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1. Disparités régionales des hospitalisations pour complication de l’hépatite chronique C en 2012

Author

Armand Abergel, Michel Rotily, Lucie de Léotoing, Anne-Françoise Gaudin, Alexandre Vainchtock, S. Branchoux, and Raoudha Akremi

Subjects
Public Health, Environmental and Occupational Health
Abstract

Objectif : Peu de donnees recentes sur l’incidence et la prevalence de l’hepatite C chronique (HCC) sont disponibles au niveau regional. De telles donnees sont indispensables afin de piloter efficacement une politique de sante publique sur la prise en charge de l’hepatite C. L’objectif de cette etude etait d’etablir la faisabilite de cartographier, a partir d’une base de donnees medico-administrative, d’eventuelles disparites regionales dans la prevalence de l’HCC et de ses complications. Methodes : La base PMSI MCO 2012 contient des informations sur la quasi-totalite des hospitalisations en France en termes de diagnostic et de consommation de soins. Les hospitalisations liees a une HCC ont ete identifiees grâce aux codes diagnostiques de la classification CIM-10. Les sejours retenus ont ete classes par stade de severite : hepatite non-cirrhotique, cirrhose compensee, cirrhose decompensee et carcinome hepatocellulaire (CHC). L’ensemble de ces informations a ete documente pour chaque region administrative en 2012. Resultats : Le nombre de patients hospitalises pour une HCC en France en 2012 a ete estime a 12 040 patients, correspondant a un taux national standardise de 19,3/100 000 personnes. La prevalence des patients hospitalises etait la plus elevee en Ile-de-France, Alsace et Provence-Alpes-Cote d’Azur, tout comme le taux standardise des patients ayant un CHC. Conclusions : Cette etude demontre la faisabilite d’utiliser la base PMSI pour identifier des disparites regionales dans la prevalence de l’hepatite C selon les stades de la maladie. Ces informations seront utiles pour adapter l’offre des soins au niveau local.

Published
2017
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2. Chronic hepatitis C: Burden of disease and cost associated with hospitalisations in France in 2012 (The HEPC-LONE study)

Author

Anne-Françoise Gaudin, Armand Abergel, Alexandre Vainchtock, S. Branchoux, Michel Rotily, Raoudha Akremi, and Lucie de Léotoing

Subjects
Adult, Liver Cirrhosis, Male, Burden of disease, Pediatrics, medicine.medical_specialty, Carcinoma, Hepatocellular, Cirrhosis, medicine.medical_treatment, Liver transplantation, Severity of Illness Index, 03 medical and health sciences, Liver disease, 0302 clinical medicine, Chronic hepatitis, medicine, Humans, Hospital Mortality, 030212 general & internal medicine, Stage (cooking), Aged, Retrospective Studies, Hepatology, business.industry, Liver Neoplasms, Gastroenterology, Hepatitis C, Chronic, Middle Aged, medicine.disease, Liver Transplantation, Hospitalization, Transplantation, Hepatocellular carcinoma, Female, 030211 gastroenterology & hepatology, France, business
Abstract

Summary Background and objective This retrospective hospital database analysis aimed to determine the burden and cost of hospitalisations related to chronic hepatitis C (CHC) infections in France in 2012. Methods All hospital stays with CHC (ICD-10 code B18.2) coded as the principal, related or significantly associated diagnosis were extracted from the French National Hospital database 2012 (PMSI). Hospitalisations not directly related to CHC were excluded. Patients were assigned to a liver disease stage, namely non-cirrhotic liver disease, compensated cirrhosis, decompensated cirrhosis, hepatocellular carcinoma or post-liver transplantation. Costing was performed using French national tariffs and expressed in 2013 Euros. We documented 22,056 hospital stays involving 12,040 patients who were considered to be directly related to CHC. Of these stays, 11,779 (53.4%) were documented in patients with severe complications (decompensated cirrhosis, hepatocellular carcinoma or liver transplantation). Results and conclusions The mean number and duration of hospital stays increased with disease severity. Overall, 1181 patients (9.8%) died during hospitalisation. The total cost of hospital stays for CHC was estimated to be € 61 million, of which 26.4% were attributable to hepatocellular carcinoma, 32.5% to post-liver transplantation and 21.0% to decompensated cirrhosis. Compared with a previous analysis in 2009, the number of patients hospitalised fell by 22%, although the patients hospitalised were overall more severely ill. The total cost of hospitalisation decreased by 8%, with a notably marked reduction in the number of biopsies performed (32%). This study illustrates the persistently high burden of CHC infections in France.

Published
2016
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3. 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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4. [Regional differences in hospitalisations for complications of chronic hepatitis C in 2012]

Author

Michel, Rotily, Armand, Abergel, Sébastien, Branchoux, Raoudha, Akremi, Lucie, de Léotoing, Alexandre, Vainchtock, and Anne-Françoise, Gaudin

Subjects
Adult, Male, Health Status Disparities, Hepatitis C, Chronic, Middle Aged, Hospitalization, Young Adult, Prevalence, Feasibility Studies, Humans, Female, France, Aged, Retrospective Studies
Abstract

Objective: Only limited recent information is available concerning the regional incidence and prevalence of chronic hepatitis C (CHC), but this information is critical for optimal definition of public health policies for the management of hepatitis C. The objective of this study was to evaluate the feasibility of mapping potential regional differences in the prevalence of CHC and its complications using data from a health administrative database. Methods: The 2012 PMSI MCO hospital database contains information on diagnosis and healthcare resource use, essentially related to all hospitalisations in France. Hospital stays related to CHC were identified on the basis of ICD-10 disease codes. Hospital stays were classified according to stage of liver disease: non-cirrhotic liver disease, compensated cirrhosis, decompensated cirrhosis or hepatocellular carcinoma (HCC). All study variables were documented for each French administrative region in 2012. Results: In 2012, 12,040 patients were hospitalised in France for a reason related to CHC, corresponding to a standardised age- and gender- adjusted prevalence rate of 19.3/100,000 persons. The highest prevalences of CHC and HCC were observed in the Ile de France, Alsace and Provence-Alpes-Côte-d’Azur regions. Conclusions: This study demonstrates the feasibility of using the PMSI database to identify regional differences in the prevalence of CHC. This information may be useful for planning regional healthcare resource provision for CHC.

Published
2017

5. Daclatasvir plus Sofosbuvir with or without Ribavirin in Patients with HCV Infection and Decompensated Cirrhosis: Interim Analysis of a French Multicentre Compassionate use Programme

Author

V. Di Martino, Frédéric Oberti, G.-P. Pageaux, D. Blaison, Fabio Conti, Eric Nguyen-Khac, D. Lacoste, Ghassan Riachi, Vincent Leroy, Christophe Hézode, Raoudha Akremi, Mariagrazia Tateo, Yacia Bennai, S. Metivier, Jean-Pierre Bronowicki, Dominique Guyader, J. Vergniol, C. Michau, Hélène Fontaine, Régine Truchi, Anne Filipovics, Epidémiologie pronostique des cancers et affections graves, Université Joseph Fourier - Grenoble 1 (UJF)-Institut National de la Santé et de la Recherche Médicale (INSERM), 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), Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Centre Hépato-Biliaire [Hôpital Paul Brousse] (CHB), Hôpital Paul Brousse-Assistance Publique - Hôpitaux de Paris, 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 Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), 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), Service d'Hépato Gastroenterologie [CHU Amiens-Picardie], CHU Amiens-Picardie, Comité de coordination Régionale de lutte contre l'infection due au Virus de l'immunodéficience Humaine, Partenaires INRAE, Service de médecine interne et maladies infectieuses [Bordeaux], CHU Bordeaux [Bordeaux]-Groupe hospitalier Saint-André, Hôpital Haut-Lévêque [CHU Bordeaux], CHU Bordeaux [Bordeaux], Centre Hospitalier Universitaire de Nice (CHU Nice), 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 Pontchaillou [Rennes], Service d'Hépato-Gastroentérologie [CHU Rouen], Hôpital Charles Nicolle [Rouen], CHU Rouen, Normandie Université (NU)-Normandie Université (NU)-CHU Rouen, Normandie Université (NU)-Normandie Université (NU)-Université de Rouen Normandie (UNIROUEN), Normandie Université (NU), Centre hospitalier de Saint-Nazaire, Centre hospitalier Troyes (CH Troyes), Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM), 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 Cochin (IC UM3 (UMR 8104 / U1016)), Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), Nutrition-Génétique et Exposition aux Risques Environnementaux (NGERE), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lorraine (UL), Bristol-Myers Squibb Company, Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), CHU Toulouse [Toulouse], Université de Rennes 1 (UR1), 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 ), and Hôpital Charles Nicolle [Rouen]-CHU Rouen

Subjects
medicine.medical_specialty, Daclatasvir, Hepatology, Sofosbuvir, business.industry, Ribavirin, [SDV]Life Sciences [q-bio], Compassionate Use, Interim analysis, Decompensated cirrhosis, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, chemistry, 030220 oncology & carcinogenesis, Internal medicine, medicine, 030211 gastroenterology & hepatology, In patient, business, medicine.drug
Abstract

EASL International Liver Congress, Barcelona, SPAIN, APR 13-17, 2016; International audience

Published
2016
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6. 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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7. SERUM TUMOUR NECROSIS FACTOR-α AND TRANSFORMING GROWTH FACTOR-β LEVELS IN CHRONIC HEPATITIS C PATIENTS ARE IMMUNOMODULATED BY THERAPY

Author

Manuela G. Neuman, Véronique Le Breton, Laurence Lecomte, Izabella M. Malkiewicz, Raoudha Akremi, Tarik Asselah, Gady G Katz, Souad Benali, Gaelle Le Guludec, Patrick Marcellin, Neil H. Shear, Nathalie Boyer, Asma Ibrahim, Jean-Pierre Benhamou, Marc Bourlière, and Michelle Martinot-Peignoux

Subjects
Adult, Liver Cirrhosis, Male, medicine.medical_specialty, Necrosis, Immunology, Alpha interferon, Hepacivirus, Interferon alpha-2, Antiviral Agents, Biochemistry, Gastroenterology, Polyethylene Glycols, chemistry.chemical_compound, Transforming Growth Factor beta, Fibrosis, Internal medicine, Ribavirin, medicine, Humans, Immunology and Allergy, Molecular Biology, biology, Tumor Necrosis Factor-alpha, business.industry, Interferon-alpha, Alanine Transaminase, Hematology, Hepatitis C, Hepatitis C, Chronic, Middle Aged, medicine.disease, Recombinant Proteins, Treatment Outcome, chemistry, Alanine transaminase, biology.protein, RNA, Viral, Drug Therapy, Combination, Female, Tumor necrosis factor alpha, medicine.symptom, business, Follow-Up Studies, Transforming growth factor
Abstract

Our aims were: (i) to characterize serum levels of tumour necrosis factor alpha (TNF-alpha) and transforming growth factor beta (TGF-beta) in non-cirrhotics with hepatitis C; (ii) to correlate levels of theses cytokines with degree of disease at baseline; (iii) to characterize the immunomodulatory effects of therapy with response and (iv) to compare profiles of cytokines in patients treated with pegylated-interferon alpha-2b monotherapy (PMT) vs its combination with ribavirin (PCT1-low dose ribavirin and PCT2-high dose ribavirin). We studied 56 patients that were part of two randomized, controlled, clinical trials. At baseline, high TNF-alpha levels paralleled the degree of inflammation as determined by histology. In PCT2, a significant reduction was seen in levels of TNF-alpha, TGF-beta and fibrosis scores when comparing baseline with follow-up. In sustained responders, regardless of therapy, the histological activity scores were lower at follow-up as compared to baseline. In conclusion, PCT2 is able to constantly reduce and sustain TNF-alpha levels, which is responsible for the sustained decline in liver inflammation as shown by the histological activity index and it is also able to reduce fibrosis as judged both by TGF-beta levels and fibrosis scores.

Published
2002
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9. A new step toward standardization of serum hepatitis C Virus-RNA quantification in patients with chronic hepatitis C

Author

Véronique Le Breton, Michèle Martinot-Peignoux, Nathalie Boyer, Raoudha Akremi, Patrick Marcellin, Corinne Castelnau, and Gaelle Le Guludec

Subjects
Hepatology, Reverse Transcriptase Polymerase Chain Reaction, business.industry, Enzyme-Linked Immunosorbent Assay, Hepacivirus, Hepatitis C, Chronic, Roche Diagnostics, Virology, Virus, Chronic hepatitis, Immunology, BDNA test, Humans, RNA, Viral, Medicine, Clinical significance, In patient, Reagent Kits, Diagnostic, Viral disease, business, Viral load, Retrospective Studies
Abstract

The need to improve efficacy of antiviral therapy for chronic hepatitis C has prompted the development of quantitative assays, which allows the assessment of viral load before therapy. The aim of our study was to evaluate the clinical relevance of 3 serum HCV-RNA quantitative assays in 87 patients with chronic hepatitis C, the noncommercially available SuperQuant assay (National Genetic Institute), recently used in large international controlled trials, the most early and widely used Quantiplex HCV RNA v2.0 assay (branched DNA [bDNA] v2.0; Bayer Diagnostics, Puteaux, France), and the new generation Cobas Amplicor HCV Monitor assay (COBAS v2.0; Roche Diagnostics Systems, Meylan, France), which is a semiautomated reverse transcription-polymerase chain reaction (RT-PCR) assay. The level and range of quantification were similar between all assays and a strong correlation was observed over all HCV genotypes among the assays. Recent publications have suggested that the baseline cut-off level of 2 × 10 6 copies/ mL, as determined by the SuperQuant assay, is able to discriminate between patients with low viral load from those with high viral load and can be used to predict responses to therapy. Because all 3 assays use different testing technologies we examined how many of our patients fell above this defined cut-off level when tested by the other assays; of 22 patients measured below 2 × 10 6 copies/mL with the SuperQuant assay, 17 of 22 and 19 of 22 patients were eligible with the bDNA v2.0 and the COBAS v2.0 assays, respectively (P >.05). Our results indicate that the 2 commercial assays can be used to determine treatment schedules in patients with chronic hepatitis C, providing a flexibility in multicenter controlled trials by offering better accessibility of test results.

Published
2000
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10. Role of cytokines in the assessment of the severity of chronic hepatitis C and the prediction of response to therapy

Author

Manuela G, Neuman, Jean-Pierre, Benhamou, Asma, Ibrahim, Izabella, Malkiewicz, Tiberius, Spircu, Michelle, Martinot-Peignoux, Neil H, Shear, Gady G, Katz, Raoudha, Akremi, Marc, Bourliere, and Patrick, Marcellin

Subjects
Liver Cirrhosis, Predictive Value of Tests, Tumor Necrosis Factor-alpha, Ribavirin, Humans, Antineoplastic Agents, Enzyme-Linked Immunosorbent Assay, Hepatitis C, Chronic, Antiviral Agents, Severity of Illness Index, Forecasting
Abstract

(i) To characterize serum levels of pro/anti-inflammatory cytokines in non-cirrhotics with hepatitis C; (ii) to correlate levels of these cytokines with degree of disease at baseline; and (iii) to characterize the immuno-modulatory effects of therapy with response.We studied 103 patients that were part of randomized, controlled, clinical trials. Serum cytokines were measured using enzyme-linked immunosorbent assay.Using standard therapy in the presence and absence of ribavirin, the sustained responders had lower baseline tumor necrosis alpha (TNF-alpha) levels as compared to relapsed responders and non-responders. In patients receiving pegylated therapy, the degree of inflammation as determined by histology was paralleled by high TNF-alpha levels at baseline. In pegylated combination therapy with high dose ribavirin, lower levels of TNF-alpha, transforming growth factor beta (TGF-beta) and fibrosis scores were seen when comparing baseline with follow up. In sustained responders, regardless of therapy, the histological activity scores were lower at follow up as compared to baseline.Pegylated combination therapy reduces and sustains TNF-alpha levels and liver inflammation as shown by the histological activity index. In addition, it is able to reduce fibrosis as judged both by TGF-beta levels and fibrosis scores as compared to standard therapy.

Published
2002

12. Cytokines as predictors for sustained response and as markers for immunomodulation in patients with chronic hepatitis C

Author

Ashima Suneja, Neil H. Shear, Manuela G. Neuman, Nathalie Boyer, Asma Ibrahim, Gady G Katz, Raoudha Akremi, Jean-Pierre Benhamou, Gaelle Le Guludec, Michelle Martinot-Peignoux, Izabella M. Malkiewicz, Patrick Marcellin, Tarik Asselah, Véronique Le Breton, and Pearl Jacobson-Brown

Subjects
Adult, Male, Alcoholic liver disease, Combination therapy, Genotype, Clinical Biochemistry, Alpha interferon, Enzyme-Linked Immunosorbent Assay, Hepacivirus, chemistry.chemical_compound, Basal (phylogenetics), Ribavirin, medicine, Humans, Interleukin 6, biology, business.industry, Tumor Necrosis Factor-alpha, Interleukins, Interleukin, Alanine Transaminase, General Medicine, Hepatitis C, Chronic, Middle Aged, Viral Load, medicine.disease, chemistry, Case-Control Studies, Immunology, biology.protein, RNA, Viral, Tumor necrosis factor alpha, Female, Interferons, business, Biomarkers
Abstract

Objectives: (i) To characterize serum cytokine levels of tumor necrosis factor alpha (TNF α), interleukin 6 (IL 6), IL 8 and IL 12 in non-cirrhotic patients with chronic hepatitis C, (ii) to correlate the levels of these cytokines with the degree of the disease at the basal level, (iii) to correlate these levels with the response to therapy, (iv) to compare profiles of cytokines in monotherapy (MT) versus combination therapy (CT), and (v) to compare the immunomodulatory effects of MT versus CT. Design and Methods: 47 patients were enrolled in the study. The controls were 120 volunteers (recruited from students and staff) that did not present HCV RNA positive and were not known to suffer any other metabolic disease. Thirty patients formed the other group of controls, with alcoholic liver disease (ALD). Serum cytokine levels were assessed using enzyme-linked immunosorbent assay (ELISA). Results: The sustained responders (SRs) have basal values much lower than relapsed responders (RRs) and non-responders (NRs) regardless of the therapy. Conclusions: Cytokines can be used as non-invasive markers for sustained response and as monitors for the outcome of therapy.

Published
2001

13. Serum tumor necrosis factor level in chronic hepatitis C

Author

M. Martinot, Raoudha Akremi, Jean-Pierre Benhamou, Manuela G. Neuman, Tarik Asselah, Patrick Marcellin, and Nathalie Boyer

Subjects
medicine.medical_specialty, Hepatology, Chronic hepatitis, business.industry, Internal medicine, medicine, Tumor necrosis factor alpha, business, Gastroenterology
Published
2001
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