1921
Volume 103, Issue 3
  • ISSN: 0002-9637
  • E-ISSN: 1476-1645

Abstract

Abstract.

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 , the 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.

[open-access] This is an open-access article distributed under the terms of the Creative Commons Attribution (CC-BY) License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

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  • Received : 11 Mar 2020
  • Accepted : 21 Apr 2020
  • Published online : 08 Jun 2020
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