Experimental Treatment with Favipiravir for Ebola Virus Disease (the JIKI Trial): A Historically Controlled, Single-Arm Proof-of-Concept Trial in Guinea

Hdl Handle:
http://hdl.handle.net/10144/601258
Title:
Experimental Treatment with Favipiravir for Ebola Virus Disease (the JIKI Trial): A Historically Controlled, Single-Arm Proof-of-Concept Trial in Guinea
Authors:
Sissoko, D; Laouenan, C; Folkesson, E; M'Lebing, AB; Beavogui, AH; Baize, S; Camara, AM; Maes, P; Shepherd, S; Danel, C; Carazo, S; Conde, MN; Gala, JL; Colin, G; Savini, H; Bore, JA; Le Marcis, F; Koundouno, FR; Petitjean, F; Lamah, MC; Diederich, S; Tounkara, A; Poelart, G; Berbain, E; Dindart, JM; Duraffour, S; Lefevre, A; Leno, T; Peyrouset, O; Irenge, L; Bangoura, N; Palich, R; Hinzmann, J; Kraus, A; Barry, TS; Berette, S; Bongono, A; Camara, MS; Chanfreau Munoz, V; Doumbouya, L; Souley H; Kighoma, PM; Koundouno, FR; Réné L; Loua, CM; Massala, V; Moumouni, K; Provost, C; Samake, N; Sekou, C; Soumah, A; Arnould, I; Komano, MS; Gustin, L; Berutto, C; Camara, D; Camara, FS; Colpaert, J; Delamou, L; Jansson, L; Kourouma, E; Loua, M; Malme, K; Manfrin, E; Maomou, A; Milinouno, A; Ombelet, S; Sidiboun, AY; Verreckt, I; Yombouno, P; Bocquin, A; Carbonnelle, C; Carmoi, T; Frange, P; Mely, S; Nguyen, VK; Pannetier, D; Taburet, AM; Treluyer, JM; Kolie, J; Moh, R; Gonzalez, MC; Kuisma, E; Liedigk, B; Ngabo, D; Rudolf, M; Thom, R; Kerber, R; Gabriel, M; Di Caro, A; Wölfel, R; Badir, J; Bentahir, M; Deccache, Y; Dumont, C; Durant, JF; El Bakkouri, K; Gasasira Uwamahoro, M; Smits, B; Toufik, N; Van Cauwenberghe, S; Ezzedine, K; Dortenzio, E; Pizarro, L; Etienne, A; Guedj, J; Fizet, A; Barte de Sainte Fare, E; Murgue, B; Tran-Minh, T; Rapp, C; Piguet, P; Poncin, M; Draguez, B; Allaford Duverger, T; Barbe, S; Baret, G; Defourny, I; Carroll, M; Raoul, H; Augier, A; Eholie, SP; Yazdanpanah, Y; Levy-Marchal, C; Antierrens, A; Van Herp, M; Günther, S; de Lamballerie, X; Keïta, S; Mentre, F; Anglaret, X; Malvy, D
Journal:
PLoS Medicine
Abstract:
Ebola virus disease (EVD) is a highly lethal condition for which no specific treatment has proven efficacy. In September 2014, while the Ebola outbreak was at its peak, the World Health Organization released a short list of drugs suitable for EVD research. Favipiravir, an antiviral developed for the treatment of severe influenza, was one of these. In late 2014, the conditions for starting a randomized Ebola trial were not fulfilled for two reasons. One was the perception that, given the high number of patients presenting simultaneously and the very high mortality rate of the disease, it was ethically unacceptable to allocate patients from within the same family or village to receive or not receive an experimental drug, using a randomization process impossible to understand by very sick patients. The other was that, in the context of rumors and distrust of Ebola treatment centers, using a randomized design at the outset might lead even more patients to refuse to seek care. Therefore, we chose to conduct a multicenter non-randomized trial, in which all patients would receive favipiravir along with standardized care. The objectives of the trial were to test the feasibility and acceptability of an emergency trial in the context of a large Ebola outbreak, and to collect data on the safety and effectiveness of favipiravir in reducing mortality and viral load in patients with EVD. The trial was not aimed at directly informing future guidelines on Ebola treatment but at quickly gathering standardized preliminary data to optimize the design of future studies.
Publisher:
Public Library of Science
Issue Date:
1-Mar-2016
URI:
http://hdl.handle.net/10144/601258
DOI:
10.1371/journal.pmed.1001967
PubMed ID:
26930627
Type:
Article
Language:
en
ISSN:
1549-1676
Appears in Collections:
Other Diseases

Full metadata record

DC FieldValue Language
dc.contributor.authorSissoko, Den
dc.contributor.authorLaouenan, Cen
dc.contributor.authorFolkesson, Een
dc.contributor.authorM'Lebing, ABen
dc.contributor.authorBeavogui, AHen
dc.contributor.authorBaize, Sen
dc.contributor.authorCamara, AMen
dc.contributor.authorMaes, Pen
dc.contributor.authorShepherd, Sen
dc.contributor.authorDanel, Cen
dc.contributor.authorCarazo, Sen
dc.contributor.authorConde, MNen
dc.contributor.authorGala, JLen
dc.contributor.authorColin, Gen
dc.contributor.authorSavini, Hen
dc.contributor.authorBore, JAen
dc.contributor.authorLe Marcis, Fen
dc.contributor.authorKoundouno, FRen
dc.contributor.authorPetitjean, Fen
dc.contributor.authorLamah, MCen
dc.contributor.authorDiederich, Sen
dc.contributor.authorTounkara, Aen
dc.contributor.authorPoelart, Gen
dc.contributor.authorBerbain, Een
dc.contributor.authorDindart, JMen
dc.contributor.authorDuraffour, Sen
dc.contributor.authorLefevre, Aen
dc.contributor.authorLeno, Ten
dc.contributor.authorPeyrouset, Oen
dc.contributor.authorIrenge, Len
dc.contributor.authorBangoura, Nen
dc.contributor.authorPalich, Ren
dc.contributor.authorHinzmann, Jen
dc.contributor.authorKraus, Aen
dc.contributor.authorBarry, TSen
dc.contributor.authorBerette, Sen
dc.contributor.authorBongono, Aen
dc.contributor.authorCamara, MSen
dc.contributor.authorChanfreau Munoz, Ven
dc.contributor.authorDoumbouya, Len
dc.contributor.authorSouley Hen
dc.contributor.authorKighoma, PMen
dc.contributor.authorKoundouno, FRen
dc.contributor.authorRéné Len
dc.contributor.authorLoua, CMen
dc.contributor.authorMassala, Ven
dc.contributor.authorMoumouni, Ken
dc.contributor.authorProvost, Cen
dc.contributor.authorSamake, Nen
dc.contributor.authorSekou, Cen
dc.contributor.authorSoumah, Aen
dc.contributor.authorArnould, Ien
dc.contributor.authorKomano, MSen
dc.contributor.authorGustin, Len
dc.contributor.authorBerutto, Cen
dc.contributor.authorCamara, Den
dc.contributor.authorCamara, FSen
dc.contributor.authorColpaert, Jen
dc.contributor.authorDelamou, Len
dc.contributor.authorJansson, Len
dc.contributor.authorKourouma, Een
dc.contributor.authorLoua, Men
dc.contributor.authorMalme, Ken
dc.contributor.authorManfrin, Een
dc.contributor.authorMaomou, Aen
dc.contributor.authorMilinouno, Aen
dc.contributor.authorOmbelet, Sen
dc.contributor.authorSidiboun, AYen
dc.contributor.authorVerreckt, Ien
dc.contributor.authorYombouno, Pen
dc.contributor.authorBocquin, Aen
dc.contributor.authorCarbonnelle, Cen
dc.contributor.authorCarmoi, Ten
dc.contributor.authorFrange, Pen
dc.contributor.authorMely, Sen
dc.contributor.authorNguyen, VKen
dc.contributor.authorPannetier, Den
dc.contributor.authorTaburet, AMen
dc.contributor.authorTreluyer, JMen
dc.contributor.authorKolie, Jen
dc.contributor.authorMoh, Ren
dc.contributor.authorGonzalez, MCen
dc.contributor.authorKuisma, Een
dc.contributor.authorLiedigk, Ben
dc.contributor.authorNgabo, Den
dc.contributor.authorRudolf, Men
dc.contributor.authorThom, Ren
dc.contributor.authorKerber, Ren
dc.contributor.authorGabriel, Men
dc.contributor.authorDi Caro, Aen
dc.contributor.authorWölfel, Ren
dc.contributor.authorBadir, Jen
dc.contributor.authorBentahir, Men
dc.contributor.authorDeccache, Yen
dc.contributor.authorDumont, Cen
dc.contributor.authorDurant, JFen
dc.contributor.authorEl Bakkouri, Ken
dc.contributor.authorGasasira Uwamahoro, Men
dc.contributor.authorSmits, Ben
dc.contributor.authorToufik, Nen
dc.contributor.authorVan Cauwenberghe, Sen
dc.contributor.authorEzzedine, Ken
dc.contributor.authorDortenzio, Een
dc.contributor.authorPizarro, Len
dc.contributor.authorEtienne, Aen
dc.contributor.authorGuedj, Jen
dc.contributor.authorFizet, Aen
dc.contributor.authorBarte de Sainte Fare, Een
dc.contributor.authorMurgue, Ben
dc.contributor.authorTran-Minh, Ten
dc.contributor.authorRapp, Cen
dc.contributor.authorPiguet, Pen
dc.contributor.authorPoncin, Men
dc.contributor.authorDraguez, Ben
dc.contributor.authorAllaford Duverger, Ten
dc.contributor.authorBarbe, Sen
dc.contributor.authorBaret, Gen
dc.contributor.authorDefourny, Ien
dc.contributor.authorCarroll, Men
dc.contributor.authorRaoul, Hen
dc.contributor.authorAugier, Aen
dc.contributor.authorEholie, SPen
dc.contributor.authorYazdanpanah, Yen
dc.contributor.authorLevy-Marchal, Cen
dc.contributor.authorAntierrens, Aen
dc.contributor.authorVan Herp, Men
dc.contributor.authorGünther, Sen
dc.contributor.authorde Lamballerie, Xen
dc.contributor.authorKeïta, Sen
dc.contributor.authorMentre, Fen
dc.contributor.authorAnglaret, Xen
dc.contributor.authorMalvy, Den
dc.date.accessioned2016-03-12T10:18:42Zen
dc.date.available2016-03-12T10:18:42Zen
dc.date.issued2016-03-01en
dc.identifier.citationExperimental Treatment with Favipiravir for Ebola Virus Disease (the JIKI Trial): A Historically Controlled, Single-Arm Proof-of-Concept Trial in Guinea. 2016, 13 (3):e1001967 PLoS Med.en
dc.identifier.issn1549-1676en
dc.identifier.pmid26930627en
dc.identifier.doi10.1371/journal.pmed.1001967en
dc.identifier.urihttp://hdl.handle.net/10144/601258en
dc.description.abstractEbola virus disease (EVD) is a highly lethal condition for which no specific treatment has proven efficacy. In September 2014, while the Ebola outbreak was at its peak, the World Health Organization released a short list of drugs suitable for EVD research. Favipiravir, an antiviral developed for the treatment of severe influenza, was one of these. In late 2014, the conditions for starting a randomized Ebola trial were not fulfilled for two reasons. One was the perception that, given the high number of patients presenting simultaneously and the very high mortality rate of the disease, it was ethically unacceptable to allocate patients from within the same family or village to receive or not receive an experimental drug, using a randomization process impossible to understand by very sick patients. The other was that, in the context of rumors and distrust of Ebola treatment centers, using a randomized design at the outset might lead even more patients to refuse to seek care. Therefore, we chose to conduct a multicenter non-randomized trial, in which all patients would receive favipiravir along with standardized care. The objectives of the trial were to test the feasibility and acceptability of an emergency trial in the context of a large Ebola outbreak, and to collect data on the safety and effectiveness of favipiravir in reducing mortality and viral load in patients with EVD. The trial was not aimed at directly informing future guidelines on Ebola treatment but at quickly gathering standardized preliminary data to optimize the design of future studies.en
dc.language.isoenen
dc.publisherPublic Library of Scienceen
dc.rightsPublished by Public Library of Science, [url]http://medicine.plosjournals.org/[/url] Archived on this site by Open Access permissionen
dc.titleExperimental Treatment with Favipiravir for Ebola Virus Disease (the JIKI Trial): A Historically Controlled, Single-Arm Proof-of-Concept Trial in Guineaen
dc.typeArticleen
dc.identifier.journalPLoS Medicineen

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