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dc.contributor.authorSim Khengen_US
dc.contributor.authorSinoun Muthen_US
dc.contributor.authorWalter R.J. Tayloren_US
dc.contributor.authorNarann Topsen_US
dc.contributor.authorKhem Kosalen_US
dc.contributor.authorKhon Sotheaen_US
dc.contributor.authorPhum Souyen_US
dc.contributor.authorSaorin Kimen_US
dc.contributor.authorChuor Meng Charen_US
dc.contributor.authorChan Vannaen_US
dc.contributor.authorPo Lyen_US
dc.contributor.authorPascal Ringwalden_US
dc.contributor.authorVirak Khieuen_US
dc.contributor.authorAlexandra Kerlegueren_US
dc.contributor.authorPety Toren_US
dc.contributor.authorJohn K. Bairden_US
dc.contributor.authorSteven Bjorgeen_US
dc.contributor.authorDidier Menarden_US
dc.contributor.authorEva Christophelen_US
dc.contributor.otherEntomology and Malaria Controlen_US
dc.contributor.otherHopitaux universitaires de Geneveen_US
dc.contributor.otherMahidol Universityen_US
dc.contributor.otherOddar Meancheyen_US
dc.contributor.otherInstitut Pasteur du Cambodgeen_US
dc.contributor.otherOrganisation Mondiale de la Santeen_US
dc.contributor.otherNuffield Department of Clinical Medicineen_US
dc.contributor.otherThe World Health Organization Regional Office for the Western Pacific philippinesen_US
dc.identifier.citationBMC Medicine. Vol.13, No.1 (2015)en_US
dc.description.abstract© 2015 World Health Organization. Background: Primaquine is used to prevent Plasmodium vivax relapse; however, it is not implemented in many malaria-endemic countries, including Cambodia, for fear of precipitating primaquine-induced acute haemolytic anaemia in patients with glucose-6-phosphate dehydrogenase deficiency (G6PDd). Reluctance to use primaquine is reinforced by a lack of quality safety data. This study was conducted to assess the tolerability of a primaquine regimen in Cambodian severely deficient G6PD variants to ascertain whether a weekly primaquine could be given without testing for G6PDd. Methods: From January 2013 to January 2014, Cambodians with acute vivax malaria were treated with dihydroartemisinin/piperaquine on days (D) 0, 1 and 2 with weekly doses of primaquine 0.75 mg/kg for 8 weeks (starting on D0, last dose on D49), and followed until D56. Participants' G6PD status was confirmed by G6PD genotype and measured G6PD activity. The primary outcome was treatment completion without primaquine toxicity defined as any one of: (1) severe anaemia (haemoglobin [Hb] <7 g/dL), (2) a >25 % fractional fall in Hb from D0, (3) the need for a blood transfusion, (4) haemoglobinuria, (5) acute kidney injury (an increase in baseline serum creatinine >50 %) or (6) methaemoglobinaemia >20 %. Results: We enrolled 75 patients with a median age of 24 years (range 5-63); 63 patients (84 %) were male. Eighteen patients were G6PDd (17/18 had the Viangchan variant) and had D0 G6PD activity ranging from 0.1 to 1.5 U/g Hb (median 0.85 U/g Hb). In the 57 patients with normal G6PD (G6PDn), D0 G6PD activity ranged from 6.9 to 18.5 U/g Hb (median 12 U/g Hb). Median D0 Hb concentrations were similar (P = 0.46) between G6PDd (13 g/dL, range 9.6-16) and G6PDn (13.5 g/dL, range 9-16.3) and reached a nadir on D2 in both groups: 10.8 g/dL (8.2-15.3) versus 12.4 g/dL (8.8-15.2) (P = 0.006), respectively. By D7, five G6PDd patients (27.7 %) had a >25 % fall in Hb, compared to 0 G6PDn patients (P = 0.00049). One of these G6PDd patients required a blood transfusion (D0-D5 Hb, 10.0-7.2 g/dL). No patients developed severe anaemia, haemoglobinuria, a methaemoglobin concentration >4.9 %, or acute kidney injury. Conclusions: Vivax-infected G6PDd Cambodian patients demonstrated significant, mostly transient, falls in Hb and one received a blood transfusion. Weekly primaquine in G6PDd patients mandates medical supervision and pre-treatment screening for G6PD status. The feasibility of implementing a package of G6PDd testing and supervised primaquine should be explored. Trial registration: The trial was registered on 3/1/2013 and the registration number is ACTRN12613000003774.en_US
dc.rightsMahidol Universityen_US
dc.titleTolerability and safety of weekly primaquine against relapse of Plasmodium vivax in Cambodians with glucose-6-phosphate dehydrogenase deficiencyen_US
Appears in Collections:Scopus 2011-2015

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