304 METABOLIC SYNDROME (MS) IS A NEGATIVE PREDICTOR OF TREATMENT OUTCOME IN PATIENTS WITH CHRONIC HEPATITIS C: RESULTS FROM THE IDEAL STUDY

Abstract

Background and Aims: Chronic hepatitis C (CHC) patients with failure to antiviral therapy are a challenge. Reports of retreatment have included nonresponders and relapsers mostly previously treated with conventional IFN and ribavirin (RBV). We evaluated the efficacy and factors related to sustained virological response (SVR) in CHC patients who have relapsed after a prior treatment with PEG-IFN plus RBV. Methods: Out of 1,228 CHC patients treated with PEG-IFN/RBV, 165 (13%) had a relapse. Among these, 62 patients were retreated between April 2003 and June 2008 with PEG-IFN-a-2a or -2b and RBV at a dose of 800 to 1200mg/day. Clinical, biological, virological and histological data were collected. Type of PEG-IFN, initial doses and modifications of therapy were analyzed. The efficacy was evaluated with a qualitative HCVRNA assay ( 15.2mg/kg/day), a better SVR rate was observed when compared to lower dose/weight (70% vs 35%, p = 0.04). All patients without complete EVR (undetectable HCVRNA at W12) did not achieve SVR (Negative Predictive Value, NPV=100%). In the logistic regression, independent predictors of response were: age (p = 0.018), genotype (p =0.048) and initial ribavirin dose/weight (p = 0.022). Conclusion: Retreatment with PEG-IFN plus ribavirin is effective in genotype 2 or 3 relapsers after a first course of PEG-IFN plus RBV, especially in young patients. High RBV dose per weight seems to be an important factor for the retreatment response. Furthermore, the presence of detectable HCVRNA at W12 should be considered a stopping rule in the retreatment of relapsers.