FLUCTUATIONS IN VIRAL LOAD (HCV RNA) ARE RELATIVELY INSIGNIFICANT IN UNTREATED PATIENTS WITH CHRONIC HCV INFECTION

A recently available assay to quantify serum viral load in hepatitis C virus (HCV) infection has been used to evaluate the effects of anti-v iral therapies, However, variability in HCV RNA levels in untreated pa tients with HCV infection has not yet been established. We therefore p rospectively measured the biological fluctuations of HCV RNA in sera f rom untreated patients with chronic HCV infection, Sera were collected from seven patients at 8 am and 4 pm on the same day to assess the ef fect of diurnal variation, daily for 5 days in a further 10 patients, biweekly for 6 weeks in nine patients and monthly for 3 months in 11 p atients. All patients had biopsy-proven chronic liver disease with ele vated alanine aminotransferase (ALT) values and had not received anti- viral treatment, HCV RNA was measured blinded, in duplicate, using the quantitative branched (bDNA) amplification assay (Quantiplex(TM) HCV RNA, Chiron Co, Emeryville, CA) 36 of the 37 patients studied had meas urable HCV RNA throughout the study, There was no significant correlat ion between HCV RNA levels and ALT values or histological activity, HC V RNA levels did not appear to vary significantly within any of the gr oups studied and there did not appear to be a change associated with d iurnal variation, All individual patients demonstrated less than a thr eefold fluctuation in HCV RNA throughout the study period. Hence HCV R NA levels remain relatively stable in untreated individuals with chron ic HCV infection, Changes of a magnitude of threefold (0.5 log) or gre ater in HCV RNA levels were not observed in untreated patients.