FDA Approves Hepatitis C Therapy: Peg
By THE ASSOCIATED PRESS
WASHINGTON (AP) -- Hepatitis C patients won another option to treat the dangerous liver disease Monday, as the government approved a once-a-week drug called Peg-Intron.
Peg-Intron is a version of the longtime hepatitis treatment interferon-alpha made with new ``pegylation'' technology that cloaks it from the immune system so it stays active longer. Manufacturer Schering-Plough Corp. said once-a-week injections of Peg-Intron are about twice as effective as taking regular interferon three times a week.
But there's a caveat: Today's top hepatitis C treatment is another Schering drug called Rebetron, which combines interferon with the medicine Ribavirin. The Food and Drug Administration didn't approve combining Peg-Intron with Ribavirin.
Schering hasn't directly compared combination therapy to the new drug. But some data suggest Rebetron may work somewhat better, said Dr. Bill Schwieterman, FDA's hepatitis chief. On the other hand, Peg-Intron may cause fewer side effects than combination therapy because Ribavirin itself raises risks of hemolytic anemia, heart dysfunction and other effects, he said.
``You have to weigh the benefits of not receiving the Ribavirin versus the risk of having what appears to be a somewhat lesser response rate with the Peg-Intron,'' he explained.
Peg-Intron and regular interferon cause similar side effects, including flu-like symptoms and depression. But Peg-Intron patients are about 1 1/2 times more likely to have mild bone-marrow suppression, Schwieterman said, something FDA suggested doctors monitor. Schering said Peg-Intron will be available next month at $962 to $1,114 a month wholesale, depending on dose. For comparison, Rebetron costs $1,560 and regular interferon alone about $480 a month.