Should patients with early loss of serum HCV-RNA during alpha interferon therapy for chronic hepatitis C be treated for 6 or 12 months?

Background/Aims: Retrospective studies have suggested that early loss of se rum HCV-RNA predicts sustained response to alpha-interferon treatment in ch ronic hepatitis C, but the optimal duration of therapy after loss of HCV-RN A is not known. The aims of this study were: a) to prospectively evaluate t he effectiveness of HCV-RNA testing after 1 month of alpha-interferon treat ment in the prediction of sustained response, and b) to compare the efficac y of 6 and 12 months of therapy in patients with a negative serum HCV-RNA t est after the first month of treatment. Methods: One hundred and thirty patients were administered interferon alpha -2b at doses related to body weight (< or greater than or equal to 60 kg) a nd to HCV genotype: 5 or 8 MU tiw for type 1, and 3 or 5 MU tiw for genotyp es 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 detec table 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%) patien ts 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 s hould be offered other treatments. Patients with early loss of HCV-RNA shou ld complete a 12-month treatment, which appeared more effective than a 6-mo nth treatment.