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"Real Life" Success Treating Chronic Hepatitis C Can Match That in Clinical Trials: Presented at AASLD

By Maria Bishop

BOSTON, MA -- November 8, 2007 -- Successful treatment of patients with chronic hepatitis C virus (HCV) matching the outcomes of rigorous clinical trials can be achieved in routine clinical practice, according to research from the Canadian observational program pegylated interferon alfa-2b prospective Optimal Weight-based dosing Response (POWeR), discussed here at the 58th Annual Scientific Meeting of the American Association for the Study of Liver Disease (AASLD).

Observational trials include a more heterogeneous patient population than populations observed in controlled trials, and provide useful information to practitioners on post-approval drug use, noted lead author, Paul Marotta, MD, Medical Director of Liver Transplantation, London Health Sciences Centre, London, Ontario, Canada.

The POWeR program was a large, open-label observational study conducted in community and academic clinics across Canada between 2002 and 2007 to determine the impact of hepatitis C virus (HCV) genotype, baseline viral load, weight, and fibrosis stage on sustained virological response (SVR) rates.

All 1,977 patients in the POWeR program had chronic HCV, were treatment-naïve, and were treated with pegylated interferon alfa-2b (PegIntron) (1.5 mcg/kg/wk) and weight-based ribavirin (800 to 1200 mg/day) in a "real-life" observational setting for either 24 weeks (genotypes 2 and 3) or 48 weeks (genotype 1).

This analysis is based on 1,800 patients, including those who discontinued because of side effects, lack of response, or personal reasons. Most patients were infected with genotype 1 disease (60.4%), followed by genotype 3 (21.8%), and genotype 2 (15.5%).

Despite poor predictive factors, such as advanced fibrosis and high baseline viral load in this difficult-to-treat population, an excellent sustained viral response (SVR) rate of 54.3% overall was achieved with pegylated interferon alfa-2b plus ribavirin.

Low relapse rates with pegylated interferon alfa-2b plus ribavirin were also attained (mean of 11.9%; 17.2% in genotype 1; 7.5% in genotype 2; 6.4% in genotype 3; and 6.9% in genotype 4 to 6).

Dr. Marotta noted that this study will be useful in adding to the published data on chronic HCV management in actual care settings.

This trial was supported by funding from Schering-Plough Canada Inc.


[Presentation title: Final Results of the Canadian POWeR (Peginterferon alfa-2b Prospective Optimal Weight-based Dosing Response) Program. Sustained Virologic Response (SVR) to Weight-Based Peginterferon alfa-2b + Ribavirin in a Large, Mixed Community and Academic Observational Study. Abstract 254]

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