FDA Approves Schering-Plough Hep-C Combo

The FDA has granted Schering-Plough marketing approval for PEGintron and Rebetol combination therapy for use in previously untreated patients three years of age and older with chronic hepatitis C. This represents the first and only approved peginterferon in combination with ribavirin for treating pediatric hepatitis C. It is estimated that approximately 130,000 children in the U.S. are infected with the hepatitis C virus (HCV); the most common mode of HCV infection for pediatric patients today is maternal-infant transmission.

The only previously approved therapy in the U.S. for treating pediatric hepatitis C is SP’s conventional interferon Intron A in combination with Rebetol. Rebetol is available both as capsules and in an oral solution formulation specifically available for pediatric use.

“With the FDA approval of PEGintron combination therapy for this new indication, U.S. physicians now have access to the current standard of care for hepatitis C for use in treating their pediatric patients. Thankfully, the number of children with hepatitis C is small, although this chronic infection over time can lead to serious liver disease,” said Robert J. Spiegel, M.D., chief medical officer and senior vice president, Schering-Plough Research Institute. “This approval further underscores Schering-Plough’s leadership and long-term commitment to developing new treatment options and innovative therapies to meet the needs of patients with hepatitis C.”

The approval of PEGINTRON for the pediatric indication is based on the results of a clinical trial in 107 previously untreated patients three to 17 years of age with chronic hepatitis C and compensated liver disease.

Weight loss and growth inhibition were common side effects in the trial, and some children who experienced growth inhibition during therapy still had inhibited growth velocity 6 months following the end of treatment. Most common adverse reactions (more than 25%) observed in these studies were pyrexia, headache, neutropenia, fatigue, anorexia, injection site erythema and vomiting. Three percent were treated for clinical hypothyroidism.