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Title: Standard Therapy Has Similar Efficacy and Safety in Elderly Patients as in Younger Patients With Chronic Hepatitis C: Presented at AASLD

"Standard Therapy Has Similar Efficacy and Safety in Elderly Patients as in Younger Patients With Chronic Hepatitis C: Presented at AASLD"

By Maria Bishop BOSTON, MA -- November 3, 2006 -- Elderly patients with chronic hepatitis C virus (HCV) who are treated with a standard regimen of pegylated interferon alfa-2b plus ribavirin have nearly identical rates of sustained virologic response (SVR) to those of adult patients in younger age groups, researchers reported here at the 57[^th Annual Meeting of the American Society for Liver Diseases (AASLD).

According to lead investigator Steven L. Flamm, MD, associate professor, division of hepatology, Northwestern University, Chicago, Illinois, the SVR rate was 46% in patients older than 65 years of age and in younger cohorts it was 41% (56-65 years of age) and 57% (18-25 years of age).

"These results strongly suggest that patients [should] not be denied antiviral therapy based on age alone," emphasized Dr. Flamm.

There is reluctance to administer antiviral therapies to older populations due to a fear of side effects and possible decreased efficacy, according to the investigators. Although patients over 65 years of age were ineligible for the WIN-R trial, however, 55 such patients were enrolled as protocol exceptions.

In its safety analysis, a retrospective review of the WIN-R trial database examined 4,913 treatment-naive patients who received at least 1 dose of pegylated interferon alfa-2b (1.5 mcg/kg/week) plus ribavirin (either a flat-dose 800 mg/day or 800-1400 mg/day based on body weight). Patients with HCV genotypes 1 or 4 received 48 weeks of therapy and those with HCV genotype 2 or 3 were randomised to 24 or 48 weeks of therapy. For this analysis, patients were stratified into 6 groups, according to age.

Baseline host and viral characteristics were comparable among the treatment arms. Dr. Flamm, noted, however, that there was a trend toward greater incidence of advanced fibrosis and alanine transaminase abnormalities with increasing age.

There were no differences in serious adverse events between all age groups. Younger patients had fewer adverse events than those in the "56 to 65 years" and the "over 65 years" age groups. The incidence of treatment discontinuation was similar to that of other age groups.

This research was supported by Schering Plough.

[Presentation title: Pegylated Interferon Alfa 2 B + Ribavirin Are Equally Efficacious and Well Tolerated in Patients >65 Years Old in Comparison to Other Age Groups: Subanalysis of a Randomized, Controlled Study (WIN-R Trial). Abstract 338]

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