NIDDK Funds Clinical Centers for Hepatitis C Research

The NIDDK today announced awards of $28 million to fund an 8 year clinical trial of anti-viral drugs on treatment for chronic hepatitis C (HCV). Researchers seek to know if long-term treatment with these drugs can slow or prevent the progression of liver disease in HCV patients. Some, but not all, HCV patients develop cirrhosis or liver cancer, which can lead to death.

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 HCV.

NIDDK will fund nine centers around the country, a virology laboratory and a data coordinating center. The trial will recruit patients with chronic HCV who have previously been treated with alpha interferon but who could not sustain reduced enzyme and virus levels. Recruitment is tentatively scheduled to begin early in 2000.

Researchers will decide which drugs will be used and the number of volunteers to be recruited this summer.

Nearly 4 million Americans are infected with hepatitis C. Hepatitis C ranks with alcohol abuse as the most common cause of chronic liver disease and leads to about 1,000 liver transplants in the United States each year. HCV is spread primarily by contact with blood and blood products. Blood transfusions and sharing unsterilized needles and syringes have been the main causes of the spread of HCV in the United States.

"As the largest and longest study of hepatitis C, this trial should provide answers to difficult questions concerning management of hepatitis C," says Jay H. Hoofnagle, M.D., director, Division of Digestive Diseases and Nutrition, NIDDK. "The study will also set clinical criteria for grading, staging, and assessing the prognosis of people infected with HCV," adds Hoofnagle.

Information about hepatitis C is available from NIDDK's National Digestive Diseases Information Clearinghouse, 2 Information Way, Bethesda, MD 20892-3570; 301-654-3810; internet address www.niddk.nih.gov.

Note: A list of principal investigators and centers is attached.

PRINCIPAL INVESTIGATORS - HEPATITIS C Clinical Centers

Herbert Bonkovsky, M.D. Professor of Medicine University of Massachusetts Medical School 55 Lake Avenue, North Room S6-737 Department of Medicine Worcester, MA 01655

Adrian M. Di Bisceglie, M.D. Professor of Internal Medicine St. Louis University 1402 South Grand Blvd. St. Louis, MO 63104

Jules Dienstag, M.D. Associate Professor Massachusetts General Hospital Fruit Street Boston, MA 02114

Gregory Everson, M.D. Professor of Medicine University of Colorado Health Sciences Center 4200 E. 9th Avenue Department of Hepatology - Box B-154 Denver, CO 80262

John Hoefs, M.D. Associate Professor of Medicine University of California, Irvine 101 The City Drive Building 53-Route 81 Room 112 Orange, CA 92668

William Lee, M.D. Professor of Internal Medicine University of Texas Southwestern Medical Center 5323 Harry Hines Blvd. Dallas, TX 75235-9151

Karen Lindsay, M.D. Associate Professor of Clinical Medicine University of Southern California Department of Medicine 1355 San Pablo Street AHC-127 Los Angeles, CA 90033

Anna Lok, M.D. Professor of Internal Medicine University of Michigan 1500 East Medical Center Drive Taubman Center, Room 3912 Ann Arbor, MI 48109-0362

Mitchell L. Shiffman, M.D. Associate Professor of Medicine Chief, Hepatology Section Medical Director, Liver Transplant Program Virginia Commonwealth University Medical College of Virginia 1200 East Broad Street Suite 1496 Richmond, VA 23219

Virology Laboratory

David Gretch, M.D. Ph.D. Assistant Professor Laboratory Medicine Director, Viral Hepatitis Laboratory University of Washington Annex Building #B210 1124 Columbia Street Seattle, WA 98104

Data Coordinating Center

Elizabeth C. Wright, Ph.D. Senior Research Scientist New England Research Institute 9 Galen Street Watertown, MA 02472

NIDDK

Tommie Sue Tralka Director, Clinical Trials Program Deputy Director, Administrative Affairs Division of Digestive Diseases & Nutrition Natcher Bldg., 6AN-12K 45 Center Dr. MSC-6600 Bethesda, MD 20892-6600

Leonard Seeff, M.D. Special Expert on Hepatitis C Division of Digestive Diseases and Nutrition Bldg.31, Room 9/A23 Bethesda, MD 20892