FDA OKs Potent Hepatitis Drug


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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 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.

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 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.

More information about Rebatron can be found at the links below:
Rebetol Recommended For European Approval For Relapse, Naive Hepatitis C Patients

A New Approach to HCV Therapy

New Hepatitis C Combination Treatment - FDA Overlooks Concerns About Pre-packaged Doses

Top Ten Questions and Answers About Interferon/Ribaviron Combination Therapy for Hepatitis C

Adding Ribavirin To Interferon Beneficial For Chronic Hepatitis C

Alpha-Interferon and Ribavirin

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