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Inflammation and Intracellular Exposure of Dolutegravir, Darunavir, Tenofovir and Emtricitabine in People living with HIV
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  • Micol Ferrara,
  • Elena Salvador ,
  • Alice Trentalange,
  • Chiara Alcantarini,
  • Mattia Trunfio,
  • Elvira Stefania Cannizzo,
  • Valeria Bono,
  • Silvia Nozza,
  • Amedeo De Nicolò,
  • Alice Ianniello,
  • Elisa De Vivo ,
  • Antonio D'Avolio,
  • Giovanni Di Perri,
  • Stefano Bonora,
  • Giulia Marchetti ,
  • Andrea Calcagno
Micol Ferrara
University of Turin

Corresponding Author:[email protected]

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Elena Salvador
University of Turin
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Alice Trentalange
Department of Infectious Diseases, University of Torino
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Chiara Alcantarini
Università degli Studi di Torino
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Mattia Trunfio
University of Torino
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Elvira Stefania Cannizzo
University of Milan
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Valeria Bono
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Silvia Nozza
San Raffaele Hospital
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Amedeo De Nicolò
University of Turin
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Alice Ianniello
Department of Infectious Diseases, University of Torino
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Elisa De Vivo
Department of Infectious Diseases, University of Torino
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Antonio D'Avolio
University of Turin
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Giovanni Di Perri
Department of Infectious Diseases, University of Torino
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Stefano Bonora
Department of Infectious Disases, University of Torino
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Giulia Marchetti
University of Milan
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Andrea Calcagno
University of Torino
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Abstract

Background: Antiretroviral therapy reduces systemic inflammation and immune activation, but not to levels like HIV-negative. Limited drug penetration within tissues has been argued as potential mechanism of persistent inflammation. Data on the role of inflammation on plasma/intracellular (IC) pharmacokinetics (PK) of ARV drugs through to downregulation/expression of cytochrome P450 3A/membrane transport proteins are limited. Aim of this study was to investigate the correlation between inflammation markers and plasma/IC PK of different ARVs regimen in HIV-positive patients. Methods: We included in the study ART-treated HIV+ pts switching to 3 different ARV regimens: 1) DTG-based dual-therapy plus boosted-PIs, 2) DTG-based triple-therapy without PIs, 3) DRV/c-based triple-therapy. Plasma and IC ARV drugs concentration means at the end of dosing interval (T0), IM on samples concomitantly with ARV PK determination: sCD14, CRP, IL-6 and LPS were analysed. Results: 60 samples from pts included in the switching study were used for measuring plasma and IC concentrations of HIV drugs. No significative differences between CRP, sCD14, IL-6 and LPS values in 3 arms of therapy were observed. Significant correlation was observed between tenofovir plasma concentrations and sCD14 (p<0.001), DRV plasma concentration and sCD14 (p=0,07) and DRV IC/plasma ratio and Log10 IL-6 concentrations (p=0.04). Furthermore, in 24 pts on DTG-TT, we observed a negative trend between DTG IC concentrations and sCD14 (p=0.09). Conclusions: Our preliminary data support the hypothesis of lower IC concentrations of DRV and DTG in pts with higher plasma IM, suggesting an interplay between HIV drug penetration and persistent inflammation in cART-treated HIV-positive patients.
17 Nov 2021Submitted to British Journal of Clinical Pharmacology
30 Dec 2021Submission Checks Completed
30 Dec 2021Assigned to Editor
03 Jan 2022Reviewer(s) Assigned
10 May 2022Review(s) Completed, Editorial Evaluation Pending
13 May 2022Editorial Decision: Revise Major
12 Jul 20221st Revision Received
05 Aug 2022Submission Checks Completed
05 Aug 2022Assigned to Editor
05 Aug 2022Review(s) Completed, Editorial Evaluation Pending
25 Aug 2022Editorial Decision: Accept
11 Oct 2022Published in British Journal of Clinical Pharmacology. 10.1111/bcp.15538