NIDDK Funds Clinical Centers for Hepatitis C Research

NATIONAL INSTITUTES OF HEALTH
National Institute of Diabetes and Digestive and Kidney Diseases

FOR IMMEDIATE RELEASE
Wednesday, July 21, 1999
Contact: Leslie Curtis
(301) 496-3583

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