Development of population pharmacokinetics model and Bayesian estimation of rifampicin exposure in Indonesian patients with tuberculosis
Copyright © 2023 The Authors. Published by Elsevier Ltd.. All rights reserved..
BACKGROUND: Interindividual variability in the pharmacokinetics (PK) of anti-tuberculosis (TB) drugs is the leading cause of treatment failure. Herein, we evaluated the influence of demographic, clinical, and genetic factors that cause variability in RIF PK parameters in Indonesian TB patients.
METHODS: In total, 210 Indonesian patients with TB (300 plasma samples) were enrolled in this study. Clinical data, solute carrier organic anion transporter family member-1B1 (SLCO1B1) haplotypes *1a, *1b, and *15, and RIF concentrations were analyzed. The population PK model was developed using a non-linear mixed effect method.
RESULTS: A one-compartment model with allometric scaling adequately described the PK of RIF. Age and SLCO1B1 haplotype *15 were significantly associated with variability in apparent clearance (CL/F). For patients in their 40s, each 10-year increase in age was associated with a 10% decrease in CL/F (7.85 L/h). Patients with the SLCO1B1 haplotype *15 had a 24% lower CL/F compared to those with the wild-type. Visual predictive checks and non-parametric bootstrap analysis indicated good model performance.
CONCLUSION: Age and SLCO1B1 haplotype *15 were significant covariates of RIF CL/F. Geriatric patients with haplotype *15 had significantly greater exposure to RIF. The model could optimize TB pharmacotherapy through its application in therapeutic drug monitoring (clinical trial no. NCT05280886).
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:139 |
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| Enthalten in: |
Tuberculosis (Edinburgh, Scotland) - 139(2023) vom: 05. März, Seite 102325 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Soedarsono, Soedarsono [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 14.03.2023 Date Revised 08.04.2023 published: Print-Electronic ClinicalTrials.gov: NCT05280886 Citation Status MEDLINE |
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| doi: |
10.1016/j.tube.2023.102325 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM353472689 |
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| 245 | 1 | 0 | |a Development of population pharmacokinetics model and Bayesian estimation of rifampicin exposure in Indonesian patients with tuberculosis |
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| 500 | |a Date Completed 14.03.2023 | ||
| 500 | |a Date Revised 08.04.2023 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT05280886 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2023 The Authors. Published by Elsevier Ltd.. All rights reserved. | ||
| 520 | |a BACKGROUND: Interindividual variability in the pharmacokinetics (PK) of anti-tuberculosis (TB) drugs is the leading cause of treatment failure. Herein, we evaluated the influence of demographic, clinical, and genetic factors that cause variability in RIF PK parameters in Indonesian TB patients | ||
| 520 | |a METHODS: In total, 210 Indonesian patients with TB (300 plasma samples) were enrolled in this study. Clinical data, solute carrier organic anion transporter family member-1B1 (SLCO1B1) haplotypes *1a, *1b, and *15, and RIF concentrations were analyzed. The population PK model was developed using a non-linear mixed effect method | ||
| 520 | |a RESULTS: A one-compartment model with allometric scaling adequately described the PK of RIF. Age and SLCO1B1 haplotype *15 were significantly associated with variability in apparent clearance (CL/F). For patients in their 40s, each 10-year increase in age was associated with a 10% decrease in CL/F (7.85 L/h). Patients with the SLCO1B1 haplotype *15 had a 24% lower CL/F compared to those with the wild-type. Visual predictive checks and non-parametric bootstrap analysis indicated good model performance | ||
| 520 | |a CONCLUSION: Age and SLCO1B1 haplotype *15 were significant covariates of RIF CL/F. Geriatric patients with haplotype *15 had significantly greater exposure to RIF. The model could optimize TB pharmacotherapy through its application in therapeutic drug monitoring (clinical trial no. NCT05280886) | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a Pharmacogenetic | |
| 650 | 4 | |a Population pharmacokinetics | |
| 650 | 4 | |a Rifampicin | |
| 650 | 4 | |a Therapeutic drug monitoring | |
| 650 | 4 | |a Tuberculosis | |
| 650 | 7 | |a Rifampin |2 NLM | |
| 650 | 7 | |a VJT6J7R4TR |2 NLM | |
| 650 | 7 | |a Antitubercular Agents |2 NLM | |
| 650 | 7 | |a SLCO1B1 protein, human |2 NLM | |
| 650 | 7 | |a Liver-Specific Organic Anion Transporter 1 |2 NLM | |
| 700 | 1 | |a Jayanti, Rannissa Puspita |e verfasserin |4 aut | |
| 700 | 1 | |a Mertaniasih, Ni Made |e verfasserin |4 aut | |
| 700 | 1 | |a Kusmiati, Tutik |e verfasserin |4 aut | |
| 700 | 1 | |a Permatasari, Ariani |e verfasserin |4 aut | |
| 700 | 1 | |a Indrawanto, Dwi Wahyu |e verfasserin |4 aut | |
| 700 | 1 | |a Charisma, Anita Nur |e verfasserin |4 aut | |
| 700 | 1 | |a Lius, Elvina Elizabeth |e verfasserin |4 aut | |
| 700 | 1 | |a Yuliwulandari, Rika |e verfasserin |4 aut | |
| 700 | 1 | |a Quang Hoa, Pham |e verfasserin |4 aut | |
| 700 | 1 | |a Ky Phat, Nguyen |e verfasserin |4 aut | |
| 700 | 1 | |a Thu, Vo Thuy Anh |e verfasserin |4 aut | |
| 700 | 1 | |a Ky Anh, Nguyen |e verfasserin |4 aut | |
| 700 | 1 | |a Ahn, Sangzin |e verfasserin |4 aut | |
| 700 | 1 | |a Phuoc Long, Nguyen |e verfasserin |4 aut | |
| 700 | 1 | |a Cho, Yong-Soon |e verfasserin |4 aut | |
| 700 | 1 | |a Shin, Jae-Gook |e verfasserin |4 aut | |
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