Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection in children and adolescents

• Published in: Journal of hepatology Vol. 52; no. 6; pp. 827 - 831
• Main Authors: Sokal, Etienne M, Bourgois, Annick, Stéphenne, Xavier, Silveira, Themis, Porta, Gilda, Gardovska, Dace, Fischler, Björn, Kelly, Deirdre
• Format: Journal Article
• Language: English
• Published: Kidlington Elsevier B.V 01.06.2010; Elsevier
• Subjects: Adolescent; Antiviral Agents - administration & dosage; Antiviral Agents - adverse effects; Biological and medical sciences; Child; Children; Drug Therapy, Combination; Female; Follow-Up Studies; Gastroenterology and Hepatology; Gastroenterology. Liver. Pancreas. Abdomen; Genotype; Hepacivirus - drug effects; Hepacivirus - genetics; Hepatitis C; Hepatitis C, Chronic - drug therapy; Human viral diseases; Humans; Immunomodulators; Infectious diseases; Interferon-alpha - administration & dosage; Interferon-alpha - adverse effects; Male; Medical sciences; Medicin och hälsovetenskap; Patient Dropouts; Pharmacology. Drug treatments; Polyethylene Glycols - administration & dosage; Polyethylene Glycols - adverse effects; Predictive Value of Tests; Prospective Studies; Recombinant Proteins; Ribavirin - administration & dosage; Ribavirin - adverse effects; RNA, Viral - genetics; Treatment; Treatment Outcome; Viral diseases; Viral hepatitis; EVR; ETR; hepatitis B; hepatitis C; end of treatment response; alanine aminotransferase; ALT; SVR; early viral response; Treatment; HIV; SAE; serious adverse event; ND; not done; human immunodeficiency virus; HCV; Children; sustained virologic response; HBV; Hepatitis C; Human; Antineoplastic agent; Cytokine; Hepatic disease; Ribavirin; Infection; Immunomodulator; Interferon alpha 2a; Peginterferon alfa-2a; Viral disease; Adolescent; Gastroenterology; Nucleoside analog; Digestive diseases; Antiviral; Pegylated form; Child; Viral hepatitis C
• ISSN: 0168-8278; 1600-0641; 1600-0641
• DOI: 10.1016/j.jhep.2010.01.028

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.