FDA approves new treatment for hepatitis CJune 3, 1998
Web posted at: 7:37 p.m. EDT (2337 GMT)
WASHINGTON (CNN) -- The Food and Drug Administration announced Wednesday that it has approved a new treatment for hepatitis C, a chronic liver disease that affects 4 million Americans.
The treatment is a six-month therapy combining two antiviral drugs, interferon A and ribavirin. The combination will be sold under the name Rebetron.
Until now, the first line of treatment for hepatitis C was giving a patient injections of interferon A. But clinical trials showed that for those who don't respond to that treatment, adding ribavirin can offer a significant benefit.
Of patients who relapsed after standard treatment, 45 percent of those who took Rebetron had undetectable virus levels, compared to 5 percent of patients who took only interferon A. However, the FDA said it is yet to be determined if the combination will delay the progression of liver disease in people with chronic hepatitis C.
And the FDA also stressed that Rebetron is not a cure and poses some serious side effects, including severe anemia, flu-like symptoms and depression that can lead to suicidal thoughts. The FDA said it knows of rare cases of suicides or suicide attempts and stressed that patients who feel depressed should immediately tell a doctor -- and doctors must take depression symptoms seriously.
Women of child-bearing age are also encouraged to use birth control while taking Rebetron because there is a risk of several birth defects or fetal death. Rebetron can also affect sperm, so male hepatitis sufferers and their partners also must use birth control.
Manufacturer Schering-Plough said it would begin shipping Rebetron to pharmacies Monday. Cost estimates range from $6,400 to $8,600 for the six months of treatment, depending on the patient's weight. That's in the same range as standard interferon treatment, the company said.
The treatment is complicated, involving up to six capsules every day of ribavirin, plus interferon injections three times a week.
Hepatitis C, a virus spread mostly by blood transfusions, can be deadly, causing chronic infections that can develop into cirrhosis and liver cancer. There is no vaccine, though a screening test was introduced in 1992 to try to get the virus out of the blood supply. Many people who are infected do not even know they have the virus, which was only identified in 1989.
Correspondent Holly Firfer and Reuters contributed to this report.
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