UNITED STATES: Schering-Plough Hepatitis C Drug Approved for Kids CDC Daily UpdateImportant note: Information in this article was accurate in 2008. The state of the art may have changed since the publication date.

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UNITED STATES: Schering-Plough Hepatitis C Drug Approved for Kids

Associated Press (12.12.08) - Monday, December 15, 2008
Linda A. Johnson


The Food and Drug Administration has approved the use of Schering-Plough Corp.'s drug Rebetol for children ages 3-17 with hepatitis C virus, the drug maker said Friday. Rebetol is a combination of ribavirin and pegylated interferon. Previously, only Schering-Plough's older interferon drug, Intron A, was approved for use in HCV-infected US children.

The approval will give some comfort to physicians who had been prescribing pegylated interferon for off-label use in pediatric patients, given its potentially serious side effects, said Jean P. Molleston, a pediatric hepatitis C expert at Indiana University School of Medicine.

"This treatment is a little more effective than [the older one] and only involves one shot a week," said Molleston, who has participated in industry-funded research. Older versions of interferon had to be injected three times a week, whereas pegylated interferon has been designed to circulate in the blood much longer. The new Rebetol approval includes a liquid formulation for younger patients.

In a clinical trial of Rebetol including 107 children, 55 percent cleared HCV genotype 1 - the most difficult to treat strain carried by about 70 percent of HCV patients in the United States. The duration of treatment was 48 weeks. In children with less common and less resistant strains, 96 percent cleared the virus from their blood during treatment lasting six months. Just 2 percent dropped treatment early in the trial, which was funded by Schering-Plough.

While 55 percent may sound disappointing, it is an improvement, said Molleston. In clinical trials involving Intron A, only 36 percent cleared the toughest-to-treat strain and 81 percent of the easier-to-treat strains.

Rebetol causes anemia and can cause birth defects or kill a fetus. Side effects can include weight loss, stunted growth persisting for several months after treatment has ended, fever, vomiting, headaches, anorexia, fatigue, and a drop in white blood cells. Nonetheless, "children tolerate these drugs much better than adults," Molleston said.
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