Therapeutic Efficacy of Pyronaridine-artesunate (Pyramax ® ) Against Uncomplicated Plasmodium Falciparum Infection at Hamusit Health Center, Northwest Ethiopia

Abstract

Abstract Background Malaria remains a major public health problem in the world. Early detection of cases and prompt treatment are the major malaria control strategies implemented in many endemic countries, including Ethiopia. Artemisinin-based combination therapy is currently recommended by the World Health Organization (WHO) for the management of uncomplicated P. falciparum and P. vivax malaria cases. However, resistance to antimalarial drugs is a major challenge to the emergence and rapid spread of drug-resistant Plasmodium strains. Pyronaridine-artesunate (Pyramax) is an artemisinin combination therapy that has shown good efficacy for uncomplicated malaria in large-scale clinical trials conducted in Asia and Africa. This study reports the first therapeutic efficacy profile of Pyronaridine-artesunate against uncomplicated P. falciparum in Ethiopia. Methods A single-arm, prospective study with a 42-day follow-up period was conducted from March to May 2021 at Hamusit health center, according to the WHO protocol. A total of 90 adult P. falciparum mono-infection malaria cases (age ≥ 18 years) consented and were enrolled in the study. A standard single-dose regimen of Pyronaridine-artesunate was administered daily for 3 days, and clinical and parasitological outcomes were assessed at 42 days follow-up. Thick and thin blood films were prepared from capillary blood and examined by microscopy. Hemoglobin was measured using HemoCue® and dried blood spots were collected on day 0 and on the day of failure. Results Out of 90 patients, 86 (95.6%) had completed the 42-day follow-up study period. The overall PCR-corrected cure rate (adequate clinical and parasitological response) was very high at 98.9% (95% CI: 92.2–99.8%) with no serious adverse events. The parasite clearance rate was high with fast resolution of clinical symptoms; 95.6% and 100% of the study participants cleared parasitemia and fever on day 3, respectively. The mean hemoglobin concentration was significantly increased (p < 0.001) on day 14 compared to that on day 0. Conclusion Pyronaridine-artesunate was highly efficacious and safe against uncomplicated P. falciparum in the study population.