WASHINGTON, D.C. (May 20, 2007) -- Research presented today at Digestive Disease Week 2007 (DDW) demonstrates the potential of statins, important cholesterol management therapies, for improving the management of hepatitis C a disease that affects nearly four million Americans. Although there have been no new treatments for hepatitis C since the introduction of pegylated interferon in 2001, the opportunity to develop a new generation of therapies that offer better outcomes may be imminent. DDW is the largest international gathering of physicians and researchers in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery.

"Studies such as these are designed to improve the effectiveness of antivirals the standard of care therapy for hepatitis C," said John Vierling, M.D., Baylor College of Medicine. "The findings from these studies support the rationale and need for larger, controlled trials that may provide additional and more advantageous hepatitis C treatment options."

Researchers have yet to report on the concept that hepatitis C virus (HCV) patients who take statins may experience improvements in alanine transaminase (ALT, liver enzymes) levels. Use of statins for hepatitis C has not occurred in the past as the FDA-approved package insert for every statin lists "active liver disease" as a contraindication for use and hepatitis C would certainly qualify as an active liver disease. In such a setting, a researcher must request a special license form from the FDA called an investigational new drug (IND) license. As part of an IRB and FDA-approved 14-day study looking at the antiviral effect of fluvastatin (FLV) in vivo, researchers reported the total bilirubin (TB, yellow breakdown product) and ALT results and compared the findings to an existing hepatitis C registry data.

Initial results
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Contact: Aimee Frank
AFrank@gastro.org
301-941-2620
American Gastroenterological Association
20-May-2007