Tuesday, January 23, 2001

FDA approves hepatitis drug

By Tim Bonfield
The Cincinnati Enquirer

        The first part of what doctors are calling a major advance in treatment for hepatitis C won approval Monday from the U.S. Food and Drug Administration.

        Hepatitis C is a potentially fatal liver disease caused by a viral infection that can develop for years before people realize they are sick. In Greater Cincinnati, a few thousand people have been diagnosed.

        On Monday, the FDA approved Peg-Intron, a once-a-week injection made by Schering-Plough Corp. that could replace a drug that requires injections three times a week.

        Doctors say the FDA action will become even more important in a few months if the agency also approves using the new product in combination with another drug, Ribavarin.

        “This is an important step in the next generation of treatment for hepatitis C,” said Dr. Kenneth Sherman, director of hepatology at the University of Cincinnati Medical Center. “We've had patients in Cincinnati getting the combination treatment (as part of a clinical trial) for almost two years. We're not calling it a cure. But we've seen sustained clearance in more than 50 percent of the patients.”

        That means the best tests were unable to detect the hepatitis C virus six months after treatment, Dr. Sherman said.

        Hepatitis C is spread through blood-to-blood contact. Intravenous drug users — including those who tried it only once — are the biggest risk group. Others risks include blood transfusions before 1991, tattoos or body piercings, and on-the-job exposure.

        For information about hepatitis C, call your doctor or the Hep C Connection Help Line, (800) 390-1202. A home test kit can be ordered via www.hepaware.com


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