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5/31/2016

EbolaconvalescentplasmasafetouseMedicalNewsToday

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Ebola

ClinicalTrials/DrugTrials

TropicalDiseases

InfectiousDiseases/Bacteria/Viruses

Ebolaconvalescentplasmasafetouse
WrittenbyYvetteBrazier
Published:Thursday7January2016
83

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reatingEbolapatientswithconvalescentplasmafromEbolasurvivorsisfeasible,
safeandacceptabletodonors,patientsandhealthworkers,sayfindingsfromthe
EbolaTxtrial,carriedoutduringtherecentcrisisandpublishedintheNewEngland
JournalofMedicine.
Untilthe2014outbreak,bloodproductsfrom
Ebolasurvivorshadonlybeenused
experimentallyfortreatmentinasmallnumber
ofEbolapatients.
TheEbolaTxtrialwascarriedoutatthe
DonkaEbolaTreatmentCenterinConakry,
Guinea,runbyMdecinsSansFrontires
(MSF).
ThetrialwasledbytheAntwerpInstituteof
TropicalMedicine(ITM)andfundedbythe
EuropeanUnion(EU),anditisthelargestever
trialofconvalescentplasma(CP)forthe
treatmentofEbola.

ManyEbolasurvivorsvolunteeredtodonateplasma
Imagecredit:AntwerpInstituteofTropicalMedicine

ItwasthehighfatalityrateofEbolathatledtotheneedtoidentifytreatmentsthatdirectlytargetedthe
virus,suchasCP.TheWorldHealthOrganization(WHO)hadprioritizedCPduetoitssuccessintreating
otherviraldiseaseslikemeasles,yellowfeverandinfluenza.

Experimentaltreatmentinacrisis
http://www.medicalnewstoday.com/articles/304666.php

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Researchersdidnotknowwhatimpact,ifany,CPmighthaveagainstEbola,whatmightbeaneffective
dose,orwhetherpatientsandthecommunitywouldaccepttransfusionswithabloodproduct.
TheGuineannationalbloodtransfusioncentre(CNTS)collectedbloodplasmaforthetrial,inclose
collaborationwiththeFrenchpublictransfusionservices,theGuineanEbolasurvivorsassociationfrom
Conakryandagroupofanthropologists.
Bloodconstituentswereseparated,andanypartsnotrequiredwerereturnedintothedonor'scirculation.
Thisprovidedover200plasmaunits.
Atotalof102patientswereenrolled,84ofwhomwerethentreatedwithCP.Patientswereofanyage,
includingpregnantwomen.Theyreceivedtwounitsof200250mlfromdifferentconvalescentdonors
within48hoursofalaboratoryconfirmeddiagnosisofEbola.
Atthetime,thelevelsofEbolavirusneutralizingantibodiesintheCPwereunknown,astestswerenot
availableonsitetomeasurethem.

Trialsafedespiteinsignificantimpactonsurvivalrates
The84CPpatientswerecomparedwith418patientswhohadbeenattendingthesametreatmentcenter
inthe5monthsbeforethetrial.Theprimaryoutcomewassurvival14daysaftertransfusion,adjustedfor
age,andthelevelofEbolavirusinthebloodatdiagnosis.
Patientswhodiedwithin2daysofdiagnosiswereexcluded.A20%lowermortalityintheCPgroupwas
consideredsignificant.
Mortalityfromday316was31%intheCPgroupand37.8%inthecomparatorgroupbutthe
differencewasreducedtoonly2.6%afteradjustingforageandviralload.Thetreatmentasgiven
inthetrialdidnotsignificantlyimprovethesurvivalrate,butnosevereadversereactionstoCP
wereobserved.
CoordinatinginvestigatorProf.JohanvanGriensven,ofAntwerpITM,believesthatwhileasingle
administrationof2unitsofCPdoesnotsavelives,amoretargetedandconcentrateduseofplasma,
withadifferentlevelofantibodies,couldimproveoutcomes.
Despitethestudynotprovidingtheanswerthatwashoped
for,hesays,scientistshavegainedimportantinformation
abouttheroleofCPintreatingEbolaandthefeasibilityof
organizingthiskindofinterventioninacrisissituation.
CPsampleshavebeenshippedtoFranceforanalysisitis
hopedthatadditionalfindingswillindicatewhetherplasma
withdifferentlevelsofantibodiescouldbemoreeffective.
ResearchersenvisageapotentialroleforCPinadifferent
doseand/orincombinationwithothertreatmentscurrently
underinvestigation,suchasFavipiravir.
CNTSdirectorDr.NyankoyeHabasaystheEbolasurvivors
madethestudypossiblebyofferingtheirplasmaand
http://www.medicalnewstoday.com/articles/304666.php

FastfactsabouttheEbola
crisis
Inthe201415Ebolacrisis,there
were28,637cases
11,315peopledied
Thethreecountriesmostbadly
affectedwereLiberia,Guineaand
SierraLeone.

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encouragingtheirpeerstodolikewise.Longtermbenefits
ofthestudy,hesays,includetheopportunityfortheCNTS
tousecuttingedgetechnology,aswellasbuildingthe

LearnmoreaboutEbola

capacityofstaff.
Dr.RuxandraDraghiaAkli,directoroftheEuropeanCommission'sHealthDirectorate,commendsthe
achievementofperformingaclinicaltrialundersuchchallengingconditions,addingthatitwasthepeople
ofGuinea,thedonorsandlocalcommunitysupportwhomadethetrialpossible.
MariePauleKieny,oftheWHO,says:

"Thistrialhasbeenhelpfulinestablishingthesafetyofconvalescentplasma,andittellsus
thattheprocedurewasacceptedbythecommunity.Whileonlyafirststep,ittellsusthat
plasmamaybeworthexploringasatreatmentinthefuture,potentiallybyusingdonationswith
highantibodylevels."

MedicalNewsTodayrecentlyreportedthattheWHOdeclaredthatEbolatransmissionhadendedin
Guinea.
WrittenbyYvetteBrazier

Ebolasurvivorsbloodtoundergo
evaluationastreatmentoption
CatharinePaddockPhD,Medical
NewsToday,2014

EbolaoutbreakinGuineais
unprecedented,saysaidagency
CatharinePaddockPhD,Medical
NewsToday,2014

Ebolatransmissionceasesin
Guinea,sayWHO
CatharinePaddockPhD,Medical
NewsToday

Labinasuitcasesettoimprove
Ebolaviruscontrol
CatharinePaddockPhD,Medical
NewsToday,2015

Theringvaccinationtrial:anovel
clusterrandomisedcontrolled
trialdesigntoevaluatevaccine
efficacyandeffectivenessduring
outbreaks,withspecialreference
toEbola.
Ebolaasuffitringvaccinationtrial
consortiumetal.,TheBMJ,2015

Deaths,latedeaths,androleof
infectingdoseinEbolavirus
diseaseinSierraLeone:
retrospectivecohortstudy
HilaryBoweretal.,TheBMJ,2016

ClinicaltrialsofEbolatreatment
tostartinAfrica
AnneGullandetal.,TheBMJ,2014

EbolaintheUnitedStates:
Managementconsiderations
duringpregnancy
TheJournalOfFamilyPractice

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References

http://www.medicalnewstoday.com/articles/304666.php

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EvaluationofConvalescentPlasmaforEbolaVirusDiseaseinGuinea,JohanvanGriensven,NewEngland
JournalofMedicine,doi:10.1056/NEJMoa1511812,published6January2016.
AntwerpInstituteofTropicalMedicinenewsrelease,accessed5January2016viaAlphaGalileo.
Additionalsource:WHO,EbolaSituationReport30December2015,accessed5January2016.

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