RECOMBINANT INTERFERON-ALFA THERAPY IN CHILDREN WITH CHRONIC HEPATITIS-C

The efficacy of recombinant interferon-alfa therapy in children with c hronic hepatitis C has been evaluated in a randomized, controlled pilo t study including 27 patients, aged 2 to 14 years, without underlying systemic diseases. On entry, all patients had abnormal alanine transam inase (ALT) levels, 22 were hepatitis C virus (HCV) RNA positive, 19 h ad mild chronic active hepatitis, and 8 had chronic persistent hepatit is on liver biopsy. Fourteen children received 5 MU/m(2) of recombinan t interferon-alfa2b thrice weekly for 4 months. If at this time ALT ha d been reduced to at least 50% the baseline level, treatment was conti nued up to 12 months. The other 13 children remained untreated. The wh ole followup period lasted 24 months. Interferon was stopped at 4 mont hs in 4 children because of an ALT increase (2 cases), unchanged ALT a nd febrile convulsions (1 case), and slight ALT decrease (1 case). Thi s latter patient, however, had normal ALT at 6 months and throughout f urther follow-up, and cleared HCV RNA, thus behaving as a sustained re sponder. All 10 children treated for 12 months had normal levels of AL T, and 9 were HCV RNA negative at the end of treatment. Of the 9 child ren who could be followed to 24 months, 4 relapsed soon after therapy withdrawal and 5 maintained a sustained biochemical and virologic resp onse. Overall, 6 (43%) of 14 treated children had a sustained ALT norm alization 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. These results suggest that recombinant interferon ther apy, at the regimen used in this study, may induce sustained ALT norma lization and HCV clearance in a significant proportion of children wit h chronic hepatitis C.