Trial reportJournal of clinical pharmacology2014
Estimation of tenofovir's population pharmacokinetic parameters without reliable dosing histories and application to tracing dosing history using simulation strategies.
Trial report in Journal of clinical pharmacology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.
What it found
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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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
9 citing papers in PubMed.
- Population Pharmacokinetics of Tenofovir in HIV-1-Uninfected Members of Serodiscordant Couples and Effect of Dose Reporting Methods.Antimicrobial agents and chemotherapy · 2016Trial
- Dose Frequency Ranging Pharmacokinetic Study of Tenofovir-Emtricitabine After Directly Observed Dosing in Healthy Volunteers to Establish Adherence Benchmarks (HPTN 066).AIDS research and human retroviruses · 2016Trial
- Population pharmacokinetics of tenofovir and tenofovir-diphosphate in healthy women.Journal of clinical pharmacology · 2015Trial
- A multicompartment population PK model to predict tenofovir and emtricitabine mucosal tissue concentrations for HIV prevention.CPT: pharmacometrics & systems pharmacology · 2023Article
- Clinical trial simulation to evaluate tenofovir disoproxil fumarate/emtricitabine HIV pre-exposure prophylaxis dosing during pregnancy.Frontiers in reproductive health · 2023Article
- Combining information to estimate adherence in studies of pre-exposure prophylaxis for HIV prevention: Application to HPTN 067.Statistics in medicine · 2022Article
- Tenofovir Plasma Concentration from Preexposure Prophylaxis at the Time of Potential HIV Exposure: a Population Pharmacokinetic Modeling and Simulation Study Involving Serodiscordant Couples in East Africa.Antimicrobial agents and chemotherapy · 2019Article
- Patterns of non-adherence to oral antiretroviral medication: frequencies of consecutively missed doses.Patient preference and adherence · 2019Article
- HIV Antiretroviral Pre-Exposure Prophylaxis: Development Challenges and Pipeline Promise.Clinical pharmacology and therapeutics · 2018Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
Abstract
The objectives of this analysis were to develop a population pharmacokinetic model (PPK) for tenofovir without using potentially unreliable patient reported dosing records and to retrace patient dosing history using pharmacokinetic simulations conditioned on protocol design constraints to assess patient adherence. MTN-001 is a multi-center, open label, 3-way cross over study comparing oral, vaginal and combination (oral and vaginal) administration of tenofovir in healthy women. It was reported that self-reported adherence in this study was high (94%), but serum concentrations indicated only 64% of participants used tablets consistently. A method based on superposition was applied to develop the population PPK considering only observable clinic visit dosing information. A two compartment model described the data well and the parameters agree with the literature reported values. Race was not a significant covariate on clearance. Retracing of the dosing history with 3-past dose resolution was not successful. Trial simulations with full adherence assumption predict a median Cmin of 68 ng/mL, which is in agreement with literature reports. Non-adherence at 25% resulted in 37-51% reduction in Cmin using one coin and two coin models, respectively. Population analyses should consider some method of correction for non-adherence to avoid biased estimates.
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Registered trials
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