Therapeutic efficacy of artemether-lumefantrine against uncomplicated Plasmodium falciparum malaria in a high-transmission area in northwest Ethiopia

Abstract

Malaria, particularly due to Plasmodium falciparum, remains a major public health threat in Ethiopia. Artemether-lumefantine (AL) has been the first-line antimalarial drug against uncomplicated P. falciparum malaria in the country since 2004. Regular monitoring of antimalarial drugs is recommended by the World Health Organization (WHO) to help early detection of drug resistant strains of the parasite and contain their rapid spread. The objective of this study was to assess the therapeutic efficacy of AL in a high-transmission setting in Ethiopia. The study site was Setit Humera, northwest Ethiopia. Single-arm prospective study of a 28-day follow-up was conducted from October 2014 to January 2015 according to the revised WHO 2009 drug efficacy study protocol. Study end-points were classified into primary end-point and secondary end-point. While the primary end-point was the day-28 adequate clinical and parasitological response the secondary end-points were clinical and parasitological evaluations (parasite, fever and gametocyte clearance rate, incidence of drug adverse events) and the relative increment in hemoglobin (Hb) level from baseline to day (D) 14 and D28. A total of 92 patients were enrolled and 79 had completed the 28-day follow-up period. The overall cure rate was 98.8% with 95% confidence interval of 0.915–0.998 without polymerase chain reaction correction. The parasite clearance rate was high with fast resolution of clinical symptoms; 100% of the study participants cleared parasitaemia and fever on D3. Gametocyte carriage was reduced from 7% on D0 to 1% on D3 and complete clearance was achieved on D14. Mean Hb concentration significantly increased on D28 compared to that on D14. There was no serious adverse event. AL was efficacious and safe in a high-transmission setting for treatment of uncomplicated falciparum malaria.

Efficacy of Artemisinin-lumefantrine for the treatment of uncomplicated malaria after more than a decade of its use in Kenya

“…However, though the 100% adequate clinical and parasitological response was observed in the present study, the results were comparable with studies in Papua New Guinea which confirms a high efficacy rate 97.8% [45]. These studies agree with the observation in Ethiopia, which shows a high therapeutic cure rate of above 98% [5][6]. The high cure rate of AL, especially in children less than five years is a good sign since treatment failure manifest easily in this age group because of low immunity [46].…”

“…We observed that fever was associated with discomfort and was the major clinical manifestation with the mean baseline body temperature being 37.5±0.62. Artemether-lumefantrine has been reported as a fast-acting drug in case of fever in parts of sub-Saharan Africa [6,[54][55] contrary to data obtained from Southeast Asian countries [29]. Of major concern for ACTs in Africa especially in areas of intense transmission is the sluggish clearance of the parasite thus facilitating the development of resistant strains, necessitating the need for continuous surveillance of its efficacy.…”

“…The component drug, lumefantrine, is a gradually acting drug with a long half-life time ranging from 4-7 days [48]. This leads to successive accumulation of the drug after the completion of the full dose sufficient enough for the elimination of residual parasites and possibly prevention of new infection [6].…”

“…Regrettably, although the malaria vaccine known by its scientific name Mosquirix has offered modest protection against malaria in children in various countries such as Malawi, Ghana, and Kenya, the vaccine may not be available in the next few years and no other highly effective vaccine is on the horizon [5]. This is calls for the integration of preventive chemotherapy and case treatment into main stream malaria interventions [6]. Early case detection and prompt treatment is the mainstay to minimize malaria-related morbidity and mortality with appropriate use of antimalarial drugs remaining the cornerstone of malaria control [1].…”

Artemeter-Lumefantrine therapeutic efficacy, safety and plasma levels in patients with uncomplicated falciparum malaria from the Colombian Pacific región

“…The treatment was generally well tolerated and no serious adverse events were observed. This finding is consistent with other studies in which no serious adverse effects were reported 22,[26][27] . Antimalarial drug's efficacy depends not only on the parasite susceptibility to the drug and on its blood concentration but also on the host's immunity.…”