ArticleThe Journal of antimicrobial chemotherapy2015
Development, validation and clinical application of a novel method for the quantification of efavirenz in dried breast milk spots using LC-MS/MS.
Article in The Journal of antimicrobial chemotherapy, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02269462 (Role of Pharmacogenetics in Efavirenz and Nevirapine Pharmacokinetics, Efficacy and Safety in Mother-infant Pairs During Pregnancy and Lactation), which is not on this map. Cited by 13 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Role of Pharmacogenetics in Efavirenz and Nevirapine Pharmacokinetics, Efficacy and Safety in Mother-infant Pairs During Pregnancy and Lactation
Who cites it
13 citing papers in PubMed, 39 citations in OpenAlex.
- Direct sub-atmospheric pressure ionization mass spectrometry: Evaporation/sublimation-driven ionization is amazing, fundamentally, and practically.Journal of mass spectrometry : JMS · 2024Review
- Drugs in Human Milk Part 1: Practical and Analytical Considerations in Measuring Drugs and Metabolites in Human Milk.Clinical pharmacokinetics · 2024Review
- Validation and application of a quantitative liquid chromatography tandem mass spectrometry assay for the analysis of rifapentine and 25-O-desacetyl rifapentine in human milk.Journal of pharmaceutical and biomedical analysis · 2022Article
- Optimizing Pharmacology Studies in Pregnant and Lactating Women Using Lessons From HIV: A Consensus Statement.Clinical pharmacology and therapeutics · 2021Article
- Development of a highly sensitive bioanalytical assay for the quantification of favipiravir.bioRxiv : the preprint server for biology · 2021Article
- Validation and clinical application of a method to quantify efavirenz in cervicovaginal secretions from flocked swabs using liquid chromatography tandem mass spectrometry.Wellcome open research · 2021Article
- Clinical lactation studies and the role of pharmacokinetic modeling and simulation in predicting drug exposures in breastfed infants.Journal of pharmacokinetics and pharmacodynamics · 2020Review
- Validation and clinical application of a novel LC-MS method for quantification of dolutegravir in breast milk.Bioanalysis · 2018Article
- Plasma and breast milk pharmacokinetics of emtricitabine, tenofovir and lamivudine using dried blood and breast milk spots in nursing African mother-infant pairs.The Journal of antimicrobial chemotherapy · 2018Article
- Article
- Development, validation and clinical application of a method for the simultaneous quantification of lamivudine, emtricitabine and tenofovir in dried blood and dried breast milk spots using LC-MS/MS.Journal of chromatography. B, Analytical technologies in the biomedical and life sciences · 2017Article
- Validation and clinical application of a method to quantify nevirapine in dried blood spots and dried breast-milk spots.The Journal of antimicrobial chemotherapy · 2015Article
- Breast milk pharmacokinetics of efavirenz and breastfed infants' exposure in genetically defined subgroups of mother-infant pairs: an observational study.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2015Observational
Corrections and comments
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Authors and funding
12 authors at 2 institutions in 2 countries.
Funding
Abstract
objectivesThis manuscript describes the development, validation and clinical application of a novel method for the quantification of the antiretroviral drug efavirenz in dried breast milk spots using LC-MS.
methodsDried breast milk spots were prepared by spotting 30 μL of human breast milk on each circle of Whatman 903 Protein Saver cards. Chromatographic separation was achieved on a reverse-phase C18 column with 1 mM ammonium acetate in water/acetonitrile using a solvent gradient at a flow rate of 400 μL/min and detection was by TSQ Quantum Access triple quadrupole mass spectrometer equipped with a heated electrospray ionization source. The method was applied to characterize the breast milk pharmacokinetic profile of efavirenz in HIV-positive nursing mothers receiving regimens containing 600 mg of efavirenz once daily.
resultsThe assay was validated over the concentration range 50-7500 ng/mL. Accuracy ranged between 95.2% and 102.5% and precision ranged between 1.05% and 9.53%. The average recovery of efavirenz from dried breast milk spots was 106.4% and the matrix effect was 8.14%. Stability of efavirenz in dried breast milk spots and processed samples at room temperature, -40°C and -80°C was demonstrated. In the pharmacokinetic study, the mean (SD) AUC0-24, Cmax and Cmin of efavirenz in breast milk were 59,620 ng·h/mL (17,440), 4527 ng/mL (1767) and 1261 ng/mL (755.9), respectively. The mean (range) milk-to-plasma concentration ratio over the dosing interval was 0.78 (0.57-1.26).
conclusionsThe dried breast milk spot method is simple, robust, accurate and precise, and can be used in settings with limited resources.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.