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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Competing interests: MS, advisor and speakers bureau for Roche.
EMY, Honoraria for lectures sponsored by Roche and Schering Plough; Advisor to Roche; Unrestricted research grants from Roche, Schering Plough, Fujisawa, Pfizer, GlaxoSmithKline; Investigator in trials sponsored by Roche, Schering Ploughm Human Genome Sciences, Idenix, Microgenix, Fujisawa, Novartis, Wyeth.
MD, no conflicts of interest to declare.
MK, unrestricted research grants from Roche, Schering Plough.
VGB, no conflicts of interest to declare.
KP, no conflicts of interest to declare.
FA, no conflicts of interest to declare.
KK, no conflicts of interest to declare.
SS, Roche employee.
SSL, research grants from Roche, speakers bureau and consulting for Roche.
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