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Success Story:Pyronaridine-Artesunate (Pyramax®) for the Treatment of Artemisinin and Piperaquine-Resistant Plasmodium falciparum in the Central Highlands of Vietnam

What is Plasmodium falciparum? Plasmodium falciparum is a unicellular protozoan parasite of humans and the deadliest species of Plasmodium that causes malaria in humans. The parasite is transmitted through the bite of a female Anopheles mosquito and causes the disease’s most dangerous form, falciparum malaria.

Problem Overview: 

    • The rise in Plasmodium falciparum resistance to dihydroartemisinin-piperaquine in Vietnam justifies the need to evaluate alternative artemisinin combination therapies. Between July 2018 and October 2019, a single-arm trial of pyronaridine-artesunate (Pyramax®, PA) was conducted in Dak Nong province, Vietnam. PA (3-day course) was administered to adults and children infected with P. falciparum.

Program Activity: 

    • Vysnova worked with its partner MIPM to assess the therapeutic efficacy of pyronaridine-artesunate for the treatment of uncomplicated mono-infections of P. falciparum and P. vivax in an area of reduced susceptibility to artemisinins.
    • Participants with mono-infections of P. falciparum, P. vivax and P. malariae or mixed infections of these Plasmodium species were treated orally with pyronaridine-artesunate (Pyramax®) given daily for 3 days. Participants with mono-infections of P. vivax or mixed infections of P. vivax also received a standard 14-day course of primaquine treatment. 
    • Sample size: 55 patients each for both the P. falciparum and P. vivax mono-infection arms. With the additional inclusions of 10 patients with P. malariae and/or mixed Plasmodium species, the overall sample size goal was 120 patients in Dak Drong Commune in Cu Jut District and Thuan An Commune in Dak Mil District, both in Dak Nong Province with the communes having WHO confirmed reduce susceptibility to artemisinins.
    • Laboratory analysis: Blood Smear Microscopy; Basic hematology and blood biochemistry; Genotyping of Malaria Parasites; Antimalarial Drug Analysis; In Vitro Drug Susceptibility Testing; Pregnancy Test.

Program Outcomes:

    • In partnership with MIPM, Vysnova recruited 50 patients into the study from the Dak Drong commune (Cu Jut district) and Thuan An commune (Dak Mil district).
    • Overall, PA was effective in treating P. falciparum in the Central Highlands of Vietnam in areas of artemisinin and piperaquine-resistant P. falciparum. 
    • Pyramax® was well tolerated in the 50 patients, with no serious adverse events or an adverse event of special interest were reported by the study physicians.
    • The manuscript has now been submitted to AAC.