A PILOT-STUDY OF CORTICOSTEROID PRIMING FOR LYMPHOBLASTOID INTERFERON-ALFA IN PATIENTS WITH CHRONIC HEPATITIS-C

Interferon treatment reduces the serum level of hepatitis C virus (HCV ) and improves inflammatory activity, but relapse is frequently observ ed, In an attempt to develop a new therapeutic strategy that may reduc e relapse and cure the disease, we evaluated the effect of corticoster oid priming on lymphoblastoid interferon alfa in an open randomized cl inical trial, The level of HCV RNA increased significantly during cort icosteroid priming (from 5.60 [median] to 21.0 x 10(5) Eq/mL; P = .000 4) but decreased to the pretreatment level 4 weeks after cessation of corticosteroid (7.0 x 10(5) Eq/mL; P = .07). Sustained normalization o f alanine transaminase (ALT) level and virus clearance, confirmed by n egative results for HCV RNA using reverse-transcription nested polymer ase chain reaction (PCR), were observed over a period of 6 months in 8 of 19 (42.1%) corticosteroid-primed patients, compared with 6 of 19 p atients (31.6%) treated with interferon only. A ''rebound'' of ALT aft er the withdrawal of corticosteroid was observed in only 2 of 19 patie nts primed with corticosteroid, but both showed sustained responses. M ultivariate analysis for factors predictive of the sustained response indicated that HCV titers measured immediately before interferon thera py and HCV genotype were statistically significant (P = .006 and P = . 025, respectively). Our results indicated that corticosteroid priming has a marginal benefit over treatment with interferon alone and that l arge-scale clinical trials are necessary to determine whether interfer on with corticosteroid priming is more effective than interferon alone .