Artemether-Lumefantrine in the Treatment of Uncomplicated Plasmodium falciparum Malaria: Insights from the Clinical Evaluation of Two Generic Drugs: Artefan® and Coartem® in Côte d’Ivoire from 2018 to 2019

Introduction: Healthcare practitioners in Côte d’Ivoire have reported low efficacy rates for the Artemether-Lumefantrine (AL) combination in treating uncomplicated malaria. This study aims to compare the therapeutic responses of two generic formulations of this antimalarial agent, Artéfan® and Coartem®, which have been available in Côte d’Ivoire’s healthcare facilities since 2008. Method: We conducted a comparative analysis of a bi-centric clinical trial in Côte d’Ivoire, evaluating the therapeutic efficacy of Artéfan® in Daloa and Coartem® in Ayamé between 2018 and 2019, following the WHO’s 42-day protocol. The primary evaluation metric was the Adequate Clinical and Parasitological Response (ACPR) at day 42 (D42) post-PCR correction. Results: A total of sixty-two patients were included at each site. The fever clearance time was 24 hours in both Daloa and Ayamé. Parasitic clearance occurred in 48 hours in Daloa and 72 hours in Ayamé. In the per-protocol analysis at D42, the ACPR was 92% in Daloa and 98% in Ayamé, with no significant difference noted (p = 0.1). Conclusion: Artéfan® and Coartem® exhibited statistically equivalent therapeutic efficacy. Nonetheless, the Artemether-Lumefantrine combination warrants further surveillance due to notable re-infestation rates.