Roche Holding AG (RHHBY) recently announced that the European Medicines Agency (:EMA) has approved a label expansion for Pegasys in combination with ribavirin for the treatment of chronic hepatitis C virus (:HCV) in children and adolescent five years and older.
We note that Pegasys plus antiviral ribavirin is approved for the treatment of chronic HCV, human immunodeficiency virus (:HIV)/HCV co-infection and chronic hepatitis B in adults.
Children and adolescents aged five years or more who have not received prior treatment and have been tested positive can now be treated with Pegasys plus ribavirin. Roche had conducted a randomized controlled study based on which approval was granted.
The study results revealed that a larger percentage of children treated with the Pegasys plus ribavirin combination achieved sustained viral response than the children treated with Pegasys alone (53% versus 21%). The results in children and adolescents were similar to the results observed in adults infected with HCV genotype I.
The label expansion on Pegasys into the children and adolescent population is a positive. Recently, Roche received US Food and Drug Administration (:FDA) approval for a next-generation viral load test for use in chronic HCV patients. We are pleased with Roche’s progress in the treatment of HCV.
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