Meta-Analysis

. 2025 Nov 14;24(1):400.

doi: 10.1186/s12936-025-05642-w.

Automated reporting of primaquine dose efficacy, tolerability and safety for Plasmodium vivax malaria using a systematic review and individual patient data meta-analysis

Peta Edler¹, Megha Rajasekhar², David J Price^{1

2}, Ishag Adam³, Ghulam Rahim Awab^{4

5}, Bridget E Barber^{6

7

8}, Larissa W Brasil^{9

10}, Nathália N Chamma-Siqueira¹¹, Cindy S Chu^{12

13}, Liwang Cui¹⁴, André Daher^{15

16}, Margarete do Socorro M Gomes^{17

18}, Lilia Gonzalez-Ceron¹⁹, Matthew J Grigg^{7

8}, Harin Karunajeewa²⁰, Marcus V G Lacerda^{21

22

23}, Simone Ladeia-Andrade^{24

25}, Toby Leslie^{26

27}, Benedikt Ley⁷, Kartini Lidia²⁸, Alejandro Llanos-Cuentas²⁹, Rhea J Longley^{30

31

32}, Laurens Manning^{33

34

35}, Daniel Abebe Mekonnen^{36

37}, Wuelton Marcelo Monteiro^{21

38}, Brioni R Moore^{34

39

40}, Francois Nosten^{12

13}, Ayodhia Pitaloka Pasaribu⁴¹, Dhelio B Pereira^{42

43}, Jeanne Rini Poespoprodjo^{44

45

46}, Sasithon Pukrittayakamee⁴, Komal Raj Rijal^{47

48}, Kavitha Saravu⁴⁹, André M Siqueira⁵⁰, Inge Sutanto⁵¹, Walter R J Taylor^{4

13}, Pham Vinh Thanh⁵², Kamala Thriemer⁷, José Luiz F Vieira⁵³, Nicholas J White^{4

13}, Asnakew K Yeshiwondim⁵⁴, Lina M Zuluaga-Idarraga^{55

56}, Philippe J Guerin^{13

57

58}, Julie A Simpson^{2

59}, Ric N Price^{7

13

59}, Robert J Commons^{60

61

62}; WorldWide Antimalarial Resistance Network (WWARN) Vivax Primaquine Dosing Efficacy, Tolerability and Safety Study Group

Collaborators, Affiliations

Collaborators

WorldWide Antimalarial Resistance Network (WWARN) Vivax Primaquine Dosing Efficacy, Tolerability and Safety Study Group:
Tesfay Abreha, Bipin Adhikari, Mohammad Shafiul Alam, Nicholas M Anstey, Ashenafi Assefa, J Kevin Baird, Sarah C Boyd, Nguyen Hoang Chau, Nicholas P J Day, Tamiru Shibiru Degaga, Arjen M Dondorp, Annette Erhart, Marcelo U Ferreira, Endalamaw Gadisa, Najia Ghanchi, Prakash Ghimire, Justin A Green, Mohammad Anwar Hassanzai, Jimee Hwang, Wasif Ali Khan, Gavin C K W Koh, Rishikesh Kumar, Asrat Hailu Mekuria, Ivo Mueller, Mohammad Nader Naadim, Suaine C Negreiros, Erni J Nelwan, Anielle de Pina-Costa, Mark Rowland, Jetsumon Sattabongkot, Guilherme Suarez-Kurtz, Fitsum G Tadesse, Giselle M R Viana, Lorenz von Seidlein, Timothy William, Charles J Woodrow, Sze-Ann Woon, Adugna Woyessa

Affiliations

¹ Department of Infectious Diseases, The University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Melbourne, VIC, Australia.
² Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, The University of Melbourne, Melbourne, VIC, Australia.
³ Department of Obstetrics and Gynecology, College of Medicine, Qassim University, Buraidah, Saudi Arabia.
⁴ Mahidol Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.
⁵ Department of Public and Global Health, Afghan International Islamic University, Kabul, Afghanistan.
⁶ QIMR Berghofer Medical Research Institute, Brisbane, QLD, Australia.
⁷ Global and Tropical Health Division, Menzies School of Health Research and Charles Darwin University, Darwin, NT, Australia.
⁸ Infectious Diseases Society Sabah-Menzies School of Health Research Clinical Research Unit, Kota Kinabalu, Sabah, Malaysia.
⁹ Diretoria de Ensino e Pesquisa, Fundação de Medicina Tropical Dr. Heitor Vieira Dourado, Manaus, Amazonas, Brazil.
¹⁰ Programa de Pós‑Graduação em Medicina Tropical, Universidade do Estado do Amazonas, Manaus, Amazonas, Brazil.
¹¹ Laboratório de Malária, Instituto Evandro Chagas, Ministério da Saúde do Brasil, Ananindeua, Pará State, Brazil.
¹² Shoklo Malaria Research Unit, Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Mae Sot, Thailand.
¹³ Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, UK.
¹⁴ Department of Internal Medicine, Morsani College of Medicine, University of South Florida, Tampa, FL, USA.
¹⁵ Fiocruz Clinical Research Platform, Oswaldo Cruz Foundation (FIOCRUZ), Rio de Janeiro, Brazil.
¹⁶ Vice‑Presidency of Research and Biological Collections, Oswaldo Cruz Foundation (FIOCRUZ), Rio de Janeiro, Brazil.
¹⁷ Superintendência de Vigilância em Saúde do Estado do Amapá - SVS/AP, Macapá, Amapá, Brazil.
¹⁸ Federal University of aMAPA, Universidade Federal do Amapá - UNIFAP), Macapá, Amapá, Brazil.
¹⁹ Regional Centre for Public Health Research, National Institute for Public Health, Tapachula, Chiapas, Mexico.
²⁰ Department of Medicine-Western Health, Melbourne Medical School, The University of Melbourne, St. Albans, VIC, Australia.
²¹ Fundação de Medicina Tropical Dr Heitor Vieira Dourado, Manaus, Brazil.
²² Instituto Leônidas E Maria Deane, Fiocruz, Manaus, Brazil.
²³ University of Texas Medical Branch, Galveston, USA.
²⁴ Laboratory of Parasitic Diseases, Oswaldo Cruz Institute, Fiocruz, Rio de Janeiro, Brazil.
²⁵ Institute of Hygiene and Tropical Medicine, Global Health and Tropical Medicine, NOVA University of Lisbon, Lisbon, Portugal.
²⁶ Department of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, UK.
²⁷ HealthNet-TPO, Kabul, Afghanistan.
²⁸ The Department of Pharmacology and Therapy, Faculty of Medicine and Veterinary Medicine, Universitas Nusa Cendana, Kupang, Indonesia.
²⁹ Unit of Leishmaniasis and Malaria, Instituto de Medicina Tropical "Alexander Von Humboldt", Universidad Peruana Cayetano Heredia, Lima, Peru.
³⁰ Mahidol Vivax Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.
³¹ Infection and Global Health Division, Walter and Eliza Hall Institute of Medical Research, Melbourne, Australia.
³² Department of Medical Biology, University of Melbourne, Melbourne, Australia.
³³ Medical School, University of Western Australia, Crawley, Australia.
³⁴ Wesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids Institute, Perth, Australia.
³⁵ Department of Infectious Diseases, Fiona Stanley Hospital, Perth, Australia.
³⁶ Malaria and Neglected Tropical Diseases Directorate, Armauer Hansen Research Institute, Addis Ababa, Ethiopia.
³⁷ Haramaya University, Dire Dawa, Ethiopia.
³⁸ Universidade do Estado do Amazonas, Manaus, Brazil.
³⁹ Curtin Medical School, Faculty of Health Science, Curtin University, Perth, Australia.
⁴⁰ Curtin Medical Research Institute, Curtin University, Perth, Australia.
⁴¹ Department of Pediatrics, Medical Faculty, Universitas Sumatera Utara, Medan, North Sumatera, Indonesia.
⁴² Centro de Pesquisa Em Medicina Tropical de Rondonia (CEPEM), Porto Velho, Brazil.
⁴³ Fundação Universidade Federal de Rondonia (UNIR), Porto Velho, Brazil.
⁴⁴ Mimika District Hospital, Timika, Indonesia.
⁴⁵ Timika Malaria Research Programme, Papuan Health and Community Development Foundation, Timika, Indonesia.
⁴⁶ Paediatric Research Office, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia.
⁴⁷ Central Department of Microbiology, Tribhuvan University, Kirtipur, Nepal.
⁴⁸ Department of Clinical Tropical Medicine, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.
⁴⁹ Department of Infectious Diseases, Kasturba Medical College Manipal, Manipal Academy of Higher Education, Manipal, Madhava Nagar, Manipal, Karnataka, India.
⁵⁰ Instituto Nacional de Infectologia Evandro Chagas, Fundação Oswaldo Cruz (Fiocruz), Rio de Janeiro, Brazil.
⁵¹ Department of Parasitology, Faculty of Medicine, University of Indonesia, Jakarta, Indonesia.
⁵² Parasitology and Entomology, National Institute of Malariology, Hanoi, Vietnam.
⁵³ Federal University of Pará (Universidade Federal Do Pará - UFPA), Belém, Pará, Brazil.
⁵⁴ World Health Organization Country Office for Addis Ababa, Addis Ababa, Ethiopia.
⁵⁵ Grupo Malaria, Facultad de Medicina, Universidad de Antioquia, Medellín, Colombia.
⁵⁶ Facultad Nacional de Salud Publica, Universidad de Antioquia, Medellín, Colombia.
⁵⁷ WorldWide Antimalarial Resistance Network (WWARN), Oxford, UK.
⁵⁸ Infectious Diseases Data Observatory (IDDO), Oxford, UK.
⁵⁹ WorldWide Antimalarial Resistance Network (WWARN), Asia-Pacific Regional Centre, Melbourne, Australia.
⁶⁰ Global and Tropical Health Division, Menzies School of Health Research and Charles Darwin University, Darwin, NT, Australia. rob.commons@wwarn.org.
⁶¹ WorldWide Antimalarial Resistance Network (WWARN), Asia-Pacific Regional Centre, Melbourne, Australia. rob.commons@wwarn.org.
⁶² General and Subspecialty Medicine, Grampians Health-Ballarat, Ballarat, Australia. rob.commons@wwarn.org.

PMID: 41239453
PMCID: PMC12619205
DOI: 10.1186/s12936-025-05642-w

Meta-Analysis

Automated reporting of primaquine dose efficacy, tolerability and safety for Plasmodium vivax malaria using a systematic review and individual patient data meta-analysis

Peta Edler et al. Malar J. 2025.

. 2025 Nov 14;24(1):400.

doi: 10.1186/s12936-025-05642-w.

Authors

Collaborators

WorldWide Antimalarial Resistance Network (WWARN) Vivax Primaquine Dosing Efficacy, Tolerability and Safety Study Group:
Tesfay Abreha, Bipin Adhikari, Mohammad Shafiul Alam, Nicholas M Anstey, Ashenafi Assefa, J Kevin Baird, Sarah C Boyd, Nguyen Hoang Chau, Nicholas P J Day, Tamiru Shibiru Degaga, Arjen M Dondorp, Annette Erhart, Marcelo U Ferreira, Endalamaw Gadisa, Najia Ghanchi, Prakash Ghimire, Justin A Green, Mohammad Anwar Hassanzai, Jimee Hwang, Wasif Ali Khan, Gavin C K W Koh, Rishikesh Kumar, Asrat Hailu Mekuria, Ivo Mueller, Mohammad Nader Naadim, Suaine C Negreiros, Erni J Nelwan, Anielle de Pina-Costa, Mark Rowland, Jetsumon Sattabongkot, Guilherme Suarez-Kurtz, Fitsum G Tadesse, Giselle M R Viana, Lorenz von Seidlein, Timothy William, Charles J Woodrow, Sze-Ann Woon, Adugna Woyessa

Affiliations

¹ Department of Infectious Diseases, The University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Melbourne, VIC, Australia.
² Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, The University of Melbourne, Melbourne, VIC, Australia.
³ Department of Obstetrics and Gynecology, College of Medicine, Qassim University, Buraidah, Saudi Arabia.
⁴ Mahidol Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.
⁵ Department of Public and Global Health, Afghan International Islamic University, Kabul, Afghanistan.
⁶ QIMR Berghofer Medical Research Institute, Brisbane, QLD, Australia.
⁷ Global and Tropical Health Division, Menzies School of Health Research and Charles Darwin University, Darwin, NT, Australia.
⁸ Infectious Diseases Society Sabah-Menzies School of Health Research Clinical Research Unit, Kota Kinabalu, Sabah, Malaysia.
⁹ Diretoria de Ensino e Pesquisa, Fundação de Medicina Tropical Dr. Heitor Vieira Dourado, Manaus, Amazonas, Brazil.
¹⁰ Programa de Pós‑Graduação em Medicina Tropical, Universidade do Estado do Amazonas, Manaus, Amazonas, Brazil.
¹¹ Laboratório de Malária, Instituto Evandro Chagas, Ministério da Saúde do Brasil, Ananindeua, Pará State, Brazil.
¹² Shoklo Malaria Research Unit, Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Mae Sot, Thailand.
¹³ Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, UK.
¹⁴ Department of Internal Medicine, Morsani College of Medicine, University of South Florida, Tampa, FL, USA.
¹⁵ Fiocruz Clinical Research Platform, Oswaldo Cruz Foundation (FIOCRUZ), Rio de Janeiro, Brazil.
¹⁶ Vice‑Presidency of Research and Biological Collections, Oswaldo Cruz Foundation (FIOCRUZ), Rio de Janeiro, Brazil.
¹⁷ Superintendência de Vigilância em Saúde do Estado do Amapá - SVS/AP, Macapá, Amapá, Brazil.
¹⁸ Federal University of aMAPA, Universidade Federal do Amapá - UNIFAP), Macapá, Amapá, Brazil.
¹⁹ Regional Centre for Public Health Research, National Institute for Public Health, Tapachula, Chiapas, Mexico.
²⁰ Department of Medicine-Western Health, Melbourne Medical School, The University of Melbourne, St. Albans, VIC, Australia.
²¹ Fundação de Medicina Tropical Dr Heitor Vieira Dourado, Manaus, Brazil.
²² Instituto Leônidas E Maria Deane, Fiocruz, Manaus, Brazil.
²³ University of Texas Medical Branch, Galveston, USA.
²⁴ Laboratory of Parasitic Diseases, Oswaldo Cruz Institute, Fiocruz, Rio de Janeiro, Brazil.
²⁵ Institute of Hygiene and Tropical Medicine, Global Health and Tropical Medicine, NOVA University of Lisbon, Lisbon, Portugal.
²⁶ Department of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, UK.
²⁷ HealthNet-TPO, Kabul, Afghanistan.
²⁸ The Department of Pharmacology and Therapy, Faculty of Medicine and Veterinary Medicine, Universitas Nusa Cendana, Kupang, Indonesia.
²⁹ Unit of Leishmaniasis and Malaria, Instituto de Medicina Tropical "Alexander Von Humboldt", Universidad Peruana Cayetano Heredia, Lima, Peru.
³⁰ Mahidol Vivax Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.
³¹ Infection and Global Health Division, Walter and Eliza Hall Institute of Medical Research, Melbourne, Australia.
³² Department of Medical Biology, University of Melbourne, Melbourne, Australia.
³³ Medical School, University of Western Australia, Crawley, Australia.
³⁴ Wesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids Institute, Perth, Australia.
³⁵ Department of Infectious Diseases, Fiona Stanley Hospital, Perth, Australia.
³⁶ Malaria and Neglected Tropical Diseases Directorate, Armauer Hansen Research Institute, Addis Ababa, Ethiopia.
³⁷ Haramaya University, Dire Dawa, Ethiopia.
³⁸ Universidade do Estado do Amazonas, Manaus, Brazil.
³⁹ Curtin Medical School, Faculty of Health Science, Curtin University, Perth, Australia.
⁴⁰ Curtin Medical Research Institute, Curtin University, Perth, Australia.
⁴¹ Department of Pediatrics, Medical Faculty, Universitas Sumatera Utara, Medan, North Sumatera, Indonesia.
⁴² Centro de Pesquisa Em Medicina Tropical de Rondonia (CEPEM), Porto Velho, Brazil.
⁴³ Fundação Universidade Federal de Rondonia (UNIR), Porto Velho, Brazil.
⁴⁴ Mimika District Hospital, Timika, Indonesia.
⁴⁵ Timika Malaria Research Programme, Papuan Health and Community Development Foundation, Timika, Indonesia.
⁴⁶ Paediatric Research Office, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia.
⁴⁷ Central Department of Microbiology, Tribhuvan University, Kirtipur, Nepal.
⁴⁸ Department of Clinical Tropical Medicine, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.
⁴⁹ Department of Infectious Diseases, Kasturba Medical College Manipal, Manipal Academy of Higher Education, Manipal, Madhava Nagar, Manipal, Karnataka, India.
⁵⁰ Instituto Nacional de Infectologia Evandro Chagas, Fundação Oswaldo Cruz (Fiocruz), Rio de Janeiro, Brazil.
⁵¹ Department of Parasitology, Faculty of Medicine, University of Indonesia, Jakarta, Indonesia.
⁵² Parasitology and Entomology, National Institute of Malariology, Hanoi, Vietnam.
⁵³ Federal University of Pará (Universidade Federal Do Pará - UFPA), Belém, Pará, Brazil.
⁵⁴ World Health Organization Country Office for Addis Ababa, Addis Ababa, Ethiopia.
⁵⁵ Grupo Malaria, Facultad de Medicina, Universidad de Antioquia, Medellín, Colombia.
⁵⁶ Facultad Nacional de Salud Publica, Universidad de Antioquia, Medellín, Colombia.
⁵⁷ WorldWide Antimalarial Resistance Network (WWARN), Oxford, UK.
⁵⁸ Infectious Diseases Data Observatory (IDDO), Oxford, UK.
⁵⁹ WorldWide Antimalarial Resistance Network (WWARN), Asia-Pacific Regional Centre, Melbourne, Australia.
⁶⁰ Global and Tropical Health Division, Menzies School of Health Research and Charles Darwin University, Darwin, NT, Australia. rob.commons@wwarn.org.
⁶¹ WorldWide Antimalarial Resistance Network (WWARN), Asia-Pacific Regional Centre, Melbourne, Australia. rob.commons@wwarn.org.
⁶² General and Subspecialty Medicine, Grampians Health-Ballarat, Ballarat, Australia. rob.commons@wwarn.org.

PMID: 41239453
PMCID: PMC12619205
DOI: 10.1186/s12936-025-05642-w

Abstract

Background: The antirelapse efficacy of primaquine is related to the total dose administered, whereas the risks of haemolysis and gastrointestinal intolerance are associated with the daily dose administered. National Malaria Control Programmes require local information on efficacy, tolerability and safety to optimize antimalarial treatment policies for Plasmodium vivax malaria control and elimination efforts.

Methods: A living systematic review identified efficacy studies of uncomplicated P. vivax malaria including patients treated with daily primaquine regimens, published since January 1, 2000. Available data were pooled and an R Shiny app was developed to integrate statistical analyses performed using R and Stata that assessed the impact of primaquine mg/kg dose on efficacy, hematological safety and gastrointestinal tolerability.

Results: As of January 16, 2025, a total of 9,270 individual patient data records from 41 studies have been collated into the standardized repository. Open-access automated reports were generated for user-selected countries or regions to investigate location specific effects of primaquine dose on efficacy, safety and tolerability. The reports include visual and tabular displays of the outcomes.

Conclusions: These automated reports leverage a large database to provide accessible data for national and regional policy makers and researchers to assess the clinical consequences of different primaquine regimens in different endemic settings. The reports will inform local and regional policy decisions and research priorities in vivax-endemic areas.

Keywords: Plasmodium vivax; Automated report; Dose; Efficacy; Haemolysis; Malaria; Primaquine; Recurrence; Relapse; Tolerability.

PubMed Disclaimer

Conflict of interest statement

Declarations. Ethics approval and consent to participate: Shared data were obtained according to ethical approvals from the country of origin and original study and were shared in a controlled framework with specific restrictions on their use. The data are pseudonymised and unable to be linked to individuals. As such, this analysis did not require additional ethical approval according to the guidelines of the Oxford Central University Research Ethics Committee. Consent for publication: Not applicable. Competing interests: JAG and GCKWK are former employees of GSK and hold shares in GSK and AstraZeneca. GCKWK reports travel support from AstraZeneca. JKB reports institutional research funding from MMV, GSK, the Wellcome Trust, and Sanaria; participation on the US National Institute of Health Data Safety Monitoring Board; and membership of the Editorial Board of Travel Medicine and Infectious Diseases and the Guidelines Development Group for Malaria Control and Elimination, Global Malaria Program, WHO. RJC, RNP and JKB report contributions to Up-to-Date. NMA reports membership of the Writing Group for the Australian national Malaria Treatment Guidelines: Therapeutic Guidelines, 2025. All other authors declare no conflicts of interest.

Figures

**Fig. 1**
Generation of region and country automated reports on primaquine efficacy and safety

**Fig. 2**
Map of study sites from which data were available for automated reports as of January 16, 2025

See this image and copyright information in PMC

References

1. Price RN, Commons RJ, Battle KE, Thriemer K, Mendis K. Plasmodium vivax in the era of the shrinking P. falciparum map. Trends Parasitol. 2020;36:560–70. - PMC - PubMed
1. Commons RJ, Simpson JA, Watson J, White NJ, Price RN. Estimating the proportion of Plasmodium vivax recurrences caused by relapse: a systematic review and meta-analysis. Am J Trop Med Hyg. 2020;103:1094–9. - PMC - PubMed
1. Robinson LJ, Wampfler R, Betuela I, Karl S, White MT, Li Wai Suen CS, et al. Strategies for understanding and reducing the Plasmodium vivax and Plasmodium ovale hypnozoite reservoir in Papua New Guinean children: a randomised placebo-controlled trial and mathematical model. PLoS Med. 2015;12:e1001891. - PMC - PubMed
1. Chu CS, White NJ. The prevention and treatment of Plasmodium vivax malaria. PLoS Med. 2021;18:e1003561. - PMC - PubMed
1. Thriemer K, Ley B, Bobogare A, Dysoley L, Alam MS, Pasaribu AP, et al. Challenges for achieving safe and effective radical cure of Plasmodium vivax: a round table discussion of the APMEN Vivax Working Group. Malar J. 2017;16:141. - PMC - PubMed

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Automated reporting of primaquine dose efficacy, tolerability and safety for Plasmodium vivax malaria using a systematic review and individual patient data meta-analysis

Collaborators

Affiliations

Automated reporting of primaquine dose efficacy, tolerability and safety for Plasmodium vivax malaria using a systematic review and individual patient data meta-analysis

Authors

Collaborators

Affiliations

Abstract

Conflict of interest statement

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