TY - JOUR
T1 - Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection in children and adolescents
AU - Sokal, Etienne M.
AU - Bourgois, Annick
AU - Stéphenne, Xavier
AU - Silveira, Themis
AU - Porta, Gilda
AU - Gardovska, Dace
AU - Fischler, Björn
AU - Kelly, Deirdre
N1 - Funding Information:
The study was designed by a panel of paediatric hepatologists and was partially supported by a study grant from the Roche Company; data belonged to the investigators, and data analysis and scientific report is made within the paediatric consortium. The patients’ parents or guardians provided written informed consent prior to enrolling into the study. The study was conducted in compliance with the Declaration of Helsinki and approved by the local independent ethical committees of all participating centres.
PY - 2010/6
Y1 - 2010/6
N2 - 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 24 weeks, and 47 children with genotypes 1, 4, 5 and 6 patients (group B) for 48 weeks. 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.
AB - 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 24 weeks, and 47 children with genotypes 1, 4, 5 and 6 patients (group B) for 48 weeks. 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.
KW - Children
KW - Hepatitis C
KW - Treatment
UR - http://www.scopus.com/inward/record.url?scp=77952419827&partnerID=8YFLogxK
U2 - 10.1016/j.jhep.2010.01.028
DO - 10.1016/j.jhep.2010.01.028
M3 - Article
C2 - 20400194
AN - SCOPUS:77952419827
SN - 0168-8278
VL - 52
SP - 827
EP - 831
JO - Journal of Hepatology
JF - Journal of Hepatology
IS - 6
ER -