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A multicenter randomized controlled trial of recombinant interferon‐α 2b in patients with acute transfusion‐associated hepatitis C
Author(s) -
Lampertico Pietro,
Rumi Mariagrazia,
Romeo Raffaella,
Craxi Antonio,
Soffredini Roberta,
Biassoni Daniela,
Colombo Massimo
Publication year - 1994
Publication title -
hepatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 5.488
H-Index - 361
eISSN - 1527-3350
pISSN - 0270-9139
DOI - 10.1002/hep.1840190105
Subject(s) - medicine , gastroenterology , interferon , hepatitis c virus , hepatitis c , hepatitis , randomized controlled trial , interferon alfa , hepatology , alpha interferon , immunology , virus
To assess whether interferon‐α might prevent non‐A, non‐B hepatitis from becoming chronic, 45 consecutive patients with transfusion‐associated 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 of recombinant interferon‐α 2b three times a week for 12 wk, whereas 19 (16 with HCV) were not. Biochemical and virological parameters were 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 serum ALT activity, compared with 7 (44) who were not treated (NS). Fifty‐three percent of the treated patients and none of the untreated patients 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 had normal ALT and no HCV RNA, compared with none of the controls (p = 0.035). Four patients (22) had had sustained complete responses to interferon, 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 patients with non‐A, non‐B, non‐C hepatitis, treated and untreated, recovered uneventfully from hepatitis. One major finding was that short‐term treatment with interferon‐α was effective in most patients with acute hepatitis C and led to complete recovery from hepatitis in 39 of the cases. (Hepatology 1994;19:19–22).