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Experimental treatment with favipiravir for ebola virus disease (the JIKI trial): A historically controlled, single-arm proof-of-concept trial in Guinea

By Daouda Sissoko, Cedric Laouenan, Elin Folkesson, Abdoul-Bing M'Lebing, Abdoul-Habib Beavogui, Sylvain Baize, Alseny-Modet Camara, Piet Maes, Susan Shepherd, Christine Danel, Sara Carazo, Mamoudou N Conde, Jean-Luc Gala, Géraldine Colin, Hélène Savini, Joseph Akoi Bore, Frederic Le Marcis, Fara Raymond Koundouno, Frédéric Petitjean, Marie-Claire Lamah, Sandra Diederich, Alexis Tounkara, Geertrui Poelart, Emmanuel Berbain, Jean-Michel Dindart, Sophie Duraffour, Annabelle Lefevre, Tamba Leno, Olivier Peyrouset, Léonid Irenge, N'Famara Bangoura, Romain Palich, Julia Hinzmann, Annette Kraus, Thierno Sadou Barry, Sakoba Berette, André Bongono, Mohamed Seto Camara, Valérie Chanfreau Munoz, Lanciné Doumbouya, Souley Harouna, Patient Mumbere Kighoma, Fara Roger Koundouno, Réné Lolamou, Cécé Moriba Loua, Vincent Massala, Kinda Moumouni, Célia Provost, Nenefing Samake, Conde Sekou, Abdoulaye Soumah, Isabelle Arnould, Michel Saa Komano, Lina Gustin, Carlotta Berutto, Diarra Camara, Fodé Saydou Camara, Joliene Colpaert, Léontine Delamou, Lena Jansson, Etienne Kourouma, Maurice Loua, Kristian Malme, Emma Manfrin, André Maomou, Adele Milinouno, Sien Ombelet, Aboubacar Youla Sidiboun, Isabelle Verreckt, Pauline Yombouno, Anne Bocquin, Caroline Carbonnelle, Thierry Carmoi, Pierre Frange, Stéphane Mely, Vinh-Kim Nguyen, Delphine Pannetier, Anne-Marie Taburet, Jean-Marc Treluyer, Jacques Kolie, Raoul Moh, Minerva Cervantes Gonzalez, Eeva Kuisma, Britta Liedigk, Didier Ngabo, Martin Rudolf, Ruth Thom, Romy Kerber, Martin Gabriel, Antonino Di Caro, Roman Wölfel, Jamal Badir, Mostafa Bentahir, Yann Deccache, Catherine Dumont, Jean-François Durant, Karim El Bakkouri, Marie Gasasira Uwamahoro, Benjamin Smits, Nora Toufik, Stéphane Van Cauwenberghe, Khaled Ezzedine, Eric Dortenzio, Louis Pizarro, Aurélie Etienne, Jérémie Guedj, Alexandra Fizet, Eric Barte de Sainte Fare, Bernadette Murgue, Tuan Tran-Minh, Christophe Rapp, Pascal Piguet, Marc Poncin, Bertrand Draguez, Thierry Allaford Duverger, Solenne Barbe, Guillaume Baret, Isabelle Defourny, Miles Carroll, Hervé Raoul, Augustin Augier, Serge P Eholie, Yazdan Yazdanpanah, Claire Levy-Marchal, Annick Antierrens, Michel Van Herp, Stephan Günther, Xavier de Lamballerie, Sakoba Keïta, France Mentre, Xavier Anglaret and Denis Malvy

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.status: publishe

Publisher: 'Public Library of Science (PLoS)'
Year: 2016
DOI identifier: 10.1371/journal.pmed.1001967
OAI identifier: oai:lirias2repo.kuleuven.be:123456789/534758
Provided by: Lirias
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