Primaquine radical cure in patients with Plasmodium falciparum malaria in areas co-endemic for P falciparum and Plasmodium vivax (PRIMA): a multicentre, open-label, superiority randomised controlled trial

Thriemer, Kamala; Degaga, Tamiru Shibiru; Christian, Michael; Alam, Mohammad Shafiul; Rajasekhar, Megha; Ley, Benedikt; Hossain, Mohammad Sharif; Kibria, Mohammad Golam; Tego, Tedla Teferi; Abate, Dagamawie Tadesse; Weston, Sophie; Mnjala, Hellen; Rumaseb, Angela; Satyagraha, Ari Winasti; Sadhewa, Arkasha; Panggalo, Lydia Vista; Ekawati, Lenny L; Lee, Grant; Anose, Rodas Temesgen; Kiros, Fitsum Getahun; Simpson, Julie A; Karahalios, Amalia; Woyessa, Adugna; Baird, J Kevin; Sutanto, Inge; Hailu, Asrat; Price, Ric N

doi:10.1016/s0140-6736(23)01553-2

Cited by 11 publications

(3 citation statements)

References 29 publications

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“…Defining acceptable tolerability of non-life- threatening events such as gastro-intestinal disturbance is even more difficult. More recent data however further support the use of higher primaquine doses in settings where G6PD testing can be provided (14, 31–33).…”

Section: Discussionmentioning

confidence: 92%

Optimizing test and treat options for Vivax malaria: an options assessment toolkit (OAT) for Asia Pacific National Malaria Control Programs

Acharya,

Shrestha,

Thang

et al. 2024

Preprint

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IntroductionDesigning policy in public health is a complex process requiring decision making that incorporates available evidence and is suitable to a country’s epidemiological and health system context. The main objective of this study was to develop an options assessment toolkit (OAT) to provide a pragmatic and evidence-based approach to the development of policies for the radical cure (prevention of relapse) of vivax malaria for national malaria control programs in the Asia-Pacific region.Materials and methodsThe OAT was developed using participatory research methods and a Delphi process using a sequential multi-phase design, adapted with apre-development phase, adevelopment phase,and afinal development phase.In thepre-development phase, a literature review was conducted to inform the toolkit development. Data collection in thedevelopment phaseconsisted of core research team discussions, multiple rounds of consultation with participants from National Malaria Control Programs (NMP) (online and in person), and two separate modified e-Delphi processes with experts. Thefinal developmentphase was the piloting of the toolkit during the annual meeting of the Asia Pacific Malaria Elimination Network (APMEN) Vivax Working Group.ResultsWe developed a tool kit containing the following elements: i) Baseline Assessment Tool (BAT) to assess the readiness of NMPs for new or improved coverage of radical cure, ii) eight scenarios representative of Asia Pacific region, iii) matching test and treat options based on available options for G6PD testing and radical cure for the given scenarios, iv) an approaches tool to allow NMPs to visualize considerations for policy change process and different implementation strategies/approaches for each test and treat option.ConclusionsThe OAT can support vivax radical cure policy formulation among NMPs and stakeholders tailoring for their unique country context. Future studies are needed to assess the utility and practicality of using the OAT for specific country context.

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Section: Discussionmentioning

confidence: 92%

Optimizing test and treat options for Vivax malaria: an options assessment toolkit (OAT) for Asia Pacific National Malaria Control Programs

Acharya,

Shrestha,

Thang

et al. 2024

Preprint

Self Cite

View full text Add to dashboard Cite

show abstract

“…Defining acceptable tolerability of non-life-threatening events such as gastro-intestinal disturbance is even more difficult. More recent data however further support the use of higher primaquine doses in settings where G6PD testing can be provided [ 14 , 32 , 33 ].…”

Section: Discussionmentioning

confidence: 99%

Optimizing test and treat options for vivax malaria: An options assessment toolkit (OAT) for Asia Pacific national malaria control programs

Acharya,

Shrestha,

Thang

et al. 2024

PLOS Glob Public Health

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Designing policy in public health is a complex process requiring decision making that incorporates available evidence and is suitable to a country’s epidemiological and health system context. The main objective of this study was to develop an options assessment toolkit (OAT) to provide a pragmatic and evidence-based approach to the development of policies for the radical cure (prevention of relapse) of vivax malaria for national malaria control programs in the Asia-Pacific region. The OAT was developed using participatory research methods and a Delphi process using a sequential multi-phase design, adapted with a pre-development phase, a development phase, and a final development phase. In the pre-development phase, a literature review was conducted to inform the toolkit development. Data collection in the development phase consisted of core research team discussions, multiple rounds of consultation with participants from National Malaria Control Programs (NMP) (online and in person), and two separate modified e-Delphi processes with experts. The final development phase was the piloting of the toolkit during the annual meeting of the Asia Pacific Malaria Elimination Network (APMEN) Vivax Working Group. We developed a tool kit containing the following elements: i) Baseline Assessment Tool (BAT) to assess the readiness of NMPs for new or improved coverage of radical cure, ii) eight scenarios representative of Asia Pacific region, iii) matching test and treat options based on available options for G6PD testing and radical cure for the given scenarios, iv) an approaches tool to allow NMPs to visualize considerations for policy change process and different implementation strategies/approaches for each test and treat option. The OAT can support vivax radical cure policy formulation among NMPs and stakeholders tailoring for their unique country context. Future studies are needed to assess the utility and practicality of using the OAT for specific country context.

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“…Doubling the dose of primaquine to 1 mg/kg/day for 7 days versus 0.5 mg/kg/day for 14 days, thus maintaining the same overall dose, resulted in equivalent efficacy [ 39 , 40 ]. In contrast, both drug-related and drug-unrelated adverse events were significantly higher in the 1 mg/kg/day arm when compared to the 0.5 mg/kg/day dosing [ 39 ] and when compared to Plasmodium falciparum standard of care treatment with a single low dose (0.25 mg/kg) primaquine administered [ 41 ]. A higher risk of haemolysis was also found in females with intermediate G6PD activity [ 26 , 42 ].…”

Section: Tafenoquine: Key Findings Of Clinical Efficacy and Safetymentioning

confidence: 99%

Optimal balance of benefit versus risk for tafenoquine in the treatment of Plasmodium vivax malaria

Sharma,

Jones

et al. 2024

Malar J

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A single 300 mg dose of tafenoquine (an 8-aminoquinoline), in combination with a standard 3-day course of chloroquine, is approved in several countries for the radical cure (prevention of relapse) of Plasmodium vivax malaria in patients aged ≥ 16 years. Despite this, questions have arisen on the optimal dose of tafenoquine. Before the availability of tafenoquine, a 3-day course of chloroquine in combination with the 8-aminoquinoline primaquine was the only effective radical cure for vivax malaria. The World Health Organization (WHO)-recommended standard regimen is 14 days of primaquine 0.25 mg/kg/day or 7 days of primaquine 0.5 mg/kg/day in most regions, or 14 days of primaquine 0.5 mg/kg/day in East Asia and Oceania, however the long treatment courses of 7 or 14 days may result in poor adherence and, therefore, low treatment efficacy. A single dose of tafenoquine 300 mg in combination with a 3-day course of chloroquine is an important advancement for the radical cure of vivax malaria in patients without glucose-6-phosphate dehydrogenase (G6PD) deficiency, as the use of a single-dose treatment will improve adherence. Selection of a single 300 mg dose of tafenoquine for the radical cure of P. vivax malaria was based on collective efficacy and safety data from 33 studies involving more than 4000 trial participants who received tafenoquine, including over 800 subjects who received the 300 mg single dose. The safety profile of single-dose tafenoquine 300 mg is similar to that of standard-dosage primaquine 0.25 mg/kg/day for 14 days. Both primaquine and tafenoquine can cause acute haemolytic anaemia in individuals with G6PD deficiency; severe haemolysis can lead to anaemia, kidney damage, and, in some cases, death. Therefore, relapse prevention using an 8-aminoquinoline must be balanced with the need to avoid clinical haemolysis associated with G6PD deficiency. To minimize this risk, the WHO recommends G6PD testing for all individuals before the administration of curative doses of 8-aminoquinolines. In this article, the authors review key efficacy and safety data from the pivotal trials of tafenoquine and argue that the currently approved dose represents a favourable benefit–risk profile.

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Primaquine radical cure in patients with Plasmodium falciparum malaria in areas co-endemic for P falciparum and Plasmodium vivax (PRIMA): a multicentre, open-label, superiority randomised controlled trial

Cited by 11 publications

References 29 publications

Optimizing test and treat options for Vivax malaria: an options assessment toolkit (OAT) for Asia Pacific National Malaria Control Programs

Optimizing test and treat options for Vivax malaria: an options assessment toolkit (OAT) for Asia Pacific National Malaria Control Programs

Optimizing test and treat options for vivax malaria: An options assessment toolkit (OAT) for Asia Pacific national malaria control programs

Optimal balance of benefit versus risk for tafenoquine in the treatment of Plasmodium vivax malaria

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