Nov. 2, 2004 -- Findings from a highly anticipated study offer hope to people with hepatitis C who do not respond to standard antiviral therapy.
The trial, known as the COPILOT study, is the first to show that progression of hepatitis C disease can be delayed and possibly prevented in patients with severe scarring (fibrosis) of the liver who have failed prior treatment with interferon.
One of three ongoing trials evaluating low-dose, long-term interferon therapy, the study was presented Monday at the annual meeting of the American Association for the Study of Liver Diseases in Boston.
"This is a new treatment paradigm, showing for the first time that we can prevent the serious complications of liver disease," says lead researcher Nezam Afdhal, MD.
Hope for the Other Half
Approximately 4 million Americans are infected with hepatitis C, a virus transmitted by blood-to-blood contact that can lead to liver damage and liver cancer. Combination therapy with the antiviral drugs interferon and ribavirin leads to viral eradication, which is tantamount to a cure, in about half of treated patients. But doctors have had little to offer patients with advanced liver disease who do not respond to this treatment.
The COPILOT trial compared a low, weekly dose of PEG-Intron (peginterferon alfa 2b) with the anti-inflammatory drug colchicine. Colchicine showed early promise as a treatment for advanced liver disease, but studies now suggest it does not slow disease progression.
Fifty-nine patients with liver scarring who had previously failed interferon therapy stayed on low doses of PEG-Intron or colchicine for two years. The PEG-Intron patients tolerated therapy well, reporting few of the troubling side effects that are common with higher doses of the drug.
The rate of serious events associated with liver disease progression was about 7% a year in the colchicine-treated patients versus 3.5% a year in the group treated with interferon. These events included liver failure, liver transplantation, liver cancer, and death.
The study was supported by Schering-Plough Corporation, which makes PEG-Intron.
Liver Cancer Cases Growing
Hepatitis treatment expert Bruce Bacon, MD, tells WebMD the hepatitis C community has been waiting for the results of this study and the two others of maintenance interferon therapy in patients with advanced disease who fail initial treatment. Bacon is director of the division of hepatology at St. Louis University School of Medicine.
"This study provides the first glimpse that maintenance therapy is beneficial," he says. "It doesn't answer all the questions, and it doesn't necessarily mean that everyone with advanced fibrosis [of the liver] who fails initial treatment should be put on maintenance. But I suspect that some physicians will look at these results and decide that they have enough evidence to offer this treatment to their patients."
The urgent need for better treatments was illustrated Monday at the Boston meeting with the announcement that liver cancer is the fastest growing type of cancer in the U.S. More than half of all liver cancers are thought to be caused by hepatitis C infection.
"The goal is to prevent cancer and other life-threatening complications from occurring in these advanced patients," Bacon says.