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1. The effect of dosing strategies on the therapeutic efficacy of artesunate-amodiaquine for uncomplicated malaria: a meta-analysis of individual patient data.

Author

WorldWide Antimalarial Resistance Network (WWARN) AS-AQ Study Group, Adjuik, Martin A, Allan, Richard, Anvikar, Anupkumar R, Ashley, Elizabeth A, Ba, Mamadou S, Barennes, Hubert, Barnes, Karen I, Bassat, Quique, Baudin, Elisabeth, Björkman, Anders, Bompart, François, Bonnet, Maryline, Borrmann, Steffen, Brasseur, Philippe, Bukirwa, Hasifa, Checchi, Francesco, Cot, Michel, Dahal, Prabin, D'Alessandro, Umberto, Deloron, Philippe, Desai, Meghna, Diap, Graciela, Djimde, Abdoulaye A, Dorsey, Grant, Doumbo, Ogobara K, Espié, Emmanuelle, Etard, Jean-Francois, Fanello, Caterina I, Faucher, Jean-François, Faye, Babacar, Flegg, Jennifer A, Gaye, Oumar, Gething, Peter W, González, Raquel, Grandesso, Francesco, Guerin, Philippe J, Guthmann, Jean-Paul, Hamour, Sally, Hasugian, Armedy Ronny, Hay, Simon I, Humphreys, Georgina S, Jullien, Vincent, Juma, Elizabeth, Kamya, Moses R, Karema, Corine, Kiechel, Jean R, Kremsner, Peter G, Krishna, Sanjeev, Lameyre, Valérie, Ibrahim, Laminou M, Lee, Sue J, Lell, Bertrand, Mårtensson, Andreas, Massougbodji, Achille, Menan, Hervé, Ménard, Didier, Menéndez, Clara, Meremikwu, Martin, Moreira, Clarissa, Nabasumba, Carolyn, Nambozi, Michael, Ndiaye, Jean-Louis, Nikiema, Frederic, Nsanzabana, Christian, Ntoumi, Francine, Ogutu, Bernhards R, Olliaro, Piero, Osorio, Lyda, Ouédraogo, Jean-Bosco, Penali, Louis K, Pene, Mbaye, Pinoges, Loretxu, Piola, Patrice, Price, Ric N, Roper, Cally, Rosenthal, Philip J, Rwagacondo, Claude Emile, Same-Ekobo, Albert, Schramm, Birgit, Seck, Amadou, Sharma, Bhawna, Sibley, Carol Hopkins, Sinou, Véronique, Sirima, Sodiomon B, Smith, Jeffery J, Smithuis, Frank, Somé, Fabrice A, Sow, Doudou, Staedke, Sarah G, Stepniewska, Kasia, Swarthout, Todd D, Sylla, Khadime, Talisuna, Ambrose O, Tarning, Joel, Taylor, Walter RJ, Temu, Emmanuel A, Thwing, Julie I, Tjitra, Emiliana, and Tine, Roger CK

Subjects
WorldWide Antimalarial Resistance Network (WWARN) AS-AQ Study Group, Humans, Malaria, Falciparum, Recurrence, Artemisinins, Amodiaquine, Drug Combinations, Antimalarials, Treatment Outcome, Risk Factors, Dose-Response Relationship, Drug, Middle Aged, Africa, Female, Male, Malaria, Plasmodium falciparum, Drug resistance, Artesunate, Dosing, Efficacy, Falciparum, Dose-Response Relationship, Drug, Medical and Health Sciences, General & Internal Medicine
Abstract

BackgroundArtesunate-amodiaquine (AS-AQ) is one of the most widely used artemisinin-based combination therapies (ACTs) to treat uncomplicated Plasmodium falciparum malaria in Africa. We investigated the impact of different dosing strategies on the efficacy of this combination for the treatment of falciparum malaria.MethodsIndividual patient data from AS-AQ clinical trials were pooled using the WorldWide Antimalarial Resistance Network (WWARN) standardised methodology. Risk factors for treatment failure were identified using a Cox regression model with shared frailty across study sites.ResultsForty-three studies representing 9,106 treatments from 1999-2012 were included in the analysis; 4,138 (45.4%) treatments were with a fixed dose combination with an AQ target dose of 30 mg/kg (FDC), 1,293 (14.2%) with a non-fixed dose combination with an AQ target dose of 25 mg/kg (loose NFDC-25), 2,418 (26.6%) with a non-fixed dose combination with an AQ target dose of 30 mg/kg (loose NFDC-30), and the remaining 1,257 (13.8%) with a co-blistered non-fixed dose combination with an AQ target dose of 30 mg/kg (co-blistered NFDC). The median dose of AQ administered was 32.1 mg/kg [IQR: 25.9-38.2], the highest dose being administered to patients treated with co-blistered NFDC (median = 35.3 mg/kg [IQR: 30.6-43.7]) and the lowest to those treated with loose NFDC-25 (median = 25.0 mg/kg [IQR: 22.7-25.0]). Patients treated with FDC received a median dose of 32.4 mg/kg [IQR: 27-39.0]. After adjusting for reinfections, the corrected antimalarial efficacy on day 28 after treatment was similar for co-blistered NFDC (97.9% [95% confidence interval (CI): 97.0-98.8%]) and FDC (98.1% [95% CI: 97.6%-98.5%]; P = 0.799), but significantly lower for the loose NFDC-25 (93.4% [95% CI: 91.9%-94.9%]), and loose NFDC-30 (95.0% [95% CI: 94.1%-95.9%]) (P

Published
2015

2. Gametocyte carriage in uncomplicated Plasmodium falciparum malaria following treatment with artemisinin combination therapy: a systematic review and meta-analysis of individual patient data

Author

Abdulla, Salim, Achan, Jane, Adam, Ishag, Alemayehu, Bereket H, Allan, Richard, Allen, Elizabeth N, Ankivar, Anupkumar R, Arinaitwe, Emmanuel, Ashley, Elizabeth A, Asih, Puji Budi Setia, Awab, Ghulam Rahib, Barnes, Karen I, Bassat, Quique, Baudin, Elisabeth, Björkman, Anders, Bompart, Francois, Bonnet, Maryline, Borrmann, Steffen, Bousema, Teun, Carrara, Verena I, Cenci, Fabio, Checchi, Francesco, Cot, Michel, Dahal, Prabin, D'Alessandro, Umberto, Deloron, Phillippe, Djimdé, Abdoulaye, Dondorp, Arjen, Dorsey, Grant, Doumbo, Ogobara K, Drakeley, Chris J, Duparc, Stephan, Espie, Emmanuelle, Faiz, Abul, Falade, Catherine O, Fanello, Caterina, Faucher, Jean-François, Faye, Babacar, Filler, Scott, Fofana, Bakary, Fogg, Carole, Gansane, Adama, Gaye, Oumar, Genton, Blaise, Gething, Peter W, Gonzalez, Raquel, Grandesso, Francesco, Greenwood, Brian, Grivoyannis, Anastasia, Guerin, Philippe J, Hamed, Kamal, Hatz, Cristoph, Hay, Simon I, Hodel, Eva Maria, Humphreys, Georgina S, Hwang, Jimee, Janssens, Bart, Juma, Elizabeth, Kachur, S Patrick, Kager, Piet, Kamya, Moses R, Kapulu, Melissa, Karema, Corine, Kayentao, Kassoum, Kiechel, Jean R, Kofoed, Poul-Erik, Lameyre, Valerie, Lee, Sue J, Lell, Bertrand, Lima, Nines, Marsh, Kevin, Mårtensson, Andreas, Massougbodji, Achille, Mayxay, Mayfong, McGready, Rose, Menan, Hervé, Menendez, Clara, Mens, Petra, Meremikwu, Martin, Mockenhaupt, Frank P, Moreira, Clarissa, Nabasumba, Carolyn, Nambozi, Michael, Ndiaye, Jean-Louis, Newton, Paul N, Ngasala, Billy E, Nosten, Francois, Nsanzabana, Christian, Offianan, Andre Toure, Oguike, Mary, Ogutu, Bernards R, Olliaro, Piero, Omar, Sabah A, Osorio, Lyda, Owusu-Agyei, Seth, Penali, Louis K, Pene, Mbaye, Peshu, Judy, Premji, Zul, Price, Ric N, Ramharter, Michael, Rombo, Lars, Roper, Cally, Rosenthal, Philip J, Sagara, Issaka, Sawa, Patrick, Schallig, Henk D F H, Schramm, Birgit, Shekalaghe, Seif A, Sibley, Carol H, Sirima, Sodiomon, Smithuis, Frank, Sow, Doudou, Staedke, Sarah G, Stepniewska, Kasia, Sutanto, Inge, Sutherland, Colin J, Swarthout, Todd D, Syafruddin, Din, Sylla, Khadime, Talisuna, Ambrose O, Taylor, Walter R, Tema, Emmanuel A, Ter Kuile, Feiko, Tinto, Halidou, Tjitra, Emiliana, Ursing, Johan, Valecha, Neena, van den Broek, Ingrid, van Herp, Michel, van Vugt, Michele, Ward, Stephen A, White, Nicholas J, Winstanley, Peter A, Woodrow, Charles J, Yeka, Adoke, Zwang, Julien, and WWARN Gametocyte Study Group

Subjects
Male, 0301 basic medicine, gametocytes, Plasmodium falciparum/drug effects, Artemisinins/therapeutic use, Amodiaquine/therapeutic use, chemistry.chemical_compound, 0302 clinical medicine, Recurrence, Malaria, Falciparum, Artemisinin, GeneralLiterature_REFERENCE(e.g.,dictionaries,encyclopedias,glossaries), Medicine(all), Microscopy, biology, Mefloquine, Malaria, Falciparum/drug therapy, Hazard ratio, General Medicine, Middle Aged, Artemisinins, 3. Good health, Drug Combinations, Child, Preschool, Drug Therapy, Combination, Research Article, medicine.drug, medicine.medical_specialty, plasmodium falciparum, Plasmodium falciparum, 030231 tropical medicine, Gametocyte, malaria, Malària, Amodiaquine, Host-Parasite Interactions, Antimalarials, 03 medical and health sciences, Internal medicine, parasitic diseases, medicine, Humans, Proportional Hazards Models, Resistència als medicaments, drug resistance, business.industry, medicine.disease, biology.organism_classification, Malaria, Logistic Models, lnfectious Diseases and Global Health Radboud Institute for Health Sciences [Radboudumc 4], 030104 developmental biology, chemistry, Host-Parasite Interactions/drug effects, Artesunate, Drug resistance, Antimalarials/therapeutic use, Immunology, business
Abstract

BACKGROUND: Gametocytes are responsible for transmission of malaria from human to mosquito. Artemisinin combination therapy (ACT) reduces post-treatment gametocyte carriage, dependent upon host, parasite and pharmacodynamic factors. The gametocytocidal properties of antimalarial drugs are important for malaria elimination efforts. An individual patient clinical data meta-analysis was undertaken to identify the determinants of gametocyte carriage and the comparative effects of four ACTs: artemether-lumefantrine (AL), artesunate/amodiaquine (AS-AQ), artesunate/mefloquine (AS-MQ), and dihydroartemisinin-piperaquine (DP). METHODS: Factors associated with gametocytaemia prior to, and following, ACT treatment were identified in multivariable logistic or Cox regression analysis with random effects. All relevant studies were identified through a systematic review of PubMed. Risk of bias was evaluated based on study design, methodology, and missing data. RESULTS: The systematic review identified 169 published and 9 unpublished studies, 126 of which were shared with the WorldWide Antimalarial Resistance Network (WWARN) and 121 trials including 48,840 patients were included in the analysis. Prevalence of gametocytaemia by microscopy at enrolment was 12.1 % (5887/48,589), and increased with decreasing age, decreasing asexual parasite density and decreasing haemoglobin concentration, and was higher in patients without fever at presentation. After ACT treatment, gametocytaemia appeared in 1.9 % (95 % CI, 1.7-2.1) of patients. The appearance of gametocytaemia was lowest after AS-MQ and AL and significantly higher after DP (adjusted hazard ratio (AHR), 2.03; 95 % CI, 1.24-3.12; P = 0.005 compared to AL) and AS-AQ fixed dose combination (FDC) (AHR, 4.01; 95 % CI, 2.40-6.72; P < 0.001 compared to AL). Among individuals who had gametocytaemia before treatment, gametocytaemia clearance was significantly faster with AS-MQ (AHR, 1.26; 95 % CI, 1.00-1.60; P = 0.054) and slower with DP (AHR, 0.74; 95 % CI, 0.63-0.88; P = 0.001) compared to AL. Both recrudescent (adjusted odds ratio (AOR), 9.05; 95 % CI, 3.74-21.90; P < 0.001) and new (AOR, 3.03; 95 % CI, 1.66-5.54; P < 0.001) infections with asexual-stage parasites were strongly associated with development of gametocytaemia after day 7. CONCLUSIONS: AS-MQ and AL are more effective than DP and AS-AQ FDC in preventing gametocytaemia shortly after treatment, suggesting that the non-artemisinin partner drug or the timing of artemisinin dosing are important determinants of post-treatment gametocyte dynamics.

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3. The effect of dosing strategies on the therapeutic efficacy of artesunate-amodiaquine for uncomplicated malaria: a meta-analysis of individual patient data.

Author

Adjuik MA, Allan R, Anvikar AR, Ashley EA, Ba MS, Barennes H, Barnes KI, Bassat Q, Baudin E, Björkman A, Bompart F, Bonnet M, Borrmann S, Brasseur P, Bukirwa H, Checchi F, Cot M, Dahal P, D'Alessandro U, Deloron P, Desai M, Diap G, Djimde AA, Dorsey G, Doumbo OK, Espié E, Etard JF, Fanello CI, Faucher JF, Faye B, Flegg JA, Gaye O, Gething PW, González R, Grandesso F, Guerin PJ, Guthmann JP, Hamour S, Hasugian AR, Hay SI, Humphreys GS, Jullien V, Juma E, Kamya MR, Karema C, Kiechel JR, Kremsner PG, Krishna S, Lameyre V, Ibrahim LM, Lee SJ, Lell B, Mårtensson A, Massougbodji A, Menan H, Ménard D, Menéndez C, Meremikwu M, Moreira C, Nabasumba C, Nambozi M, Ndiaye JL, Nikiema F, Nsanzabana C, Ntoumi F, Ogutu BR, Olliaro P, Osorio L, Ouédraogo JB, Penali LK, Pene M, Pinoges L, Piola P, Price RN, Roper C, Rosenthal PJ, Rwagacondo CE, Same-Ekobo A, Schramm B, Seck A, Sharma B, Sibley CH, Sinou V, Sirima SB, Smith JJ, Smithuis F, Somé FA, Sow D, Staedke SG, Stepniewska K, Swarthout TD, Sylla K, Talisuna AO, Tarning J, Taylor WR, Temu EA, Thwing JI, Tjitra E, Tine RC, Tinto H, Vaillant MT, Valecha N, Van den Broek I, White NJ, Yeka A, and Zongo I

Subjects
Africa, Dose-Response Relationship, Drug, Drug Combinations, Female, Humans, Male, Middle Aged, Recurrence, Risk Factors, Treatment Outcome, Amodiaquine administration & dosage, Antimalarials administration & dosage, Artemisinins administration & dosage, Malaria, Falciparum drug therapy
Abstract

Background: Artesunate-amodiaquine (AS-AQ) is one of the most widely used artemisinin-based combination therapies (ACTs) to treat uncomplicated Plasmodium falciparum malaria in Africa. We investigated the impact of different dosing strategies on the efficacy of this combination for the treatment of falciparum malaria., Methods: Individual patient data from AS-AQ clinical trials were pooled using the WorldWide Antimalarial Resistance Network (WWARN) standardised methodology. Risk factors for treatment failure were identified using a Cox regression model with shared frailty across study sites., Results: Forty-three studies representing 9,106 treatments from 1999-2012 were included in the analysis; 4,138 (45.4%) treatments were with a fixed dose combination with an AQ target dose of 30 mg/kg (FDC), 1,293 (14.2%) with a non-fixed dose combination with an AQ target dose of 25 mg/kg (loose NFDC-25), 2,418 (26.6%) with a non-fixed dose combination with an AQ target dose of 30 mg/kg (loose NFDC-30), and the remaining 1,257 (13.8%) with a co-blistered non-fixed dose combination with an AQ target dose of 30 mg/kg (co-blistered NFDC). The median dose of AQ administered was 32.1 mg/kg [IQR: 25.9-38.2], the highest dose being administered to patients treated with co-blistered NFDC (median = 35.3 mg/kg [IQR: 30.6-43.7]) and the lowest to those treated with loose NFDC-25 (median = 25.0 mg/kg [IQR: 22.7-25.0]). Patients treated with FDC received a median dose of 32.4 mg/kg [IQR: 27-39.0]. After adjusting for reinfections, the corrected antimalarial efficacy on day 28 after treatment was similar for co-blistered NFDC (97.9% [95% confidence interval (CI): 97.0-98.8%]) and FDC (98.1% [95% CI: 97.6%-98.5%]; P = 0.799), but significantly lower for the loose NFDC-25 (93.4% [95% CI: 91.9%-94.9%]), and loose NFDC-30 (95.0% [95% CI: 94.1%-95.9%]) (P < 0.001 for all comparisons). After controlling for age, AQ dose, baseline parasitemia and region; treatment with loose NFDC-25 was associated with a 3.5-fold greater risk of recrudescence by day 28 (adjusted hazard ratio, AHR = 3.51 [95% CI: 2.02-6.12], P < 0.001) compared to FDC, and treatment with loose NFDC-30 was associated with a higher risk of recrudescence at only three sites., Conclusions: There was substantial variation in the total dose of amodiaquine administered in different AS-AQ combination regimens. Fixed dose AS-AQ combinations ensure optimal dosing and provide higher antimalarial treatment efficacy than the loose individual tablets in all age categories.

Published
2015
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