|
Interferon with Ribavirin Is Safe and Effective for Children
with Chronic Hepatitis C
Nearly half of 118 children
with chronic Hepatitis C virus
(HCV) treated with a combination of interferon-alfa-2b
and an optimized dose of ribavirin achieved
sustained
viral response, and side
effects were generally mild. These results are
reported in the November 2005 issue of Hepatology,
the official journal of the American Association for the Study
of Liver Diseases (AASLD).
HCV is usually asymptomatic in children though it can lead
to serious liver damage. Treatment with interferon is standard
and induces lasting remission in more than a third of infected
children. The addition of ribavirin to treatment with interferon
has been shown to markedly improve outcomes for adults with
HCV, but the combination has not been extensively studied
in children.
Led
by Regino González-Peralta, M.D. of the Division of Pediatric
Gastroenterology, Hepatology, and Nutrition at the University
of Florida, researchers addressed combination therapy for
children with a twofold program.
The first part searched for the optimal
dose of ribavirin for children with HCV while
testing the drug’s safety and efficacy. Fifty-six children,
ages five to 16, were randomly assigned to take interferon
along with ribavirin in varying doses for 48 weeks. They were
evaluated for efficacy and side effects at regular intervals,
and followed-up for an additional 24 weeks.
By
the end of the follow-up period, 35 percent of children taking
8 mg/kg/day of ribavirin, 37 percent taking 12 mg/kg/day,
and 47 percent of 15/mg/kg/day had undetectable levels of
HCV in their blood. Side effects were similar among all doses.
Based on this data, the researchers selected the dosage 15
mg/kg/day for further study.
In all, 118 children with HCV received the optimized treatment—interferon
with 15 mg/kg/day of ribavirin. They were evaluated regularly
throughout treatment and follow-up to determine viral response
and assess and manage side effects. At the end of the study,
46 percent (54/118) had
achieved sustained viral response. Children with HCV
genotype 2/3 had higher sustained virologic
response rates than those with HCV
genotype 1.
All subjects experienced some side effects, but most were
mild, the most common being flu-like symptoms. Severe side
effects included anemia,
neutropenia,
depression
and suicidal thoughts,
and one child in the study attempted suicide. The researchers
responded to adverse side effects by dose modification in
37 (31%), and 8 subjects (7%) completely discontinued treatment
because of adverse
events.
As
in previous studies, children in this one exhibited growth
inhibition while receiving the therapy, however, they typically
experienced height and weight catch-up gains after it ended.
Interestingly, none of the African-American
children in the study had a sustained virologic
response to combination therapy. “The number of African-American
children studied was too small to draw firm conclusions,”
say the authors. But this observation matches previous reports
that African-American adults have lower response rates to
combination therapy.
Overall, “our studies demonstrate that interferon alfa 2b
in combination with oral ribavirin is effective and reasonably
safe for the treatment of childhood chronic hepatitis C,”
the authors conclude.
Importantly,
“Sustained virologic response rates in children with chronic
HCV given interferon alfa-2b with ribavirin in these studies
are higher than in those using interferon alone.”
11/02/05
Reference
R
P González-Peralta and others (for the International Pediatric
Hepatitis C Therapy Group). Interferon Alfa-2b in Combination
with Ribavirin for the Treatment of Chronic Hepatitis C in
Children: Efficacy, Safety, and Pharmacokinetics. Hepatology
42(5): 1010-1018.). November 2005.
Published
by John Wiley & Sons, Inc., Hepatology is available online
via Wiley InterScience at http://www.interscience.wiley.com/journal/hepatology.
|
