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“The only thing necessary for these diseases to the triumph is for good people and governments to do nothing.”


Subject: Effectiveness of Hepatitis C Drug Can Now Be Determined Sooner
(WebMD), on 2/7/2002 12:12:40 AM

Subject: Effectiveness of Hepatitis C Drug Can Now Be Determined Sooner


Effectiveness of Hepatitis C Drug Can Now Be Determined Sooner; VCU
Physician Co-Authors New Study Analysis, Says Findings May Improve
Patient Care

RICHMOND, Va., Nov. 13 /PRNewswire/ -- Patients being treated for the
hepatitis C virus -- a blood-borne disease that attacks the liver --
now can learn earlier than ever before if they are likely to benefit
from an investigational drug therapy. The findings are based on
analysis of data from a Phase-3 study of pegylated interferon alfa-2a
(Pegasys), a longer acting form of the medication interferon. The
report was presented today (Nov.12) in Dallas, TX at the annual
meeting of the American Association for the Study of Liver Disease.


According to the data, how patients respond after 12 weeks of
treatment to pegylated interferon alfa-2a, combined with the anti-
viral drug ribavirin, is a good indicator of how likely they are to
respond to the medication long-term. Until now physicians had to wait
six months before they could determine initial treatment results.

64 percent of patients who showed a marked decrease in the presence
of the hepatitis C virus at week 12 were more likely to have a long-
term sustained virologic response. At the sginia Commonwealth
University's Medical College of Virginia Hospitals.

Treatment for hepatitis C generally involves a year-long regimen of
interferon -- the only known medication for treating the virus. But
because the side effects from the drug can be severe, including flu-
like symptoms, depression, dizziness and nausea, patients are often
reluctant to commit to taking the drug for such a long period of

"Committing to one year of therapy is difficult for many patients,"
said Shiffman. "When patients hear the initial phase of treatment is
now only three months long, and then we evaluate how they are doing,
it becomes a more reasonable time frame for them. If the drug is
working, we continue with it. If not, we stop and look for other

The potency of pegylated interferon alfa-2a is the primary factor in
being able to determine the drug's early effectiveness, according to
Shiffman. "Its ability to drive down the levels of the virus in some
patients so quickly after initiating treatment has enabled us to
better predict the drugs long-term effectiveness."

Standard interferon therapy must be administered by injection three
times a week and leaves the body in six hours. Pegylated interferon
is injected only once a week and remains in the body for up to a week
because the body absorbs it more slowly. The long-acting properties
of pegylated interferon alfa-2a result in constant viral suppression,
while at the same time, stimulate the immune system to attack it.


Chronic hepatitis C affects an estimated 3 million Americans and is
the most common cause of liver disease. Left untreated, the virus can
lead to cirrhosis, liver cancer and, in some cases, necessitate a
liver transplant.

VCU is one of about 40 sites worldwide studying pegylated interferon
alfa-2a. The drug, manufactured by Hoffmann-La Roche Inc., is
awaiting approval from the U.S. Food and Drug Administration.


SOURCE Virginia Commonwealth University

CO: Virginia Commonwealth University

ST: Virginia


11/13/2001 08:01 EST