Abstract
It has been reported (Lancet 1987; ii: 877-880) that recombinant interferon alpha (rIFN-α) is not useful in Chinese children with chronic hepatitis B. We carried out a controlled study in Caucasian children. We included 36 children (mean age 8.2 years) with an histologically proven chronic hepatitis. All of them were HBsAg, HBeAg and HBV-DNA positive for at least 1 year before entry into the study. All the children were anti-HD and anti-HIV-1 negative. They were randomly allocated to one of the following groups: group 1) 12 children received 10 MU/m2 b.s. of rIFN-α 2b (Intron A) subcutaneously thrice weekly for 6 months; group II) 12 children received 5 MU/m2 b.s. under the same schedule: group iii) 12 children, control without treatment. No basal differences between the three groups were observed with respect to age, sex, ALT, etc.
The treatment was well tolerated and all children completed the therapy period. Side effects included flu-like syndrome, anorexia, myalgia, neutropenia and moderate thrombopenia.
At the end of the treatment period, HBV-DNA became negative in 7 patients (59%) from Group I and 5 cases (42%) from Group II as compared to 2 (17%) from the control group (p < 0.05). This situation remained unchanged until the end of the trial (1 year). HBeAg was negative in 33% of the treated patients and only in 8% of the controls. The ALT was normal in 21% of the treated children and in 8% of the controls. Anti-IFN-α antibodies (as detected by ELISA) developed in 8 patients (4 with and 4 without HBV-DNA) and remained positive at the end of the treatment period.
In summary, therapy with rIFN-α in children is well tolerated. A 6 months course of rIFN-α 2b induces a significant antiviral effect in caucasian children with chronic hepatitis B as compared with a control group.
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Ruiz-Moreno, M., Rua, M., García-aguado, J. et al. EFFICACY OF INTERFERON ALPHA IN THE TREATMENT OF CHILDREN WITH CHRONIC HEPATITIS B. Pediatr Res 27, 535 (1990). https://doi.org/10.1203/00006450-199005000-00061
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DOI: https://doi.org/10.1203/00006450-199005000-00061
