Time course of serum hepatitis C virus-RNA during chronic hepatitis C treatment accurately predicts the type of response

Aim: To establish the value of alanine aminotransferase normalization and h epatitis C virus-RNA clearance as predictors of sustained virological respo nse in naive and relapser chronic hepatitis C patients on mono or combinati on therapy. Methods: A total of 282 hepatitis C patients were studied: 98 naives on int erferon, and 64 naives and 75 relapsers on interferon plus oral ribavirin; 45 patients were excluded. Drugs were administered at standard doses for 12 months. Alanine aminotransferase and hepatitis C virus-RNA were determined at baseline and at weeks 4, 12, 24, 48, and at 72 and 96 weeks after compl etion of therapy. Results: The rate of sustained response was greater (P < 0.05) in naives an d relapsers on combination therapy (33% and 48%, respectively) than in naiv es on interferon alone (16%). Hepatitis C virus-RNA significantly decreased from baseline by week 4 in naives on interferon and relapsers on combinati on therapy and by week 12 in naives on combination therapy. Alanine aminotr ansferase levels paralleled viremic load in naives on interferon, yet in pa tients on combination therapy, alanine aminotransferase normalized independ ently of the virological response. During treatment, the main factor associ ated with sustained response was hepatitis C virus-RNA clearance by week 4 in naives on interferon and relapsers on combination therapy, and by week 2 4 in naives on combination therapy. Conclusion: Clearance of viraemia constitutes the best predictor of a susta ined response to therapy, but needs to be measured at patient-specific time s.