BACKGROUND & AIMS: This multi-center study aimed to prospectively evaluate the safety and efficacy of a genotype-based Pegylated Interferon alfa-2a/Ribavirin therapy in treatment-naïve hepatitis C virus (HCV), positive HCV serology, and quantifiable HCV RNA, infected children. METHODS: Eighteen children with genotypes 2 and 3 patients (group A) were assigned to medication for 24weeks, and 47 children with genotypes 1, 4, 5 and 6 patients (group B) for 48weeks. RESULTS: Early response at week 12 was observed in 83% of group A patients and in 57% of group B patients (p<0.05). End of treatment response was achieved in 94% of patients in group A and in 57% in group B (p<0.001). Sustained virologic response was maintained in 89% of patients in group A and in 57% of patients in group B (p<0.01). Ten patients stopped prematurely the treatment, 2 for serious adverse event (acute hepatitis and thyrotoxicosis), and 8 because of no virologic response at week 24. Peginterferon alfa-2a and Ribavirin dose was adjusted in 15 patients (23%), 11 for neutropenia (17%), and 3 patients (5%), for anemia, respectively. Treatment-related adverse events included fever and flu-like symptoms (54%), irritability-depression-change of mood (34%), vomiting (23%), abdominal pain (38%), loss of appetite (21.5%) and dermatitis (29%). No influence on height growth was observed. CONCLUSIONS: Pegylated inteferon alfa-2a and Ribavirin treatment allowed to achieve SVR in 57% of pediatric patients with genotypes 1, 4, 5 and 6, and in 94% of genotypes 2 and 3. These results show an improved SVR as compared to reference series in adults with similar regimen. Copyright 2010 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.
BACKGROUND & AIMS: This multi-center study aimed to prospectively evaluate the safety and efficacy of a genotype-based Pegylated Interferon alfa-2a/Ribavirin therapy in treatment-naïve hepatitis C virus (HCV), positive HCV serology, and quantifiable HCV RNA, infected children. METHODS: Eighteen children with genotypes 2 and 3 patients (group A) were assigned to medication for 24weeks, and 47 children with genotypes 1, 4, 5 and 6 patients (group B) for 48weeks. RESULTS: Early response at week 12 was observed in 83% of group A patients and in 57% of group B patients (p<0.05). End of treatment response was achieved in 94% of patients in group A and in 57% in group B (p<0.001). Sustained virologic response was maintained in 89% of patients in group A and in 57% of patients in group B (p<0.01). Ten patients stopped prematurely the treatment, 2 for serious adverse event (acute hepatitis and thyrotoxicosis), and 8 because of no virologic response at week 24. Peginterferon alfa-2a and Ribavirin dose was adjusted in 15 patients (23%), 11 for neutropenia (17%), and 3 patients (5%), for anemia, respectively. Treatment-related adverse events included fever and flu-like symptoms (54%), irritability-depression-change of mood (34%), vomiting (23%), abdominal pain (38%), loss of appetite (21.5%) and dermatitis (29%). No influence on height growth was observed. CONCLUSIONS: Pegylated inteferon alfa-2a and Ribavirin treatment allowed to achieve SVR in 57% of pediatric patients with genotypes 1, 4, 5 and 6, and in 94% of genotypes 2 and 3. These results show an improved SVR as compared to reference series in adults with similar regimen. Copyright 2010 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.
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