The efficacy of recombinant
interferon-alfa therapy in children with
chronic hepatitis C has been evaluated in a randomized, controlled pilot study including 27 patients, aged 2 to 14 years, without underlying systemic diseases. On entry, all patients had abnormal
alanine transaminase (ALT) levels, 22 were hepatitis C virus (HCV)
RNA positive, 19 had mild
chronic active hepatitis, and 8 had
chronic persistent hepatitis on liver biopsy. Fourteen children received 5 MU/m2 of recombinant interferon-alfa2b thrice weekly for 4 months. If at this time ALT had been reduced to at least 50% the baseline level, treatment was continued up to 12 months. The other 13 children remained untreated. The whole follow-up period lasted 24 months.
Interferon was stopped at 4 months in 4 children because of an ALT increase (2 cases), unchanged ALT and
febrile convulsions (1 case), and slight ALT decrease (1 case). This latter patient, however, had normal ALT at 6 months and throughout further follow-up, and cleared HCV
RNA, thus behaving as a sustained responder. All 10 children treated for 12 months had normal levels of ALT, and 9 were HCV
RNA negative at the end of treatment. Of the 9 children who could be followed to 24 months, 4 relapsed soon after
therapy withdrawal and 5 maintained a sustained biochemical and virologic response. Overall, 6 (43%) of 14 treated children had a sustained ALT normalization associated with HCV
RNA clearance as compared with only 1 (7.5%) untreated child who had a sustained ALT normalization but did not clear HCV
RNA.(ABSTRACT TRUNCATED AT 250 WORDS)