Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection in children and adolescents.
OBJECTIVE
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.
Sokal
Etienne M
EM
Université Catholique de Louvain, Cliniques universitaires St Luc, Bruxelles, Belgium. etienne.sokal@uclouvain.be
Bourgois
Annick
A
Stéphenne
Xavier
X
Silveira
Themis
T
Porta
Gilda
G
Gardovska
Dace
D
Fischler
Björn
B
Kelly
Deirdre
D
D000293:Adolescent; D000998:Antiviral Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002648:Child; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D005838:Genotype; D016174:Hepacivirus / Q000187:drug effects* / Q000235:genetics; D019698:Hepatitis C, Chronic / Q000188:drug therapy*; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D010352:Patient Dropouts; D011092:Polyethylene Glycols / Q000008:administration & dosage* / Q000009:adverse effects; D011237:Predictive Value of Tests; D011446:Prospective Studies; D012367:RNA, Viral / Q000235:genetics; D011994:Recombinant Proteins; D012254:Ribavirin / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D012367:RNA, Viral; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C100416:peginterferon alfa-2a