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270 results on '"Gagnieu, Marie-Claude"'

3. Therapeutic drug monitoring and virological response at week 48 in a cohort of HIV‐1‐infected patients switching to dolutegravir/rilpivirine dual maintenance therapy (ANRS‐MIE‐BIRIDER study).

Author

Lemaitre, Florian, Lagoutte‐Renosi, Jennifer, Gagnieu, Marie‐Claude, Parant, François, Venisse, Nicolas, Grégoire, Matthieu, Bouchet, Stéphane, Garraffo, Rodolphe, Lê, Minh P., Muret, Patrice, Comets, Emmanuelle, Solas, Caroline, Peytavin, Gilles, Chirouze, Catherine, Hustache‐Mathieu, Laurent, Gendrin, Vincent, Drobatcheff‐Thiebaut, Marie‐Christine, Foltzer, Adeline, Obry‐Roguet, Véronique, and Brégigeon, Sylvie

Subjects
DRUG monitoring, HIV-positive persons, HIV, DOLUTEGRAVIR, HEPATITIS C virus, VIRAL load, NON-nucleoside reverse transcriptase inhibitors
Abstract

Aims: Dolutegravir (DTG) and rilpivirine (RPV) dual therapy is now recommended as a switch option in virologically suppressed HIV patients. Literature suggests that virological failure with dual therapy could possibly relate to subtherapeutic drug concentrations. In this study, we aimed at describing the DTG and RPV trough plasma concentrations (Cmin) and plasma HIV‐1 RNA viral load (VL) during maintenance dual therapy. Methods: We performed a retrospective analysis of DTG and RPV therapeutic drug monitoring in people living with HIV/AIDS (PLWHA) with dual therapy in 9 French centres. DTG and RPV trough plasma concentrations were estimated using a Bayesian approach to predict Cmin. The relationship between the pharmacokinetics of DTG and RPV and VL > 50 copies (cp)/mL was explored using joint nonlinear mixed models. The frequency of subtherapeutic threshold (DTG Cmin below 640 ng/mL and RPV Cmin below 50 ng/mL) were compared between PLWHA presenting VL > 50 cp/mL or not during the study. Results: At baseline, 209 PLWHA were enrolled in the study. At week 48, 19 people living with HIV/AIDS (9.1%) discontinued their treatment and 15 PLWHA (7.1%) exhibited VL > 50 cp/mL. Six PLWHA out of 15 (40.0%) with VL > 50 cp/mL during the follow‐up had at least 1 Cmin below the respective thresholds while only 26/194 patients (13.4%) without virological replication had at least 1 concentration below the threshold (P =.015). Conclusion: A majority of PLWHA receiving DTG/RPV maintenance dual therapy demonstrated VL < 50 cp/mL but virological replication was more frequent in people living with HIV/AIDS with subtherapeutic Cmin. [ABSTRACT FROM AUTHOR]

Published
2024
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6. Nilotinib and peginterferon alfa-2a for newly diagnosed chronic-phase chronic myeloid leukaemia (NiloPeg): a multicentre, non-randomised, open-label phase 2 study

Author

Nicolini, Franck E, Etienne, Gabriel, Dubruille, Viviane, Roy, Lydia, Huguet, Françoise, Legros, Laurence, Giraudier, Stéphane, Coiteux, Valérie, Guerci-Bresler, Agnès, Lenain, Pascal, Cony-Makhoul, Pascale, Gardembas, Martine, Hermet, Eric, Rousselot, Philippe, Amé, Shanti, Gagnieu, Marie-Claude, Pivot, Christine, Hayette, Sandrine, Maguer-Satta, Veronique, Etienne, Madeleine, Dulucq, Stéphanie, Rea, Delphine, and Mahon, François-Xavier

Published
2015
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7. Disappearance of FDG uptake on PET scan after antimicrobial therapy could help for the diagnosis of Coxiella burnetii spondylodiscitis

Author

Gaudé, Marine, Julien, Saison, Laurent, Frédéric, Ferry, Tristan, Perpoint, Thomas, Boibieux, André, Biron, François, Ader, Florence, Valour, Florent, Roux, Sandrine, Daoud, Fatiha, Lippman, Johanna, Braun, Evelyne, Vallat, Marie-Paule, Miailhes, Patrick, Chidiac, Christian, Gillet, Yves, Hees, Laure, Lustig, Sébastien, Neyret, Philippe, Reynaud, Olivier, Peltier, Adrien, Viste, Anthony, Bérard, Jean-Baptiste, Dalat, Frédéric, Cantin, Olivier, Desmarchelier, Romain, Vermersch, Thibault, Fessy, Michel-Henry, Barrey, Cédric, Signorelli, Francesco, Jouanneau, Emmanuel, Jacquesson, Timothée, Mojallal, Ali, Boucher, Fabien, Shipkov, Hristo, Ismail, Mehdi, Chateau, Joseph, Vandenesch, François, Rasigade, Jean-Philippe, Dupieux, Céline, Trouillet-Assant, Sophie, Morelec, Isabelle, Janier, Marc, Giammarile, Francesco, Tod, Michel, Gagnieu, Marie-Claude, Goutelle, Sylvain, and Mabrut, Eugénie

Published
2016
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8. Reactivation of Clostridium tertium bone infection 30 years after the Iran–Iraq war

Author

Virot, Emilie, Servien, Elvire, Laurent, Frederic, Ferry, Tristan, Perpoint, Thomas, Boibieux, André, Biron, François, Ader, Florence, Saison, Julien, Valour, Florent, Daoud, Fatiha, Lippman, Johanna, Braun, Evelyne, Vallat, Marie-Paule, Miailhes, Patrick, Chidiac, Christian, Peyramond, Dominique, Lustig, Sébastien, Neyret, Philippe, Reynaud, Olivier, Debette, Caroline, Peltier, Adrien, Viste, Anthony, Bérard, Jean-Baptiste, Dalat, Frédéric, Cantin, Olivier, Desmarchelier, Romain, Fessy, Michel-Henry, Barrey, Cédric, Signorelli, Francesco, Jouanneau, Emmanuel, Jacquesson, Timothée, Breton, Pierre, Mojallal, Ali, Boucher, Fabien, Shipkov, Hristo, Vandenesch, François, Rasigade, Jean-Philippe, Dupieux, Céline, Boussel, Loïc, Pialat, Jean-Baptiste, Morelec, Isabelle, Janier, Marc, Giammarile, Francesco, Tod, Michel, Gagnieu, Marie-Claude, Goutelle, Sylvain, and Mabrut, Eugénie

Published
2015
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9. A 22-year-old woman with right lumpy jaw syndrome and fistula

Author

Valour, F, Chidiac, C, Ferry, T, Ferry, Tristan, Perpoint, Thomas, Boibieux, André, Biron, François, Ader, Florence, Saison, Julien, Valour, Florent, Daoud, Fatiha, Lippman, Johanna, Braun, Evelyne, Vallat, Marie-Paule, Miailhes, Patrick, Chidiac, Christian, Peyramond, Dominique, Lustig, Sébastien, Neyret, Philippe, Reynaud, Olivier, Debette, Caroline, Peltier, Adrien, Viste, Anthony, Bérard, Jean-Baptiste, Dalat, Frédéric, Cantin, Olivier, Desmarchelier, Romain, Vermersch, Thibault, Fessy, Michel-Henry, Barrey, Cédric, Signorelli, Francesco, Jouanneau, Emmanuel, Jacquesson, Timothée, Breton, Pierre, Mojallal, Ali, Boucher, Fabien, Shipkov, Hristo, Laurent, Frederic, Vandenesch, François, Rasigade, Jean-Philippe, Dupieux, Céline, Morelec, Isabelle, Janier, Marc, Giammarile, Francesco, Tod, Michel, Gagnieu, Marie-Claude, Goutelle, Sylvain, and Mabrut, Eugénie

Published
2015
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12. Implementation of a complex bone and joint infection phage therapy centre in France: lessons to be learned after 4 years' experience

Author

Ferry, Tristan, primary, Kolenda, Camille, additional, Briot, Thomas, additional, Lustig, Sébastien, additional, Leboucher, Gilles, additional, Laurent, Frédéric, additional, Ferry, Tristan, additional, Valour, Florent, additional, Perpoint, Thomas, additional, Ader, Florence, additional, Roux, Sandrine, additional, Becker, Agathe, additional, Triffault-Fillit, Claire, additional, Conrad, Anne, additional, Pouderoux, Cécile, additional, Chauvelot, Pierre, additional, Chabert, Paul, additional, Lippman, Johanna, additional, Braun, Evelyne, additional, Servien, Elvire, additional, Batailler, Cécile, additional, Gunst, Stanislas, additional, Schmidt, Axel, additional, Sappey-Marinier, Eliott, additional, Ode, Quentin, additional, Fessy, Michel-Henry, additional, Viste, Anthony, additional, Besse, Jean-Luc, additional, Chaudier, Philippe, additional, Louboutin, Lucie, additional, Van Haecke, Adrien, additional, Mercier, Marcelle, additional, Belgaid, Vincent, additional, Gazarian, Aram, additional, Walch, Arnaud, additional, Bertani, Antoine, additional, Rongieras, Frédéric, additional, Martres, Sébastien, additional, Trouillet, Franck, additional, Barrey, Cédric, additional, Mojallal, Ali, additional, Brosset, Sophie, additional, Hanriat, Camille, additional, Person, Hélène, additional, Céruse, Philippe, additional, Fuchsmann, Carine, additional, Gleizal, Arnaud, additional, Aubrun, Frédéric, additional, Dziadzko, Mikhail, additional, Macabéo, Caroline, additional, Patrascu, Dana, additional, Beraud, Laetitia, additional, Roussel-Gaillard, Tiphaine, additional, Dupieux, Céline, additional, Josse, Jérôme, additional, Craighero, Fabien, additional, Boussel, Loic, additional, Pialat, Jean-Baptiste, additional, Morelec, Isabelle, additional, Tod, Michel, additional, Gagnieu, Marie-Claude, additional, Goutelle, Sylvain, additional, Mabrut, Eugénie, additional, Medina, Mathieu, additional, Laumay, Floriane, additional, Bonhomme, Melanie, additional, Blazere, Leslie, additional, Legendre, Tiphaine, additional, Terrazzoni, Eline, additional, Pirot, Fabrice, additional, Merienne, Camille, additional, Filali, Samira, additional, and Lapras, Benjamine, additional

Published
2022
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13. Pristinamycin in the treatment of MSSA bone and joint infection

Author

Valour, Florent, Boibieux, André, Karsenty, Judith, Vallat, Marie-Paule, Braun, Evelyne, Perpoint, Thomas, Biron, François, Laurent, Frédéric, Lustig, Sébastien, Chidiac, Christian, Ferry, Tristan, Ader, Florence, Biron, François, Boibieux, André, Braun, Evelyne, Chidiac, Christian, Daoud, Fatiha, Ferry, Tristan, Gillet, Yves, Hees, Laure, Lippmann, Johanna, Miailhes, Patrick, Perpoint, Thomas, Roux, Sandrine, Saison, Julien, Vallat, Marie-Paule, Valour, Florent, Barrey, Cédric, Bérard, Jean-Baptiste, Boucher, Fabien, Breton, Pierre, Cantin, Olivier, Dalat, Frédéric, Desmarchelier, Romain, Fessy, Michel-Henry, Jacquesson, Timothée, Jouanneau, Emmanuel, Lustig, Sébastien, Mojallal, Ali, Neyret, Philippe, Peltier, Adrien, Reynaud, Olivier, Shipkov, Hristo, Signorelli, Francesco, Vermersch, Thibault, Viste, Anthony, Dupieux, Céline, Laurent, Frederic, Rasigade, Jean-Philippe, Vandenesch, François, Giammarile, Francesco, Janier, Marc, Morelec, Isabelle, Gagnieu, Marie-Claude, Goutelle, Sylvain, Tod, Michel, and Mabrut, Eugénie

Published
2016
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14. Association between voriconazole exposure and Sequential Organ Failure Assessment (SOFA) score in critically ill patients

Author

Bienvenu, Anne-Lise, primary, Pradat, Pierre, additional, Plesa, Alexandra, additional, Leclerc, Vincent, additional, Piriou, Vincent, additional, Fellahi, Jean-Luc, additional, Argaud, Laurent, additional, Rimmelé, Thomas, additional, Menotti, Jean, additional, Aubrun, Frédéric, additional, Richard, Jean-Christophe, additional, Gagnieu, Marie-Claude, additional, Parant, François, additional, Chidiac, Christian, additional, Leboucher, Gilles, additional, Tod, Michel, additional, and Goutelle, Sylvain, additional

Published
2021
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17. Population pharmacokinetics of daptomycin in patients with bone and joint infection: minimal effect of rifampicin co-administration and confirmation of a sex difference

Author

Garreau, Romain, Bricca, Romain, Gagnieu, Marie-Claude, Roux, Sandrine, Conrad, Anne, Bourguignon, Laurent, Ferry, Tristan, Goutelle, Sylvain, Valour, Florent, Perpoint, Thomas, Miailhes, Patrick, Ader, Florence, Becker, Agathe, Triffault-Fillit, Claire, Pouderoux, Cécile, Benech, Nicolas, Chauvelot, Pierre, Perry, Marielle, Daoud, Fatiha, Lippman, Johanna, Braun, Evelyne, Chidiac, Christian, Servien, Elvire, Lustig, Sébastien, Batailler, Cécile, Gunst, Stanislas, Schmidt, Axel, Malatray, Matthieu, Sappey-Marinier, Elliot, Fessy, Michel-Henry, Viste, Anthony, Besse, Jean-Luc, Chaudier, Philippe, Louboutin, Lucie, Ode, Quentin, van Haecke, Adrien, Mercier, Marcelle, Belgaid, Vincent, Walch, Arnaud, Martres, Sébastien, Trouillet, Franck, Barrey, Cédric, Mojallal, Ali, Brosset, Sophie, Hanriat, Camille, Person, Hélène, Sigaux, Nicolas, Céruse, Philippe, Fuchsmann, Carine, Aubrun, Frédéric, Dziadzko, Mikhail, Macabéo, Caroline, Laurent, Frederic, Beraud, Laetitia, Roussel-Gaillard, Tiphaine, Dupieux, Céline, Kolenda, Camille, Josse, Jérôme, Brevet, Marie, Trecourt, Alexis, Craighero, Fabien, Boussel, Loic, Pialat, Jean-Baptiste, Morelec, Isabelle, Tod, Michel, Mabrut, Eugénie, Hospices Civils de Lyon (HCL), Lyon Bone and Joint Infection Study Group (BJI), Hôpital Nord-Ouest de Villefranche-sur-Saône, Service de Maladies Infectieuses et Tropicales [Hôpital de la Croix-Rousse - HCL], Hôpital de la Croix-Rousse [CHU - HCL], Hospices Civils de Lyon (HCL)-Hospices Civils de Lyon (HCL), Centre interrégional de référence Rhône-Alpes - Auvergne des infections ostéo-articulaires complexes, Institut des Sciences Pharmaceutiques et Biologiques (ISPB), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon, Laboratoire de Biométrie et Biologie Evolutive - UMR 5558 (LBBE), Université de Lyon-Université de Lyon-Institut National de Recherche en Informatique et en Automatique (Inria)-VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Centre National de la Recherche Scientifique (CNRS), Centre International de Recherche en Infectiologie (CIRI), École normale supérieure de Lyon (ENS de Lyon)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Université Jean Monnet - Saint-Étienne (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Centre de Recherche en Acquisition et Traitement de l'Image pour la Santé (CREATIS), Université de Lyon-Université de Lyon-Institut National des Sciences Appliquées de Lyon (INSA Lyon), Université de Lyon-Institut National des Sciences Appliquées (INSA)-Institut National des Sciences Appliquées (INSA)-Université Jean Monnet - Saint-Étienne (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Modeling & analysis for medical imaging and Diagnosis (MYRIAD), and Université de Lyon-Institut National des Sciences Appliquées (INSA)-Institut National des Sciences Appliquées (INSA)-Université Jean Monnet - Saint-Étienne (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université Claude Bernard Lyon 1 (UCBL)

Subjects
Male, 0301 basic medicine, Microbiology (medical), medicine.medical_specialty, 030106 microbiology, Population, MESH: Daptomycin, 03 medical and health sciences, 0302 clinical medicine, Daptomycin, Pharmacokinetics, MESH: Drug Monitoring, Internal medicine, MESH: Anti-Bacterial Agents, medicine, polycyclic compounds, Humans, Pharmacology (medical), 030212 general & internal medicine, Dosing, education, Pharmacology, Volume of distribution, Sex Characteristics, education.field_of_study, MESH: Humans, medicine.diagnostic_test, business.industry, Drug interaction, [SDV.SP]Life Sciences [q-bio]/Pharmaceutical sciences, bacterial infections and mycoses, MESH: Rifampin, MESH: Male, Anti-Bacterial Agents, Infectious Diseases, Therapeutic drug monitoring, Female, Drug Monitoring, Rifampin, business, MESH: Female, Rifampicin, medicine.drug, MESH: Sex Characteristics
Abstract

Background Daptomycin is increasingly used in the treatment of bone and joint infection (BJI), but its pharmacokinetics (PK) and dosage requirements have not been thoroughly investigated in this indication. Daptomycin may be co-administered with rifampicin, which raises questions about a potential drug interaction. Objectives To investigate the population PK and dosage requirements of daptomycin in patients with BJI, and examine the influence of rifampicin co-administration. Methods A population approach was used to analyse PK data from patients who received daptomycin in our regional reference for BJI. We examined the influence of available covariates, including rifampicin co-administration on daptomycin PK. Simulations performed with the final model investigated the influence of dosages and covariates on PTA for both efficacy and safety. Results A total of 1303 daptomycin concentrations from 183 patients were analysed. A two-compartment model best described the data. Significant intra-individual variability was observed. Daptomycin clearance was influenced by renal function and sex, with females having a 26% lower typical clearance than males. Central volume of distribution (V1) was influenced by body weight, age, sex and rifampicin co-administration. Typical V1 was 11% lower in patients who were co-administered rifampicin. In PK/PD simulations, sex influenced the probability of AUC24/MIC target attainment, while rifampicin had a marginal effect. Conclusions A daptomycin dosage of 8 mg/kg/24 h in women and 10 mg/kg/24 h in men should optimize efficacy but may lead to excessive trough concentrations in many patients, especially in women. Therapeutic drug monitoring appears necessary for precision dosing of daptomycin.

Published
2021

18. Pharmacokinetic/Pharmacodynamic Dosage Individualization of Suppressive Beta-Lactam Therapy Administered by Subcutaneous Route in Patients With Prosthetic Joint Infection

Author

Goutelle, Sylvain, Conrad, Anne, Pouderoux, Cécile, Braun, Evelyne, Laurent, Frédéric, Gagnieu, Marie-Claude, Cohen, Sabine, Guitton, Jérôme, Valour, Florent, and Ferry, Tristan

Subjects
prosthetic-joint infection, pharmacodynamics, Medicine, Brief Research Report, beta-lactam, pharmacokinetics, antimicrobial therapy, subcutaneous administration
Abstract

Suppressive parenteral antibiotic therapy with beta-lactams may be necessary in patients with Gram-negative bone and joint infection (BJI). Subcutaneous drug administration can facilitate this therapy in outpatient setting, but there is limited information about this practice. We have developed an original approach for drug dosing in this context, based on therapeutic drug monitoring (TDM) and pharmacokinetic/pharmacodynamic (PK/PD) principles. The objective of this study was to describe our approach and its first results in a case series. We analyzed data from patients who received suppressive antibiotic therapy by subcutaneous (SC) route with beta-lactams as salvage therapy for prosthetic joint infection (PJI) and had TDM with PK/PD-based dose adjustment. Ten patients (six women and four men with a mean age of 77 years) were included from January 2017 to May 2020. The drugs administered by SC route were ceftazidime (n = 4), ertapenem (n = 4), and ceftriaxone (n = 2). In each patient, PK/PD-guided dosage individualization was performed based on TDM and minimum inhibitory concentration (MIC) measurements. The dose interval could be prolonged from twice daily to thrice weekly in some patients, while preserving the achievement of PK/PD targets. The infection was totally controlled by the strategy in nine out the 10 patients during a median follow-up of 1,035 days (~3 years). No patient acquired carbapenem-resistant Gram-negative bacteria during the follow-up. One patient presented treatment failure with acquired drug resistance under therapy, which could be explained by late MIC determination and insufficient exposure, retrospectively. To conclude, our innovative approach, based on model-based TDM, MIC determination, and individualized PK/PD goals, facilitates, and optimizes suppressive outpatient beta-lactam therapy administered by SC route for PJI. These encouraging results advocate for larger clinical evaluation.

Published
2021

19. Chronic Propionibacterium acnes prosthesis joint infection manifesting as a large abscess with gas, without prosthesis loosening

Author

Lorillou, Marjolie, Martha, Benoit, Chidiac, Christian, Ferry, Tristan, Ferry, Tristan, Perpoint, Thomas, Boibieux, André, Biron, François, Ader, Florence, Karsenty, Judith, Valour, Florent, Daoud, Fatiha, Lippman, Johanna, Braun, Evelyne, Vallat, Marie-Paule, Miailhes, Patrick, Chidiac, Christian, Peyramond, Dominique, Lustig, Sébastien, Neyret, Philippe, Guyen, Olivier, Bérard, Jean-Baptiste, Desmarchelier, Romain, Fessy, Michel-Henry, Barrey, Cédric, Signorelli, Francesco, Breton, Pierre, Mojallal, Ali, Boucher, Fabien, Laurent, Frederic, Vandenesch, François, Rasigade, Jean-Philippe, Morelec, Isabelle, Janier, Marc, Giammarile, Francesco, Tod, Michel, Gagnieu, Marie-Claude, Goutelle, Sylvain, and Mabrut, Eugénie

Published
2013
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20. Population pharmacokinetics of tenofovir in AIDS patients

Author

Gagnieu, Marie-Claude, El Barkil, Mirna, Livrozet, Jean-Michel, Cotte, Laurent, Miailhes, Patrick, Boibieux, Andre, Guitton, Jerome, and Tod, Michel

Subjects
Drug interactions -- Research, Tenofovir -- Dosage and administration, Tenofovir -- Research, Pharmacokinetics -- Research, Pharmacokinetics -- Demographic aspects, Health
Published
2008

35. Bronchoalveolar lavage in trauma patients for diagnosis of fat embolism syndrome

Author

Vedrinne, Jean Marc, Guillaume, Christian, Gagnieu, Marie Claude, Gratadour, Pierre, Fleuret, Carole, and Motin, Jean

Subjects
Fat embolism -- Diagnosis -- Complications and side effects, Fractures -- Complications and side effects -- Diagnosis, Bronchoalveolar lavage, Bones, Health, Diagnosis, Complications and side effects
Abstract

Fat embolism syndrome (FES) is a rare but serious complication occurring after long bone fractures. Presence of fat droplets in cells obtained by bronchoalveolar lavage has been proposed as a [...]

Published
1992

36. Efficiency and Safety of an Early Dose Adjustment of Ribavirin in Patients Infected With Hepatitis C Underexposed to the Drug and Treated With Peginterferon Ribavirin

Author

Loustaud-Ratti, Véronique, Maynard, Marianne, Thevenon, Sylvie, Pradat, Pierre, Rousseau, Annick, Alain, Sophie, Deny, Paul, Gagnieu, Marie-Claude, Tran, Albert, Dao, Thông, Silvain, Christine, Lunel-Fabiani, Françoise, Picard, Nicolas, Zublena, Irène, Marquet, Pierre, Trepo, Christian, ribajuste, group, Pharmacologie des Immunosuppresseurs et de la Transplantation (PIST), Institut National de la Santé et de la Recherche Médicale (INSERM)-Génomique, Environnement, Immunité, Santé, Thérapeutique (GEIST FR CNRS 3503)-Université de Limoges (UNILIM)-CHU Limoges, Service d'Hépato-Gastro-Entérologie et Nutrition [CHU Limoges], CHU Limoges, Hospices Civils de Lyon (HCL), Equipe 16, Centre de Recherche en Cancérologie de Lyon (UNICANCER/CRCL), Centre Léon Bérard [Lyon]-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Centre Léon Bérard [Lyon]-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Anti-infectieux : supports moléculaires des résistances et innovations thérapeutiques (RESINFIT), CHU Limoges-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut Génomique, Environnement, Immunité, Santé, Thérapeutique (GEIST), Université de Limoges (UNILIM)-Université de Limoges (UNILIM), Centre Hospitalier Universitaire de Nice (CHU Nice), Centre méditerranéen de médecine moléculaire (C3M), Université Nice Sophia Antipolis (... - 2019) (UNS), COMUE Université Côte d'Azur (2015-2019) (COMUE UCA)-COMUE Université Côte d'Azur (2015-2019) (COMUE UCA)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Côte d'Azur (UCA), CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN), Centre hospitalier universitaire de Poitiers (CHU Poitiers), Laboratoire Inflammation, Tissus épithéliaux et Cytokines (LITEC), Université de Poitiers, Hémodynamique, Interaction Fibrose et Invasivité tumorales Hépatiques (HIFIH), Université d'Angers (UA), Service de Pharmacologie, toxicologie et pharmacovigilance [CHU Limoges], Pharmacologie des Immunosuppresseurs et de la Transplantation ( PIST ), Université de Limoges ( UNILIM ) -CHU Limoges-Génomique, Environnement, Immunité, Santé, Thérapeutique ( GEIST FR CNRS 3503 ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ), Hospices Civils de Lyon ( HCL ), Centre de Recherche en Cancérologie de Lyon ( CRCL ), Centre Léon Bérard [Lyon]-Université Claude Bernard Lyon 1 ( UCBL ), Université de Lyon-Université de Lyon-Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Centre National de la Recherche Scientifique ( CNRS ) -Centre Léon Bérard [Lyon]-Université Claude Bernard Lyon 1 ( UCBL ), Université de Lyon-Université de Lyon-Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Centre National de la Recherche Scientifique ( CNRS ), Anti-infectieux : supports moléculaires des résistances et innovations thérapeutiques ( RESINFIT ), Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Institut Génomique, Environnement, Immunité, Santé, Thérapeutique ( GEIST ), Université de Limoges ( UNILIM ) -Université de Limoges ( UNILIM ) -CHU Limoges, CHU Nice, Centre méditérannéen de médecine moléculaire ( C3M ), Université Nice Sophia Antipolis ( UNS ), Université Côte d'Azur ( UCA ) -Université Côte d'Azur ( UCA ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ), CHU de Poitiers, Laboratoire Inflammation, Tissus épithéliaux et Cytokines ( LITEC ), Hémodynamique, Interaction Fibrose et Invasivité tumorales Hépatiques ( HIFIH ), and PRES Université Nantes Angers Le Mans ( UNAM ) -IFR 132-UPRES EA 3859-Angers Technopole

Subjects
Male, 0301 basic medicine, analysis, Efficiency, Gastroenterology, [ SDV.CAN ] Life Sciences [q-bio]/Cancer, law.invention, Hepatitis, chemistry.chemical_compound, 0302 clinical medicine, Randomized controlled trial, law, Pharmacology (medical), media_common, virus diseases, Anemia, Hepatitis C, Middle Aged, Recombinant Proteins, 3. Good health, Intention to Treat Analysis, Female, 030211 gastroenterology & hepatology, France, Adult, Drug, medicine.medical_specialty, Patients, Genotype, media_common.quotation_subject, [SDV.CAN]Life Sciences [q-bio]/Cancer, Antiviral Agents, methods, 03 medical and health sciences, Dose adjustment, Internal medicine, Pragmatic Clinical Trials as Topic, Ribavirin, medicine, Humans, In patient, Pharmacology, Dose-Response Relationship, Drug, business.industry, medicine.disease, 030112 virology, digestive system diseases, Discontinuation, chemistry, Interferons, business
Abstract

International audience; BACKGROUND: Ribavirin exposure after the first dose (D0AUC0-4h) \textgreater1755 mcg.h.L is predictive of sustained virological response (SVR) in patients with hepatitis C treated with peginterferon and ribavirin. The aim of this study was to test the benefit of ribavirin early dose adjustment based on this target in naive patients infected with genotype 1. METHODS: A multicenter randomized controlled trial with two parallel groups; fixed-dose (FD) group: standard of care in 2010-2011, ie, peginterferon-alpha2a 180 mcg.wk and weight-based ribavirin 1000-1200 mg/d during 48 weeks; adapted-dose (AD) group: increase of ribavirin dose if D0AUC0-4h \textless1755 mcg.h.L. RESULTS: A total of 221 patients were included, 110 in the AD group and 111 in the FD group with similar baseline characteristics. In the perprotocol analysis, SVR was higher in the AD group (55.1% versus 40.4%; P = 0.042), especially in patients with D0AUC0-4h \textless1755 mcg.h.L (54.3% versus 31.9%; P = 0.029). In the intention-to-treat analysis, the difference was not significant (50% versus 41%; P = 0.197). Ribavirin trough concentrations (C0s) at week 4 of treatment (intention-to-treat analysis) were higher in patients achieving SVR (2.06 versus 1.72 mg/L, P = 0.003). In the subgroup of patients with AUC0-4h \textless1755 mcg.h.L, 46% of patients with AD achieved a C0 \textgreater2.0 mg/L versus 22% of patients with FD (P = 0.013). Grade 1 anemia (but not other grades) was more frequent in the AD group (70% versus 48%, P = 0.001). The number of dose reductions or discontinuation of ribavirin was similar in both groups. CONCLUSIONS: Early ribavirin dose adjustment increases SVR in patients underexposed to ribavirin without increasing grade II-IV anemia. Such a strategy could be useful in patients with no access to new antiviral drugs

Published
2016

38. Daptomycin > 6 mg/kg/day as salvage therapy in patients with complex bone and joint infection: cohort study in a regional reference center

Author

Roux, Sandrine, Valour, Florent, Karsenty, Judith, Gagnieu, Marie-Claude, Perpoint, Thomas, Lustig, Sebastien, Ader, Florence, Martha, Benoit, Laurent, Fréderic, Chidiac, Christian, Ferry, Tristan, Group, The Lyon Bji Study, Pathogénie des Staphylocoques – Staphylococcal Pathogenesis (StaPath), Centre International de Recherche en Infectiologie (CIRI), École normale supérieure de Lyon (ENS de Lyon)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Université Jean Monnet - Saint-Étienne (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-École normale supérieure de Lyon (ENS de Lyon)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Université Jean Monnet - Saint-Étienne (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Service de Maladies Infectieuses et Tropicales [Hôpital de la Croix-Rousse - HCL], Hôpital de la Croix-Rousse [CHU - HCL], Hospices Civils de Lyon (HCL)-Hospices Civils de Lyon (HCL), Unité fonctionnelle de Pharmacologie Spécialisée, Hospices Civils de Lyon (HCL), Laboratoire de Biomécanique et Mécanique des Chocs (LBMC UMR T9406), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut Français des Sciences et Technologies des Transports, de l'Aménagement et des Réseaux (IFSTTAR), Pathogenèse des légionelles- Legionella pathogenesis (LegioPath), Maladies infectieuses, Centre Hospitalier Chalon-sur-Saône William Morey, Laboratoire de bactériologie, Centre national de référence staphlocoques, Centre International de Recherche en Infectiologie - UMR (CIRI), École normale supérieure - Lyon (ENS Lyon)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-École normale supérieure - Lyon (ENS Lyon)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), and Cadic, Ifsttar

Subjects
0301 basic medicine, Male, Joint Prosthesis, ARTICULATION HUMAINE, Salvage therapy, Kaplan-Meier Estimate, 0302 clinical medicine, [SDV.MHEP.MI]Life Sciences [q-bio]/Human health and pathology/Infectious diseases, Eosinophilic pneumonia, Medicine, 030212 general & internal medicine, Treatment Failure, Aged, 80 and over, OS, Middle Aged, Staphylococcal Infections, DAPTOMYCIN, 3. Good health, Anti-Bacterial Agents, Treatment Outcome, Infectious Diseases, [SDV.MHEP.MI] Life Sciences [q-bio]/Human health and pathology/Infectious diseases, Female, Cohort study, medicine.drug, Research Article, Adult, medicine.medical_specialty, [SDV.SP.MED] Life Sciences [q-bio]/Pharmaceutical sciences/Medication, Prosthesis-Related Infections, Adolescent, 030106 microbiology, Drug Administration Schedule, 03 medical and health sciences, Cmin, Young Adult, BIOMECANIQUE, [SDV.SP.MED]Life Sciences [q-bio]/Pharmaceutical sciences/Medication, Humans, Adverse effect, Aged, Proportional Hazards Models, Retrospective Studies, Salvage Therapy, business.industry, Retrospective cohort study, EOSINOPHILIC PNEUMONIA, medicine.disease, Surgery, Concomitant, Daptomycin, BONE AND JOINT INFECTION, business
Abstract

Background: Even if daptomycin does not have approval for the treatment of bone and joint infections (BJI), the Infectious Diseases Society of America guidelines propose this antibiotic as alternative therapy for prosthetic joint infection. The recommended dose is 6 mg/kg/d, whereas recent data support the use of higher doses in these patients.Methods: We performed a cohort study including consecutive patients that have received daptomycin >6 mg/kg/d for complex BJI between 2011 and 2013 in a French regional reference center. Factors associated with treatment failure were determined on univariate Cox analysis and Kaplan-Meier curves.Results: Forty-three patients (age, 61 ± 17 years) received a mean dose of 8 ± 0.9 mg/kg/d daptomycin, for a mean 81 ± 59 days (range, 6-303 days). Most had chronic (n = 37, 86 %) implant-associated (n = 37, 86 %) BJI caused by coagulasenegative staphylococci (n = 32, 74 %). A severe adverse event (SAE) occurred in 6 patients (14 %), including 2 cases of eosinophilic pneumonia, concomitant with daptomycin Cmin >24 mg/L. Outcome was favorable in 30 (77 %) of the 39 clinically assessable patients. Predictors for treatment failure were age, non-optimal surgery and daptomycin withdrawal for SAE.Conclusions: Prolonged high-dose daptomycin therapy was effective in patients with complex BJI. However, optimal surgery remains the cornerstone of medico-surgical strategy; and a higher incidence of eosinophilic pneumonia than expected was recorded.

Published
2016

39. EVESOR, a model-based, multiparameter, Phase I trial to optimize the benefit/toxicity ratio of everolimus and sorafenib

Author

El-Madani, Mévidette, primary, Colomban, Olivier, additional, Tod, Michel, additional, Maillet, Denis, additional, Peron, Julien, additional, Rodriguez-Lafrasse, Claire, additional, Badary, Osama A, additional, Valette, Pierre-Jean, additional, Lefort, Thibaud, additional, Cassier, Philippe, additional, El-Shenawy, Siham M, additional, EL-Demerdash, Ebtehal, additional, Hommel-Fontaine, Juliette, additional, Guitton, Jerome, additional, Gagnieu, Marie-Claude, additional, Ibrahim, Bassant MM, additional, Barrois, Catherine, additional, Freyer, Gilles, additional, and You, Benoit, additional

Published
2017
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40. Genetic polymorphisms of ABCB1 (P-glycoprotein) as a covariate influencing daptomycin pharmacokinetics: a population analysis in patients with bone and joint infection.

Author

Bricca, Romain, Goutelle, Sylvain, Roux, Sandrine, Gagnieu, Marie-Claude, Becker, Agathe, Conrad, Anne, Valour, Florent, Laurent, Frederic, Triffault-Fillit, Claire, Chidiac, Christian, Ferry, Tristan, and Lyon Bone and Joint Infection Study Group

Subjects
GENETIC polymorphisms, PHARMACOKINETICS, LIPOPEPTIDE antibiotics, METHICILLIN-resistant staphylococcus aureus, MEDICAL care
Abstract

Background: Daptomycin has been recognized as a therapeutic option for the treatment of bone and joint infection (BJI). Gene polymorphism of ABCB1, the gene encoding P-glycoprotein (P-gp), may influence daptomycin pharmacokinetics (PK).Objectives: We aimed to examine population PK of daptomycin and its determinants, including genetic factors, in patients with BJI.Patients and Methods: We analysed data from patients who received daptomycin for BJI between 2012 and 2016 in our regional reference centre and who had measured daptomycin concentrations and P-gp genotyping. A population approach was used to analyse PK data. In covariate analysis, we examined the influence of three single nucleotide variations (SNVs) of ABCB1 (3435C > T, 2677G > T/A and 1236C > T) and that of the corresponding haplotype on daptomycin PK parameters. Simulations performed with the final model examined the influence of covariates on the probability to achieve pharmacodynamic (PD) targets.Results: Data from 81 patients were analysed. Daptomycin body CL (CLDAP) correlated with CLCR and was 23% greater in males than in females. Daptomycin central V (V1) was allometrically scaled to body weight and was 25% lower in patients with homozygous CGC ABCB1 haplotype than in patients with any other genotype. Simulations performed with the model showed that sex and P-gp haplotype may influence the PTA for high MIC values and that a dosage of 10 mg/kg/24 h would optimize efficacy.Conclusions: Daptomycin dosages higher than currently recommended should be evaluated in patients with BJI. Gender and P-gp gene polymorphism should be further examined as determinants of dosage requirements. [ABSTRACT FROM AUTHOR]

Published
2019
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41. Sofosbuvir-based antiviral therapy in hepatitis C virus patients with severe renal failure

Author

Dumortier, Jérôme, primary, Bailly, François, additional, Pageaux, Georges-Philippe, additional, Vallet-Pichard, Anaïs, additional, Radenne, Sylvie, additional, Habersetzer, François, additional, Gagnieu, Marie-Claude, additional, Grangé, Jean-Didier, additional, Minello, Anne, additional, Guillaud, Olivier, additional, Kamar, Nassim, additional, Alric, Laurent, additional, and Leroy, Vincent, additional

Published
2016
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42. Maraviroc/raltegravir simplification strategy following 6 months of quadruple therapy with tenofovir/emtricitabine/maraviroc/raltegravir in treatment-naive HIV patients

Author

Pradat, Pierre, primary, Durant, Jacques, additional, Brochier, Corinne, additional, Trabaud, Mary-Anne, additional, Cottalorda-Dufayard, Jacqueline, additional, Izopet, Jacques, additional, Raffi, François, additional, Lucht, Frédéric, additional, Gagnieu, Marie-Claude, additional, Gatey, Caroline, additional, Jacomet, Christine, additional, Vassallo, Matteo, additional, Dellamonica, Pierre, additional, and Cotte, Laurent, additional

Published
2016
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46. Pegylated Interferon-Alpha 2a in Combination with Nilotinib As First-Line Therapy in Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia (Nilopeg trial). Four-Year Follow-up Results

Author

Nicolini, Franck E., primary, Etienne, Gabriel, additional, Dubruille, Viviane, additional, Roy, Lydia, additional, Huguet, Françoise, additional, Legros, Laurence, additional, Giraudier, Stéphane, additional, Coiteux, Valérie, additional, Guerci-Bresler, Agnes, additional, Lenain, Pascal, additional, Rea, Delphine, additional, Amé, Shanti, additional, Cony-Makhoul, Pascale, additional, Gardembas, Martine, additional, Hermet, Eric, additional, Rousselot, Philippe, additional, Gagnieu, Marie-Claude, additional, Morisset, Stéphane, additional, Pivot, Christine, additional, Etienne, Madeleine, additional, Guilhot, Francois, additional, Dulucq, Stéphanie, additional, and Mahon, Francois-Xavier, additional

Published
2015
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47. Population pharmacokinetics and probability of target attainment of ertapenem administered by subcutaneous or intravenous route in patients with bone and joint infection.

Author

Goutelle, Sylvain, Valour, Florent, Gagnieu, Marie-Claude, Laurent, Frédéric, Chidiac, Christian, Ferry, Tristan, Group, Lyon Bone and Joint Infection Study, and Lyon Bone and Joint Infection Study Group

Subjects
SUBCUTANEOUS injections, BIOTRANSFORMATION (Metabolism), BONE diseases, CREATININE, INTRAVENOUS therapy, KIDNEY diseases, MICROBIAL sensitivity tests, PROBABILITY theory, RETROSPECTIVE studies, CARBAPENEMS, PHARMACODYNAMICS, THERAPEUTICS
Abstract

Background: Ertapenem is a therapeutic option in patients with Gram-negative bone and joint infection (BJI). The subcutaneous (sc) route of administration is convenient in the outpatient setting and has shown favourable pharmacokinetics (PK), but available data on ertapenem are limited.Objectives: To perform population PK analysis and pharmacokinetic/pharmacodynamic (PK/PD) simulation of ertapenem administered by the intravenous (iv) or sc route to patients with BJI.Patients and methods: This was a retrospective analysis of PK data collected in patients with BJI who received iv or sc ertapenem. Measured ertapenem concentrations were analysed with a non-parametric population approach. Then, simulations were performed based on the final model to investigate the influence of ertapenem route of administration, dosage and renal function on the probability of achieving a pharmacodynamic (PD) target, defined as the percentage of time for which free plasma concentrations of ertapenem remained above the MIC (fT>MIC) of 40%.Results: Forty-six PK profiles (13 with iv and 33 with sc ertapenem) with a total of 133 concentrations from 31 subjects were available for the analysis. A two-compartment model with linear sc absorption and linear elimination best fitted the data. Creatinine clearance was found to significantly influence ertapenem plasma clearance. Simulations showed that twice daily dosing, sc administration and renal impairment were associated with an increase in fT>MIC and target attainment.Conclusions: Our results indicate that 1 g of ertapenem administered twice daily, by the iv or sc route, may optimize ertapenem exposure and achievement of PK/PD targets in patients with BJI. [ABSTRACT FROM AUTHOR]

Published
2018
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48. Sofosbuvir-based antiviral therapy in hepatitis C virus patients with severe renal failure.

Author

Dumortier, Jérôme, Bailly, François, Pageaux, Georges-Philippe, Vallet-Pichard, Anaïs, Radenne, Sylvie, Habersetzer, François, Gagnieu, Marie-Claude, Grangé, Jean-Didier, Minello, Anne, Guillaud, Olivier, Kamar, Nassim, Alric, Laurent, and Leroy, Vincent

Subjects
ANTIVIRAL agents, HEPATITIS C treatment, CHRONIC kidney failure, DRUG efficacy, RECOMBINANT erythropoietin
Abstract

Background. Chronic hepatitis C virus (HCV) infection is the most common chronic liver disease in patients with end-stage renal disease (ESRD). Over the last few years, secondgeneration direct-acting antivirals have been revolutionary in the treatment of hepatitis C, and sofosbuvir (SOF) is the backbone of most modern treatment strategies. Since SOF is eliminated through the kidney, the aim of this multicentre retrospective study was to assess its antiviral efficacy and safety in HCVinfected patients with severe renal failure [including haemodialysis (HD) patients]. Methods. Fifty patients (36 males, mean age 6 standard deviation 60.56 7.5 years) with chronic HCV infection (G1: 28/56%, cirrhosis: 27/54%) and severe renal failure [i.e. MDRD estimated glomerular filtration rate (eGFR) <35 mL/min], including 35 on HD, were enrolled. Antiviral treatment consisted of SOF/ribavirin (RBV) (n = 7), SOF/RBV/pegylated interferon (n = 2), SOF/daclatasvir 6 RBV (n = 30) or SOF/simeprevir6 RBV (n = 11) for 12 or 24 weeks. A reduced dose of SOF (400 mg three times a week or 400 mg every other day) was given to all HD patients. Initial dose of RBV (n = 12) ranged from 400 to 4200 mg/week. Results. On an intent-to-treat-based analysis, sustained virological response rate was 86% at 12 weeks. During therapy, haemoglobin levels were not significantly modified, but recombinant erythropoietin (rEPO) dose significantly increased in patients treated with RBV. Two patients (4%) required blood transfusion. No patient had treatment discontinuation due to side effects. Dose of RBV was reduced in two patients (16.7%) during antiviral therapy. Dose of SOF was reduced in two non-HD patients because of side effects. In non-HD patients, median eGFR was not significantly modified during treatment. Conclusions. Our results strongly suggest that SOF-based antiviral therapy, with a reduced dose of SOF, is safe and effective for the treatment of HCV patients with ESRD, including HD patients. [ABSTRACT FROM AUTHOR]

Published
2017
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49. Prolonged subcutaneous high dose (1 g bid) of Ertapenem as salvage therapy in patients with difficult-to-treat bone and joint infection.: Prolonged high-dose ertapenem in BJI

Author

Ferry, Tristan, Sénéchal, Agathe, Gagnieu, Marie-Claude, Boibieux, André, Laurent, Frédéric, Perpoint, Thomas, Tod, Michel, Chidiac, Christian, Ferry, Tristan, Immunité infection vaccination (I2V), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-IFR128-Institut National de la Santé et de la Recherche Médicale (INSERM), Service de Maladies Infectieuses et Tropicales [Hôpital de la Croix-Rousse - HCL], Hôpital de la Croix-Rousse [CHU - HCL], Hospices Civils de Lyon (HCL)-Hospices Civils de Lyon (HCL), and Lyon Bone and Joint Infection Study Group

Subjects
[SDV.MHEP.MI]Life Sciences [q-bio]/Human health and pathology/Infectious diseases, [SDV.MHEP.MI] Life Sciences [q-bio]/Human health and pathology/Infectious diseases, ComputingMilieux_MISCELLANEOUS
Abstract

International audience; n.a

Published
2012

50. Tolerability of everolimus-based immunosuppression in maintenance liver transplant recipients

Author

Vallin, Mélanie, Guillaud, Olivier, Morard, Isabelle, Gagnieu, Marie-Claude, Mentha, Gilles, Adham, Mustapha, Morelon, Emmanuel, Boillot, Olivier, Giostra, Emiliano, and Dumortier, Jérôme

Subjects
Graft Rejection, Male, Tacrolimus/therapeutic use, Immune Tolerance/drug effects, Calcineurin Inhibitors, Tacrolimus, Cohort Studies, Immune Tolerance, Humans, Everolimus, Graft Rejection/drug therapy, Cyclosporine/therapeutic use, ddc:616, Sirolimus, ddc:617, Graft Survival, Calcineurin/antagonists & inhibitors, Middle Aged, Liver Transplantation, Survival Rate, Treatment Outcome, Cyclosporine, Immunosuppressive Agents/therapeutic use, Female, Immunosuppressive Agents, Sirolimus/analogs & derivatives/therapeutic use, Follow-Up Studies
Abstract

The aim of this study was to evaluate the tolerability of the conversion from calcineurin inhibitor (CNI) to everolimus (ERL) in maintenance liver transplant (LT) recipients.From January 2005 to March 2008, ERL was introduced after LT as maintenance immunosuppressive therapy because of (i) de novo or recurrent cancer after LT, (ii) pre-existing liver carcinoma on the liver explant or (iii) CNI toxicity. CNI dosage was progressively reduced until discontinuation.The study population included 94 patients, of mean age 57 ± 10. The mean delay between LT and ERL introduction was 5 ± 5 yr. After a mean follow-up of 12 ± 7 months, 70% of the patients did present at least one side effect. The mean trough level of ERL was 6 μg/L at the end of follow-up. Main side effects included hyperlipidemia (37%), dermatitis (19%), mucositis (15%), and proteinuria (18%). Biopsy-proven acute rejection occurred in 9% of patients. Global ERL discontinuation rate was 21% (16% because of side effects).The results of our experience indicate that conversion to ERL is associated with adverse effects in 70% of patients leading to drug discontinuation in 16% (and amenable to dose reduction in the remainders). Longer follow-up periods are necessary to capture the impact of ERL fully on renal function and survival in cancer patients.

Published
2010

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