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
- hepatitis C
- peginterferon alfa-2a (40KD)
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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.
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