From rxpgnews.com
PegInterferon-alfa-2b with Ribavirin Shows Promise
By American Association for the Study of Liver Diseases (AASLD),
May 3, 2005 - 1:25:38 PM
More than half of 61 children infected with chronic hepatitis C achieved a sustained viral response after treatment with peginterferon-alfa-2b and ribavirin, report the authors of a new study published in the May 2005 issue of Hepatology, the official journal of the American Association for the Study of Liver Diseases (AASLD).
The combined treatment regimen is considered the best available treatment for adults with chronic hepatitis C, but until now, no published studies have examined its value of for children. To address this lack of information, researchers, led by Stefan Wirth of HELIOS Children's Hospital Wuppertal, Germany sought to evaluate the efficacy and tolerability of the therapy in infected children based on HCV genotype, liver enzyme tests, and route of disease transmission.
The researchers recruited 62 children ranging in age from 2 to 17 years, of mixed genders and races, all with chronic hepatitis C. Researchers determined their HCV genotype, mode of infection, and liver enzyme levels, then initiated the therapy that included a weekly subcutaneous dose of peginterferon-alfa-2b and a daily oral dose of ribavirin. All 62 completed the therapy according to the study protocol, save one who dropped out after developing an allergic reaction at the injection site.
Twelve months later, 39 of the 61 patients (64 percent) had undetectable levels of HCV RNA. Three of these responders relapsed during the 6-month follow-up period, but 36 (59 percent) remained HCV-free. All of the children with HCV genotype 2 or 3 achieved a persistent sustained viral response, in contrast to the fewer than half of the patients with HCV genotype 1. The study also showed that children who had been infected via needle (for example, from a blood transfusion) responded better to treatment than those who were infected by their mothers at birth. Lastly, the researchers found that patients with normal liver enzyme levels before treatment responded better than those with elevated levels.
Most of the children experienced side effects from the treatment ranging from mild flu-like symptoms to weight loss to leucopenia (a decrease in white blood cell count). One girl developed diabetes mellitus, a rare but permanent side effect associated with interferon. She continued treatment and achieved sustained viral response. All other side effects resolved when the treatment protocol ended.
"The data of this uncontrolled study confirms that treatment with recombinant peginterferon-alfa-2b plus ribavirin in children and adolescents with chronic hepatitis C was well tolerated and yielded an encouraging result with 59 percent sustained viral response," the authors report. While the response rate was not significantly higher compared to studies using non-pegylated interferon-alfa-2b plus ribavirin, "it is particularly remarkable that all patients infected by genotype 2 and 3 showed permanent response."
The authors also emphasized the importance of the high viral response rate of children whose liver enzyme tests were normal before treatment began, which suggests that such children should not be excluded from treatment. The lower response rates among children with genotype 1 and in those who were infected by their mothers implies a need for additional research.
"Further studies with larger numbers of patients have to elucidate whether there is a different response rate in relation to mode of transmission," the authors conclude. Other studies "should focus on treatment duration for genotype 2 and 3 patients and particularly on vertically infected children with genotype 1."
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