Efficacy and Safety of Peginterferon-α2b and Ribavirin Combination Therapy in Children With Chronic Hepatitis C Infection

BACKGROUND:Interferon (IFN)-α2b plus ribavirin is approved for treatment of hepatitis C in children; however, little is known about efficacy and tolerability of pegylated IFN (PEG-IFN)-α2b in this population. The objective of this study was to test the efficacy and safety of PEG-IFN-α2b plus ribavirin in children with chronic hepatitis C. METHODS:Thirty children 3–16 years of age who had detectable hepatitis C virus (HCV) RNA for ≥3 years after exposure and elevated alanine aminotransferase values received PEG-IFN-α2b 1.0 μg/kg/wk plus ribavirin 15 mg/kg/d for 24 weeks (genotype 2/3) or 48 weeks (genotype 1/4). The primary endpoint was sustained virologic response (SVR), defined as undetectable HCV RNA (2 log10 decrease in viral load, compared with baseline; 87% and 71% of these patients, respectively, attained an SVR. Therapy was discontinued in 3 patients as a result of adverse events. No patient required ribavirin dose reduction; PEG-IFN-α2b dose was reduced in 23% of patients to manage neutropenia. CONCLUSIONS:Combination therapy with PEG-IFN-α2b and ribavirin treatment was effective in children with chronic hepatitis C. Virologic status at week 12 identified future responders and nonresponders. PEG-IFN-α2b and ribavirin were reasonably well tolerated, with no unexpected or permanent adverse effects. Further studies are needed to identify the optimum treatment regimen for this patient population.