Abstract
BackgroundThe effect of peginterferon and ribavirin treatment on chronic hepatitis C virus (HCV) infection has been established in several controlled clinical studies. However, the effectiveness of treatment and predictors of treatment success in routine clinical practice remains to be established. Our aim was to estimate the effectiveness of peginterferon and ribavirin treatment in unselected HCV patients handled in routine clinical practice. The endpoint was sustained virological response (SVR), determined by the absence of HCV RNA 24 weeks after the end of treatment.MethodsWe determined the proportion of SVR in a nationwide, population-based cohort of 432 patients with chronic HCV infection who were starting treatment, and analyzed the impact of known covariates on SVR by using a logistic regression analysis.ResultsThe majority of treated patients had genotype 1 (133 patients) and genotype 2/3 (285 patients) infections, with 44% and 72%, respectively, obtaining SVR. Other than genotype, the predictors of SVR were age ≤ 45 years at the start of treatment, completion of unmodified treatment, the absence of cirrhosis and non-European origin.ConclusionsThe effectiveness of peginterferon and ribavirin treatment for chronic hepatitis C in a routine clinical practice is comparable to that observed in controlled clinical trials, with a higher SVR rate in genotype 2 and 3 patients compared to genotype 1 patients. Our data further indicate that age at start of treatment is a strong predictor of SVR irrespective of HCV genotype, with patients 45 years or younger having a higher SVR rate.
Highlights
The effect of peginterferon and ribavirin treatment on chronic hepatitis C virus (HCV) infection has been established in several controlled clinical studies
Controversial whether the promising treatment effects observed in clinical trials can be transformed into an equivalent effectiveness in a routine clinical setting, one retrospective observational cohort study by Backus et al of patients treated in a routine clinical setting at Veterans Affairs facilities showed efficacy of treatment to be 20-52% [12]
In an analysis only including patients who had had a liver biopsy performed prior to treatment initiation, we found that cirrhosis was negatively associated with SVR, Table 3 Odds ratios and 95% confidence intervals (CI) for age as predictor of sustained virological response after treatment with peginterferon and ribavirin in 418 chronically HCV infected patients, divided by genotype (133 genotype 1, 285 genotype 2/3)
Summary
The effect of peginterferon and ribavirin treatment on chronic hepatitis C virus (HCV) infection has been established in several controlled clinical studies. It was found that female gender, young age, being infected with genotype 2 or 3, absence of cirrhosis, Asian origin and early inhibition of viral replication predict a better response to treatment [5,6,7,8,9,10,11,12,13,14,15,16,17] It is controversial whether the promising treatment effects observed in clinical trials can be transformed into an equivalent effectiveness in a routine clinical setting, one retrospective observational cohort study by Backus et al of patients treated in a routine clinical setting at Veterans Affairs facilities showed efficacy of treatment to be 20-52% [12].
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