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Reuters Health Information (2005-05-11): Peginterferon plus ribavirin shows promise in children with chronic HCV


Peginterferon plus ribavirin shows promise in children with chronic HCV

Last Updated: 2005-05-11 14:10:39 -0400 (Reuters Health)

NEW YORK (Reuters Health) - New findings suggest that peginterferon alfa-2b plus ribavirin, the standard treatment for adults with chronic hepatitis C virus (HCV) infection, is safe and effective for children and adolescents with chronic HCV as well.

"Tolerability of peginterferon and ribavirin is very good in children, probably considerably better than in adults, and treatment response is comparable to the response rate in adults," Dr. Stefan Wirth from HELIOS Children's Hospital Wuppertal in Germany told Reuters Health.

Until now, there were no published reports on the efficacy and tolerability of peginterferon/ribavirin treatment in children, he and colleagues note in the May issue of the journal Hepatology.

In an open-label, pilot study, Dr. Wirth and colleagues treated 62 HCV-infected patients between 2 and 17 years of age with weekly subcutaneous injections of peginterferon alfa-2b plus a daily oral dose of ribavirin for 48 weeks.

Of the 61 subjects who completed the trial, 39 (63.9%) had undetectable levels of HCV RNA at 1 year.

Sustained viral response was documented in 22 of 46 patients infected with HCV genotype 1 (47.8%), in all 13 infected with genotype 2 or 3 (100%), and in 1 of 2 infected with HCV genotype 4 (50%).

"The response rate may be dependent on the mode of transmission," Dr. Wirth said, noting that vertically infected children may have a lower response rate than parenterally infected children. "More data are needed in this respect," he said.

The investigators also found it "of interest" that patients with normal alanine aminotransferase (ALT) levels had a tendency to respond better than those with elevated ALT values (66.6% vs 48%), suggesting that these children should not be excluded from treatment.

Overall, the children tolerated peginterferon plus ribavirin well, however, some side effects were observed in all patients. Leucopenia developed in 83% of patients but only 3 required a dose reduction and 10.3% developed thyroid autoantibodies and thyroid dysfunction.

Based on these "encouraging results," further studies of peginterferon plus ribavirin in children and adolescents are warranted, they conclude.

Hepatology 2005;41:1013-1018.

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