Establishment of the Ivermectin Research for Malaria Elimination Network: updating the research agenda

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Abstract

The potential use of ivermectin as an additional vector control tool is receiving increased attention from the malaria elimination community, driven by the increased importance of outdoor/residual malaria transmission and the threat of insecticide resistance where vector tools have been scaled-up. This report summarizes the emerging evidence presented at a side meeting on “Ivermectin for malaria elimination: current status and future directions” at the annual meeting of the American Society of Tropical Medicine and Hygiene in New Orleans on November 4, 2014. One outcome was the creation of the “Ivermectin Research for Malaria Elimination Network” whose main goal is to establish a common research agenda to generate the evidence base on whether ivermectin-based strategies should be added to the emerging arsenal to interrupt malaria transmission.

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Safety, tolerability, and pharmacokinetics of escalating high doses of ivermectin in healthy adult subjects.

C.A. Guzzo, C.I. Furtek, A.G. Porras … (2002)

Safety and pharmacokinetics (PK) of the antiparasitic drug ivermectin, administered in higher and/or more frequent doses than currently approved for human use, were evaluated in a double-blind, placebo-controlled, dose escalation study. Subjects (n = 68) were assigned to one of four panels (3:1, ivermectin/placebo): 30 or 60 mg (three times a week) or 90 or 120 mg (single dose). The 30 mg panel (range: 34 7-594 microg/kg) also received a single dose with food after a 1-week washout. Safety assessments addressed both known ivermectin CNS effects and general toxicity. The primary safety endpoint was mydriasis, accurately quantitated by pupillometry. Ivermectin was generally well tolerated, with no indication of associated CNS toxicity for doses up to 10 times the highest FDA-approved dose of 200 microg/kg. All dose regimens had a mydriatic effect similar to placebo. Adverse experiences were similar between ivermectin and placebo and did not increase with dose. Following single doses of 30 to 120 mg, AUC and Cmax were generally dose proportional, with t(max) approximately 4 hours and t1/2 approximately 18 hours. The geometric mean AUC of 30 mg ivermectin was 2.6 times higher when administered with food. Geometric mean AUC ratios (day 7/day 1) were 1.24 and 1.40 for the 30 and 60 mg doses, respectively, indicating that the accumulation of ivermectin given every fourth day is minimal. This study demonstrated that ivermectin is generally well tolerated at these higher doses and more frequent regimens.

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World malaria report 2013

(2014)

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Designing the next generation of medicines for malaria control and eradication

Jeremy N Burrows, Rob Hooft van Huijsduijnen, Jörg Möhrle … (2013)

In the fight against malaria new medicines are an essential weapon. For the parts of the world where the current gold standard artemisinin combination therapies are active, significant improvements can still be made: for example combination medicines which allow for single dose regimens, cheaper, safer and more effective medicines, or improved stability under field conditions. For those parts of the world where the existing combinations show less than optimal activity, the priority is to have activity against emerging resistant strains, and other criteria take a secondary role. For new medicines to be optimal in malaria control they must also be able to reduce transmission and prevent relapse of dormant forms: additional constraints on a combination medicine. In the absence of a highly effective vaccine, new medicines are also needed to protect patient populations. In this paper, an outline definition of the ideal and minimally acceptable characteristics of the types of clinical candidate molecule which are needed (target candidate profiles) is suggested. In addition, the optimal and minimally acceptable characteristics of combination medicines are outlined (target product profiles). MMV presents now a suggested framework for combining the new candidates to produce the new medicines. Sustained investment over the next decade in discovery and development of new molecules is essential to enable the long-term delivery of the medicines needed to combat malaria.

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Author and article information

Contributors

Carlos J Chaccour: carlos.chaccour@isglobal.org

N Regina Rabinovich: regina.rabinovich@isglobal.org

Hannah Slater: hannah.slater08@imperial.ac.uk

Sara E Canavati: saracanavati@yahoo.com

Teun Bousema: teun.bousema@radboudumc.nl

Marcus Lacerda: marcuslacerda.br@gmail.com

Feiko ter Kuile: feiko.terkuile@lstmed.ac.uk

Chris Drakeley: Chris.Drakeley@lshtm.ac.uk

Quique Bassat: quique.bassat@isglobal.org

Brian D Foy: Brian.Foy@ColoState.EDU

Kevin Kobylinski: Kevin.Kobylinski.gst@afrims.org

Journal

Journal ID (nlm-ta): Malar J

Journal ID (iso-abbrev): Malar. J

Title: Malaria Journal

Publisher: BioMed Central (London )

ISSN (Electronic): 1475-2875

Publication date (Electronic): 11 June 2015

Publication date PMC-release: 11 June 2015

Publication date Collection: 2015

Volume: 14

Electronic Location Identifier: 243

Affiliations

[ ]Department of Internal Medicine, Clinica Universidad de Navarra, Pamplona, Spain

[ ]ISGlobal, Barcelona Ctr. Int. Health Res. (CRESIB), Hospital Clínic - Universitat de Barcelona, Barcelona, Spain

[ ]Instituto de Salud Tropical, Universidad de Navarra, Pamplona, Spain

[ ]Harvard T.H. Chan School of Public Health, Boston, MA USA

[ ]Department of Infectious Disease Epidemiology, MRC Centre for Outbreak Analysis and Modelling, Imperial College London, London, UK

[ ]Department of Clinical Tropical Medicine, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand

[ ]Radboud University Medical Center, Nijmegen, The Netherlands

[ ]Fundação de Medicina Tropical Dr. Heitor Vieira Dourado/FIOCRUZ, Manaus, Brazil

[ ]Liverpool School of Tropical Medicine, Liverpool, UK

[ ]Malaria Centre, London School of Tropical Medicine and Hygiene, London, UK

[ ]Centro de Investigação em Saúde de Manhiça (CISM), Maputo, Mozambique

[ ]Department of Microbiology, Arthropod-borne and Infectious Diseases Laboratory, Immunology and Pathology, Colorado State University, Fort Collins, CO USA

[ ]Department of Entomology, Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand

[ ]Entomology Branch, Walter Reed Institute of Research, Silver Spring, MD USA

Article

Publisher ID: 691

DOI: 10.1186/s12936-015-0691-6

PMC ID: 4475618

PubMed ID: 26068560

SO-VID: a05a3136-6b62-4275-b022-b11792ad2590

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This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

History

Date received : 7 March 2015

Date accepted : 7 April 2015

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ScienceOpen disciplines: Infectious disease & Microbiology

Keywords: ivermectin,endectocides,vector control,residual malaria transmission,malaria elimination,research agenda

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ScienceOpen disciplines: Infectious disease & Microbiology

Keywords: ivermectin, endectocides, vector control, residual malaria transmission, malaria elimination, research agenda

Establishment of the Ivermectin Research for Malaria Elimination Network: updating the research agenda

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Most cited references 31

Safety, tolerability, and pharmacokinetics of escalating high doses of ivermectin in healthy adult subjects.

World malaria report 2013

Designing the next generation of medicines for malaria control and eradication

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