Antonia Morita I Saktiawati1,2,3, Marcel Harkema4, Althaf Setyawan5, Yanri W Subronto1,3, Ymkje Stienstra6, Rob E Aarnoutse7, Cecile Magis-Escurra8, Jos G W Kosterink9,10, Tjip S van der Werf2,6, Jan-Willem C Alffenaar9,11, Marieke G G Sturkenboom12. 1. Department of Internal Medicine, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia. 2. Department of Pulmonary Diseases and Tuberculosis, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands. 3. Center for Tropical Medicine, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia. 4. , Groningen, The Netherlands. 5. Department of Biostatistics, Epidemiology, and Population Health, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia. 6. Department of Internal Medicine/Infectious Diseases, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands. 7. Department of Pharmacy, Radboud University Medical Center, Radboud Institute for Health Sciences, Nijmegen, The Netherlands. 8. Department of Pulmonary Diseases, Radboud University Medical Center-Dekkerswald, Groesbeek, The Netherlands. 9. Department of Clinical Pharmacy and Pharmacology, University Medical Center Groningen, University of Groningen, PO Box 30.001, 9700 RB, Groningen, The Netherlands. 10. Unit Pharmacotherapy, Epidemiology and Economy, Groningen Research Institute of Pharmacy, University of Groningen, Groningen, The Netherlands. 11. Faculty of Medicine and Health, School of Pharmacy, University of Sydney, Sydney, NSW, Australia. 12. Department of Clinical Pharmacy and Pharmacology, University Medical Center Groningen, University of Groningen, PO Box 30.001, 9700 RB, Groningen, The Netherlands. m.g.g.sturkenboom@umcg.nl.
Abstract
BACKGROUND: The 24-h area under the concentration-time curve (AUC24)/minimal inhibitory concentration ratio is the best predictive pharmacokinetic/pharmacodynamic (PK/PD) parameter of the efficacy of first-line anti-tuberculosis (TB) drugs. An optimal sampling strategy (OSS) is useful for accurately estimating AUC24; however, OSS has not been developed in the fed state or in the early phase of treatment for first-line anti-TB drugs. METHODS: An OSS for the prediction of AUC24 of isoniazid, rifampicin, ethambutol and pyrazinamide was developed for TB patients starting treatment. A prospective, randomized, crossover trial was performed during the first 3 days of treatment in which first-line anti-TB drugs were administered either intravenously or in fasting or fed conditions. The PK data were used to develop OSS with best subset selection multiple linear regression. The OSS was internally validated using a jackknife analysis and externally validated with other patients from different ethnicities and in a steady state of treatment. RESULTS: OSS using time points of 2, 4 and 8 h post-dose performed best. Bias was < 5% and imprecision was < 15% for all drugs except ethambutol in the fed condition. External validation showed that OSS2-4-8 cannot be used for rifampicin in steady state conditions. CONCLUSION: OSS at 2, 4 and 8 h post-dose enabled an accurate and precise prediction of AUC24 values of first-line anti-TB drugs in this population. TRIAL REGISTRATION: ClinicalTrials.gov (NCT02121314).
RCT Entities:
BACKGROUND: The 24-h area under the concentration-time curve (AUC24)/minimal inhibitory concentration ratio is the best predictive pharmacokinetic/pharmacodynamic (PK/PD) parameter of the efficacy of first-line anti-tuberculosis (TB) drugs. An optimal sampling strategy (OSS) is useful for accurately estimating AUC24; however, OSS has not been developed in the fed state or in the early phase of treatment for first-line anti-TB drugs. METHODS: An OSS for the prediction of AUC24 of isoniazid, rifampicin, ethambutol and pyrazinamide was developed for TB patients starting treatment. A prospective, randomized, crossover trial was performed during the first 3 days of treatment in which first-line anti-TB drugs were administered either intravenously or in fasting or fed conditions. The PK data were used to develop OSS with best subset selection multiple linear regression. The OSS was internally validated using a jackknife analysis and externally validated with other patients from different ethnicities and in a steady state of treatment. RESULTS:OSS using time points of 2, 4 and 8 h post-dose performed best. Bias was < 5% and imprecision was < 15% for all drugs except ethambutol in the fed condition. External validation showed that OSS2-4-8 cannot be used for rifampicin in steady state conditions. CONCLUSION:OSS at 2, 4 and 8 h post-dose enabled an accurate and precise prediction of AUC24 values of first-line anti-TB drugs in this population. TRIAL REGISTRATION: ClinicalTrials.gov (NCT02121314).
Authors: Jan-Willem C Alffenaar; Simon Tiberi; Roger K Verbeeck; Scott K Heysell; Martin P Grobusch Journal: Clin Infect Dis Date: 2016-10-06 Impact factor: 9.079
Authors: Abdullah Alsultan; Rada Savic; Kelly E Dooley; Marc Weiner; William Whitworth; William R Mac Kenzie; Charles A Peloquin Journal: Antimicrob Agents Chemother Date: 2017-05-24 Impact factor: 5.191
Authors: Helen McIlleron; Peter Wash; André Burger; Jennifer Norman; Peter I Folb; Pete Smith Journal: Antimicrob Agents Chemother Date: 2006-04 Impact factor: 5.191
Authors: Marieke G G Sturkenboom; Leonie W Mulder; Arthur de Jager; Richard van Altena; Rob E Aarnoutse; Wiel C M de Lange; Johannes H Proost; Jos G W Kosterink; Tjip S van der Werf; Jan-Willem C Alffenaar Journal: Antimicrob Agents Chemother Date: 2015-06-08 Impact factor: 5.191
Authors: Antonia M I Saktiawati; Marieke G G Sturkenboom; Ymkje Stienstra; Yanri W Subronto; Jos G W Kosterink; Tjip S van der Werf; Jan-Willem C Alffenaar Journal: J Antimicrob Chemother Date: 2015-12-11 Impact factor: 5.790
Authors: Roy Gerona; Anita Wen; David Aguilar; Jamie Shum; Andrew Reckers; Peter Bacchetti; Monica Gandhi; John Metcalfe Journal: J Chromatogr B Analyt Technol Biomed Life Sci Date: 2019-07-23 Impact factor: 3.205
Authors: Reihaneh Abolhassani-Chimeh; Onno W Akkerman; Antonia M I Saktiawati; Nieko C Punt; Mathieu S Bolhuis; Yanri W Subronto; Tjip S van der Werf; Jos G W Kosterink; Jan-Willem C Alffenaar; Marieke G G Sturkenboom Journal: Antimicrob Agents Chemother Date: 2022-06-21 Impact factor: 5.938
Authors: Marieke G G Sturkenboom; Anne-Grete Märtson; Elin M Svensson; Derek J Sloan; Kelly E Dooley; Simone H J van den Elsen; Paolo Denti; Charles A Peloquin; Rob E Aarnoutse; Jan-Willem C Alffenaar Journal: Clin Pharmacokinet Date: 2021-03-06 Impact factor: 6.447