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Prospective, randomized controlled trial of interferon‐α in children with chronic hepatitis B
Author(s) -
RuizMoreno Mercedes,
Rua Maria José,
Molina Josefina,
Moraleda Gloria,
Moreno Alberto,
Garcíaaguado Jaime,
Carréño Vicente
Publication year - 1991
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.1840130605
Subject(s) - medicine , hepatology , gastroenterology , interferon , hbeag , hepatitis b , hepatitis b virus , hepatitis , immunology , serology , virus , liver disease , hbsag , antibody
Thirty‐six children with chronic hepatitis B were entered into a randomized controlled trial of recombinant human interferon‐α All patients had hepatitis B virus DNA and increased levels of aminotransferases in serum for at least 1 yr. Twelve children received 10 MU of interferon‐α 2b/m 2 body surface area three times a week (group I); 12 children received 5 MU/m 2 under the same conditions (group II); and 12 children served as controls (group III). During 6 mo of therapy, 12 of 24 (50%) treated patients (7 from group I, 58%, and 5 from group II, 42%) and 2 of 12 (17%) controls lost hepatitis B virus DNA from serum and subsequently remained negative. Comparison of the rate of response in group I vs. controls showed a statistically significant difference (p < 0.05). Eleven of 12 (92%) treated patients who cleared hepatitis B virus DNA from serum lost HBeAg, seroconverted to anti‐HBe and had improvement in liver histological findings with loss of hepatitis B virus DNA from liver. In 10, serum ALT levels became normal. Interferon‐α was well tolerated and all children finished therapy. These findings indicate that a 6‐mo course of interferon‐α is effective in inducing a serological, biochemical and histological remission of disease in approximately 50% of children with chronic hepatitis B. (H EPATOLOGY 1991;13:1035–1039.)