801 RESCUE THERAPY WITH OPTIMIZED PEG-INTERFERON PLUS RIBAVIRIN IN HIV/HCV COINFECTED PATIENTS: CRITICAL ROLE OF RIBAVIRIN PLASMA LEVELS IN THE PILOT-NR TRIAL

44[suppl 2]:S275).The study aim was to confirm this finding in pediatric patients treated with IFN+RBV.Methods: 97/166 (58%) patients treated with IFN+RBV in 2 pediatric clinical trials (González-Peralta et al, Hepatology 2005; 42(5): 1010-8) who completed 24 weeks of follow-up were assessed annually for up to 5 years for clinical evidence of liver disease progression and for virologic relapse in sustained responders.Results: 56 sustained responders (SRs) and 41 nonresponders (NRs) entered the study and were followed for a mean of 261 and 238 weeks, respectively.82% and 75% of SRs and 71% and 63% of NRs completed 3 and 5 years of follow-up, respectively.One SR patient relapsed during the 5-year follow-up at year 1.The patient had a baseline HCV-RNA level of 31,000,000 copies/mL before receiving 48 weeks of treatment with IFN+RBV 15 mg/kg/day and had genotype 1a prior to treatment and at relapse.Kaplan-Meier estimate for continued sustained response at 5 years is 98% (95%-100%).Of the 56 SRs with normal alanine aminotransferase (ALT) values at the end of the initial 24-week follow-up, 54 (96%) maintained normal levels throughout the 5-year follow-up and 1 (2%) had missing data.The only SR with elevated ALT values during the 5-year follow-up had levels <3× upper limit of normal.None of the patients had clinical progression of liver disease and no deaths occurred.Serious adverse events were reported for 5 patients; all were considered unlikely related to study drugs.Conclusions: SVR 24 weeks following therapy with IFN+RBV in pediatric patients predicts long-term clearance of HCV.These results, and those by McHutchison, et al., suggest that successful treatment (SVR) of HCV infection with IFN+RBV leads to a clinical cure in both adults and children.