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| |  Statins May Prove to Be Effective Therapy for Hepatitis C Virus Infection: Presented at DDW By Em Brown WASHINGTON, DC -- May 28, 2007 -- Abnormal liver enzymes often begin to normalize with statin therapy in patients with hepatitis C virus (HCV) infection. This suggests statins may actually improve the cure rate in HCV infection, rather than having a harmful effect on the liver, investigators reported here during Digestive Disease Week (DDW). If the findings are confirmed, it result in a major change in the Food and Drug Administration's labeling on statins, which carry a prominent warning against their use in patients with active liver disease. Results of both a retrospective and a prospective study show, presented here on May 21st, show that instead of harming the liver, statins may have a sustained viral response (SVR) against HCV and cause alanine transaminase (ALT) levels to begin to fall, said lead investigator Ted Bader, MD, associate clinical professor of medicine, University of Oklahoma, Oklahoma City, Oklahoma. In a prospective study of the antiviral effect of fluvastatin in patients with HCV infection, Dr. Bader and colleagues randomized 12 patients to fluvastatin at doses of 80 mg, 160 mg, 240 mg, or 360 mg per day for 14 days. At baseline, 3 patients had abnormally high ALT values (above 64 IU/mL). Levels normalized in all 3 patients by day 14. One week after discontinuing statin therapy, ALT levels showed evidence of returning to pretreatment levels in patients with elevated levels pretreatment. The 9 patients with normal ALT values at baseline continued to have normal levels during the treatment period. Total bilirubin levels did not change significantly with fluvastatin. Dr. Bader's team also analyzed the effect of statin therapy on 60 patients in the Oklahoma City Veteran's Affairs Medical Center's HCV registry. Thirteen of the 60 had abnormal ALT values at baseline. Levels normalized in 12 while on fluvastatin and the other patient's ALT value did not worsen. There were 47 HCV-infected patients in the registry with normal ALT levels at baseline. Levels remained normal in 45 patients. The 2 who developed mildly abnormal ALT elevations reported being heavy alcohol users. There were 30 patients in the HCV registry on triple therapy with peginterferon, ribavirin, and statin therapy, and these were compared with 104 patients on standard HCV treatment with peginterferon and ribavirin who did not have statin therapy. Patients on standard therapy had a pooled sustained viral response of 37%, while patients on triple therapy had a sustained viral response of 63%. Dr. Bader commented that a sustained viral response is considered a cure. "That means that statins are associated with a doubling of the cure rate," he said. "Hepatitis C patients should not be denied treatment with statins," he asserted. "The LDL [low-density lipoprotein] receptor is how the hepatitis C virus enters the cell. LDL receptors act differently in HCV-infected individuals," Dr. Bader explained. "The FDA removed recommendations for routine liver function monitoring from the labeling of 3 statins -- lovastatin, simvastatin, and pravastatin. They've done this quietly," he said. "They haven't publicized this removal."
[Presentation titles: Statins Improve ALT Values in Chronic Hepatitis C Patients With Abnormal Values. Abstract M1783. Retrospective Analysis of the Effect of Taking Statins Along With Peginterferon and Ribavirin on SVR. Abstract M1845]
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