A RANDOMIZED, CONTROLLED TRIAL OF HUMAN LYMPHOBLASTOID INTERFERON IN PATIENTS WITH COMPENSATED TYPE-C CIRRHOSIS

Objective: To determine the efficacy of human lymphoblastoid interfero n (L-IFN) in the treatment of compensated type C cirrhosis, 30 patient s were assigned randomly to three groups, consisting of 10 patients ea ch, who were treated as follows. Methods: The 1- and 3-megaunit (MU) g roups received 1 or 3 MU of L-IFN, respectively, daily for 2 wk, and t hree times weekly for 24 wk thereafter. The control group received no treatment. All of the patients had positive C100-3 hepatitis C virus a ntibody (anti-HCV) titers. Results: The serum alanine aminotransferase (ALT) levels decreased 26 wk after L-IFN treatment was began, in both treatment groups. In the 3-MU group, the ALT levels became normal [co mplete response (CR)] in 40%, improved to less than twice the upper li mit of the normal value [partial response (PR)] in 10%, and remained u nchanged [no change (NC)] in 50%. In the 1-MU group, a PR occurred in 30%. There was NC in 70%, and NC occurred in the control group. Twenty -four weeks after stopping L-IFN, the CR and NC rates in the 3-MU grou p were 10% and 90%, respectively, and NC was observed in all of the 1- MU and control patients. 2',5'-Oligoadenylate synthetase activities in creased in both treatment groups (p < 0.05), but not in the control gr oup. The anti-HCV titers decreased in the 3-MU group (p < 0.05), but n ot in the 1-MU and control groups. Higher doses of L-IFN were more eff ective. No serious side effects occurred. Conclusions: These findings suggest that IFN administration can be effective and safe in patients with compensated type C cirrhosis, and that it would be worthwhile to evaluate IFN therapy for cirrhotic patients further.