LYMPHOBLASTOID INTERFERON THERAPY IN CHRONIC HEPATITIS-C - BIOCHEMICAL, VIROLOGICAL AND HISTOLOGICAL-EVALUATION OF 2 DIFFERENT DOSES

Sixty patients of both sexes with biopsy-proven chronic hepatitis C we re randomized to receive lymphoblastoid interferon 3 MU or 6 MU three times weekly for 6 months. A follow-up period of 3 months at the end o f the therapy was scheduled. Thirty-two patients (53.3%) normalized al anine aminotransferase at the end of the therapy. Of these, 17 receive d 3 MU (56.7%) and 15 (50%) received 6 MU. Eighteen of the 32 patients (56.2%) relapsed in the follow-up period after treatment. No signific ant difference in relapse rate was observed between the two groups. Th e overall percentage of the non-responder patients was 36.6%. The trea tment was discontinued because of non-compliance and/or side effects i n six patients (10%): three in the 3-MU group and three in the 6-MU gr oup. An improvement in liver histology was observed in about a quarter of chronic active hepatitis patients whose overall diagnosis changed to chronic persistent hepatitis. Knodell's score system showed a signi ficant improvement (p < 0.05) with regard to peripheral necrosis, fibr osis and total score. HCV-RNA was positive at the beginning in all pat ients and it became undetectable in almost all responder patients. In some cases there was no correlation between viraemia and biochemical s igns of liver disease. Our study shows that 6 MU does not increase the response rate compared to 3 MU. Moreover, the lower dose is able to i mprove the liver histology and to abolish the HCV viraemia in responde r patients.