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Title: FDA Approves PEG-IFN Alfa-2b/Ribavirin Combination Therapy for Paediatric HCV

"FDA Approves PEG-IFN Alfa-2b/Ribavirin Combination Therapy for Paediatric HCV"

NEW YORK -- December 12, 2008 -- The US Food and Drug Administration (FDA) has approved pegylated interferon alfa-2b (PEG-IFN [Pegintron]) and ribavirin (Rebetol) combination therapy for use in previously untreated patients aged 3 years of age and older with chronic hepatitis C virus (HCV). The approval for the paediatric indication is based on the results of a clinical trial in 107 previously untreated patients aged 3 to 17 years with chronic hepatitis C and compensated liver disease. In the study, patients infected with HCV genotype 1 or 4 and those with HCV genotype 3 with HCV RNA greater than 600,000 IU/mL were assigned 48 weeks of therapy, while those infected with HCV genotype 2 or 3 with HCV RNA less than 600,000 IU/mL received 24 weeks of therapy. Of the patients with HCV genotype 1, 4 or 3 high viral load (HVL) who were assigned to 48 weeks of treatment, 55% achieved sustained viral response (SVR). As with adult patients, SVR in paediatric patients with HCV genotype 2 or 3 low viral load (LVL) was much higher than in those with genotype 1; the SVR rate was 96% in children with HCV genotype 2 or 3 LVL. Patients receiving PEG-IFN alfa-2b combination therapy (excluding those with HCV genotype 2 or 3) should be discontinued from therapy at week 12 if their HCV RNA dropped less than 2 log[₁₀ compared to pretreatment or at 24 weeks if they have detectable HCV RNA at treatment week 24.

During the course of therapy lasting up to 48 weeks, weight loss and growth inhibition were common. Some children who experienced growth inhibition during therapy still had inhibited growth velocity 6 months following the end of treatment.

Most common adverse reactions (>25%) observed in these studies were pyrexia, headache, neutropenia, fatigue, anorexia, injection-site erythema, and vomiting. Three percent were treated for clinical hypothyroidism.

Dose modifications were required in 25% of patients, most commonly for anaemia, neutropenia, and weight loss. Therapy was discontinued prematurely in 2% of the patients.

SOURCE Schering-Plough Corporation

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