MIAMI--(BUSINESS WIRE)--April 6, 1998--Hepatitis C
patients, who previously relapsed following conventional interferon
therapy, are now experiencing a three-times better chance of
achieving remission, thanks to a recently approved bioengineered
interferon studied at the University of Miami's Center for Liver
Diseases and 40 other centers across the nation.
Treatment results are published in the April issue of
Hepatology.
To date, interferons are the only FDA-approved treatment for
hepatitis C, but only about half of the patients initially respond
to therapy. Of those, only 20 percent ultimately achieve
remission.
Yet, results from the multi-center study demonstrated that after
48 weeks of treatment with a high dose (15 mcg) of Infergen
(Interferon-alfacon-1) nearly 60 percent of patients who initially
responded to interferon treatment but eventually relapsed,
successfully achieved a sustained response.
The Hepatitis C Virus: -- Is estimated to have infected
3.9 million Americans.
-- Is three to four times more common than the AIDS virus in the
United States.
-- Is the leading cause of liver cirrhosis.
-- Is the leading cause of liver transplantation in adults because
of the damage it causes.
The new treatment, Infergen, manufactured by Amgen, is a
non-naturally occurring recombinant type-1 interferon. Interferon
is a natural substance located in the body for the purpose of
traveling from cell to cell to attack viruses, in this case, the
hepatitis C virus.
Amgen's goal was to create the most successful interferon from
taking the most commonly occurring amino acid sequences from each
of the naturally occurring alpha interferons, thereby creating a
"consensus interferon."
Also benefiting from Infergen are some hepatitis C patients who
previously have had no response to therapy. The study showed that
even these patients experienced a 13 to 17 percent success rate
after 48 weeks of subsequent treatment with Infergen.
"Our data demonstrate that a higher dose of Infergen is safe and
effective and can achieve a meaningful sustained response in
hepatitis C patients who have failed or relapsed following previous
interferon treatment," said K. Rajender Reddy, M.D., a University
of Miami professor and a co-author of the Hepatology article.
"It is our hope that with each new advance in the fight against
hepatitis C, we are able to offer newer and better treatment
options for the millions of Americans who suffer from this chronic
and serious health condition," Reddy added.
Benefits Shown for Relapsers
In this study, 337 patients with hepatitis C virus who had
either not responded or relapsed after previous interferon therapy
were treated with a higher dose of Infergen for 24 or 48 weeks,
followed by a 24-week observation period.
Of the relapsed patients treated with Infergen for 48 weeks, the
sustained virological response rate, which was measured by serum
HCV RNA using a highly sensitive polymerase chain reaction (PCR)
technique, was 58 percent. The sustained alanine aminotransferase
(ALT) response rate was 52 percent at the end of the post-treatment
observation period.
The principal biochemical marker of the disease is a persistent
elevation in blood levels of the liver enzyme ALT. Another
important blood measurement is the presence of HCV RNA, the genetic
material of the hepatitis C virus. Normalization of ALT and
reduction in viral HCV RNA concentration are the most common
measures of response to therapy.
Data Demonstrates Success in Nonresponders
According to study investigators, a notable finding in this
study was the achievement of significant responses among prior
nonresponders. Of the patients treated with Infergen for 48 weeks,
the sustained HCV RNA response rate among prior nonresponders was
13 percent and the sustained ALT response rate was 17 percent at
the end of the post-treatment observation period.
The administration of Infergen was well tolerated and not
associated with increased side effects. The most frequently
reported adverse events were flu- like symptoms such as headache,
unusual tiredness, fever, muscle aches and stiffness, joint pain
and increased sweating.
One of the nation's youngest medical schools, founded in 1952,
the University of Miami School of Medicine has already established
a research enterprise which routinely ranks in the top 25 percent
of the country's 125 medical schools in terms of research grants
and other sponsored programs.
With a $109 million research budget and 1.5 million square feet
of research space, the medical school's 1,000-plus full-time
faculty members and an additional 400 research personnel, conduct
clinical and basic science research crossing all disciplines, from
epidemiology and pediatrics to AIDS, psychiatry and the
neurosciences.
CONTACT: University of Miami School of Medicine, Miami
Rebecca Riordan, 305/243-5671
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