Efficacy and Safety of Pyronaridine-Artesunate for the Treatment of Uncomplicated Plasmodium falciparum and Plasmodium vivax Malaria in Myanmar

01 Sep 2020

Han KT, Lin K, Han ZY, Myint MK, Aye KH, Thi A, Thapa B, Bustos MD, Borghini-Fuhrer I, Ringwald P, Duparc S

The American Journal of Tropical Medicine and Hygiene
PMID: 32524960

Doi: 10.4269/ajtmh.20-0185

Four single-arm, prospective, clinical studies of pyronaridine-artesunate efficacy in uncomplicated or malaria were conducted in Myanmar between 2017 and 2019. Eligible subjects were aged at least 6 years, with microscopically confirmed ( = 196) or mono-infection ( = 206). Patients received pyronaridine-artesunate once daily for 3 days with follow-up until day 42 for or day 28 for . For the primary efficacy analysis, adequate clinical and parasitological response (ACPR) in the per-protocol population at day 42 for malaria was 100% (88/88; 95% CI: 95.9, 100) in northern Myanmar (Kachin State and northern Shan State), and 100% (101/101; 95% CI: 96.4, 100) in southern Myanmar (Tanintharyi Region and Kayin State). day-3 parasite clearance was observed for 96.9% (190/196) of patients. Mutations in the Kelch propeller domain () were detected in 39.0% (69/177) of isolates: F446I (14.7% [26/177]), R561H (13.0% [23/177]), C580Y (10.2% [18/177]), and P574L (1.1% [2/177]). For day-28 ACPR was 100% (104/104; 95% CI: 96.5, 100) in northern Myanmar and 100% (97/97; 95% CI: 96.3, 100) in southern Myanmar. Across both studies, 100% (206/206) of patients had day-3 parasite clearance. There were no adverse events. Pyronaridine-artesunate had excellent efficacy in Myanmar against and and was well tolerated. This study supports the inclusion of pyronaridine-artesunate in national malaria treatment guidelines for Myanmar.

To view the full article please visit the ASTMH website