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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