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• W2028934479 abstract "Epidemiological data from UNICEF Guinea1UNICEFUNICEF Guinea: Ebola Situation Report.http://www.unicef.org/appeals/files/UNICEF_Guinea_Ebola_Situation_Report_5_Nov_2014.pdfDate: Nov 5, 2014Google Scholar showed that children have accounted for a substantial proportion of patients admitted to west African medical centres for Ebola. 390 (22%) of 1744 reported patients infected with Ebola virus from the present outbreak in Guinea were children.1UNICEFUNICEF Guinea: Ebola Situation Report.http://www.unicef.org/appeals/files/UNICEF_Guinea_Ebola_Situation_Report_5_Nov_2014.pdfDate: Nov 5, 2014Google Scholar The overall case fatality proportion in the outbreak tends to be higher in children (73·4%) than in adults aged 15–44 years (70·8%).2WHO Ebola Response TeamEbola virus disease in West Africa—the first 9 months of the epidemic and forward projections.N Engl J Med. 2014; 371: 1481-1495Crossref PubMed Scopus (1119) Google Scholar In the context of an urgent need to assess potential specific interventions for Ebola in children, favipiravir is an interesting drug candidate because of its efficacy against Ebola virus in vitro and animal models, good tolerance profile in adults, immediate availability, and ability to be used in the paediatric population because pills can be crushed and mixed with food and liquid. So far, there is no clinical experience of favipiravir use in children, making prediction of the optimum dose for Ebola difficult. However, the fact that maturation profiles of enzymes (mainly aldehyde oxydase) included in the metabolic pathway of favipiravir are fully achieved at the age of 12 months makes the drug a good candidate for treatment in children older than 1 year.3Tayama Y Miyake K Sugihara K et al.Developmental changes of aldehyde oxidase activity in young Japanese children.Clin Pharmacol Ther. 2007; 81: 567-572Crossref PubMed Scopus (30) Google Scholar We aim to explain the approach we used to propose a dosage regimen in an ongoing trial (NCT02329054) in Guinea assessing survival in children infected with Ebola and treated with favipiravir. We previously estimated that plasma daily minimal (Cmin) and average concentrations to be targeted in humans were 10 μg/mL and 113 μg/mL, respectively.4Mentré F Taburet AM Guedj J et al.Dose regimen of faripiravir for Ebola virus disease.Lancet Infect Dis. 2015; 2: 150-151Summary Full Text Full Text PDF Scopus (73) Google Scholar We used the pharmacokinetic model developed by the manufacturer with the parameter values (along with their estimated between-subject variability) estimated in healthy US adult volunteers to predict the disposition in paediatric patients, using weight-based allometric scaling. According to allometry theory, clearance, volume of distribution, and rate-constant parameters were scaled with a fixed exponent of 0·75, 1·0, and −0·25 respectively.5Anderson BJ Holford NHG Mechanism-based concepts of size and maturity in pharmacokinetics.Annu Rev Pharmacol Toxicol. 2008; 48: 303-332Crossref PubMed Scopus (784) Google Scholar We then determined paediatric favipiravir doses according to bodyweight to reach a Cmin of more than 10 μg/mL without exceeding the predicted maximum concentration obtained in adults.4Mentré F Taburet AM Guedj J et al.Dose regimen of faripiravir for Ebola virus disease.Lancet Infect Dis. 2015; 2: 150-151Summary Full Text Full Text PDF Scopus (73) Google Scholar Because viral spread has to be blocked as soon and as strongly as possible after appearance of the first symptoms, several loading-dose strategies on day 1 were assessed by modelling to rapidly achieve high levels of exposure, and simulations were then done with various maintenance doses (table). Similar to adults, we suggest that children receive the treatment for 10 days, to reduce the risk of relapse. Tolerance, virological, and pharmacokinetic data will be collected in the trial to help refine the dosage regimen.TableWeight-band dosing table for faripiravir in children infected with Ebola virus diseaseDay 1Days 2–10H0 (first dose)H8H1610–15 kg500 mg500 mg200 mg200 mg three times daily16–21 kg800 mg800 mg400 mg400 mg twice daily22–35 kg1200 mg1200 mg600 mg600 mg twice daily36–45 kg1600 mg1600 mg800 mg800 mg twice daily46–55 kg2000 mg2000 mg1000 mg1000 mg twice daily>55 kg (adults)2400 mg2400 mg1200 mg1200 mg twice dailyH=hour Open table in a new tab H=hour We declare no competing interests. We thank Toyama Chemical, Médecins Sans Frontières, the REACTing network of Aviesan for their scientific support, and the Horizon 2020 programme of the European commission for funding the REACTION project." @default.
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• W2028934479 date "2015-02-01" @default.
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• W2028934479 title "Favipiravir for children with Ebola" @default.
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• W2028934479 doi "https://doi.org/10.1016/s0140-6736(15)60232-x" @default.
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