SERUM HEPATITIS-C VIRUS CORE PROTEIN LEVEL DURING INTERFERON-ALPHA THERAPY IN PATIENTS WITH CHRONIC HEPATITIS-C - RELATIONSHIP BETWEEN BIOCHEMICAL AND VIROLOGICAL RESPONSES

Although interferon-alpha (IFN) has been shown to provide effective th erapy in patients with chronic hepatitis C, the relationship between v irologic and biochemical responses to IFN therapy is not well understo od. To quantitate viremia levels of hepatitis C virus (HCV) - with a s imple and stable method compared with quantitation methods of HCV RNA - a fluorescent enzyme immunoassay (FEIA) has been developed to quanti fy core protein level. To investigate the biochemical and virologic re sponses to IFN therapy, serum HCV core protein levels were serially qu antitated by FEIA before, during and after IFN therapy in 35 Japanese patients with chronic hepatitis C. The biochemical response to IFN the rapy was defined by the serum alanine aminotransferase (ALT) level, as complete and sustained response (SR, n = 14), complete response durin g IFN followed by relapse after IFN (Rel, n = 7), complete response bu t followed by relapse of ALT during IFN (BT, n = 6) and no response (N R, n = 8). In the same way, the virologic response to IFN was defined by the serum HCV core protein level as vSR (n = 14), vRel (n = 10), vB T (n = 7) and vNR (n = 4). All the SR patients showed vSR. Of seven Re 1 patients, six showed vRel and one showed VNR. All six BT patients al so showed VET. In contrast, of eight NR patients, four (50%) showed vR el and one (12.5%) showed vBT, while three (37.5%) were VNR. Among the four biochemical response groups, there was no difference of age, gen der, history of transfusion and the ratio of HCV genotype (1:2), howev er there was a significant difference in the pretreatment HCV viremia levels between the SR patients and other patients (P < 0.01). There wa s no significant difference in clinical and virologic characteristics among the Rel, BT and NR patients. This data indicates that (1) the lo w pretreatment HCV core protein level was a predicting factor of SR an d (2) there were heterogeneous virologic responders in the NR patients . (C) 1997 Elsevier Science Ireland Ltd.