Improving clinical management of P. vivax malaria

Photo: Anna Wang/MMV

The WHO Standard Treatment Guildelines and national treatment guidelines recommend treating both the blood-and liver-stages of P. vivax (relapsing) malariaUntil recently, primaquine was the only approved treatment for the relapsing, liver-stage, of the P. vivax life cycle. However, physicians do not always prescribe primaquine to prevent relapse, due to concerns about possible haemolysis in patients deficient in the glucose-6-phosphate dehydrogenase (G6PD) enzyme, limited access to G6PD tests, and poor compliance with the 14-day course of treatment. 

Tafenoquine, a single-dose treatment developed by GSK and MMV for the radical cure of P. vivax malaria, was approved by the US Food and Drug Administration and the Australian Therapeutic Goods Administration in July and September 2018, under the names of Krintafel and Kozenis,1 respectively. 

With these approvals, tafenoquine became the first new medicine for this indication in more than 60 years, marking a major milestone on the road to malaria eradication. Following these stringent regulatory approvals, dossiers have already been submitted to regulatory agencies in priority malaria endemic countries and additional submissions are planned for 2019.  

Tafenoquine shares similar limitations with primaquine regarding use in G6PD-deficient patients and its simplified dosing regimen with a single dose should improve real-life treatment compliance and drug effectiveness. 

The development of a paediatric formulation of tafenoquine is ongoing. The first two cohorts of a paediatric pharmacokinetic bridging study is complete; recruitment of the third cohort is anticipated to be completed by the end of 2019. 

A study is also on-going in Indonesia to assess the safety and efficacy of tafenoquine co-administered with an artemisinin-based combination therapy, DHA-PQP.  

In parallel, PATH in collaboration with industry partners, has developed a quantitative, point-of-care G6PD test to ensure that only patients with adequate levels of G6PD enzymatic activity will receive tafenoquine. 

  • Access in Action

    • MMV and PATH are leading a joint initiative, VivAccess, to support access to a suite of products to address the challenges associated with P. vivax malaria. These include malaria diagnostics, G6PD diagnostics, medicines to treat the symptoms of P. vivax malaria and medicines to treat malaria relapse. Guided by the leadership of national health agencies, VivAccess will provide support in terms of market analytics, technical expertise, and product delivery coordination as countries seek to introduce effective radical cure into national malaria protocols and accelerate progress towards malaria elimination goals.

    • Studies in Brazil and Ethiopia and a pilot implementation in Thailand to assess the operational feasibility of introducing a G6PD test before appropriate radical cure at various levels of the health services are planned in 2020-2021. These initiatives will help to inform potential adoption of tafenoquine in other countries affected by P. vivax malaria. 

    • In addition, mathematical modelling and cost-effectiveness analyses are planned to assess the the potential public health impact of introducing tafenoquine as part of malaria case management to prevent P. vivax relapses in Brazil in 2019-2020.

    Past and current partners:

    GlaxoSmithKline (GSK), PATH

     1. Trademarks owned or licensed by GSK


    Updated October 2019