title: Efficacy and safety of peginterferon-alpha2b and ribavirin combination therapy in children with chronic hepatitis C infection.
abstract: BACKGROUND
  Interferon (IFN)-alpha2b plus ribavirin is approved for treatment of hepatitis C in children; however, little is known about efficacy and tolerability of pegylated IFN (PEG-IFN)-alpha2b in this population. The objective of this study was to test the efficacy and safety of PEG-IFN-alpha2b plus ribavirin in children with chronic hepatitis C.
  
  
  METHODS
  Thirty children 3-16 years of age who had detectable hepatitis C virus (HCV) RNA for >or=3 years after exposure and elevated alanine aminotransferase values received PEG-IFN-alpha2b 1.0 microg/kg/wk plus ribavirin 15 mg/kg/d for 24 weeks (genotype 2/3) or 48 weeks (genotype 1/4). The primary endpoint was sustained virologic response (SVR), defined as undetectable HCV RNA (<50 IU/mL) at week 24 of follow-up.
  
  
  RESULTS
  SVR was achieved in 50% of patients (3/3 genotype 3; 12/27 genotype 1/4). At week 12, 52% of patients were HCV RNA negative and 72% had a >2 log10 decrease in viral load, compared with baseline; 87% and 71% of these patients, respectively, attained an SVR. Therapy was discontinued in 3 patients as a result of adverse events. No patient required ribavirin dose reduction; PEG-IFN-alpha2b dose was reduced in 23% of patients to manage neutropenia.
  
  
  CONCLUSIONS
  Combination therapy with PEG-IFN-alpha2b and ribavirin treatment was effective in children with chronic hepatitis C. Virologic status at week 12 identified future responders and nonresponders. PEG-IFN-alpha2b and ribavirin were reasonably well tolerated, with no unexpected or permanent adverse effects. Further studies are needed to identify the optimum treatment regimen for this patient population.
authors.affiliation: Pediatric Liver Service, La Paz University Hospital, Madrid, Spain. pjara.hulp@salud.madrid.org
authors.forename: Paloma
authors.initials: P
authors.lastname: Jara
authors.forename: Loreto
authors.initials: L
authors.lastname: Hierro
authors.forename: Angela
authors.initials: A
authors.lastname: de la Vega
authors.forename: Carmen
authors.initials: C
authors.lastname: Díaz
authors.forename: Carmen
authors.initials: C
authors.lastname: Camarena
authors.forename: Esteban
authors.initials: E
authors.lastname: Frauca
authors.forename: Gema
authors.initials: G
authors.lastname: Miños-Bartolo
authors.forename: Ruth
authors.initials: R
authors.lastname: Díez-Dorado
authors.forename: Concepción Ladrón
authors.initials: CL
authors.lastname: de Guevara
authors.forename: Javier
authors.initials: J
authors.lastname: Larrauri
authors.forename: Magdalena
authors.initials: M
authors.lastname: Rueda
mesh_terms: D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D019698:Hepatitis C, Chronic / Q000188:drug therapy*; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D011092:Polyethylene Glycols; D011994:Recombinant Proteins; D012254:Ribavirin / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C417083:peginterferon alfa-2b