WASHINGTON - 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
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
Women must use birth control while taking Rebetron and for six
months afterwards, until the potent medicine fully clears their
bodies, the FDA said. Rebetron can cause serious birth defects and
even fetal death, the agency warned.
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
About 4 million Americans have hepatitis C, which kills about
10,000 annually and is the leading reason for liver
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.
More information about Rebatron can be found
at the links below:
Recommended For European Approval For Relapse, Naive Hepatitis C
Approach to HCV Therapy
Hepatitis C Combination Treatment - FDA Overlooks Concerns About
Questions and Answers About Interferon/Ribaviron Combination
Therapy for Hepatitis C
Ribavirin To Interferon Beneficial For Chronic Hepatitis C
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