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Individual risk of post-ivermectin serious adverse events in subjects infected with Loa loa

BACKGROUND: Implementation of onchocerciasis elimination programmes has been delayed in Central Africa because of the risk of ivermectin-related serious adverse events (SAEs) in individuals with high Loa loa microfilarial densities (MFD). We developed the first statistical models enabling prediction...

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Autores principales: Chesnais, Cédric B., Pion, Sébastien D., Boullé, Charlotte, Gardon, Jacques, Gardon-Wendel, Nathalie, Fokom-Domgue, Joël, Kamgno, Joseph, Boussinesq, Michel
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7700892/
https://www.ncbi.nlm.nih.gov/pubmed/33294807
http://dx.doi.org/10.1016/j.eclinm.2020.100582
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author Chesnais, Cédric B.
Pion, Sébastien D.
Boullé, Charlotte
Gardon, Jacques
Gardon-Wendel, Nathalie
Fokom-Domgue, Joël
Kamgno, Joseph
Boussinesq, Michel
author_facet Chesnais, Cédric B.
Pion, Sébastien D.
Boullé, Charlotte
Gardon, Jacques
Gardon-Wendel, Nathalie
Fokom-Domgue, Joël
Kamgno, Joseph
Boussinesq, Michel
author_sort Chesnais, Cédric B.
collection PubMed
description BACKGROUND: Implementation of onchocerciasis elimination programmes has been delayed in Central Africa because of the risk of ivermectin-related serious adverse events (SAEs) in individuals with high Loa loa microfilarial densities (MFD). We developed the first statistical models enabling prediction of SAE risk in individuals with a given MFD. METHODS: We used individual participant data from two trials conducted in loiasis-onchocerciasis co-endemic areas in Cameroon. among the 10 506 ivermectin-treated subjects included in the analysis, 38 (0·36%) developed an ivermectin-related SAE. To predict individual-level risk of SAE, we developed mixed multivariate logistic models including subjects’ sex, age, pre-treatment L loa and Mansonella perstans MFDs, and study region. FINDINGS: The models predicted that regardless of sex, about 1% of people with 20 000 L loa microfilariae per millilitre of blood (mf/mL), 10% of people with 50 000 mf/mL and about one third of those with 100 000 mf/mL will develop an SAE. For a given MFD, males have a three-fold higher risk of developing an SAE than females. INTERPRETATION: By enabling the prediction of post-ivermectin SAE risk in communities with known distribution of L loa MFDs, our results can guide decisions on the choice of ivermectin-based treatment strategies. They also predict that 37 SAEs were prevented in 2015 by using a Test-and-Treat strategy in the Okola District of Cameroon. FUNDING: UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases; Institut de Recherche pour le Développement; Mectizan Donation Program; Bill & Melinda Gates Foundation.
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spelling pubmed-77008922020-12-07 Individual risk of post-ivermectin serious adverse events in subjects infected with Loa loa Chesnais, Cédric B. Pion, Sébastien D. Boullé, Charlotte Gardon, Jacques Gardon-Wendel, Nathalie Fokom-Domgue, Joël Kamgno, Joseph Boussinesq, Michel EClinicalMedicine Research Paper BACKGROUND: Implementation of onchocerciasis elimination programmes has been delayed in Central Africa because of the risk of ivermectin-related serious adverse events (SAEs) in individuals with high Loa loa microfilarial densities (MFD). We developed the first statistical models enabling prediction of SAE risk in individuals with a given MFD. METHODS: We used individual participant data from two trials conducted in loiasis-onchocerciasis co-endemic areas in Cameroon. among the 10 506 ivermectin-treated subjects included in the analysis, 38 (0·36%) developed an ivermectin-related SAE. To predict individual-level risk of SAE, we developed mixed multivariate logistic models including subjects’ sex, age, pre-treatment L loa and Mansonella perstans MFDs, and study region. FINDINGS: The models predicted that regardless of sex, about 1% of people with 20 000 L loa microfilariae per millilitre of blood (mf/mL), 10% of people with 50 000 mf/mL and about one third of those with 100 000 mf/mL will develop an SAE. For a given MFD, males have a three-fold higher risk of developing an SAE than females. INTERPRETATION: By enabling the prediction of post-ivermectin SAE risk in communities with known distribution of L loa MFDs, our results can guide decisions on the choice of ivermectin-based treatment strategies. They also predict that 37 SAEs were prevented in 2015 by using a Test-and-Treat strategy in the Okola District of Cameroon. FUNDING: UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases; Institut de Recherche pour le Développement; Mectizan Donation Program; Bill & Melinda Gates Foundation. Elsevier 2020-10-10 /pmc/articles/PMC7700892/ /pubmed/33294807 http://dx.doi.org/10.1016/j.eclinm.2020.100582 Text en © 2020 The Authors http://creativecommons.org/licenses/by-nc-nd/4.0/ This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
spellingShingle Research Paper
Chesnais, Cédric B.
Pion, Sébastien D.
Boullé, Charlotte
Gardon, Jacques
Gardon-Wendel, Nathalie
Fokom-Domgue, Joël
Kamgno, Joseph
Boussinesq, Michel
Individual risk of post-ivermectin serious adverse events in subjects infected with Loa loa
title Individual risk of post-ivermectin serious adverse events in subjects infected with Loa loa
title_full Individual risk of post-ivermectin serious adverse events in subjects infected with Loa loa
title_fullStr Individual risk of post-ivermectin serious adverse events in subjects infected with Loa loa
title_full_unstemmed Individual risk of post-ivermectin serious adverse events in subjects infected with Loa loa
title_short Individual risk of post-ivermectin serious adverse events in subjects infected with Loa loa
title_sort individual risk of post-ivermectin serious adverse events in subjects infected with loa loa
topic Research Paper
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7700892/
https://www.ncbi.nlm.nih.gov/pubmed/33294807
http://dx.doi.org/10.1016/j.eclinm.2020.100582
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