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  

作　　者：Yapo Thomas Aba Kalou Dibert Zika Martine Tatiana Yapo Serge Brice Assi Offianan Touré Jean-Marie Karidioula Tiacoh Landry N’Guessan N’guetta Didier Kanga Emmanuel Bissagnené Yapo Thomas Aba;Kalou Dibert Zika;Martine Tatiana Yapo;Serge Brice Assi;Offianan Touré;Jean-Marie Karidioula;Tiacoh Landry N’Guessan;N’guetta Didier Kanga;Emmanuel Bissagnené(Infectious and Tropical Diseases Department, Alassane Ouattara Université, Bouaké, Cte d’Ivoire;Scientific Group Supporting National Malaria Control Program, Abidjan, Cte d’Ivoire;Parasitology and Mycology Department, Alassane Ouattara Université, Bouaké, Cte d’Ivoire;Pierre Richet Institute, Bouake, Cte d’Ivoire;Malaria Department, Pasteur Institute, Abidjan, Cte d’Ivoire)

机构地区：[1]Infectious and Tropical Diseases Department, Alassane Ouattara Université, Bouaké, Cte d’Ivoire [2]Scientific Group Supporting National Malaria Control Program, Abidjan, Cte d’Ivoire [3]Parasitology and Mycology Department, Alassane Ouattara Université, Bouaké, Cte d’Ivoire [4]Pierre Richet Institute, Bouake, Cte d’Ivoire [5]Malaria Department, Pasteur Institute, Abidjan, Cte d’Ivoire

出　　处：《Advances in Infectious Diseases》2024年第4期682-690,共9页传染病进展(英文)

摘　　要：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.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.

关 键 词：Efficacy Artéfan®/Coartem® Plasmodium falciparum Malaria Côte d’Ivoire 

分 类 号：D73[政治法律—政治学]