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Real-Life Therapeutic Concentration Monitoring of Long-Acting Cabotegravir and Rilpivirine: Preliminary Results of an Ongoing Prospective Observational Study in Switzerland

SHCS#879 is an ongoing Switzerland-wide multicenter observational study conducted within the Swiss HIV Cohort Study (SHCS) for the prospective follow-up of people living with HIV (PLWH) receiving long-acting injectable cabotegravir-rilpivirine (LAI-CAB/RPV). All adults under LAI-CAB/RPV and part of...

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Autores principales: Thoueille, Paul, Alves Saldanha, Susana, Schaller, Fabian, Munting, Aline, Cavassini, Matthias, Braun, Dominique, Günthard, Huldrych F., Kusejko, Katharina, Surial, Bernard, Furrer, Hansjakob, Rauch, Andri, Ustero, Pilar, Calmy, Alexandra, Stoeckle, Marcel, Battegay, Manuel, Marzolini, Catia, Andre, Pascal, Guidi, Monia, Buclin, Thierry, Decosterd, Laurent A.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9413113/
https://www.ncbi.nlm.nih.gov/pubmed/36015214
http://dx.doi.org/10.3390/pharmaceutics14081588
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author Thoueille, Paul
Alves Saldanha, Susana
Schaller, Fabian
Munting, Aline
Cavassini, Matthias
Braun, Dominique
Günthard, Huldrych F.
Kusejko, Katharina
Surial, Bernard
Furrer, Hansjakob
Rauch, Andri
Ustero, Pilar
Calmy, Alexandra
Stoeckle, Marcel
Battegay, Manuel
Marzolini, Catia
Andre, Pascal
Guidi, Monia
Buclin, Thierry
Decosterd, Laurent A.
author_facet Thoueille, Paul
Alves Saldanha, Susana
Schaller, Fabian
Munting, Aline
Cavassini, Matthias
Braun, Dominique
Günthard, Huldrych F.
Kusejko, Katharina
Surial, Bernard
Furrer, Hansjakob
Rauch, Andri
Ustero, Pilar
Calmy, Alexandra
Stoeckle, Marcel
Battegay, Manuel
Marzolini, Catia
Andre, Pascal
Guidi, Monia
Buclin, Thierry
Decosterd, Laurent A.
author_sort Thoueille, Paul
collection PubMed
description SHCS#879 is an ongoing Switzerland-wide multicenter observational study conducted within the Swiss HIV Cohort Study (SHCS) for the prospective follow-up of people living with HIV (PLWH) receiving long-acting injectable cabotegravir-rilpivirine (LAI-CAB/RPV). All adults under LAI-CAB/RPV and part of SHCS are enrolled in the project. The study addresses an integrated strategy of treatment monitoring outside the stringent frame of controlled clinical trials, based on relevant patient characteristics, clinical factors, potential drug-drug interactions, and measurement of circulating blood concentrations. So far, 91 blood samples from 46 PLWH have been collected. Most individuals are less than 50 years old, with relatively few comorbidities and comedications. The observed concentrations are globally in accordance with the available values reported in the randomized clinical trials. Yet, low RPV concentrations not exceeding twice the reported protein-adjusted 90% inhibitory concentration have been observed. Data available at present confirm a considerable between-patient variability overall. Based on the growing amount of PK data accumulated during this ongoing study, population pharmacokinetic analysis will characterize individual concentration-time profiles of LAI-CAB/RPV along with their variability in a real-life setting and their association with treatment response and tolerability, thus bringing key data for therapeutic monitoring and precision dosage adjustment of this novel long-acting therapy.
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spelling pubmed-94131132022-08-27 Real-Life Therapeutic Concentration Monitoring of Long-Acting Cabotegravir and Rilpivirine: Preliminary Results of an Ongoing Prospective Observational Study in Switzerland Thoueille, Paul Alves Saldanha, Susana Schaller, Fabian Munting, Aline Cavassini, Matthias Braun, Dominique Günthard, Huldrych F. Kusejko, Katharina Surial, Bernard Furrer, Hansjakob Rauch, Andri Ustero, Pilar Calmy, Alexandra Stoeckle, Marcel Battegay, Manuel Marzolini, Catia Andre, Pascal Guidi, Monia Buclin, Thierry Decosterd, Laurent A. Pharmaceutics Article SHCS#879 is an ongoing Switzerland-wide multicenter observational study conducted within the Swiss HIV Cohort Study (SHCS) for the prospective follow-up of people living with HIV (PLWH) receiving long-acting injectable cabotegravir-rilpivirine (LAI-CAB/RPV). All adults under LAI-CAB/RPV and part of SHCS are enrolled in the project. The study addresses an integrated strategy of treatment monitoring outside the stringent frame of controlled clinical trials, based on relevant patient characteristics, clinical factors, potential drug-drug interactions, and measurement of circulating blood concentrations. So far, 91 blood samples from 46 PLWH have been collected. Most individuals are less than 50 years old, with relatively few comorbidities and comedications. The observed concentrations are globally in accordance with the available values reported in the randomized clinical trials. Yet, low RPV concentrations not exceeding twice the reported protein-adjusted 90% inhibitory concentration have been observed. Data available at present confirm a considerable between-patient variability overall. Based on the growing amount of PK data accumulated during this ongoing study, population pharmacokinetic analysis will characterize individual concentration-time profiles of LAI-CAB/RPV along with their variability in a real-life setting and their association with treatment response and tolerability, thus bringing key data for therapeutic monitoring and precision dosage adjustment of this novel long-acting therapy. MDPI 2022-07-29 /pmc/articles/PMC9413113/ /pubmed/36015214 http://dx.doi.org/10.3390/pharmaceutics14081588 Text en © 2022 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Thoueille, Paul
Alves Saldanha, Susana
Schaller, Fabian
Munting, Aline
Cavassini, Matthias
Braun, Dominique
Günthard, Huldrych F.
Kusejko, Katharina
Surial, Bernard
Furrer, Hansjakob
Rauch, Andri
Ustero, Pilar
Calmy, Alexandra
Stoeckle, Marcel
Battegay, Manuel
Marzolini, Catia
Andre, Pascal
Guidi, Monia
Buclin, Thierry
Decosterd, Laurent A.
Real-Life Therapeutic Concentration Monitoring of Long-Acting Cabotegravir and Rilpivirine: Preliminary Results of an Ongoing Prospective Observational Study in Switzerland
title Real-Life Therapeutic Concentration Monitoring of Long-Acting Cabotegravir and Rilpivirine: Preliminary Results of an Ongoing Prospective Observational Study in Switzerland
title_full Real-Life Therapeutic Concentration Monitoring of Long-Acting Cabotegravir and Rilpivirine: Preliminary Results of an Ongoing Prospective Observational Study in Switzerland
title_fullStr Real-Life Therapeutic Concentration Monitoring of Long-Acting Cabotegravir and Rilpivirine: Preliminary Results of an Ongoing Prospective Observational Study in Switzerland
title_full_unstemmed Real-Life Therapeutic Concentration Monitoring of Long-Acting Cabotegravir and Rilpivirine: Preliminary Results of an Ongoing Prospective Observational Study in Switzerland
title_short Real-Life Therapeutic Concentration Monitoring of Long-Acting Cabotegravir and Rilpivirine: Preliminary Results of an Ongoing Prospective Observational Study in Switzerland
title_sort real-life therapeutic concentration monitoring of long-acting cabotegravir and rilpivirine: preliminary results of an ongoing prospective observational study in switzerland
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9413113/
https://www.ncbi.nlm.nih.gov/pubmed/36015214
http://dx.doi.org/10.3390/pharmaceutics14081588
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