The leading treatment for chronic hepatitis C infection in adults also appears to be both safe and effective for use in children.
More than half of the children treated with a long-acting form of the drugs interferon and ribavirin had no evidence of hepatitis C infection in their bodies after almost a year of treatment.
The pegylated-interferon/ribavirin combination is now considered the most effective treatment for adults with chronic hepatitis C infection, a common cause of liver failure. The FDA has not approved its use in children.
The issue of whether to treat children with hepatitis C infection at all remains controversial. That's because the virus does not seem to do as much long-term damage in children as it does in adults. Chronic hepatitis C infection is the leading cause of liver disease in adults in the United States.
"Generally speaking, it is true that children with hepatitis C infection do very well [without treatment] but we don't have enough data to say with confidence that they won't have problems decades down the line," pediatric hepatitis expert Kathleen Schwarz, MD, of Johns Hopkins Children's Center, tells WebMD. "Also, there is a tremendous negative social stigma associated with hepatitis C infection."
Most Children Infected at Birth
The main way that children acquire the hepatitis C virus is by being infected at birth by a mother with hepatitis C. Between 5 percent and 8 percent of babies born to infected mothers also become infected.
In the newly reported study, published in the May issue of the journal Hepatology, 62 hepatitis C-infected children ranging in age from 2 to 17 years were treated with a weekly injected dose of pegylated interferon and a daily oral dose of ribavirin.
All but one of the children who responded to the combination treatment completed the 48-week course of treatment. Kids that did not improve were taken off the drugs after six months.
Six months after treatment ended, 36 of the 61 patients showed no evidence of hepatitis C infection, meaning that they were effectively cured.
All of the children with a form of the infection that is considered easiest to treat -- types 2 or 3 -- showed lasting evidence of being free of infection. Just under half of those with a harder-to-treat form of infection -- type 1 -- responded to the combination therapy.
Most of the children experienced mild flu-like symptoms during the first weeks of treatment. Other less commonly reported treatment side effects included weight loss and weakened immunity due to declines in white blood cell counts. One young girl also developed treatment-related diabetes.
"Children actually seem to tolerate this treatment better than adults do," study researcher Stefan Wirth, MD, tells WebMD. "It is clear that you should not ignore this infection in children. They should be offered treatment."
Are 2 Drugs Needed?
But Schwarz says it is not so clear if the combination approach is the best treatment for children with chronic hepatitis C infection. She says children and adolescents tend to respond well to pegylated interferon alone and the addition of ribavirin may be not only unnecessary but also unsafe. Its use has been associated with birth defects.
"We estimate that there are about 150,000 children and adolescents with hepatitis C in the United States, and many are probably sexually active teenage females," she says. "For this reason, we think it is very important to find out if ribavirin is really needed."
Schwarz is now recruiting children with hepatitis C between the ages of 5 and 18 for a study comparing treatment with pegylated interferon alone to combination treatment with pegylated interferon and ribavirin. She hopes to have findings from the study by the fall of 2006.
"The long-term risks of hepatitis C infection in children aren't well understood, but we do know that these children are at risk," she says. "There are case reports of children with hepatitis-C- related cirrhosis and children who need liver transplants because of infection."
SOURCES: Wirth, S. Hepatology, May 2005; vol 41: pp 1013-1018. Stefan Wirth, MD, HELIOS Children's Hospital, Wuppertal, Germany. Kathleen Schwarz, MD, director of the division of gastroenterology and nutrition, Johns Hopkins Children's Center, Baltimore.