Clinical

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.

Hepatology 2005;42:1010-1018.