Randomized, Double-Blind Study of the Safety, Tolerability, and Efficacy of Tafenoquine versus Mefloquine for Malaria Prophylaxis in Nonimmune Subjects

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Published inAntimicrobial Agents and Chemotherapy Vol. 54; no. 2; pp. 792 - 798
Main Authors Nasveld, Peter E., Edstein, Michael D., Reid, Mark, Brennan, Leonard, Harris, Ivor E., Kitchener, Scott J., Leggat, Peter A., Pickford, Philip, Kerr, Caron, Ohrt, Colin, Prescott, William
Format Journal Article
LanguageEnglish
Published Washington, DC American Society for Microbiology 01.02.2010
American Society for Microbiology (ASM)
Subjects
Adult
Aminoquinolines
Aminoquinolines - adverse effects
Aminoquinolines - therapeutic use
Antibiotics. Antiinfectious agents. Antiparasitic agents
Antimalarials
Antimalarials - adverse effects
Antimalarials - therapeutic use
Australia
Biological and medical sciences
Clinical Therapeutics
Double-Blind Method
Female
Human protozoal diseases
Humans
Infectious diseases
Malaria
Malaria - drug therapy
Male
Medical sciences
Mefloquine
Mefloquine - adverse effects
Mefloquine - therapeutic use
Middle Aged
Military Personnel
Parasitic diseases
Pharmacology. Drug treatments
Plasmodium vivax
Protozoal diseases
Treatment Outcome
Young Adult
Australia
East Timor
Human
Antimalarial
Protozoal disease
Mefloquine
Malaria
Toxicity
Treatment efficiency
Parasitosis
Infection
Prevention
Tafenoquine
Randomization
Double blind study
Parasiticide
Safety
Comparative study
Online AccessGet full text
ISSN0066-4804
1098-6596
1070-6283
1098-6596
DOI10.1128/AAC.00354-09

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Abstract Classifications Services AAC Citing Articles Google Scholar PubMed Related Content Social Bookmarking CiteULike Delicious Digg Facebook Google+ Mendeley Reddit StumbleUpon Twitter current issue AAC About AAC Subscribers Authors Reviewers Advertisers Inquiries from the Press Permissions & Commercial Reprints ASM Journals Public Access Policy AAC RSS Feeds 1752 N Street N.W. • Washington DC 20036 202.737.3600 • 202.942.9355 fax • journals@asmusa.org Print ISSN: 0066-4804 Online ISSN: 1098-6596 Copyright © 2014 by the American Society for Microbiology.   For an alternate route to AAC .asm.org, visit: AAC       
AbstractList This study represents the first phase III trial of the safety, tolerability, and effectiveness of tafenoquine for malaria prophylaxis. In a randomized (3:1), double-blinded study, Australian soldiers received weekly malaria prophylaxis with 200 mg tafenoquine (492 subjects) or 250 mg mefloquine (162 subjects) for 6 months on a peacekeeping deployment to East Timor. After returning to Australia, tafenoquine-receiving subjects received a placebo and mefloquine-receiving subjects received 30 mg primaquine daily for 14 days. There were no clinically significant differences between hematological and biochemical parameters of the treatment groups. Treatment-related adverse events for the two groups were similar (tafenoquine, 13.4%; mefloquine, 11.7%). Three subjects on tafenoquine (0.6%) and none on mefloquine discontinued prophylaxis because of possible drug-related adverse events. No diagnoses of malaria occurred for either group during deployment, but 4 cases (0.9%) and 1 case (0.7%) of Plasmodium vivax infection occurred among the tafenoquine and mefloquine groups, respectively, up to 20 weeks after discontinuation of medication. In a subset of subjects recruited for detailed safety assessments, treatment-related mild vortex keratopathy was detected in 93% (69 of 74) of tafenoquine subjects but none of the 21 mefloquine subjects. The vortex keratopathy was not associated with any effect on visual acuity and was fully resolved in all subjects by 1 year. Tafenoquine appears to be safe and well tolerated as malaria prophylaxis. Although the volunteers' precise exposure to malaria could not be proven in this study, tafenoquine appears to be a highly efficacious drug for malaria prophylaxis.This study represents the first phase III trial of the safety, tolerability, and effectiveness of tafenoquine for malaria prophylaxis. In a randomized (3:1), double-blinded study, Australian soldiers received weekly malaria prophylaxis with 200 mg tafenoquine (492 subjects) or 250 mg mefloquine (162 subjects) for 6 months on a peacekeeping deployment to East Timor. After returning to Australia, tafenoquine-receiving subjects received a placebo and mefloquine-receiving subjects received 30 mg primaquine daily for 14 days. There were no clinically significant differences between hematological and biochemical parameters of the treatment groups. Treatment-related adverse events for the two groups were similar (tafenoquine, 13.4%; mefloquine, 11.7%). Three subjects on tafenoquine (0.6%) and none on mefloquine discontinued prophylaxis because of possible drug-related adverse events. No diagnoses of malaria occurred for either group during deployment, but 4 cases (0.9%) and 1 case (0.7%) of Plasmodium vivax infection occurred among the tafenoquine and mefloquine groups, respectively, up to 20 weeks after discontinuation of medication. In a subset of subjects recruited for detailed safety assessments, treatment-related mild vortex keratopathy was detected in 93% (69 of 74) of tafenoquine subjects but none of the 21 mefloquine subjects. The vortex keratopathy was not associated with any effect on visual acuity and was fully resolved in all subjects by 1 year. Tafenoquine appears to be safe and well tolerated as malaria prophylaxis. Although the volunteers' precise exposure to malaria could not be proven in this study, tafenoquine appears to be a highly efficacious drug for malaria prophylaxis.
This study represents the first phase III trial of the safety, tolerability, and effectiveness of tafenoquine for malaria prophylaxis. In a randomized (3:1), double-blinded study, Australian soldiers received weekly malaria prophylaxis with 200 mg tafenoquine (492 subjects) or 250 mg mefloquine (162 subjects) for 6 months on a peacekeeping deployment to East Timor. After returning to Australia, tafenoquine-receiving subjects received a placebo and mefloquine-receiving subjects received 30 mg primaquine daily for 14 days. There were no clinically significant differences between hematological and biochemical parameters of the treatment groups. Treatment-related adverse events for the two groups were similar (tafenoquine, 13.4%; mefloquine, 11.7%). Three subjects on tafenoquine (0.6%) and none on mefloquine discontinued prophylaxis because of possible drug-related adverse events. No diagnoses of malaria occurred for either group during deployment, but 4 cases (0.9%) and 1 case (0.7%) of Plasmodium vivax infection occurred among the tafenoquine and mefloquine groups, respectively, up to 20 weeks after discontinuation of medication. In a subset of subjects recruited for detailed safety assessments, treatment-related mild vortex keratopathy was detected in 93% (69 of 74) of tafenoquine subjects but none of the 21 mefloquine subjects. The vortex keratopathy was not associated with any effect on visual acuity and was fully resolved in all subjects by 1 year. Tafenoquine appears to be safe and well tolerated as malaria prophylaxis. Although the volunteers' precise exposure to malaria could not be proven in this study, tafenoquine appears to be a highly efficacious drug for malaria prophylaxis.
Classifications Services AAC Citing Articles Google Scholar PubMed Related Content Social Bookmarking CiteULike Delicious Digg Facebook Google+ Mendeley Reddit StumbleUpon Twitter current issue AAC About AAC Subscribers Authors Reviewers Advertisers Inquiries from the Press Permissions & Commercial Reprints ASM Journals Public Access Policy AAC RSS Feeds 1752 N Street N.W. • Washington DC 20036 202.737.3600 • 202.942.9355 fax • journals@asmusa.org Print ISSN: 0066-4804 Online ISSN: 1098-6596 Copyright © 2014 by the American Society for Microbiology.   For an alternate route to AAC .asm.org, visit: AAC       
This study represents the first phase III trial of the safety, tolerability, and effectiveness of tafenoquine for malaria prophylaxis. In a randomized (3:1), double-blinded study, Australian soldiers received weekly malaria prophylaxis with 200 mg tafenoquine (492 subjects) or 250 mg mefloquine (162 subjects) for 6 months on a peacekeeping deployment to East Timor. After returning to Australia, tafenoquine-receiving subjects received a placebo and mefloquine-receiving subjects received 30 mg primaquine daily for 14 days. There were no clinically significant differences between hematological and biochemical parameters of the treatment groups. Treatment-related adverse events for the two groups were similar (tafenoquine, 13.4%; mefloquine, 11.7%). Three subjects on tafenoquine (0.6%) and none on mefloquine discontinued prophylaxis because of possible drug-related adverse events. No diagnoses of malaria occurred for either group during deployment, but 4 cases (0.9%) and 1 case (0.7%) of Plasmodium vivax infection occurred among the tafenoquine and mefloquine groups, respectively, up to 20 weeks after discontinuation of medication. In a subset of subjects recruited for detailed safety assessments, treatment-related mild vortex keratopathy was detected in 93% (69 of 74) of tafenoquine subjects but none of the 21 mefloquine subjects. The vortex keratopathy was not associated with any effect on visual acuity and was fully resolved in all subjects by 1 year. Tafenoquine appears to be safe and well tolerated as malaria prophylaxis. Although the volunteers' precise exposure to malaria could not be proven in this study, tafenoquine appears to be a highly efficacious drug for malaria prophylaxis.
Author Michael D. Edstein
Leonard Brennan
Peter A. Leggat
and the Tafenoquine Study Team
Ivor E. Harris
William Prescott
Colin Ohrt
Scott J. Kitchener
Peter E. Nasveld
Caron Kerr
Philip Pickford
Mark Reid
AuthorAffiliation Australian Army Malaria Institute, Brisbane, Queensland, Australia, 1 GlaxoSmithKline Research & Development Limited, Harlow, Essex, United Kingdom, 2 Division of Experimental Therapeutics, Walter Reed Army Institute of Research, Silver Spring, Maryland, 3 U.S. Army Medical Materiel Development Activity, Frederick, Maryland, 4 Centre for Military and Veterans' Health, University of Queensland, Herston, Queensland, Australia 5
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Auliff, Alyson
Russell, Bruce
Frances, Stephen
Aultman, Ann
Potter, Brian
Rowcliffe, Kerryn
Barker, Keith
Staley, John
Galvin, Dominic
Rieckmann, Karl
McLeod-Robertson, Stephen
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Copyright 2015 INIST-CNRS
Copyright © 2010 American Society for Microbiology
Copyright © 2010, American Society for Microbiology 2010
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– notice: Copyright © 2010 American Society for Microbiology
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Issue 2
Keywords Human
Antimalarial
Protozoal disease
Mefloquine
Malaria
Toxicity
Treatment efficiency
Parasitosis
Infection
Prevention
Tafenoquine
Randomization
Double blind study
Parasiticide
Safety
Comparative study
Language English
License CC BY 4.0
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For a list of Tafenoquine Study Team members, see the Acknowledgments.
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PublicationTitle Antimicrobial Agents and Chemotherapy
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This study represents the first phase III trial of the safety, tolerability, and effectiveness of tafenoquine for malaria prophylaxis. In a randomized (3:1),...
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SubjectTerms Adult
Aminoquinolines
Aminoquinolines - adverse effects
Aminoquinolines - therapeutic use
Antibiotics. Antiinfectious agents. Antiparasitic agents
Antimalarials
Antimalarials - adverse effects
Antimalarials - therapeutic use
Australia
Biological and medical sciences
Clinical Therapeutics
Double-Blind Method
Female
Human protozoal diseases
Humans
Infectious diseases
Malaria
Malaria - drug therapy
Male
Medical sciences
Mefloquine
Mefloquine - adverse effects
Mefloquine - therapeutic use
Middle Aged
Military Personnel
Parasitic diseases
Pharmacology. Drug treatments
Plasmodium vivax
Protozoal diseases
Treatment Outcome
Young Adult
Title Randomized, Double-Blind Study of the Safety, Tolerability, and Efficacy of Tafenoquine versus Mefloquine for Malaria Prophylaxis in Nonimmune Subjects
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