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News from Hepatitis Week of May 25, 2003 / Vol. 3 No. 21 Study: Peginterferon Alfa-2a Effective and Safe for Children

The first study to examine how the hepatitis C drug peginterferon alfa-2a affects children has found that it is safe and effective.

About 150,000 children in the United States have chronic hepatitis C.

Study author Dr. Kathleen B. Schwarz, director of the Division of Gastroenterology and Nutrition at Johns Hopkins Children's Center, said the findings may change the way doctors treat children with hepatitis C.

Researchers from the center and five other institutions presented findings from their study May 19 at Digestive Disease Week, an annual meeting of gastroenterologists in Orlando, FL.

The U.S. Food and Drug Administration (FDA) recently approved the drug to treat hepatitis C in adults, but the agency has not approved any treatment for children 18 years old and younger with the disease.

Schwarz said the findings provide a basis for conducting a large-scale, randomized controlled trial to test this new form of interferon alone or in combination with ribavirin. Such a study is necessary before the FDA can approve the drug for children, she added.

In the study, 14 pediatric patients with chronic hepatitis C were given peginterferon alfa-2a once weekly for 48 weeks. Forty-three percent of the children treated were free of the virus 24 weeks after the treatment ended. No serious side effects were reported.

Schwartz said the drug "offers hope to both the children suffering from this infection and their worried families."

"Thanks to screening programs for blood donors, transfusion-acquired HCV is now very rare. However, new pediatric cases continue to occur through maternal-fetal acquisition," she added.

Other sources: Johns Hopkins Medical Institutions

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