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Next year begins an eight-year, $28 million clinical trial to test antiviral drug treatments for patients infected with chronic hepatitis C virus (HCV). Government-funded researchers will set out to determine if long-term treatment can slow or prevent the progression of liver disease. The study will also provide information on the natural history of hepatitis C and help researchers identify factors that predict or correlate with liver damage caused by the virus.
For the study, researchers will recruit patients with the disease who have previously been treated with alpha interferon but who could not sustain reduced enzyme and virus levels. Recruitment is tentatively scheduled to begin in early 2000. The trials will begin at nine centers around the country: University of California, Irvine; University of Southern California, Los Angeles; University of Colorado Health Sciences Center, Denver; Massachusetts General Hospital, Boston; Univers ity of Massachusetts Medical School, Worcester; St. Louis University; University of Michigan, Ann Arbor; University of Texas Southwestern Medical Center, Dallas; and Medical College of Virginia, Richmond.
"As the largest and longest study of hepatitis C, this trial should provide answers to difficult questions concerning management of hepatitis C," said Jay H. Hoofnagle, MD, in a statement. "The study will also set clinical criteria for grading, staging, and assessing the prognosis of people infected with HCV." Hoofnagle is director of the Division of Digestive Diseases and Nutrition at the National Institute of Diabetes and Digestive and Kidney Diseases, a division of the National Institutes of Health.