Abstract

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 (HCV) 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 Trial is to evaluate whether continuous therapy with 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 Trial will also evaluate the natural history of hepatitis C and the factors that predict or correlate with disease progression. The major focus will be to evaluate whether 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 the Trial.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research and Development Contracts (N01)
Project #
N01DK092319-006
Application #
6365907
Study Section
Project Start
1999-05-01
Project End
2007-04-30
Budget Start
2000-09-27
Budget End
2002-04-30
Support Year
Fiscal Year
2000
Total Cost
$211,068
Indirect Cost

  Institution

Name
Massachusetts General Hospital
Department
Type
DUNS #
City
Boston
State
MA
Country
United States
Zip Code
02199

  Publications

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
Corey, Kathleen E; Zheng, Hui; Mendez-Navarro, Jorge et al. (2012) Serum vitamin D levels are not predictive of the progression of chronic liver disease in hepatitis C patients with advanced fibrosis. PLoS One 7:e27144
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, Neal D; Curto, Teresa M; Lindsay, Karen L et al. (2011) Coffee consumption is associated with response to peginterferon and ribavirin therapy in patients with chronic hepatitis C. Gastroenterology 140:1961-9
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

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