Aims: To assess the relationship between changes in liver histology and virological parameters of HCV infection in patients with a sustained biochemical response to alpha-interferon treatment for chronic hepatitis, with the aim of identifying the most reliable indicator of treatment efficacy.
Methods: Quantitative serial testing of HCV-RNA in plasma samples collected on a monthly basis over the last period of post-treatment follow-up were tested in sixteen subjects with > or = 12 months aminotransferase normalisation following discontinuation of interferon therapy. The quantitative HCV-RNA determination in plasma was performed by a competitive reverse-transcription polymerase-chain reaction. Pretreatment and 12-month post-treatment liver histologies were blindly evaluated using a semi-quantitative scoring system. At these times a qualitative HCV-RNA analysis was also carried out.
Results: The post-treatment histological grading score was significantly reduced. Nevertheless, all patients except one tested positive for HCV-RNA in plasma (mean 1.7 x 10(6) molecules/ml): nine were positive in all the serial determinations, while the remaining 6 were intermittently positive. No relationship between genotype, viral load, pattern of viremia (intermittent or continuous) and change in histological score was found.
Conclusions: Changes in liver histology are the most reliable indicator of the efficacy of interferon treatment in hepatitis C related liver disease. HCV-RNA clearance based on serial sampling does not appear to be a reliable indicator, even in the presence of a sustained biochemical response and histological improvement.