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Journal article
Pharmacokinetics of Coencapsulated Antiretrovirals with Ingestible Sensors
AIDS research and human retroviruses, v 36(1), pp 65-74
01 Jan 2020
PMID: 31516025
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Abstract
We investigated the use of a system with an ingestible sensor (Proteus Digital Health Feedback system) coencapsulated with antiretrovirals (ARVs) to measure real-time adherence. To assess the safety and impact, if any, coencapsulation might have on ARV concentrations, we evaluated the pharmacokinetics of ARVs coencapsulated with an ingestible sensor for eight commonly used fixed-dose combination ARVs: emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF); FTC/tenofovir alafenamide (TAF); efavirenz (EFV)/FTC/TDF; abacavir (ABC)/lamivudine (3TC); dolutegravir (DTG)/ABC/3TC; rilpivirine (RPV)/TAF/FTC; elvitegravir (EVG)/cobicistat (COBI)/FTC/TAF; and bictegravir (BIC)/FTC/TAF. The steady-state apparent peak plasma concentration (Cmax) and area under the concentration-time curve (AUC) were determined from plasma concentrations measured at predose, 1, 2, 4, and 6 h postdose, and compared with literature values. A total of 49 unique patients on stable regimens for at least 12 weeks with undetectable viral loads were recruited. Cmax and AUC values were not statistically significantly different from literature values for all of the formulations except the Cmax of FTC/TDF, Cmax of BIC, and the Cmax of RPV. In a subsequent evaluation of FTC/TDF and BIC/FTC/TAF using a crossover design, the geometric mean ratio (GMR) between the coencapsulated and the unencapsulated formulations for FTC/TDF were the following: FTC, 84.6% (90% confidence interval [CI] 66.6-107.4) for AUC and 77.5% (60.1-99.9) for Cmax. For tenofovir (TFV), the GMR was 96.2% (90% CI 89.2-103.8) for AUC and 87.3% (64.2-118.7) for Cmax. The GMR for BIC (from the BIC/FTC/TAF formulation) was 98.0% (90% CI 84.5-113.5) for AUC and 89.9% (84.5-95.7) for Cmax. The observed deviation in FTC/TDF (Truvada) may be due to participant characteristics, fasted/fed conditions, and/or random variation and may warrant further investigations with a larger sample size. These findings provide assurance for use of coencapsulated ARVs for future HIV treatment-adherence research.
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Details
- Title
- Pharmacokinetics of Coencapsulated Antiretrovirals with Ingestible Sensors
- Creators
- Honghu Liu - Univ Calif Los Angeles, Div Publ Hlth & Community Dent, Los Angeles, CA USAEric Daar - The Lundquist InstituteYan Wang - Univ Calif Los Angeles, Fielding Sch Publ Hlth, Dept Biostat, Los Angeles, CA USALisa Siqueiros - Harbor UCLA Med Ctr, Lundquist Inst, Dept Med, Div HIV Med, Torrance, CA 90509 USAKayla Campbell - Univ Nebraska Med Ctr, Ctr Drug Discovery, Omaha, NE USAJie Shen - University of California, Los AngelesMario Guerrero - Harbor UCLA Med Ctr, Lundquist Inst, Dept Med, Div HIV Med, Torrance, CA 90509 USAMeng-Wei Ko - Univ Calif Los Angeles, Sch Dent, Div Oral Biol & Med, Los Angeles, CA 90024 USADi Xiong - Univ Calif Los Angeles, Fielding Sch Publ Hlth, Dept Biostat, Los Angeles, CA USAJohn Dao - Proteus Digital Hlth, Redwood City, CA USATodd Young - Proteus Digital Hlth, Redwood City, CA USAMarc Rosen - Yale Univ, Sch Med, New Haven, CT USACourtney V. Fletcher - Univ Nebraska Med Ctr, Ctr Drug Discovery, Omaha, NE USA
- Publication Details
- AIDS research and human retroviruses, v 36(1), pp 65-74
- Publisher
- Mary Ann Liebert, Inc
- Number of pages
- 10
- Grant note
- R01-MH110056 / National Institute of Mental Health (NIMH)/National Institute of Health (NIH)
- Resource Type
- Journal article
- Language
- English
- Academic Unit
- Dana and David Dornsife School of Public Health
- Web of Science ID
- WOS:000492695600001
- Scopus ID
- 2-s2.0-85077403198
- Other Identifier
- 991021860772504721
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- Collaboration types
- Domestic collaboration
- Web of Science research areas
- Immunology
- Infectious Diseases
- Virology