High rate of chronicity in HCV infection determined by antibody confirmatory assay and PCR in 4110 patients during long-term follow-up

Background: It is still unclear how many patients with hepatitis C virus (H CV) antibodies have viremia and hence are infectious. Objectives: To determine the chronicity of HCV infection by correlation of HCV antibodies with presence of viremia in long-term follow-up. Study design: In a longitudinal study sera of 4110 patients were analyzed w ith second generation HCV-enzyme immunoassay (EIA) and polymerase chain rea ction (PCR). Only those patients were included in this study in whom sequen tial serum samples over a period of 2 years were available. To avoid preana lytical and analytical failures, we used a transport solution to prevent RN A degradation and a four-antigen recombinant immunoblot assay, established in our laboratory, for confirmation of antibody reactivity. Results: Of 2815 patients with confirmed HCV antibodies 2784 (98.9%) were a lso positive in HCV-PCR assay. False reactive EIA results were detected in 177 (13.7%) individuals as shown by confirmatory assay and PCR. Only one pa tient (0.04%) spontaneously lost detectable HCV viremia and subsequently HC V-specific antibodies. Conclusions: Our study clearly demonstrates that presence of confirmed HCV- specific antibodies correlates significantly (98.9%; P < 0.001) with HCV vi remia, and that spontaneous loss of viremia is a very rare event in HCV inf ection. We also found that elimination of HCV infection is not sufficiently predicted by the loss of detectable viremia in PCR, but can be concluded f rom the disappearance of virus-specific antibodies. (C) 1999 Elsevier Scien ce B.V. All rights reserved.