The first high-tech, long-acting treatment for hepatitis C in children, a two-drug combination from Schering-Plough Corp., has been approved by the Food and Drug Administration.
Schering-Plough said last week that the FDA had approved sales of a treatment combining its antiviral pill, Rebetol, with its PEG-Intron, an advanced, genetically engineered version of the immune-system protein interferon, for children age 3 to 17 infected with the hepatitis C virus.
It's estimated that 130,000 American children are infected with hepatitis C, with most of them acquiring it from an infected mother while in the womb. Some adolescents are infected with the liver-destroying virus through illegal drug use that involves sharing contaminated needles or by getting tattoos or body piercings at establishments with poor hygiene.
Many adults and even some children don't know they are infected because hepatitis C can display no obvious symptoms for years.
Earlier versions of interferon drugs, which are widely used in adults to treat chronic hepatitis C, had to be injected every couple of days. PEG-Intron has a technology called pegylation that allows the drug to circulate in the bloodstream much longer, limiting shots to once a week.
Patient testing that led to the approval showed the virus was cleared from 55 percent of the children with the most difficult-to-treat strains of hepatitis C, most of whom had a strain called genotype 1, the type carried by about 70 percent of U.S. hepatitis-C patients. In children with less-common, less-resistant strains, 96 percent had the virus cleared from their blood.
Those studies were financed by Schering-Plough, which is based in Kenilworth, N.J.
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