ArticleAIDS research and human retroviruses2019
Short Communication: Bioequivalence of Tenofovir Component of Tenofovir/Rilpivirine/Emtricitabine in Digital Pills.
Article in AIDS research and human retroviruses, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 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.
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Who cites it
6 citing papers in PubMed, 8 citations in OpenAlex.
- Tenofovir-Diphosphate and Emtricitabine-Triphosphate Adherence Benchmarks in Dried Blood Spots for Persons With HIV Receiving Tenofovir Alafenamide and Emtricitabine-Based Antiretroviral Therapy (QUANTI-TAF).Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2024Observational
- Ingestible Electronic Sensors for Monitoring Real-time Adherence to HIV Pre-exposure Prophylaxis and Antiretroviral Therapy.Current HIV/AIDS reports · 2022Review
- Design and Delivery of Real-Time Adherence Data to Men Who Have Sex with Men Using Antiretroviral Pre-exposure Prophylaxis via an Ingestible Electronic Sensor.AIDS and behavior · 2021Article
- Long-Term Stability of the Electronic Sensor Component of a Digital Pill System in Real-World Storage Settings.The Journal of pharmacy technology : jPT : official publication of the Association of Pharmacy Technicians · 2021Article
- Approaches to Objectively Measure Antiretroviral Medication Adherence and Drive Adherence Interventions.Current HIV/AIDS reports · 2020Review
- Pharmacokinetics of Coencapsulated Antiretrovirals with Ingestible Sensors.AIDS research and human retroviruses · 2020Article
Corrections and comments
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Authors and funding
7 authors at 4 institutions in 1 country.
Funding
Abstract
Digital pills, gelatin capsules with radiofrequency transmitters activated by stomach chloride ions, directly measure antiretroviral therapy adherence. In individuals with substance use disorders and HIV, real-time nonadherence detected by digital pills creates a platform to deliver substance use and adherence interventions. In this study, we determined the bioequivalence of tenofovir (TFV), administered as tenofovir disoproxil fumarate (TDF) in healthy human volunteers administered a commercial drug product and a digital pill formulation. We adhered generally to the US FDA Analytical Procedures and Methods for Validation for Drugs and Biologics guidelines. Ten HIV-uninfected adults without reported allergy to TFV, emtricitabine, or rilpivirine were enrolled. Participants ingested a digital pill containing TDF/emtricitabine/rilpivirine. Peripheral venous blood samples were collected at 0.5, 1, 2, 4, 8, and 24 h postingestion. After a 14-day washout period, the same participants ingested Complera™. Serial venous blood samples were collected using the same protocol as the digital pill. Liquid chromatography/mass spectrometry was used to determine a maximum concentration (Cmax), area under curve from time zero to last measured concentration (AUCo-t), and area under curve from time zero to infinity (AUCoo) of TFV. Ten participants with an average age of 27 and body mass index of 25.4 successfully completed the study. Predose TFV was undetectable before the second administration of Complera confirming adequate washout period after ingestion of the digital pill. The geometric means of AUCo-t, AUCoo, and Cmax for test and reference products were within the 95% confidence intervals and, therefore, bioequivalent. TFV overencapsulated in digital pills are bioequivalent to TFV in commercial formulations.
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Registered trials
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