SourceURL: http://www.medicalpost.com

By Nancy Deutsch

BOSTON-- For the first time, a study confirms what many doctors thought was true: The progression of hepatitis C can be prevented or delayed by using pegylated interferon alfa-2b (PEG-Intron) as long-term maintenance therapy in patients who have not responded to full-dose interferon therapy.

The study, led by Dr. Nezam Afdhal of the Beth Israel Deaconess Medical Centre here, is not yet complete, but the results are promising.

The study includes 550 chronic hepatitis C patients with advanced fibrosis who have failed interferon therapy to eradicate the virus. The patients, enrolled in the COPILOT (Colchicine versus PEG-INTRON long-term) study, have completed two years of the four-year study. The study is testing low-dose PEG-interferon alpha-2b against colchicine, an anti-inflammatory and antifibrotic medication.

Those patients receiving PEG-interferon alfa-2b have experienced a 50% reduced chance of reaching a clinical endpoint, such as liver failure or liver transplantation, compared with patients in the colchicine group.

"It's a totally different approach" from trying to eradicate the virus with full-dose interferon, Dr. Afdhal said in an interview. In patients for whom interferon does not eradicate the virus, many die of complications from the disease, he said.

"Why not try to lower the dose (to 0.5 mcg/kg/week) to prevent complications" and see what would happen, he said he thought before beginning the study.

The drug does not appear to become less effective with time, and patients experience much fewer complications on 0.5 mcg/kg/week, about one-third the regular dose, he said. Since many patients on interferon fail to complete therapy due to side-effects, this is an important outcome.

The mid-study results, which Dr. Afdhal presented at the annual meeting of the American Association for the Study of Liver Diseases here, showed that of the 550 patients enrolled, 59 had reached a clinical verified endpoint so far: 39 in the colchicine group (taking 0.6 mg orally twice a day), but only 20 in the PEG-interferon alfa-2b group.

"This study shows an option for high-risk patients with advanced liver disease," Dr. Afdhal said.

"I think it's important information," said Dr. Kelly Kaita, director of the viral hepatitis unit at the University of Manitoba in Winnipeg. "A lot of us assumed it would be true, but this proves it to be true."

Dr. Kaita has given patients who did not have the virus eradicated with full-dose interferon this alternate regimen of PEG-interferon for about four years now, he said. "This validates my rationale for using this," he said. "This is the first large study that gives us a glimpse into how effective it is."