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The amount of copies of HCV-RNA and count of CD8+ lymphocytes was retrospectively evaluated in 326 patients: sampling was performed in basal condition, during treatment with α-IFN (n=232) and post-treatment follow-up, and at the same time points in untreated patients (n=94). In the treated group the difference between CD8+ lymphocytes in the patients successfully treated (n=65) and those with an unfavourable outcome (n=176) is statistically significant (898±172 vs., 440±176 CD8+ lymphocytes per mm3 P<0.005 ANOVA). Also, in the untreated patients the average count of CD8+ cells is statistically higher in patients with a favourable outcome (P<0.01 ANOVA). The present data show that the count of CD8+ lymphocyte is of clinical value in order to predict the outcome of HCV infection and may be used together with the viral load and genotype, already established predictors. [Copyright &y& Elsevier]