The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) plans to spend $28 million on an eight-year clinical trial to determine if long-term treatment with antiviral drugs can slow or prevent the progression of liver disease in patients with chronic hepatitis C virus (HCV).
"As the largest and longest study of hepatitis C, this trial should provide answers to difficult questions concerning management of hepatitis C. The study will also set clinical criteria for grading, staging, and assessing the prognosis of people infected with HCV," said Jay H. Hoofnagle, MD, director of the NIDDK's Division of Digestive Diseases and Nutrition.
In addition, the study will provide information on the natural history of hepatitis C and help researchers identify factors that predict or correlate with liver damage caused by HCV.
Patient recruitment is expected to begin early next year. The investigators are looking for patients with chronic HCV who previously have been treated with alpha interferon but could not sustain reduced enzyme and virus levels. Researchers have not decided what drugs or how many volunteers will be used in the trial.
The study will be conducted at nine centers in the United States: University of Massachusetts Medical School, St. Louis University, Massachusetts General Hospital, University of Colorado Health Sciences Center, University of California at Irvine, University of Texas Southwestern Medical Center, University of Southern California, University of Michigan, and Virginia Commonwealth University.
HCV leads to about 1,000 liver transplants in the United States every year.
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National Institutes of Health news release
www.nih.gov/news/pr/jul99/niddk-21.htm
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