Randomized, double-blind study of the safety, tolerability, and efficacy of tafenoquine versus mefloquine for malaria prophylaxis in nonimmune subjects

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 and Tafenoquine Study Team (2010) Randomized, double-blind study of the safety, tolerability, and efficacy of tafenoquine versus mefloquine for malaria prophylaxis in nonimmune subjects. Antimicrobial Agents and Chemotherapy, 54 2: 792-798. doi:10.1128/AAC.00354-09

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Author 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
Tafenoquine Study Team
Title Randomized, double-blind study of the safety, tolerability, and efficacy of tafenoquine versus mefloquine for malaria prophylaxis in nonimmune subjects
Journal name Antimicrobial Agents and Chemotherapy   Check publisher's open access policy
ISSN 0066-4804
1098-6596
Publication date 2010-02
Year available 2009
Sub-type Article (original research)
DOI 10.1128/AAC.00354-09
Open Access Status File (Publisher version)
Volume 54
Issue 2
Start page 792
End page 798
Total pages 7
Place of publication Washington, DC, United States
Publisher American Society for Microbiology
Collection year 2011
Language eng
Formatted abstract
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. Copyright © 2010, American Society for Microbiology. All Rights Reserved.
Keyword Australian defence force
Plasmodium-falciparum malaria
East Timor
Controlled trial
Q-Index Code C1
Q-Index Status Confirmed Code
Institutional Status UQ
Additional Notes Available online 7 December 2009

 
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Created: Sun, 07 Feb 2010, 00:09:25 EST