Randomized, double-blind, placebo-controlled trial of eight-week course of recombinant ?-interferon for chronic non-A, non-B hepatitis

Abstract

Forty-nine Japanese patients were enrolled in a randomized, placebo-controlled, doubleblind trial of α-interferon for chronic non-A, non-B hepatitis: 24 patients received 3 million units of recombinant human alpha α-interferon (α-2a) thrice weekly for eight weeks, and 25 patients received placebo in a similar schedule. The mean serum alanine aminotransferase (ALT) dropped from 155±91 (sd) to 69±72 during interferon treatment, but remained unchanged (158±140 to 147±130) during placebo treatment (P<0.001). Serum ALT level fell to the normal range in 29% of interferon-treated patients, but in only 4% of placebo-treated patients. Pre- and posttreatment liver biopsies were obtained in all but one case. Average histological activity indices (HAI) were markedly improved in the interferon-treated group (9.5±3.7 to 7.0±4.3), but were unchanged in the placebo group (8.5±4.3 to 8.5±4.9). In addition, we compared the efficacy of interferon treatment between anti-hepatitis C virus (HCV) antibody positive and negative groups. Biochemical and histological improvements were similar and statistically significant in patients with and without antibody to hepatitis C virus. These data indicate that a eight-week course of α-interferon induces biochemical and histological improvement in more than half the patients with chronic non-A, non-B hepatitis.