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1. Patients Treated for HCV Infection and Listed for Liver Transplantation in a French Multicenter Study: What Happens at Five Years?

Author: Lucy Meunier, Mohamed Belkacemi, George Philippe Pageaux, Sylvie Radenne, Anaïs Vallet-Pichard, Pauline Houssel-Debry, Christophe Duvoux, Danielle Botta-Fridlund, Victor de Ledinghen, Filomena Conti, Rodolphe Anty, Vincent Di Martino, Marilyne Debette-Gratien, Vincent Leroy, Theophile Gerster, Pascal Lebray, Laurent Alric, Armand Abergel, Jérôme Dumortier, Camille Besch, Helene Montialoux, Didier Samuel, Jean-Charles Duclos-Vallée, and Audrey Coilly
Subjects: anti HCV therapy, DAAs, liver transplantation, decompensated cirrhosis, hepatocellular carcinoma, waiting list, Microbiology, QR1-502
Abstract: Background: Direct-acting antiviral (DAA) agents for the treatment of hepatitis C virus (HCV) infection have been proven safe and effective in cirrhotic patients awaiting liver transplantation (LT). However, in the long term, data remain minimal regarding the clinical impact of viral eradication on patients listed for decompensated cirrhosis or hepatocellular carcinoma (HCC). We aimed to elucidate the clinical outcomes of patients regarding delisting and the evolution of HCC during the long-term follow-up. Methods: An observational, multicenter, retrospective analysis was carried out on prospectively collected data from HCV-positive patients treated with an interferon-free regimen while awaiting LT in 18 French hospitals. Results: A total of 179 patients were included in the study. The indication for LT was HCC in 104 (58.1%) patients and cirrhosis in 75 (41.9%) patients. The sustained virological response was 84.4% and the treatment was well tolerated. At five years, among 75 patients with cirrhosis treated for HCV, 19 (25.3%) were delisted following improvement after treatment. Predictive factors for delisting highlighted an absence of ascites, MELD score ≤ 15, and Child–Pugh score ≤ 7. No patients with refractory ascites were delisted. Among patients with HCC, 82 (78.9%) were transplanted. The drop-out rate was low (6.7%) and few recurrences of HCC after LT were observed. Conclusions: DAAs are safe and effective in patients awaiting LT for cirrhosis or HCC. A quarter of patients with cirrhosis can be delisted because of clinical improvement. Predictive factors for delisting, as a result of improvement, may assist prescribers, before initiating HCV infection therapy in the long-term perspective.
Published: 2022
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2. Multidisciplinary approach for the treatment of 1155 HCV/HCV-HIV co-infected patients

Author: Isabelle Ravaux, Albert Darque, Amélie Ménard, Catherine Dhiver, Philippe Halfon, Thierry Allègre, Patrick Philibert, Christelle Tomei, Philippe Colson, Rolande Cohen, Laurence Pellissier, Sylvie Brégigeon, Malika Mokhtari, Jacques Moreau, Marie-Josephe Soavi, Caroline Solas, Isabelle Poizot-Martin, Bernard Castan, Valérie Oulès, Marc Bourlière, Isabelle Portal, and Danielle Botta-Fridlund
Subjects: Microbiology, QR1-502, Public aspects of medicine, RA1-1270
Published: 2016
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3. Multicenter Experience with Boceprevir or Telaprevir to Treat Hepatitis C Recurrence after Liver Transplantation: When Present Becomes Past, What Lessons for Future?

Author: Audrey Coilly, Jérôme Dumortier, Danielle Botta-Fridlund, Marianne Latournerie, Vincent Leroy, Georges-Philippe Pageaux, Hélène Agostini, Emiliano Giostra, Christophe Moreno, Bruno Roche, Teresa Maria Antonini, Olivier Guillaud, Pascal Lebray, Sylvie Radenne, Anne-Catherine Saouli, Yvon Calmus, Laurent Alric, Maryline Debette-Gratien, Victor De Ledinghen, François Durand, Christophe Duvoux, Didier Samuel, and Jean-Charles Duclos-Vallée
Subjects: Medicine, Science
Abstract: First generation protease inhibitors (PI) with peg-interferon (PEG-IFN) and ribavirin (RBV) have been the only therapy available for hepatitis C virus (HCV) genotype 1 infection in most countries for 3 years. We have investigated the efficacy and tolerance of this triple therapy in transplanted patients experiencing a recurrence of HCV infection on the liver graft.This cohort study enrolled 81 liver transplant patients (Male: 76%, mean age: 55.8±9.7 years) with severe HCV recurrence (F3 or F4: n = 34 (42%), treatment experienced: n = 44 (54%)), treated with boceprevir (n = 36; 44%) or telaprevir (n = 45; 56%). We assessed the percentages of patients with sustained virological responses 24 weeks after therapy (SVR24), and safety.The SVR24 rate was 47% (telaprevir: 42%; boceprevir: 53%, P = ns). At baseline, a normal bilirubin level (p = 0.0145) and albumin level >35g/L (p = 0.0372) and an initial RBV dosage of ≥800 mg/day (p = 0.0033) predicted SVR24. During treatment, achieving an early virological response after 12 weeks was the strongest independent factor to predict SVR24 (p
Published: 2015
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4. Patients Treated for HCV Infection and Listed for Liver Transplantation in a French Multicenter Study: What Happens at Five Years?

Author: Lucy Meunier, Mohamed Belkacemi, George Philippe Pageaux, Sylvie Radenne, Anaïs Vallet-Pichard, Pauline Houssel-Debry, Christophe Duvoux, Danielle Botta-Fridlund, Victor de Ledinghen, Filomena Conti, Rodolphe Anty, Vincent Di Martino, Marilyne Debette-Gratien, Vincent Leroy, Theophile Gerster, Pascal Lebray, Laurent Alric, Armand Abergel, Jérôme Dumortier, Camille Besch, Helene Montialoux, Didier Samuel, Jean-Charles Duclos-Vallée, Audrey Coilly, CHU Montpellier, Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), CHU Pontchaillou [Rennes], Institut de recherche en santé, environnement et travail (Irset), Université d'Angers (UA)-Université de Rennes (UR)-École des Hautes Études en Santé Publique [EHESP] (EHESP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), Hôpital Paul Brousse, and Funding support came solely from institutional and/or departmental sources (institute: Montpellier University Hospital, 34000, France).
Subjects: MESH: Hepatitis C, MESH: Antiviral Agents, MESH: Liver Transplantation, MESH: Humans, liver transplantation, DAAs, MESH: Retrospective Studies, hepatocellular carcinoma, waiting list, MESH: Hepatitis C, Chronic, anti HCV therapy, decompensated cirrhosis, recurrence after liver transplantation, Infectious Diseases, MESH: Waiting Lists, MESH: Liver Neoplasms, [SDV.MHEP.MI]Life Sciences [q-bio]/Human health and pathology/Infectious diseases, Virology, MESH: Hepacivirus, MESH: Ascites, MESH: Liver Cirrhosis, MESH: Carcinoma, Hepatocellular
Abstract: International audience; Background: Direct-acting antiviral (DAA) agents for the treatment of hepatitis C virus (HCV) infection have been proven safe and effective in cirrhotic patients awaiting liver transplantation (LT). However, in the long term, data remain minimal regarding the clinical impact of viral eradication on patients listed for decompensated cirrhosis or hepatocellular carcinoma (HCC). We aimed to elucidate the clinical outcomes of patients regarding delisting and the evolution of HCC during the long-term follow-up. Methods: An observational, multicenter, retrospective analysis was carried out on prospectively collected data from HCV-positive patients treated with an interferon-free regimen while awaiting LT in 18 French hospitals. Results: A total of 179 patients were included in the study. The indication for LT was HCC in 104 (58.1%) patients and cirrhosis in 75 (41.9%) patients. The sustained virological response was 84.4% and the treatment was well tolerated. At five years, among 75 patients with cirrhosis treated for HCV, 19 (25.3%) were delisted following improvement after treatment. Predictive factors for delisting highlighted an absence of ascites, MELD score ≤ 15, and Child–Pugh score ≤ 7. No patients with refractory ascites were delisted. Among patients with HCC, 82 (78.9%) were transplanted. The drop-out rate was low (6.7%) and few recurrences of HCC after LT were observed. Conclusions: DAAs are safe and effective in patients awaiting LT for cirrhosis or HCC. A quarter of patients with cirrhosis can be delisted because of clinical improvement. Predictive factors for delisting, as a result of improvement, may assist prescribers, before initiating HCV infection therapy in the long-term perspective.
Published: 2023
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5. 12 Weeks of a Ribavirin‐Free Sofosbuvir and Nonstructural Protein 5A Inhibitor Regimen Is Enough to Treat Recurrence of Hepatitis C After Liver Transplantation

Author: Audrey Coilly, Carole Cagnot, Pascal Lebray, Stéphane Chevaliez, Alpha Diallo, Victor de Lédinghen, Jean-Charles Duclos-Vallée, Danielle Botta-Fridlund, Claire Francoz, Camille Besch, Nassim Kamar, Christine Silvain, P. Perré, Albert Tran, Jérôme Dumortier, François Habersetzer, Claire Fougerou-Leurent, Aurelie Veislinger, Valérie Canva, Vincent Di Martino, Georges-Philippe Pageaux, Filomena Conti, Caroline Jezequel, Christophe Duvoux, Armando Abergel, Christophe Moreno, Sylvie Radenne, Maryline Debette-Gratien, H. Montialoux, Emilie Rossignol, Vincent Leroy, Louis d’Alteroche, and Pauline Houssel-Debry
Subjects: Liver Cirrhosis, Male, Sofosbuvir, medicine.medical_treatment, Viral Nonstructural Proteins, 030230 surgery, Liver transplantation, medicine.disease_cause, Gastroenterology, chemistry.chemical_compound, 0302 clinical medicine, Belgium, Recurrence, Prospective Studies, 10. No inequality, education.field_of_study, Graft Survival, virus diseases, Hepatitis C, Middle Aged, Sciences bio-médicales et agricoles, Prognosis, 3. Good health, Treatment Outcome, Disease Progression, Drug Therapy, Combination, Female, 030211 gastroenterology & hepatology, France, Viral load, medicine.drug, Adult, medicine.medical_specialty, Hepatitis C virus, Population, Drug Administration Schedule, 03 medical and health sciences, Internal medicine, Ribavirin, medicine, Humans, education, Aged, Dose-Response Relationship, Drug, Hepatology, business.industry, Hepatitis C, Chronic, medicine.disease, digestive system diseases, Liver Transplantation, Regimen, chemistry, business
Abstract: Sofosbuvir (SOF) combined with nonstructural protein 5A (NS5A) inhibitors has demonstrated its efficacy in treating a recurrence of hepatitis C virus (HCV) after liver transplantation (LT). However, the duration of treatment and need for ribavirin (RBV) remain unclear in this population. Our aim was to determine whether LT recipients could be treated with an SOF + NS5A inhibitor-based regimen without RBV for 12 weeks post-LT. Between October 2013 and December 2015, 699 LT recipients experiencing an HCV recurrence were enrolled in the multicenter ANRS CO23 CUPILT cohort. We selected patients receiving SOF and NS5A inhibitor ± RBV and followed for at least 12 weeks after treatment discontinuation. The primary efficacy endpoint was a sustained virological response 12 weeks after the end of treatment (SVR12). Among these 699 patients, 512 fulfilled the inclusion criteria. Their main characteristics were: 70.1% genotype 1, 18.2% genotype 3, 21.1% cirrhosis, and 34.4% previously treated patients. We identified four groups of patients according to their treatment and duration: SOF + NS5A without RBV for 12 (156 patients) or 24 (239 patients) weeks; SOF + NS5A + RBV for 12 (47 patients) or 24 (70 patients) weeks. SVR12 values reached 94.9%, 97.9%, 95.7%, and 92.9%, respectively (P = 0.14). Only 20 patients experienced a treatment failure. Under multivariate analysis, factors such as fibrosis stage, previous treatment, HCV genotype, and baseline HCV viral load did not influence SVR12 rates in the four groups (P = 0.21). Hematological adverse events (AEs) were more common in the RBV group: anemia (P < 0.0001) and blood transfusion (P = 0.0001). Conclusion: SOF + NS5A inhibitors without RBV for 12 weeks constituted reliable therapy for recurrent HCV post-LT with an excellent SVR12 whatever the fibrosis stage, HCV genotype, and previous HCV treatment. (Hepatology 2018; 00:000-000)., SCOPUS: ar.j, info:eu-repo/semantics/published
Published: 2018
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6. Direct-acting antiviral agent–based regimen for HCV recurrence after combined liver-kidney transplantation: Results from the ANRS CO23 CUPILT study

Author: Jérôme Dumortier, A. Rohel, Jean-Charles Duclos-Vallée, Christophe Duvoux, Vincent Di Martino, Christine Silvain, Sébastien Dharancy, Danielle Botta-Fridlund, Sylvie Radenne, Maryline Debette-Gratien, Nassim Kamar, Audrey Coilly, Vincent Leroy, Georges-Philippe Pageaux, Armand Abergel, Louis d’Alteroche, Emilie Rossignol, Claire Francoz, Pauline Houssel-Debry, P. Perré, Filomena Conti, Claire Fougerou-Leurent, François Habersetzer, Camille Besch, Christophe Moreno, H. Montialoux, Valérie Canva, Albert Tran, Didier Samuel, Victor de Lédinghen, Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Hôpital Paul Brousse, Physiopathologie et traitement des maladies du foie, Université Paris-Sud - Paris 11 (UP11)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Pontchaillou [Rennes], Service d'Hépatologie, Hôpital Henri Mondor, AP-HP, Créteil, France., Hôpital Henri Mondor, Institut de médecine moléculaire de Rangueil (I2MR), Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-IFR150-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre de Physiopathologie Toulouse Purpan (CPTP), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Département de Gastroentérologie et hépatologie, Université Joseph Fourier - Grenoble 1 (UJF)-CHU Grenoble-Hôpital Michallon, 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)-Université Côte d'Azur (UCA)-Institut National de la Santé et de la Recherche Médicale (INSERM), Service d'hépato-gastro-entérologie, Hôpital Huriez-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Hôpital Erasme [Bruxelles] (ULB), Faculté de Médecine [Bruxelles] (ULB), Université libre de Bruxelles (ULB)-Université libre de Bruxelles (ULB), Hôpital Edouard Herriot [CHU - HCL], Hospices Civils de Lyon (HCL), Département d'hépatologie, Service d'hépatologie, Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC)-Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), Hôpital de la Croix-Rousse [CHU - HCL], Physiopathologie du cancer du foie, Université Bordeaux Segalen - Bordeaux 2-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Trousseau [Tours], Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Hôpital de la Milétrie, Centre hospitalier universitaire de Poitiers (CHU Poitiers), Chirurgie Digestive, Assistance Publique - Hôpitaux de Marseille (APHM)-Hôpital de la Conception [CHU - APHM] (LA CONCEPTION), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7)-Hôpital Beaujon [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Interactions Virus-Hôte et Maladies Hépatiques, Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut de Virologie, Chirurgie digestive et hépatobiliaire, CHU Estaing [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand, 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), Service d'Hépato-Gastro-Entérologie et Nutrition [CHU Limoges], CHU Limoges, ANRS France Recherche Nord & sud Sida-hiv hépatites, Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Cellules Souches, Plasticité Cellulaire, Médecine Régénératrice et Immunothérapies (IRMB), Université de Montpellier (UM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Institut National de la Santé et de la Recherche Médicale (INSERM)-Hôpital Paul Brousse-Université Paris-Sud - Paris 11 (UP11), Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon)-Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC), 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, Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Université de Toulouse (UT)-Université de Toulouse (UT)- Institut Fédératif de Recherche Bio-médicale Institution (IFR150)-Institut National de la Santé et de la Recherche Médicale (INSERM), Université de Toulouse (UT)-Université de Toulouse (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Université Nice Sophia Antipolis (1965 - 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), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées- Institut Fédératif de Recherche Bio-médicale Institution (IFR150)-Institut National de la Santé et de la Recherche Médicale (INSERM), and Jonchère, Laurent
Subjects: Graft Rejection, Male, Sofosbuvir, [SDV]Life Sciences [q-bio], medicine.medical_treatment, kidney transplantation/nephrology, Hepacivirus, 030230 surgery, Liver transplantation, medicine.disease_cause, 0302 clinical medicine, Recurrence, Risk Factors, Immunology and Allergy, liver disease: infectious, Pharmacology (medical), Prospective Studies, Prospective cohort study, education.field_of_study, Graft Survival, Middle Aged, Prognosis, Hepatitis C, 3. Good health, [SDV] Life Sciences [q-bio], kidney failure/injury, [SDV.MP]Life Sciences [q-bio]/Microbiology and Parasitology, Drug Therapy, Combination, Female, 030211 gastroenterology & hepatology, medicine.drug, Adult, medicine.medical_specialty, infectious disease, Hepatitis C virus, Population, clinical research/practice, Antiviral Agents, 03 medical and health sciences, Internal medicine, medicine, Humans, Adverse effect, education, [SDV.MP] Life Sciences [q-bio]/Microbiology and Parasitology, Transplantation, business.industry, Kidney Transplantation, Liver Transplantation, Regimen, Immunology, infection and infectious agents - viral: hepatitis C, business, liver transplantation/hepatology, Follow-Up Studies
Abstract: International audience; Hepatitis C virus (HCV) infection is associated with reduced patient survival following combined liver-kidney transplantation (LKT). The aim of this study was to assess the efficacy and safety of second-generation direct-acting antivirals (DAAs) in this difficult-to-treat population. The ANRS CO23 "Compassionate use of Protease Inhibitors in Viral C Liver Transplantation" (CUPILT) study is a prospective cohort including transplant recipients with recurrent HCV infection treated with DAAs. The present work focused on recipients with recurrent infection following LKT. The study population included 23 patients. All patients received at least one NS5B inhibitor (sofosbuvir) in their antiviral regimen an average of 90 months after LKT. Ninety-six percent of recipients achieved a sustained virological response (SVR) at week 12 (SVR12). In terms of tolerance, 39% of recipients presented with at least one serious adverse event. None of the patients experienced acute rejection during therapy and there were no deaths during follow-up. The glomerular filtration rate (GFR) decreased significantly from baseline to the end of therapy. However, this study did not show that the decline in GFR persisted over time or that it was directly related to DAAs. The DAA-based regimen is well tolerated with excellent results in terms of efficacy. It will become the gold standard for the treatment of recurrent HCV following LKT.
Published: 2017
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7. Comparison of the effect of direct-acting antiviral with and without ribavirin on cyclosporine and tacrolimus clearance values results from the ANRS CO23 CUPILT cohort

Author: Thibaut Gelé, Christophe Duvoux, Anne Marie Taburet, Didier Samuel, Carole Cagnot, Claire Laforest, Christophe Moreno, Valérie Canva, H. Danjou, Georges-Philippe Pageaux, Victor de Lédinghen, Danielle Botta-Fridlund, Nassim Kamar, Audrey Lavenu, Lauriane Goldwirt, Sylvie Radenne, Claire Fougerou-Leurent, Filomena Conti, François Durand, Aurélie Barrail-Tran, Vincent Leroy, Louis d’Alteroche, Jean-Charles Duclos-Vallée, Pauline Houssel-Debry, Audrey Coilly, Université Paris-Sud - Paris 11 (UP11), AP-HP Hôpital Bicêtre (Le Kremlin-Bicêtre), Immunologie des Maladies Virales et Autoimmunes (IMVA - U1184), Université Paris-Sud - Paris 11 (UP11)-Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Institut National de la Santé et de la Recherche Médicale (INSERM), Hopital Saint-Louis [AP-HP] (AP-HP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), CHU Pontchaillou [Rennes], Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Hôpital de la Croix-Rousse [CHU - HCL], Hospices Civils de Lyon (HCL), CHU Grenoble, Hôpital Claude Huriez [Lille], CHU Lille, Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), CHU Marseille, Université libre de Bruxelles (ULB), ANRS France Recherche Nord & sud Sida-hiv hépatites, Physiopathologie et traitement des maladies du foie, Université Paris-Sud - Paris 11 (UP11)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM), Hôpital Paul Brousse, Hôpital Lapeyronie [Montpellier] (CHU), Cellules Souches, Plasticité Cellulaire, Médecine Régénératrice et Immunothérapies (IRMB), Université de Montpellier (UM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Agence Nationale de Recherches sur le Sida et les Hépatites Virales, Université Paris-Sud - Paris 11 (UP11)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Commissariat à l'énergie atomique et aux énergies alternatives (CEA), Centre Hospitalier Régional Universitaire de Tours (CHRU TOURS), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), and Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM)
Subjects: Male, Pyrrolidines, Sofosbuvir, medicine.medical_treatment, [SDV]Life Sciences [q-bio], HIV Infections, Liver transplantation, Pharmacologie, Gastroenterology, chemistry.chemical_compound, 0302 clinical medicine, Pharmacology (medical), Drug Interactions, 030212 general & internal medicine, ComputingMilieux_MISCELLANEOUS, Imidazoles, Anemia, Valine, General Medicine, Hepatitis C, Middle Aged, 3. Good health, Cyclosporine, 030211 gastroenterology & hepatology, Drug Therapy, Combination, Female, Immunosuppressive Agents, medicine.drug, medicine.medical_specialty, Daclatasvir, Liver fibrosis, Anaemia, Antiviral Agents, Tacrolimus, 03 medical and health sciences, Internal medicine, Ribavirin, medicine, Humans, Aged, Pharmacology, business.industry, medicine.disease, Liver Transplantation, Calcineurin, Regimen, chemistry, Carbamates, business
Abstract: Purpose: Direct-acting antiviral agents have demonstrated their efficacy in treating HCV recurrence after liver transplantation and particularly the sofosbuvir/daclatasvir combination. Pharmacokinetic data on both calcineurin inhibitors and direct-acting antiviral exposure in liver transplant recipients remain sparse. Methods: Patients were enrolled from the ANRS CO23 CUPILT cohort. All patients treated with sofosbuvir/daclatasvir with or without ribavirin were included in this study when blood samples were available to estimate the clearance of immunosuppressive therapy before direct-acting antiviral initiation and during follow-up. Apparent tacrolimus and cyclosporine clearances were estimated from trough concentrations measured using validated quality control assays. Results: Sixty-seven mainly male patients (79%) were included, with a mean age of 57 years and mean MELD score of 8.2; 50 were on tacrolimus, 17 on cyclosporine. Ribavirin was combined with sofosbuvir/daclatasvir in 52% of patients. Cyclosporine clearance remained unchanged as well as tacrolimus clearance under the ribavirin-free regimen. Tacrolimus clearance increased 4 weeks after direct-acting antivirals and ribavirin initiation versus baseline (geometric mean ratio 1.81; 90% CI 1.30–2.52). Patients under ribavirin had a significantly higher fibrosis stage (> 2) (p = 0.02) and lower haemoglobin during direct-acting antiviral treatment (p = 0.02) which impacted tacrolimus measurements. Direct-acting antiviral exposure was within the expected range. Conclusion: Our study demonstrated that liver transplant patients with a recurrence of hepatitis C who are initiating ribavirin combined with a sofosbuvir-daclatasvir direct-acting antiviral regimen may be at risk of lower tacrolimus concentrations because of probable ribavirin-induced anaemia and higher fibrosis score, although there are no effects on cyclosporine levels. Trial registration: NCT 01944527., SCOPUS: ar.j, info:eu-repo/semantics/published
Published: 2019
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8. Sofosbuvir‐based treatment of hepatitis C with severe fibrosis (METAVIR F3/F4) after liver transplantation

Author: A. Rohel, Christophe Moreno, Jean-Charles Duclos-Vallée, Sylvie Radenne, Camille Besch, Armand Abergel, Nassim Kamar, Albert Tran, Georges-Philippe Pageaux, Pascal Lebray, Pauline Houssel-Debry, Valérie Canva, Claire Francoz, Danielle Botta-Fridlund, Jérôme Dumortier, Alpha Diallo, Vincent Leroy, Christophe Duvoux, Louis d’Alteroche, Claire Fougerou-Leurent, Audrey Coilly, Vincent Di Martino, Didier Samuel, Filomena Conti, Victor de Lédinghen, and Emilie Rossignol
Subjects: Compassionate Use Trials, Liver Cirrhosis, Male, Pyrrolidines, Cirrhosis, Sofosbuvir, medicine.medical_treatment, Hepacivirus, 030230 surgery, Liver transplantation, medicine.disease_cause, Gastroenterology, chemistry.chemical_compound, 0302 clinical medicine, Belgium, Recurrence, Prospective Studies, Imidazoles, Valine, Hepatitis C, Middle Aged, 3. Good health, Treatment Outcome, Female, 030211 gastroenterology & hepatology, France, Immunosuppressive Agents, medicine.drug, Reoperation, medicine.medical_specialty, Daclatasvir, Genotype, Hepatitis C virus, Antiviral Agents, 03 medical and health sciences, Internal medicine, Ribavirin, medicine, Humans, Protease Inhibitors, Aged, Transplantation, Hepatology, business.industry, medicine.disease, Liver Transplantation, chemistry, Immunology, Surgery, Carbamates, business
Abstract: Recurrence of hepatitis C virus (HCV) after liver transplantation (LT) can rapidly lead to liver graft cirrhosis and, therefore, graft failure and retransplantation or death. The aim of the present study was to assess efficacy and tolerance of sofosbuvir (SOF)–based regimens for the treatment of HCV recurrence in patients with severe fibrosis after LT. The Compassionate Use of Protease Inhibitors in Viral C Liver Transplantation (CULPIT) study is a prospective multicenter cohort including patients with HCV recurrence following LT treated with second generation direct antivirals. The present study focused on patients included between October 2013 and November 2014 and diagnosed with HCV recurrence and liver graft extensive fibrosis (METAVIR F3/F4). A SOF-based regimen was administered to 125 patients fulfilling inclusion criteria. The median delay from LT was 95.9 ± 69.6 months. The characteristics of patients were as follows: mean age, 59.4 ± 9.0 years; 78.4% male; infected by HCV genotype 1: 78.2%, mean HCV RNA: 6.1 ± 1.0 log10 IU/mL. Eighty patients had failed previous post-LT antiviral therapy (64.0%) including triple therapy with first generation protease inhibitors in 19 (15.2%) patients. The main combination regimen was SOF/daclatasvir (73.6%). Ribavirin was used in 60 patients. Sustained virological response 12 weeks after treatment was 92.8% (on an intention-to-treat basis); 7 patients with virological failure were observed. Serious adverse events occurred in 25.6% of the patients during antiviral treatment. During antiviral treatment and follow-up, 3 patients were retransplanted and 4 patients died. In conclusion, SOF-based antiviral treatment shows very promising results in patients with HCV recurrence and severe fibrosis after LT. Liver Transplantation 22 1367–1378 2016 AASLD. © 2016 by the American Association for the Study of Liver Diseases
Published: 2016
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9. Safety of sofosbuvir-based regimens after liver transplantation longitudinal assessment of renal function in the prospective ANRS CO23 CUPILT study

Author: Rodolphe Anty, Alpha Diallo, Vincent Leroy, L. D’Alteroche, Jean Charles Duclos-Vallée, Claire Fougerou-Leurent, Christophe Duvoux, Vincent L.M. Esnault, P. Perré, François Habersetzer, Audrey Coilly, Aurelie Veislinger, Nassim Kamar, V. Di Martino, Emilie Rossignol, Valérie Canva, Maryline Debette-Gratien, Carole Cagnot, François Durand, Didier Samuel, Clémence M. Canivet, Danielle Botta-Fridlund, H. Montialoux, V. de Ledinghen, Christine Silvain, Camille Besch, Jérôme Dumortier, Albert Tran, Guillaume Favre, Pauline Houssel-Debry, Georges Philippe Pageaux, S. Radenne, H. Danjou, Sébastien Dharancy, Fabio Conti, Pascal Lebray, Armando Abergel, Christophe Moreno, 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), Laboratoire de PhysioMédecine Moléculaire (LP2M), COMUE Université Côte d'Azur (2015-2019) (COMUE UCA)-COMUE Université Côte d'Azur (2015-2019) (COMUE UCA)-Centre National de la Recherche Scientifique (CNRS)-Université Côte d'Azur (UCA), CHU Pontchaillou [Rennes], Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Physiopathologie du cancer du foie, Université Bordeaux Segalen - Bordeaux 2-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Grenoble, Centre Hospitalier Lyon Sud [CHU - HCL] (CHLS), Hospices Civils de Lyon (HCL), CHU Toulouse [Toulouse], Hôpital Claude Huriez [Lille], CHU Lille, Hôpital Edouard Herriot [CHU - HCL], Service d'Hépato-Gastro-Entérologie [CHU Pitié-Salpêtrière], CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), CHU Strasbourg, CHU Marseille, CHU Rouen, Normandie Université (NU), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Centre hospitalier universitaire de Poitiers (CHU Poitiers), Interactions Virus-Hôte et Maladies Hépatiques, Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut de Virologie, CHU Estaing [Clermont-Ferrand], CHU Clermont-Ferrand, CHU Limoges, ANRS France Recherche Nord & sud Sida-hiv hépatites, Hôpital Lapeyronie [Montpellier] (CHU), Université Nice Sophia Antipolis (1965 - 2019) (UNS), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), and Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)
Subjects: medicine.medical_specialty, Sofosbuvir, Hepatitis C virus, medicine.medical_treatment, [SDV]Life Sciences [q-bio], Urology, Renal function, Hepacivirus, 030230 surgery, Liver transplantation, medicine.disease_cause, Kidney, Cohort Studies, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Recurrence, Ribavirin, Medicine, Humans, Pharmacology (medical), Longitudinal Studies, Prospective Studies, Renal Insufficiency, Chronic, Aged, Creatinine, Hepatology, business.industry, Gastroenterology, Middle Aged, Hepatitis C, 3. Good health, Liver Transplantation, medicine.anatomical_structure, chemistry, Cohort, 030211 gastroenterology & hepatology, Female, business, medicine.drug, Glomerular Filtration Rate
Abstract: International audience; Background In liver transplant recipients with hepatitis C virus recurrence, there is concern about renal safety of sofosbuvir-based regimens. Changes in serum creatinine or in the estimated glomerular filtration rate (eGFR) under treatment are used to look for possible renal toxicity. However, serum creatinine and eGFR are highly variable. Aim To analyse renal function trajectory with numerous assays of serum creatinine over a long period of time. Methods In a multicentre cohort of 139 patients, the eGFR was obtained from serum creatinine using the Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) equation. Slopes of eGFR were defined as a change in eGFR during a period divided by time. Pre-treatment, on-treatment and post-treatment periods were 9 months, 3-9 months and 4.5 months. Interactions between eGFR slopes and the pre-treatment eGFR, use of ribavirin or mycophenolate mofetil, and stage of fibrosis were addressed. On-treatment eGFR slopes were separated in tertiles. Pre- and post-treatment eGFR slopes were compared globally and according to tertiles. Results The post-treatment eGFR slope was significantly better than pre-treatment eGFR slope (+0.18 (IQR -0.76 to +1.32) vs -0.11 (IQR -1.01 to +0.73) mL/min/1.73 m(2)/month, P=0.03) independently of the pre-treatment eGFR (P=0.99), ribavirin administration (P=0.26), mycophenolate mofetil administration (P=0.51) and stage of fibrosis (F3 and F4 vs lower stages, P=0.18; F4 vs lower stages, P=0.08; F4 Child-Pugh B and C vs lower stages, P=0.38). Tertiles of on-treatment eGFR slopes were -1.71 (IQR -2.54 to -1.48), -0.78 (IQR -1.03 to -0.36) and +0.75 (IQR +0.28 to +1.47) mL/min/1.73 m(2)/month. Pre- and post-treatment eGFR slopes were not significantly different according to tertiles (respectively, P=0.34, 0.08, 0.73). Conclusion The eGFR varies during treatment and gives a confusing picture of the renal safety of sofosbuvir-based regimens. In contrast, longitudinal assessment of the eGFR shows a rising trajectory over longer time, meaning that these therapies are safe for the kidneys in our cohort of liver transplant recipients.
Published: 2018
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10. Sofosbuvir-Based Regimens in HIV/HCV Coinfected Patients after Liver Transplantation: Results from the ANRS CO23 CUPILT Study

Author: Didier Samuel, Audrey Coilly, Jérôme Dumortier, Vincent Leroy, Danielle Botta-Fridlund, Anne-Marie Taburet, P. Perré, A. Rohel, Aurelie Veislinger, Emilie Rossignol, Teresa Antonini, Valérie Canva, Pauline Houssel-Debry, Jean Charles Duclos-Vallée, Sylvie Radenne, Georges Philippe Pageaux, Alpha Diallo, Nassim Kamar, Claire Fougerou-Leurent, François Durand, V. de Ledinghen, Physiopathologie et traitement des maladies du foie, Université Paris-Sud - Paris 11 (UP11)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon, Dynamique des systèmes d'adhérence et différenciation (DySAD), Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Hôpital de la Croix-Rousse [CHU - HCL], Hospices Civils de Lyon (HCL), CHU Marseille, Centre de recherche biomédicale Bichat-Beaujon (CRB3), Université Paris Diderot - Paris 7 (UPD7)-Institut National de la Santé et de la Recherche Médicale (INSERM), Foie, métabolismes et cancer, Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), Centre de Physiopathologie Toulouse Purpan (CPTP), Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Services de Maladies de l'Appareil Digestif, Hôpital Claude Huriez, Centre Hospitalier Universitaire de Lille, Lille, France, Hôpital Claude Huriez [Lille], CHU Lille-CHU Lille, CHU Bordeaux [Bordeaux], ANRS France Recherche Nord & sud Sida-hiv hépatites, Immunologie des Maladies Virales et Autoimmunes (IMVA - U1184), Université Paris-Sud - Paris 11 (UP11)-Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Institut National de la Santé et de la Recherche Médicale (INSERM), Hôpital Lapeyronie [Montpellier] (CHU), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), and Université de Toulouse (UT)-Université de Toulouse (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)
Subjects: Ledipasvir, Male, medicine.medical_specialty, Daclatasvir, Sofosbuvir, medicine.medical_treatment, Hepatitis C virus, [SDV]Life Sciences [q-bio], HIV Infections, Liver transplantation, medicine.disease_cause, Gastroenterology, Antiviral Agents, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Internal medicine, medicine, Humans, 030212 general & internal medicine, Transplantation, business.industry, Coinfection, Ribavirin, virus diseases, Hepatitis C, Middle Aged, medicine.disease, 3. Good health, Liver Transplantation, chemistry, Liver, 030211 gastroenterology & hepatology, Female, business, Viral load, medicine.drug
Abstract: Background A recurrence of hepatitis C virus (HCV) after liver transplantation affects survival in human immunodeficiency virus (HIV)/HCV coinfected patients. This study assessed the efficacy and safety of sofosbuvir (SOF)-based regimens in HIV/HCV coinfected patients after liver transplantation. Methods Twenty-nine HIV/HCV coinfected transplanted patients receiving tacrolimus-, cyclosporine-, or everolimus-based immunosuppressive therapy were enrolled in the Compassionate Use of Protease Inhibitors in Viral C Liver Transplantation cohort. Their antiviral treatment combined SOF, daclatasvir with or without ribavirin (n = 10/n = 6), or SOF, ledipasvir with or without ribavirin (n = 2/n = 11). Results The median delay between liver transplantation and treatment initiation was 37.5 months (interquartile range [IQR], 14.4-99.2). The breakdown of HCV genotypes was G1, 22 patients (75.9%); G3, 3 patients (10.3%); and G4, 4 patients (13.8%). The treatment indications were HCV recurrence (≥ F1 n = 23) or fibrosing cholestatic hepatitis (n = 6). Before starting SOF, the HCV viral load and CD4 count were 6.7 log 10 IU/mL (IQR, 5.9-7.2) and 342 cells/mm 3 (IQR, 172-483), respectively. At week 4, the HCV viral load was less than 15 IU/mL in 12 (42.9%) patients. The overall sustained virological response 12 was 96.6%. No significant drug-drug interactions were observed. Conclusions SOF-based treatment regimens produced excellent results in HIV/HCV coinfected patients after liver transplantation, suggesting an important change in their prognosis. Copyright © 2017 Wolters Kluwer Health, Inc. All rights reserved.
Published: 2018
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11. Nucleotide and amino acid diversity of hepatitis B virus surface antigen in acute infections, southeastern France

Author: Alban Benezech, René Gerolami, Catherine Tamalet, Patrick Borentain, Danielle Botta-Fridlund, Paul Rémi Petit, Philippe Colson, Sarah Aherfi, Anne Motte, Microbes évolution phylogénie et infections (MEPHI), Institut de Recherche pour le Développement (IRD)-Aix Marseille Université (AMU)-Centre National de la Recherche Scientifique (CNRS), Service de Gastroentérologie, Assistance Publique - Hôpitaux de Marseille (APHM)- Hôpital Nord [CHU - APHM], Chirurgie Digestive, Assistance Publique - Hôpitaux de Marseille (APHM)-Hôpital de la Conception [CHU - APHM] (LA CONCEPTION), Virology, Hôpital de la Timone [CHU - APHM] (TIMONE), Assistance Publique - Hôpitaux de Marseille (APHM), and Centre National de la Recherche Scientifique (CNRS)-Institut de Recherche pour le Développement (IRD)-Aix Marseille Université (AMU)
Subjects: 0301 basic medicine, Hepatitis B virus, Hepatitis B virus DNA polymerase, 030106 microbiology, medicine.disease_cause, 03 medical and health sciences, [SDV.MHEP.MI]Life Sciences [q-bio]/Human health and pathology/Infectious diseases, Genetic variation, medicine, Humans, Nucleotide, Amino Acids, Genotyping, ComputingMilieux_MISCELLANEOUS, chemistry.chemical_classification, Mutation, Hepatitis B virus surface Antigen, Hepatitis B Surface Antigens, Hepatology, Nucleotides, business.industry, Gastroenterology, Genetic Variation, Hepatitis B, Virology, 3. Good health, Amino acid, 030104 developmental biology, chemistry, Acute Disease, France, business
Abstract: International audience
Published: 2018
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12. SAT-248-Patients treated for HCV and listed for LT in a French multicenter study: What happens at 3 years?

Author: Camille Besch, Armand Abergel, Sylvie Radenne, A.V. Pichard, Christophe Duvoux, Audrey Coilly, Georges-Philippe Pageaux, Jérôme Dumortier, Danielle Botta Fridlund, Vincent Di Martino, Marilyne Gratien, Rodolphe Anty, Pauline Houssel-Debry, Lucy Meunier, Laurent Alric, Vincent Leroy, Montialoux Helene, Didier Samuel, Filomena Conti, Victor de Ledinghen, Pascal Lebray, and Jean-Charles Duclos-Vallée
Subjects: Pediatrics, medicine.medical_specialty, Hepatology, Multicenter study, business.industry, Medicine, business
Published: 2019
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13. Association de sofosbuvir et daclatasvir chez un patient transplanté hépatique traité par hémodialyse

Author: Mourad Hachicha and Danielle Botta-Fridlund
Subjects: 03 medical and health sciences, 0302 clinical medicine, Nephrology, 030232 urology & nephrology, 030211 gastroenterology & hepatology
Abstract: Resume Nous rapportons le cas d’une remission virale soutenue, avec l’association de sofosbuvir 400 mg administre apres chaque seance d’hemodialyse et daclatasvir 60 mg par jour, pendant 3 mois, chez un patient infecte par le virus de l’hepatite C (VHC) genotype 1, transplante hepatique et traite par hemodialyse. Peu d’effets secondaires sont survenus au cours du traitement. Les parametres biologiques sont restes stables et aucune interaction medicamenteuse n’a ete notee. Ce schema, s’il est valide par d’autres etudes, pourrait contribuer a ameliorer la morbi-mortalite chez les patients hemodialyses infectes par le VHC.
Published: 2016
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14. Spontaneous clearance of chronic hepatitis C virus infection in HIV positive patients, southeastern France

Author: Philippe Colson, Sarah Aherfi, Amélie Menard, Maxime Algoud, Hervé Tissot-Dupont, Danielle Botta-Fridlund, Unité de Recherche sur les Maladies Infectieuses Tropicales Emergentes (URMITE), Unité de Recherche sur les Maladies Infectieuses et Tropicales Emergentes (URMITE), Institut de Recherche pour le Développement (IRD)-Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-IFR48, Institut des sciences biologiques (INSB-CNRS)-Institut des sciences biologiques (INSB-CNRS)-Centre National de la Recherche Scientifique (CNRS)-Institut de Recherche pour le Développement (IRD)-Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-IFR48, Institut des sciences biologiques (INSB-CNRS)-Institut des sciences biologiques (INSB-CNRS)-Centre National de la Recherche Scientifique (CNRS), Service de Maladies Infectieuses, Hôpital de la Conception [CHU - APHM] (LA CONCEPTION)-Centre de Référence des Infections Ostéo-articulaires Sud-Méditerranée (CRIOA), Assistance Publique - Hôpitaux de Marseille (APHM)-Institut Hospitalier Universitaire Méditerranée Infection (IHU Marseille)-Hôpital de la Conception [CHU - APHM] (LA CONCEPTION)-Assistance Publique - Hôpitaux de Marseille (APHM)-Institut Hospitalier Universitaire Méditerranée Infection (IHU Marseille), Chirurgie Digestive, Assistance Publique - Hôpitaux de Marseille (APHM)-Hôpital de la Conception [CHU - APHM] (LA CONCEPTION), INSB-INSB-Centre National de la Recherche Scientifique (CNRS)-Institut de Recherche pour le Développement (IRD)-Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-IFR48, INSB-INSB-Centre National de la Recherche Scientifique (CNRS), and Hôpital de la Conception [CHU - APHM] (LA CONCEPTION)-Assistance Publique - Hôpitaux de Marseille (APHM)-Institut Hospitalier Universitaire Méditerranée Infection (IHU Marseille)-Assistance Publique - Hôpitaux de Marseille (APHM)-Institut Hospitalier Universitaire Méditerranée Infection (IHU Marseille)
Subjects: Cirrhosis, Hepatitis C virus, Remission, Spontaneous, Human immunodeficiency virus (HIV), Spontaneous remission, HIV Infections, medicine.disease_cause, Virus, 03 medical and health sciences, 0302 clinical medicine, Chronic hepatitis, HIV Seropositivity, medicine, Humans, 030212 general & internal medicine, ComputingMilieux_MISCELLANEOUS, Hepatology, business.industry, Gastroenterology, Hepatitis C, Chronic, Hiv seropositivity, medicine.disease, Virology, 3. Good health, Chronic infection, Immunology, 030211 gastroenterology & hepatology, France, business, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology
Abstract: International audience
Published: 2017
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15. Daclatasvir plus sofosbuvir, with or without ribavirin, for hepatitis C virus genotype 3 in a French early access programme

Author: Hélène Fontaine, Victor de Ledinghen, Eric Nguyen-Khac, Pascal Lebray, Fabien Zoulim, Jean-Pierre Bronowicki, Christophe Hézode, Raoudha Akremi, Yue Zhao, Larysa Fedchuk, Yacia Bennai, Marc Bourlière, Isabelle Hubert-Fouchard, Louis d’Alteroche, Anne Filipovics, Vincent Di Martino, Christine Silvain, Dominique Larrey, Dominique Guyader, Isabelle Rosa, Danielle Botta-Fridlund, Vincent Leroy, Nathalie Boyer, Service d'hépato-gastro-entérologie [APHP Henri Mondor], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Henri Mondor-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), Institut Mondor de Recherche Biomédicale (IMRB), Institut National de la Santé et de la Recherche Médicale (INSERM)-IFR10-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), Service d'Hépato-Gastro-Entérologie [CHU Pitié-Salpêtrière], CHU Pitié-Salpêtrière [AP-HP], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Hôpital Haut-Lévêque [CHU Bordeaux], CHU Bordeaux [Bordeaux], Hôpital de la Croix-Rousse [CHU - HCL], Hospices Civils de Lyon (HCL), Service d'hépatologie, Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC)-Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7)-Hôpital Beaujon [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Service d'oncologie digestive et hépato-gastro-entérologie [Hôpital de la Timone - APHM], Assistance Publique - Hôpitaux de Marseille (APHM)- Hôpital de la Timone [CHU - APHM] (TIMONE), Centre hospitalier universitaire de Poitiers (CHU Poitiers), Laboratoire Inflammation, Tissus épithéliaux et Cytokines (LITEC), Université de Poitiers, Service d'hépatologie médicale [CHU Cochin], Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Institut Pasteur [Paris], Centre Hospitalier Régional Universitaire de Tours (CHRU TOURS), Département d'hépato-gastroentérologie, Université Grenoble Alpes (UGA)-CHU Grenoble, Hôpital Saint-Joseph [Marseille], Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM), CHU Pontchaillou [Rennes], CHI Créteil, CHU Amiens-Picardie, Bristol-Myers Squibb Company, Nutrition-Génétique et Exposition aux Risques Environnementaux (NGERE), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lorraine (UL), This was a compassionate use programme authorized by a regulatory authority. No financial support was provided by BMS., Herrada, Anthony, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon)-Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC), Cellules Souches, Plasticité Cellulaire, Médecine Régénératrice et Immunothérapies (IRMB), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM), Institut Pasteur [Paris] (IP), Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), CHU Grenoble-Université Grenoble Alpes (UGA), and Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)
Subjects: Liver Cirrhosis, Male, Cirrhosis, Pyrrolidines, Sofosbuvir, Sustained Virologic Response, Viral Hepatitis, MESH: Sustained Virologic Response, Hepacivirus, medicine.disease_cause, Gastroenterology, Cohort Studies, MESH: Genotype, chemistry.chemical_compound, Liver disease, 0302 clinical medicine, Recurrence, MESH: Hepacivirus, 030212 general & internal medicine, MESH: Cohort Studies, MESH: Aged, education.field_of_study, MESH: Middle Aged, Imidazoles, Valine, Hepatitis C, Middle Aged, real‐world data, 3. Good health, MESH: Hepatitis C, Chronic, 030211 gastroenterology & hepatology, Drug Therapy, Combination, Female, France, MESH: Liver Cirrhosis, MESH: Imidazoles, medicine.drug, Adult, MESH: Antiviral Agents, medicine.medical_specialty, MESH: Liver Transplantation, Daclatasvir, Genotype, Hepatitis C virus, Population, compassionate use, Antiviral Agents, sofosbuvir, 03 medical and health sciences, MESH: Ribavirin, Internal medicine, Ribavirin, medicine, Humans, genotype 3, daclatasvir, education, Aged, MESH: Humans, Hepatology, real-world data, business.industry, MESH: Sofosbuvir, MESH: Adult, [SDV.MHEP.HEG]Life Sciences [q-bio]/Human health and pathology/Hépatology and Gastroenterology, Hepatitis C, Chronic, medicine.disease, Virology, [SDV.MHEP.HEG] Life Sciences [q-bio]/Human health and pathology/Hépatology and Gastroenterology, MESH: Male, Liver Transplantation, MESH: Recurrence, MESH: France, MESH: Drug Therapy, Combination, chemistry, Carbamates, hepatitis C, business, MESH: Female
Abstract: International audience; BACKGROUND & AIMS:Optimally effective treatment for hepatitis C virus genotype 3 (GT3) is urgently needed, particularly in advanced liver disease. Daclatasvir plus sofosbuvir was efficacious in phase 3 studies. Real-world data for daclatasvir+sofosbuvir in advanced GT3 infection are presented from the French Temporary Authorisation for Use programme, which allowed patients in need without other treatment options access to daclatasvir ahead of its market authorization.METHODS:Patients with F3/F4 fibrosis and/or extrahepatic hepatitis C virus manifestations, post-liver transplant hepatitis C virus recurrence and/or indication for liver/kidney transplant, were treated with daclatasvir+sofosbuvir (60+400 mg daily) for a recommended duration of 24 weeks. Addition of ribavirin and/or shorter treatment was at physician's discretion. The primary efficacy analysis was sustained virological response at post-treatment week 12 (SVR12; modified intention-to-treat). Safety was assessed by spontaneous adverse event reporting.RESULTS:The efficacy population comprised 333 patients, mostly cirrhotic (77%, of whom 18% were decompensated) and treatment experienced (72%). After 24 weeks of daclatasvir+sofosbuvir, SVR12 was 89% (174/196) overall (95% CI 83.6-92.5%), 98% (43/44) without cirrhosis (95% CI 88.2-99.6%) and 86% (129/150) with any degree of cirrhosis (95% CI 79.5-90.7%), without SVR12 increase in those who received additional ribavirin for 24 weeks (SVR12 82% [50/61; 95% CI 70.5-89.6%]). Among 516 GT3-infected patients with safety data, 5 discontinued for adverse events and 11 died.CONCLUSIONS:Daclatasvir+sofosbuvir achieved high SVR12 rates and was well tolerated in this large real-world cohort of GT3-infected patients with advanced liver disease, without benefit of ribavirin in those treated 24 weeks.
Published: 2017
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16. Hepatitis C Virus Relapse 78 Weeks After Completion of Successful Direct-Acting Therapy

Author: Philippe Colson, Danielle Botta-Fridlund, Céline Boschi, Hervé Tissot-Dupont, Emmanuelle Bernit, Sarah Aherfi, Unité de Recherche sur les Maladies Infectieuses et Tropicales Emergentes (URMITE), Institut de Recherche pour le Développement (IRD)-Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-IFR48, INSB-INSB-Centre National de la Recherche Scientifique (CNRS), Aix Marseille Université (AMU), Hôpital de la Timone [CHU - APHM] (TIMONE), Chirurgie Digestive, Assistance Publique - Hôpitaux de Marseille (APHM)-Hôpital de la Conception [CHU - APHM] (LA CONCEPTION), and Institut des sciences biologiques (INSB-CNRS)-Institut des sciences biologiques (INSB-CNRS)-Centre National de la Recherche Scientifique (CNRS)
Subjects: 0301 basic medicine, Microbiology (medical), business.industry, Hepatitis C virus, 030106 microbiology, virus diseases, Hepacivirus, Hepatitis C, Chronic, medicine.disease_cause, Virology, Hepatitis C, 3. Good health, 03 medical and health sciences, 0302 clinical medicine, Infectious Diseases, Recurrence, Major Article, Medicine, Humans, 030211 gastroenterology & hepatology, business, ComputingMilieux_MISCELLANEOUS, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology, Direct acting
Abstract: BACKGROUND: Development of direct-acting antivirals in recent years has dramatically enhanced rates of viral eradication to >90% in patients with chronic hepatitis C virus (HCV) infection. To determine true treatment efficacy and to define the most appropriate retreatment, it is important to distinguish virologic relapse from reinfection where patients who achieve HCV eradication during treatment become infected with a new HCV strain posttreatment. METHODS: Here, we investigated prevalence of late recurrent viremia (patients who achieved SVR12 but had detectable HCV RNA at follow up week 24) and used refined phylogenetic analysis of multiple HCV genes to distinguish virologic relapse from reinfection. RESULTS: Across 11 phase 3 ledipasvir/sofosbuvir and sofosbuvir clinical trials, only 12 out of 3004 patients had detectable HCV RNA after SVR12. Of these 12 patients with late recurrent viremia, 11 had the same HCV genotype/subtype at baseline and at the time of recurrence. Phylogenetic analysis demonstrated that 58% (7/12) of these patients with late recurrent viremia were successfully treated with the SOF-based regimen and achieved HCV eradication however became reinfected with a different HCV strain posttreatment. The remaining five patients with late recurrent viremia had virologic relapse in which the HCV present at baseline persisted in the liver or in another compartment and reemerged in the blood 24 weeks posttreatment. CONCLUSIONS: The incidence of late recurrent viremia was low. Distinguishing reinfection from virologic relapse has implications for determining true treatment efficiency and selection of optimal retreatment strategies.
Published: 2017
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17. Efficacy and safety of boceprevir-based triple therapy in HCV cirrhotic patients awaiting liver transplantation (ANRS HC29 BOCEPRETRANSPLANT)

Author: Amir Guidoum, Laurent Alric, Vincent Leroy, Si-Nafa Si-Ahmed, Didier Samuel, Jean-Charles Duclos-Vallée, Jean-Didier Grangé, Sébastien Dharancy, Lawrence Serfaty, Célia Wellems, Christophe Hézode, François Durand, Anne-Marie Taburet, François Bailly, Christelle Paul, Maria Patrizia Carrieri, Pierre Pradat, Cécile Bouix, Elina Teicher, Sophie Metivier, Antoine Vilotitch, Christophe Duvoux, Georges-Philippe Pageaux, Anne-Marie Roque-Afonso, Bruno Roche, Filomena Conti, Ventzislava Petrov-Sanchez, Rodolphe Anty, Hélène Fontaine, Frédérik Beaulieux, Michelle Sizorn, Louis d’Alteroche, Marianne Maynard, Valérie Canva, Danielle Botta-Fridlund, Pascal Lebray, Département d'hépatologie [CHU Cochin], Institut Pasteur [Paris]-CHU Cochin [AP-HP]-Institut National de la Santé et de la Recherche Médicale ( INSERM ), Université Paris Descartes - Paris 5 ( UPD5 ), Service d'Hépatologie [Hôpital de la Croix-Rousse - HCL], Hôpital de la Croix-Rousse [CHU - HCL], Hospices Civils de Lyon ( HCL ) -Hospices Civils de Lyon ( HCL ), Sciences Economiques et Sociales de la Santé & Traitement de l'Information Médicale ( SESSTIM - U912 INSERM - Aix Marseille Univ - IRD ), Institut de Recherche pour le Développement ( IRD ) -Aix Marseille Université ( AMU ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ), ORS PACA, Hôpital de la Conception [CHU - APHM] ( LA CONCEPTION ), Département d'hépato-gastro-entérologie [Hôpital Trousseau : CHRU Tours], CHU Trousseau [APHP]-Centre Hospitalier Régional Universitaire de Tours ( CHRU TOURS ), Service d'hépatologie [Saint-Antoine], Université Pierre et Marie Curie - Paris 6 ( UPMC ) -Assistance publique - Hôpitaux de Paris (AP-HP)-CHU Saint-Antoine [APHP], Fédération Médico-Chirurgicale des Maladies de l'Appareil Digestif, Centre Hospitalier Régional Universitaire [Montpellier] ( CHRU Montpellier ) -CHU Saint-Eloi, Département d'hépato-gastroentérologie, Université Joseph Fourier - Grenoble 1 ( UJF ) -CHU Grenoble, Service de Gastro-entérologie - Hépatologie [Purpan], CHU Toulouse [Toulouse]-Hôpital Purpan [Toulouse], CHU Toulouse [Toulouse], Centre Hospitalier Universitaire de Nice ( CHU Nice ), Service d’Hépatologie [Hôpital Beaujon], Hôpital Beaujon, Hôpital Claude Huriez, Université de Lille, Droit et Santé-Centre Hospitalier Régional Universitaire [Lille] ( CHRU Lille ), Service d'Hépato-Gastroentérologie [CHU Pitié-Salpêtrière], Assistance publique - Hôpitaux de Paris (AP-HP)-CHU Pitié-Salpêtrière [APHP], Hôpital Purpan [Toulouse], Service d'hépato-gastro-entérologie [APHP Henri Mondor], Assistance publique - Hôpitaux de Paris (AP-HP)-Hôpital Henri Mondor-Université Paris-Est Créteil Val-de-Marne - Paris 12 ( UPEC UP12 ), ANRS, France REcherche Nord & sud Sida-hiv Hépatites (FRENSH), Unit for Basic and Clinical research on Viral Hepatitis, Centre hépato-biliaire ( CHB ), Assistance publique - Hôpitaux de Paris (AP-HP)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale ( INSERM ), Physiopathologie et traitement des maladies du foie, Université Paris-Sud - Paris 11 ( UP11 ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ) -AP-HP Hôpital Paul Brousse, This work was funded and sponsored by ANRS (France REcherche Nord & sud Sida-HIV Hépatites [FRENSH]), Paris.Dr Fontaine reports personal fees from Gilead, Janssen, BMS, MSD, AbbVie, outside the submitted work.Dr Leroy reports advisory role for BMS, Gilead, AbbVie, and Janssen and personal fees from BMS, Gilead, AbbVie, and Janssen.Dr Alric reports personal fees from MSD, Janssen, Gilead, AbbVie, BMS, research grants from MSD, Janssen, Gilead, AbbVie, BMS, and non-financial support from MSD, Janssen, Gilead, AbbVie, BMS., The authors thank Audrey Kremer-Cochet, Laure Roguet, and Dr Alpha Diallo for their continued deep involvement in the study. They also thank members of the independent committee: Prof Eric Belissant (methodologist), Dr Michel Biour (pharmacologist), Dr Marc Bourlière (hepatologist), Dr Rodolphe Garraffo (pharmacologist), Prof Dominique Larrey (pharmacologist), Prof Philippe Mathurin (hepatologist), Prof Christophe Moréno (hepatologist). They also thank Merck Schering-Plough for supplying the boceprevir. Finally, the authors thank the patients and their families., Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM), Université Paris Descartes - Paris 5 (UPD5), Hospices Civils de Lyon (HCL)-Hospices Civils de Lyon (HCL), Sciences Economiques et Sociales de la Santé & Traitement de l'Information Médicale (SESSTIM - U912 INSERM - Aix Marseille Univ - IRD), Institut de Recherche pour le Développement (IRD)-Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Hôpital de la Conception [CHU - APHM] (LA CONCEPTION), Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Hôpital Saint Eloi (CHRU Montpellier), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), CHU Grenoble-Université Grenoble Alpes (UGA), Pôle Maladies de l'appareil digestif [CHU Toulouse], Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Centre Hospitalier Universitaire de Nice (CHU Nice), Hôpital Beaujon [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Hôpital Claude Huriez [Lille], CHU Lille, CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Henri Mondor-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), ANRS France Recherche Nord & sud Sida-hiv hépatites, Centre hépato-biliaire (CHB), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM), Université Paris-Sud - Paris 11 (UP11)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM), Département d'hépathologie - Hôpital Cochin [Paris], Institut Pasteur [Paris]-Institut National de la Santé et de la Recherche Médicale ( INSERM ) -CHU Cochin [AP-HP], Sciences Economiques et Sociales de la Santé & Traitement de l'Information Médicale ( SESSTIM ), Institut de Recherche pour le Développement ( IRD ) -Aix Marseille Université ( AMU ) -ORS PACA-Institut National de la Santé et de la Recherche Médicale ( INSERM ), CHU Nice, Institut National de la Santé et de la Recherche Médicale (INSERM)-Hôpital Cochin [AP-HP], Institut de Recherche pour le Développement (IRD)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Aix Marseille Université (AMU), Centre Hospitalier Régional Universitaire de Tours (CHRU TOURS)-CHU Trousseau [APHP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Université Pierre et Marie Curie - Paris 6 (UPMC), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-CHU Saint-Eloi, Université Grenoble Alpes (UGA)-CHU Grenoble, Service d'Hépato-Gastro-Entérologie [CHU Pitié-Salpêtrière], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Pharmacochimie et Biologie pour le Développement (PHARMA-DEV), Institut de Recherche pour le Développement (IRD)-Institut de Chimie de Toulouse (ICT-FR 2599), Institut National Polytechnique (Toulouse) (Toulouse INP), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Centre National de la Recherche Scientifique (CNRS)-Institut de Recherche pour le Développement (IRD)-Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Institut de Chimie du CNRS (INC)-Institut National Polytechnique (Toulouse) (Toulouse INP), Université Fédérale Toulouse Midi-Pyrénées-Institut de Chimie du CNRS (INC), Institut National de la Santé et de la Recherche Médicale (INSERM)-Hôpital Paul Brousse-Université Paris-Sud - Paris 11 (UP11), Herrada, Anthony, CHU Trousseau [APHP], Service d'hépatologie [CHU Saint-Antoine], Université Pierre et Marie Curie - Paris 6 (UPMC)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Sorbonne Université (SU), and Centre Hospitalier Régional Universitaire de Tours (CHRU Tours)-CHU Trousseau [APHP]
Subjects: Liver Cirrhosis, Male, medicine.medical_treatment, Liver transplantation, Gastroenterology, chemistry.chemical_compound, Liver disease, 0302 clinical medicine, 030212 general & internal medicine, Liver Neoplasms, Hepatitis C, Middle Aged, 3. Good health, Treatment Outcome, Hepatocellular carcinoma, Drug Therapy, Combination, Female, 030211 gastroenterology & hepatology, [ SDV.MHEP.HEG ] Life Sciences [q-bio]/Human health and pathology/Hépatology and Gastroenterology, France, Adult, medicine.medical_specialty, Carcinoma, Hepatocellular, Adolescent, Proline, Antiviral Agents, 03 medical and health sciences, Pharmacotherapy, Internal medicine, Boceprevir, Ribavirin, medicine, Humans, Adverse effect, Aged, Retrospective Studies, Hepatology, business.industry, Interferon-alpha, [SDV.MHEP.HEG]Life Sciences [q-bio]/Human health and pathology/Hépatology and Gastroenterology, Hepatitis C, Chronic, medicine.disease, [SDV.MHEP.HEG] Life Sciences [q-bio]/Human health and pathology/Hépatology and Gastroenterology, Liver Transplantation, Surgery, chemistry, Quality of Life, business
Abstract: International audience; BACKGROUND AND AIMS:In this French multicentre, open-label study, we analyzed the efficacy, safety and patient-reported outcomes of a boceprevir-based triple therapy in HCV genotype 1 cirrhotic patients awaiting liver transplantation (LT).METHODS:Patients received PEG-IFN/ribavirin (RBV) for 48 weeks (W) and boceprevir from W4 to W48 or until LT.RESULTS:Fifty-one patients (80% males, median age: 56 years) were included. Fifty-seven percent had hepatocellular carcinoma and 43% end-stage liver disease. At enrolment, the median MELD score was 9 (range: 6-18); the Child-Pugh score was A in 65%, B in 35% and C in 2%. Therapy was discontinued because of severe adverse events (SAEs) in 39% of cases and virological inefficacy in 24%. 16% of patients had undetectable HCV RNA 24 weeks after the end of treatment (SVR24). LT was performed in 18 patients (35%). HCV RNA was undetectable in 16.6% at LT. Seven patients (14%) died and three deaths were attributed to treatment. SAEs (n=129) were observed in 84% of patients. Twenty-four percent of patients developed severe infections. Albumin
Published: 2017
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18. Hepatitis C virus NS3 protease genotyping and drug concentration determination during triple therapy with telaprevir or boceprevir for chronic infection with genotype 1 viruses, southeastern France

Author: Saadia Mokhtari, Jean-Marie Ruiz, Catherine Tamalet, Caroline Solas, Isabelle Portal, Philippe Brouqui, Sarah Aherfi, Anne Motte, Isabelle Ravaux, Sylvie Bregigeon, Andreas Stein, Catherine Dhiver, René Gerolami, Philippe Colson, Isabelle Poizot-Martin, Jacques Moreau, Patrick Borentain, and Danielle Botta-Fridlund
Subjects: education.field_of_study, business.industry, Ribavirin, Hepatitis C virus, Population, virus diseases, medicine.disease_cause, Virology, digestive system diseases, Telaprevir, chemistry.chemical_compound, Infectious Diseases, chemistry, Pegylated interferon, Boceprevir, Medicine, Protease inhibitor (pharmacology), education, business, Viral load, medicine.drug
Abstract: Telaprevir and boceprevir, the two first hepatitis C virus (HCV) NS3 protease inhibitors (PIs), considerably increase rates of sustained virologic response in association with pegylated interferon and ribavirin in chronic HCV genotype 1 infections. The 30 first patients treated by telaprevir or boceprevir including anti-HCV therapies since 2011 in Marseille University hospitals, France, were monitored. HCV loads and plasmatic concentrations of telaprevir and boceprevir were determined on sequential blood samples. HCV NS3 protease gene population sequencing was performed at baseline of treatment and in case of treatment failure. Fifteen patients (including 7 co-infected with HIV) received telaprevir and the other 15 patients (including 4 co-infected with HIV) received boceprevir. At baseline, HCV NS3 protease from six patients harbored amino acid substitutions associated with PI-resistance. Treatment failure occurred at week 12 for 7 patients. Amino acid substitutions associated with PI-resistance were observed in six of these cases. HCV NS3 R155K and T54A/S mutants, all of genotype 1a, were found from four patients. Median (interquartile range) plasma concentrations were 3,092 ng/ml (2,320-3,525) for telaprevir and 486 ng/ml (265-619) for boceprevir. For HIV-HCV co-infected patients, median concentrations were 3,162 ng/ml (2,270-4,232) for telaprevir and 374 ng/ml (229-519) for boceprevir. Plasma drug concentration monitoring revealed undetectable concentrations for two patients at week 4, and probable non-adherence to therapy for another patient. These findings indicate that routine HCV NS3 protease sequencing and plasma PI concentration monitoring might be helpful to characterize cases of therapy failure, at a cost dramatically low compared to that of anti-HCV therapy.
Published: 2014
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19. Liver transplantation for acute liver failure related to autochthonous genotype 3 hepatitis E virus infection

Author: Anne Motte, Jean-Charles Grimaud, Christophe Renou, Sarah Aherfi, Cyril Nafati, Stéphane Garcia, Yves Patrice Le Treut, Aude Le Goffic, Danielle Botta-Fridlund, René Gerolami, Michel Guisset, Jean Hardwigsen, Ferdaous Raissouni, Patrick Borentain, and Philippe Colson
Subjects: Adult, Male, Genotype, viruses, medicine.medical_treatment, Fulminant, Context (language use), Liver transplantation, medicine.disease_cause, chemistry.chemical_compound, Fulminant hepatic failure, Hepatitis E virus, medicine, Humans, Hepatology, business.industry, Ribavirin, Gastroenterology, virus diseases, Liver Failure, Acute, Middle Aged, Hepatitis E, medicine.disease, digestive system diseases, Liver Transplantation, Europe, chemistry, Immunology, business
Abstract: Hepatitis E virus of genotype 3 (HEV-3) is an emerging cause of sporadic autochthonous acute hepatitis in Europe. Although spontaneous outcome of hepatitis E is usually favorable, fulminant liver failure has been described worldwide. In Europe, autochthonous hepatitis E associated with fulminant hepatic failure and leading to liver transplantation has been exceptionally reported. We report here four cases of fulminant and sub-fulminant hepatitis E proposed for liver transplantation in Marseille University hospitals between July 2006 and March 2010. HEV diagnosis relied on detection of anti-HEV IgM antibodies and HEV RNA in serum samples. All cases were men, with no travel history in hyperendemic areas. HEV sequence analyses revealed genotype 3 HEV in the four patients. Liver histology indicated severe acute hepatitis in all of them, pre-existing fibrosis being found in two cases. Two patients underwent liver transplantation, and the two other patients could not be transplanted due to septic complications and died. HEV testing should be performed for the initial evaluation of every acute liver failure regardless of the epidemiological and clinical context. With respect to the potentially fulminant evolution of HEV genotype 3 infections, treatment with ribavirin of severe acute hepatitis E should be considered.
Published: 2014
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20. Safety and efficacy of protease inhibitors to treat hepatitis C after liver transplantation: A multicenter experience

Author: Olivier Guillaud, Georges-Philippe Pageaux, Si-nafaa Si-ahmed, S. Radenne, Jérôme Dumortier, Jean-Charles Duclos-Vallée, Vincent Leroy, Didier Samuel, Danielle Botta-Fridlund, Stéphanie Haim-Boukobza, Anne-Marie Roque-Afonso, Teresa Antonini, Bruno Roche, and Audrey Coilly
Subjects: medicine.medical_specialty, Hepatology, business.industry, Ribavirin, Hepatitis C virus, medicine.medical_treatment, Hepatitis C, Liver transplantation, medicine.disease_cause, medicine.disease, Gastroenterology, Telaprevir, chemistry.chemical_compound, Model for End-Stage Liver Disease, chemistry, Pegylated interferon, Boceprevir, Internal medicine, Immunology, medicine, business, medicine.drug
Abstract: Background & Aims Protease inhibitors (PI) with peginterferon/ribavirin have significantly improved SVR rates in HCV G1 patients. Their use to treat HCV recurrence after liver transplantation (LT) is a challenge. Methods This cohort study included 37 liver transplant recipients (male, 92%, age 57±11years), treated with boceprevir (n=18) or telaprevir (n=19). The indication for therapy was HCV recurrence (fibrosis stage ⩾F2 (n=31, 83%) or fibrosing cholestatic hepatitis (n=6, 16%). Results Eighteen patients were treatment-naive, five were relapsers and fourteen were non-responders to dual therapy after LT. Twenty-two patients received cyclosporine and fifteen tacrolimus. After 12weeks of PI therapy, a complete virological response was obtained in 89% of patients treated with boceprevir, and 58% with telaprevir ( p =0.06). The end of treatment virological response rate was 72% (13/18) in the boceprevir group and 40% (4/10) in the telaprevir group ( p =0.125). A sustained virological response 12weeks after treatment discontinuation was observed in 20% (1/5) and 71% (5/7) of patients in the telaprevir and boceprevir groups, respectively ( p =0.24). Treatment was discontinued in sixteen patients (treatment failures (n=11), adverse events (n=5)). Infections occurred in ten patients (27%), with three fatal outcomes (8%). The most common adverse effect was anemia (n=34, 92%), treated with erythropoietin and/or a ribavirin dose reduction; thirteen patients (35%) received red blood cell transfusions. The cyclosporine dose was reduced by 1.8±1.1-fold and 3.4±1.0-fold with boceprevir and telaprevir, respectively. The tacrolimus dose was reduced by 5.2±1.5-fold with boceprevir and 23.8±18.2-fold with telaprevir. Conclusions Our results suggest that triple therapy is effective in LT recipients, particularly those experiencing a severe recurrence. The occurrence of anemia and drug-drug interactions, and the risk of infections require close monitoring.
Published: 2014
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21. Assessment of chronic rejection in liver graft recipients receiving immunosuppression with low-dose calcineurin inhibitors

Author: Jérôme Cros, Danielle Botta-Fridlund, Louise Barbier, Yves-Patrice Le Treut, Jean Hardwigsen, Stéphane Garcia, Valérie Paradis, and Patrick Borentain
Subjects: Adult, Graft Rejection, Male, medicine.medical_specialty, Adolescent, medicine.medical_treatment, Calcineurin Inhibitors, Liver transplantation, Gastroenterology, Internal medicine, Biopsy, medicine, Humans, Aged, Hepatology, medicine.diagnostic_test, business.industry, Immunosuppression, Middle Aged, Hepatitis B, medicine.disease, Tacrolimus, Liver Transplantation, Calcineurin, Regimen, Chronic Disease, Immunology, Female, Liver function tests, business, Immunosuppressive Agents
Abstract: Calcineurin inhibitors represent the cornerstone immunosuppressants after liver transplantation despite their side effects. As liver graft is particularly well tolerated, low doses may be proposed. The aim of this study was to assess the prevalence of chronic rejection in patients with low calcineurin inhibitors regimen and to compare their characteristics with patients under standard doses.All patients with liver transplantation between 1997 and 2004 were divided into two groups. Low-dose patients (n=57) had tacrolimus baseline levels5ng/ml or cyclosporine levels50ng/ml at t0 or100ng/ml at t+2h and were prospectively proposed a liver biopsy, searching for chronic rejection according to Banff criteria. The remaining patients constituted the standard-doses group (n=40).Among the low-dose group, 36 patients in the low-dose group were assessed by biopsy. No chronic rejection was found. Fifty-six percent had only calcineurin inhibitors and 8% received other immunosuppressants only. The median time between liver transplantation and biopsy was 90 months (64-157) and between IS regimen decrease and biopsy was 41 months (11-115). Liver tests were normal in 72% of the patients. Low-dose patients had more often hepatitis B (p=0.045), less past acute rejection episodes (p=0.028), and better renal function (p=0.040). Decrease of calcineurin inhibitors failed in 15% of standard-dose patients without impacting the graft function. In the low-dose group, co-prescription of other immunosuppressants facilitated the decrease (p=0.051).The minimization, or even cessation, of calcineurin inhibitors may be an achievable goal in the long term for most of the liver graft recipients.
Published: 2013
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22. [Sofosbuvir and daclatasvir combination therapy in hemodialysis patient with liver transplantation]

Author: Mourad, Hachicha and Danielle, Botta-Fridlund
Subjects: Liver Cirrhosis, Male, Carcinoma, Hepatocellular, Pyrrolidines, Liver Neoplasms, Imidazoles, Valine, Middle Aged, Antiviral Agents, Hepatitis C, Liver Transplantation, Treatment Outcome, Renal Dialysis, Risk Factors, Humans, Drug Therapy, Combination, Carbamates, Renal Insufficiency, Chronic, Sofosbuvir
Abstract: We report a case of sustained remission of a liver transplant patient infected with hepatitis C virus (HCV) genotype 1 undergoing hemodialysis treatment. Oral treatment regimen of the HCV infection consists of a combination of sofosbuvir 400 mg after each hemodialysis session and daclatasvir 60 mg daily, for a period of 3 months. Laboratory testing indicate that the combination regimen was well-tolerated with no sign of drug-drug interaction. Confirmation of these clinical observations in large clinical studies may help improve morbidity and decrease mortality outcome in patients infected with HCV and undergoing hemodialysis treatment.
Published: 2016

23. Multidisciplinary approach for the treatment of 1155 HCV/HCV-HIV co-infected patients

Author: Laurence Pellissier, Caroline Solas, Malika Mokhtari, Danielle Botta-Fridlund, B. Castan, M. Soavi, Rolande Cohen, Sylvie Bregigeon, Philippe Halfon, Catherine Dhiver, Isabelle Portal, Christelle Tomei, Albert Darque, Thierry Allegre, Isabelle Poizot-Martin, Patrick Philibert, Amélie Menard, Isabelle Ravaux, Jacques Moreau, Valérie Oules, Marc Bourlière, and Philippe Colson
Subjects: medicine.medical_specialty, Epidemiology, business.industry, Immunology, Public Health, Environmental and Occupational Health, Human immunodeficiency virus (HIV), medicine.disease_cause, Microbiology, QR1-502, Infectious Diseases, Multidisciplinary approach, Virology, Internal medicine, medicine, Public aspects of medicine, RA1-1270, business
Published: 2016

24. Should we keep using Ribavirin to Treat Hepatitis C Recurrence after Liver Transplantation? Results from the CO23 ANRS Cupilt Study

Author: Jean Charles Duclos-Vallée, F. Durand, Valérie Canva, V. Di Martino, Abou Diallo, G.-P. Pageaux, S. Radenne, Claire Fougerou-Leurent, Emilie Rossignol, Aurelie Veislinger, Pauline Houssel-Debry, Rodolphe Anty, H. Danjou, Vincent Leroy, Christophe Duvoux, L. D’Alteroche, C. Silvain, Audrey Coilly, V. de Ledinghen, Camille Besch, Caroline Jezequel, Maryline Debette-Gratien, A. Rohel, François Habersetzer, Nassim Kamar, H. Montialoux, Jérôme Dumortier, Armando Abergel, Christophe Moreno, Fabio Conti, Pascal Lebray, Danielle Botta-Fridlund, P. Perré, Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Pontchaillou [Rennes], Service d'Hépatologie, Hôpital Henri Mondor, AP-HP, Créteil, France., Hôpital Henri Mondor, Hôpital Paul Brousse, Département d'hépatologie, Hospices Civils de Lyon (HCL), Institut de médecine moléculaire de Rangueil (I2MR), Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-IFR150-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), CHU Trousseau [APHP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Services de Maladies de l'Appareil Digestif, Hôpital Claude Huriez, Centre Hospitalier Universitaire de Lille, Lille, France, Hôpital Claude Huriez [Lille], CHU Lille-CHU Lille, CHU Pitié-Salpêtrière [AP-HP], Service d'hépato-gastroentérologie, Hôpital de la Conception, AP-HM, Marseille, Hôpital de la Conception [CHU - APHM] (LA CONCEPTION), Hôpital Erasme [Bruxelles] (ULB), Faculté de Médecine [Bruxelles] (ULB), Université libre de Bruxelles (ULB)-Université libre de Bruxelles (ULB), Centre hospitalier universitaire de Poitiers (CHU Poitiers), Laboratoire Inflammation, Tissus épithéliaux et Cytokines (LITEC), Université de Poitiers, Service de Transplantation, Centre Hospitalier Universitaire de Strasbourg, Centre Hospitalier Universitaire de Strasbourg (CHU de Strasbourg ), CHU Estaing [Clermont-Ferrand], CHU Clermont-Ferrand, Unité de la recherche fondamentale et clinique sur l' hépatite virale, France Recherche Nord & Sud Asdi-VIH Hépatites, Agence Nationale de Recherche sur le Sida, Agence Nationale de Recherches sur le Sida et les Hépatites Virales (ANRS), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), and Université de Toulouse (UT)-Université de Toulouse (UT)- Institut Fédératif de Recherche Bio-médicale Institution (IFR150)-Institut National de la Santé et de la Recherche Médicale (INSERM)
Subjects: medicine.medical_specialty, Hepatology, business.industry, medicine.medical_treatment, Ribavirin, [SDV]Life Sciences [q-bio], Hepatitis C, 030230 surgery, Liver transplantation, medicine.disease, Gastroenterology, 3. Good health, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, chemistry, Internal medicine, Medicine, 030211 gastroenterology & hepatology, business
Abstract: International audience; EASL International Liver Congress, APR 13-17, 2016, Barcelona, SPAIN
Published: 2016
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25. Pitfall of hepatitis B surface antigen testing in a kidney transplant recipient presenting hepatitis B reactivation

Author: Anne Motte, Philippe Colson, Pauline Romanet, Valérie Moal, Danielle Botta-Fridlund, and Henri Vacher-Coponat
Subjects: Male, HBsAg, medicine.disease_cause, Serology, Recurrence, medicine, Humans, False Positive Reactions, Aged, Hepatitis, Hepatitis B virus, Hepatitis B Surface Antigens, Hepatology, biology, business.industry, Gastroenterology, virus diseases, Hepatitis B, medicine.disease, Kidney Transplantation, Virology, digestive system diseases, Transplantation, Titer, Immunology, biology.protein, Antibody, business
Abstract: Diagnosis of hepatitis B virus (HBV) infection based on hepatitis B surface antigen (HBsAg) detection can be hampered in the setting of HBV reactivation in immunocompromized patients with prior serology indicating past cured infection, and can be associated with severe or fulminant and fatal hepatitis. We present a case of HBV reactivation in a renal transplant patient in whom HBsAg failed to be confirmed as a true positive result. One year after transplantation, systematic testing showed HBsAg positivity with a titer at 244 pg/mL, anti-hepatitis B core antibody and concurrent anti-hepatitis B surface antibody positivity. Confirmation of HBsAg detection by seroneutralization did not confirm HBsAg positivity, indicating that HBsAg detection was a false positive result. Notwithstanding, HBV DNA titer in serum was concurrently 8.6 Log IU/mL. HBV DNA sequencing showed a genotype D and several amino acid substitutions within HBsAg, including some previously involved in impaired diagnosis and altered immunogenicity. Although no perturbation of liver biochemical markers was observed, treatment with tenofovir was introduced. One month later, HBV DNA level had decreased by 2.6 Log IU/mL and no clinical and biochemical symptoms of hepatitis had occurred. The present case underlines that serologic diagnosis of HBV reactivation can be tricky in transplant recipients with a prior serology indicating past HBV infection. This prompts to perform HBV DNA testing in case of positive HBsAg testing, regardless of the result of neutralization by anti-HBs antibodies.
Published: 2011
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26. Tuberculose céphalopancréatique : une cause rare d’ictère obstructif accessible à un traitement conservateur

Author: Jean-Marc Durand, Pascal Ananian, Séverine Meunier-Carpentier, Jean-Marc Escoffier, Philippe Grandval, David Bernardini, Patrick Borentain, Danielle Botta-Fridlund, and René Gerolami
Subjects: Conservative treatment, Gynecology, medicine.medical_specialty, business.industry, Biliary tract obstruction, Gastroenterology, Medicine, General Medicine, Endoscopic ultrasonography, Jaundice, medicine.symptom, business, Biliary tract disease
Abstract: Resume La tuberculose pancreatique est rare. Elle survient generalement dans un contexte de miliaire et se manifeste le plus souvent par un ictere obstructif lie a un syndrome de masse cephalopancreatique. Le diagnostic preoperatoire permet d’eviter un traitement chirurgical dont la morbi-mortalite reste elevee, au profit d’un traitement conservateur associant antituberculeux oraux et levee d’obstacle instrumentale. Dans notre observation, le diagnostic de tuberculose pancreatique a pu etre porte par ponction sous echoendoscopie.
Published: 2007
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27. Clinical and virological significance of the co-existence of HBsAg and anti-HBs antibodies in hepatitis B chronic carriers

Author: Mireille Henry, Philippe Colson, Patrick Borentain, Catherine Tamalet, Anne Motte, René Gerolami, Danielle Botta-Fridlund, and Valérie Moal
Subjects: Adult, Male, Concurrent HBsAg and anti-HBs antibodies detection, HBsAg, Hepatitis B virus, Genotype, Drug resistance, Biology, medicine.disease_cause, Serology, Hepatitis B, Chronic, HBV mutants, Virology, medicine, Prevalence, Humans, Hepatitis B Antibodies, Aged, Aged, 80 and over, Hepatitis B Surface Antigens, Hospitals, Public, HBV chronic infection, virus diseases, HBV reverse transcriptase, Hepatitis B, Middle Aged, medicine.disease, Reverse transcriptase, HIV Reverse Transcriptase, digestive system diseases, Amino Acid Substitution, Immunology, Carrier State, biology.protein, Female, France, Antibody
Abstract: The co-existence of hepatitis B surface antigen (HBsAg) and anti-HBs antibodies (HBsAb) in serum of hepatitis B virus (HBV)-chronic carriers has been previously associated with HBsAg-amino acid (aa) substitutions. However, the aa pattern of HBV-reverse transcriptase (RT) and the clinical settings associated with this serological profile remain largely unknown. We studied thirteen HBsAg-positive/HBsAb-positive patients. Newly diagnosed HBsAg-positive/HBsAb-negative patients (n=51) served as controls. HBsAg/RT sequences were obtained using in-house protocols. HBsAg-positive/HBsAb-positive patients were predominantly immunosuppressed (69%). Five presented advanced liver fibrosis. HBV DNA >5.0 log10 copies/ml was significantly more frequent than in controls. A significantly higher aa variability was observed versus controls within HBsAg major hydrophilic region (MHR), especially the a-determinant, and within RT for regions overlapping the MHR, the a-determinant, and HBsAg C terminal region where drug resistance mutations occur. Further studies are needed to determine whether this higher HBsAg/HBV-RT variability might favor dissemination of anti-HBsAb escape HBV mutants and concomitantly alter nucleos(t)ide analogs efficacy.
Published: 2007
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28. Multicentre experience using daclatasvir and sofosbuvir to treat hepatitis C recurrence - The ANRS CUPILT study

Author: Armando Abergel, Christophe Moreno, Danielle Botta-Fridlund, Sylvie Radenne, Maryline Debette-Gratien, Pauline Houssel-Debry, Pascal Lebray, A. Rohel, Claire Francoz, Jean-Charles Duclos-Vallée, P. Perré, François Habersetzer, Nassim Kamar, Christine Silvain, Didier Samuel, H. Danjou, Rodolphe Anty, Vincent Leroy, Emilie Rossignol, Victor de Lédinghen, Louis d’Alteroche, Anne-Marie Roque-Afonso, Camille Besch, Filomena Conti, Christophe Duvoux, Georges-Philippe Pageaux, Valérie Canva, Claire Fougerou-Leurent, Jérôme Dumortier, Vincent Di Martino, Audrey Coilly, Hôpital Paul Brousse, Université Paris-Sud - Paris 11 (UP11)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Paul Brousse, Centre hépato-biliaire (CHB), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM), Physiopathologie et traitement des maladies du foie, Université Paris-Sud - Paris 11 (UP11)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Pontchaillou [Rennes], Physiopathologie du cancer du foie, Université Bordeaux Segalen - Bordeaux 2-Institut National de la Santé et de la Recherche Médicale (INSERM), Pôle Recherche Clinique-Santé Publique [Mondor], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Henri Mondor, Service d'hépatologie, Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon)-Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC), Hospices Civils de Lyon (HCL)-Hôpital de la Croix-Rousse [CHU - HCL], Hospices Civils de Lyon (HCL), Institut de médecine moléculaire de Rangueil (I2MR), Université Toulouse III - Paul Sabatier (UT3), Université de Toulouse (UT)-Université de Toulouse (UT)- Institut Fédératif de Recherche Bio-médicale Institution (IFR150)-Institut National de la Santé et de la Recherche Médicale (INSERM), Département de Néphrologie et Transplantation d'organes [CHU Toulouse], Pôle Urologie - Néphrologie - Dialyse - Transplantations - Brûlés - Chirurgie plastique - Explorations fonctionnelles et physiologiques [CHU Toulouse], Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), CHU Trousseau [APHP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), CHU Trousseau [Tours], Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), ScaLable Information Discovery and Exploitation [Grenoble] (SLIDE), Laboratoire d'Informatique de Grenoble (LIG ), Institut polytechnique de Grenoble - Grenoble Institute of Technology (Grenoble INP )-Centre National de la Recherche Scientifique (CNRS)-Université Grenoble Alpes [2016-2019] (UGA [2016-2019])-Institut polytechnique de Grenoble - Grenoble Institute of Technology (Grenoble INP )-Centre National de la Recherche Scientifique (CNRS)-Université Grenoble Alpes [2016-2019] (UGA [2016-2019]), Service d'hépato-gastro-entérologie, Hôpital Huriez-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Université Pierre et Marie Curie - Paris 6 (UPMC), Hôpital Erasme [Bruxelles] (ULB), Faculté de Médecine [Bruxelles] (ULB), Université libre de Bruxelles (ULB)-Université libre de Bruxelles (ULB), service d'Hépato-gastro-entérologie, Hospices Civiles de Lyon-Hôpital Edouard Heriault, Hôpital de la Milétrie, Centre hospitalier universitaire de Poitiers (CHU Poitiers), Chirurgie Digestive, Assistance Publique - Hôpitaux de Marseille (APHM)-Hôpital de la Conception [CHU - APHM] (LA CONCEPTION), Centre méditerranéen de médecine moléculaire (C3M), Université Nice Sophia Antipolis (1965 - 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), Département Digestif, Centre Hospitalier Universitaire de Nice (CHU Nice)-Hôpital de l'Archet, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7)-Hôpital Beaujon [AP-HP], 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), CHU Pitié-Salpêtrière [AP-HP], Centre de Recherche Saint-Antoine (UMRS893), Université Pierre et Marie Curie - Paris 6 (UPMC)-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Saint-Antoine [AP-HP], Interactions Virus-Hôte et Maladies Hépatiques, Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut de Virologie, Pathogénèse et traitement de l'hépatite fulminante et du cancer du foie, Université Paris-Sud - Paris 11 (UP11)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre hépato-biliaire - CHB [Paul Brousse, Paris], Université Paris-Sud - Paris 11 (UP11)-Hôpital Paul Brousse, Hepatinov (DHU), Université Paris-Sud - Paris 11 (UP11)-Centre Hépato-Biliaire Paul Brousse, Centre National de Référence pour la maladie de Wilson (CNR wilson), CNR Wilson, Service de Neurologie, Hôpital Lariboisière, Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Hôpital Saint Eloi (CHRU Montpellier), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), ANRS (France REcherche Nord & sud Sida-HIV Hepatites-FRENCH), Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-IFR150-Institut National de la Santé et de la Recherche Médicale (INSERM), Department of Multiorgan Transplantation, CHU Toulouse [Toulouse], Service de gastro-entérologie [CHU Trousseau], Université Pierre et Marie Curie - Paris 6 (UPMC)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Trousseau [APHP], Service de Chirurgie Digestive, Hépato-Bilio-pancréatique et Transplantation Hépatique [CHU Pitié-Salpétrière], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-CHU Saint-Eloi, Hôpital Paul Brousse-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris-Sud - Paris 11 (UP11), Institut National de la Santé et de la Recherche Médicale (INSERM)-Hôpital Paul Brousse-Université Paris-Sud - Paris 11 (UP11), Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC)-Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Sorbonne Université (SU), Université Nice Sophia Antipolis (... - 2019) (UNS), COMUE Université Côte d'Azur (2015-2019) (COMUE UCA)-COMUE Université Côte d'Azur (2015-2019) (COMUE UCA)-Université Côte d'Azur (UCA)-Institut National de la Santé et de la Recherche Médicale (INSERM), 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, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Hôpital Paul Brousse-Université Paris-Sud - Paris 11 (UP11), Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Université Paris-Sud - Paris 11 ( UP11 ) -Assistance publique - Hôpitaux de Paris (AP-HP)-Hôpital Paul Brousse, Centre hépato-biliaire ( CHB ), Assistance publique - Hôpitaux de Paris (AP-HP)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale ( INSERM ), Université Paris-Sud - Paris 11 ( UP11 ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ) -AP-HP Hôpital Paul Brousse, Centre d'Investigation Clinique [Rennes] ( CIC ), Université de Rennes 1 ( UR1 ), Université de Rennes ( UNIV-RENNES ) -Université de Rennes ( UNIV-RENNES ) -Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale ( INSERM ), Université Bordeaux Segalen - Bordeaux 2-Institut National de la Santé et de la Recherche Médicale ( INSERM ), Assistance publique - Hôpitaux de Paris (AP-HP)-Hôpital Henri-Mondor, Centre Hospitalier Régional Universitaire [Besançon] ( CHRU Besançon ) -Hôpital Jean Minjoz-Université de Franche-Comté ( UFC ), Hospices Civils de Lyon ( HCL ) -Hôpital de la Croix-Rousse [CHU - HCL], Hospices Civils de Lyon ( HCL ), Institut de médecine moléculaire de Rangueil ( I2MR ), Université Toulouse III - Paul Sabatier ( UPS ), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-IFR150-Institut National de la Santé et de la Recherche Médicale ( INSERM ), Service de gastro-entérologie, Université Pierre et Marie Curie - Paris 6 ( UPMC ) -Assistance publique - Hôpitaux de Paris (AP-HP)-CHU Trousseau [APHP], CHRU Tours, ScaLable Information Discovery and Exploitation [Saint Martin d’Hères] ( SLIDE ), Laboratoire d'Informatique de Grenoble ( LIG ), Université Pierre Mendès France - Grenoble 2 ( UPMF ) -Université Joseph Fourier - Grenoble 1 ( UJF ) -Institut National Polytechnique de Grenoble ( INPG ) -Centre National de la Recherche Scientifique ( CNRS ) -Université Grenoble Alpes ( UGA ) -Université Pierre Mendès France - Grenoble 2 ( UPMF ) -Université Joseph Fourier - Grenoble 1 ( UJF ) -Institut National Polytechnique de Grenoble ( INPG ) -Centre National de la Recherche Scientifique ( CNRS ) -Université Grenoble Alpes ( UGA ), Hôpital Huriez-Centre Hospitalier Régional Universitaire [Lille] ( CHRU Lille ), APHP, Université Pierre et Marie Curie - Paris 6 ( UPMC ), Hôpital Erasme, Université Libre de Bruxelles [Bruxelles] ( ULB ), Centre hospitalier universitaire de Poitiers ( CHU Poitiers ), Assistance Publique - Hôpitaux de Marseille ( APHM ) -Hôpital de la Conception [CHU - APHM] ( LA CONCEPTION ), Centre méditérannéen de médecine moléculaire ( C3M ), Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Université Nice Sophia Antipolis ( UNS ), Université Côte d'Azur ( UCA ) -Université Côte d'Azur ( UCA ), CHU Nice-Hôpital de l'Archet, Assistance publique - Hôpitaux de Paris (AP-HP)-Université Paris Diderot - Paris 7 ( UPD7 ) -Hôpital Beaujon, 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, Service de chirurgie digestive hépato-bilio-pancréatique transplantation hépatique [CHU Pitié-Salpêtrière], Assistance publique - Hôpitaux de Paris (AP-HP)-CHU Pitié-Salpêtrière [APHP], Centre de Recherche Saint-Antoine ( CR Saint-Antoine ), Université Pierre et Marie Curie - Paris 6 ( UPMC ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ), Human HepCell [AP-HP Hôpital Saint-Antoine], Université Pierre et Marie Curie - Paris 6 ( UPMC ) -Université Paris Descartes - Paris 5 ( UPD5 ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ) -AP-HP - Hôpital Saint-Antoine -Paris Biotech santé, Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Institut de Virologie, Université Paris-Sud - Paris 11 ( UP11 ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ), Université Paris-Sud - Paris 11 ( UP11 ) -AP-HP Hôpital Paul Brousse, Hepatinov ( DHU ), Université Paris-Sud - Paris 11 ( UP11 ) -Centre Hépato-Biliaire Paul Brousse, Centre National de Référence pour la maladie de Wilson ( CNR wilson ), and Centre Hospitalier Régional Universitaire [Montpellier] ( CHRU Montpellier ) -CHU Saint-Eloi
Subjects: Compassionate Use Trials, medicine.medical_specialty, drug-drug interactions, Daclatasvir, Sofosbuvir, Hepatitis C virus, medicine.medical_treatment, Hepacivirus, Liver transplantation, medicine.disease_cause, Gastroenterology, Antiviral Agents, virus-infection, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Model for End-Stage Liver Disease, Pegylated interferon, Internal medicine, Ribavirin, medicine, Humans, Prospective Studies, combination, Hepatology, business.industry, association, natural-history, Hepatitis C, interferon, [SDV.SP]Life Sciences [q-bio]/Pharmaceutical sciences, medicine.disease, 3. Good health, liver-transplant recipients, hcv infection, [ SDV.SP ] Life Sciences [q-bio]/Pharmaceutical sciences, Treatment Outcome, chemistry, 030220 oncology & carcinogenesis, triple therapy, Immunology, 030211 gastroenterology & hepatology, Drug Therapy, Combination, France, business, medicine.drug
Abstract: International audience; Background & Aims:HCV recurrence remains a major issue in the liver transplant field, as it has a negative impact on both graft and patient survival. The purpose of this study was to investigate the efficacy and safety of treating HCV recurrence with sofosbuvir (SOF) and daclatasvir (DCV) combination therapy. Methods: From October 2013 to March 2015, 559 liver recipients were enrolled in the prospective multicentre France REcherche Nord&Sud Sida-hiv Hepatites (ANRS) Compassionate use of Protease Inhibitors in viral C Liver Transplantation cohort. We selected 137 patients with an HCV recurrence receiving SOF and DCV, whatever the genotype or fibrosis stage. The use of ribavirin and the duration of therapy were at the investigator's discretion. The primary efficacy end point was a sustained virological response (SVR) 12 weeks after the end of treatment. Results: The SVR rate 12 weeks after completing treatment was 96% under the intention-to treat analysis and 99% when excluding non-virological failures. Only two patients experienced a virological failure. The serious adverse event (SAE) rate reached 17.5%. Four patients (3%) stopped their treatment prematurely because of SAEs. Anaemia was the most common AE, with significantly more cases in the ribavirin group (56% vs. 18%; p
Published: 2015
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29. O109 : Treatment of severe HCV-recurrence after liver transplantation using sofosbuvir-based regimens: The ANRS CO23 CUPILT study

Author: G.-P. Pageaux, Jean Charles Duclos-Vallée, F. Durand, L. D’Alteroche, Valérie Canva, H. Danjou, Audrey Coilly, Vincent Leroy, Danielle Botta-Fridlund, Claire Fougerou-Leurent, Pauline Houssel-Debry, Abou Diallo, Fabio Conti, Nassim Kamar, V. Di Martino, S. Radenne, Christophe Duvoux, A. Rohel, V. de Ledinghen, Jérôme Dumortier, Département d'hépatologie, Hospices Civils de Lyon (HCL), Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Institut de médecine moléculaire de Rangueil (I2MR), Université Toulouse III - Paul Sabatier (UT3), Université de Toulouse (UT)-Université de Toulouse (UT)- Institut Fédératif de Recherche Bio-médicale Institution (IFR150)-Institut National de la Santé et de la Recherche Médicale (INSERM), Département de Néphrologie et Transplantation d'organes [CHU Toulouse], Pôle Urologie - Néphrologie - Dialyse - Transplantations - Brûlés - Chirurgie plastique - Explorations fonctionnelles et physiologiques [CHU Toulouse], Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-IFR150-Institut National de la Santé et de la Recherche Médicale (INSERM), Department of Multiorgan Transplantation, and CHU Toulouse [Toulouse]
Subjects: medicine.medical_specialty, Hepatology, Sofosbuvir, business.industry, medicine.medical_treatment, [SDV]Life Sciences [q-bio], Hcv recurrence, Liver transplantation, Gastroenterology, 3. Good health, Internal medicine, medicine, business, ComputingMilieux_MISCELLANEOUS, medicine.drug
Abstract: International audience; no abstract
Published: 2015
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30. G15 : The association of sofosbuvir and daclatasvir for treating severe recurrence of HCV infection after liver transplantation: Results from a large french prospective multicentric ANRS CO23 CUPILT cohort

Author: Nassim Kamar, Jérôme Dumortier, Pascal Lebray, P. Perré, C. Silvain, Jean Charles Duclos-Vallée, Vincent Leroy, Audrey Coilly, Valérie Canva, V. Di Martino, Alain Renault, Pauline Houssel-Debry, G.-P. Pageaux, Danielle Botta-Fridlund, H. Danjou, C. Fougerou, Sylvie Radenne, Christophe Moreno, L. D’Alteroche, V. de Ledinghen, Camille Besch, Rodolphe Anty, Christophe Duvoux, A. Rohel, Service de Pharmacologie [Rennes], CHU Pontchaillou [Rennes], Institut de médecine moléculaire de Rangueil (I2MR), Université Toulouse III - Paul Sabatier (UT3), Université de Toulouse (UT)-Université de Toulouse (UT)- Institut Fédératif de Recherche Bio-médicale Institution (IFR150)-Institut National de la Santé et de la Recherche Médicale (INSERM), Département de Néphrologie et Transplantation d'organes [CHU Toulouse], Pôle Urologie - Néphrologie - Dialyse - Transplantations - Brûlés - Chirurgie plastique - Explorations fonctionnelles et physiologiques [CHU Toulouse], Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Département d'hépatologie, Hospices Civils de Lyon (HCL), Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-IFR150-Institut National de la Santé et de la Recherche Médicale (INSERM), Department of Multiorgan Transplantation, CHU Toulouse [Toulouse], Université de Rennes 1 (UR1), and Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM)
Subjects: medicine.medical_specialty, Daclatasvir, Hepatology, Sofosbuvir, business.industry, medicine.medical_treatment, [SDV]Life Sciences [q-bio], Liver transplantation, 3. Good health, 03 medical and health sciences, 0302 clinical medicine, 030220 oncology & carcinogenesis, Internal medicine, Immunology, Cohort, medicine, 030211 gastroenterology & hepatology, business, ComputingMilieux_MISCELLANEOUS, medicine.drug
Abstract: International audience; no abstract
Published: 2015
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31. LP05 : Daclatasvir plus sofosbuvir with or without ribavirin in patients with HCV genotype 3 infection: Interim analysis of a french multicenter compassionate use program

Author: Isabelle Rosa, V. de Ledinghen, Jean-Pierre Bronowicki, C. Silvain, Danielle Botta-Fridlund, Christophe Hézode, Yacia Bennai, Raoudha Akremi, M. Bourlière, Eric Nguyen-Khac, Pascal Lebray, I. Hubert-Fouchard, Dominique Larrey, Vincent Leroy, Hélène Fontaine, V. Di Martino, L. D’Alteroche, Dominique Guyader, Fabien Zoulim, Nathalie Boyer, Larysa Fedchuk, Fabrice Carrat, Service d'hépato-gastro-entérologie [APHP Henri Mondor], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Henri Mondor-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), Institut de Recherche en Cancérologie de Montpellier (IRCM - U1194 Inserm - UM), CRLCC Val d'Aurelle - Paul Lamarque-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM), 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), Institut de biologie et chimie des protéines [Lyon] (IBCP), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Centre National de la Recherche Scientifique (CNRS), Institut de pharmacologie moléculaire et cellulaire (IPMC), Université Nice Sophia Antipolis (1965 - 2019) (UNS), COMUE Université Côte d'Azur (2015-2019) (COMUE UCA)-COMUE Université Côte d'Azur (2015-2019) (COMUE UCA)-Centre National de la Recherche Scientifique (CNRS), Matière et Systèmes Complexes (MSC), Université Paris Diderot - Paris 7 (UPD7)-Centre National de la Recherche Scientifique (CNRS), Service d'Hépato-gastroentérologie, Assistance Publique - Hôpitaux de Marseille (APHM), Service des maladies du foie [CHU Rennes], Centre Hospitalier Universitaire [Rennes], Foie, métabolismes et cancer, Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), CHU Amiens-Picardie, Groupe de Recherche sur l'alcool et les pharmacodépendances - UMR INSERM_S 1247 (GRAP), Université de Picardie Jules Verne (UPJV)-Institut National de la Santé et de la Recherche Médicale (INSERM), ESIM - Déterminants Sociaux de la Santé et du Recours aux Soins (DS3), Université Pierre et Marie Curie - Paris 6 (UPMC)-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12)-Hôpital Henri Mondor-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Université Nice Sophia Antipolis (... - 2019) (UNS), Matière et Systèmes Complexes (MSC (UMR_7057)), Centre National de la Recherche Scientifique (CNRS)-Université Paris Diderot - Paris 7 (UPD7), Service des maladies du foie, Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Centre Hospitalier Universitaire [Rennes], Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Hôpital Henri Mondor-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), CRLCC Val d'Aurelle - Paul Lamarque-Université de Montpellier (UM)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre de Recherche en Cancérologie de Lyon (CRCL), Université Côte d'Azur (UCA)-Université Côte d'Azur (UCA)-Centre National de la Recherche Scientifique (CNRS), Centre Hospitalier Universitaire [Rennes]-Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou, Epidémiologie, Systèmes dínformation et modélisation (ESIM), and CHU Saint-Antoine [APHP]
Subjects: medicine.medical_specialty, Daclatasvir, Hepatology, Sofosbuvir, business.industry, Ribavirin, [SDV]Life Sciences [q-bio], Compassionate Use, Interim analysis, Virology, 3. Good health, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, chemistry, 030220 oncology & carcinogenesis, Internal medicine, Genotype, Medicine, 030211 gastroenterology & hepatology, In patient, business, ComputingMilieux_MISCELLANEOUS, medicine.drug
Abstract: International audience; no abstract
Published: 2015
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32. P0804 : Efficacy of sofosbuvir-based treatment regimens in HIV/HCV co-infected patients after liver transplantation: The ANRS CO23 CUPILT study

Author: Jérôme Dumortier, Audrey Coilly, G.-P. Pageaux, Aurelie Veislinger, Teresa Antonini, I. Bertucci, Sylvie Radenne, Vincent Leroy, Didier Samuel, Nassim Kamar, Pauline Houssel-Debry, Franck Durand, Jean Charles Duclos-Vallée, Valérie Canva, P. Perré, Danielle Botta-Fridlund, Océan du Large et Variabilité Climatique (OLVAC), Laboratoire d'études en Géophysique et océanographie spatiales (LEGOS), Institut de Recherche pour le Développement (IRD)-Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Institut national des sciences de l'Univers (INSU - CNRS)-Observatoire Midi-Pyrénées (OMP), Météo France-Centre National d'Études Spatiales [Toulouse] (CNES)-Université Fédérale Toulouse Midi-Pyrénées-Centre National de la Recherche Scientifique (CNRS)-Institut de Recherche pour le Développement (IRD)-Météo France-Centre National d'Études Spatiales [Toulouse] (CNES)-Centre National de la Recherche Scientifique (CNRS)-Institut de Recherche pour le Développement (IRD)-Centre National de la Recherche Scientifique (CNRS)-Institut de Recherche pour le Développement (IRD)-Université Toulouse III - Paul Sabatier (UT3), Météo France-Centre National d'Études Spatiales [Toulouse] (CNES)-Université Fédérale Toulouse Midi-Pyrénées-Centre National de la Recherche Scientifique (CNRS)-Institut de Recherche pour le Développement (IRD)-Météo France-Centre National d'Études Spatiales [Toulouse] (CNES)-Centre National de la Recherche Scientifique (CNRS)-Institut de Recherche pour le Développement (IRD)-Centre National de la Recherche Scientifique (CNRS), Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Institut de médecine moléculaire de Rangueil (I2MR), Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-IFR150-Institut National de la Santé et de la Recherche Médicale (INSERM), Department of Multiorgan Transplantation, CHU Toulouse [Toulouse], Centre Hospitalier Départemental - Hôpital de La Roche-sur-Yon, Département d'hépatologie, Hospices Civils de Lyon (HCL), Matière et Systèmes Complexes (MSC (UMR_7057)), Centre National de la Recherche Scientifique (CNRS)-Université Paris Diderot - Paris 7 (UPD7), Institut de biologie et chimie des protéines [Lyon] (IBCP), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Centre National de la Recherche Scientifique (CNRS), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Centre National d'Études Spatiales [Toulouse] (CNES)-Observatoire Midi-Pyrénées (OMP), Université Fédérale Toulouse Midi-Pyrénées-Centre National de la Recherche Scientifique (CNRS)-Institut de Recherche pour le Développement (IRD)-Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Centre National de la Recherche Scientifique (CNRS), Université Paris Diderot - Paris 7 (UPD7)-Centre National de la Recherche Scientifique (CNRS), Université de Toulouse (UT)-Université de Toulouse (UT)-Institut national des sciences de l'Univers (INSU - CNRS)-Observatoire Midi-Pyrénées (OMP), Université de Toulouse (UT)-Université de Toulouse (UT)-Institut national des sciences de l'Univers (INSU - CNRS)-Centre National d'Études Spatiales [Toulouse] (CNES)-Centre National de la Recherche Scientifique (CNRS)-Météo-France -Institut de Recherche pour le Développement (IRD)-Institut national des sciences de l'Univers (INSU - CNRS)-Centre National d'Études Spatiales [Toulouse] (CNES)-Centre National de la Recherche Scientifique (CNRS)-Météo-France -Centre National de la Recherche Scientifique (CNRS)-Institut de Recherche pour le Développement (IRD)-Université Toulouse III - Paul Sabatier (UT3), Université de Toulouse (UT)-Université de Toulouse (UT)-Institut national des sciences de l'Univers (INSU - CNRS)-Centre National d'Études Spatiales [Toulouse] (CNES)-Centre National de la Recherche Scientifique (CNRS)-Météo-France -Institut de Recherche pour le Développement (IRD)-Institut national des sciences de l'Univers (INSU - CNRS)-Centre National d'Études Spatiales [Toulouse] (CNES)-Centre National de la Recherche Scientifique (CNRS)-Météo-France -Centre National de la Recherche Scientifique (CNRS), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Université de Toulouse (UT)-Université de Toulouse (UT)- Institut Fédératif de Recherche Bio-médicale Institution (IFR150)-Institut National de la Santé et de la Recherche Médicale (INSERM), Département de Néphrologie et Transplantation d'organes [CHU Toulouse], Pôle Urologie - Néphrologie - Dialyse - Transplantations - Brûlés - Chirurgie plastique - Explorations fonctionnelles et physiologiques [CHU Toulouse], Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Centre Hospitalier Départemental - Hôpital de La Roche-sur-Yon (CHD Vendée), and Matière et Systèmes Complexes (MSC)
Subjects: 0303 health sciences, medicine.medical_specialty, Hepatology, Sofosbuvir, Treatment regimen, business.industry, medicine.medical_treatment, [SDV]Life Sciences [q-bio], Liver transplantation, Gastroenterology, 3. Good health, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, medicine, 030211 gastroenterology & hepatology, business, ComputingMilieux_MISCELLANEOUS, 030304 developmental biology, medicine.drug
Abstract: International audience; no abstract
Published: 2015
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33. Validation and comparison of indexes for fibrosis and cirrhosis prediction in chronic hepatitis C patients: proposal for a pragmatic approach classification without liver biopsies

Author: Isabelle Portal, Christophe Renou, Paul Castellani, M. A. Rosenthal-Allieri, Guillaume Penaranda, Albert Tran, L. Lecomte, Marc Bourlière, C. Degott, Denis Ouzan, Danielle Botta-Fridlund, René Gerolami, R. Deydier, and Philippe Halfon
Subjects: Adult, Liver Cirrhosis, Male, medicine.medical_specialty, Cirrhosis, Biopsy, Hepatitis C virus, medicine.disease_cause, Gastroenterology, Cohort Studies, Fibrosis, Virology, Internal medicine, medicine, Humans, alpha-Macroglobulins, Aspartate Aminotransferases, Apolipoprotein A-I, Haptoglobins, Hepatology, medicine.diagnostic_test, Platelet Count, FibroTest, business.industry, Bilirubin, gamma-Glutamyltransferase, Hepatitis C, Hepatitis C, Chronic, Middle Aged, medicine.disease, Confidence interval, Infectious Diseases, Liver, Liver biopsy, Female, business
Abstract: Noninvasive indexes have been developed to predict fibrosis staging. The aim of this study was to assess the diagnostic accuracy of these indexes in comparison with liver histology in hepatitis C virus (HCV)-infected patients. A total of 235 consecutive patients with HCV infection from the Fibropaca multicentre independent study were included in this paper. FibroTest (FT), aspartate aminotransferase to platelet ratio index (APRI) and Forns score were assessed in the cohort and compared with liver histology performed on the same day. The main end point was the area under characteristic curves (AUCs) for the diagnosis of significant fibrosis (F2-F4) and cirrhosis (F4) by the METAVIR classification. Mean age was 46 (+/-11) years, 55% were males, 42% (n = 99) had significant fibrosis (F2-F4) and 7% (n = 16) had cirrhosis (F4). For the diagnosis of significant fibrosis, respective AUCs of FT, APRI and Forns score were 0.81 (95% confidence interval: 0.76-0.86), 0.71 (0.67-0.79) and 0.76 (0.70-0.82); for cirrhosis prognosis, AUCs of FT and APRI were 0.82 (0.77-0.87) and 0.81 (0.76-0.86) (AUCs not significantly different). Using each index independently, all patients were classified by FT, 214 (91%) patients were classified by APRI and 129 (55%) by Forns score. There were significantly more cases of discordances between APRI and liver biopsy than between FT or Forns score and liver biopsy (P < 0.05). Performing all scores (FT, Forns and APRI) without liver biopsy allowed fibrosis to be well evaluated in 191 patients (81.3%), including patients with FT failure. Liver biopsy remained mandatory to evaluate fibrosis in 44 patients (18.7%). Our study shows that performing all the tests and liver biopsy improves the diagnostic accuracy for liver fibrosis in chronic hepatitis C patients without patent comorbidities. The combination of all tests with liver biopsy allowed 225/235 (96%) patients to be correctly classified. The combination of all tests without liver biopsy allowed 191/235 (81.3%) patients to be correctly classified; liver biopsy remained mandatory in some patients (18.7%).
Published: 2006
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34. Independent Prospective Multicenter Validation of Biochemical Markers (Fibrotest-Actitest) for the Prediction of Liver Fibrosis and Activity in Patients with Chronic Hepatitis C: The Fibropaca Study

Author: Philippe Halfon, Marc Bourliere, Romaric Deydier, Danielle Botta-Fridlund, Christophe Renou, Albert Tran, Isabelle Portal, Isabelle Allemand, Jean Jacques Bertrand, Alessandra Rosenthal-Allieri, Michel Rotily, Christophe Sattonet, Thierry Benderitter, Marie Christine Saint Paul, Henry Pierre Bonnot, Guillaume Penaranda, Claude Degott, Marie France Masseyeff, and Denis Ouzan
Subjects: Adult, Liver Cirrhosis, Male, medicine.medical_specialty, Adolescent, Cross-sectional study, Biopsy, Statistics as Topic, Gastroenterology, Liver Function Tests, Predictive Value of Tests, Internal medicine, medicine, Humans, alpha-Macroglobulins, In patient, Aspartate Aminotransferases, Prospective Studies, Prospective cohort study, Aged, Apolipoprotein A-I, Haptoglobins, Hepatology, medicine.diagnostic_test, business.industry, FibroTest, Alanine Transaminase, Hepatitis C, Hepatitis C, Chronic, Middle Aged, medicine.disease, Cross-Sectional Studies, Liver, Predictive value of tests, Practice Guidelines as Topic, Female, Hepatic fibrosis, business, Biomarkers
Abstract: Fibrotest (FT) and Actitest (AT) are biochemical markers of fibrosis and activity for use as a non-invasive alternative to liver biopsy in patients with chronic hepatitis C virus (HCV). The aim of this study was to perform an external validation of FT and AT and to study the discordances between FT/AT and liver biopsy in patients with chronic hepatitis C.A total of 519 consecutive patients with chronic HCV were prospectively included in five centers, with liver biopsy and biochemical markers taken at the same day. Fifteen patients were excluded because their biopsies could not be interpreted. Diagnostic accuracies were assessed by receiver operating characteristic (ROC) curve analysis.Median biopsy size was 15 mm (range: 2-58), with 9 portal tracts (1-37) and 1 fragment (1-12). 46% (230/504) were classified F2-F4 in fibrosis and 39% A2-A3 in activity. FT area under ROC curve for diagnosis of activity (A2-A3), significant fibrosis (F2-F4), and severe fibrosis (F3-F4) were 0.73 [0.69-0.77], 0.79 [0.75-0.82], and 0.80 [0.76-0.83], respectively. Among the 92 patients (18%) with 2 fibrosis stages of discordance between FT and biopsy, the discordance was attributable to FT in 5% of cases, to biopsy in 4%, and undetermined in 9%.This prospective independent and multicenter study confirms the diagnostic value of FT and AT found in the princeps study and suggests that FT and AT can be an alternative to biopsy in most patients with chronic HCV.
Published: 2006
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35. Effect of Ischemia–Reperfusion on Na+,K+-ATPase Expression in Human Liver Tissue Allograft: Image Analysis by Confocal Laser Scanning Microscopy

Author: Yves Patrice Le Treut, Benkoel L, Anne-Marie Benoliel, Dominique Lombardo, Dodero F, Chamlian A, Jean Hardwigsen, Eric Mas, and Danielle Botta-Fridlund
Subjects: Adult, Male, Physiology, ATPase, Microfilament, Sensitivity and Specificity, law.invention, Cohort Studies, Tissue Culture Techniques, Cell membrane, Ischemia, Reference Values, Confocal microscopy, law, Cadaver, medicine, Humans, Transplantation, Homologous, Na+/K+-ATPase, Probability, Analysis of Variance, Microscopy, Confocal, Tight junction, biology, Biopsy, Needle, Gastroenterology, Middle Aged, Immunohistochemistry, Tissue Donors, Liver Transplantation, Transplantation, medicine.anatomical_structure, Membrane, Liver, Biochemistry, Reperfusion Injury, Hepatocytes, biology.protein, Biophysics, Female, Sodium-Potassium-Exchanging ATPase, Biomarkers
Abstract: We have analyzed the effect of ischemia-reperfusion on expression of hepatic Na+,K+-ATPase on bile canalicular (BCM) and basolateral membranes (BLM) in human liver allografts using confocal laser scanning microscopy imaging. Na+, K+-ATPase, an integral membrane enzyme, plays a key role in the physiology and structure of hepatocytes, where it maintains the electrochemical gradients for Na+ and K+ across the cell membrane. The concentrations of these ions as well as their gradients regulate the active transport across the plasma membrane for bile acid and water from sinusoidal to canalicular membranes. In addition, Na+,K+-ATPase is also involved in cellular structure because of its close relationship with submembrane microfilaments and its implication in tight junction assembly. Therefore, Na+,K+-ATPase appears as an indicator of tissue viability and hepatic functionality during liver transplantation. Its localization and its function in BCM are still controversial. As in previous studies, we found an enzyme expression in both BLM and BCM. We show that ischemia induced a decrease in Na+,K+-ATPase expression only in BCM. This result could be explained by the differences in biochemical membrane environment between basolateral and bile canalicular Na+,K+-ATPase. Membrane lipid fluidity, which is more elevated in BLM than in BCM, could protect the enzyme during ischemia. After reperfusion, Na+,K+-ATPase expression was strongly decreased in both BCM and BLM. This alteration following reperfusion is probably due to multiple factors: direct alteration of the enzyme catalytic subunit and modification of its environment and membrane lipid fluidity by free radicals and changes in ATP levels and ionic distribution. This important decrease in Na+,K+-ATPase expression of both BLM and BCM could disturb not only hepatic secretory function but also cellular volume and structure during the postoperative period.
Published: 2004
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36. Successful treatment with sofosbuvir of fibrosing cholestatic hepatitis C after liver transplantation in an HIV-HCV-coinfected patient

Author: Jean Hardwigsen, Emilie Gregoire, Catherine Dhiver, Danielle Botta-Fridlund, Philippe Colson, Patrick Borentain, Stéphane Garcia, and René Gerolami
Subjects: Drug, Adult, Male, medicine.medical_specialty, Sofosbuvir, Genotype, media_common.quotation_subject, medicine.medical_treatment, HIV Infections, Hepacivirus, Liver transplantation, Gastroenterology, Antiviral Agents, chemistry.chemical_compound, Internal medicine, medicine, Humans, Pharmacology (medical), media_common, Pharmacology, business.industry, Coinfection, Ribavirin, virus diseases, Hepatitis C, digestive system diseases, Liver Transplantation, Calcineurin, Transplantation, Regimen, Infectious Diseases, Treatment Outcome, chemistry, business, Viral load, medicine.drug
Abstract: Fibrosing cholestatic hepatitis is a severe form of post-liver transplantation HCV recurrence. Fibrosing cholestatic hepatitis is characterized by its early onset and severe prognosis in HIV-infected patients. We report the case of an HIV–HCV genotype-4 coinfected patient successfully treated with a combination of sofosbuvir and ribavirin. After 4 weeks of treatment we observed a resolution of HCV recurrence related symptoms associated with a normalization of liver biochemistry and dramatic decrease of HCV viral load. This case illustrates the efficiency and tolerance of a sofosbuvir-based anti-HCV interferon-free regimen in post-liver HCV recurrence. Because of the absence of drug interactions between sofosbuvir and antiretroviral treatment or calcineurin inhibitors, its administration in HIV–HCV-coinfected liver transplanted patients is very promising.
Published: 2014

37. Hepatitis C virus NS3 protease genotyping and drug concentration determination during triple therapy with telaprevir or boceprevir for chronic infection with genotype 1 viruses, southeastern France

Author: Sarah, Aherfi, Caroline, Solas, Anne, Motte, Jacques, Moreau, Patrick, Borentain, Saadia, Mokhtari, Danielle, Botta-Fridlund, Catherine, Dhiver, Isabelle, Portal, Jean-Marie, Ruiz, Isabelle, Ravaux, Sylvie, Bregigeon, Isabelle, Poizot-Martin, Andreas, Stein, René, Gérolami, Philippe, Brouqui, Catherine, Tamalet, and Philippe, Colson
Subjects: Adult, Male, Genotype, Proline, Mutation, Missense, Interferon-alpha, Hepacivirus, Hepatitis C, Chronic, Middle Aged, Viral Load, Viral Nonstructural Proteins, Antiviral Agents, Hospitals, University, Plasma, Young Adult, Amino Acid Substitution, Drug Resistance, Viral, Ribavirin, Humans, Drug Therapy, Combination, Female, France, Treatment Failure, Oligopeptides
Abstract: Telaprevir and boceprevir, the two first hepatitis C virus (HCV) NS3 protease inhibitors (PIs), considerably increase rates of sustained virologic response in association with pegylated interferon and ribavirin in chronic HCV genotype 1 infections. The 30 first patients treated by telaprevir or boceprevir including anti-HCV therapies since 2011 in Marseille University hospitals, France, were monitored. HCV loads and plasmatic concentrations of telaprevir and boceprevir were determined on sequential blood samples. HCV NS3 protease gene population sequencing was performed at baseline of treatment and in case of treatment failure. Fifteen patients (including 7 co-infected with HIV) received telaprevir and the other 15 patients (including 4 co-infected with HIV) received boceprevir. At baseline, HCV NS3 protease from six patients harbored amino acid substitutions associated with PI-resistance. Treatment failure occurred at week 12 for 7 patients. Amino acid substitutions associated with PI-resistance were observed in six of these cases. HCV NS3 R155K and T54A/S mutants, all of genotype 1a, were found from four patients. Median (interquartile range) plasma concentrations were 3,092 ng/ml (2,320-3,525) for telaprevir and 486 ng/ml (265-619) for boceprevir. For HIV-HCV co-infected patients, median concentrations were 3,162 ng/ml (2,270-4,232) for telaprevir and 374 ng/ml (229-519) for boceprevir. Plasma drug concentration monitoring revealed undetectable concentrations for two patients at week 4, and probable non-adherence to therapy for another patient. These findings indicate that routine HCV NS3 protease sequencing and plasma PI concentration monitoring might be helpful to characterize cases of therapy failure, at a cost dramatically low compared to that of anti-HCV therapy.
Published: 2014

38. Transjugular intrahepatic porto-systemic shunt is a risk factor for liver dysplasia but not hepatocellular carcinoma: a retrospective study of explanted livers

Author: Patrick Borentain, Pascal Ananian, Yves Patrice Le Treut, Stéphane Garcia, Emilie Gregoire, Vincent Vidal, Jean-Michel Bartoli, Jean Hardwigsen, Guy Moulin, René Gerolami, Danielle Botta-Fridlund, and Emmanuelle Ressiot
Subjects: Adult, Liver Cirrhosis, Male, medicine.medical_specialty, Carcinoma, Hepatocellular, medicine.medical_treatment, Liver transplantation, Gastroenterology, Lesion, Risk Factors, Internal medicine, Hypertension, Portal, medicine, Hepatectomy, Humans, Pathological, Retrospective Studies, Hepatology, business.industry, Liver Neoplasms, Age Factors, Retrospective cohort study, Middle Aged, medicine.disease, Shunt (medical), Liver Transplantation, Transplantation, Liver, Dysplasia, Hepatocellular carcinoma, Hepatocytes, Female, medicine.symptom, Portasystemic Shunt, Transjugular Intrahepatic, business
Abstract: Conflicting data exist regarding the risk for hepatocellular carcinoma after transjugular intrahepatic porto-systemic shunt (TIPS) insertion in cirrhotic patients.We retrospectively analysed histopathological data from 214 patients who were transplanted in our Institution including 68 patients who underwent TIPS placement before transplantation. Pathological lesions from explanted livers, including incidental hepatocellular carcinoma, small cell dysplasia and large cell dysplasia were recorded.Pathological lesions were found in 36.4% of explanted livers. TIPS insertion was an independent risk factor for pathological lesion (HR = 2.11, p0.05), concurrently with age (HR = 1.10 per year, p0.001) and viral aetiology of cirrhosis (HR = 3.05, p0.001). When considering the different type of lesions, TIPS insertion was not associated with an increased risk for hepatocellular carcinoma but was an independent risk factor for liver dysplasia (HR = 2.15, p = 0.042).Although a direct relationship between TIPS insertion and hepatocellular carcinoma risk was not demonstrated in this study, the increased frequency of liver dysplasia observed in TIPS-bearing explanted livers deserves further prospective investigations with adequate follow-up.
Published: 2014

39. Boceprevir (BOC) and Telaprevir (TPV) therapeutic drug monitoring in HCV and HIV-HCV infected patients treated with triple therapy Ribavirine/Peg-interferon/Boceprevir or Telaprevir: impact of the antiretroviral (ARV) treatment

Author: Olivia Faucher-Zaegel, Assi Assi, Catherine Dhiver, Philippe Halfon, Danielle Botta-Fridlund, Anne-Sophie Chantry, Jean-Marie Ruiz, M Tching-Sin, Caroline Solas, Thierry Allegre, Service de Pharmacocinétique et de Toxicologie, Assistance Publique - Hôpitaux de Marseille (APHM)- Hôpital de la Timone [CHU - APHM] (TIMONE), Service des Maladies Infectieuses, Assistance Publique - Hôpitaux de Marseille (APHM)-Hôpital de la Conception [CHU - APHM] (LA CONCEPTION), Service Hématologie et Médecine Interne, Centre Hospitalier du Pays d'Aix, Unité de Consultation et Soins Ambulatoires, Assistance Publique - Hôpitaux de Marseille (APHM)-Groupe Hospitalier Sud-Centre pénitentiaire de Marseille (prison des Baumettes), Infectiologie - Maladies infectueuses et conseils aux voyageurs, Centre Hospitalier Intercommunal Toulon-La Seyne sur Mer - Hôpital Sainte-Musse-Centre Hospitalier Intercommunal de Toulon - La Seyne-sur-Mer, Chirurgie Digestive, Médecine générale, Assistance Publique - Hôpitaux de Marseille (APHM)-Hôpital Européen [Fondation Ambroise Paré - Marseille], Laboratore Alphabio, Service Immuno-Hématologie, Assistance Publique - Hôpitaux de Marseille (APHM)-Hôpital Sainte-Marguerite [CHU - APHM] (Hôpitaux Sud ), Centre de Recherches en Oncologie biologique et Oncopharmacologie (CRO2), Aix Marseille Université (AMU)- Hôpital de la Timone [CHU - APHM] (TIMONE)-Institut National de la Santé et de la Recherche Médicale (INSERM), and BMC, Ed.
Subjects: Efavirenz, Pharmacology, Telaprevir, chemistry.chemical_compound, immune system diseases, [SDV.MHEP.MI]Life Sciences [q-bio]/Human health and pathology/Infectious diseases, Boceprevir, Medicine, Darunavir, ComputingMilieux_MISCELLANEOUS, Hepatitis, medicine.diagnostic_test, business.industry, virus diseases, Lopinavir, Drug interaction, medicine.disease, Virology, 3. Good health, Infectious Diseases, chemistry, Therapeutic drug monitoring, Poster Presentation, [SDV.MHEP.MI] Life Sciences [q-bio]/Human health and pathology/Infectious diseases, business, medicine.drug
Abstract: BOC and TPV are potent NS3/4A protease inhibitors for the treatment of chronic hepatitis C (HCV) genotype 1 infection. BOC and TPV are both substrates and strong inhibitors of the CYP3A, therefore presenting a wide interindividual pharmacokinetic variability and multiple drug interactions especially with ARV such as lopinavir/r, darunavir/r or efavirenz, thus restricting options for concomitant ARV therapy. We evaluated plasma concentrations of coinfected and monoinfected patients treated with BOC and TPV and the PK data of patients treated with non recommended ARV.
Published: 2014

40. [Untitled]

Author: Dominique Lombardo, Jean Hardwigsen, Yves Patrice Le Treut, Benkoel L, Dodero F, Chamlian A, Danielle Botta-Fridlund, and P. Campan
Subjects: chemistry.chemical_classification, Reactive oxygen species, Pathology, medicine.medical_specialty, Contraction (grammar), Physiology, Gastroenterology, Ischemia, Biology, medicine.disease, Microfilament, digestive system, Staining, law.invention, chemistry, Confocal microscopy, law, medicine, Perfusion, Actin
Abstract: We studied and quantified the effect of ischemia-reperfusion on hepatic F-actin on bile canalicular and basolateral membranes in human liver allografts by means of confocal laser scanning microscopy imaging. The phalloidin-FITC staining of F-actin was normal in liver hepatocytes before reperfusion but decreased significantly after reperfusion (by 25% of controls). These results indicate that hepatic F-actin alteration is produced during the reperfusion phase. This modification, probably induced by reactive oxygen species, could impair bile canalicular contraction and tight junction permeability and consequently bile secretion in the postoperative period.
Published: 2001
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41. Absence of hepatitis C genome in semen of infected men by polymerase chain reaction, branched DNA and in situ hybridization

Author: Emmanuel Debono, Philippe Halfon, Paul Castellani, G. Cartouzou, Danielle Botta-Fridlund, Pierre Cau, Marguerite Gastaldi, Victoria Gerolami‐Santandrea, A. P. Gauthier, and Marc Bourlière
Subjects: Sexual transmission, Hepatology, urogenital system, Hepatitis C virus, virus diseases, RNA, Semen, In situ hybridization, Biology, medicine.disease_cause, Virology, Molecular biology, law.invention, Nucleic acid thermodynamics, law, medicine, Viral load, Polymerase chain reaction
Abstract: Background/aims The presence or absence of hepatitis C virus (HCV) RNA in the semen of infected man remains controversial, mainly due to technical difficulties associated with nucleic acid detection. The aims of this study were to assess the presence of HCV RNA in spermatozoa and in seminal fluid using different polymerase chain reaction (PCR)- and non-PCR-dependent methods and, in the case of HCV presence, to correlate this detection with the viraemia. Methods Serum and semen from 25 chronically infected hepatitis C patients were studied. The semen was separated into spermatozoa and seminal fluid and HCV RNA was analysed in the two fractions using RT-PCR and branched DNA. The presence of HCV RNA in pelleted cells was also assessed using in situ hybridization. Results All three approaches failed to demonstrate HCV RNA in semen. The presence of an inhibitor of the PCR was demonstrated in seminal fluid but not in spermatoza. Conclusion Our results confirmed the lack of detection of HCV RNA in semen by PCR- and non-PCR-dependent techniques and support the view that viral contamination in semen remains, if present, at a very low level. Nevertheless, epidemiological studies are required to definitively assess the absence of sexual transmission of HCV
Published: 2000
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42. European collaborative study on factors influencing outcome after liver transplantation for hepatitis C

Author: Henri Bismuth, Michele Gigou, Anne Minello Franza, Cyrille Feray, Carmelo Loinaz, Danielle Botta Fridlund, Lucio Caccamo, Solko W. Schalm, Béatrice Ducot, Thierry Bizollon, Jean Gugenheim, Lisbeth Barkholt, Graeme J.M. Alexander, Patrizia Burra, Pierre Bernard, Teresa Casanovas, Jan Lerut, Didier Samuel, Raffael Esteban, and Karl Nachbaur
Subjects: Hepatitis B virus, Hepatitis, medicine.medical_specialty, HBsAg, Hepatology, business.industry, medicine.medical_treatment, Gastroenterology, Hepatitis C, Liver transplantation, medicine.disease, medicine.disease_cause, Transplantation, Liver disease, Internal medicine, Immunology, medicine, Coinfection, business
Abstract: Background & Aims: Liver transplantation for hepatitis C virus (HCV)-related liver disease is characterized by frequent graft infection by HCV. The prognosis and risk factors for morbidity and mortality in this condition were determined. Methods: A retrospective study of 652 consecutive anti-HCV-positive patients undergoing liver transplantation between 1984 and 1995 in 15 European centers was conducted; 102 patients coinfected with hepatitis B virus (HBV) received immunoglobulin prophylaxis for antibody to hepatitis B surface antigen. Results: Overall, 5-year survival was 72%. Five-year actuarial rates of hepatitis and cirrhosis were 80% and 10%. Genotypes 1b, 1a, and 2 were detected in 214 (80%), 24 (9%), and 24 (9%) of 268 patients analyzed. The only discriminant factor for patient or graft survival was hepatocellular carcinoma as primary indication. Independent risk factors for recurrent hepatitis included the absence of HBV coinfection before transplantation (relative risk [RR], 1.7; 95% confidence interval [CI], 1.2-2.6; P = 0.005), genotype Ib (RR, 2; 95% CI, 1.3-2.9; P = 0.01), and age > 49 years (RR, 1.4; 95% CI, 1.1-1.8; P = 0.01). Conclusions: The results of transplantation for HCV-related disease are compromised by a significant risk of cirrhosis, although 5-year survival is satisfactory. Genotype 1b, age, and absence of pretransplantation coinfection by HBV are risk factors for recurrent HCV.
Published: 1999
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43. P0137 : Safety of boceprevir-based triple therapy in HCV cirrhotic patients awaiting liver transplantation. Analysis from a French multicenter, open-label study (ANRS HC29 bocepretransplant)

Author: Christophe Duvoux, Hélène Fontaine, G.-P. Pageaux, François Durand, C. Willems, Danielle Botta-Fridlund, Jean Charles Duclos-Vallée, Didier Samuel, Sophie Metivier, F. Beaulieux, Valérie Canva, Vincent Leroy, Fabio Conti, Pascal Lebray, C. Bouix, C. Paul, Rodolphe Anty, Louis d’Alteroche, Ventzislava Petrov-Sanchez, Pierre Pradat, Laurent Alric, and Marianne Maynard-Muet
Subjects: medicine.medical_specialty, chemistry.chemical_compound, Hepatology, Open label study, chemistry, business.industry, Internal medicine, medicine.medical_treatment, Boceprevir, medicine, Liver transplantation, business, Gastroenterology
Published: 2015
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44. Impact of transjugular intrahepatic portosystemic shunting on liver transplantation: 12-year single-center experience

Author: Patrick Borentain, Yves-Patrice Le Treut, Nicolas Biance, G. Louis, Jean Hardwigsen, Danielle Botta-Fridlund, Amine Daghfous, and Louise Barbier
Subjects: Adult, Liver Cirrhosis, Male, medicine.medical_specialty, Hepatorenal Syndrome, medicine.medical_treatment, Collateral Circulation, Anastomosis, Liver transplantation, Single Center, Young Adult, Occlusion, Ascites, medicine, Humans, Retrospective Studies, Hepatology, business.industry, Portacaval Shunt, Surgical, Gastroenterology, Postoperative complication, Length of Stay, Middle Aged, Collateral circulation, Shunt (medical), Surgery, Liver Transplantation, Case-Control Studies, Female, medicine.symptom, Portasystemic Shunt, Transjugular Intrahepatic, business, Gastrointestinal Hemorrhage, Liver Circulation
Abstract: Summary Background The purpose of this study was to assess the impact of transjugular intrahepatic portosystemic shunting (TIPS) on liver transplantation (LT). Methods Seventy-two patients transplanted after TIPS insertion between 1996 and 2008 were compared with 136 matched patients transplanted without prior TIPS. Results At time of LT, 10% of the TIPS were occluded and 32% were misplaced. Shunt removal was difficult in 17% of the TIPS patients and required vena cava clamping in 10%. Collateral venous circulation was less extensive and intra-operative portocaval anastomosis was required more frequently in the TIPS group. No significant difference in transfusion requirements and operative times were observed between the two groups. Postoperatively, liver and renal function tests, in-hospital stay, graft rejection, re-transplantation and 1-year mortality rates were not statistically different. Ascites volume in the first week was greater in the TIPS group (7.6 L vs 6.9 L, P = 0.036). In the TIPS group, ascites and collateral circulation were greater if the shunt was occluded at the time of LT. Shunt misplacement or occlusion was not associated with higher intra-operative or postoperative complication rates. Conclusion TIPS did not impair LT and can provide a safe bridge for LT in the end-stage cirrhotic patients.
Published: 2013

45. Renal Dysfunction in Liver Transplant Patients Treated with Sofosbuvir Based-Regimen for HCV Recurrence: Results from a Large French Prospective Multicentric ANRS CO23 Cupilt

Author: A. Rohel, Sébastien Dharancy, Pascal Lebray, S. Radenne, C. Silvain, Christophe Duvoux, V. Di Martino, G.-P. Pageaux, V. de Ledinghen, Camille Besch, Nassim Kamar, Emilie Rossignol, François Habersetzer, Jean Charles Duclos-Vallée, Christophe Moreno, Rodolphe Anty, Alain Renault, H. Danjou, F. Durand, Valérie Canva, Guillaume Favre, Pauline Houssel-Debry, L. D’Alteroche, H. Montialoux, Jérôme Dumortier, Audrey Coilly, Vincent Leroy, C. Fougerou, A. Tran, and Danielle Botta-Fridlund
Subjects: medicine.medical_specialty, Hepatology, Sofosbuvir, business.industry, Hcv recurrence, Gastroenterology, 03 medical and health sciences, Regimen, 0302 clinical medicine, 030220 oncology & carcinogenesis, Internal medicine, Medicine, 030211 gastroenterology & hepatology, Transplant patient, business, medicine.drug
Published: 2016
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46. Sofosbuvir-Based-Regimen for HCV Recurrence after Combined Liver-Kidney Transplantation : Results from the ANRS CO23 Cupilt Study

Author: V. Di Martino, P. Perré, A. Tran, François Habersetzer, Danielle Botta-Fridlund, C. Silvain, L. D’Alteroche, G.-P. Pageaux, Claire Fougerou-Leurent, H. Montialoux, Vincent Leroy, Jérôme Dumortier, Audrey Coilly, Christophe Duvoux, V. de Ledinghen, Pauline Houssel-Debry, Camille Besch, Maryline Debette-Gratien, S. Radenne, Nassim Kamar, Jean-Charles Duclos Vallee, Valérie Canva, Armando Abergel, Christophe Moreno, Sébastien Dharancy, Fabio Conti, Claire Francoz, and A. Rohel
Subjects: medicine.medical_specialty, Liver kidney transplantation, Hepatology, Sofosbuvir, business.industry, Hcv recurrence, Gastroenterology, 03 medical and health sciences, Regimen, 0302 clinical medicine, 030220 oncology & carcinogenesis, Internal medicine, medicine, 030211 gastroenterology & hepatology, business, medicine.drug
Published: 2016
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47. Treatment of recurrent HCV infection following liver transplantation: results of a multicenter, randomized, versus placebo, trial of ribavirin alone as maintenance therapy after one year of PegIFNα-2a plus ribavirin

Author: Philippe Wolf, Didier Samuel, Karim Boudjema, Christophe Duvoux, Lionel Rostaing, Olivier Boillot, Claire Vanlemmens, Yvon Calmus, Martine Neau-Cransac, Jean Gugenheim, Danielle Botta-Fridlund, Georges Philippe Pageaux, François Durand, Olivier Chazouillères, Sébastien Dharancy, L. Samelson, Service de Chirurgie Digestive, Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Pôle Recherche Clinique-Santé Publique [Mondor], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Henri Mondor, Service de Chirurgie Générale et Transplantation Multi Organes, CHU Strasbourg, Service de Néphrologie - Hypertension Artérielle Dialyse - Transplantation, Service d'hépatologie, Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon)-Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC), Hôpital Claude Hurriez, CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Foie, métabolismes et cancer, Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), French National Direction for Clinical Research (Direction de la Recherche Clinique), Roche Pharma France., CHU Toulouse [Toulouse]-Hôpital de Rangueil, CHU Toulouse [Toulouse], Service d'hépatologie [Saint-Antoine], Université Pierre et Marie Curie - Paris 6 (UPMC)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Sorbonne Université (SU), Université de Rennes 1 (UR1), and Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique )
Subjects: Liver Cirrhosis, Male, medicine.medical_treatment, MESH: Logistic Models, Hepacivirus, Liver transplantation, Kidney, Gastroenterology, MESH: Cyclosporine, Polyethylene Glycols, Placebos, MESH: Recombinant Proteins, MESH: Genotype, chemistry.chemical_compound, 0302 clinical medicine, Maintenance therapy, Recurrence, MESH: Double-Blind Method, MESH: Hepacivirus, MESH: Treatment Outcome, 0303 health sciences, MESH: Middle Aged, Hepatitis C virus, virus diseases, Hepatitis C, Induction Chemotherapy, Middle Aged, Viral Load, MESH: Induction Chemotherapy, Recombinant Proteins, 3. Good health, MESH: Maintenance Chemotherapy, Treatment Outcome, Cyclosporine, 030211 gastroenterology & hepatology, Drug Therapy, Combination, Female, MESH: Immunosuppressive Agents, MESH: Interferon-alpha, MESH: Liver Cirrhosis, MESH: Viral Load, Viral load, Immunosuppressive Agents, MESH: Antiviral Agents, medicine.medical_specialty, MESH: Liver Transplantation, Combination therapy, Genotype, MESH: Placebos, Placebo, Antiviral Agents, Tacrolimus, Maintenance Chemotherapy, 03 medical and health sciences, Double-Blind Method, MESH: Ribavirin, Internal medicine, Viral response, Ribavirin, medicine, MESH: Tacrolimus, Humans, Peginterferon, Erythropoietin, 030304 developmental biology, MESH: Hepatitis C, Intention-to-treat analysis, MESH: Humans, Hepatology, business.industry, Interferon-alpha, [SDV.MHEP.HEG]Life Sciences [q-bio]/Human health and pathology/Hépatology and Gastroenterology, MESH: Kidney, medicine.disease, Fibrosis, digestive system diseases, MESH: Male, Liver Transplantation, MESH: Recurrence, MESH: Drug Therapy, Combination, Logistic Models, chemistry, MESH: Polyethylene Glycols, Immunology, business, MESH: Female
Abstract: International audience; BACKGROUND & AIMS: We aimed at determining the effect of maintenance therapy with ribavirin alone, after a year of combined peginterferon-alfa 2a (PegIFNα-2a) and ribavirin therapy, on viral response and liver histology after liver transplantation (LT). METHODS: Hundred and one patients with recurrent HCV and a minimum of stage 1 fibrosis (METAVIR scoring), 1-5years after LT, were enrolled. PegIFNα-2a and ribavirin were initiated at 90 μg/wk and 600 mg/d, respectively, then increased or adjusted as a function of tolerance. At 12 months, combination therapy was discontinued and patients were randomized to ribavirin or placebo for a further 12 months. Growth factor use was permitted. RESULTS: At 18 months, a sustained virological response (SVR) was obtained in 47.9% of patients in Per Protocol (PP) analysis, and was higher in patients with genotype 2 or 3 than in patients with genotype 1 or 4, in patients with genotypes 1+4 receiving ciclosporine than in those receiving tacrolimus, in patients with worse renal function, in those having received EPO, in patients with lower weight, and in those with lower viral load at 3 months. Using logistic regression, only the early viral response, recipient weight and renal function were independently associated with better SVR. SVR, viral load, activity, and fibrosis scores were similar, at M18 and M30, in patients randomized to ribavirin, or to placebo. CONCLUSIONS: A PP SVR was achieved in 47.9% of patients with established recurrent hepatitis C after LT. Maintenance therapy with ribavirin alone does not improve the virological response or the histological parameters.
Published: 2012
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48. Optimized stepwise combination algorithms of non-invasive liver fibrosis scores including Hepascore in hepatitis C virus patients

Author: Marc Bourlière, Danielle Botta-Fridlund, C. Wartelle-Bladou, Denis Ouzan, M. A. Rosenthal-Allieri, Patrick Delasalle, Philippe Halfon, Paul Castellani, E. Rosenthal, Christophe Renou, Isabelle Portal, Guillaume Penaranda, Albert Tran, L. Lecomte, and Valérie Oules
Subjects: Liver Cirrhosis, Male, Hepatitis C virus, Biopsy, medicine.disease_cause, Cohort Studies, Predictive Value of Tests, Medicine, Humans, Pharmacology (medical), Hepatology, Receiver operating characteristic, medicine.diagnostic_test, business.industry, FibroTest, Gastroenterology, Hepatitis C, Hepatitis C, Chronic, Middle Aged, Viral Load, medicine.disease, Cross-Sectional Studies, Treatment Outcome, Liver, ROC Curve, Predictive value of tests, Liver biopsy, Disease Progression, Female, business, Algorithm, Viral load, Algorithms, Biomarkers
Abstract: Summary Background Non-invasive liver fibrosis scores such as Hepascore (HS) have been proposed as an alternative to liver biopsy in hepatitis C virus (HCV)-infected patients. Aim To validate HS as an alternative to liver biopsy and Fibrotest (FT) and propose five optimized combination algorithms to improve diagnostic accuracy. Methods The cohort included 467 patients with HCV. There were 274/467 (59%) men, and mean age was 47 ± 12 years. Results Hepascore area under ROC curves (AUC) for ≥F2, F3F4 and F4 diagnosis were 0.82, 0.84 and 0.90 respectively, in the same range as FT. HS and FT were concordant in 387/467 (82%) for fibrosis staging. Among these patients, 342/387 (88%) were concordant with liver biopsy. AUCs of aspartate aminotransferase (AST) to Platelets Ratio Index (APRI) and Forns for ≥F2 were 0.76 and 0.73 (0.65–0.79) respectively. The algorithm combining APRI and HS had the highest rate of avoided liver biopsies (45%) with a high diagnostic accuracy (91%). Conclusions Hepascore is an accurate non-invasive marker for ≥F2 and F4 diagnosis in HCV patients. In a pragmatic approach, a stepwise optimized algorithm combining APRI and FT or HS considerably increases diagnostic accuracy and avoided liver biopsies.
Published: 2008

49. [Pancreatic tuberculosis: an unusual cause of obstructive jaundice accessible to endoscopic management]

Author: Patrick, Borentain, Philippe, Grandval, Pascal, Ananian, Séverine, Meunier-Carpentier, René, Gérolami, Jean-Marc, Escoffier, Jean-Marc, Durand, Danielle, Botta-Fridlund, and David, Bernardini
Subjects: Adult, Cholangiopancreatography, Endoscopic Retrograde, Common Bile Duct, Male, Jaundice, Obstructive, Biopsy, Fine-Needle, Humans, Pancreatic Diseases, Tuberculosis, Stents, Ultrasonography, Interventional
Abstract: Tuberculosis of the pancreas is unusual and often secondary to generalized tuberculosis. In most cases clinical presentation is obstructive jaundice due to pancreatic mass lesion. Although diagnosis is usually obtained after resection of the mass lesion, endoscopic procedures might avoid non-necessary surgical procedure. We report a clinical case of pancreatic tuberculosis diagnosed by endoscopic ultrasound guided fine needle aspiration biopsy and treated by biliary stenting.
Published: 2008

50. [Budd-Chiari syndrome with medullar compression]

Author: Patrick, Borentain, Bénédicte, Mugnier, Carlos, Barrantes, Jean, Hardwigsen, Nicolas, Schleinitz, René, Gérolami, Yves Patrice, Letreut, and Danielle, Botta-Fridlund
Subjects: Varicose Veins, Adolescent, Liver, Humans, Protein C Deficiency, Female, Thrombosis, Vena Cava, Inferior, Syndrome, Budd-Chiari Syndrome, Nervous System Diseases
Abstract: We report a case of Budd-Chiari syndrome caused by protein C deficiency. The association of thrombosis of the the inferior vein cava of the hepatic vein resulted in the development of epidural varices and a central and peripheral neurological syndrome. These symptoms, which are atypical in this disease, resolved after surgical treatment of the Budd-Chiari syndrome (cavoatrial and mesocaval stenting).
Published: 2006

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