Safety of single low-dose primaquine in glucose-6-phosphate dehydrogenase deficient falciparum-infected African males: Two open-label, randomized, safety trials

Background Primaquine (PQ) actively clears mature Plasmodium falciparum gametocytes but in glu-cose-6-phosphate dehydrogenase deficient (G6PDd) individuals can cause hemolysis. We assessed the safety of low-dose PQ in combination with artemether-lumefantrine

[1]  J. Ndiaye,et al.  Safety and Efficacy of Adding a Single Low Dose of Primaquine to the Treatment of Adult Patients With Plasmodium falciparum Malaria in Senegal, to Reduce Gametocyte Carriage: A Randomized Controlled Trial , 2017, Clinical infectious diseases : an official publication of the Infectious Diseases Society of America.

[2]  Hannah C. Slater,et al.  Mathematical Modelling to Guide Drug Development for Malaria Elimination , 2017, Trends in parasitology.

[3]  A. Dicko,et al.  Comparison of molecular quantification of Plasmodium falciparum gametocytes by Pfs25 qRT-PCR and QT-NASBA in relation to mosquito infectivity , 2016, Malaria Journal.

[4]  B. Ngasala,et al.  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 , 2016, Malaria Journal.

[5]  A. Dicko,et al.  Primaquine to reduce transmission of Plasmodium falciparum malaria in Mali: a single-blind, dose-ranging, adaptive randomised phase 2 trial. , 2016, The Lancet. Infectious diseases.

[6]  F. Nosten,et al.  Single Low Dose Primaquine (0.25mg/kg) Does Not Cause Clinically Significant Haemolysis in G6PD Deficient Subjects , 2016, PloS one.

[7]  T. Bousema,et al.  Single low dose primaquine to reduce gametocyte carriage and Plasmodium falciparum transmission after artemether-lumefantrine in children with asymptomatic infection: a randomised, double-blind, placebo-controlled trial , 2016, BMC Medicine.

[8]  J. Rubio,et al.  Tafenoquine treatment of Plasmodium vivax malaria: suggestive evidence that CYP2D6 reduced metabolism is not associated with relapse in the Phase 2b DETECTIVE trial , 2016, Malaria Journal.

[9]  I. Elyazar,et al.  Randomized trial of primaquine hypnozoitocidal efficacy when administered with artemisinin-combined blood schizontocides for radical cure of Plasmodium vivax in Indonesia , 2015, BMC Medicine.

[10]  Emmaculate Lum,et al.  Malarial Anaemia and Anaemia Severity in Apparently Healthy Primary School Children in Urban and Rural Settings in the Mount Cameroon Area: Cross Sectional Survey , 2015, PloS one.

[11]  T. Bousema,et al.  The gametocytocidal efficacy of primaquine in malaria asymptomatic carriers treated with dihydroartemisinin-piperaquine in The Gambia (PRINOGAM): study protocol for a randomised controlled trial , 2015, Trials.

[12]  B. Tekwani,et al.  Differential CYP 2D6 Metabolism Alters Primaquine Pharmacokinetics , 2015, Antimicrobial Agents and Chemotherapy.

[13]  T. Bousema,et al.  Glucose-6-Phosphate Dehydrogenase Status and Risk of Hemolysis in Plasmodium falciparum-Infected African Children Receiving Single-Dose Primaquine , 2014, Antimicrobial Agents and Chemotherapy.

[14]  J. Crump,et al.  Evaluation of In-Hospital Management for Febrile Illness in Northern Tanzania before and after 2010 World Health Organization Guidelines for the Treatment of Malaria , 2014, PloS one.

[15]  T. Bousema,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. , 2014, The Lancet. Infectious diseases.

[16]  J. Swen,et al.  Challenges in CYP2D6 phenotype assignment from genotype data: a critical assessment and call for standardization. , 2014, Current drug metabolism.

[17]  David L. Smith,et al.  Modeling Within-Host Effects of Drugs on Plasmodium falciparum Transmission and Prospects for Malaria Elimination , 2014, PLoS Comput. Biol..

[18]  Q. Cheng,et al.  G6PD testing in support of treatment and elimination of malaria: recommendations for evaluation of G6PD tests , 2013, Malaria Journal.

[19]  D. Caridha,et al.  The metabolism of primaquine to its active metabolite is dependent on CYP 2D6 , 2013, Malaria Journal.

[20]  D. Caridha,et al.  An in vivo drug screening model using glucose-6-phosphate dehydrogenase deficient mice to predict the hemolytic toxicity of 8-aminoquinolines. , 2013, The American journal of tropical medicine and hygiene.

[21]  L. Okell,et al.  Malaria transmission after artemether-lumefantrine and dihydroartemisinin-piperaquine: a randomized trial. , 2013, The Journal of infectious diseases.

[22]  N. White.  Primaquine to prevent transmission of falciparum malaria. , 2013, The Lancet. Infectious diseases.

[23]  I. Elyazar,et al.  Randomized, Open-Label Trial of Primaquine against Vivax Malaria Relapse in Indonesia , 2012, Antimicrobial Agents and Chemotherapy.

[24]  T. Bousema,et al.  Rationale for short course primaquine in Africa to interrupt malaria transmission , 2012, Malaria Journal.

[25]  A. Gaedigk,et al.  CYP2D6 update: revised nomenclature for CYP2D7/2D6 hybrid genes. , 2012, Pharmacogenetics and genomics.

[26]  Q. Bassat,et al.  Tolerability and Safety of Primaquine in Papua New Guinean Children 1 to 10 Years of Age , 2012, Antimicrobial Agents and Chemotherapy.

[27]  S. Hoffman,et al.  Quantitative assessment of Plasmodium falciparum sexual development reveals potent transmission-blocking activity by methylene blue , 2011, Proceedings of the National Academy of Sciences.

[28]  Teun Bousema,et al.  Epidemiology and Infectivity of Plasmodium falciparum and Plasmodium vivax Gametocytes in Relation to Malaria Control and Elimination , 2011, Clinical Microbiology Reviews.

[29]  David Schellenberg,et al.  A Research Agenda for Malaria Eradication: Diagnoses and Diagnostics , 2011, PLoS medicine.

[30]  T. Bousema,et al.  In Tanzania, Hemolysis after a Single Dose of Primaquine Coadministered with an Artemisinin Is Not Restricted to Glucose-6-Phosphate Dehydrogenase-Deficient (G6PD A−) Individuals , 2010, Antimicrobial Agents and Chemotherapy.

[31]  Paul Garner,et al.  Artemisinin-based combination therapy for treating uncomplicated malaria. , 2009, The Cochrane database of systematic reviews.

[32]  Pardis C Sabeti,et al.  Allelic heterogeneity of G6PD deficiency in West Africa and severe malaria susceptibility , 2009, European Journal of Human Genetics.

[33]  Teun Bousema,et al.  Reduction of transmission from malaria patients by artemisinin combination therapies: a pooled analysis of six randomized trials , 2008, Malaria Journal.

[34]  A. Gaedigk,et al.  The CYP2D6 Activity Score: Translating Genotype Information into a Qualitative Measure of Phenotype , 2008, Clinical pharmacology and therapeutics.

[35]  T. Bousema,et al.  Primaquine Clears Submicroscopic Plasmodium falciparum Gametocytes that Persist after Treatment with Sulphadoxine-Pyrimethamine and Artesunate , 2007, PloS one.

[36]  Ernest Beutler,et al.  Glucose-6-phosphate dehydrogenase deficiency and antimalarial drug development. , 2007, The American journal of tropical medicine and hygiene.

[37]  S. Hoffman,et al.  Primaquine therapy for malaria. , 2004, Clinical infectious diseases : an official publication of the Infectious Diseases Society of America.

[38]  R. Price,et al.  Factors contributing to anemia after uncomplicated falciparum malaria. , 2001, The American journal of tropical medicine and hygiene.

[39]  C. Drakeley,et al.  Artesunate reduces but does not prevent posttreatment transmission of Plasmodium falciparum to Anopheles gambiae. , 2001, The Journal of infectious diseases.

[40]  P. Reeve,et al.  Acute intravascular haemolysis in Vanuatu following a single dose of primaquine in individuals with glucose-6-phosphate dehydrogenase deficiency. , 1992, The Journal of tropical medicine and hygiene.

[41]  R S Galen,et al.  Application of the predictive value model in the analysis of test effectiveness. , 1982, Clinics in laboratory medicine.

[42]  R. Galen,et al.  The predictive value of serum haptoglobin in hemolytic disease. , 1980, JAMA.

[43]  J. Kaplan,et al.  International Committee for Standardization in Haematology: Recommended Screening Test for Glucose‐6‐Phosphate Dehydrogenase (G‐6‐PD) Deficiency , 1979, British journal of haematology.

[44]  H. Notopuro,et al.  Glucose-6-phosphate dehydrogenase deficiency. , 1972, Paediatrica Indonesiana.

[45]  R. J. Dern,et al.  The hemolytic effect of primaquine. IV. The relationship of cell age to hemolysis. , 1954, The Journal of laboratory and clinical medicine.

[46]  E. Ashley,et al.  Primaquine: the risks and the benefits , 2014, Malaria Journal.

[47]  A. Kleinman,et al.  Primaquine Failure and Cytochrome P-450 2D6 in Plasmodium vivax Malaria , 2013 .

[48]  R. J. Dern,et al.  The hemolytic effect of primaquine V. Primaquine sensitivity as a manifestation of a multiple drug sensitivity. , 1981, The Journal of laboratory and clinical medicine.

[49]  A. Tarlov,et al.  Mitigation of the haemolytic effect of primaquine and enhancement of its action against exoerythrocytic forms of the Chesson strain of Piasmodium vivax by intermittent regimens of drug administration: a preliminary report. , 1960, Bulletin of the World Health Organization.

[50]  R. J. Dern,et al.  The hemolytic effect of primaquine. V. Primaquine sensitivity as a manifestation of a multiple drug sensitivity. , 1955, The Journal of laboratory and clinical medicine.