Dual-centre, double-blind, randomised trial of lymphoblastoid interferon alpha with or without steroid pretreatment in children with chronic hepatitis B.
Thirty-five children with chronic HBV infection, HBV-DNA and eAg serum positivity, and HBcAg in liver tissue were treated with lymphoblastoid human interferon alpha with (16 cases) or without (19 cases) prednisolone pretreatment. The patients were double-blind randomized to receive steroid or placebo for 4 weeks, followed after 2 weeks by 5 or 10 MU/m2 interferon for 12 weeks. The e anti-e seroconversion rate reached 48%, which is much higher than the spontaneous seroconversion rate. The influence of "prednisolone priming" was not statistically significant. HBeAg clearance was similar in both groups (44% after prednisolone/interferon and 53% after interferon alone). The response to either treatment did not correlate with the pretreatment serum transaminase. HBV-DNA or degree of histological activity. Interferon was well tolerated, the side effects being less severe than in adults, and never led to suspension of the treatment.
Giacchino
R
R
Department of Infectious Diseases, University of Genoa, Italy.
Main
J
J
Timitilli
A
A
Giambartolomei
G
G
Facco
F
F
Cirillo
C
C
Jacyna
M R
MR
Brook
M G
MG
Callea
F
F
Kariayannis
P
P
D000293:Adolescent; D001706:Biopsy; D002648:Child; D002675:Child, Preschool; D002908:Chronic Disease; D004279:DNA, Viral / Q000032:analysis; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006509:Hepatitis B / Q000188:drug therapy* / Q000378:metabolism; D006514:Hepatitis B Surface Antigens / Q000032:analysis; D006801:Humans; D016898:Interferon-alpha / Q000627:therapeutic use*; D008297:Male; D011239:Prednisolone / Q000627:therapeutic use*; D000637:Transaminases / Q000378:metabolism
D004279:DNA, Viral; D006514:Hepatitis B Surface Antigens; D016898:Interferon-alpha; D011239:Prednisolone; D000637:Transaminases