Operational effectiveness of tafenoquine and primaquine for the prevention of Plasmodium vivax recurrence in Brazil: a retrospective observational study
Prevention of Plasmodium vivax malaria recurrence is essential for malaria elimination in Brazil. We evaluated the real-world effectiveness of an updated treatment algorithm for P vivax radical cure in the Brazilian Amazon. In this non-interventional observational study, we used retrospective data f...
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| Veröffentlicht in: | The Lancet infectious diseases 2024-06, Vol.24 (6), p.629-638 |
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| creator | Brito, Marcelo Rufatto, Rosilene Brito-Sousa, José Diego Murta, Felipe Sampaio, Vanderson Balieiro, Patrícia Baía-Silva, Djane Castro, Vanessa Alves, Brenda Alencar, Aline Duparc, Stephan Grewal Daumerie, Penny Borghini-Fuhrer, Isabelle Jambert, Elodie Peterka, Cássio Edilson Lima, Francisco Carvalho Maia, Leonardo Lucena Cruz, Catherine Maciele, Bruna Vasconcelos, Mariana Machado, Myrna Augusto Figueira, Elder Alcirley Balieiro, Antônio Batista Pereira, Dhelio Lacerda, Marcus |
| description | Prevention of Plasmodium vivax malaria recurrence is essential for malaria elimination in Brazil. We evaluated the real-world effectiveness of an updated treatment algorithm for P vivax radical cure in the Brazilian Amazon.
In this non-interventional observational study, we used retrospective data from the implementation of a P vivax treatment algorithm at 43 health facilities in Manaus and Porto Velho, Brazil. The treatment algorithm consisted of chloroquine (25 mg/kg over 3 days) and point-of-care quantitative glucose-6-phosphate dehydrogenase (G6PD) testing followed by single-dose tafenoquine 300 mg (G6PD normal, aged ≥16 years, not pregnant and not breastfeeding), 7-day primaquine 0·5 mg/kg per day (G6PD intermediate or normal, aged ≥6 months, not pregnant, and not breastfeeding or breastfeeding for >1 month), or primaquine 0·75 mg/kg per week for 8 weeks (G6PD deficient, aged ≥6 months, not pregnant, and not breastfeeding or breastfeeding for >1 month). P vivax recurrences were identified from probabilistic linkage of routine patient records from the Brazilian malaria epidemiological surveillance system. Recurrence-free effectiveness at day 90 and day 180 was estimated using Kaplan–Meier analysis and hazard ratios (HRs) by multivariate analysis. This clinical trial is registered with ClinicalTrials.gov, NCT05096702, and is completed.
Records from Sept 9, 2021, to Aug 31, 2022, included 5554 patients with P vivax malaria. In all treated patients of any age and any G6PD status, recurrence-free effectiveness at day 180 was 75·8% (95% CI 74·0–77·6) with tafenoquine, 73·4% (71·9–75·0) with 7-day primaquine, and 82·1% (77·7–86·8) with weekly primaquine. In patients aged at least 16 years who were G6PD normal, recurrence-free effectiveness until day 90 was 88·6% (95% CI 87·2–89·9) in those who were treated with tafenoquine (n=2134) and 83·5% (79·8–87·4) in those treated with 7-day primaquine (n=370); after adjustment for confounding factors, the HR for recurrence following tafenoquine versus 7-day primaquine was 0·65 (95% CI 0·49–0·86; p=0·0031), with similar outcomes between the two treatments at day 180 (log-rank p=0·82). Over 180 days, median time to recurrence in patients aged at least 16 years who were G6PD normal was 92 days (IQR 76–120) in those treated with tafenoquine and 68 days (52–94) in those treated with 7-day primaquine.
In this real-world setting, single-dose tafenoquine was more effective at preventing P vivax recurrence in patients aged at |
| doi_str_mv | 10.1016/S1473-3099(24)00074-4 |
| format | Article |
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In this non-interventional observational study, we used retrospective data from the implementation of a P vivax treatment algorithm at 43 health facilities in Manaus and Porto Velho, Brazil. The treatment algorithm consisted of chloroquine (25 mg/kg over 3 days) and point-of-care quantitative glucose-6-phosphate dehydrogenase (G6PD) testing followed by single-dose tafenoquine 300 mg (G6PD normal, aged ≥16 years, not pregnant and not breastfeeding), 7-day primaquine 0·5 mg/kg per day (G6PD intermediate or normal, aged ≥6 months, not pregnant, and not breastfeeding or breastfeeding for >1 month), or primaquine 0·75 mg/kg per week for 8 weeks (G6PD deficient, aged ≥6 months, not pregnant, and not breastfeeding or breastfeeding for >1 month). P vivax recurrences were identified from probabilistic linkage of routine patient records from the Brazilian malaria epidemiological surveillance system. Recurrence-free effectiveness at day 90 and day 180 was estimated using Kaplan–Meier analysis and hazard ratios (HRs) by multivariate analysis. This clinical trial is registered with ClinicalTrials.gov, NCT05096702, and is completed.
Records from Sept 9, 2021, to Aug 31, 2022, included 5554 patients with P vivax malaria. In all treated patients of any age and any G6PD status, recurrence-free effectiveness at day 180 was 75·8% (95% CI 74·0–77·6) with tafenoquine, 73·4% (71·9–75·0) with 7-day primaquine, and 82·1% (77·7–86·8) with weekly primaquine. In patients aged at least 16 years who were G6PD normal, recurrence-free effectiveness until day 90 was 88·6% (95% CI 87·2–89·9) in those who were treated with tafenoquine (n=2134) and 83·5% (79·8–87·4) in those treated with 7-day primaquine (n=370); after adjustment for confounding factors, the HR for recurrence following tafenoquine versus 7-day primaquine was 0·65 (95% CI 0·49–0·86; p=0·0031), with similar outcomes between the two treatments at day 180 (log-rank p=0·82). Over 180 days, median time to recurrence in patients aged at least 16 years who were G6PD normal was 92 days (IQR 76–120) in those treated with tafenoquine and 68 days (52–94) in those treated with 7-day primaquine.
In this real-world setting, single-dose tafenoquine was more effective at preventing P vivax recurrence in patients aged at least 16 years who were G6PD normal compared with 7-day primaquine at day 90, while overall efficacy at 180 days was similar. The public health benefits of the P vivax radical cure treatment algorithm incorporating G6PD quantitative testing and tafenoquine support its implementation in Brazil and potentially across South America.
Brazilian Ministry of Health, Municipal and State Health Secretariats; Fiocruz; Medicines for Malaria Venture; Bill & Melinda Gates Foundation; Newcrest Mining; and the UK Government.
For the Portuguese translation of the abstract see Supplementary Materials section.</description><identifier>ISSN: 1473-3099</identifier><identifier>ISSN: 1474-4457</identifier><identifier>EISSN: 1474-4457</identifier><identifier>DOI: 10.1016/S1473-3099(24)00074-4</identifier><identifier>PMID: 38452779</identifier><language>eng</language><publisher>United States: Elsevier Ltd</publisher><subject><![CDATA[Adolescent ; Adult ; Aged ; Algorithms ; Aminoquinolines - administration & dosage ; Aminoquinolines - therapeutic use ; Antimalarials - administration & dosage ; Antimalarials - therapeutic use ; Brazil - epidemiology ; Breast feeding ; Breastfeeding & lactation ; Charities ; Child ; Child, Preschool ; Chloroquine ; Chloroquine - administration & dosage ; Chloroquine - therapeutic use ; Clinical outcomes ; Clinical trials ; Dehydrogenases ; Drug dosages ; Effectiveness ; Enzymes ; Epidemiology ; Female ; Glucose 6 phosphate dehydrogenase ; Glucosephosphate dehydrogenase ; Health care facilities ; Humans ; Infant ; Malaria ; Malaria, Vivax - drug therapy ; Malaria, Vivax - prevention & control ; Male ; Middle Aged ; Multivariate analysis ; Observational studies ; Patients ; Plasmodium vivax ; Plasmodium vivax - drug effects ; Population ; Pregnancy ; Prevention ; Primaquine ; Primaquine - administration & dosage ; Primaquine - therapeutic use ; Public health ; Recurrence ; Retrospective Studies ; Secondary Prevention - methods ; Surveillance systems ; Tafenoquine ; Translation ; Treatment Outcome ; Vector-borne diseases ; Young Adult]]></subject><ispartof>The Lancet infectious diseases, 2024-06, Vol.24 (6), p.629-638</ispartof><rights>2024 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license</rights><rights>Copyright © 2024 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.</rights><rights>2024. The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. This work is published under https://creativecommons.org/licenses/by/3.0/ (theLicense”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c440t-8595b8e5dad8476df18c208df694b4308fa5d568a809558623068c487237d2963</citedby><cites>FETCH-LOGICAL-c440t-8595b8e5dad8476df18c208df694b4308fa5d568a809558623068c487237d2963</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S1473309924000744$$EHTML$$P50$$Gelsevier$$Hfree_for_read</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65306</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/38452779$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Brito, Marcelo</creatorcontrib><creatorcontrib>Rufatto, Rosilene</creatorcontrib><creatorcontrib>Brito-Sousa, José Diego</creatorcontrib><creatorcontrib>Murta, Felipe</creatorcontrib><creatorcontrib>Sampaio, Vanderson</creatorcontrib><creatorcontrib>Balieiro, Patrícia</creatorcontrib><creatorcontrib>Baía-Silva, Djane</creatorcontrib><creatorcontrib>Castro, Vanessa</creatorcontrib><creatorcontrib>Alves, Brenda</creatorcontrib><creatorcontrib>Alencar, Aline</creatorcontrib><creatorcontrib>Duparc, Stephan</creatorcontrib><creatorcontrib>Grewal Daumerie, Penny</creatorcontrib><creatorcontrib>Borghini-Fuhrer, Isabelle</creatorcontrib><creatorcontrib>Jambert, Elodie</creatorcontrib><creatorcontrib>Peterka, Cássio</creatorcontrib><creatorcontrib>Edilson Lima, Francisco</creatorcontrib><creatorcontrib>Carvalho Maia, Leonardo</creatorcontrib><creatorcontrib>Lucena Cruz, Catherine</creatorcontrib><creatorcontrib>Maciele, Bruna</creatorcontrib><creatorcontrib>Vasconcelos, Mariana</creatorcontrib><creatorcontrib>Machado, Myrna</creatorcontrib><creatorcontrib>Augusto Figueira, Elder</creatorcontrib><creatorcontrib>Alcirley Balieiro, Antônio</creatorcontrib><creatorcontrib>Batista Pereira, Dhelio</creatorcontrib><creatorcontrib>Lacerda, Marcus</creatorcontrib><title>Operational effectiveness of tafenoquine and primaquine for the prevention of Plasmodium vivax recurrence in Brazil: a retrospective observational study</title><title>The Lancet infectious diseases</title><addtitle>Lancet Infect Dis</addtitle><description>Prevention of Plasmodium vivax malaria recurrence is essential for malaria elimination in Brazil. We evaluated the real-world effectiveness of an updated treatment algorithm for P vivax radical cure in the Brazilian Amazon.
In this non-interventional observational study, we used retrospective data from the implementation of a P vivax treatment algorithm at 43 health facilities in Manaus and Porto Velho, Brazil. The treatment algorithm consisted of chloroquine (25 mg/kg over 3 days) and point-of-care quantitative glucose-6-phosphate dehydrogenase (G6PD) testing followed by single-dose tafenoquine 300 mg (G6PD normal, aged ≥16 years, not pregnant and not breastfeeding), 7-day primaquine 0·5 mg/kg per day (G6PD intermediate or normal, aged ≥6 months, not pregnant, and not breastfeeding or breastfeeding for >1 month), or primaquine 0·75 mg/kg per week for 8 weeks (G6PD deficient, aged ≥6 months, not pregnant, and not breastfeeding or breastfeeding for >1 month). P vivax recurrences were identified from probabilistic linkage of routine patient records from the Brazilian malaria epidemiological surveillance system. Recurrence-free effectiveness at day 90 and day 180 was estimated using Kaplan–Meier analysis and hazard ratios (HRs) by multivariate analysis. This clinical trial is registered with ClinicalTrials.gov, NCT05096702, and is completed.
Records from Sept 9, 2021, to Aug 31, 2022, included 5554 patients with P vivax malaria. In all treated patients of any age and any G6PD status, recurrence-free effectiveness at day 180 was 75·8% (95% CI 74·0–77·6) with tafenoquine, 73·4% (71·9–75·0) with 7-day primaquine, and 82·1% (77·7–86·8) with weekly primaquine. In patients aged at least 16 years who were G6PD normal, recurrence-free effectiveness until day 90 was 88·6% (95% CI 87·2–89·9) in those who were treated with tafenoquine (n=2134) and 83·5% (79·8–87·4) in those treated with 7-day primaquine (n=370); after adjustment for confounding factors, the HR for recurrence following tafenoquine versus 7-day primaquine was 0·65 (95% CI 0·49–0·86; p=0·0031), with similar outcomes between the two treatments at day 180 (log-rank p=0·82). Over 180 days, median time to recurrence in patients aged at least 16 years who were G6PD normal was 92 days (IQR 76–120) in those treated with tafenoquine and 68 days (52–94) in those treated with 7-day primaquine.
In this real-world setting, single-dose tafenoquine was more effective at preventing P vivax recurrence in patients aged at least 16 years who were G6PD normal compared with 7-day primaquine at day 90, while overall efficacy at 180 days was similar. The public health benefits of the P vivax radical cure treatment algorithm incorporating G6PD quantitative testing and tafenoquine support its implementation in Brazil and potentially across South America.
Brazilian Ministry of Health, Municipal and State Health Secretariats; Fiocruz; Medicines for Malaria Venture; Bill & Melinda Gates Foundation; Newcrest Mining; and the UK Government.
For the Portuguese translation of the abstract see Supplementary Materials section.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Aged</subject><subject>Algorithms</subject><subject>Aminoquinolines - administration & dosage</subject><subject>Aminoquinolines - therapeutic use</subject><subject>Antimalarials - administration & dosage</subject><subject>Antimalarials - therapeutic use</subject><subject>Brazil - epidemiology</subject><subject>Breast feeding</subject><subject>Breastfeeding & lactation</subject><subject>Charities</subject><subject>Child</subject><subject>Child, Preschool</subject><subject>Chloroquine</subject><subject>Chloroquine - administration & dosage</subject><subject>Chloroquine - therapeutic use</subject><subject>Clinical outcomes</subject><subject>Clinical trials</subject><subject>Dehydrogenases</subject><subject>Drug dosages</subject><subject>Effectiveness</subject><subject>Enzymes</subject><subject>Epidemiology</subject><subject>Female</subject><subject>Glucose 6 phosphate dehydrogenase</subject><subject>Glucosephosphate dehydrogenase</subject><subject>Health care facilities</subject><subject>Humans</subject><subject>Infant</subject><subject>Malaria</subject><subject>Malaria, Vivax - drug therapy</subject><subject>Malaria, Vivax - prevention & control</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Multivariate analysis</subject><subject>Observational studies</subject><subject>Patients</subject><subject>Plasmodium vivax</subject><subject>Plasmodium vivax - drug effects</subject><subject>Population</subject><subject>Pregnancy</subject><subject>Prevention</subject><subject>Primaquine</subject><subject>Primaquine - administration & dosage</subject><subject>Primaquine - therapeutic use</subject><subject>Public health</subject><subject>Recurrence</subject><subject>Retrospective Studies</subject><subject>Secondary Prevention - methods</subject><subject>Surveillance systems</subject><subject>Tafenoquine</subject><subject>Translation</subject><subject>Treatment Outcome</subject><subject>Vector-borne diseases</subject><subject>Young Adult</subject><issn>1473-3099</issn><issn>1474-4457</issn><issn>1474-4457</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><recordid>eNqFkUtvFiEUhidGYy_6EzQkbupiFAYYwE2jTb0kTWqirgkfHCLNzPAJzMT6S_y5Mt-0Lty44nDynNv7Ns0zgl8RTPrXXwgTtKVYqbOOvcQYC9ayB81xTdeAcfHwEG_IUXOS8w3GRBDMHjdHVDLeCaGOm9_Xe0imhDiZAYH3YEtYYIKcUfSoGA9T_DGHCZCZHNqnMJrt62NC5TvUFFR-bbAWfB5MHqML84iWsJifKIGdU4LJAgoTepfMrzC8QabmS4p5v41DcZchLfdr5DK72yfNI2-GDE_v3tPm2_vLrxcf26vrD58u3l61ljFcWskV30ngzjjJRO88kbbD0vlesR2jWHrDHe-lkVhxLvuO4l5aJkVHhetUT0-bs63vPtVDIRc9hmxhGMwEcc66U7z2VZSqir74B72Jc6obZ00xl5wSiWWl-EbZemBO4PVBtXSrCdardfpgnV590R3TB-s0q3XP77rPuxHc36p7rypwvgFQ5VgCJJ1tWJV1oapctIvhPyP-AAaVqwk</recordid><startdate>202406</startdate><enddate>202406</enddate><creator>Brito, Marcelo</creator><creator>Rufatto, Rosilene</creator><creator>Brito-Sousa, José Diego</creator><creator>Murta, Felipe</creator><creator>Sampaio, Vanderson</creator><creator>Balieiro, Patrícia</creator><creator>Baía-Silva, Djane</creator><creator>Castro, Vanessa</creator><creator>Alves, Brenda</creator><creator>Alencar, Aline</creator><creator>Duparc, Stephan</creator><creator>Grewal Daumerie, Penny</creator><creator>Borghini-Fuhrer, Isabelle</creator><creator>Jambert, Elodie</creator><creator>Peterka, Cássio</creator><creator>Edilson Lima, Francisco</creator><creator>Carvalho Maia, Leonardo</creator><creator>Lucena Cruz, Catherine</creator><creator>Maciele, Bruna</creator><creator>Vasconcelos, Mariana</creator><creator>Machado, Myrna</creator><creator>Augusto Figueira, Elder</creator><creator>Alcirley Balieiro, Antônio</creator><creator>Batista Pereira, Dhelio</creator><creator>Lacerda, Marcus</creator><general>Elsevier Ltd</general><general>Elsevier Limited</general><scope>6I.</scope><scope>AAFTH</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>0TZ</scope><scope>3V.</scope><scope>7QL</scope><scope>7RV</scope><scope>7U9</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8C1</scope><scope>8C2</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AEUYN</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>C1K</scope><scope>CCPQU</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>H94</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M1P</scope><scope>M7N</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>7X8</scope></search><sort><creationdate>202406</creationdate><title>Operational effectiveness of tafenoquine and primaquine for the prevention of Plasmodium vivax recurrence in Brazil: a retrospective observational study</title><author>Brito, Marcelo ; Rufatto, Rosilene ; Brito-Sousa, José Diego ; Murta, Felipe ; Sampaio, Vanderson ; Balieiro, Patrícia ; Baía-Silva, Djane ; Castro, Vanessa ; Alves, Brenda ; Alencar, Aline ; Duparc, Stephan ; Grewal Daumerie, Penny ; Borghini-Fuhrer, Isabelle ; Jambert, Elodie ; Peterka, Cássio ; Edilson Lima, Francisco ; Carvalho Maia, Leonardo ; Lucena Cruz, Catherine ; Maciele, Bruna ; Vasconcelos, Mariana ; Machado, Myrna ; Augusto Figueira, Elder ; Alcirley Balieiro, Antônio ; Batista Pereira, Dhelio ; Lacerda, Marcus</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c440t-8595b8e5dad8476df18c208df694b4308fa5d568a809558623068c487237d2963</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Aged</topic><topic>Algorithms</topic><topic>Aminoquinolines - administration & dosage</topic><topic>Aminoquinolines - therapeutic use</topic><topic>Antimalarials - administration & dosage</topic><topic>Antimalarials - therapeutic use</topic><topic>Brazil - epidemiology</topic><topic>Breast feeding</topic><topic>Breastfeeding & lactation</topic><topic>Charities</topic><topic>Child</topic><topic>Child, Preschool</topic><topic>Chloroquine</topic><topic>Chloroquine - administration & dosage</topic><topic>Chloroquine - therapeutic use</topic><topic>Clinical outcomes</topic><topic>Clinical trials</topic><topic>Dehydrogenases</topic><topic>Drug dosages</topic><topic>Effectiveness</topic><topic>Enzymes</topic><topic>Epidemiology</topic><topic>Female</topic><topic>Glucose 6 phosphate dehydrogenase</topic><topic>Glucosephosphate dehydrogenase</topic><topic>Health care facilities</topic><topic>Humans</topic><topic>Infant</topic><topic>Malaria</topic><topic>Malaria, Vivax - drug therapy</topic><topic>Malaria, Vivax - prevention & control</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Multivariate analysis</topic><topic>Observational studies</topic><topic>Patients</topic><topic>Plasmodium vivax</topic><topic>Plasmodium vivax - drug effects</topic><topic>Population</topic><topic>Pregnancy</topic><topic>Prevention</topic><topic>Primaquine</topic><topic>Primaquine - administration & dosage</topic><topic>Primaquine - therapeutic use</topic><topic>Public health</topic><topic>Recurrence</topic><topic>Retrospective Studies</topic><topic>Secondary Prevention - methods</topic><topic>Surveillance systems</topic><topic>Tafenoquine</topic><topic>Translation</topic><topic>Treatment Outcome</topic><topic>Vector-borne diseases</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Brito, Marcelo</creatorcontrib><creatorcontrib>Rufatto, Rosilene</creatorcontrib><creatorcontrib>Brito-Sousa, José Diego</creatorcontrib><creatorcontrib>Murta, Felipe</creatorcontrib><creatorcontrib>Sampaio, Vanderson</creatorcontrib><creatorcontrib>Balieiro, Patrícia</creatorcontrib><creatorcontrib>Baía-Silva, Djane</creatorcontrib><creatorcontrib>Castro, Vanessa</creatorcontrib><creatorcontrib>Alves, Brenda</creatorcontrib><creatorcontrib>Alencar, Aline</creatorcontrib><creatorcontrib>Duparc, Stephan</creatorcontrib><creatorcontrib>Grewal Daumerie, Penny</creatorcontrib><creatorcontrib>Borghini-Fuhrer, Isabelle</creatorcontrib><creatorcontrib>Jambert, Elodie</creatorcontrib><creatorcontrib>Peterka, Cássio</creatorcontrib><creatorcontrib>Edilson Lima, Francisco</creatorcontrib><creatorcontrib>Carvalho Maia, Leonardo</creatorcontrib><creatorcontrib>Lucena Cruz, Catherine</creatorcontrib><creatorcontrib>Maciele, Bruna</creatorcontrib><creatorcontrib>Vasconcelos, Mariana</creatorcontrib><creatorcontrib>Machado, Myrna</creatorcontrib><creatorcontrib>Augusto Figueira, Elder</creatorcontrib><creatorcontrib>Alcirley Balieiro, Antônio</creatorcontrib><creatorcontrib>Batista Pereira, Dhelio</creatorcontrib><creatorcontrib>Lacerda, Marcus</creatorcontrib><collection>ScienceDirect Open Access Titles</collection><collection>Elsevier:ScienceDirect:Open Access</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Pharma and Biotech Premium PRO</collection><collection>ProQuest Central (Corporate)</collection><collection>Bacteriology Abstracts (Microbiology B)</collection><collection>Nursing & Allied Health Database</collection><collection>Virology and AIDS Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Public Health Database</collection><collection>Lancet Titles</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest One Sustainability</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central</collection><collection>Environmental Sciences and Pollution Management</collection><collection>ProQuest One Community College</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>MEDLINE - Academic</collection><jtitle>The Lancet infectious diseases</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Brito, Marcelo</au><au>Rufatto, Rosilene</au><au>Brito-Sousa, José Diego</au><au>Murta, Felipe</au><au>Sampaio, Vanderson</au><au>Balieiro, Patrícia</au><au>Baía-Silva, Djane</au><au>Castro, Vanessa</au><au>Alves, Brenda</au><au>Alencar, Aline</au><au>Duparc, Stephan</au><au>Grewal Daumerie, Penny</au><au>Borghini-Fuhrer, Isabelle</au><au>Jambert, Elodie</au><au>Peterka, Cássio</au><au>Edilson Lima, Francisco</au><au>Carvalho Maia, Leonardo</au><au>Lucena Cruz, Catherine</au><au>Maciele, Bruna</au><au>Vasconcelos, Mariana</au><au>Machado, Myrna</au><au>Augusto Figueira, Elder</au><au>Alcirley Balieiro, Antônio</au><au>Batista Pereira, Dhelio</au><au>Lacerda, Marcus</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Operational effectiveness of tafenoquine and primaquine for the prevention of Plasmodium vivax recurrence in Brazil: a retrospective observational study</atitle><jtitle>The Lancet infectious diseases</jtitle><addtitle>Lancet Infect Dis</addtitle><date>2024-06</date><risdate>2024</risdate><volume>24</volume><issue>6</issue><spage>629</spage><epage>638</epage><pages>629-638</pages><issn>1473-3099</issn><issn>1474-4457</issn><eissn>1474-4457</eissn><abstract>Prevention of Plasmodium vivax malaria recurrence is essential for malaria elimination in Brazil. We evaluated the real-world effectiveness of an updated treatment algorithm for P vivax radical cure in the Brazilian Amazon.
In this non-interventional observational study, we used retrospective data from the implementation of a P vivax treatment algorithm at 43 health facilities in Manaus and Porto Velho, Brazil. The treatment algorithm consisted of chloroquine (25 mg/kg over 3 days) and point-of-care quantitative glucose-6-phosphate dehydrogenase (G6PD) testing followed by single-dose tafenoquine 300 mg (G6PD normal, aged ≥16 years, not pregnant and not breastfeeding), 7-day primaquine 0·5 mg/kg per day (G6PD intermediate or normal, aged ≥6 months, not pregnant, and not breastfeeding or breastfeeding for >1 month), or primaquine 0·75 mg/kg per week for 8 weeks (G6PD deficient, aged ≥6 months, not pregnant, and not breastfeeding or breastfeeding for >1 month). P vivax recurrences were identified from probabilistic linkage of routine patient records from the Brazilian malaria epidemiological surveillance system. Recurrence-free effectiveness at day 90 and day 180 was estimated using Kaplan–Meier analysis and hazard ratios (HRs) by multivariate analysis. This clinical trial is registered with ClinicalTrials.gov, NCT05096702, and is completed.
Records from Sept 9, 2021, to Aug 31, 2022, included 5554 patients with P vivax malaria. In all treated patients of any age and any G6PD status, recurrence-free effectiveness at day 180 was 75·8% (95% CI 74·0–77·6) with tafenoquine, 73·4% (71·9–75·0) with 7-day primaquine, and 82·1% (77·7–86·8) with weekly primaquine. In patients aged at least 16 years who were G6PD normal, recurrence-free effectiveness until day 90 was 88·6% (95% CI 87·2–89·9) in those who were treated with tafenoquine (n=2134) and 83·5% (79·8–87·4) in those treated with 7-day primaquine (n=370); after adjustment for confounding factors, the HR for recurrence following tafenoquine versus 7-day primaquine was 0·65 (95% CI 0·49–0·86; p=0·0031), with similar outcomes between the two treatments at day 180 (log-rank p=0·82). Over 180 days, median time to recurrence in patients aged at least 16 years who were G6PD normal was 92 days (IQR 76–120) in those treated with tafenoquine and 68 days (52–94) in those treated with 7-day primaquine.
In this real-world setting, single-dose tafenoquine was more effective at preventing P vivax recurrence in patients aged at least 16 years who were G6PD normal compared with 7-day primaquine at day 90, while overall efficacy at 180 days was similar. The public health benefits of the P vivax radical cure treatment algorithm incorporating G6PD quantitative testing and tafenoquine support its implementation in Brazil and potentially across South America.
Brazilian Ministry of Health, Municipal and State Health Secretariats; Fiocruz; Medicines for Malaria Venture; Bill & Melinda Gates Foundation; Newcrest Mining; and the UK Government.
For the Portuguese translation of the abstract see Supplementary Materials section.</abstract><cop>United States</cop><pub>Elsevier Ltd</pub><pmid>38452779</pmid><doi>10.1016/S1473-3099(24)00074-4</doi><tpages>10</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1473-3099 |
| ispartof | The Lancet infectious diseases, 2024-06, Vol.24 (6), p.629-638 |
| issn | 1473-3099 1474-4457 1474-4457 |
| language | eng |
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| source | MEDLINE; Elsevier ScienceDirect Journals |
| subjects | Adolescent Adult Aged Algorithms Aminoquinolines - administration & dosage Aminoquinolines - therapeutic use Antimalarials - administration & dosage Antimalarials - therapeutic use Brazil - epidemiology Breast feeding Breastfeeding & lactation Charities Child Child, Preschool Chloroquine Chloroquine - administration & dosage Chloroquine - therapeutic use Clinical outcomes Clinical trials Dehydrogenases Drug dosages Effectiveness Enzymes Epidemiology Female Glucose 6 phosphate dehydrogenase Glucosephosphate dehydrogenase Health care facilities Humans Infant Malaria Malaria, Vivax - drug therapy Malaria, Vivax - prevention & control Male Middle Aged Multivariate analysis Observational studies Patients Plasmodium vivax Plasmodium vivax - drug effects Population Pregnancy Prevention Primaquine Primaquine - administration & dosage Primaquine - therapeutic use Public health Recurrence Retrospective Studies Secondary Prevention - methods Surveillance systems Tafenoquine Translation Treatment Outcome Vector-borne diseases Young Adult |
| title | Operational effectiveness of tafenoquine and primaquine for the prevention of Plasmodium vivax recurrence in Brazil: a retrospective observational study |
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