Samuel Lee, MD, professor, division of medicine, University of Calgary, Calgary, Alberta, Canada, presented the results from a study evaluating 24 to 48 weeks of treatment with peginterferon alfa-2A 180 mcg/week plus ribavirin as part of an open-label expanded access program.

This combination is the treatment of choice for chronic hepatitis C and has produced overall sustained virological response (SVR) rates of 54% to 63% in treatment-naïve patients in large phase 3 registration studies (Manns 2001, Fried 2002, Hadziyannis 2004), Dr. Lee and colleagues noted in their abstract. However, HALT-C Among nonresponders to previous treatment, the SVR rate is lower (18%, Shiffman 2004), they note.

The trial included 2,702 Canadian adults with chronic hepatitis C, quantifiable serum HCV RNA levels, and compensated liver disease.

The protocol-defined dose of ribavirin was 800 mg/d in the first stage of the expanded access program (EAP-1) and 1000/1200 mg/d in the second stage (EAP-2), Dr. Lee said in a presentation on April 12^th.

Results showed that in EAP-2, the SVR rate in treatment- naïve, genotype 1 patients with normal ALT levels at baseline was higher than that in the overall group of treatment- naïve, genotype 1 patients (59% versus 51%).

SVR rates in treatment-naïve genotype 1 patients were similar in patients with fibrosis scores of F0 (58%), F1 (57%), and F2 (59%) but decreased progressively in patients with fibrosis scores of F3 (49%) and F4 (43%). "Thus, more aggressive and prolonged therapy may be needed to increase SVR rates in patients with advanced fibrosis," Dr. Lee commented.

Among previously treated patients, SVR rates were higher in relapsers than non-responders and in patients who had received prior interferon monotherapy rather than combination therapy. Thus, retreatment is a valid option for such patients, Dr. Lee said.

He concluded that the results in the study's diverse population are in line with those observed with the same treatment regimens in large phase 3 trials. Importantly, the diverse cohort, he said, represents populations encountered in a typical clinical practice unlike clinical trials which tend to include a highly selective cohort.


[Presentation title: Management of Chronic Hepatitis C in a Diverse Population With Peginterferon Alfa-2A and Ribavirin: Final Results of the Canadian Pegasys Expanded Access Program. Abstract Number 615]

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