Chronic Hepatitis C virus infection is usually asymptomatic in children, but significant liver disease may occur.
Dr Regino González-Peralta and colleagues considered interferon alfa-2b and ribavirin therapy in children with chronic Hepatitis C.
The research team evaluated the efficacy, safety, and pharmacokinetics of this therapy.
The team determined the optimal ribavirin dose in an initial cohort of a phase 1 study.
After determining the optimal ribavirin dose, the researchers then used it, in combination with interferon alfa-2b, in a second cohort and a phase 3 trial.
The primary efficacy endpoint in all studies was sustained virological response, defined by undetectable serum Hepatitis C virus RNA 24 weeks after therapy.
| Sustained virological response occurred in 84% with Hep C genotype 2/3|
All efficacy and safety analyses were performed on the intent-to-treat population.
The researchers found that children receiving interferon alfa-2b plus ribavirin 15 mg/kg/d in the phase 1 study had maximum reduction in serum Hepatitis C RNA.
The reduction occurred at treatment weeks 4 and 12 with an acceptable safety profile.
This ribavirin dose was selected as optimal and used in all subsequent studies.
In all, the team noted that 46% of optimally treated children achieved sustained virological response.
Sustained virological response occurred in 84% of children with Hepatitis C genotype 2/3 compared with 36% with genotype 1.
The researchers observed that adverse events led to dose modification in 31% and discontinuation in 7% of children.
Multiple-dose interferon alfa-2b and ribavirin peak and trough concentrations and area-under-the-curve were found to be similar between children and adults.
Dr González-Peralta's team concludes, “Interferon alfa-2b in combination with ribavirin is effective and safe in children with chronic Hepatitis C virus.”