Reuters Health Information (2005-11-08): Ribavirin plus interferon OK for children with hepatitis
Ribavirin plus interferon OK for children with hepatitis
Last Updated: 2005-11-08 14:30:30 -0400 (Reuters Health)
NEW YORK (Reuters Health) - The drug combo interferon
alfa-2b plus ribavirin appears to be effective and relatively safe for
children with chronic hepatitis C infection (HCV). Most serious adverse
events can be managed by lowering the dose of ribavirin, the
investigators report in the November issue of Hepatology.
This drug combination improves virological responses in adults, lead
author Dr. Regino P. Gonzalez-Peralta and colleagues note, but data are
limited regarding its use in children.
In a phase I study, Dr. Gonzalez-Peralta, from the University of
Florida in Gainesville, and his team tested three doses of ribavirin
(3, 12, or 15 mg/kg/day) in combination with interferon alfa-2b (3
million IU/m2 three times weekly) in 56 children ages 5 to 16 years
with hepatitis C. The highest dose of ribavirin tested was the most
effective in reducing levels of serum HCV RNA and had a comparable
safety profile to the lower dose regimens.
They then tested the efficacy of the higher dose regimen in 118
children ages 3 to 16. At the end of the 48-week treatment period, 59%
had undetectable HCV RNA levels, which declined to 46% who achieved a
sustained viral response during a 24-week follow-up period.
Response rates were higher in children with baseline levels of 2
million copies/mL or lower and those with HCV genotype 2/3 compared
with genotype 1. None of the five African-American patients had a
sustained viral response.
Severe adverse events were reported by 19% of subjects, neutropenia
being the most common. Depression was reported by 13%, including three
with suicidal ideation and one attempted suicide. Dose modification
occurred in 31% of cases, and 7% discontinued treatment.
Although growth slowed during treatment, it rebounded during the follow-up period.
"The pediatric safety data, pharmacokinetic profiles, and efficacy
for the combination are similar to that reported in adults for the
treatment of HCV infection," Dr. Gonzalez-Peralta's group concludes.