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Back To Vidyya FDA Approves Hepatitis C Therapy

Once-A-Week Drug Is Known As Peg-Intron

Hepatitis C patients won another option to treat the dangerous liver disease Monday, as the Food and Drug administration 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.

Peg-Intron is administered subcutaneously once weekly for one year. The dose should be administered on the same day of each week and may be self-administered by patients.

"Chronic hepatitis C is one of the most prevalent and serious public health problems in the United States," said Richard W. Zahn, president of Schering Laboratories. "Peg-Intron offers convenient once weekly dosing that may enhance patient compliance, an important factor in determining optimal clinical outcome," Zahn said.

"While combination therapy with alpha interferon and ribavirin is a recognized standard of care for chronic hepatitis C, Peg-Intron monotherapy offers an alternative to patients in whom combination therapy may be a contraindication or who are intolerant of this therapy," said John G. McHutchison, M.D., medical director, liver transplantation, division of gastroenterology and hepatology, Scripps Clinic and Research Foundation, La Jolla, Calif. "As the first pegylated interferon product approved for marketing, Peg-Intron provides a valuable addition to the therapies available to physicians for treating this serious disease," McHutchison said.

The safety and efficacy of Peg-Intron has been demonstrated in a randomized, controlled clinical study involving 1,219 adult patients with chronic hepatitis C who were not previously treated with alpha interferon. The study compared Peg-Intron (0.5, 1.0 or 1.5 mcg/kg) administered subcutaneously once weekly to Schering-Plough’s INTRON A (interferon alfa-2b, recombinant) Injection (3 MIU) administered subcutaneously three times weekly. Patients were treated for 48 weeks and were followed for 24 weeks post-treatment. In the study, patients receiving the 1.0 mcg/kg dose of Peg-Intron achieved a 24 percent treatment response rate of sustained virologic response and ALT1 normalization as compared to a 12 percent treatment response rate in patients receiving INTRON A. The safety and efficacy of Peg-Intron in combination with ribavirin have not been established.

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.

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Editor: Susan K. Boyer, RN
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