Embargoed for Release Until: Sunday, October 11, 1998, 6:00 p.m. Contact: Dana Victor Montenegro 202/973-5871 or [email protected]
New Treatment Regimens for Chronic Hepatitis C Show Success Treating Those for Whom Other Therapies Have Failed
Boston, MA, October 11, 1998 -- The addition of ribavirin to standard interferon treatment for patients with chronic Hepatitis C who have not responded to interferon treatment alone appears to be beneficial according to two separate studies presented at the 63rd Annual Scientific Meeting of the American College of Gastroenterology. Ribavirin is a new therapy recently approved by the U.S. Food & Drug Administration.
At least half of patients with chronic Hepatitis C treated with interferon are "non-responders," unable to achieve complete viral clearance. The combination of ribavirin with interferon in non-responders achieved complete virologic response in 20 to 26% of patients who had not responded to prior treatments with interferon alone, according to a study conducted by Mitchell L. Shiffman, MD and the Virginia Hepatitis Treatment Group.
Dr. Shiffman randomly assigned 146 patients who were non-responders to prior interferon treatment to three treatment groups. Patients in Group A received interferon 5 million units three times a week. Of these, 9.4 percent experienced complete virologic response at 3 months, and 11.1 percent at 6 months. Patients in Group B were treated with interferon 3 million units three times a week plus 600 mg ribavirin twice a day, with a 20.7 percent achieving a complete response at 3 months; and 21.1 percent at 6 months. The regimen for Group C was interferon 5 million units three times a week plus 600 mg ribavirin twice a day. This group experienced a 14.7 percent response rate at 3 months; and 26.1 percent at 6 months. Dr. Shiffman's study concluded that 20-26 percent of patients who were non-responders to interferon alone acheived response when re-treated with the combination of ribavirin and interferon, and that the dose of 5 million units compared to 3 million units of inter! feron appears no more effective in these patients.
In a study at Georgetown University Medical Center, James H. Lewis, MD, FACG found that 31 percent of interferon non-responders who were treated with combination therapy of interferon and ribavirin experienced complete response at three months, and most maintained this complete response at 6 months. However, among Dr. Lewis's subjects who were non-responders at 3 months of combined treatment, only 2 of 24 had a complete response after 3 more months. "The utility of continuing interferon plus ribavirin beyond 3 months appears to be limited, but seems to benefit non-responders who exhibit a significant fall in viral load and normalizing ALT after the initial 3 month treatment," says Dr. Lewis.
Hepatitis C is a major cause of chronic liver disease in the United States, with over 4 million Americans infected according to the National Institutes of Health. Hepatitis C causes an estimated 8,000 - 10,000 deaths each year. Chronic Hepatitis C varies greatly in its course and outcome. At one end of the spectrum are certain patients experiencing no symptoms and normal liver enzymes, while at the other end are patients with severe disease who, over a span of 10 to 20 years, may develop cirrhosis and end-stage liver disease and account for approximately 20 percent of Hepatitis C patients. Those infected for 20 to 40 years are at high risk for developing liver cancer.
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