(Schering-Plough) FDA OKs Potent Hepatitis C Drug
JUNE 03, 14:00 EDT
By LAURAN NEERGAARD
AP Medical Writer
WASHINGTON (AP) - The Food and
Drug Administration approved a
combination of two powerful antiviral
drugs today to treat liver-destroying
hepatitis C, a therapy that promises to
be almost 10 times better than
standard treatment.
Rebetron therapy is not a cure, the
FDA warned - and it comes with some
serious side effects.
But the approval means new hope for
patients who have failed the only
other hepatitis C treatment: 45
percent of them had dramatically
suppressed levels of the liver virus
after Rebetron treatment vs. just 5
percent of patients who merely tried
standard therapy again.
Rebetron is a combination of
interferon A injections, today's
standard treatment, and a new oral
version of the antiviral drug ribavirin.
Therapy takes six months.
But the FDA said patients must be
closely watched for side effects.
Because of those reactions, the FDA
decided that Rebetron should be used
only by patients who relapse after
standard interferon treatment.
Both women and men must use birth
control while taking Rebetron and for
six months afterwards, until the
potent medicine fully clears their
bodies, the FDA said. In pregnant
women, Rebetron can cause serious
birth defects and even fetal death, the
agency warned. But the FDA also
warned male Rebetron patients to
practice birth control as well, in case
the drug affects sperm.
Other risks include severe anemia in
certain patients and occasionally
psychiatric symptoms such as
depression that led to rare suicides,
the FDA said. Most patients also
experience flulike symptoms that
respond to over-the-counter
treatment.
Manufacturer Schering-Plough Corp.
said it would begin shipping Rebetron
to pharmacies Monday. A price was not
immediately announced.
About 4 million Americans have
hepatitis C, which kills about 10,000
annually and is the leading reason for
liver transplants.
The vast majority of patients caught
the virus from contaminated
intravenous drug needles. But
thousands were infected by blood
transfusions prior to 1992, when
scientists developed the first effective
way to protect the blood supply.
Many don't know they're infected
because they experience few if any
symptoms for years, and about 15
percent of patients somehow recover
on their own.
But others develop serious, even fatal,
liver disease. Few respond to standard
treatment with interferon A, a
synthetic version of an immune
system protein that naturally fights
viruses - and of those, many later
relapse.
So Schering studied the combination
therapy, and found it significantly
more potent: Six months after
treatment ended, 34 percent of
patients treated with interferon alone
had some improvement in liver
inflammation, but 50 percent of the
Rebetron patients' livers had
improved.
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