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Treatment of Pregnant Women with Ivermectin during Mass Drug Distribution: Time to Investigate Its Safety and Potential Benefits

To date, pregnant women are excluded from programmes delivering community-directed treatment of ivermectin (CDTI) for onchocerciasis and preventive chemotherapy of other helminthiases because of concerns over ivermectin safety during pregnancy. This systematic exclusion sustains an infection reservo...

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Autores principales: Erber, Astrid Christine, Ariyo, Esther, Olliaro, Piero, Nicolas, Patricia, Chaccour, Carlos, Colebunders, Robert
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8703637/
https://www.ncbi.nlm.nih.gov/pubmed/34959543
http://dx.doi.org/10.3390/pathogens10121588
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author Erber, Astrid Christine
Ariyo, Esther
Olliaro, Piero
Nicolas, Patricia
Chaccour, Carlos
Colebunders, Robert
author_facet Erber, Astrid Christine
Ariyo, Esther
Olliaro, Piero
Nicolas, Patricia
Chaccour, Carlos
Colebunders, Robert
author_sort Erber, Astrid Christine
collection PubMed
description To date, pregnant women are excluded from programmes delivering community-directed treatment of ivermectin (CDTI) for onchocerciasis and preventive chemotherapy of other helminthiases because of concerns over ivermectin safety during pregnancy. This systematic exclusion sustains an infection reservoir at the community level and deprives a vulnerable population from known benefits—there are indications that treating O. volvulus infected women may improve pregnancy outcomes and reduce the risk that their children develop onchocerciasis-associated morbidities. Furthermore, teratogenic effects are seen in non-clinical experiments at doses that far exceed those used in CDTI. Lastly, early, undetected and undeclared pregnancies are being systematically exposed to ivermectin in practice. Treatment of this population requires appropriate supporting evidence, for which we propose a three-pronged approach. First, to develop a roadmap defining the key steps needed to obtain regulatory clearance for the safe and effective use of ivermectin in all pregnant women who need it. Second, to conduct a randomised placebo-controlled double-blind clinical trial to evaluate the safety and benefits of ivermectin treatment in O. volvulus infected pregnant women. Such a trial should evaluate the possible effects of ivermectin in reducing adverse pregnancy outcomes and neonatal mortality, as well as in reducing the incidence of onchocerciasis-associated epilepsy. Third, to establish a pregnancy registry for women who inadvertently received ivermectin during pregnancy. This situation is not unique to ivermectin. Access to valuable therapies is often limited, delayed, or denied to pregnant women due to a lack of evidence. Concerns over protecting vulnerable people may result in harming them. We need to find acceptable ways to build robust evidence towards providing essential interventions during pregnancy.
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spelling pubmed-87036372021-12-25 Treatment of Pregnant Women with Ivermectin during Mass Drug Distribution: Time to Investigate Its Safety and Potential Benefits Erber, Astrid Christine Ariyo, Esther Olliaro, Piero Nicolas, Patricia Chaccour, Carlos Colebunders, Robert Pathogens Viewpoint To date, pregnant women are excluded from programmes delivering community-directed treatment of ivermectin (CDTI) for onchocerciasis and preventive chemotherapy of other helminthiases because of concerns over ivermectin safety during pregnancy. This systematic exclusion sustains an infection reservoir at the community level and deprives a vulnerable population from known benefits—there are indications that treating O. volvulus infected women may improve pregnancy outcomes and reduce the risk that their children develop onchocerciasis-associated morbidities. Furthermore, teratogenic effects are seen in non-clinical experiments at doses that far exceed those used in CDTI. Lastly, early, undetected and undeclared pregnancies are being systematically exposed to ivermectin in practice. Treatment of this population requires appropriate supporting evidence, for which we propose a three-pronged approach. First, to develop a roadmap defining the key steps needed to obtain regulatory clearance for the safe and effective use of ivermectin in all pregnant women who need it. Second, to conduct a randomised placebo-controlled double-blind clinical trial to evaluate the safety and benefits of ivermectin treatment in O. volvulus infected pregnant women. Such a trial should evaluate the possible effects of ivermectin in reducing adverse pregnancy outcomes and neonatal mortality, as well as in reducing the incidence of onchocerciasis-associated epilepsy. Third, to establish a pregnancy registry for women who inadvertently received ivermectin during pregnancy. This situation is not unique to ivermectin. Access to valuable therapies is often limited, delayed, or denied to pregnant women due to a lack of evidence. Concerns over protecting vulnerable people may result in harming them. We need to find acceptable ways to build robust evidence towards providing essential interventions during pregnancy. MDPI 2021-12-08 /pmc/articles/PMC8703637/ /pubmed/34959543 http://dx.doi.org/10.3390/pathogens10121588 Text en © 2021 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Viewpoint
Erber, Astrid Christine
Ariyo, Esther
Olliaro, Piero
Nicolas, Patricia
Chaccour, Carlos
Colebunders, Robert
Treatment of Pregnant Women with Ivermectin during Mass Drug Distribution: Time to Investigate Its Safety and Potential Benefits
title Treatment of Pregnant Women with Ivermectin during Mass Drug Distribution: Time to Investigate Its Safety and Potential Benefits
title_full Treatment of Pregnant Women with Ivermectin during Mass Drug Distribution: Time to Investigate Its Safety and Potential Benefits
title_fullStr Treatment of Pregnant Women with Ivermectin during Mass Drug Distribution: Time to Investigate Its Safety and Potential Benefits
title_full_unstemmed Treatment of Pregnant Women with Ivermectin during Mass Drug Distribution: Time to Investigate Its Safety and Potential Benefits
title_short Treatment of Pregnant Women with Ivermectin during Mass Drug Distribution: Time to Investigate Its Safety and Potential Benefits
title_sort treatment of pregnant women with ivermectin during mass drug distribution: time to investigate its safety and potential benefits
topic Viewpoint
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8703637/
https://www.ncbi.nlm.nih.gov/pubmed/34959543
http://dx.doi.org/10.3390/pathogens10121588
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