a and ribavirin combination therapy. PLoS One 9:e100131
Everhart, James E; Wright, Elizabeth C (2013) Association of ?-glutamyl transferase (GGT) activity with treatment and clinical outcomes in chronic hepatitis C (HCV). Hepatology 57:1725-33
Sterling, Richard K; Wright, Elizabeth C; Morgan, Timothy R et al. (2012) Frequency of elevated hepatocellular carcinoma (HCC) biomarkers in patients with advanced hepatitis C. Am J Gastroenterol 107:64-74
Morishima, C; Di Bisceglie, A M; Rothman, A L et al. (2012) Antigen-specific T lymphocyte proliferation decreases over time in advanced chronic hepatitis C. J Viral Hepat 19:404-13
Everson, Gregory T; Shiffman, Mitchell L; Hoefs, John C et al. (2012) Quantitative liver function tests improve the prediction of clinical outcomes in chronic hepatitis C: results from the Hepatitis C Antiviral Long-term Treatment Against Cirrhosis Trial. Hepatology 55:1019-29
Morishima, Chihiro; Shiffman, Mitchell L; Dienstag, Jules L et al. (2012) Reduction in Hepatic Inflammation Is Associated With Less Fibrosis Progression and Fewer Clinical Outcomes in Advanced Hepatitis C. Am J Gastroenterol 107:1388-98
Freedman, N D; Curto, T M; Morishima, C et al. (2011) Silymarin use and liver disease progression in the Hepatitis C Antiviral Long-Term Treatment against Cirrhosis trial. Aliment Pharmacol Ther 33:127-37
Ghany, Marc G; Kim, Hae-Young; Stoddard, Anne et al. (2011) Predicting clinical outcomes using baseline and follow-up laboratory data from the hepatitis C long-term treatment against cirrhosis trial. Hepatology 54:1527-37
O'Brien, Thomas R; Everhart, James E; Morgan, Timothy R et al. (2011) An IL28B genotype-based clinical prediction model for treatment of chronic hepatitis C. PLoS One 6:e20904

Showing the most recent 10 out of 70 publications