Safety and therapeutic efficacy of artemether-lumefantrine in the treatment of uncomplicated Plasmodium falciparum malaria at Shecha health centre, Arba Minch, Ethiopia

Abstract

Background In 2004, Ethiopia adopted artemether-lumefantrine (AL, Coartem®) as first-line treatment for the management of uncomplicated Plasmodium falciparum malaria. Continuous monitoring of AL therapeutic efficacy is crucial in Ethiopia, as per the World Health Organization (WHO) recommendation. This study aimed to assess the therapeutic efficacy of AL in the treatment of uncomplicated P. falciparum infection. Methods A 28 day onearm, prospective evaluation of the clinical and parasitological response to AL was conducted at Shecha Health Centre, Arba Minch town, Southern Ethiopia. Patients were treated with six-dose regimen of AL over three days and monitored for 28 days with clinical and laboratory assessments. Participant recruitment and outcome classification was done in accordance with the 2009 WHO methods for surveillance of anti-malarial drug efficacy guidelines. Results A total of 88 study participants were enrolled and 69 of them completed the study with adequate clinical and parasitological response. Two late parasitological failures were observed, of which one was classified as a recrudescence by polymerase chain reaction (PCR). The PCRcorrected cure rate was 98.6% (95% CI 92.3–100). AL demonstrated a rapid parasite and fever clearance with no parasitaemia on day 2 and febrile cases on day 3. Gametocyte clearance was complete by day three. No serious adverse events were reported during the 28 days follow-up. Conclusion The study demonstrated high therapeutic efficacy and good safety profile of AL. This suggests the continuation of AL as the first-line drug for the treatment of uncomplicated P. falciparum malaria in Ethiopia. Periodic therapeutic efficacy studies and monitoring of markers of resistance are recommended for early detection of resistant parasites.

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“…In Tanzania, AL were observed to have therapeutic efficacy of 98% which is the WHO recommended threshold and remain well tolerated in the country ( 96 ). The therapeutic efficacy of AL in Ethiopia was 98.6% (95% CI 92.3–100) for malaria infection, which suggests the continuation of AL as the first-line antimalarial drug for the treatment of uncomplicated plasmodium falciparum malaria in Ethiopia ( 97 ). Abacassamo et al assessed the clinical efficacy and parasitological response of Plasmodium falciparum to antimalarial drugs, he found that the therapeutic efficacy of 91.6% of amodiaquine (AQ) was better than that of 82.7% of sulphadoxine–pyrimethamine (SP) and 47.1% of chloroquine (CQ) to malaria infection ( 98 ).…”