BACKGROUND/AIMS: Retrospective studies have suggested that early loss of serum HCV-RNA predicts sustained response to alpha-interferon treatment in chronic hepatitis C, but the optimal duration of therapy after loss of HCV-RNA is not known. The aims of this study were: a) to prospectively evaluate the effectiveness of HCV-RNA testing after 1 month of alpha-interferon treatment in the prediction of sustained response, and b) to compare the efficacy of 6 and 12 months of therapy in patients with a negative serum HCV-RNA test after the first month of treatment. METHODS:One hundred and thirty patients were administeredinterferon alpha-2b at doses related to body weight (< or > or = 60 kg) and to HCV genotype: 5 or 8 MU tiw for type 1, and 3 or 5 MU tiw for genotypes non-1. Serum HCV-RNA testing was performed using in-house nested RT-PCR at month 1, at the end of treatment and 6 months afterwards. We considered sustained response to be the maintenance of normal alanine aminotransferase and negativity at serum HCV-RNA testing until the end of follow-up. RESULTS:Sustained response was observed in 2/72 (2.8%) patients with detectable HCV-RNA after the initial month of therapy, in 8/30 (26.7%) patients with early loss of HCV-RNA treated for 6 months and in 20/28 (71.4%) patients treated for 12 months (p<0.01). CONCLUSIONS:Serum HCV-RNA detectability after the first month is strongly associated with a very poor chance of sustained response, and these cases should be offered other treatments. Patients with early loss of HCV-RNA should complete a 12-month treatment, which appeared more effective than a 6-month treatment.
RCT Entities:
BACKGROUND/AIMS: Retrospective studies have suggested that early loss of serum HCV-RNA predicts sustained response to alpha-interferon treatment in chronic hepatitis C, but the optimal duration of therapy after loss of HCV-RNA is not known. The aims of this study were: a) to prospectively evaluate the effectiveness of HCV-RNA testing after 1 month of alpha-interferon treatment in the prediction of sustained response, and b) to compare the efficacy of 6 and 12 months of therapy in patients with a negative serum HCV-RNA test after the first month of treatment. METHODS: One hundred and thirty patients were administered interferon alpha-2b at doses related to body weight (< or > or = 60 kg) and to HCV genotype: 5 or 8 MU tiw for type 1, and 3 or 5 MU tiw for genotypes non-1. Serum HCV-RNA testing was performed using in-house nested RT-PCR at month 1, at the end of treatment and 6 months afterwards. We considered sustained response to be the maintenance of normal alanine aminotransferase and negativity at serum HCV-RNA testing until the end of follow-up. RESULTS: Sustained response was observed in 2/72 (2.8%) patients with detectable HCV-RNA after the initial month of therapy, in 8/30 (26.7%) patients with early loss of HCV-RNA treated for 6 months and in 20/28 (71.4%) patients treated for 12 months (p<0.01). CONCLUSIONS: Serum HCV-RNA detectability after the first month is strongly associated with a very poor chance of sustained response, and these cases should be offered other treatments. Patients with early loss of HCV-RNA should complete a 12-month treatment, which appeared more effective than a 6-month treatment.