Chloroquine–Primaquine Therapeutic Efficacy, Safety, and Plasma Levels in Patients with Uncomplicated Plasmodium vivax Malaria in a Colombian Pacific Region

Abstract

In Colombia, published studies for the treatment of uncomplicated Plasmodium vivax malaria with chloroquine-primaquine (CQ-PQ) are scarce. The aim of the study was to evaluate the therapeutic efficacy and safety profile of this combination. A clinical trial was performed in adults with uncomplicated P. vivax malaria using the 28-day World Health Organization validated protocol. Patients received supervised antimalarial treatment and the primary efficacy end point was the clinical and parasitological response. Safety was assessed through adverse events surveillance, and plasma levels of antimalarial drugs were measured. A total of 77 patients were included. Adequate clinical and parasitological response rate diagnosed by thick blood smear examination was achieved in 72 of 73 patients (98.6%) with a complete 28-day follow-up. There were two parasitological therapeutic failures (TFs) (2.9%) on day 28, established by polymerase chain reaction among 68 patients, one of them with a positive film. No adverse events were detected. After completing the antimalarial treatment, all patients reached adequate plasma concentrations of CQ and desethylchloroquine (DECQ), with medians of 302.9 and 104.0 ng/mL, respectively. Uncomplicated P. vivax malaria treatment with CQ-PQ standard treatment was effective and safe in the study population; TFs were not associated with low plasma levels of CQ and DECQ.

Evaluación de la eficacia y seguridad de la monoterapia con cloroquina para tratar malaria gestacional aguda no complicada debida P. vivax, Córdoba, Colombia, 2015-2017

“…En el primer informe (7) se dieron dosis variables de PQ a partir del día 1 y eso no influyó en la eficacia para curar el ataque agudo; en el segundo trabajo (26) dosis estándar de CQ y de PQ para malaria vivax, pero la PQ se dio en diferente cantidad de días (3 vs. 7 días) y tampoco hubo diferencias en la curación del ataque agudo, pero sí en las RR medidas en 120 días (68 % en grupo de 3 días y 34 % en grupo de 7 días). Un informe de 2019 indica una falla terapéutica de 2,9 % detectada el día 28, en dos pacientes de la costa Pacífica tratados con CQ-PQ (27). Con base en lo expuesto, puede asegurarse que la CQ sigue siendo muy eficaz contra la malaria vivax en Colombia en niños, adultos y gestantes, y que la permanencia endémica de ella no puede explicarse como consecuencia de resistencia del parásito al medicamento, a pesar de unos pocos informes que narran eficacia un poco menor de 100 %.…”

Chloroquine and hydroxychloroquine in the treatment of malaria and repurposing in treating COVID-19

“…CQ monotherapy or CQ combined with PQ is the first-line policy for fighting P. vivax in parts of the Americas, South-East Asia, Western Pacific regions, and Eastern Mediterranean regions ( World Health Organization, 2019 ). Therapy efficacy tests have been conducted to confirm high efficacy of CQ or CQ-PQ in Bhutan ( Wangchuk, et al, 2016 ), Colombia ( Mesa-Echeverry, Niebles-Bolívar, & Tobón-Castaño, 2019 ), India ( Rishikesh et al, 2015 ; Saravu et al, 2016 ), Thailand ( Chu et al, 2018 ), Iran ( Azarian et al, 2018 ), Pakistan ( Waqar, Khushdil, & Haque, 2016 ), China-Myanmar border (Hui Liu et al, 2014 ), and Cambodia ( Amaratunga et al, 2014 ). Only a few countries in Africa are with endemic of vivax malaria.…”

Supervised administration of primaquine may enhance adherence to radical cure for P. vivax malaria in India

“…14 Studies in Indian and international settings reveal efficacy of chloroquine-primaquine regimen in uncomplicated P. vivax malaria. 15 , 16 , 17 , 18 , 19 Therefore, it is worthwhile to continue with the existing drugs at optimum compliance rate.…”