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HEPATITIS |
1 University Health Network, Toronto General Hospital, Toronto, Ontario, Canada
2 Vancouver Hospital Health Sciences Centre, Vancouver, British Columbia, Canada
3 Royal Victoria Hospital, Montreal, Quebec, Canada
4 British Columbia Centre for Disease Control, Vancouver, British Columbia, Canada
5 University of Alberta, Edmonton, Alberta, Canada
6 QEII-Health Sciences Centre, Hepatology Services, Halifax, Nova Scotia, Canada
7 The Liver and Intestinal Research Centre, Vancouver, British Columbia, Canada
8 Viral Hepatitis Investigative Unit, University of Manitoba, Winninpeg, Manitoba, Canada
9 Roche, Mississauga, Ontario, Canada
10 Syreon Corporation, British Columbia, Canada
11 University of Calgary, Calgary, Alberta, Canada
Correspondence to:
Correspondence to:
Dr M Sherman
Toronto General Hospital, 200 Elizabeth St, Toronto, Ontario, M5G 2C4 Canada; morris.sherman{at}uhn.on.ca
ABSTRACT
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.
Abbreviations: 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
Keywords: hepatitis C; non-responder; relapser; efficacy; peginterferon alfa-2a (40KD)
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  H. C. Highbarger, Z. Hu, S. Kottilil, J. A. Metcalf, M. A. Polis, M. B. Vasudevachari, H. C. Lane, and R. L. Dewar Comparison of the Abbott 7000 and Bayer 340 Systems for Measurement of Hepatitis C Virus Load J. Clin. Microbiol., September 1, 2007; 45(9): 2808 - 2812. [Abstract] [Full Text] [PDF]
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