FDA Clears New Treatment Option For Hepatitis C Patients
THOUSAND OAKS, CA. -- October 7, 1997
The U.S. Food and Drug Administration has granted marketing
clearance for Amgen's Infergen(R) (Interferon alfacon-1), a
bioengineered drug indicated for the treatment of chronic hepatitis
C viral (HCV) infection.
The drug has been shown to be safe and effective in HCV patients
who have never been treated with previous interferon therapy. In
addition, HCV patients who have not responded or who have relapsed
after prior treatment with Interferon alpha-2b or Infergen may also
benefit from subsequent treatment with Infergen.
Infergen will be Amgen's third product. Infergen is a
new-generation, non-naturally occurring recombinant type-1
interferon. The drug is administered three times weekly by
subcutaneous injection.
"There is a considerable need for a new hepatitis C therapy
because a significant number of HCV patients fail to respond or
relapse following treatment," said Donald M. Jensen, M.D.,
director, section of hepatology, department of medicine,
Rush-Presbyterian-St. Luke's Medical Center in Chicago. "Results
from the phase III clinical trial indicated Infergen provided an
effective first-line therapy for HCV and may benefit patients who
have failed previous therapy with Interferon alpha-2b or
Infergen."
In a randomized, double-blind study involving 704 patients,
Infergen was shown to be an effective and safe option for the
initial treatment of HCV. In a phase III clinical study, patients
were treated for 24 weeks followed by an additional 24-week
observation period.
At the end of the post-treatment observation period, 17 percent
of patients who received the optimal dose of Infergen (nine mcg)
experienced a sustained normalization of the liver enzyme
serumalanine aminotransferase (ALT), a biochemical marker of liver
injury; and nine percent experienced a sustained virological
response, as measured by serum HCV RNA using a highly-sensitive
polymerase chain reaction (PCR) technique.
The safety profile of Infergen was similar to that observed with
standard regimens of alfa interferons. 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. Since the use of type-I interferons have been
associated with depression, Infergen therapy should not be used in
patients with a history of severe psychiatric disorders and should
be discontinued in patients developing severe depression, suicidal
ideation or other severe psychiatric disorders. Infergen should be
administered with caution to HCV patients with pre-existing cardiac
disease.
Until recently, Interferon alfa-2a and -2b were the only
approved therapies for the treatment of HCV. A significant
percentage of patients who had been treated with interferon therapy
either failed to respond to treatment or relapsed.
In a subsequent randomized, controlled clinical trial, 107
hepatitis C patients who failed to respond or who relapsed after
prior interferon therapy were treated with a higher dose of
Infergen (15 mcg) for 24 weeks and observed for an additional 24
weeks.
Of the Infergen treated patients, 15 percent (16/107)
experienced a sustained normalization of ALT concentrations and
nine percent (10/107) experienced a sustained virological response
as measured by serum HCV RNA. Results from a 48-week subsequent
treatment trial with 15 mcg of Infergen have been submitted to and
are under review by the FDA.
Researchers at a recent National Institutes of Health Consensus
Development Conference on the management of hepatitis C reported
nearly four million Americans are currently infected with the
virus. Of these, there are up to 180,000 total diagnosed infections
per year in the United States, according to the Centers for Disease
Control and Prevention.
HCV is four times more common than HIV, the virus that causes
AIDS and approximately 8,000 to 10,000 Americans die from HCV each
year. In 1991, the last year for which numbers were available,
medical and job-related costs from hepatitis C were estimated at
$600 million.
Hepatitis C is an insidious and progressive blood-borne virus
that can cause liver injury over a period of years and in some
cases decades, often without specific symptoms revealing its
presence. When they do appear, the infection is usually severe or
cirrhosis is present.
Symptoms include loss of appetite, vomiting, stomach pain,
fatigue and, in rare cases, jaundice (yellowing of the skin and
whites of the eyes). Because the symptoms are common to
less-serious conditions, they may often be overlooked or
misdiagnosed.
(SOURCE: Doctor's Guide to Medical News, October 7, 1997 -
http://www.pslgroup.com)
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