May 19, 2003

MEDIA CONTACT: Jessica Collins
PHONE: 410- 516-4570

Hopkins Researchers Find Potential New Treatment for Children with Chronic Hepatitis C

Researchers from the Johns Hopkins Children's Center and five other institutions have found that a drug recently approved for adults with chronic hepatitis C (CHC) also may be a safe and effective treatment for children with the disease. The study is believed to be the first to examine how the drug, peginterferon alfa-2a, affects the young.

The hepatitis C virus (HCV), the leading cause of liver disease in the United States, is responsible for an estimated 10,000 to 12,000 deaths annually. It is spread primarily by contact with blood and blood products. Blood transfusions and the use of shared, unsterilized, or poorly sterilized needles and syringes have been the main causes of the spread of the virus in the U.S. among adults.

Presented today at the Digestive Disease Week conference, the findings could change the way doctors treat children with CHC, according to the study's lead author, Kathleen B. Schwarz, M.D., director of the Division of Gastroenterology and Nutrition at the Children's Center.

"At present, there is no FDA-approved treatment for children 18 years old and younger with the disease. Our results provide a basis for conducting a large-scale, randomized controlled trial to test this new form of interferon alone, or in combination with ribavirin, an antiviral medication, which is the current treatment of choice for adults with CHC,"
she said. "Such a study will be necessary before the Food and Drug Administration can approve the drug for children."

Some children with CHC have been treated with three shots a week of interferon to increase the amount of the naturally occurring infection fighter. Peginterferon alfa-2a is a new, longer acting version that, when taken weekly, maintains interferon levels in the blood for a longer period of time. The drug also has been shown more effective in adults with CHC than standard interferon.

In the multi-center study, 14 pediatric patients with CHC were given peginterferon alfa-2a once weekly for 48 weeks. No serious side effects were observed, and 43 percent of the children treated were free of the virus 24 weeks after the treatment ended.

"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," said Schwarz. "There are approximately 150,000 children in the U.S. with CHC, and this new approach to treatment offers hope to both the children suffering from this infection and their worried families."

This study was sponsored by Hoffmann La Roche Inc., manufacturer of peginterferon alfa-2a (40KD) (Pegasys«). The Digestive Disease Week conference was sponsored by the American Association for the Study of Liver
Diseases, American Gastroenterological Association, American Society for Gastrointestinal Endoscopy, and the Society for Surgery of the Alimentary Tract.

Digestive Disease Week is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. DDW showcases approximately 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. The meeting also provides an opportunity for professionals in the field to discuss the medical, technological, ethical, regulatory and legal issues facing the profession today.