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FDA approves HCV treatment for children
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The FDA has approved an expansion of the indication for the combination of peginterferon alfa-2a (40 KD) and ribavirin to be used in patients with chronic hepatitis C aged 5 to 17 years. The indication is for patients with compensated liver disease and no prior history of interferon therapy.
The approval of the combination — which is marketed as Pegasys and Copegus, both of which are manufactured by Hoffman-LaRoche — came on the heels of study NV17424, which was conducted by Hoffman-LaRoche. The study was conducted in accordance with FDA postmarketing requirements for pediatric evaluation.
The study involved 114 children who received 48 weeks of treatment with either peginterferon alfa-2a (body surface area × 180 mcg/1.73 m2 once weekly) plus ribavirin (about 15 mg/kg per day in two divided doses) or with peginterferon alfa-2a plus placebo.
Previous findings in adults indicated that the addition of ribavirin yielded significant improvements in the rate of sustained viral response — defined as HCV RNA of less than 50 IU/mL — at 24 weeks after treatment. The viral response rate was 53% in the ribavirin group and 20% in the placebo group. Patients with non-genotype 1 HCV benefited most from the addition of ribavirin.
Pediatric patients in the combination therapy experienced growth delay relative to baseline, which the researchers said was the most important adverse event. However, pediatric patients, similar to adults, also experienced influenza-like illness, headache, gastrointestinal disorders, injection site reactions, irritability, fatigue, rash, pruritis, insomnia and decreased appetite. Thirty-five percent of patients in each group also required dose modifications.
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