A controlled trial of recombinant interferon-alpha in Caucasian children with chronic hepatitis B.
Twenty-four children with chronic active hepatitis due to hepatitis B virus (HBV) infection, who were positive for HBeAg and had increased levels of transaminases, were included in a controlled study of treatment using recombinant interferon-alpha (rIFN-alpha), 10 MU/m2 body surface, intramuscularly, 3 times a week over a period of 3 months. During therapy, a significant decrease in HBV-DNAp was observed in the 12 patients treated. By the end of therapy, the HBV-DNA had disappeared in 3 children, the same occurring in 1 child (33% overall) during the course of the 4th month. By this time, all the controls remained with HBV replication markers (p less than 0.05). The 4 treated patients who responded became HBeAg-negative, developing anti-HBe during the first 12 months after therapy. In the control group, the HBV-DNA disappeared in 3 children in the 7th month of follow-up. All of the children remained HBsAg-positive. The therapy with rIFN-alpha was well tolerated, secondary effects consisting of a flu-like syndrome and a slight decrease in leukocytes and platelets. At the second biopsy, 15 months after the beginning of therapy, a significant decrease in Knodell's index of histological activity was observed in the responders. In the light of these results and since treated children lost viral replication markers in a shorter period of time than the controls, who seroconverted spontaneously, we consider that rIFN-alpha may be useful in the treatment of chronic hepatitis B in childhood.
Department of Pediatrics, Fundación Jiménez Díaz, Madrid, Spain.
M
M
Ruiz Moreno
J
J
Jimenez
J C
JC
Porres
J
J
Bartolomé
A
A
Moreno
V
V
Carreño
D002648:Child; D002675:Child, Preschool; D004279:DNA, Viral / Q000032:analysis; D006509:Hepatitis B / Q000382:microbiology / Q000473:pathology / Q000503:physiopathology / Q000628:therapy*; D006515:Hepatitis B virus / Q000235:genetics / Q000302:isolation & purification; D006521:Hepatitis, Chronic / Q000382:microbiology / Q000473:pathology / Q000503:physiopathology / Q000628:therapy*; D006801:Humans; D007370:Interferon Type I / Q000009:adverse effects / Q000627:therapeutic use*; D008099:Liver / Q000473:pathology; D008111:Liver Function Tests; D016032:Randomized Controlled Trials as Topic; D011994:Recombinant Proteins
D004279:DNA, Viral; D007370:Interferon Type I; D011994:Recombinant Proteins