Experimental Treatment Guidelines to Be Tested at 100 Study Sites Nationwide


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National Study Underway to Determine Whether Hepatitis C Treatment Should Be Extended to More Patients
Experimental Treatment Guidelines to Be Tested at 100 Study Sites Nationwide
Updated 8:04 AM ET April 12, 2000

ST. LOUIS, April 12 /PRNewswire/ -- Saint Louis University School of Medicine researchers are studying hepatitis C patients with normal liver enzymes (alanine aminotransferase, or ALT) to determine if they have the same treatment response as patients with elevated liver enzymes. Hepatitis C patients with normal ALT levels are often denied standard treatment, even though their condition will eventually deteriorate, researchers say. "Current medical recommendations exclude those patients with normal or low ALT levels from treatment with the leading drug combination therapy, but we believe early drug intervention may protect these patients from more severe complications of the disease," said Bruce R. Bacon, M.D., Professor of Internal Medicine, Division of Gastroenterology and Hepatology, Saint Louis University School of Medicine. "This study will determine if it makes sense to help patients before their condition worsens by reducing or eliminating the hepatitis C virus in its early stages." According to Dr. Bacon, elevated enzyme levels should not be the sole determinant of virus activity or of significant liver disease.

Hepatitis C is the leading cause of liver transplantation in the United States and affects approximately 4 million people nationwide. Almost 3 million of those infected with the hepatitis C virus (HCV) will develop a chronic infection, which can lead to cirrhosis of the liver, liver cancer, liver failure and death, if left untreated.

Study Details
Approximately 2,500 patients with normal liver enzyme levels will be treated for up to 12 months with the leading FDA-approved therapy most commonly used in patients with elevated ALT levels. In clinical studies, REBETRON Combination Therapy containing interferon alfa-2b (immune system booster) and ribavirin (antiviral drug) has been shown to help reduce the hepatitis C virus in the bloodstream, often to below detectable levels. The only other approved therapy for hepatitis C, alpha interferon monotherapy, shows only a moderate response in patients.

Hepatitis C kills up to 10,000 Americans annually and the death rate is expected to triple in the next two to three decades, exceeding the rate associated with AIDS. The virus sometimes does not exhibit noticeable symptoms for up to three decades. According to the Centers for Disease Control and Prevention, only about 350,000 of those infected have been diagnosed.

"We hope the results of this study will be a call to action for medical professionals nationwide to reduce the inadequacies in current treatment guidelines for hepatitis C patients," said Bacon. "Physicians should consider further testing and potential administration of combination therapy to patients with normal ALT."

The hepatitis C virus (HCV) is spread by contact with infected blood and infected blood products. Since the blood supply was not screened for HCV before 1992, anyone who received a blood transfusion before then could have been infected with the disease.

Those who have injected drugs even once, shared needles to apply tattoos, or had unsafe sex with infected partners also are considered to be at-risk for the disease and should be tested.

Saint Louis University is a co-educational private university, sponsored and assisted by the Society of Jesus (Jesuits), located in Saint Louis, Missouri. Established in 1836, Saint Louis University School of Medicine had the distinction of awarding the first M.D. west of the Mississippi River in 1939 and is a pioneer in organ transplantation, chronic disease prevention, cardiovascular disease, neurosciences, vaccine research, and geriatrics, among others. The School of Medicine trains physicians and biomedical scientists, conducts medical research, and provides health services on a local, national and international level.
CONTACT: Jennifer Frakes; (314) 268-5940

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