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Active Pharmacovigilance for Primaquine Radical Cure of Plasmodium vivax Malaria in Odisha, India. | LitMetric

AI Article Synopsis

  • Plasmodium vivax malaria treatment in patients requires the use of chloroquine and primaquine, but primaquine can cause hemolysis in individuals with glucose-6-phosphate dehydrogenase deficiency (G6PDd).
  • A study in Odisha, India, involving 100 malaria patients assessed the safety of chloroquine and primaquine, revealing a mean hemoglobin decline of -0.62 g/dL in males and -0.24 g/dL in females, with a small percentage experiencing significant drops without symptoms of hemolysis.
  • G6PDd prevalence was higher in tribal populations (12.0%) compared to nontribal (3.1%), indicating a need for awareness and screening to prevent

Article Abstract

Plasmodium vivax malaria elimination requires radical cure with chloroquine/primaquine. However, primaquine causes hemolysis in glucose-6-phosphate dehydrogenase-deficient (G6PDd) individuals. Between February 2016 and July 2017 in Odisha State, India, a prospective, observational, active pharmacovigilance study assessed the hematologic safety of directly observed 25 mg/kg chloroquine over 3 days plus primaquine 0.25 mg/kg/day for 14 days in 100 P. vivax patients (≥ 1 year old) with hemoglobin (Hb) ≥ 7 g/dL. Pretreatment G6PDd screening was not done, but patients were advised on hemolysis signs and symptoms using a visual aid. For evaluable patients, the mean absolute change in Hb between day 0 and day 7 was -0.62 g/dL (95% confidence interval [CI]: -0.93, -0.31) for males (N = 53) versus -0.24 g/dL (95%CI: -0.59, 0.10) for females (N = 45; P = 0.034). Hemoglobin declines ≥ 3 g/dL occurred in 5/99 (5.1%) patients (three males, two females); none had concurrent clinical symptoms of hemolysis. Based on G6PD qualitative testing after study completion, three had a G6PD-normal phenotype, one female was confirmed by genotyping as G6PDd heterozygous, and one male had an unknown phenotype. A G6PDd prevalence survey was conducted between August 2017 and March 2018 in the same region using qualitative G6PD testing, confirmed by genotyping. G6PDd prevalence was 12.0% (14/117) in tribal versus 3.1% (16/509) in nontribal populations, with G6PD Orissa identified in 29/30 (96.7%) of G6PDd samples. Following chloroquine/primaquine, notable Hb declines were observed in this population that were not recognized by patients based on clinical signs and symptoms.

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Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8922502PMC
http://dx.doi.org/10.4269/ajtmh.21-0816DOI Listing

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