Mm. Jonas et al., INTERFERON-ALPHA TREATMENT OF CHRONIC HEPATITIS-C VIRUS-INFECTION IN CHILDREN, The Pediatric infectious disease journal, 17(3), 1998, pp. 241-246
Objectives. To determine the safety and efficacy of interferon-alpha t
herapy of chronic hepatitis C virus (HCV) infection in children. Study
design. This was an open-labeled prospective trial of interferon-alph
a-2a (IFN-alpha) in children with evidence of HCV infection for at lea
st 6 months, Twenty-three children were enrolled and treated with IFN-
alpha at a dosage of 3 million units/m(2) three times weekly. Beginnin
g in 1995 patients defined as complete or partial responders after 6 m
onths were offered an additional 6 months of treatment. Endpoints were
alanine aminotransferase normalization and loss of hepatitis C viral
ribonucleic acid from serum. Responders were compared with nonresponde
rs for age, gender, duration of infection, pretreatment alanine aminot
ransferase and hepatitis C viral ribonucleic acid levels, saturation o
f serum iron-binding capacity, histologic score of chronic hepatitis a
nd viral genotype. Statistical methods used for these comparisons incl
uded the Kruskal-Wallis test, the Mann-Whitney two-sample test and the
Fisher exact test. Results. Of the 21 children who completed at least
6 months of treatment, 4 (19%) had complete response, 8 (38%) had par
tial response and 9 (43%) had no response. Three of the 4 complete res
ponders had prolonged treatment; in 2 the response was maintained. One
responder re lapsed but responded to a second, longer course of treat
ment. Four of the 8 partial responders had prolonged therapy and 3 of
them became complete responders. One child who was originally a nonres
ponder lost HCV RNA within the first year after therapy. Thus eventual
ly 7 (33%) of 21 patients were complete responders. After at least 12
months of follow-up on most of these children, no relapses have been o
bserved. No differences in any of the variables tested could be demons
trated between responders and nonresponders, but small sample size lim
its power. IFN-alpha was discontinued in only one child because of sid
e effects, and temporary dosage adjustments were needed in 4 children.
Conclusions. IFN-alpha is of some efficacy in the treatment of chroni
c HCV infection in children. Complete or partial responders at 6 month
s should undergo prolonged treatment.