Safety of a single low-dose of primaquine in addition to standard artemether-lumefantrine regimen for treatment of acute uncomplicated Plasmodium falciparum malaria in Tanzania

Malaria Journal

Volumn 15, Issue 1, 2016, Pages

  Mwaiswelo, Richard ^a   Ngasala, Billy E ^a   Jovel, Irina ^b   Gosling, Roland ^c,d   Premji, Zul ^e   Poirot, Eugenie ^c,d   Mmbando, Bruno P ^f   Björkman, Anders ^b   Mårtensson, Andreas ^g  

^a MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES   (Tanzania)

^b KAROLINSKA INSTITUTE   (Sweden)

^c UNIVERSITY OF CALIFORNIA   (United States)

^d UNIVERSITY OF CALIFORNIA   (United States)

^e AGA KHAN UNIVERSITY   (Kenya)

^f NATIONAL INSTITUTE FOR MEDICAL RESEARCH   (Tanzania)

^g UPPSALA UNIVERSITY   (Sweden)

Author keywords

Anaemia; Glucose 6 phosphate dehydrogenase; Plasmodium falciparum malaria; Primaquine

Indexed keywords

ARTEMETHER PLUS BENFLUMETOL; GLUCOSE 6 PHOSPHATE DEHYDROGENASE; HEMOGLOBIN; PRIMAQUINE; ANTIMALARIAL AGENT; ARTEMISININ DERIVATIVE; DRUG COMBINATION; ETHANOLAMINE DERIVATIVE; FLUORENE DERIVATIVE;

ABDOMINAL PAIN; ADOLESCENT; ADULT; AGED; ARTICLE; BLISTER; BLURRED VISION; CHILD; CLINICAL EFFECTIVENESS; COLD SORE; CONTROLLED STUDY; DIARRHEA; DISEASE ASSOCIATION; DIZZINESS; DRUG EFFICACY; DRUG RESPONSE; DRUG SAFETY; DRUG TOLERABILITY; ENZYME ACTIVITY; ENZYME ASSAY; FEMALE; FEVER; HEADACHE; HEMOGLOBINURIA; HEMOLYTIC ANEMIA; HETEROZYGOSITY; HOMOZYGOSITY; HUMAN; LOW DRUG DOSE; MAJOR CLINICAL STUDY; MALARIA FALCIPARUM; MALE; NAUSEA; NONHUMAN; OUTCOME ASSESSMENT; PARASITE IDENTIFICATION; PHENOTYPE; PLASMODIUM FALCIPARUM; PRESCHOOL CHILD; RANDOMIZED CONTROLLED TRIAL; RASH; SCHOOL CHILD; SINGLE DRUG DOSE; TANZANIA; VOMITING; WEAKNESS; DRUG COMBINATION; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; GENETICS; GENOTYPING TECHNIQUE; INFANT; MALARIA, FALCIPARUM; MIDDLE AGED; PATHOLOGY; SINGLE BLIND PROCEDURE; VERY ELDERLY; YOUNG ADULT;

ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; ANTIMALARIALS; ARTEMISININS; CHILD; CHILD, PRESCHOOL; DRUG COMBINATIONS; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; ETHANOLAMINES; FEMALE; FLUORENES; GENOTYPING TECHNIQUES; GLUCOSEPHOSPHATE DEHYDROGENASE; HEMOGLOBINS; HUMANS; INFANT; MALARIA, FALCIPARUM; MALE; MIDDLE AGED; PRIMAQUINE; SINGLE-BLIND METHOD; TANZANIA; YOUNG ADULT;

EID: 84975495306     PISSN: None     EISSN: 14752875     Source Type: Journal    
DOI: 10.1186/s12936-016-1341-3     Document Type: Article

References (29)

1. WHO. World malaria report 2014. Geneva: World Health Organization; 2014.
2. Bhatt S, Weiss DJ, Cameron E, Bisanzio D, Mappin B, Dalrymple U. The effect of malaria control on Plasmodium falciparum in Africa between 2000 and 2015. Nature. 2015;526:207-11.
3. Recht J, Ashley E, White N. Safety of 8-aminoquinoline antimalarial medicines. Geneva: World Health Organization; 2014.
4. Ashley E, Recht J, White N. Primaquine: the risks and the benefits. Malar J. 2014;13:418.
5. Graves PM, Gelband H, Garner P. Primaquine for reducing Plasmodium falciparum transmission. Cochrane database Syst Rev. 2012;9:CD008152.
6. WHO. WHO Evidence Review Group: The Safety and Effectiveness of Single Dose Primaquine as a P. falciparum gametocytocide. Geneva: World Health Organization. 2012.
7. WHO. Guidelines for the treatment of malaria. Third edition. Geneva: World Health Organization. 2015.
8. White NJ, Qiao LG, Qi G, Luzzatto L. Rationale for recommending a lower dose of primaquine as a Plasmodium falciparum gametocytocide in populations where G6PD deficiency is common. Malar J. 2012;11:418.
9. WHO. Proposal for an Evidence Review Group (ERG) on G6PD testing to support increased access to primaquine for radical cure of Plasmodium vivax and for malaria chemoprophylaxis. Geneva: World Health Organization. 2013.
10. Mnzava AEP, Kilama WL. Observations on the distribution of Anopheles gambiae complex in Tanzania. Acta Trop. 1986;43:277-82.
11. Kabula B, Derua Y, Tungu P, Massue DJ, Sambu E, Stanley G, et al. Malaria entomological profile in Tanzania from 1950 to 2010: a review of mosquito distribution, vectorial capacity and insecticide resistance. Tanzan J Health Res. 2011;13:1-14.
12. Carter N, Pamba A, Duparc S, Waitumbi JN. Frequency of glucose-6-phosphate dehydrogenase deficiency in malaria patients from six African countries enrolled in two randomized anti-malarial clinical trials. Malar J. 2011;10:241.
13. Eziefula AC, Bousema T, Yeung S, Kamya M, Owaraganise A, Gabagaya G, et al. Single dose primaquine for clearance of Plasmodium falciparum gametocytes in children with uncomplicated malaria in Uganda: a randomised, controlled, double-blind, dose-ranging trial. Lancet Infect Dis. 2014;14:130-9.
14. Urbaniak GC, Plous S. Research Randomizer (version 4.0) [Computer software]. http://www.randomizer.org/. Accessed 22 Jun 2013.
15. NMCP. Tanzania malaria programme review 2010. Programme review proposal. National Malaria Control Programme. Ministry of Health and Social Welfare. Dar es Salaam, Tanzania. 2010; p. 1-22.
16. Ezzet F, Van Vugt M, Nosten F, Looareesuwan S. Pharmacokinetics and Pharmacodynamics of lumefantrine (Benflumetol) in acute falciparum malaria. Antimicrob Agents Chemother. 2000;44:697-704.
17. Poirot E, Hwang J, Brown J, Gosling R. A safety-monitoring tool for primaquine use to reduce transmission of Plasmodium falciparum. Poster presentation for the 62nd American Society of Tropical Medicine and Hygiene annual conference. Am J Trop Med Hyg. 2013;62:63-71.
18. ICH. International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use. 1994. http://www.ich.org/.
19. Hillmen P, Hall C, Marsh JCW, Elebute M, Bombara MP, Petro BE, et al. Effect of eculizumab on hemolysis and transfusion requirements in patients with paroxysmal nocturnal hemoglobinuria. N Engl J Med. 2004;350:552-9.
20. Hsiang MS, Lin MS, Dokomajilar M, Kemere CPJ. CD D, Greenhouse G. PCR-based pooling of dried blood spots for detection of malaria parasites: optimization and application to a cohort. J Clin Microbiol. 2010;48:3539-43.
21. Shekalaghe S, Drakeley C, Gosling R, Ndaro A, van Meegeren M, Enevold A, et al. Primaquine clears submicroscopic Plasmodium falciparum gametocytes that persist after treatment with sulphadoxine-pyrimethamine and artesunate. PLoS One. 2007;2:1023.
22. Eziefula AC, Pett H, Grignard L, Opus S, Kiggundu M, Kamya MR, et al. Glucose-6-phosphate dehydrogenase status and risk of hemolysis in Plasmodium falciparum-infected African children receiving single-dose primaquine. Antimicrob Agents Chemother. 2014;58:4971-3.
23. Bancone G, Chowwiwat N, Somsakchaicharoen R, Nyo N, Ling CL, Wiladphaingern J, et al. Single low dose primaquine (0.25 mg/kg) does not cause clinically significant haemolysis in G6PD deficient subjects. PLoS One. 2016;11(3):e0151898.
24. Mårtensson A, Strömberg J, Sisowath C, Msellem MI, Gil JP, Montgomery SM, et al. Efficacy of artesunate plus amodiaquine versus that of artemether-lumefantrine for the treatment of uncomplicated childhood Plasmodium falciparum malaria in Zanzibar, Tanzania. Clin Infect Dis. 2005;41:1079-86.
25. Makanga M, Premji Z, Falade C, Karbwang J, Mueller E, Andriano K, et al. Efficacy and safety of the six-dose regimen of artemether-lumefantrine in pediatrics with uncomplicated Plasmodium falciparum malaria: a pooled analysis of individual patient data. Am J Trop Med Hyg. 2006;74:991-8.
26. Kayentao K, Maiga H, Newman RD, McMorrow ML, Hoppe A, Yattara O, et al. Artemisinin-based combinations versus amodiaquine plus sulphadoxine-pyrimethamine for the treatment of uncomplicated malaria in Faladje, Mali. Malar J. 2009;8:5.
27. Beutler E, Duparc S. Glucose-6-phosphate dehydrogenase deficiency and antimalarial drug development. Am J Trop Med Hyg. 2007;77:779-89.
28. Kim S, Nguon C, Guillard B, Duong S, Chy S, Sum S, et al. Performance of the carestart™ G6PD deficiency screening test, a point-of-care diagnostic for primaquine therapy screening. PLoS One. 2011;6:e28357.
29. Luzzatto L, Seneca E. G6PD deficiency: a classic example of pharmacogenetics with on-going clinical implications. Br J Haematol. 2014;64:469-80.