Treating chronic hepatitis C with pegylated interferon alfa-2a (40 KD) and ribavirin in clinical practice
Article first published online: 16 JAN 2006
DOI: 10.1111/j.1365-2036.2006.02748.x
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How to Cite
LEE, S. S., BAIN, V. G., PELTEKIAN, K., KRAJDEN, M., YOSHIDA, E. M., DESCHENES, M., HEATHCOTE, J., BAILEY, R. J., SIMONYI, S., SHERMAN, M. and THE CANADIAN PEGASYS STUDY GROUP (2006), Treating chronic hepatitis C with pegylated interferon alfa-2a (40 KD) and ribavirin in clinical practice. Alimentary Pharmacology & Therapeutics, 23: 397–408. doi: 10.1111/j.1365-2036.2006.02748.x
Publication History
- Issue published online: 16 JAN 2006
- Article first published online: 16 JAN 2006
- Publication data Submitted 7 September 2005 First decision 28 September 2005 Resubmitted 22 October 2005 Accepted 23 October 2005
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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.

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