Background: Malaria remains a major public health problem, with half the world population at risk of contracting\nmalaria. The effects of Plasmodium vivax on prosperity and longevity have been highlighted in several recent clinical\ncase reports. The first line of vivax treatment drugs has seen no radical innovation for more than 60 years. This study\nintroduces a subtle incremental innovation to vivax treatment: a chloroquine and primaquine co-blister. The co-blister\nincludes a new chloroquine formulation incorporating coated tablets to mask the drugââ?¬â?¢s bitter taste and user-friendly\npackaging containing tablets of each drug, which may improve patient adherence and facilitate the appropriate use\nof the drugs. This new formulation will replace the non-coated chloroquine distributed in Brazil.\nMethods: Patients were orally treated with 150 mg coated chloroquine tablets for 3 days: an initial 450 mg dose,\nfollowed by two 300 mg doses. The patients were treated concomitantly with two 15 mg primaquine tablets for\n7ââ?¬â??9 days, according to their weight. The primary objective of this study was to prove parasitological and clinical cure\nrates above 90 % by day 28.\nResults: This single-arm open-label non-comparative trial was conducted according to the WHO recommended methodology\nfor the surveillance of anti-malarial drug efficacy in the Brazilian Amazon. On day 28, the parasitological and clinical\nresponse was adequate in 98.8 % of patients (CI 95 % 93.4ââ?¬â??100 %). The success rate on day 3 was 100 %, and the cumulative\nsuccess rate by day 28 was 98.8 % (CI 95 % 91.7ââ?¬â??99.8 %). There were no serious adverse events, with most adverse\nevents classified as mild. The pharmacokinetic parameters of chloroquine analysed in whole blood dry spot samples\nshowed mean (coefficient of variation) Cmax and AUC0ââ?¬â??t values of 374.44 (0.35) and 3700.43 (0.36) ng/mL, respectively.\nDiscussion: This study reports an appropriate safety and efficacy profile of a new formulation of coated chloroquine\ntablets for vivax malaria treatment in the Brazilian Amazon. The cure rates meet the WHO efficacy criteria, supporting\ncurrent Brazilian guidelines and the use of the formulation for vivax malaria treatment. Nevertheless, further studies\nshould be conducted to address adherence and the effectiveness of the formulation.
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