Ribavirin does not potentiate favipiravir antiviral activity against Ebola virus in non-human primates.


Journal

Antiviral research
ISSN: 1872-9096
Titre abrégé: Antiviral Res
Pays: Netherlands
ID NLM: 8109699

Informations de publication

Date de publication:
05 2020
Historique:
received: 21 12 2019
revised: 24 02 2020
accepted: 26 02 2020
pubmed: 7 3 2020
medline: 2 4 2021
entrez: 6 3 2020
Statut: ppublish

Résumé

In spite of recurrent and dramatic outbreaks, there are no therapeutics approved against Ebola virus disease. Favipiravir, a RNA polymerase inhibitor active against several RNA viruses, recently demonstrated significant but not complete protection in a non-human primate model of Ebola virus disease. In this study, we assessed the benefit of the combination of favipiravir and ribavirin, another broad spectrum antiviral agent, in the same model. 15 female cynomolgus macaques were challenged intramuscularly with 1,000 FFU of Ebola virus Gabon 2001 strain and followed for 21 days. All animals received favipiravir 180 mg/kg twice a day (BID), either as monotherapy (n = 5) or in combination with ribavirin (n = 10). Ribavirin was given either at the dose 10 mg/kg BID (n = 5) or 5 mg/kg BID (n = 5). Favipiravir and ribavirin were initiated two and one days before viral challenge respectively and treatment were continued for 14 days. Treatment effects on viral and hematological markers were assessed using a mathematical model. Survival rate of 0% and 20% were obtained in macaques receiving favipiravir plus ribavirin 10 and 5 mg/kg BID, respectively, compared to 40% in the favipiravir monotherapy group (P = 0.061 when comparing monotherapy and bitherapy, log rank). Viral dynamic modeling analysis did not identify an association between plasma concentrations of ribavirin and viral load levels. Using a model of erythropoiesis, plasma concentrations of ribavirin were strongly associated with a hemoglobin drop (p = 0.0015). Ribavirin plus favipiravir did not extend survival rates and did not lower viral replication rate compared to favipiravir monotherapy in this animal model. Patients receiving this combination in other indications, such as Lassa fever, should be closely monitored to prevent potential toxicity associated with anemia.

Sections du résumé

BACKGROUND
In spite of recurrent and dramatic outbreaks, there are no therapeutics approved against Ebola virus disease. Favipiravir, a RNA polymerase inhibitor active against several RNA viruses, recently demonstrated significant but not complete protection in a non-human primate model of Ebola virus disease. In this study, we assessed the benefit of the combination of favipiravir and ribavirin, another broad spectrum antiviral agent, in the same model.
METHODS
15 female cynomolgus macaques were challenged intramuscularly with 1,000 FFU of Ebola virus Gabon 2001 strain and followed for 21 days. All animals received favipiravir 180 mg/kg twice a day (BID), either as monotherapy (n = 5) or in combination with ribavirin (n = 10). Ribavirin was given either at the dose 10 mg/kg BID (n = 5) or 5 mg/kg BID (n = 5). Favipiravir and ribavirin were initiated two and one days before viral challenge respectively and treatment were continued for 14 days. Treatment effects on viral and hematological markers were assessed using a mathematical model. Survival rate of 0% and 20% were obtained in macaques receiving favipiravir plus ribavirin 10 and 5 mg/kg BID, respectively, compared to 40% in the favipiravir monotherapy group (P = 0.061 when comparing monotherapy and bitherapy, log rank). Viral dynamic modeling analysis did not identify an association between plasma concentrations of ribavirin and viral load levels. Using a model of erythropoiesis, plasma concentrations of ribavirin were strongly associated with a hemoglobin drop (p = 0.0015).
CONCLUSION
Ribavirin plus favipiravir did not extend survival rates and did not lower viral replication rate compared to favipiravir monotherapy in this animal model. Patients receiving this combination in other indications, such as Lassa fever, should be closely monitored to prevent potential toxicity associated with anemia.

Identifiants

pubmed: 32135218
pii: S0166-3542(19)30734-X
doi: 10.1016/j.antiviral.2020.104758
pii:
doi:

Substances chimiques

Amides 0
Antiviral Agents 0
Pyrazines 0
Ribavirin 49717AWG6K
favipiravir EW5GL2X7E0

Types de publication

Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

104758

Informations de copyright

Copyright © 2020 Elsevier B.V. All rights reserved.

Déclaration de conflit d'intérêts

Declaration of competing interest The authors declare no competing interests.

Auteurs

Vincent Madelain (V)

Université de Paris, IAME, INSERM, F-75018, Paris, France.

Aurélie Duthey (A)

Laboratoire P4 Inserm-Jean Mérieux, US003 Inserm, 69365, Lyon, France.

France Mentré (F)

Université de Paris, IAME, INSERM, F-75018, Paris, France.

Frédéric Jacquot (F)

Laboratoire P4 Inserm-Jean Mérieux, US003 Inserm, 69365, Lyon, France.

Caroline Solas (C)

Aix-Marseille Univ, APHM, UMR "Emergence des Pathologies Virales" IRD190-Inserm1207-EHESP, Laboratoire Pharmacocinétique-Toxicologie, Hôpital La Timone, 13005, Marseille, France.

Bruno Lacarelle (B)

Aix-Marseille Univ, APHM, UMR "Emergence des Pathologies Virales" IRD190-Inserm1207-EHESP, Laboratoire Pharmacocinétique-Toxicologie, Hôpital La Timone, 13005, Marseille, France.

Audrey Vallvé (A)

Laboratoire P4 Inserm-Jean Mérieux, US003 Inserm, 69365, Lyon, France.

Stéphane Barron (S)

Laboratoire P4 Inserm-Jean Mérieux, US003 Inserm, 69365, Lyon, France.

Laura Barrot (L)

Laboratoire P4 Inserm-Jean Mérieux, US003 Inserm, 69365, Lyon, France.

Stéphanie Mundweiler (S)

Laboratoire P4 Inserm-Jean Mérieux, US003 Inserm, 69365, Lyon, France.

Damien Thomas (D)

Laboratoire P4 Inserm-Jean Mérieux, US003 Inserm, 69365, Lyon, France.

Caroline Carbonnelle (C)

Laboratoire P4 Inserm-Jean Mérieux, US003 Inserm, 69365, Lyon, France.

Hervé Raoul (H)

Laboratoire P4 Inserm-Jean Mérieux, US003 Inserm, 69365, Lyon, France.

Xavier de Lamballerie (X)

UMR "Emergence des Pathologies Virales" (EPV: Aix-Marseille University - IRD 190 - Inserm 1207 - EHESP), Institut Hospitalo-Universitaire Méditerranée Infection, F-13385, Marseille, France.

Jérémie Guedj (J)

Université de Paris, IAME, INSERM, F-75018, Paris, France. Electronic address: jeremie.guedj@inserm.fr.

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Classifications MeSH