New Hepatitis C Treatment Appears Safe in Children

May 23, 2003 - A hepatitis C treatment currently approved for adults also appears to be safe and effective in children with the disease, according to a new study. Researchers say it's the first study to examine how the drug, Pegasys (peginterferon alfa-2a), affects children with chronic hepatitis C.

The virus that causes hepatitis C is the leading cause of liver disease in the U.S. It is spread primarily through contact with infected blood and blood products, such as shared or unsterilized needles. If left untreated, it can lead to cirrhosis, liver failure, and liver cancer. But researchers say that although rare, there's a 10% chance that mother with hepatitis C will pass the virus to her baby during birth. An estimated 150,000 children in the U.S. suffer from chronic hepatitis C.

"At present, there is no FDA-approved treatment for children 18 years old and younger with the disease," says researcher Kathleen B. Schwarz, MD, director of the Division of Gastroenterology and Nutrition at Johns Hopkins Children's Center, in a news release.

Some children with chronic hepatitis C are treated with three shots a week of interferon, which acts as a natural infection fighter. But Pegasys is a new, longer-lasting form of interferon that is taken weekly. The FDA has approved the drug for use in adults with chronic hepatitis C, but until now little was known about the safety and effectiveness of the new treatment in children.

In this study, presented this week at Digestive Disease Week in Orlando, Fla., researchers gave 14 children with chronic hepatitis C Pegasys once a week for 48 weeks.

After 24 weeks of follow-up, 43% of the children were free of the hepatitis C virus in their body, and only mild side effects, such as fever, headache, vomiting, and abdominal pain, were reported.

"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 [chronic hepatitis C]," says Schwarz.

Such a trial would be required before the FDA would approve the drug for use in children with chronic hepatitis C.

SOURCES: Digestive Disease Week, May 17-23, 2003, Orlando, Fla., News release, Johns Hopkins Medical Institutions. WebMD Medical News: "New Hepatitis C Drug Introduced for Free."

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