Development and validation of a liquid chromatography-tandem mass spectrometry method for quantifying delamanid and its metabolite in small hair samples

Reckers, Andrew; Huo, Stella; Esmail, Ali; Dheda, Keertan; Bacchetti, Peter; Gandhi, Monica; Metcalfe, John; Gerona, Roy

doi:10.1016/j.jchromb.2020.122467

Cited by 5 publications

(4 citation statements)

References 31 publications

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“…A total of 13 articles reported on measured hair concentrations of three first-line TB drugs (isoniazid, pyrazinamide, and ethambutol) and eight second-line drugs (levofloxacin, moxifloxacin, linezolid, clofazimine, bedaquiline, pretomanid, ethionamide, and delamanid). Apart from parent compounds, three articles also measured TB drug metabolites in hair (acetyl-INH [ 21 , 82 ] and DM-6705 [ 83 ], a metabolite of delamanid). Study populations comprised both adults and pediatric patients, and sample sizes ranged from two to 264 participants.…”

Section: Resultsmentioning

confidence: 99%

“…All studies were assessed for the risk of bias and two studies had a moderate risk of bias because of the selection of participants as one study [85] had 98% female participants and the other [22] enrolled all male participants. Other studies [21,[82][83][84][86][87][88][89][90][91][92] had a low overall risk of bias. Similar to urine and saliva, the TRL score for hair was 7 (Table 5) as all studies were performed in patients with TB in operational settings.…”

Section: Hairmentioning

confidence: 99%

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Alternative Methods for Therapeutic Drug Monitoring and Dose Adjustment of Tuberculosis Treatment in Clinical Settings: A Systematic Review

et al. 2023

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Background and Objective Quantifying exposure to drugs for personalized dose adjustment is of critical importance in patients with tuberculosis who may be at risk of treatment failure or toxicity due to individual variability in pharmacokinetics. Traditionally, serum or plasma samples have been used for drug monitoring, which only poses collection and logistical challenges in high-tuberculosis burden/low-resourced areas. Less invasive and lower cost tests using alternative biomatrices other than serum or plasma may improve the feasibility of therapeutic drug monitoring. Methods A systematic review was conducted to include studies reporting anti-tuberculosis drug concentration measurements in dried blood spots, urine, saliva, and hair. Reports were screened to include study design, population, analytical methods, relevant pharmacokinetic parameters, and risk of bias. Results A total of 75 reports encompassing all four biomatrices were included. Dried blood spots reduced the sample volume requirement and cut shipping costs whereas simpler laboratory methods to test the presence of drug in urine can allow point-of-care testing in high-burden settings. Minimal pre-processing requirements with saliva samples may further increase acceptability for laboratory staff. Multi-analyte panels have been tested in hair with the capacity to test a wide range of drugs and some of their metabolites. Conclusions Reported data were mostly from small-scale studies and alternative biomatrices need to be qualified in large and diverse populations for the demonstration of feasibility in operational settings. High-quality interventional studies will improve the uptake of alternative biomatrices in guidelines and accelerate implementation in programmatic tuberculosis treatment.

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Section: Resultsmentioning

confidence: 99%

Section: Hairmentioning

confidence: 99%

Alternative Methods for Therapeutic Drug Monitoring and Dose Adjustment of Tuberculosis Treatment in Clinical Settings: A Systematic Review

et al. 2023

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“…To date, it is still a major global public health and social problem [ 3–8 ]. The core treatment of the directly observed treatment, short-course (DOTS) strategy is standard short-term chemotherapy based on the reasonable combination of sterilization, bacteriostasis, and prevention of drug resistance [ 9 , 10 ]. Three first-line drugs, including isoniazid (INH, H), rifampicin (RIF, R) and pyrazinamide (PZA, Z), are recommended by the WHO as standard short-term chemotherapy regimens.…”

Section: Introductionmentioning

confidence: 99%

Study on the associations between liver damage and antituberculosis drug rifampicin and relative metabolic enzyme gene polymorphisms

Liu

et al. 2021

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The occurrence of antituberculosis drug-induced liver injury affects the effectiveness of antituberculosis treatments. Understanding the mechanism and risk factors of such liver injury may improve the outcomes of those patients who received antituberculosis treatments. In this study, 2,255 pulmonary tuberculosis patients were included. Their medical records were reviewed, questionnaire surveys, liver function tests at the end of February (including patients with uncomfortable symptoms during the intensive treatment period), and blood samples were saved. Afterward, cases of liver damage were determined using Chinese liver damage criteria. The genotype of all participants was determined using the PCR-LDR method. Finally, the association between genetic polymorphism and ATB-DILI susceptibility was assessed using the univariate Logistic regression models. Among the 2,255 tuberculosis patients who received rifampicin, 612 (27.1%) had antituberculosis drug-induced liver injury. We observed higher proportions of older age, male, and lower levels of AST, ALT, and TBil among patients with liver injury. Results of univariate of logistic regression models showed that patients with CYP2C19 were more likely to have liver injury compared with no such genotypes patients (all P < 0.05). Patients with tuberculosis with older age and genetic polymorphism of CYP3A4, CYP2C9, and CYP2C19 who received long-term rifampicin treatment were more likely to have antituberculosis drug-induced liver injury. It is important for healthcare providers to carefully evaluate and monitor rifampicin use for these patients.

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“…The core treatment of DOTS strategy is standard short-term chemotherapy, which is based on the reasonable combination of sterilization, bacteriostasis and prevention of drug resistance [3]. Three rstline drugs, INH, RIF and PZA, which are recommended by who as standard short-term chemotherapy regimens, can cause adverse drug reactions (ADRs) of different degrees and frequencies while killing tuberculosis [4].…”

Section: Introductionmentioning

confidence: 99%

Study on the relationship between liver damage caused by anti-tuberculosis drug rifampicin and related metabolic enzyme gene polymorphisms

Liu

et al. 2021

Preprint

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Background The occurrence of Anti-TB Drug-induced Liver Injury (ATLI) affects the progress of anti-tuberculosis treatment and the cure rate of tuberculosis. To understand the mechanism and risk factors of ATLI, it is helpful to reduce or avoid the occurrence of liver damage. It is of great significance for the smooth completion of anti-tuberculosis treatment. Methods In this study, 2255 pulmonary tuberculosis patients were included as the research object, and their medical records were reviewed, questionnaire surveys, liver function tests at the end of February (including patients with uncomfortable symptoms during the intensive treatment period) and blood samples were saved. Determine cases of liver damage based on the criteria for liver damage. The genotype was determined by the PCR-LDR method, and the single factor and unconditional Logistic regression methods were used to explore the relationship between genetic polymorphism and ATLI susceptibility. Results Through the screening of related factors affecting ATLI, this study found that ATLI may be related to gender, year and age is related to body weight; there is an association between the genetic polymorphism site CYP2C9 *2 and ATLI, and the best association model is a dominant inheritance model. Conclusions In-depth discussion of the genetic nature of ATLI is of great practical significance and practicality for preventing the occurrence of liver damage in patients with tuberculosis in our region, reducing the damage to the liver by anti-tuberculosis drugs, and formulating individualized chemotherapy regimens to avoid treatment failure due to liver damage.

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Development and validation of a liquid chromatography-tandem mass spectrometry method for quantifying delamanid and its metabolite in small hair samples

Cited by 5 publications

References 31 publications

Alternative Methods for Therapeutic Drug Monitoring and Dose Adjustment of Tuberculosis Treatment in Clinical Settings: A Systematic Review

Alternative Methods for Therapeutic Drug Monitoring and Dose Adjustment of Tuberculosis Treatment in Clinical Settings: A Systematic Review

Study on the associations between liver damage and antituberculosis drug rifampicin and relative metabolic enzyme gene polymorphisms

Study on the relationship between liver damage caused by anti-tuberculosis drug rifampicin and related metabolic enzyme gene polymorphisms

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