Population pharmacokinetics of peginterferon alfa-2b in pediatric patients with chronic hepatitis C.
Purpose: The aim of this study was to characterize the population pharmacokinetics of peginterferon (PEG-IFN) alfa-2b in pediatric patients with chronic hepatitis C and to identify covariates influencing PEG-IFN alfa-2b disposition. Methods: Pharmacokinetic data from a multicenter open-label study o...
| Publicado en: | European Journal of Clinical Pharmacology Vol. 69; no. 12; pp. 2045 - 2055 |
|---|---|
| Autores principales: | , , , , , , , , , |
| Formato: | equations & formulas research tables/charts Journal Article |
| Publicado: |
Springer Nature
Dec2013
|
| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=104160782&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 104160782 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 00316970 NP9 jtl: European Journal of Clinical Pharmacology issn: 00316970 maglogo: N pubinfo: dt: Dec2013 vid: 69 iid: 12 pid: 237 pub: Springer Nature place: New York, New York artinfo: ui: 104160782 92014268 10.1007/s00228-013-1574-9 NLM23975236 104160782 ppf: 2045 ppct: 10 formats: fmt: @attributes: type: P tig: atl: Population pharmacokinetics of peginterferon alfa-2b in pediatric patients with chronic hepatitis C. aug: au: Xu, C. Gupta, S. Krishna, G. Cutler, D. Wirth, S. Galoppo, C. Ciocca, M. Kolz, K. Noviello, S. Sniukiene, V. affil: Merck Research Laboratories, Kenilworth, NJ, USA; Sanofi US, 55 Corporate Drive, Mail Stop: 55B-405A, Bridgewater, NJ, 08807, USA sug: subj: Interferons Pharmacokinetics Hepatitis C, Chronic Drug Therapy Interferons Administration and Dosage Ribavirin Administration and Dosage Human Multicenter Studies Child, Preschool Child Adolescence Models, Statistical Americas Europe Data Analysis Software Descriptive Statistics Confidence Intervals Male Female Funding Source Child, Preschool: 2-5 years Child: 6-12 years Adolescent: 13-18 years Male Female ab: Purpose: The aim of this study was to characterize the population pharmacokinetics of peginterferon (PEG-IFN) alfa-2b in pediatric patients with chronic hepatitis C and to identify covariates influencing PEG-IFN alfa-2b disposition. Methods: Pharmacokinetic data from a multicenter open-label study of subcutaneously administered peginterferon alfa-2b (60 μg/m 2/wk) plus oral ribavirin (15 mg/kg/day) in patients with chronic hepatitis C aged 3–17 years old was used to develop a population pharmacokinetic nonlinear mixed-effects model. Results: The final population pharmacokinetic analysis was conducted with the pooled data from 107 pediatric patients. A one-compartment model with first-order absorption, first-order elimination, exponential inter-individual variability on clearance, and a combination additive and proportional residual error model adequately described the PEG-IFN alfa-2b pharmacokinetic profile. Age (apparent clearance and apparent volume of distribution) and sex (apparent clearance) were significant covariates. The mean body surface area normalized apparent clearance of PEG-IFN alfa-2b was 0.56 L/h/m 2, and was similar when evaluated across the pediatric age groups. Conclusion: The final population model suggests age-dependent increases in clearance and volume of distribution of PEG-IFN alfa-2b in pediatric patients with chronic hepatitis C. The apparent clearance normalized to body surface area was similar across pediatric age groups, supporting the use of body size–adjusted dosing in pediatric subjects. pubtype: Academic Journal doctype: equations & formulas research tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
|---|