Authors: LEE, S. S.¹; BAIN, V. G.²; PELTEKIAN, K.³; KRAJDEN, M.⁴; YOSHIDA, E. M.⁵; DESCHENES, M.⁶; HEATHCOTE, J.⁷; BAILEY, R. J.⁸; SIMONYI, S.⁹; SHERMAN, M.¹⁰

Source: Alimentary Pharmacology & Therapeutics, Volume 23, Number 3, February 2006 , pp. 397-408(12)

Publisher: Wiley-Blackwell

Abstract:

Summary Background

Pegylated interferon alfa-2a (40 KD) plus ribavirin therapy induces sustained virological response rates up to 63% in randomized-controlled trials. Aim

To conduct a prospective open-label programme to examine the efficacy and safety of this therapy in routine clinical practice. Methods

Treatment-naive patients with chronic hepatitis C received, at the discretion of the investigator, pegylated interferon alfa-2a 180 μg/week + ribavirin 800 mg/day for 24 or 48 weeks. In total, 508 patients were enrolled [334 non-cirrhotic; 174 cirrhotic (defined as stage F3 and F4)]. Results

In genotype 1 patients treated for 48 weeks, sustained virological response rates were 41% in non-cirrhotics and 34% in cirrhotics. Sustained virological response rates in genotype 2 or 3 non-cirrhotics were 79% (24 weeks) and 72% (48 weeks). Corresponding values for cirrhotic genotype 2/3 were 66% and 44%. The negative predictive value of an early virological response at week 12 was 94%. Predictive factors for sustained virological response on multivariate analysis were genotype (2/3 vs. 1), low viral load and degree of fibrosis. Rates of serious adverse events (≤5%) and adverse events inducing withdrawal (≤8%) were comparable with the phase III trials. Conclusion

Efficacy and safety of pegylated interferon alfa-2a + ribavirin in clinical practice is comparable with results of randomized-controlled trials.

Document Type: Research article

DOI: http://dx.doi.org/10.1111/j.1365-2036.2006.02748.x

Affiliations: 1: Liver Unit, University of Calgary, Calgary, AB 2: University of Alberta, Edmonton, AB 3: QEII, Health Sciences Centre, Halifax, NS 4: British Columbia Center for Disease Control, Vancouver, BC 5: Vancouver Hospital Health Sciences Centre, Vancouver, BC 6: Royal Victoria Hospital, Montreal, QC 7: University Health Network, Toronto Western Hospital, Toronto, ON 8: Royal Alexandra Hospital, Edmonton, AB 9: Roche Canada, Mississauga, ON 10: University Health Network, Toronto General Hospital, Toronto, ON, Canada

Publication date: 2006-02-01

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• In this Subject: Pathology ,  Pharmacology ,  Surgery ,  Therapeutics & Alternative Medicine
• By this author: LEE, S. S. ;  BAIN, V. G. ;  PELTEKIAN, K. ;  KRAJDEN, M. ;  YOSHIDA, E. M. ;  DESCHENES, M. ;  HEATHCOTE, J. ;  BAILEY, R. J. ;  SIMONYI, S. ;  SHERMAN, M.

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