The tolerability of single low dose primaquine in glucose-6-phosphate deficient and normal falciparum-infected Cambodians View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2019-03-12

AUTHORS

Lek Dysoley, Saorin Kim, Sergio Lopes, Nimol Khim, Steven Bjorges, Samphornarann Top, Chea Huch, Huy Rekol, Nelli Westercamp, Mark M. Fukuda, Jimee Hwang, Arantxa Roca-Feltrer, Mavuto Mukaka, Didier Menard, Walter R. Taylor

ABSTRACT

BACKGROUND: The WHO recommends single low-dose primaquine (SLDPQ, 0.25 mg/kg body weight) in falciparum-infected patients to block malaria transmission and contribute to eliminating multidrug resistant Plasmodium falciparum from the Greater Mekong Sub region (GMS). However, the anxiety regarding PQ-induced acute haemolytic anaemia in glucose-6-phosphate dehydrogenase deficiency (G6PDd) has hindered its use. Therefore, we assessed the tolerability of SLDPQ in Cambodia to inform national policy. METHODS: This open randomised trial of dihydroartemisinin-piperaquine (DHAPP) + SLDPQ vs. DHAPP alone recruited Cambodians aged ≥1 year with acute uncomplicated P. falciparum. Randomisation was 4:1 DHAPP+SLDPQ: DHAPP for G6PDd patients and 1:1 for G6PDn patients, according to the results of the qualitative fluorescent spot test. Definitive G6PD status was determined by genotyping. Day (D) 7 haemoglobin (Hb) concentration was the primary outcome measure. RESULTS: One hundred nine patients (88 males, 21 females), aged 4-76 years (median 23) were enrolled; 12 were G6PDd Viangchan (9 hemizygous males, 3 heterozygous females). Mean nadir Hb occurred on D7 [11.6 (range 6.4 ─ 15.6) g/dL] and was significantly lower (p = 0.040) in G6PDd (n = 9) vs. G6PDn (n = 46) DHAPP+SLDPQ recipients: 10.9 vs. 12.05 g/dL, Δ = -1.15 (95% CI: -2.24 ─ -0.05) g/dL. Three G6PDn patients had D7 Hb concentrations < 8 g/dL; D7-D0 Hbs were 6.4 ─ 6.9, 7.4 ─ 7.4, and 7.5 ─ 8.2 g/dL. For all patients, mean (range) D7-D0 Hb decline was -1.45 (-4.8 ─ 2.4) g/dL, associated significantly with higher D0 Hb, higher D0 parasitaemia, and receiving DHAPP; G6PDd was not a factor. No patient required a blood transfusion. CONCLUSIONS: DHAPP+SLDPQ was associated with modest Hb declines in G6PD Viangchan, a moderately severe variant. Our data augment growing evidence that SLDPQ in SE Asia is well tolerated and appears safe in G6PDd patients. Cambodia is now deploying SLDPQ and this should encourage other GMS countries to follow suit. TRIAL REGISTRATION: The clinicaltrials.gov reference number is NCT02434952 . More... »

PAGES

250

References to SciGraph publications

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  • 2016-06-10. 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 in MALARIA JOURNAL
  • Journal

    TITLE

    BMC Infectious Diseases

    ISSUE

    1

    VOLUME

    19

    Identifiers

    URI

    http://scigraph.springernature.com/pub.10.1186/s12879-019-3862-1

    DOI

    http://dx.doi.org/10.1186/s12879-019-3862-1

    DIMENSIONS

    https://app.dimensions.ai/details/publication/pub.1112767253

    PUBMED

    https://www.ncbi.nlm.nih.gov/pubmed/30871496


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        "description": "BACKGROUND: The WHO recommends single low-dose primaquine (SLDPQ, 0.25\u2009mg/kg body weight) in falciparum-infected patients to block malaria transmission and contribute to eliminating multidrug resistant Plasmodium falciparum from the Greater Mekong Sub region (GMS). However, the anxiety regarding PQ-induced acute haemolytic anaemia in glucose-6-phosphate dehydrogenase deficiency (G6PDd) has hindered its use. Therefore, we assessed the tolerability of SLDPQ in Cambodia to inform national policy.\nMETHODS: This open randomised trial of dihydroartemisinin-piperaquine (DHAPP)\u2009+\u2009SLDPQ vs. DHAPP alone recruited Cambodians aged \u22651\u2009year with acute uncomplicated P. falciparum. Randomisation was 4:1 DHAPP+SLDPQ: DHAPP for G6PDd patients and 1:1 for G6PDn patients, according to the results of the qualitative fluorescent spot test. Definitive G6PD status was determined by genotyping. Day (D) 7 haemoglobin (Hb) concentration was the primary outcome measure.\nRESULTS: One hundred nine patients (88 males, 21 females), aged 4-76\u2009years (median 23) were enrolled; 12 were G6PDd Viangchan (9 hemizygous males, 3 heterozygous females). Mean nadir Hb occurred on D7 [11.6 (range 6.4 \u2500 15.6) g/dL] and was significantly lower (p\u00a0=\u20090.040) in G6PDd (n\u00a0=\u20099) vs. G6PDn (n\u00a0=\u200946) DHAPP+SLDPQ recipients: 10.9 vs. 12.05\u2009g/dL, \u0394\u2009=\u2009-1.15 (95% CI: -2.24 \u2500 -0.05) g/dL. Three G6PDn patients had D7 Hb concentrations <\u20098\u2009g/dL; D7-D0 Hbs were 6.4 \u2500 6.9, 7.4 \u2500 7.4, and 7.5 \u2500 8.2\u2009g/dL. For all patients, mean (range) D7-D0 Hb decline was -1.45 (-4.8 \u2500 2.4) g/dL, associated significantly with higher D0 Hb, higher D0 parasitaemia, and receiving DHAPP; G6PDd was not a factor. No patient required a blood transfusion.\nCONCLUSIONS: DHAPP+SLDPQ was associated with modest Hb declines in G6PD Viangchan, a moderately severe variant. Our data augment growing evidence that SLDPQ in SE Asia is well tolerated and appears safe in G6PDd patients. Cambodia is now deploying SLDPQ and this should encourage other GMS countries to follow suit.\nTRIAL REGISTRATION: The clinicaltrials.gov reference number is NCT02434952 .", 
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    35 schema:description BACKGROUND: The WHO recommends single low-dose primaquine (SLDPQ, 0.25 mg/kg body weight) in falciparum-infected patients to block malaria transmission and contribute to eliminating multidrug resistant Plasmodium falciparum from the Greater Mekong Sub region (GMS). However, the anxiety regarding PQ-induced acute haemolytic anaemia in glucose-6-phosphate dehydrogenase deficiency (G6PDd) has hindered its use. Therefore, we assessed the tolerability of SLDPQ in Cambodia to inform national policy. METHODS: This open randomised trial of dihydroartemisinin-piperaquine (DHAPP) + SLDPQ vs. DHAPP alone recruited Cambodians aged ≥1 year with acute uncomplicated P. falciparum. Randomisation was 4:1 DHAPP+SLDPQ: DHAPP for G6PDd patients and 1:1 for G6PDn patients, according to the results of the qualitative fluorescent spot test. Definitive G6PD status was determined by genotyping. Day (D) 7 haemoglobin (Hb) concentration was the primary outcome measure. RESULTS: One hundred nine patients (88 males, 21 females), aged 4-76 years (median 23) were enrolled; 12 were G6PDd Viangchan (9 hemizygous males, 3 heterozygous females). Mean nadir Hb occurred on D7 [11.6 (range 6.4 ─ 15.6) g/dL] and was significantly lower (p = 0.040) in G6PDd (n = 9) vs. G6PDn (n = 46) DHAPP+SLDPQ recipients: 10.9 vs. 12.05 g/dL, Δ = -1.15 (95% CI: -2.24 ─ -0.05) g/dL. Three G6PDn patients had D7 Hb concentrations < 8 g/dL; D7-D0 Hbs were 6.4 ─ 6.9, 7.4 ─ 7.4, and 7.5 ─ 8.2 g/dL. For all patients, mean (range) D7-D0 Hb decline was -1.45 (-4.8 ─ 2.4) g/dL, associated significantly with higher D0 Hb, higher D0 parasitaemia, and receiving DHAPP; G6PDd was not a factor. No patient required a blood transfusion. CONCLUSIONS: DHAPP+SLDPQ was associated with modest Hb declines in G6PD Viangchan, a moderately severe variant. Our data augment growing evidence that SLDPQ in SE Asia is well tolerated and appears safe in G6PDd patients. Cambodia is now deploying SLDPQ and this should encourage other GMS countries to follow suit. TRIAL REGISTRATION: The clinicaltrials.gov reference number is NCT02434952 .
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