Recently published in the New England Journal of Medicine, the largest prospective study of chronic hepatitis C virus (HCV) treatments Pegetron and Pegasys RBV (R) found both treatments equal in achieving sustained viral response. The study also found that Pegetron had a significantly lower relapse rate and is a safe and effective treatment option which has shown long term viral eradication.
The IDEAL study, conducted by researchers at Duke University Medical Center in Durham, North Carolina, John Hopkins University in Baltimore, and 116 other US centres, will help the 250,000 Canadians who are infected with HCV, 20 per cent of whom do not know they are infected and will remain undiagnosed.
"The results from this study are exciting as they demonstrate the effectiveness of the two leading treatment regimens," says Dr. Stephen Shafran, Professor, Division of Infectious Diseases, Department of Medicine, University of Alberta.
"A noteworthy finding is that patients receiving the peginterferon alfa-2b and ribavirin (Pegetron) treatment regimen were significantly less likely to relapse. Lower relapse rates are important for patients because the side effects of hepatitis C treatments can be quite debilitating."
The IDEAL study involved 3,070 patients with HCV genotype 1 infection. Researchers compared a standard dose of peginterferon alfa-2b plus ribavirin (Pegetron) with an investigational low dose of peginterferon alfa-2b combined with ribavirin and a standard dose of peginterferon alfa-2a also with ribavirin (Pegasys RBV).
The study found that there was no overall difference in achieving a sustained viral response between the two approved treatments with response rates of 39.8 per cent, 38.0 per cent and 40.9 per cent, for the Pegetron standard dose, Pegetron low dose and Pegasys RBV regimens, respectively. The findings from the study also show significant differences in relapse rates between the two approved regimens studied. For Pegasys RBV, the relapse rate was 31.5 per cent, whereas with Pegetron, significantly lower rates were seen at both the standard and low dose regimens; 23.5 per cent and 20 per cent respectively.
Another important finding from the study was the confirmation of early responses to treatment exhibited among patients as an indication of overall success. Researchers noted that in patients whose virus was undetectable after just four weeks of therapy, the rates of sustained response after the full course of treatment were 92.2 per cent and 87.3 per cent for the standard and low dose pegylated interferon alfa-2b, and 79.7 per cent for pegylated interferon alfa-2a.
The IDEAL study was sponsored by Schering-Plough, the company manufacturing peginterferon alfa-2b plus ribavirin, marketed in Canada as Pegetron.
Globally, approximately 180 million people are chronically infected with HCV. In Canada, hepatitis C is the leading cause of liver transplants. An estimated 250,000 Canadians are infected with HCV.