Peginterferon alfa-2a (40KD) plus ribavirin in chronic hepatitis C patients who failed previous interferon therapy
- M Sherman1,
- E M Yoshida2,
- M Deschenes3,
- M Krajden4,
- V G Bain5,
- K Peltekian6,
- F Anderson7,
- K Kaita8,
- S Simonyi9,
- R Balshaw10,
- S S Lee11,
- the Canadian Pegasys Study Group
- 1University Health Network, Toronto General Hospital, Toronto, Ontario, Canada
- 2Vancouver Hospital Health Sciences Centre, Vancouver, British Columbia, Canada
- 3Royal Victoria Hospital, Montreal, Quebec, Canada
- 4British Columbia Centre for Disease Control, Vancouver, British Columbia, Canada
- 5University of Alberta, Edmonton, Alberta, Canada
- 6QEII-Health Sciences Centre, Hepatology Services, Halifax, Nova Scotia, Canada
- 7The Liver and Intestinal Research Centre, Vancouver, British Columbia, Canada
- 8Viral Hepatitis Investigative Unit, University of Manitoba, Winninpeg, Manitoba, Canada
- 9Roche, Mississauga, Ontario, Canada
- 10Syreon Corporation, British Columbia, Canada
- 11University of Calgary, Calgary, Alberta, Canada
- Correspondence to:
Dr M Sherman
Toronto General Hospital, 200 Elizabeth St, Toronto, Ontario, M5G 2C4 Canada;
- Accepted 25 April 2006
- Revised 7 April 2006
- Published Online First 18 May 2006
Background: The management of patients with chronic hepatitis C who have relapsed or failed to respond to interferon based therapies is an important issue facing hepatologists.
Aims: We evaluated the efficacy and safety of peginterferon alfa-2a (40KD) plus ribavirin in this population by conducting a multicentre open label study.
Patients: Data from adults with detectable serum hepatitis C virus (HCV) RNA who had not responded or had relapsed after previous conventional interferon or conventional interferon/ribavirin combination therapy were analysed.
Methods: Patients were retreated with peginterferon alfa-2a (40KD) 180 µg/week plus ribavirin 800 mg/day for 24 or 48 weeks at the investigators’ discretion. The study was conceived before the optimal dose of ribavirin (1000/1200 mg/day) for patients with genotype 1 was known. The primary endpoint was sustained virological response (SVR), defined as undetectable HCV RNA (<50 IU/ml) after 24 weeks of follow up. The analysis was conducted by intention to treat.
Results: A total of 312 patients (212 non-responders, 100 relapsers) were included. Of these, 28 patients were treated for 24 weeks and 284 for 48 weeks. Baseline characteristics between non-responders and relapsers were similar although more non-responders had genotype 1 infection (87% v 69%). Overall SVR rates were 23% (48/212) for non-responders and 41% (41/100) for relapsers. When data were analysed by genotype, SVR rates were 24% (61/253) in genotype 1 and 47% (28/59) in genotype 2/3.
Conclusions: These results in a large patient cohort demonstrate that it is possible to cure a proportion of previous non-responders and relapsers by retreating with peginterferon alfa-2a (40KD) plus ribavirin.
- ALT, alanine aminotransferase
- HCV, hepatitis C virus
- SVR, sustained virological response
- EVR, early virological response
- BMI, body mass index
- ITT, intent to treat
- NPV, negative predictive value
- PPV, positive predictive value
Published online first 27 June 2006
The design, collection, analysis, and interpretation of data in the Canadian extended access program, as well as the resulting manuscript, were supported by a grant from Roche Canada.
Conflict of interest: None declared.