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1. HCV NS3 sequencing as a reliable and clinically useful tool for the assessment of genotype and resistance mutations for clinical samples with different HCV-RNA levels

Author

Di Maio, V C, Cento, V, Di Paolo, D, Aragri, M, De Leonardis, F, Tontodonati, M, Micheli, V, Bellocchi, M C, Antonucci, F P, Bertoli, A, Lenci, I, Milana, M, Gianserra, L, Melis, M, Di Biagio, A, Sarrecchia, C, Sarmati, L, Landonio, S, Francioso, S, Lambiase, L, Nicolini, L A, Marenco, S, Nosotti, L, Giannelli, V, Siciliano, M, Romagnoli, D, Pellicelli, A, Vecchiet, J, Magni, C F, Babudieri, S, Mura, M S, Taliani, G, Mastroianni, C, Vespasiani-Gentilucci, U, Romano, M, Morisco, F, Gasbarrini, A, Vullo, V, Bruno, S, Baiguera, C, Pasquazzi, C, Tisone, G, Picciotto, A, Andreoni, M, Parruti, G, Rizzardini, G, Angelico, M, Perno, C F, Ceccherini-Silberstein, F, Collaborators (129) Mariani R, HCV Italian Resistance Network Study Group., Paoloni, M, Iapadre, N, Grimaldi, A, Menzaghi, B, Quirino, T, Bruzzone, B, De Maria, A, Nicolini, La, Viscoli, C, Casinelli, K, Monache, Md, Lichtner, M, Aghemo, A, Cerrone, M, Colombo, M, Monforte, Ad, Danieli, E, Donato, F, Gubertini, G, Magni, Cf, Mancon, A, Monico, S, Niero, F, Puoti, M, Russo, Ml, Alfieri, R, Gnocchi, M, Orro, A, Milanesi, L, Baldelli, E, Bertolotti, M, Borghi, V, Mussini, C, Brancaccio, G, Caporaso, N, Gaeta, Gb, Lembo, V, Calvaruso, V, Craxì, A, Di Marco, V, Mazzola, A, Petta, S, D'Amico, E, Cacciatore, P, Consorte, A, Palitti, Vp, Pieri, A, Polilli, E, Antenucci, F, Antonucci, Fp, Armenia, D, Baiocchi, L, Bellocchi, M, Biliotti, E, Biolato, M, Carioti, L, Cerasari, G, Cerva, C, Ciotti, M, D'Ambrosio, C, D'Ettorre, G, De Sanctis, A, Di Maio VC, Furlan, C, Gallo, P, Grieco, A, Grieco, S, Lattanzi, B, Malagnino, V, Manuelli, M, Merli, M, Miglioresi, L, Palazzo, D, Perno, Cf, Santopaolo, F, Santoro, Mm, Sforza, D, Sorbo, Mc, Spaziante, M, Svicher, V, Teti, E, Mangia, A, Maida, I, Mura, Ms, Falconi, L, Di Giammartino, D, Tarquini, P., Di Maio, V C, Cento, V, Di Paolo, D, Aragri, M, De Leonardis, F, Tontodonati, M, Micheli, V, Bellocchi, M C, Antonucci, F P, Bertoli, A, Lenci, I, Milana, M, Gianserra, L, Melis, M, Di Biagio, A, Sarrecchia, C, Sarmati, L, Landonio, S, Francioso, S, Lambiase, L, Nicolini, L A, Marenco, S, Nosotti, L, Giannelli, V, Siciliano, M, Romagnoli, D, Pellicelli, A, Vecchiet, J, Magni, C F, Babudieri, S, Mura, M S, Taliani, G, Mastroianni, C, Vespasiani-Gentilucci, U, Romano, M, Morisco, F, Gasbarrini, A, Vullo, V, Bruno, S, Baiguera, C, Pasquazzi, C, Tisone, G, Picciotto, A, Andreoni, M, Parruti, G, Rizzardini, G, Angelico, M, Perno, C F, Ceccherini-Silberstein, F, HCV Italian Resistance Network Study Group., Collaborators (129) Mariani R, Paoloni, M, Iapadre, N, Grimaldi, A, Menzaghi, B, Quirino, T, Bruzzone, B, De Maria, A, Nicolini, La, Viscoli, C, Casinelli, K, Monache, Md, Lichtner, M, Aghemo, A, Cerrone, M, Colombo, M, Monforte, Ad, Danieli, E, Donato, F, Gubertini, G, Magni, Cf, Mancon, A, Monico, S, Niero, F, Puoti, M, Russo, Ml, Alfieri, R, Gnocchi, M, Orro, A, Milanesi, L, Baldelli, E, Bertolotti, M, Borghi, V, Mussini, C, Brancaccio, G, Caporaso, N, Gaeta, Gb, Lembo, V, Calvaruso, V, Craxì, A, Di Marco, V, Mazzola, A, Petta, S, D'Amico, E, Cacciatore, P, Consorte, A, Palitti, Vp, Pieri, A, Polilli, E, Antenucci, F, Antonucci, Fp, Armenia, D, Baiocchi, L, Bellocchi, M, Biliotti, E, Biolato, M, Carioti, L, Cerasari, G, Cerva, C, Ciotti, M, D'Ambrosio, C, D'Ettorre, G, De Sanctis, A, Di Maio, Vc, Furlan, C, Gallo, P, Grieco, A, Grieco, S, Lattanzi, B, Malagnino, V, Manuelli, M, Merli, M, Miglioresi, L, Palazzo, D, Perno, Cf, Santopaolo, F, Santoro, Mm, Sforza, D, Sorbo, Mc, Spaziante, M, Svicher, V, Teti, E, Mangia, A, Maida, I, Mura, M, Falconi, L, Di Giammartino, D, Tarquini, P., Di Maio, V. C, Bellocchi, M. C, Antonucci, F. P, Nicolini, L. A, Magni, C. F, Mura, M. S, Vespasiani Gentilucci, U, Morisco, Filomena, Perno, C. F, Ceccherini Silberstein, F., Caporaso, Nicola, Di Maio, V., Cento, V., Di Paolo, D., Aragri, M., De Leonardis, F., Tontodonati, M., Micheli, V., Bellocchi, M., Antonucci, F., Bertoli, A., Lenci, I., Milana, M., Gianserra, L., Melis, M., Di Biagio, A., Sarrecchia, C., Sarmati, L., Landonio, S., Francioso, S., Lambiase, L., Nicolini, L., Marenco, S., Nosotti, L., Giannelli, V., Siciliano, M., Romagnoli, D., Pellicelli, A., Vecchiet, J., Magni, C., Babudieri, S., Mura, M., Taliani, G., Mastroianni, C., Vespasiani-Gentilucci, U., Romano, M., Morisco, F., Gasbarrini, A., Vullo, V., Bruno, S., Baiguera, C., Pasquazzi, C., Tisone, G., Picciotto, A., Andreoni, M., Parruti, G., Rizzardini, G., Angelico, M., Perno, C., Ceccherini-Silberstein, F., Mariani, R., Paoloni, M., Iapadre, N., Grimaldi, A., Menzaghi, B., Quirino, T., Bruzzone, B., De Maria, A., Viscoli, C., Casinelli, K., Delle Monache, M., Lichtner, M., Aghemo, A., Cerrone, M., Colombo, M., D'Arminio Monforte, A., Danieli, E., Donato, F., Gubertini, G., Mancon, A., Monico, S., Niero, F., Puoti, M., Russo, M., Alfieri, R., Gnocchi, M., Orro, A., Milanesi, L., Baldelli, E., Bertolotti, M., Borghi, V., Mussini, C., Brancaccio, G., Caporaso, N., Gaeta, G., Lembo, V., Calvaruso, V., Craxã­, A., DI MARCO, V., Mazzola, A., Petta, S., D'Amico, E., Cacciatore, P., Consorte, A., Pace Palitti, V., Pieri, A., Polilli, E., Antenucci, F., Armenia, D., Baiocchi, L., Biliotti, E., Biolato, M., Carioti, L., Cerasari, G., Cerva, C., Ciotti, M., D'Ambrosio, C., D'Ettorre, G., De Sanctis, A., Furlan, C., Gallo, P., Grieco, A., Grieco, S., Lattanzi, B., Malagnino, V., Manuelli, M., Merli, M., Miglioresi, L., Palazzo, D., Santopaolo, F., Santoro, M., Sforza, D., Sorbo, M., Spaziante, M., Svicher, V., Teti, E., Mangia, A., Maida, I., Falconi, L., and Di Giammartino, D.

Subjects
0301 basic medicine, ns3, Genotyping Techniques, viruses, Drug Resistance, Hepacivirus, Viral Nonstructural Proteins, medicine.disease_cause, Gastroenterology, Telaprevir, chemistry.chemical_compound, genotype, genotyping techniques, hepacivirus, hepatitis C, humans, RNA viral, retrospective studies, sequence analysis, DNA, viral nonstructural proteins, drug resistance, viral, mutation, pharmacology, infectious diseases, 0302 clinical medicine, Retrospective Studie, Genotype, Pharmacology (medical), Viral, Hepatitis C, Humans, RNA, Viral, Retrospective Studies, Sequence Analysis, DNA, Drug Resistance, Viral, Mutation, Proteolytic enzymes, virus diseases, Settore MED/07 - Microbiologia e Microbiologia Clinica, hcv-rna levels, Infectious Diseases, HCV-RNA, 030211 gastroenterology & hepatology, Sequence Analysis, medicine.drug, Human, Microbiology (medical), medicine.medical_specialty, Hepatitis C virus, Concordance, Settore MED/12 - GASTROENTEROLOGIA, Pharmacology, Biology, 03 medical and health sciences, Boceprevir, Internal medicine, medicine, hcv, Genotyping, Hepaciviru, Viral Nonstructural Protein, Settore MED/09 - MEDICINA INTERNA, Virology, digestive system diseases, 030104 developmental biology, chemistry, Sequence Analysi, RNA, Genotyping Technique
Abstract

OBJECTIVES: This study aims to evaluate the reliability and clinical utility of NS3 sequencing in hepatitis C virus (HCV) 1-infected patients who were candidates to start a PI-containing regimen. METHODS: NS3 protease sequencing was performed by in-house-developed HCV-1 subtype-specific protocols. Phylogenetic analysis was used to test sequencing reliability and concordance with previous genotype/subtype assignment by commercial genotyping assays. RESULTS: Five hundred and sixty-seven HCV plasma samples with quantifiable HCV-RNA from 326 HCV-infected patients were collected between 2011 and 2014. Overall, the success rate of NS3 sequencing was 88.9%. The success rate between the two subtype protocols (HCV-1a/HCV-1b) was similarly high for samples with HCV-RNA >3 log IU/mL (>92% success rate), while it was slightly lower for HCV-1a samples with HCV-RNA ≤3 log IU/mL compared with HCV-1b samples. Phylogenetic analysis confirmed the genotype/subtype given by commercial genotyping assays in 92.9% (303/326) of cases analysed. In the remaining 23 cases (7.1%), 1 was HCV-1g (previously defined as subtype 1a), 1 was HCV-4d (previously defined as genotype 1b) and 1 was HCV-1b (previously defined as genotype 2a/2c). In the other cases, NS3 sequencing precisely resolved the either previous undetermined/discordant subtype 1 or double genotype/subtype assignment by commercial genotyping assays. Resistance-associated variants (RAVs) to PI were detected in 31.0% of samples. This prevalence changed according to PI experience (17.1% in PI-naive patients versus 79.2% in boceprevir/telaprevir/simeprevir-failing patients). Among 96 patients with available virological outcome following boceprevir/telaprevir treatment, a trend of association between baseline NS3 RAVs and virological failure was observed (particularly for HCV-1a-infected patients: 3/21 failing patients versus 0/22 achieving sustained virological response; P = 0.11). CONCLUSIONS: HCV-NS3 sequencing provides reliable results and at the same time gives two clinically relevant pieces of information: a correct subtype/genotype assignment and the detection of variants that may interfere with the efficacy of PI.

Published
2016

2. Multiclass HCV resistance to direct-acting antiviral failure in real-life patients advocates for tailored second-line therapies

Author

Di Maio, Velia C., Cento, Valeria, Lenci, Ilaria, Aragri, Marianna, Rossi, Piera, Barbaliscia, Silvia, Melis, Michela, Verucchi, Gabriella, Magni, Carlo F., Teti, Elisabetta, Bertoli, Ada, Antonucci, Francescopaolo, Bellocchi, Maria C., Micheli, Valeria, Masetti, Chiara, Landonio, Simona, Francioso, Simona, Santopaolo, Francesco, Pellicelli, Adriano M., Calvaruso, Vincenza, Gianserra, Laura, Siciliano, Massimo, Romagnoli, Dante, Cozzolongo, Raffaele, Grieco, Antonio, Vecchiet, Jacopo, Morisco, Filomena, Merli, Manuela, Brancaccio, Giuseppina, Di Biagio, Antonio, Loggi, Elisabetta, Mastroianni, Claudio Maria, Pace Palitti, Valeria, Tarquini, Pierluigi, Puoti, Massimo, Taliani, Gloria, Sarmati, Loredana, Picciotto, Antonino, Vullo, Vincenzo, Caporaso, Nicola, Paoloni, Maurizio, Pasquazzi, Caterina, Rizzardini, Giuliano, Parruti, Giustino, Craxì, Antonio, Babudieri, Sergio, Andreoni, Massimo, Angelico, Mario, Perno, Carlo F., Ceccherini Silberstein, Francesca, Mariani, R., Iapadre, N., Grimaldi, A., Cozzolongo, R., Andreone, P., Verucchi, G., Menzaghi, B., Quirino, T., Pisani, V., Torti, MARIA CHIARA, Vecchiet, J., Bruzzone, B., De Maria, A., Marenco, S., Nicolini, L. A., Viscoli, C., Casinelli, K., Delle Monache, M., Lichtner, Miriam, Aghemo, A., Boccaccio, V., Bruno, S., Cerrone, M., Colombo, M., D'Arminio Monforte, A., Danieli, E., Donato, F., Gubertini, G., Lleo, A., Magni, C. F., Mancon, A., Monico, S., Niero, F., Russo, M. L., Gnocchi, M., Orro, A., Milanesi, L., Baldelli, E., Bertolotti, M., Borghi, V., Mussini, C., Brancaccio, G., Gaeta, G. B., Lembo, V., Sangiovanni, V., Di Marco, V., Mazzola, A., Petta, S., D'Amico, E., Cacciatore, P., Consorte, A., Pieri, A., Polilli, E., Sozio, F., Antenucci, F., Aragri, M., Baiocchi, L., Barbaliscia, S., Biliotti, Elisa, Biolato, M., Carioti, L., Ceccherini Silberstein, F., Cerasari, G., Cerva, C., Ciotti, M., D'Ambrosio, C., D'Ettorre, G., De Leonardis, F., De Sanctis, A., Di Maio, V. C., Di Paolo, D., Furlan, Caterina, Gallo, P., Gasbarrini, A., Giannelli, V., Grieco, S., Lambiase, L., Lattanzi, B., Lenci, I., Lula, R., Malagnino, V., Manuelli, M., Miglioresi, L., Milana, M., Moretti, A., Nosotti, L., Palazzo, Donatella, Pellicelli, A., Romano, M., Sarrecchia, C., Sforza, D., Sorbo, M. C., Spaziante, M., Svicher, V., Tisone, G., Vespasiani Gentilucci, U., D'Adamo, G., Mangia, A., Maida, I., Mura, M. S., Falconi, L., Di Giammartino, D., Di Maio, V., Cento, V., Lenci, I., Aragri, M., Rossi, P., Barbaliscia, S., Melis, M., Verucchi, G., Magni, C., Teti, E., Bertoli, A., Antonucci, F., Bellocchi, M., Micheli, V., Masetti, C., Landonio, S., Francioso, S., Santopaolo, F., Pellicelli, A., Calvaruso, V., Gianserra, L., Siciliano, M., Romagnoli, D., Cozzolongo, R., Grieco, A., Vecchiet, J., Morisco, F., Merli, M., Brancaccio, G., Di Biagio, A., Loggi, E., Mastroianni, C., Pace Palitti, V., Tarquini, P., Puoti, M., Taliani, G., Sarmati, L., Picciotto, A., Vullo, V., Caporaso, N., Paoloni, M., Pasquazzi, C., Rizzardini, G., Parruti, G., Craxã¬, A., Babudieri, S., Andreoni, M., Angelico, M., Perno, C., Ceccherini-Silberstein, F., Mariani, R., Iapadre, N., Grimaldi, A., Andreone, P., Menzaghi, B., Quirino, T., Pisani, V., Torti, C., Bruzzone, B., De Maria, A., Marenco, S., Nicolini, L., Viscoli, C., Casinelli, K., Delle Monache, M., Lichtner, M., Aghemo, A., Boccaccio, V., Bruno, S., Cerrone, M., Colombo, M., D'Arminio Monforte, A., Danieli, E., Donato, F., Gubertini, G., Lleo, A., Mancon, A., Monico, S., Niero, F., Russo, M., Gnocchi, M., Orro, A., Milanesi, L., Baldelli, E., Bertolotti, M., Borghi, V., Mussini, C., Gaeta, G., Lembo, V., Sangiovanni, V., DI MARCO, V., Mazzola, A., Petta, S., D'Amico, E., Cacciatore, P., Consorte, A., Pieri, A., Polilli, E., Sozio, F., Antenucci, F., Baiocchi, L., Biliotti, E., Biolato, M., Carioti, L., Cerasari, G., Cerva, C., Ciotti, M., D'Ambrosio, C., D'Ettorre, G., De Leonardis, F., De Sanctis, A., Di Paolo, D., Furlan, C., Gallo, P., Gasbarrini, A., Giannelli, V., Grieco, S., Lambiase, L., Lattanzi, B., Lula, R., Malagnino, V., Manuelli, M., Miglioresi, L., Milana, M., Moretti, A., Nosotti, L., Palazzo, D., Romano, M., Sarrecchia, C., Sforza, D., Sorbo, M., Spaziante, M., Svicher, V., Tisone, G., Vespasiani-Gentilucci, U., D'Adamo, G., Mangia, A., Maida, I., Mura, M., Falconi, L., Di Giammartino, D., Di Maio, V, Cento, V, Lenci, I, Aragri, M, Rossi, P, Barbaliscia, S, Melis, M, Verucchi, G, Magni, C, Teti, E, Bertoli, A, Antonucci, F, Bellocchi, M, Micheli, V, Masetti, C, Landonio, S, Francioso, S, Santopaolo, F, Pellicelli, A, Calvaruso, V, Gianserra, L, Siciliano, M, Romagnoli, D, Cozzolongo, R, Grieco, A, Morisco, F, Merli, M, Brancaccio, G, Di Biagio, A, Loggi, E, Mastroianni, C, Pace Palitti, V, Tarquini, P, Puoti, M, Taliani, G, Sarmati, L, Picciotto, A, Vullo, V, Caporaso, N, Paoloni, M, Pasquazzi, C, Rizzardini, G, Parruti, G, Craxì, A, Babudieri, S, Andreoni, M, Angelico, M, Perno, C, Ceccherini-Silberstein, F, Velia C. Di Maio, Valeria Cento, Ilaria Lenci, Marianna Aragri, Piera Rossi, Silvia Barbaliscia, Michela Meli, Gabriella Verucchi, Carlo F. Magni, Elisabetta Teti, Ada Bertoli, Francesco Paolo Antonucci, Maria C. Bellocchi, Valeria Micheli, Chiara Masetti, Simona Landonio, Simona Francioso, Francesco Santopaolo, Adriano M. Pellicelli, Vincenza Calvaruso, Laura Gianserra, Massimo Siciliano, Dante Romagnoli, Raffaele Cozzolongo, Antonio Grieco, Jacopo Vecchiet, Filomena Morisco, Manuela Merli, Giuseppina Brancaccio, Antonio Di Biagio, Elisabetta Loggi, Claudio M. Mastroianni, Valeria Pace Palitti, Pierluigi Tarquini, Massimo Puoti, Gloria Taliani, Loredana Sarmati, Antonino Picciotto, Vincenzo Vullo, Nicola Caporaso, Maurizio Paoloni, Caterina Pasquazzi, Giuliano Rizzardini, Giustino Parruti, Antonio Craxì, Sergio Babudieri, Massimo Andreoni, Mario Angelico, Carlo F. Perno, Francesca Ceccherini-Silberstein, for the HCV Italian Resistance Network Study Group: [.., P. Andreone, E. Loggi, G. Verucchi, ], Di Maio, Velia C., Cento, Valeria, Lenci, Ilaria, Aragri, Marianna, Rossi, Piera, Barbaliscia, Silvia, Melis, Michela, Verucchi, Gabriella, Magni, Carlo F., Teti, Elisabetta, Bertoli, Ada, Antonucci, Francescopaolo, Bellocchi, Maria C., Micheli, Valeria, Masetti, Chiara, Landonio, Simona, Francioso, Simona, Santopaolo, Francesco, Pellicelli, Adriano M., Calvaruso, Vincenza, Gianserra, Laura, Siciliano, Massimo, Romagnoli, Dante, Cozzolongo, Raffaele, Grieco, Antonio, Vecchiet, Jacopo, Morisco, Filomena, Merli, Manuela, Brancaccio, Giuseppina, Di Biagio, Antonio, Loggi, Elisabetta, Mastroianni, Claudio M., Pace Palitti, Valeria, Tarquini, Pierluigi, Puoti, Massimo, Taliani, Gloria, Sarmati, Loredana, Picciotto, Antonino, Vullo, Vincenzo, Caporaso, Nicola, Paoloni, Maurizio, Pasquazzi, Caterina, Rizzardini, Giuliano, Parruti, Giustino, Craxã¬, Antonio, Babudieri, Sergio, Andreoni, Massimo, Angelico, Mario, Perno, Carlo F., Ceccherini-Silberstein, Francesca, Nicolini, L. A., Magni, C. F., Russo, M. L., Gaeta, G. B., Di Marco, V., Di Maio, V. C., Sorbo, M. C., Mura, M. S., Di Maio, Velia C, Magni, Carlo F, Bellocchi, Maria C, Pellicelli, Adriano M, Mastroianni, Claudio M, Craxì, Antonio, Perno, Carlo F, and Ceccherini Silberstein, Francesca

Subjects
Male, 0301 basic medicine, hepatitis C virus, Sustained Virologic Response, Sofosbuvir, Hepacivirus, Drug Resistance, resistance-associated substitutions, Viral Nonstructural Proteins, VARIANTS, NS5A, medicine.disease_cause, Gastroenterology, chemistry.chemical_compound, 0302 clinical medicine, Recurrence, INFECTION, antiviral therapy, Medicine, hepatitis C viru, Viral, Treatment Failure, Chronic, direct-acting antivirals, resistance test, hepatology, biology, GENOTYPE 1, virus diseases, Middle Aged, Settore MED/07 - Microbiologia e Microbiologia Clinica, Hepatitis C, Italy, Combination, Interferon, Drug Therapy, Combination, Female, 030211 gastroenterology & hepatology, Author Keywords:antiviral therapy, RIBAVIRIN, Sequence Analysis, Human, medicine.drug, medicine.medical_specialty, Daclatasvir, Genotype, Hepatitis C virus, Antiviral Agents, LONG-TERM PERSISTENCE, DACLATASVIR, 03 medical and health sciences, Drug Therapy, Aged, Drug Resistance, Viral, Hepatitis C, Chronic, Humans, Interferons, Mutation, Ribavirin, Sequence Analysis, DNA, Hepatology, TREATMENT-NAIVE, Internal medicine, Antiviral Agent, resistance-associated substitution, direct-acting antiviral, Hepaciviru, resistance test KeyWords Plus:HEPATITIS-C VIRUS, business.industry, Viral Nonstructural Protein, DNA, biology.organism_classification, Clinical trial, 030104 developmental biology, SOFOSBUVIR, chemistry, Sequence Analysi, Immunology, business
Abstract

Background & Aims: Despite the excellent efficacy of direct-acting antivirals (DAA) reported in clinical trials, virological failures can occur, often associated with the development of resistance-associated substitutions (RASs). This study aimed to characterize the presence of clinically relevant RASs to all classes in real-life DAA failures. Methods: Of the 200 virological failures that were analyzed in 197 DAA-treated patients, 89 with pegylated-interferon+ribavirin (PegIFN+RBV) and 111 without (HCV-1a/1b/1g/2/3/4=58/83/1/6/24/25; 56.8% treatment experienced; 65.5% cirrhotic) were observed. Sanger sequencing of NS3/NS5A/NS5B was performed by home-made protocols, at failure (N= 200) and whenever possible at baseline (N= 70). Results: The majority of the virological failures were relapsers (57.0%), 22.5% breakthroughs, 20.5% non-responders. RAS prevalence varied according to IFN/RBV use, DAA class, failure type and HCV genotype/subtype. It was 73.0% in IFN group vs 49.5% in IFN free, with the highest prevalence of NS5A-RASs (96.1%), compared to NS3-RASs (75.9% with IFN, 70.5% without) and NS5B-RASs (66.6% with IFN, 20.4% without, in sofosbuvir failures). In the IFN-free group, RASs were higher in breakthrough/non-responders than in relapsers (90.5% vs 40.0%, P= 2 DAA classes showed multiclass resistance, including 11/11 NS3+NS5A failures. Furthermore, 20.0% of patients had baseline-RASs, which were always confirmed at failure. Conclusions: In our failure setting, RAS prevalence was remarkably high in all genes, with a partial exception for NS5B, whose limited resistance is still higher than previously reported. This multiclass resistance advocates for HCV resistance testing at failure, in all three genes for the best second-line therapeutic tailoring.

Published
2017

3. Treatment of genotype-1 hepatitis C recurrence after liver transplant improves survival in both sustained responders and relapsers

Author

Ponziani FR, Milani A, Gasbarrini A, Zaccaria R, Viganò R, Iemmolo RM, Donato MF, Rendina M, Toniutto P, Pasulo L, CESCON, MATTEO, Burra P, Miglioresi L, Merli M, Paolo DD, Fagiuoli S, Pompili M, AISF RECOLT C. Group, Ponziani FR, Milani A, Gasbarrini A, Zaccaria R, Viganò R, Iemmolo RM, Donato MF, Rendina M, Toniutto P, Pasulo L, Cescon M, Burra P, Miglioresi L, Merli M, Paolo DD, Fagiuoli S, Pompili M, AISF RECOLT-C Group, Ponziani, F, Milani, A, Gasbarrini, A, Zaccaria, R, Viganò, R, Iemmolo, R, Donato, M, Rendina, M, Toniutto, P, Pasulo, L, Cescon, M, Burra, P, Miglioresi, L, Merli, M, Paolo, D, Fagiuoli, S, and Pompili, M

Subjects
Graft Rejection, Male, hepatitis C virus, pegylated interferon, ribavirin, liver transplant, survival, hepatitis c recurrence, antiviral treatment, responders, hepatitis c virus, genotype-1, medicine.medical_treatment, hepatitis C recurrence, Kaplan-Meier Estimate, Liver transplantation, Gastroenterology, Polyethylene Glycols, Cohort Studies, chemistry.chemical_compound, Pegylated interferon, Recurrence, Hepatitis C, liver transplantation, hepatitis C viru, Chronic, medicine.diagnostic_test, Graft Survival, Middle Aged, Recombinant Proteins, Treatment Outcome, Italy, Liver biopsy, Retreatment, Regression Analysis, Female, Drug, medicine.drug, medicine.medical_specialty, Genotype, Settore MED/12 - GASTROENTEROLOGIA, responder, Alpha interferon, antiviral treatment, genotype-1, hepatitis C recurrence, hepatitis C virus , liver transplant, pegylated interferon, ribavirin, responders, survival, Antiviral Agents, Risk Assessment, Drug Administration Schedule, Viral Relapse, Dose-Response Relationship, Predictive Value of Tests, Internal medicine, medicine, Humans, Survival analysis, Retrospective Studies, Transplantation, Dose-Response Relationship, Drug, business.industry, Ribavirin, Settore MED/09 - MEDICINA INTERNA, Interferon-alpha, Hepatitis C, Chronic, medicine.disease, Survival Analysis, Surgery, Liver Transplantation, chemistry, Multivariate Analysis, business, Follow-Up Studies
Abstract

Summary The aim of this study was to evaluate the factors affecting the response to treatment and how it could affect survival in a large series of genotype-1 HCV-transplanted patients. Three-hundred and twenty six genotype-1 HCV patients were enrolled. One hundred and ninety-six patients (60.1%) were nonresponders and 130 (39.9%) showed negative HCV-RNA at the end of treatment. Eighty-four of them (25.8%) achieved sustained virological response, while 46 (14.1%) showed viral relapse. Five-year cumulative survival was significantly worse in nonresponders (76.4%) compared with sustained viral response (93.2) or relapsers (94.9%). Sustained responders and relapsers were therefore considered as a single ‘response group’ in further analysis. Pretreatment variables significantly associated with virological response at multivariate regression analysis were the absence of ineffective pretransplant antiviral therapy, the recurrence of HCV-hepatitis more than 1 year after transplant, an histological grading 4 at pretreatment liver biopsy, a pretreatment HCV-RNA level

Published
2013

4. Worse Graft Survival in HCV-Infected Transplanted Females Receiving a Male Donor Graft. The Liver Match Study

Author

Romagnoli, R., Rossi, M., Gerunda, G. E., Pinna, A. D., Agnes, S., Marco Spada, Colledan, M., Tisone, G., Carlis, L., Baccarani, U., Ettorre, G. M., Cillo, U., Calise, F., Caccamo, L., Cuomo, O., Lupo, L., Corradini, S., Zamboni, F., Marianelli, T., Risaliti, A., Patrono, D., Petri, S. Li, Tagliabue, F., Mangoni, J. M. E., Antonelli, B., Sposito, C., Gringeri, E., Rompianesi, G., Sforza, D., Cucchetti, A., Miglioresi, L., Donataccio, M., Gelli, M., Gavrila, C., Nardi, A., Angelico, M., Romagnoli, R, Rossi, M, Gerunda, G, Pinna, A, Agnes, S, Spada, M, Colledan, M, Tisone, G, De Carlis, L, Baccarani, U, Ettorre, G, Cillo, U, Calise, F, Caccamo, L, Cuomo, O, Lupo, L, Corradini, S, Zamboni, F, Marianelli, T, Risaliti, A, Patrono, D, Petri, S, Tagliabue, F, Mangoni, J, Antonelli, B, Sposito, C, Gringeri, E, Rompianesi, G, Sforza, D, Cucchetti, A, Miglioresi, L, Donataccio, M, Gelli, M, Gavrila, C, Nardi, A, and Angelico, M

Subjects
HCV infection, liver transplantation, Transplantation, Hepatology, HCV-infected transplanted females, Gastroenterology, Surgery
Published
2012

5. Long-term maintenance of sustained virological response in liver transplant recipients treated for recurrent hepatitis C

Author

Ponziani, Fr, Viganò, R, Iemmolo, Rm, Donato, Mf, Rendina, M, Toniutto, P, Pasulo, L, Morelli, Mc, Burra, Patrizia, Miglioresi, L, Merli, M, Di Paolo, D, Fagiuoli, S, Gasbarrini, A, Pompili, M, Belli, L, Gerunda, Ge, Marino, M, Montalti, R, Di Benedetto, F, De Ruvo, N, Rigamonti, C, Colombo, M, Rossi, G, Di Leo, A, Lupo, L, Memeo, V, Bringiotti, R, Zappimbulso, M, Bitetto, D, Vero, V, Colpani, M, Fornasiere, E, Pinna, Ad, Bertuzzo, V, DE MARTIN, Eleonora, Senzolo, M, Ettorre, Gm, Visco Comandini, U, Antonucci, G, Angelico, M, Tisone, G, Giannelli, V, Giusto, M, Group, AISF RECOLT C., Ponziani, Francesca Romana, Viganò, Raffaella, Iemmolo, Rosa Maria, Donato, Maria Francesca, Rendina, Maria, Toniutto, Pierluigi, Pasulo, Luisa, Morelli, Maria Cristina, Burra, Patrizia, Miglioresi, Lucia, Merli, Manuela, Di Paolo, Daniele, Fagiuoli, Stefano, Gasbarrini, Antonio, Pompili, Maurizio, Belli, L, Gerunda, G E, Marino, M, Montalti, R, Di Benedetto, F, De Ruvo, N, Rigamonti, C, Colombo, M, Rossi, G, Di Leo, A, Lupo, L, Memeo, V, Bringiotti, R, Zappimbulso, M, Bitetto, D, Vero, V, Colpani, M, Fornasiere, E, Pinna, A D, Morelli, M C, Bertuzzo, V, De Martin, E, Senzolo, M, Ettorre, G M, Visco-Comandini, U, Antonucci, G, Angelico, M, Tisone, G, Giannelli, V, Giusto, M, Ponziani, F, Fagiuoli, S, Gasbarrini, A, Pompili, M, Francesca Romana Ponziani, Raffaella Viganò, Rosa Maria Iemmolo, Maria Francesca Donato, Maria Rendina, Pierluigi Toniutto, Luisa Pasulo, Maria Cristina Morelli, Patrizia Burra, Lucia Miglioresi, Manuela Merli, Daniele Di Paolo, Stefano Fagiuoli, Antonio Gasbarrini, Maurizio Pompili, L. Belli, G.E. Gerunda, M. Marino, R. Montalti, F. Di Benedetto, N. De Ruvo, C. Rigamonti, M. Colombo, G. Rossi, A. Di Leo, L. Lupo, V. Memeo, R. Bringiotti, M. Zappimbulso, D. Bitetto, V. Vero, M. Colpani, E. Fornasiere, A.D. Pinna, M.C. Morelli, V. Bertuzzo, E. De Martin, M. Senzolo, G.M. Ettorre, U. Visco-Comandini, G. Antonucci, M. Angelico, G. Tisone, V. Giannelli, and M. Giusto

Subjects
Male, Sustained viral response, Time Factors, medicine.medical_treatment, Hepacivirus, Liver transplantation, medicine.disease_cause, Gastroenterology, Polyethylene Glycol, Polyethylene Glycols, Virological response, HCV antiviral treatment, Recurrence, Retrospective Studie, antiviral therapy, Viral, Recurrent hepatitis, Chronic, hepatitis c, Univariate analysis, Graft Survival, Hepatitis C recurrence, Long term maintenance, Hepatitis C, Middle Aged, Recombinant Protein, Recombinant Proteins, Survival Rate, Combination, RNA, Viral, Drug Therapy, Combination, Female, Human, medicine.medical_specialty, Genotype, Time Factor, Hepatitis C virus, Settore MED/12 - GASTROENTEROLOGIA, Antiviral Agents, liver transplantation, hepatitis c recurrence, sustained viral response, hcv antiviral treatment, Follow-Up Studie, Maintenance Chemotherapy, Drug Therapy, Internal medicine, Ribavirin, medicine, Follow-Up Studies, Hepatitis C, Chronic, Humans, Interferon-alpha, Interleukins, Retrospective Studies, Liver Transplantation, Survival rate, Antiviral Agent, Hepaciviru, Hepatology, business.industry, Interleukin, medicine.disease, Immunology, HCV, virological response, liver transplant, RNA, Interferons, business
Abstract

Background The recurrence of hepatitis C viral infection is common after liver transplant, and achieving a sustained virological response to antiviral treatment is desirable for reducing the risk of graft loss and improving patients’ survival. Aim To investigate the long-term maintenance of sustained virological response in liver transplant recipients with hepatitis C recurrence. Methods 436 Liver transplant recipients (74.1% genotype 1) who underwent combined antiviral therapy for hepatitis C recurrence were retrospectively evaluated. Results The overall sustained virological response rate was 40% (173/436 patients), and the mean follow-up after liver transplantation was 11 ± 3.5 years (range, 5–24). Patients with a sustained virological response demonstrated a 5-year survival rate of 97% and a 10-year survival rate of 93%; all but 6 (3%) patients remained hepatitis C virus RNA-negative during follow-up. Genotype non-1 (p = 0.007), treatment duration >80% of the scheduled period (p = 0.027), and early virological response (p = 0.002), were associated with the maintenance of sustained virological response as indicated by univariate analysis. Early virological response was the only independent predictor of sustained virological response maintenance (p = 0.008). Conclusions Sustained virological response achieved after combined antiviral treatment is maintained in liver transplant patients with recurrent hepatitis C and is associated with an excellent 5-year survival.

Published
2014

6. AFP score and metroticket 2.0 perform similarly and could be used in a 'within-ALL' clinical decision tool

Author

Federico Piñero, Charlotte Costentin, Helena Degroote, Andrea Notarpaolo, Ilka FSF. Boin, Karim Boudjema, Cinzia Baccaro, Aline Chagas, Philippe Bachellier, Giuseppe Maria Ettorre, Jaime Poniachik, Fabrice Muscari, Fabrizio Dibenedetto, Sergio Hoyos Duque, Ephrem Salame, Umberto Cillo, Sebastián Marciano, Claire Vanlemmens, Stefano Fagiuoli, Flair Carrilho, Daniel Cherqui, Patrizia Burra, Hans Van Vlierberghe, Quirino Lai, Marcelo Silva, Fernando Rubinstein, Christophe Duvoux, Filomena Conti, Olivier Scatton, Pierre Henri Bernard, Claire Francoz, Francois Durand, Sébastien Dharancy, Marie-lorraine Woehl, Alexis Laurent, Sylvie Radenne, Jérôme Dumortier, Armand Abergel, Louise Barbier, Pauline Houssel-Debry, Georges Philippe Pageaux, Laurence Chiche, Victor Deledinghen, Jean Hardwigsen, J. Gugenheim, M. altieri, Marie Noelle Hilleret, Thomas Decaens, Paulo Costa, Elaine Cristina de Ataide, Emilio Quiñones, Margarita Anders, Adriana Varón, Alina Zerega, Alejandro Soza, Martín Padilla Machaca, Diego Arufe, Josemaría Menéndez, Rodrigo Zapata, Mario Vilatoba, Linda Muñoz, Ricardo Chong Menéndez, Martín Maraschio, Luis G. Podestá, Lucas McCormack, Juan Mattera, Adrian Gadano, Jose Huygens Parente García, Giulia Magini, Lucia Miglioresi, Martina Gambato, Cecilia D’Ambrosio, Alessandro Vitale, Michele Colledan, Domenico Pinelli, Paolo Magistri, Giovanni Vennarecci, Marco Colasanti, Valerio Giannelli, Adriano Pellicelli, Callebout Eduard, Iesari Samuele, Dekervel Jeroen, Schreiber Jonas, Pirenne Jacques, Verslype Chris, Ysebaert Dirk, Michielsen Peter, Lucidi Valerio, Moreno Christophe, Detry Olivier, Delwaide Jean, Troisi Roberto, Lerut Jan Paul, Piñero, F, Costentin, C, Degroote, H, Notarpaolo, A, Boin, I, Boudjema, K, Baccaro, C, Chagas, A, Bachellier, P, Ettorre, G, Poniachik, J, Muscari, F, Dibenedetto, F, Duque, S, Salame, E, Cillo, U, Marciano, S, Vanlemmens, C, Fagiuoli, S, Carrilho, F, Cherqui, D, Burra, P, Van Vlierberghe, H, Lai, Q, Silva, M, Rubinstein, F, Duvoux, C, Conti, F, Scatton, O, Bernard, P, Francoz, C, Durand, F, Dharancy, S, Woehl, M, Laurent, A, Radenne, S, Dumortier, J, Abergel, A, Barbier, L, Houssel-Debry, P, Pageaux, G, Chiche, L, Deledinghen, V, Hardwigsen, J, Gugenheim, J, Altieri, M, Hilleret, M, Decaens, T, Costa, P, de Ataide, E, Quiñones, E, Anders, M, Varón, A, Zerega, A, Soza, A, Machaca, M, Arufe, D, Menéndez, J, Zapata, R, Vilatoba, M, Muñoz, L, Menéndez, R, Maraschio, M, Podestá, L, Mccormack, L, Mattera, J, Gadano, A, Parente García, J, Magini, G, Miglioresi, L, Gambato, M, D'Ambrosio, C, Vitale, A, Colledan, M, Pinelli, D, Magistri, P, Vennarecci, G, Colasanti, M, Giannelli, V, Pellicelli, A, Eduard, C, Samuele, I, Jeroen, D, Jonas, S, Jacques, P, Chris, V, Dirk, Y, Peter, M, Valerio, L, Christophe, M, Olivier, D, Jean, D, Roberto, T, and Paul, L

Subjects
recurrence, Hepatology, reclassification, Gastroenterology, Internal Medicine, Immunology and Allergy, Prediction, transplantation
Abstract

Background & Aims: Two recently developed composite models, the alpha-fetoprotein (AFP) score and Metroticket 2.0, could be used to select patients with hepatocellular carcinoma (HCC) who are candidates for liver transplantation (LT). The aim of this study was to compare the predictive performance of both models and to evaluate the net risk reclassification of post-LT recurrence between them using each model's original thresholds. Methods: This multicenter cohort study included 2,444 adult patients who underwent LT for HCC in 47 centers from Europe and Latin America. A competing risk regression analysis estimating sub-distribution hazard ratios (SHRs) and 95% CIs for recurrence was used (Fine and Gray method). Harrell's adapted c-statistics were estimated. The net reclassification index for recurrence was compared based on each model's original thresholds. Results: During a median follow-up of 3.8 years, there were 310 recurrences and 496 competing events (20.3%). Both models predicted recurrence, HCC survival and survival better than Milan criteria (p

Published
2023

7. Liver Match, a prospective observational cohort study on liver transplantation in Italy: study design and current practice of donor-recipient matching

Author

Mario Angelico 1, Umberto Cillo, Stefano Fagiuoli, Antonio Gasbarrini, Caius Gavrila, Tania Marianelli, Alessandro Nanni Costa, Alessandra Nardi, Mario Strazzabosco, Patrizia Burra, Salvatore Agnes, Umberto Baccarani, Fulvio Calise, Michele Colledan, Oreste Cuomo, Luciano De Carlis, Matteo Donataccio, Giuseppe M Ettorre, Giorgio E Gerunda, Bruno Gridelli, Luigi Lupo, Vincenzo Mazzaferro, Antonio Pinna, Andrea Risaliti, Mauro Salizzoni, Giuseppe Tisone, Umberto Valente, Giorgio Rossi, Massimo Rossi, Fausto Zamboni, S Fagiuoli, A Gasbarrini, M Strazzabosco, D Prati, F Piscaglia, P G Toniutto, L Rizzato, S Venettoni, A Nardi, A Ricci, R Romagnoli, G Bertolotti, D Patrono, J M E Mangoni, L Caccamo, B Antonelli, E Regalia, C Sposito, V Corno, F Tagliabue, S Marin, E Gringeri, D Donataccio, F Bresadola, D Lorenzin, M Gelli, G Rompianesi, A Cucchetti, M G Faraci, D Sforza, S Agnes, M Di Mugno, L Miglioresi, M Rossi, S Ginanni Corradini, A Molinaro, V Scuderi, G Arenga, G Notarnicola, B Gridelli, S Li Petri, G Carbotta, S Dedola, C Gavrila, F Vespasiano, Angelico M, Cillo U, Fagiuoli S, Gasbarrini A, Costa AN, Strazzabosco M, Prati D, Piscaglia F, Toniutto PG, Burra P, Rizzato L, Venettoni S, Marianelli T, Salizzoni M, Romagnoli R, Bertolotti G, Patrono D, De Carolis L, Mangoni JM, Rossi G, Caccamo L, Antonelli B, Mazzaferro V, Regalia E, Sposito C, Colledan M, Corno V, Tagliabue F, Marin S, Gringeri E, Donataccio, Donataccio D, Bresadola F, Lorenzin D, Valente U, Gelli M, Gerunda GE, Rompianesi G, Pinna A, Grazi GL, Cucchetti A, Risaliti A, Faraci MG, Tisone G, Sforza D, Agnes S, Di Mugno M, Ettorre GM, Miglioresi L, Berloco P, Rossi M, Ginanni Corradini S, Molinaro A, Calise F, Scuderi V, Cuomo O, Arenga G, Lupo L, Notarnicola G, Gridelli B, Li Petri S, Zamboni F, Carbotta G, Dedola S, Nardi A, Gavrila C, Ricci A, Vespasiano F, Baccarani U, 1, Mario Angelico, Cillo, Umberto, Fagiuoli, Stefano, Gasbarrini, Antonio, Gavrila, Caiu, Marianelli, Tania, Nanni Costa, Alessandro, Nardi, Alessandra, Strazzabosco, Mario, Burra, Patrizia, Agnes, Salvatore, Baccarani, Umberto, Calise, Fulvio, Colledan, Michele, Cuomo, Oreste, De Carlis, Luciano, Donataccio, Matteo, M Ettorre, Giuseppe, E Gerunda, Giorgio, Gridelli, Bruno, Lupo, Luigi, Mazzaferro, Vincenzo, Pinna, Antonio, Risaliti, Andrea, Salizzoni, Mauro, Tisone, Giuseppe, Valente, Umberto, Rossi, Giorgio, Rossi, Massimo, Zamboni, Fausto, Fagiuoli, S, Gasbarrini, A, Strazzabosco, M, Prati, D, Piscaglia, F, G Toniutto, P, Rizzato, L, Venettoni, S, Nardi, A, Ricci, A, Romagnoli, R, Bertolotti, G, Patrono, D, E Mangoni, J M, Caccamo, L, Antonelli, B, Regalia, E, Sposito, C, Corno, V, Tagliabue, F, Marin, S, Gringeri, E, Donataccio, D, Bresadola, F, Lorenzin, D, Gelli, M, Rompianesi, G, Cucchetti, A, G Faraci, M, Sforza, D, Agnes, S, Di Mugno, M, Miglioresi, L, Rossi, M, Ginanni Corradini, S, Molinaro, A, Scuderi, V, Arenga, G, Notarnicola, G, Gridelli, B, Li Petri, S, Carbotta, G, Dedola, S, Gavrila, C, Vespasiano, F, Angelico, M, Cillo, U, Marianelli, T, Costa, A, Burra, P, Baccarani, U, Calise, F, Colledan, M, Cuomo, O, DE CARLIS, L, Donataccio, M, Ettorre, G, Gerunda, G, Lupo, L, Mazzaferro, V, Pinna, A, Risaliti, A, Salizzoni, M, Tisone, G, Valente, U, Rossi, G, Zamboni, F, and Liver Match, I

Subjects
impact of donor/recipient matching on outcomes, Male, Alcoholic liver disease, Cirrhosis, Multicenter Study, Humans, Prospective Study, Liver Transplantation, Donor Risk Index, Hepatocellular Carcinoma, Italy, Donor Liver transplant Recipient, donor match, liver transplantation, donor, recipient, Settore MED/18 - CHIRURGIA GENERALE, medicine.medical_treatment, liver-match, liver transplant, Liver transplantation, Model for End-Stage Liver Disease, MED/12 - GASTROENTEROLOGIA, Prospective Studies, Prospective cohort study, Child, Liver transplant, donor, Aged, 80 and over, Settore MED/12 - Gastroenterologia, education.field_of_study, liver transplantation, Histocompatibility Testing, Graft Survival, Liver Neoplasms, Gastroenterology, Middle Aged, liver transplantations, liver transplant, information on donors and recipients, recipient, Tissue Donors, Treatment Outcome, Donor, Recipient, Hepatocellular carcinoma, Female, Cohort study, Adult, medicine.medical_specialty, Tissue and Organ Procurement, Adolescent, Waiting Lists, Population, NO, Internal medicine, medicine, education, donor match, Aged, Hepatology, business.industry, Patient Selection, Settore MED/09 - MEDICINA INTERNA, medicine.disease, Fibrosis, Surgery, business
Abstract

BACKGROUND: The Liver Match is an observational cohort study that prospectively enrolled liver transplantations performed at 20 out of 21 Italian Transplant Centres between June 2007 and May 2009. Aim of the study is to investigate the impact of donor/recipient matching on outcomes. In this report we describe the study methodology and provide a cross-sectional description of donor and recipient characteristics and of graft allocation. METHODS: Adult primary transplants performed with deceased heart-beating donors were included. Relevant information on donors and recipients, organ procurement and allocation were prospectively entered in an ad hoc database within the National Transplant Centre web-based Network. Data were blindly analysed by an independent Biostatistical Board. RESULTS: The study enrolled 1530 donor/recipient matches. Median donor age was 56 years. Female donors (n = 681, median 58, range 12-92 years) were older than males (n = 849, median 53, range 2-97 years, p < 0.0001). Donors older than 60 years were 42.2%, including 4.2% octogenarians. Brain death was due to non-traumatic causes in 1126 (73.6%) cases. Half of the donor population was overweight, 10.1% was obese and 7.6% diabetic. Hepatitis B core antibody (HBcAb) was present in 245 (16.0%) donors. The median Donor Risk Index (DRI) was 1.57 (>1.7 in 35.8%). The median cold ischaemia time was 7.3h (≥ 10 in 10.6%). Median age of recipients was 54 years, and 77.7% were males. Hepatocellular carcinoma (HCC) was the most frequent indication overall (44.4%), being a coindication in roughly 1/3 of cases, followed by viral cirrhosis without HCC (28.2%) and alcoholic cirrhosis without HCC (10.2%). Hepatitis C virus infection (with or without HCC) was the most frequent etiologic factor (45.9% of the whole population and 71.4% of viral-related cirrhosis), yet hepatitis B virus infection accounted for 28.6% of viral-related cirrhosis, and HBcAb positivity was found in 49.7% of recipients. The median Model for End Stage Liver Disease (MELD) at transplant was 12 in patients with HCC and 18 in those without. Multivariate analysis showed a slight but significant inverse association between DRI and MELD at transplant. CONCLUSIONS: The deceased donor population in Italy has a high-risk profile compared to other countries, mainly due to older donor age. Almost half of the grafts are transplanted in recipients with HCC. Higher risk donors tend to be preferentially allocated to recipients with HCC, who are usually less ill and older. No other relevant allocation strategy is currently adopted at national level.

Published
2010

8. R3-AFP score is a new composite tool to refine prediction of hepatocellular carcinoma recurrence after liver transplantation

Author

Charlotte Costentin, Federico Piñero, Helena Degroote, Andrea Notarpaolo, Ilka F. Boin, Karim Boudjema, Cinzia Baccaro, Luis G. Podestá, Philippe Bachellier, Giuseppe Maria Ettorre, Jaime Poniachik, Fabrice Muscari, Fabrizio Dibenedetto, Sergio Hoyos Duque, Ephrem Salame, Umberto Cillo, Sebastian Marciano, Claire Vanlemmens, Stefano Fagiuoli, Patrizia Burra, Hans Van Vlierberghe, Daniel Cherqui, Quirino Lai, Marcelo Silva, Fernando Rubinstein, Christophe Duvoux, Filomena Conti, Olivier Scatton, Pierre Henri Bernard, Claire Francoz, Francois Durand, Sébastien Dharancy, Marie-lorraine Woehl, Alexis Laurent, Sylvie Radenne, Jérôme Dumortier, Armand Abergel, Louise Barbier, Pauline Houssel-Debry, Georges Philippe Pageaux, Laurence Chiche, Victor Deledinghen, Jean Hardwigsen, J. Gugenheim, M. Altieri, Marie Noelle Hilleret, Thomas Decaens, Aline Chagas, Paulo Costa, Elaine Cristina de Ataide, Emilio Quiñones, Sebastián Marciano, Margarita Anders, Adriana Varón, Alina Zerega, Alejandro Soza, Martín Padilla Machaca, Diego Arufe, Josemaría Menéndez, Rodrigo Zapata, Mario Vilatoba, Linda Muñoz, Ricardo Chong Menéndez, Martín Maraschio, Lucas McCormack, Juan Mattera, Adrian Gadano, Ilka S.F. Fatima Boin, Jose Huygens Parente García, Flair Carrilho, Giulia Magini, Lucia Miglioresi, Martina Gambato, Fabrizio Di Benedetto, Cecilia D’Ambrosio, Alessandro Vitale, Michele Colledan, Domenico Pinelli, Paolo Magistri, Giovanni Vennarecci, Marco Colasanti, Valerio Giannelli, Adriano Pellicelli, Cizia Baccaro, Callebout Eduard, Iesari Samuele, Dekervel Jeroen, Schreiber Jonas, Pirenne Jacques, Verslype Chris, Ysebaert Dirk, Michielsen Peter, Lucidi Valerio, Moreno Christophe, Detry Olivier, Delwaide Jean, Troisi Roberto, Lerut Jan Paul, Costentin, C, Piñero, F, Degroote, H, Notarpaolo, A, Boin, I, Boudjema, K, Baccaro, C, Podestá, L, Bachellier, P, Ettorre, G, Poniachik, J, Muscari, F, Dibenedetto, F, Hoyos Duque, S, Salame, E, Cillo, U, Marciano, S, Vanlemmens, C, Fagiuoli, S, Burra, P, Van Vlierberghe, H, Cherqui, D, Lai, Q, Silva, M, Rubinstein, F, Duvoux, C, Conti, F, Scatton, O, Bernard, P, Francoz, C, Durand, F, Dharancy, S, Woehl, M, Laurent, A, Radenne, S, Dumortier, J, Abergel, A, Barbier, L, Houssel-Debry, P, Pageaux, G, Chiche, L, Deledinghen, V, Hardwigsen, J, Gugenheim, J, Altieri, M, Hilleret, M, Decaens, T, Chagas, A, Costa, P, Cristina de Ataide, E, Quiñones, E, Duque, S, Anders, M, Varón, A, Zerega, A, Soza, A, Machaca, M, Arufe, D, Menéndez, J, Zapata, R, Vilatoba, M, Muñoz, L, Menéndez, R, Maraschio, M, Mccormack, L, Mattera, J, Gadano, A, Fatima Boin, I, Parente García, J, Carrilho, F, Magini, G, Miglioresi, L, Gambato, M, Benedetto, F, D’Ambrosio, C, Vitale, A, Colledan, M, Pinelli, D, Magistri, P, Vennarecci, G, Colasanti, M, Giannelli, V, Pellicelli, A, Vlierberghe, H, Eduard, C, Samuele, I, Jeroen, D, Jonas, S, Jacques, P, Chris, V, Dirk, Y, Peter, M, Valerio, L, Christophe, M, Olivier, D, Jean, D, Roberto, T, Paul, L, Institute for Advanced Biosciences / Institut pour l'Avancée des Biosciences (Grenoble) (IAB), Centre Hospitalier Universitaire [Grenoble] (CHU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Etablissement français du sang - Auvergne-Rhône-Alpes (EFS)-Centre National de la Recherche Scientifique (CNRS)-Université Grenoble Alpes (UGA), Hôpital la Tronche, Universidad Austral de Chile, Ghent University Hospital, Arcispedale S Maria Nuova, Universidade Estadual de Campinas = University of Campinas (UNICAMP), CHU Pontchaillou [Rennes], Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES), CHU Strasbourg, Universidad de Chile = University of Chile [Santiago] (UCHILE), Hôpital Universitaire de Rangueil, Università degli Studi di Modena e Reggio Emilia = University of Modena and Reggio Emilia (UNIMORE), Universidad de Antioquia = University of Antioquia [Medellín, Colombia], CHU Trousseau [Tours], Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Azienda Ospedale Università di Padova = Hospital-University of Padua (AOUP), Instituto Universitario del Hospital Italiano [Buenos Aires, Argentina], Hôpital JeanMinjoz, Hospital Papa Giovanni XXIII (Hosp P Giovanni XXIII), Hôpital Paul Brousse, Università degli Studi di Roma 'La Sapienza' = Sapienza University [Rome] (UNIROMA), CHU Henri Mondor, Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), None, French-Italian-Belgium and Latin American collaborative group for HCC and liver transplantation: Karim Boudjema, Philippe Bachellier, Filomena Conti, Olivier Scatton, Fabrice Muscari, Ephrem Salame, Pierre Henri Bernard, Claire Francoz, Francois Durand, Sébastien Dharancy, Marie-Lorraine Woehl, Claire Vanlemmens, Alexis Laurent, Sylvie Radenne, Jérôme Dumortier, Armand Abergel, Daniel Cherqui, Louise Barbier, Pauline Houssel-Debry, Georges Philippe Pageaux, Laurence Chiche, Victor Deledinghen, Jean Hardwigsen, J Gugenheim, M Altieri, Marie Noelle Hilleret, Thomas Decaens, Christophe Duvoux, Federico Piñero, Aline Chagas, Paulo Costa, Elaine Cristina de Ataide, Emilio Quiñones, Sergio Hoyos Duque, Sebastián Marciano, Margarita Anders, Adriana Varón, Alina Zerega, Jaime Poniachik, Alejandro Soza, Martín Padilla Machaca, Diego Arufe, Josemaría Menéndez, Rodrigo Zapata, Mario Vilatoba, Linda Muñoz, Ricardo Chong Menéndez, Martín Maraschio, Luis G Podestá, Lucas McCormack, Juan Mattera, Adrian Gadano, Ilka Sf Fatima Boin, Jose Huygens Parente García, Flair Carrilho, Marcelo Silva, Andrea Notarpaolo, Giulia Magini, Lucia Miglioresi, Martina Gambato, Fabrizio Di Benedetto, Cecilia D'Ambrosio, Giuseppe Maria Ettorre, Alessandro Vitale, Patrizia Burra, Stefano Fagiuoli, Umberto Cillo, Michele Colledan, Domenico Pinelli, Paolo Magistri, Giovanni Vennarecci, Marco Colasanti, Valerio Giannelli, Adriano Pellicelli, Cizia Baccaro, Quirino Lai, Helena Degroote, Hans Van Vlierberghe, Callebout Eduard, Iesari Samuele, Dekervel Jeroen, Schreiber Jonas, Pirenne Jacques, Verslype Chris, Ysebaert Dirk, Michielsen Peter, Lucidi Valerio, Moreno Christophe, Detry Olivier, Delwaide Jean, Troisi Roberto, Lerut Jan Paul, Université de Rennes (UR), Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), and CHU Henri Mondor [Créteil]

Subjects
TTR= time to recurrence, [SDV.CAN]Life Sciences [q-bio]/Cancer, Explants pathology, Liver cancer, Liver transplantation, Prediction, Recurrence, MVI= microvascular invasion, VC= validation cohort, VALIDATION, LT= liver transplantation, RETREAT SCORE, SHR= sub-distribution of hazard ratio, R3= recurrence risk reassessment, HBV= hepatitis B virus, SIROLIMUS-BASED IMMUNOSUPPRESSION, Internal Medicine, HCV= hepatitis C virus, Medicine and Health Sciences, IMPROVES, Immunology and Allergy, Hepatology, TC= test cohort, Gastroenterology, DEATH, COMPETING RISKS, MODEL, AFP= alpha-foetoprotein, SORAFENIB, SURVIVAL, HCC= hepatocellular carcinoma, RETREAT= Risk Estimation of Tumour Recurrence After Transplant
Abstract

Background & Aims: Patients with hepatocellular carcinoma (HCC) are selected for liver transplantation (LT) based on pre-LT imaging +/- alpha-foetoprotein (AFP) level, but discrepancies between pre-LT tumour assessment and explant are frequent. Our aim was to design an explant-based recurrence risk reassessment score to refine prediction of recurrence after LT and provide a framework to guide post-LT management.Methods: Adult patients who underwent transplantation between 2000 and 2018 for HCC in 47 centres were included. A prediction model for recurrence was developed using competing-risk regression analysis in a European training cohort (TC; n = 1,359) and tested in a Latin American validation cohort (VC; n=1,085).Results: In the TC, 76.4% of patients with HCC met the Milan criteria, and 89.9% had an AFP score of -4 nodules (sub-distribution of hazard ratio [SHR] = 1.88, 1 point), size of largest nodule (3-6 cm: SHR = 1.83,1 point; >6 cm: SHR = 5.82, 5 points), presence of microvascular invasion (MVI; SHR = 2.69, 2 points), nuclear grade >II (SHR = 1.20, 1 point), and last pre-LT AFP value (101-1,000 ng/ml: SHR = 1.57, 1 point; >1,000 ng/ml: SHR = 2.83, 2 points). Wolber's c-index was 0.76 (95% CI 0.72-0.80), significantly superior to an R3 model without AFP (0.75; 95% CI 0.72-0.79; p = 0.01). Four 5-year recurrence risk categories were identified: very low (score = 0; 5.5%), low (1-2 points; 15.1%), high (3-6 points; 39.1%), and very high (>6 points; 73.9%). The R3-AFP score performed well in the VC (Wolber's c-index of 0.78; 95% CI 0.73-0.83). Conclusions: The R3 score including the last pre-LT AFP value (R3-AFP score) provides a user-friendly, standardised framework to design post-LT surveillance strategies, protocols, or adjuvant therapy trials for HCC not limited to the Milan criteria.Clinical Trials Registration: NCT03775863.Lay summary: Considering discrepancies between pre-LT tumour assessment and explant are frequent, reassessing the risk of recurrence after LT is critical to further refine the management of patients with HCC. In a large and international cohort of patients who underwent transplantation for HCC, we designed and validated the R3-AFP model based on variables inde-pendently associated with recurrence post-LT (number of nodules, size of largest nodule, presence of MVI, nuclear grade, and last pre-LT AFP value). The R3-AFP model including last available pre-LT AFP value outperformed the original R3 model only based on explant features. The final R3-AFP scoring system provides a robust framework to design post-LT surveillance strategies, protocols, or adjuvant therapy trials, irrespective of criteria used to select patients with HCC for LT. (c) 2022 The Author(s). Published by Elsevier B.V. on behalf of European Association for the Study of the Liver (EASL).

Published
2022

9. Incidence and risk factors of early HCC occurrence in HCV patients treated with direct acting antivirals: a prospective multicentre study

Author

Maria Guarino, Nicola Coppola, Luigi Elio Adinolfi, Guido Piai, Massimo De Luca, Antonio Izzi, Morena Fasano, Luca Rinaldi, Fortunato Ciardiello, Ferdinando Carlo Sasso, Riccardo Nevola, Filomena Morisco, Giovanna Valente, Alessandro Perrella, Caterina Monari, Pia Clara Pafundi, Lucia Miglioresi, Erika Martinelli, Barbara Guerrera, Massimiliano Berretta, Rinaldi, Luca, Perrella, Alessandro, Guarino, Maria, De Luca, Massimo, Piai, Guido, Coppola, Nicola, Pafundi, Pia Clara, Ciardiello, Fortunato, Fasano, Morena, Martinelli, Erika, Valente, Giovanna, Nevola, Riccardo, Monari, Caterina, Miglioresi, Lucia, Guerrera, Barbara, Berretta, Massimiliano, Sasso, Ferdinando Carlo, Morisco, Filomena, Izzi, Antonio, Adinolfi, Luigi Elio, Rinaldi, L., Perrella, A., Guarino, M., De Luca, M., Piai, G., Coppola, N., Pafundi, P. C., Ciardiello, F., Fasano, M., Martinelli, E., Valente, G., Nevola, R., Monari, C., Miglioresi, L., Guerrera, B., Berretta, M., Sasso, F. C., Morisco, F., Izzi, A., and Adinolfi, L. E.

Subjects
Liver Cirrhosis, Male, 0301 basic medicine, Cirrhosis, Sustained Virologic Response, Sofosbuvir, lcsh:Medicine, Gastroenterology, chemistry.chemical_compound, 0302 clinical medicine, Risk Factors, Medicine, Cumulative incidence, Prospective Studies, HCC, Incidence, Incidence (epidemiology), HCV cirrhosis, Liver Neoplasms, General Medicine, Middle Aged, 030220 oncology & carcinogenesis, Female, Immune-surveillance, Off Treatment, medicine.drug, medicine.medical_specialty, Carcinoma, Hepatocellular, Antiviral Agents, General Biochemistry, Genetics and Molecular Biology, Direct acting antivirals, 03 medical and health sciences, Diabetes mellitus, Internal medicine, Humans, Aged, business.industry, Research, Ribavirin, lcsh:R, Hepatitis C, Chronic, medicine.disease, digestive system diseases, Regimen, HCV cirrhosi, Logistic Models, 030104 developmental biology, chemistry, Multivariate Analysis, Direct acting antiviral, business
Abstract

Background An unexpected increased HCC recurrence and occurrence rate among HCV patients treated with direct acting antivirals combination has been reported. Aim of the study was the evaluation of early HCC occurrence rate and its risk factors in a HCV infected population, treated with direct-acting-antivirals. Methods According to the Italian ministerial guidelines for direct-acting-antivirals treatment, 1022 consecutive HCV patients treated with direct-acting-antivirals were enrolled. Patients either with active HCC at imaging or history of previous treated HCC, HBV or HIV co-infection, or liver transplant recipients were excluded. The SVR, defined as the persistent absence of detectable serum HCV-RNA 12 weeks after the end of treatment (SVR12), was assessed for all enrolled patients. Abdominal ultrasound was performed before starting antiviral therapy, and repeated every 6 months. HCC was diagnosed according to the international guidelines. Patients showing either nodular patterns suggestive of HCC or with uncertain dynamic vascular behaviour were excluded from a further follow-up. Results Nine hundred and eighty-five patients completed the 48 weeks follow-up after the end of treatment. A Sofosbuvir-based regimen was administered in the 74.9% of patients, among whom, the 71.6% underwent a simultaneous Ribavirin administration. A sustained virological response at 12 weeks off treatment was documented in 966 patients (98.2%). During the post treatment follow-up HCC was detected in 35 patients, with a cumulative incidence rate of the 3.55%. At multivariate analysis, four variables resulted independently associated with HCC development, both in a cirrhosis based and a class B Child based model, respectively: cirrhosis/class B Child, therapeutic schedule including Sofosbuvir without Ribavirin, liver stiffness values, male gender and presence of diabetes. A multivariate analysis performed on Child A cirrhotic patients, showed that Sofosbuvir based therapeutic treatment without Ribavirin had a HCC occurrence 5.7 higher than Ribavirin-based schedules with or without Sofosbuvir (p

Published
2019

10. A Bayesian methodology to improve prediction of early graft loss after liver transplantation derived from the Liver Match study

Author

Mario Angelico, Alessandra Nardi, Renato Romagnoli, Tania Marianelli, Stefano Ginanni Corradini, Francesco Tandoi, Caius Gavrila, Mauro Salizzoni, Antonio D. Pinna, Umberto Cillo, Bruno Gridelli, Luciano G. De Carlis, Michele Colledan, Giorgio E. Gerunda, Alessandro Nanni Costa, Mario Strazzabosco, M. Angelico, U. Cillo, S. Fagiuoli, M. Strazzabosco, P. Caraceni, P.L. Toniutto, A. Nanni Costa, Torino M. Salizzoni, R. Romagnoli, G. Bertolotti, D. Patrono, L. De Carlis, A. Slim, J.M.E. Mangoni, G. Rossi, L. Caccamo, B. Antonelli, V. Mazzaferro, E. Regalia, C. Sposito, M. Colledan, V. Corno, F. Tagliabue, S. Marin, A. Vitale, E. Gringeri, M. Donataccio, D. Donataccio, U. Baccarani, D. Lorenzin, D. Bitetto, U. Valente, M. Gelli, P. Cupo, G.E. Gerunda, G. Rompianesi, A.D. Pinna, G.L. Grazi, A. Cucchetti, C. Zanfi, A. Risaliti, M.G. Faraci, G. Tisone, A. Anselmo, I. Lenci, D. Sforza, S. Agnes, M. Di Mugno, A.W. Avolio, G.M. Ettorre, L. Miglioresi, G. Vennarecci, P. Berloco, M. Rossi, S. Ginanni Corradini, A. Molinaro, F. Calise, V. Scuderi, O. Cuomo, C. Migliaccio, L. Lupo, G. Notarnicola, B. Gridelli, R. Volpes, S. Li Petri, F. Zamboni, G. Carbotta, S. Dedola, A. Nardi, T. Marianelli, C. Gavrila, A. Ricci, F. Vespasiano, Angelico, M., Nardi, A., Romagnoli, R., Marianelli, T., Corradini, S. G., Tandoi, F., Gavrila, C., Salizzoni, M., Pinna, A. D., Cillo, U., Gridelli, B., De Carlis, L. G., Colledan, M., Gerunda, G. E., Costa, A. N., Strazzabosco, M., Fagiuoli, S., Caraceni, P., Toniutto, P. L., Sal-izzoni, T. M., Bertolotti, G., Patrono, D., Decarlis, L., Slim, A., Mangoni, J. M. E., Rossi, G., Caccamo, L., Antonelli, B., Mazzaferro, V., Regalia, E., Sposito, C., Corno, V., Marin, S., Vitale, A., Gringeri, E., Donataccio, M., Donataccio, D., Baccarani, U., Lorenzin, D., Bitetto, D., Valente, U., Gelli, M., Cupo, P., Rompianesi, G., Grazi, G. L., Cucchetti, A., Zanfi, C., Risaliti, A., Faraci, M. G., Tisone, G., Anselmo, A., Lenci, I., Sforza, D., Agnes, S., Di Mugno, M., Avolio, A. M., Ettorre, G. M., Miglioresi, L., Vennarecci, G., Berloco, P., Rossi, M., Corradini, G., Molinaro, A., Calise, F., Scuderi, V., Cuomo, O., Migliaccio, C., Lupo, L., Notarnicola, G., Volpes, R., Lipetri, S., Zamboni, G., Carbotta, G., Dedola, S., Angelico, M, Nardi, A, Romagnoli, R, Marianelli, T, Corradini, S, Tandoi, F, Gavrila, C, Salizzoni, M, Pinna, A, Cillo, U, Gridelli, B, DE CARLIS, L, Colledan, M, Gerunda, G, Costa, A, Strazzabosco, M, and Fagiuoli, S

Subjects
Graft Rejection, Male, liver match, Multivariate analysis, medicine.medical_treatment, Settore MED/18 - CHIRURGIA GENERALE, Disease, Liver transplantation, Body Mass Index, Cohort Studies, MED/12 - GASTROENTEROLOGIA, Risk Factors, liver transplantation, early graft loss, Age Factor, Prospective Studies, Multivariate Analysi, hepatitis c, donor risk index, donor-recipient match, graft failure, transplantation outcome, risk factors, Donor Risk Index, Donor-recipient match, Graft failure, Hepatitis C, Risk factors, Transplantation outcome, Settore MED/12 - Gastroenterologia, Cold Ischemia, Graft Survival, Age Factors, Gastroenterology, Middle Aged, Tissue Donors, Treatment Outcome, Italy, Cohort, Female, Human, Adult, United Network for Organ Sharing, medicine.medical_specialty, Tissue Donor, Delayed Graft Function, Bayesan methodology, Risk Assessment, End Stage Liver Disease, medicine, Humans, Aged, Proportional Hazards Models, Hepatology, business.industry, Proportional hazards model, Risk Factor, Bayes Theorem, medicine.disease, Surgery, Prospective Studie, Multivariate Analysis, Proportional Hazards Model, Cohort Studie, Primary Graft Dysfunction, business, Body mass index, Transplantation Outcome
Abstract

Background: To generate a robust predictive model of Early (3 months) Graft Loss after liver transplantation, we used a Bayesian approach to combine evidence from a prospective European cohort (Liver-Match) and the United Network for Organ Sharing registry. Methods: Liver-Match included 1480 consecutive primary liver transplants performed from 2007 to 2009 and the United Network for Organ Sharing a time-matched series of 9740 transplants. There were 173 and 706 Early Graft Loss, respectively. Multivariate analysis identified as significant predictors of Early Graft Loss: donor age, donation after cardiac death, cold ischaemia time, donor body mass index and height, recipient creatinine, bilirubin, disease aetiology, prior upper abdominal surgery and portal thrombosis. Results: A Bayesian Cox model was fitted to Liver-Match data using the United Network for Organ Sharing findings as prior information, allowing to generate an Early Graft Loss-Donor Risk Index and an Early Graft Loss-Recipient Risk Index. A Donor-Recipient Allocation Model, obtained by adding Early Graft Loss-Donor Risk Index to Early Graft Loss-Recipient Risk Index, was then validated in a distinct United Network for Organ Sharing (year 2010) cohort including 2964 transplants. Donor-Recipient Allocation Model updating using the independent Turin Transplant Centre dataset, allowed to predict Early Graft Loss with good accuracy (c-statistic: 0.76). Conclusion: Donor-Recipient Allocation Model allows a reliable donor and recipient-based Early Graft Loss prediction. The Bayesian approach permits to adapt the original Donor-Recipient Allocation Model by incorporating evidence from other cohorts, resulting in significantly improved predictive capability. © 2013 Editrice Gastroenterologica Italiana S.r.l.

Published
2014

11. Treatment of recurrent genotype 4 hepatitis C after liver transplantation: early virological response is predictive of sustained virological response. An AISF RECOLT-C group study

Author

Luisa Pasulo, Stefano Fagiuoli, L. Miglioresi, Maria Rendina, Maria Marino, Pierluigi Toniutto, Maria Cristina Morelli, Raffaella Viganò, A. Milani, Maria Francesca Donato, Antonio Gasbarrini, Francesca Romana Ponziani, Maurizio Pompili, Raffaella Zaccaria, Daniele Di Paolo, Ponziani, F, Milani, A, Gasbarrini, A, Zaccaria, R, Viganò, R, Donato, M, Morelli, M, Miglioresi, L, Pasulo, L, Rendina, M, Paolo, D, Marino, M, Toniutto, P, Fagiuoli, S, and Pompili, M

Subjects
Adult, Male, medicine.medical_specialty, Genotype, medicine.medical_treatment, Specialties of internal medicine, Hepacivirus, Liver transplantation, Antiviral Agents, Gastroenterology, Polyethylene Glycols, Cohort Studies, Virological response, chemistry.chemical_compound, Hepatitis B, Chronic, Recurrence, Interferon, Internal medicine, Ribavirin, medicine, Humans, Retrospective Studies, Hepatology, Group study, business.industry, Settore MED/09 - MEDICINA INTERNA, Interferon-alpha, Genotype 4, General Medicine, Hepatitis C, Middle Aged, medicine.disease, Recombinant Proteins, Transplantation, Treatment Outcome, Italy, chemistry, RC581-951, Immunology, HCV treatment, Drug Therapy, Combination, Female, business, EVR, medicine.drug, HCV recurrence
Abstract

Introduction. Hepatitis C virus genotype 4 is predominant in the Middle East and Northern Africa, even if it has recently spread to Southern Europe. Data about the treatment of post-liver transplantation (LT) genotype 4 hepatitis C recurrence are scarce. We report a retrospective analysis of post-LT genotype 4 hepatitis C treatment in 9 Italian transplant centres, focusing on the overall survival rates and treatment outcome. Results. Among 452 recipients, we identified 17 HCV genotype 4 patients (16 males, 1 female) transplanted between 1998 and 2007. All patients received combined antiviral treatment with conventional doses of interferon (recombinant or pegylated) and ribavirin after histological diagnosis of hepatitis C recurrence. The observed overall survival after LT was 100% at 1 year and 83.3% at 5 years. More than 1/3 (35.3%) of patients achieved a sustained virological response (SVR) and 40% (data available in 15 subjects) an early virological response (EVR), which was significantly associated with the achievement of SVR (overall accuracy: 85.7%; predictive values of EVR absence/presence 80/88.8%; chi-square p < 0.05). Conclusion. In conclusion, in post-LT genotype 4 hepatitis C treatment, SVR rates are similar to genotype 1. Patients who don't show an EVR are not likely to achieve a SVR.

Published
2012

12. Hepatitis B-core Antibody Positive Donors in Liver Transplantation and Their Impact on Graft Survival: Evidence From The Liver Match Cohort Study

Author

Angelico M, Nardi A, Marianelli T, Caccamo L, Romagnoli R, Tisone G, Pinna AD, Avolio AW, Fagiuoli S, Burra P, Strazzabosco M, Nanni Costa A, U Cillo, P Caraceni, P L Toniutto, M Salizzoni, G Bertolotti, D Patrono, L De Carlis, A Slim, J M E Mangoni, G Rossi, B Antonelli, V Mazzaferro, E Regalia, C Sposito, M Colledan, V Corno, F Tagliabue, S Marin, A Vitale, E Gringeri, M Donataccio, D Donataccio, U Baccarani, D Lorenzin, D Bitetto, U Valente, M Gelli, P Cupo, G E Gerunda, G Rompianesi, G L Grazi, A Cucchetti, C Zanfi, A Risaliti, M G Faraci, A Anselmo, I Lenci, D Sforza, S Agnes, M Di Mugno, G M Ettorre, L Miglioresi, G Vennarecci, Roma Sapienza, P Berloco, M Rossi, S Ginanni-Corradini, A Molinaro, F Calise, V Scuderi, O Cuomo, C Migliaccio, L Lupo, G Notarnicola, B Gridelli, R Volpes, S Li Petri, F Zamboni, G Carbotta, S Dedola, C Gavrila, A Ricci, F Vespasiano, Angelico, M, Nardi, A, Marianelli, T, Caccamo, L, Romagnoli, R, Tisone, G, Pinna, A, Avolio, A, Fagiuoli, S, Burra, P, Strazzabosco, M, Costa, A, M, Angelico, A, Nardi, T, Marianelli, L, Caccamo, R, Romagnoli, G, Tisone, Ad, Pinna, Aw, Avolio, S, Fagiuoli, P, Burra, M, Strazzabosco, A, Nanni Costa, Cillo, U, Caraceni, P, L Toniutto, P, Salizzoni, M, Bertolotti, G, Patrono, D, De Carlis, L, Slim, A, E Mangoni, J M, Rossi, G, Antonelli, B, Mazzaferro, V, Regalia, E, Sposito, C, Colledan, M, Corno, V, Tagliabue, F, Marin, S, Vitale, A, Gringeri, E, Donataccio, M, Donataccio, D, Baccarani, U, Lorenzin, D, Bitetto, D, Valente, U, Gelli, M, Cupo, P, E Gerunda, G, Rompianesi, G, L Grazi, G, Cucchetti, A, Zanfi, C, Risaliti, A, G Faraci, M, Anselmo, A, Lenci, I, Sforza, D, Agnes, S, Di Mugno, M, M Ettorre, G, Miglioresi, L, Vennarecci, G, Sapienza, Roma, Berloco, P, Rossi, M, Ginanni-Corradini, S, Molinaro, A, Calise, F, Scuderi, V, Cuomo, O, Migliaccio, C, Lupo, L, Notarnicola, G, Gridelli, B, Volpes, R, Li Petri, S, Zamboni, F, Carbotta, G, Dedola, S, Gavrila, C, Ricci, A, Vespasiano, F, Mario Angelico, Alessandra Nardi, Tania Marianelli, Lucio Caccamo, Renato Romagnoli, Giuseppe Tisone, Antonio D. Pinna, Alfonso W. Avolio, Stefano Fagiuoli, Patrizia Burra, Mario Strazzabosco, Alessandro Nanni Costa, For the Liver Match Investigators [.., Paolo Caraceni, and ]

Subjects
Male, HBsAg, medicine.medical_treatment, Settore MED/18 - CHIRURGIA GENERALE, graft survival, De novo HBV infection, Donor Risk Index, Donor-recipient matching, HBcAb positive donors, Liver transplantation, medicine.disease_cause, Gastroenterology, Cohort Studies, Model for End-Stage Liver Disease, MED/12 - GASTROENTEROLOGIA, HBcAb positive donor, liver transplantation, Prospective Studies, Prospective cohort study, Settore MED/12 - Gastroenterologia, Hepatitis B Core Antigen, Hazard ratio, Middle Aged, Hepatitis B, Hepatitis B Core Antigens, Tissue Donors, Italy, Hepatocellular carcinoma, HCV, outcome, Female, Human, hbcab positive donors, Adult, medicine.medical_specialty, donor risk index, HBcAb positive, Tissue Donor, survival, donor-recipient matching, Donor Selection, Hepatitis B Antibodie, HBV, liver transplantation, Internal medicine, medicine, Humans, de novo hbv infection, Hepatitis B Antibodies, Donor-recipient matching, HBcAb positive donors, De novo HBV infection, Donor Risk Index, Aged, Hepatitis B virus, Hepatitis, Hepatology, business.industry, LIVER TRANSPLANTATION, medicine.disease, Surgery, Prospective Studie, Liver Transplantation, Graft Survival, Cohort Studie, business
Abstract

Background & Aims: The appropriate allocation of grafts from HBcAb positive donors in liver transplantation is crucial, yet a consensus is still lacking. Methods: We evaluated this issue within Liver Match, a prospective observational Italian study. Data from 1437 consecutive, first transplants performed in 2007-2009 using grafts from deceased heart beating donors were analyzed (median follow-up: 1040 days). Of these, 219 (15.2%) were HBcAb positive. Sixty-six HBcAb positive grafts were allocated to HBsAg positive and 153 to HBsAg negative recipients. Results: 329 graft losses occurred (22.9%): 66 (30.1%) among 219 recipients of HBcAb positive grafts, and 263 (21.6%) among 1218 recipients of HBcAb negative grafts. Graft survival was lower in recipients of HBcAb positive compared to HBcAb negative donors, with unadjusted 3-year graft survival of 0.69 (s.e. 0.032) and 0.77 (0.013), respectively (log-rank, p = 0.0047). After stratifying for recipient HBsAg status, this difference was only observed among HBsAg negative recipients (log rank, p = 0.0007), 3-year graft survival being excellent (0.88, s.e. 0.020) among HBsAg positive recipients, regardless of the HBcAb donor status (log rank, p = 0.4478). Graft loss due to de novo HBV hepatitis occurred only in one patient. At Cox regression, hazard ratios for graft loss were: MELD (1.30 per 10 units, p = 0.0002), donor HBcAb positivity (1.56, p = 0.0015), recipient HBsAg positivity (0.43, p

Published
2012

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