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AIDS and Behavior

, Volume 17, Issue 1, pp 298–306 | Cite as

Oral Adherence Monitoring Using a Breath Test to Supplement Highly Active Antiretroviral Therapy

  • Timothy E. Morey
  • Matthew Booth
  • Scott Wasdo
  • Judith Wishin
  • Brian Quinn
  • Daniel Gonzalez
  • Hartmut Derendorf
  • Susan P. McGorray
  • Jane Simoni
  • Richard J. Melker
  • Donn M. Dennis
Original Paper

Abstract

A breath-based adherence system to document ingestion of oral medications (e.g., HAART) was investigated. Specifically, the food additive 2-butanol, which can be easily packaged with a drug, is converted via alcohol dehydrogenase to the volatile metabolite 2-butanone that rapidly appears in breath, indicating adherence. In healthy adults using a portable sensor and GC–MS, the following experiments were performed: yield of 2-butanone in breath following ingestion of 2-butanol, adherence system accuracy, and potential interference of the adherence system by food or misplacement of 2-butanol on the tongue. During feasibility testing, every subject exhaled 2-butanone with 6.6 ± 1.5 min to peak concentrations of 548 ± 235 ppb following ingestion of 2-butanol (40 mg). ROC areas at 5 and 10 min were 0.95 (0.86–1.00) and 1.00 (1.00–1.00). Food did not interfere. Tongue application resulted in large concentrations of 2-butanol, but not 2-butanone. A breath test to provide definitive evidence of oral medication adherence appears technically feasible.

Keywords

Adherence Antiretroviral therapy Behavioral interventions Prevention of sexual transmission Sexual behavior 

Resumen

Un sistema de la adherencia basada en el aliento, para documentar la ingestión de medicamentos por vía oral (por ejemplo, HAART), se investigo. Específicamente el aditivo alimentario 2-butanol, el cual puede ser fácilmente empaquetado con un fármaco, se convierte mediante el alcohol deshidrogenasa en el metabolito volátil 2-butanona que rápidamente aparece en la respiración, indicando la adherencia. En adultos sanos utilizando un sensor portátil y GC–MS, los siguientes experimentos se llevaron a cabo: rendimiento de 2-butanona en el aliento tras la ingestión de 2-butanol, la precisión del sistema de adherencia, y la interferencia potencial del sistema de adherencia por medio de la comida o extravió de 2-butanol en la lengua. Durante los ensayos de viabilidad, cada sujeto exhaló 2-butanona con 6.6 ± 1.5 min a concentraciones máximas de 548 ± 235 ppb tras la ingestión de 2-butanol (40 mg). Áreas ROC a 5 y 10 minutos fueron de 0.95 (0.86–1.00) y 1.00 (1.00–1.00). La comida no interfiere. La aplicación en la lengua dió por resultado altas concentraciones de 2-butanol, pero no la 2-butanona. Una prueba de aliento para proporcionar evidencia definitiva de la adherencia a los medicamentos oral parece técnicamente factible.

Notes

Acknowledgments

The project described was supported by Award Number R44MH081767 (“A Breath-based Medication Adherence Monitoring System for HIV/AIDS Therapies”) from the National Institute of Mental Health. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institute of Mental Health or the National Institutes of Health. This work was also supported by Xhale, Inc. (Gainesville, FL, USA), the Department of Anesthesiology, University of Florida College of Medicine (Gainesville, FL, USA), and the Joachim S. Gravenstein, M.D. Professorship in Anesthesiology. Drs. Melker and Dennis are employees of Xhale, Inc., the company that sponsored the study. Drs. Morey and Derendorf are consultants for Xhale, Inc. Drs. Melker, Dennis, and Morey also own equity in Xhale, Inc. In addition, the University of Florida owns equity in Xhale, Inc.If a device is sold commercially, then the authors listed above and the University of Florida could benefit financially. For the remaining authors and institutions, no conflict is declared.

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Copyright information

© Springer Science+Business Media New York 2012

Authors and Affiliations

  • Timothy E. Morey
    • 1
  • Matthew Booth
    • 1
  • Scott Wasdo
    • 1
  • Judith Wishin
    • 1
  • Brian Quinn
    • 2
  • Daniel Gonzalez
    • 3
  • Hartmut Derendorf
    • 3
  • Susan P. McGorray
    • 4
  • Jane Simoni
    • 5
  • Richard J. Melker
    • 1
    • 2
  • Donn M. Dennis
    • 1
    • 2
    • 6
  1. 1.Department of AnesthesiologyUniversity of Florida College of MedicineGainesvilleUSA
  2. 2.Xhale, Inc.GainesvilleUSA
  3. 3.Department of PharmaceuticsUniversity of Florida College of PharmacyGainesvilleUSA
  4. 4.Department of BiostatisticsUniversity of Florida College of MedicineGainesvilleUSA
  5. 5.Department of PsychologyUniversity of WashingtonSeattleUSA
  6. 6.Departments of Pharmacology and Experimental Therapeutics, and PsychiatryUniversity of Florida College of MedicineGainesvilleUSA

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