title: Safety and Efficacy of Combined Treatment with Pegylated Interferon Alpha-2b and Ribavirin for HCV Genotype 4 in Children.
abstract: Combined treatment with pegylated interferon (PEG-IFN)-α2b and ribavirin (RBV) is the only currently approved treatment for hepatitis C virus (HCV) infection in children. The aim of this study was to assess the safety and efficacy of combined treatment with PEG-IFN-α2b and RBV in Egyptian children and adolescents with genotype 4 (GT4) HCV infection. The study included 66 patients (3-17 years of age), of both sexes, infected with HCV GT4, treated with PEG-IFN-α2b (60 μg/m(2)), subcutaneously once weekly plus RBV (15 mg/kg/day) in 2 divided oral doses. Efficacy was assessed by achievement of sustained virological response (SVR). Safety was assessed by questionnaires directed to the patients at specific intervals, growth assessment and laboratory tests. SVR was achieved in 28 patients (42.4%). Nonresponders had significantly commoner history of treated malignancies (P = 0.03), baseline lower absolute neutrophil count (ANC; P = 0.009), higher gamma glutamyl transpeptidase (GGT; P = 0.003), and higher viral load (P = 0.03). Fever was the most frequently reported side effect occurring in 98.5% of the patients followed by musculoskeletal symptoms. Neutropenia was observed in 36 patients (54.6%) and necessitated treatment discontinuation in 1 patient. Decline in both weight and height percentiles was observed in 70% of children who received the combined therapy for a total of 48 weeks. In conclusion, the currently available treatment for HCV GT4 in pediatric patients has modest SVR with numerous adverse events necessitating meticulous monitoring to optimize care of the patients. Side effects could be managed with dose modifications and specific treatment when necessary.
authors.affiliation: 1 Department of Pediatrics, Kasr Alainy Medical School, Cairo University , Cairo, Egypt .
authors.forename: Hanaa M
authors.initials: HM
authors.lastname: El-Karaksy
authors.affiliation: 1 Department of Pediatrics, Kasr Alainy Medical School, Cairo University , Cairo, Egypt .
authors.forename: Engy A
authors.initials: EA
authors.lastname: Mogahed
authors.affiliation: 1 Department of Pediatrics, Kasr Alainy Medical School, Cairo University , Cairo, Egypt .
authors.forename: Mona S
authors.initials: MS
authors.lastname: El-Raziky
authors.affiliation: 2 Department of Community Medicine, Kasr Alainy Medical School, Cairo University , Cairo, Egypt .
authors.forename: Doaa
authors.initials: D
authors.lastname: Saleh
authors.affiliation: 1 Department of Pediatrics, Kasr Alainy Medical School, Cairo University , Cairo, Egypt .
authors.forename: Mahmoud
authors.initials: M
authors.lastname: Besheer
authors.affiliation: 1 Department of Pediatrics, Kasr Alainy Medical School, Cairo University , Cairo, Egypt .
authors.forename: Samah
authors.initials: S
authors.lastname: Mubarak
mesh_terms: D000293:Adolescent; D000998:Antiviral Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001827:Body Height / Q000187:drug effects; D001835:Body Weight / Q000187:drug effects; D002648:Child; D002675:Child, Preschool; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D005334:Fever / Q000209:etiology / Q000473:pathology; D005838:Genotype; D016174:Hepacivirus / Q000187:drug effects* / Q000235:genetics / Q000254:growth & development; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000276:immunology / Q000473:pathology / Q000821:virology; D006801:Humans; D007279:Injections, Subcutaneous; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage* / Q000009:adverse effects; D007958:Leukocyte Count; D008297:Male; D009503:Neutropenia / Q000209:etiology / Q000473:pathology; D009504:Neutrophils / Q000187:drug effects / Q000276:immunology / Q000473:pathology; D011092:Polyethylene Glycols / Q000008:administration & dosage* / Q000009:adverse effects; D011446:Prospective Studies; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects; D012254:Ribavirin / Q000008:administration & dosage* / Q000009:adverse effects; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D019562:Viral Load / Q000187:drug effects; D005723:gamma-Glutamyltransferase
chemical_list: D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; D005723:gamma-Glutamyltransferase; C554782:gamma-glutamyltransferase, human; C417083:peginterferon alfa-2b