A MULTICENTER RANDOMIZED CONTROLLED TRIAL OF RECOMBINANT INTERFERON-ALPHA-2B IN PATIENTS WITH ACUTE TRANSFUSION-ASSOCIATED HEPATITIS-C

To assess whether interferon-alpha might prevent non-A, non-B hepatiti s from becoming chronic, 45 consecutive patients with transfusion-asso ciated hepatitis were enrolled in a randomized clinical trial. Thirty- eight patients had hepatitis C virus infection, and 7 had non-A, non-B , non-C hepatitis. Twenty-six patients (22 with HCV) were given 3 MU o f recombinant interferon-alpha2b three times a week for 12 wk, whereas 19 (16 with HCV) were not. Biochemical and virological parameters wer e monitored at regular intervals during an 18-mo follow-up. At the end of the 3-mo therapy, 16 (73%) patients with hepatitis C had normal se rum ALT activity, compared with 7 (44%) who were not treated (NS). Fif ty-three percent of the treated patients and none of the untreated pat ients had normal ALT levels and no HCV RNA (p = 0.0087). At the end of the 18-mo follow-up, 13 (59%) treated patients had normal ALT levels, compared with 6 (37%) untreated controls (NS). Thirty-nine percent ha d normal ALT and no HCV RNA, compared with none of the controls (p = 0 .035). Four patients (22%) had had sustained complete responses to int erferon, defined as normal ALT levels and no HCV RNA at the end of the 3-mo treatment period and the 18-mo follow-up period. All seven patie nts with non-A, non-B, non-C hepatitis, treated and untreated, recover ed uneventfully from hepatitis. One major finding was that short-term treatment with interferon-alpha was effective in most patients with ac ute hepatitis C and led to complete recovery from hepatitis in 39% of the cases.