The effect of sickle cell genotype on the pharmacokinetic properties of artemether-lumefantrine in Tanzanian children

Sri Riyati Sugiarto1, George M. Bwire2, Brioni R. Moore1,3,4, Madhu Page-Sharp3, Laurens Manning1,5,6, Kevin T. Batty3,4, Omary M.S. Minzi2, Billy Ngasala7, Timothy M.E. Davis1, Julie Makani8, Sam Salman1,5,9
1Medical School, University of Western Australia, Fremantle Hospital, Fremantle, Western Australia, Australia
2Department of Clinical Pharmacy and Pharmacology, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania
3Curtin Medical School, Curtin University, Bentley, Western Australia, Australia
4Curtin Health Innovation Research Institute (CHIRI), Curtin University, Bentley, Western Australia, Australia
5Wesfarmers Centre for Vaccines and Infectious Diseases, Telethon Kids Institute, Perth, Western Australia, Australia
6Department of Infectious Diseases, Fiona Stanley Hospital, Murdoch, Western Australia, Australia
7Department of Parasitology and Medical Entomology, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania
8Muhimbili Sickle Cell Centre, Muhimbili University of Health and Allied Sciences, Dar Es Salaam, Tanzania
9Clinical Pharmacology and Toxicology, PathWest, Nedlands, Western Australia, Australia

Tài liệu tham khảo

Abdulla, 2008, Efficacy and safety of artemether-lumefantrine dispersible tablets compared with crushed commercial tablets in African infants and children with uncomplicated malaria: a randomised, single-blind, multicentre trial, Lancet, 372, 1819, 10.1016/S0140-6736(08)61492-0 Adjei, 2014, A randomized trial of artesunate-amodiaquine versus artemether-lumefantrine in Ghanaian paediatric sickle cell and non-sickle cell disease patients with acute uncomplicated malaria, Malar. J., 13, 369, 10.1186/1475-2875-13-369 Adjei, 2019, Population pharmacokinetic estimates suggest elevated clearance and distribution volume of desethylamodiaquine in pediatric patients with sickle cell disease treated with artesunate-amodiaquine, Curr. Ther. Res. Clin. Exp., 90, 9, 10.1016/j.curtheres.2019.01.005 Ambe, 2001, Associated morbidities in children with sickle-cell anaemia presenting with severe anaemia in a malarious area, Trop. Doct., 31, 26, 10.1177/004947550103100109 Ambrose, 2018, High birth prevalence of sickle cell disease in Northwestern Tanzania, Pediatr. Blood Cancer, 65, 10.1002/pbc.26735 Ambrose, 2020, Surveillance for sickle cell disease, United Republic of Tanzania, Bull. World Health Organ., 98, 859, 10.2471/BLT.20.253583 Anderson, 2009, Mechanistic basis of using body size and maturation to predict clearance in humans, Drug Metabol. Pharmacokinet., 24, 25, 10.2133/dmpk.24.25 Ashley, 2007, Pharmacokinetic study of artemether-lumefantrine given once daily for the treatment of uncomplicated multidrug-resistant falciparum malaria, Trop. Med. Int. Health, 12, 201, 10.1111/j.1365-3156.2006.01785.x Bindschedler, 2000, Cardiac effects of co-artemether (artemether/lumefantrine) and mefloquine given alone or in combination to healthy volunteers, Eur. J. Clin. Pharmacol., 56, 375, 10.1007/s002280000155 Blessborn, 2013, Heat stabilization of blood spot samples for determination of metabolically unstable drug compounds, Bioanalysis, 5, 31, 10.4155/bio.12.294 Byakika-Kibwika, 2012, Lopinavir/ritonavir significantly influences pharmacokinetic exposure of artemether/lumefantrine in HIV-infected Ugandan adults, J. Antimicrob. Chemother., 67, 1217, 10.1093/jac/dkr596 Darbari, 2011, Increased clearance of morphine in sickle cell disease: implications for pain management, J. Pain, 12, 531, 10.1016/j.jpain.2010.10.012 Djimde, 2009, Understanding the pharmacokinetics of coartem, Malar. J., 8, S4, 10.1186/1475-2875-8-S1-S4 Eridani, 2011, Sickle cell protection from malaria, Hematol. Rep., 3, e24, 10.4081/hr.2011.e24 Ezzet, 2000, Pharmacokinetics and pharmacodynamics of lumefantrine (benflumetol) in acute falciparum malaria, Antimicrob. Agents Chemother., 44, 697, 10.1128/AAC.44.3.697-704.2000 German, 2009, Lopinavir/Ritonavir affects pharmacokinetic exposure of artemether/lumefantrine in HIV-uninfected healthy volunteers, J. Acquir. Immune Defic. Syndr., 51, 424, 10.1097/QAI.0b013e3181acb4ff Gremse, 1998, Hepatic function as assessed by lidocaine metabolism in sickle cell disease, J. Pediatr., 132, 989, 10.1016/S0022-3476(98)70396-8 Hatz, 2008, Treatment of acute uncomplicated falciparum malaria with artemether-lumefantrine in nonimmune populations: a safety, efficacy, and pharmacokinetic study, Am. J. Trop. Med. Hyg., 78, 241, 10.4269/ajtmh.2008.78.241 Hietala, 2010, Population pharmacokinetics and pharmacodynamics of artemether and lumefantrine during combination treatment in children with uncomplicated falciparum malaria in Tanzania, Antimicrob. Agents Chemother., 54, 4780, 10.1128/AAC.00252-10 Horst, 2016, Pharmacokinetics and analgesic effects of methadone in children and adults with sickle cell disease, Pediatr. Blood Cancer, 63, 2123, 10.1002/pbc.26207 Howie, 2011, Blood sample volumes in child health research: review of safe limits, Bull. World Health Organ., 89, 46, 10.2471/BLT.10.080010 Huang, 2013, Determination of artemether and dihydroartemisinin in human plasma with a new hydrogen peroxide stabilization method, Bioanalysis, 5, 1501, 10.4155/bio.13.91 Huang, 2018, Strong correlation of lumefantrine concentrations in capillary and venous plasma from malaria patients, PLoS One, 13 Hughes, 2020, Efavirenz-based antiretroviral therapy reduces artemether-lumefantrine exposure for malaria treatment in HIV-infected pregnant women, J. Acquir. Immune Defic. Syndr., 83, 140, 10.1097/QAI.0000000000002237 Ittarat, 1998, Effects of alpha-thalassemia on pharmacokinetics of the antimalarial agent artesunate, Antimicrob. Agents Chemother., 42, 2332, 10.1128/AAC.42.9.2332 Kamchonwongpaisan, 1994, Resistance to artemisinin of malaria parasites (Plasmodium falciparum) infecting alpha-thalassemic erythrocytes in vitro. Competition in drug accumulation with uninfected erythrocytes, J. Clin. Invest., 93, 467, 10.1172/JCI116994 Kane, 2022 Karunajeewa, 2004, Disposition of artesunate and dihydroartemisinin after administration of artesunate suppositories in children from Papua New Guinea with uncomplicated malaria, Antimicrob. Agents Chemother., 48, 2966, 10.1128/AAC.48.8.2966-2972.2004 Kloprogge, 2013, Population pharmacokinetics of lumefantrine in pregnant and nonpregnant women with uncomplicated Plasmodium falciparum malaria in Uganda, CPT Pharmacometrics Syst. Pharmacol., 2, e83, 10.1038/psp.2013.59 Kloprogge, 2015, Lumefantrine and desbutyl-lumefantrine population pharmacokinetic-pharmacodynamic relationships in pregnant women with uncomplicated Plasmodium falciparum malaria on the Thailand-Myanmar border, Antimicrob. Agents Chemother., 59, 6375, 10.1128/AAC.00267-15 Kloprogge, 2018, Artemether-lumefantrine dosing for malaria treatment in young children and pregnant women: a pharmacokinetic-pharmacodynamic meta-analysis, PLoS Med., 15, 10.1371/journal.pmed.1002579 Komba, 2009, Malaria as a cause of morbidity and mortality in children with homozygous sickle cell disease on the coast of Kenya, Clin. Infect. Dis., 49, 216, 10.1086/599834 Kredo, 2016, The interaction between artemether-lumefantrine and lopinavir/ritonavir-based antiretroviral therapy in HIV-1 infected patients, BMC Infect. Dis., 16, 30, 10.1186/s12879-016-1345-1 Lefevre, 1999, Clinical pharmacokinetics of artemether and lumefantrine (Riamet (R)), Clin. Drug Invest., 18, 467, 10.2165/00044011-199918060-00006 Lefevre, 2002, Interaction trial between artemether-lumefantrine (Riamet) and quinine in healthy subjects, J. Clin. Pharmacol., 42, 1147, 10.1177/009127002401382632 Lohy Das, 2018, Population pharmacokinetics of artemether, dihydroartemisinin, and lumefantrine in Rwandese pregnant women treated for uncomplicated Plasmodium falciparum malaria, Antimicrob. Agents Chemother., 62, 10.1128/AAC.00518-18 Maganda, 2015, The influence of nevirapine and efavirenz-based anti-retroviral therapy on the pharmacokinetics of lumefantrine and anti-malarial dose recommendation in HIV-malaria co-treatment, Malar. J., 14, 179, 10.1186/s12936-015-0695-2 Makani, 2010, Malaria in patients with sickle cell anemia: burden, risk factors, and outcome at the outpatient clinic and during hospitalization, Blood, 115, 215, 10.1182/blood-2009-07-233528 Maksoud, 2018, Population pharmacokinetics of cefotaxime and dosage recommendations in children with sickle cell disease, Antimicrob. Agents Chemother., 62, 10.1128/AAC.00637-17 McAuley, 2010, High mortality from Plasmodium falciparum malaria in children living with sickle cell anemia on the coast of Kenya, Blood, 116, 1663, 10.1182/blood-2010-01-265249 McGready, 2006, The pharmacokinetics of artemether and lumefantrine in pregnant women with uncomplicated falciparum malaria, Eur. J. Clin. Pharmacol., 62, 1021, 10.1007/s00228-006-0199-7 Michael, 2017, The malaria testing and treatment landscape in mainland Tanzania, Malar. J., 16, 202, 10.1186/s12936-017-1819-7 Mwesigwa, 2010, Pharmacokinetics of artemether-lumefantrine and artesunate-amodiaquine in children in Kampala, Uganda, Antimicrob. Agents Chemother., 54, 52, 10.1128/AAC.00679-09 Ndeffo Mbah, 2015, Comparing the impact of artemisinin-based combination therapies on malaria transmission in sub-Saharan Africa, Am. J. Trop. Med. Hyg., 92, 555, 10.4269/ajtmh.14-0490 Ndounga, 2015, Artesunate-amodiaquine versus artemether-lumefantrine for the treatment of acute uncomplicated malaria in Congolese children under 10 years old living in a suburban area: a randomized study, Malar. J., 14, 423, 10.1186/s12936-015-0918-6 Olafuyi, 2017, Development of a paediatric physiologically based pharmacokinetic model to assess the impact of drug-drug interactions in tuberculosis co-infected malaria subjects: a case study with artemether-lumefantrine and the CYP3A4-inducer rifampicin, Eur. J. Pharmaceut. Sci., 106, 20, 10.1016/j.ejps.2017.05.043 Pearson, 1979, Developmental aspects of splenic function in sickle cell diseases, Blood, 53, 358, 10.1182/blood.V53.3.358.358 Salman, 2011, Population pharmacokinetics of artemether, lumefantrine, and their respective metabolites in Papua New Guinean children with uncomplicated malaria, Antimicrob. Agents Chemother., 55, 5306, 10.1128/AAC.05136-11 Sugiarto, 2017, Pharmacokinetic considerations for use of artemisinin-based combination therapies against falciparum malaria in different ethnic populations, Expet Opin. Drug Metabol. Toxicol., 13, 1115, 10.1080/17425255.2017.1391212 Sugiarto, 2018, Artemisinin therapy for malaria in hemoglobinopathies: a systematic review, Clin. Infect. Dis., 66, 799, 10.1093/cid/cix785 Sugiarto, 2022, The pharmacokinetic properties of artemether and lumefantrine in Malaysian patients with Plasmodium knowlesi malaria, Br. J. Clin. Pharmacol., 88, 691, 10.1111/bcp.15001 Taneja, 2013, Dried blood spots in bioanalysis of antimalarials: relevance and challenges in quantitative assessment of antimalarial drugs, Bioanalysis, 5, 2171, 10.4155/bio.13.180 Tarning, 2009, Population pharmacokinetics of lumefantrine in pregnant women treated with artemether-lumefantrine for uncomplicated Plasmodium falciparum malaria, Antimicrob. Agents Chemother., 53, 3837, 10.1128/AAC.00195-09 Taylor, 2012, Haemoglobinopathies and the clinical epidemiology of malaria: a systematic review and meta-analysis, Lancet Infect. Dis., 12, 457, 10.1016/S1473-3099(12)70055-5 Tchaparian, 2016, Population pharmacokinetics and pharmacodynamics of lumefantrine in young Ugandan children treated with artemether-lumefantrine for uncomplicated malaria, J. Infect. Dis., 214, 1243, 10.1093/infdis/jiw338 Wong, 2011, Desbutyl-lumefantrine is a metabolite of lumefantrine with potent in vitro antimalarial activity that may influence artemether-lumefantrine treatment outcome, Antimicrob. Agents Chemother., 55, 1194, 10.1128/AAC.01312-10 2021 Zimmerman, 2019, Duration of pediatric clinical trials submitted to the US Food and Drug Administration, JAMA Pediatr., 173, 60, 10.1001/jamapediatrics.2018.3227