RELATIONSHIP BETWEEN BIOCHEMICAL AND VIROLOGICAL RESPONSES TO INTERFERON THERAPY IN CHRONIC HEPATITIS-C INFECTION

We have investigated the relationship between serum alanine aminotrans ferase (ALT) and hepatitis C virus (HCV) RNA in the assessment of resp onses to interferon (IFN) therapy in chronic HCV infection. Data from 704 patients with HCV infection who were randomized to receive consens us IFN-alpha (CIFN) 3 mu g (n=232 patients) or 9 mu g (n=232 patients) , or IFN-alpha 2b 3 million units (MU) (n = 240 patients), were used f or these analyses. All patients were treated three times weekly for 24 weeks and then were observed for a further 24 weeks. Hepatitis C vira l RNA (HCV RNA) was determined by quantitative reverse transcriptase-p olymerase chain reaction (RT-PCR) with a lower limit of detection of 1 00 copies ml(-1). Of patients with normal serum ALT concentrations, 53 % (120/225) had undetectable HCV RNA at the end-of-treatment period an d 47% (51/109) had undetectable HCV RNA at the end of the post-treatme nt observation period. In contrast, of the patients with undetectable HCV RNA, 75% (120/161) and 84% (51/61) had normal serum ALT activities at the end-of-treatment and post-treatment observations periods, resp ectively. The majority of patients with undetectable HCV RNA had norma l ALT values. In contrast, only half of the patients with normal ALT v alues were negative for HCV. End-of-treatment HCV RNA response also be tter predicted sustained virological response than did end-of-treatmen t ALT response.