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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
immunology and microbiology
Efficacy and safety of pyronaridine–artesunate for the treatment of uncomplicated Pplasmodium falciparum and plasmodium vivax malaria in Myanmar
American Journal of Tropical Medicine and Hygiene, Volume 103, No. 3, Year 2020
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Description
Four single-arm, prospective, clinical studies of pyronaridine–artesunate efficacy in uncomplicated Plasmodium falciparum or Plasmodium vivax malaria were conducted in Myanmar between 2017 and 2019. Eligible subjects were aged at least 6 years, with microscopically confirmed P. falciparum (n = 196) or P. vivax mono-infection (n = 206). Patients received pyronaridine–artesunate once daily for 3 days with follow-up until day 42 for P. falciparum or day 28 for P. vivax. For the primary efficacy analysis, adequate clinical and parasitological response (ACPR) in the per-protocol population at day 42 for P. falciparum 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). Plasmodium falciparum day-3 parasite clearance was observed for 96.9% (190/196) of patients. Mutations in the P. falciparum Kelch propeller domain (K13) 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 P. vivax, 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 P. vivax studies, 100% (206/206) of patients had day-3 parasite clearance. There were no adverse events. Pyronaridine–artesunate had excellent efficacy in Myanmar against P. falciparum and P. vivax and was well tolerated. This study supports the inclusion of pyronaridine–artesunate in national malaria treatment guidelines for Myanmar. Copyright © 2020 by The American Society of Tropical Medicine and Hygiene
Authors & Co-Authors
Han, Kay Thwe
Myanmar, Yangon
Ministry of Health and Sports
Lin, Khin
Myanmar, Yangon
Ministry of Health and Sports
Aye, Kay Hla
Myanmar, Yangon
Ministry of Health and Sports
Thi, Aung
Myanmar, Yangon
Ministry of Health and Sports
Bustos, Maria Dorina Geluz
Switzerland, Geneva
Organisation Mondiale de la Santé
Borghini-Fuhrer, Isabelle
Switzerland, Geneva
Medicines for Malaria Venture
Ringwald, Pascal
Switzerland, Geneva
Organisation Mondiale de la Santé
Duparc, Stephan
Switzerland, Geneva
Medicines for Malaria Venture
Statistics
Citations: 9
Authors: 8
Affiliations: 3
Identifiers
Doi:
10.4269/ajtmh.20-0185
ISSN:
00029637
Research Areas
Health System And Policy
Infectious Diseases
Study Design
Cross Sectional Study
Cohort Study