NDDIC News

NIDDK Sponsors Largest Hepatitis C Study

To try to prevent the development of cirrhosis and liver cancer in people with chronic hepatitis C, the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is funding a clinical trial of long-term antiviral treatment using the drugs interferon (in a new form) and ribavirin. The trial, called HALT-C (Hepatitis C Antiviral Long-Term Treatment Against Cirrhosis), will be conducted at 10 Hepatitis C Cooperative Research Centers across the country. Spanning 8 years and involving more than 1,300 patients, HALT-C will be the largest and longest hepatitis C study ever conducted.

Hepatitis C affects almost 4 million Americans, or 1.8 percent of the U.S. population. The virus causes an estimated 8,000 to 10,000 deaths annually in the United States and accounts for 60 to 70 percent of chronic hepatitis cases, and 30 percent of cirrhosis, end-stage liver disease, and liver cancer cases. At least 75 percent of patients with acute hepatitis C ultimately develop chronic infection, and most of them have accompanying chronic liver disease. Liver failure from hepatitis C is the most common reason for a liver transplant.

More than half of all patients treated with interferon and ribavirin do not respond. If the virus is still present after 6 months of treatment, therapy is usually discontinued. In the HALT-C trial, researchers want to learn whether continuing treatment beyond this point will decrease liver damage in the long run.

Researchers will recruit 1,350 people with chronic hepatitis C who have been treated unsuccessfully with interferon (with or without ribavirin). These participants will receive pegylated interferon (Pegasys, Hoffman LaRoche) and ribavirin for 20 weeks. Pegylated interferon is a new, long-acting form that people appear to tolerate better than standard interferon.

After the initial treatment, those whose blood continues to harbor the virus will be randomly divided into two groups. The control group will discontinue treatment, and the study group will continue treatment with pegylated interferon alone for 42 months. Patients in both groups will be evaluated every 3 months to determine whether the rate of cirrhosis and its complications declines. Patients will also receive liver biopsies at the start of the study and at the end of the second and fourth years.

In addition to studying the impact of long-term interferon treatment on liver disease, the study will also allow researchers to learn more about the long-term effects of interferon; the natural history of hepatitis C; and the effect of nutrition, obesity, smoking, and alcohol use on disease progression. Also, since the trial is part of NIDDK's strategic plan for addressing health disparities among minorities, minority recruitment will be emphasized. (The draft strategic plan is at www.niddk.nih.gov/federal/planning/strategicplan_minority.htm on the Internet.)

Patient recruitment began in July 2000. Participating clinical centers are

• Liver Disease Section, NIDDK (Bethesda, MD)
• Massachusetts General Hospital (Boston)
• Medical College of Virginia (Richmond)
• Saint Louis University (Missouri)
• University of California at Irvine
• University of Colorado Health Sciences Center at Denver
• University of Massachusetts (Amherst)
• University of Michigan (Ann Arbor)
• University of Southern California (Los Angeles)
• University of Texas Southwestern Medical Center (Dallas)

Additional information about the study, including eligibility and exclusion criteria, is available by contacting Study Coordinators Roxanne Lockhart at 617–724–9456 or Amanda Ludwig at 617–726–3670.

NIH Publication No. 01–4552
March 2001