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

• Published in: Digestive diseases and sciences 1991-09, Vol.36 (9), p.1217-1222
• Main Authors: OMATA, M, ITO, Y, OKUDA, K, YOKOSUKA, O, IMAZEKI, F, TAGAWA, M, TAKANO, S, HOSODA, K, TADA, M, OHTO, M, ITO, K
• Format: Article
• Language: English
• Subjects: Alanine Transaminase - blood; Biological and medical sciences; Digestive system; Double-Blind Method; Drug Administration Schedule; Female; Hepacivirus - immunology; Hepatitis Antibodies - analysis; Hepatitis C - therapy; Humans; Interferon Type I - administration & dosage; Interferon Type I - therapeutic use; Male; Medical sciences; Middle Aged; Pharmacology. Drug treatments; Recombinant Proteins; Time Factors
• ISSN: 0163-2116; 1573-2568
• DOI: 10.1007/bf01307512

Forty-nine Japanese patients were enrolled in a randomized, placebo-controlled, double-blind trial of alpha-interferon for chronic non-A, non-B hepatitis: 24 patients received 3 million units of recombinant human alpha alpha-interferon (alpha-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 less than 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 alpha-interferon induces biochemical and histological improvement in more than half the patients with chronic non-A, non-B hepatitis.