S-P's Pegintron/Rebetol approved in children
US drug major Schering-Plough has received marketing approval from the US Food and Drug Administration for a combination of Pegintron (peginterferon alfa-2b) and Rebetol (ribavirin) in previously-untreated children three years of age and older with chronic hepatitis C.
The approval is based on the results of a trial in 107 previously-untreated patients aged three to 17 years with chronic hepatitis C and compensated liver disease. Of the patients with HCV genotype 1, 4 or 3, 55% achieved sustained virologic response. As with adult patients, SVR rates were higher in pediatric patients with HCV genotype 2 or 3, reaching 96% in low viral load patients.
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