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1. Economic Impact of European Liver and Intestine Transplantation Association (ELITA) Recommendations for Hepatitis B Prophylaxis After Liver Transplantation

Author

Cortesi, Paolo Angelo, Viganò, Raffaella, Conti, Sara, Lenci, Ilaria, Volpes, Riccardo, Martini, Silvia, Angelico, Mario, Fung, James, Buti, Maria, Coilly, Audrey, Durand, Francois, Fondevila, Constantino, Lebray, Pascal, Nevens, Frederik, Polak, Wojciech G., Rizzetto, Mario, Zoulim, Fabien, Perricone, Giovanni, Berenguer, Marina, Mantovani, Lorenzo Giovanni, Duvoux, Christophe, Belli, Luca Saverio, Cortesi, P, Vigano, R, Conti, S, Lenci, I, Volpes, R, Martini, S, Angelico, M, Fung, J, Buti, M, Coilly, A, Durand, F, Fondevila, C, Lebray, P, Nevens, F, Polak, W, Rizzetto, M, Zoulim, F, Perricone, G, Berenguer, M, Mantovani, L, Duvoux, C, Belli, L, and Surgery

Subjects
liver transplant, Transplantation, economic, SDG 3 - Good Health and Well-being, prophylaxi, Humans, Drug Therapy, Combination, economics, prophylaxis, hepatitis B, immunoglobulin (IgG), Antiviral Agents, Liver Transplantation
Abstract

The European Liver and Intestine Transplant Association, ELITA, promoted a Consensus Conference involving 20 experts across the world which generated updated guidelines on HBV prophylaxis in liver transplant candidates and recipients. This study explores the economic impact associated with the implementation of the new ELITA guidelines. To this aim, a condition-specific cohort simulation model has been developed to compare new and historical prophylaxis, including only pharmaceutical cost and using the European perspective. The target population simulated in the model included both prevalent and incident cases, and consisted of 6,133 patients after the first year, that increased to 7,442 and 8,743 patents after 5 and 10 years from its implementation. The ELITA protocols allowed a cost saving of around € 235.65 million after 5 years and € 540.73 million after 10 years; which was mainly due to early HIBG withdrawal either after the first 4 weeks or after the first year post Liver Transplantation (LT) depending on the virological risk at transplantation. Results were confirmed by sensitivity analyses. The money saved by the implementation of the ELITA guidelines would allow healthcare decision makers and budget holders to understand where costs could be reduced and resources re-allocated to different needs. ispartof: TRANSPLANT INTERNATIONAL vol:36 ispartof: location:Switzerland status: published

Published
2023
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2. Effect of direct-acting antivirals on future occurrence of hepatocellular carcinoma in compensated cirrhotic patients

Author

Cucchetti, Alessandro, D’Amico, Gennaro, Trevisani, Franco, Morelli, Maria Cristina, Vitale, Alessandro, Pinna, Antonio Daniele, Cescon, Matteo, Cillo, Umberto, Burra, Patrizia, Russo, Francesco P., Mescoli, Claudia, Rendina, Maria, Lupo, Luigi G., Losito, Francesco, Fucilli, Fabio, Brancaccio, Giusep-Pina, Persico, Marcello, Viganò, Luca, Iavarone, Massimo, D’Ambrosio, Roberta, Sangiovanni, Angelo, Renzulli, Matteo, Galati, Giovanni, Ponziani, Francesca Romana, Pompili, Maurizio, Miele, Luca, Grieco, Antonio, Rapaccini, Gianlodovico, Gasbarrini, Antonio, Sandri, Giovanni Battisa Levi, Lai, Quirino, Melandro, Fabio, Rossi, Massimo, Lenci, Ilaria, Manzia, Tommaso Maria, Tortora, Raffaella, Di Costanzo, Giovan Giuseppe, Sacco, Rodolfo, Simonetti, Natalia, Morisco, Filomena, Guarino, Maria, Cabibbo, Giuseppe, Bhoori, Carlo Sposito Sherrie, Di Sandro, Stefano, Foschi, Francesco Giuseppe, Gardini, Andrea Casadei, Nicolini, Daniele, Mazzocato, Susanna, Alba, Kostandini, Violi, Paola, Baccarani, Umberto, Pravisani, Riccardo, A. Cucchetti, G. D'Amico, F. Trevisani, M.C. Morelli, A. Vitale, A.D.Pinna, M. Cescon, Cucchetti, Alessandro, D’Amico, Gennaro, Trevisani, Franco, Morelli, Maria Cristina, Vitale, Alessandro, Pinna, Antonio Daniele, Cescon, Matteo, Cillo, Umberto, Burra, Patrizia, Russo, Francesco P., Mescoli, Claudia, Rendina, Maria, Lupo, Luigi G., Losito, Francesco, Fucilli, Fabio, Brancaccio, Giusep-Pina, Persico, Marcello, Viganò, Luca, Iavarone, Massimo, D’Ambrosio, Roberta, Sangiovanni, Angelo, Renzulli, Matteo, Galati, Giovanni, Ponziani, Francesca Romana, Pompili, Maurizio, Miele, Luca, Grieco, Antonio, Rapaccini, Gianlodovico, Gasbarrini, Antonio, Sandri, Giovanni Battisa Levi, Lai, Quirino, Melandro, Fabio, Rossi, Massimo, Lenci, Ilaria, Manzia, Tommaso Maria, Tortora, Raffaella, Di Costanzo, Giovan Giuseppe, Sacco, Rodolfo, Simonetti, Natalia, Morisco, Filomena, Guarino, Maria, Cabibbo, Giuseppe, Bhoori, Carlo Sposito Sherrie, Di Sandro, Stefano, Foschi, Francesco Giuseppe, Gardini, Andrea Casadei, Nicolini, Daniele, Mazzocato, Susanna, Alba, Kostandini, Violi, Paola, Baccarani, Umberto, and Pravisani, Riccardo

Subjects
Male, Time Factors, Sustained Virologic Response, Hepatocellular carcinoma, Hepacivirus, Direct-acting antiviral, Direct-acting antivirals, medicine.disease_cause, Gastroenterology, Competing risk, Hepatitis C, Markov model, Survival benefit, Sustained virological response, Hepatology, 0302 clinical medicine, Risk Factors, 030212 general & internal medicine, biology, Incidence, Incidence (epidemiology), Liver Neoplasms, Middle Aged, Markov Chains, Competing risk Direct-acting antivirals Hepatitis C Hepatocellular carcinoma Markov model Survival benefit Sustained virological response, Italy, Liver Neoplasm, Female, 030211 gastroenterology & hepatology, Human, Adult, medicine.medical_specialty, Carcinoma, Hepatocellular, Time Factor, Hepatitis C virus, Antiviral Agents, 03 medical and health sciences, Internal medicine, medicine, Humans, Antiviral Agent, Hepaciviru, business.industry, Risk Factor, Carcinoma, Hepatocellular, Markov Chain, medicine.disease, biology.organism_classification, digestive system diseases, Settore MED/18 - Chirurgia Generale, Liver function, Varices, business
Abstract

Background: The achievement of high rates of sustained virological response (SVR) with direct-acting antivirals (DAAs) in hepatitis C virus (HCV) infected patients will reduce decompensating terminal events. Aims: To investigate whether hepatocellular carcinoma (HCC) occurrence could change due to the DAA-induced increase in life-expectancy. Methods: A Markov model was built on clinical data of 494 cirrhotic patients and available literature to estimate probabilities of “death before HCC” and of “HCC occurrence” without and with DAA. Results: In comparison to untreated patients, DAA therapy reduced the 20-year mortality before HCC by 21.9% in patients without varices and by 21.5% in those with varices, considering an SVR of 95% and no direct effect on hepatocarcinogenesis. Tumour occurrence increased by 5%–8.2% and the proportion of HCCs diagnosed in compensated stages increased to >98%. If we consider DAA as having “anti-tumoral” effects, the benefit becomes greater, achieving a 20-year survival of 81.5% in patients without varices, and 52.2% in patients with varices. Instead, if we consider DAA as having a “pro-tumoral” effect, then, the increased incidence of HCC nullifies the survival benefits. Conclusion: DAAs drastically reduce the mortality caused by the liver function worsening, increasing the proportion of HCCs diagnosed in compensated stages. Knowledge of the DAA effect on hepatocarcinogenesis remains pivotal. © 2017 Editrice Gastroenterologica Italiana S.r.l.

Published
2018
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3. Recurrence of hepatocellular carcinoma after direct acting antiviral treatment for hepatitis C virus infection: Literature review and risk analysis

Author

Guarino, Maria, Viganò, Luca, Ponziani, Francesca Romana, Giannini, Edoardo Giovanni, Lai, Quirino, Morisco, Filomena, Vitale, Alessandro, Russo, Francesco Paolo, Cillo, Umberto, Burra, Patrizia, Mescoli, Claudia, Gambato, Martina, Sessa, Anna, Cabibbo, Giuseppe, Viganò, Mauro, Galati, Giovanni, Villa, Erica, Iavarone, Massimo, Brancaccio, Giuseppina, Rendina, Maria, Lupo, Luigi G., Losito, Francesco, Fucilli, Fabio, Persico, Marcello, D'Ambrosio, Roberta, Sangiovanni, Angelo, Cucchetti, Alessandro, Trevisani, Franco, Matteo, Renzulli, Miele, Luca, Grieco, Antonio, Lodovico Rapaccini, Gian, Pompili, Maurizio, Gasbarrini, Antonio, Battisa Levi Sandri, Giovanni, Melandro, Fabio, Rossi, Massimo, Lenci, Ilaria, Manzia, Tommaso Maria, Tortora, Raffaella, Di Costanzo, Giovan Giuseppe, Sacco, Rodolfo, Ghinolfi, Davide, Rreka, Erion, Carrai, Paola, Simonetti, Natalia, Sposito, Carlo, Bhoori, Sherrie, di Sandro, Stefano, Foschi, Francesco Giuseppe, Casadei Gardini, Andrea, Nicolini, Daniele, Mazzocato, Susanna, Kostandini, Alba, Violi, Paola, Baccarani, Umberto, Pravisani, Riccardo, Vincenzi, Valter, ROSA MARIA, Guarino, Luca, Viganò, Francesca Romana, Ponziani, Edoardo Giovanni, Giannini, Quirino, Lai, Filomena, Morisco, Alessandro, Vitale, Russo, Francesco Paolo, Umberto, Cillo, Patrizia, Burra, Claudia, Mescoli, Martina, Gambato, Anna, Sessa, Cabibbo, Giuseppe, Viganò, Mauro, Galati, Giovanni, Erica, Villa, Iavarone, Massimo, Brancaccio, Giuseppina, Maria, Rendina, Luigi G., Lupo, Francesco, Losito, Fabio, Fucilli, Marcello, Persico, Roberta, D'Ambrosio, Angelo, Sangiovanni, Alessandro, Cucchetti, Franco, Trevisani e Matteo Renzulli, Luca, Miele, Antonio, Grieco, Gian, Lodovico Rapaccini, Maurizio, Pompili, Antonio, Gasbarrini, Giovanni, Battisa Levi Sandri, Fabio, Melandro, Massimo, Rossi, Ilaria, Lenci, Tommaso, Maria Manzia, Raffaella, Tortora, Giovan Giuseppe, Di Costanzo, Sacco, Rodolfo, Davide, Ghinolfi, Erion, Rreka, Paola, Carrai, Natalia, Simonetti, Carlo, Sposito, Sherrie, Bhoori, Stefano, di Sandro, Francesco Giuseppe, Foschi, Andrea, Casadei Gardini, Daniele, Nicolini, Susanna, Mazzocato, Kostandini, Alba, Paola, Violi, Umberto, Baccarani, Riccardo, Pravisani, Valter, Vincenzi, Guarino, Maria, Viganò, Luca, Ponziani, Francesca Romana, Giannini, Edoardo Giovanni, Lai, Quirino, Morisco, Filomena, Vitale, Alessandro, Cillo, Umberto, Burra, Patrizia, Mescoli, Claudia, Gambato, Martina, Sessa, Anna, Villa, Erica, Rendina, Maria, Lupo, Luigi G., Losito, Francesco, Fucilli, Fabio, Persico, Marcello, D'Ambrosio, Roberta, Sangiovanni, Angelo, Cucchetti, Alessandro, Trevisani e Matteo Renzulli, Franco, Miele, Luca, Grieco, Antonio, Lodovico Rapaccini, Gian, Pompili, Maurizio, Gasbarrini, Antonio, Battisa Levi Sandri, Giovanni, Melandro, Fabio, Rossi, Massimo, Lenci, Ilaria, Manzia, Tommaso Maria, Tortora, Raffaella, Di Costanzo, Giovan Giuseppe, Ghinolfi, Davide, Rreka, Erion, Carrai, Paola, Simonetti, Natalia, Sposito, Carlo, Bhoori, Sherrie, di Sandro, Stefano, Foschi, Francesco Giuseppe, Casadei Gardini, Andrea, Nicolini, Daniele, Mazzocato, Susanna, Violi, Paola, Baccarani, Umberto, Pravisani, Riccardo, Vincenzi, Valter, CASADEI GARDINI, Andrea, Trevisani, Franco, and Matteo, Renzulli

Subjects
Oncology, Liver Cirrhosis, Cirrhosis, Sustained Virologic Response, DAA, HCC, HCV, Recurrence, medicine.disease_cause, law.invention, 0302 clinical medicine, Randomized controlled trial, law, Antiviral Agents, Carcinoma, Hepatocellular, Disease Progression, Hepatitis C, Chronic, Humans, Liver Neoplasms, Neoplasm Recurrence, Local, Neoplasm Staging, Risk Assessment, Chronic, Gastroenterology, hepatocellular carcinoma, Hepatitis C, Local, Hepatology, 030220 oncology & carcinogenesis, Hepatocellular carcinoma, 030211 gastroenterology & hepatology, Risk assessment, Direct acting, Risk analysis, medicine.medical_specialty, Hepatitis C virus, DAA, HCC, HCV, Recurrence, 03 medical and health sciences, Internal medicine, medicine, Antiviral treatment, business.industry, Carcinoma, Hepatocellular, medicine.disease, Settore MED/18 - Chirurgia Generale, Neoplasm Recurrence, business
Abstract

Although studies suggest decreased incident hepatocellular carcinoma (HCC) after treatment with direct-acting antivirals (DAAs) for hepatitis C virus (HCV) infection, data are conflicting regarding risk and aggressiveness of recurrence in patients who have a history of treated HCC. This review analyses data available in literature in order to elucidate the impact of DAAs on the risk of HCC recurrence after successful treatment of the tumor. Overall 24 papers were identified. The available data cannot be considered definitive, but the initial alarmist data indicating an increased risk of recurrence have not been confirmed by most subsequent studies. The suggested aggressive pattern (rapid growth and vascular invasion) of tumor recurrence after DAAs still remains to be confirmed. Several limitations of the available studies were highlighted, and should drive future researches. The time-to-recurrence should be computed since the last HCC treatment and results stratified for cirrhosis and sustained viral response. Any comparison with historical series is of limited interest because of a number of biases affecting these studies and differences between enrolled patients. Prospective intention-to-treat analyses will be probably the best contribution to drive clinical practice, provided that a randomized trial can be difficult to design.

Published
2018

4. Prevalence of Single and Multiple Natural NS3, NS5A and NS5B Resistance-Associated Substitutions in Hepatitis C Virus Genotypes 1-4 in Italy

Author

Bertoli, Ada, Sorbo, Maria Chiara, Aragri, Marianna, Lenci, Ilaria, Teti, Elisabetta, Polilli, Ennio, Di Maio, Velia Chiara, Gianserra, Laura, Biliotti, Elisa, Masetti, Chiara, Magni, Carlo F., Babudieri, Sergio, Nicolini, Laura A., Milana, Martina, Cacciatore, Pierluigi, Sarmati, Loredana, Pellicelli, Adriano, Paolucci, Stefania, Craxì, Antonio, Morisco, Filomena, Palitti, Valeria Pace, Siciliano, Massimo, Coppola, Nicola, Iapadre, Nerio, Puoti, Massimo, Rizzardini, Giuliano, Taliani, Gloria, Pasquazzi, Caterina, Andreoni, Massimo, Parruti, Giustino, Angelico, Mario, Perno, Carlo Federico, Cento, Valeria, Ceccherini-Silberstein, Francesca, Andreone, Pietro, Baldanti, Fausto, Barbarini, Giorgio, Boccaccio, Vincenzo, Boglione, Lucio, Bolis, Matteo, Bonora, Stefano, Borghi, Vanni, Brancaccio, Giuseppina, Bruno, Savino, Bruzzone, Bianca, Calvaruso, Vincenza, Caporaso, Nicola, Ciaccio, Antonio, Ciancio, Alessia, Colombatto, Piero, Cozzolongo, Raffaele, D'Ambrosio, Cecilia, D'Ettorre, Gabriella, De Leonardis, Francesco, De Luca, Andrea, Di Biagio, Antonio, Di Perri, Giovanni, Francioso, Simona, Gaeta, Giovanni Battista, Gasbarrini, Antonio, Ghisetti, Valeria, Giorgini, Alessia, Grieco, Antonio, Gubertini, Guido, Gulminetti, Roberto, Lambiase, Lara, Landonio, Simona, Lichtner, Miriam, Maida, Ivana, Marenco, Simona, Marinaro, Letizia, Maserati, Renato, Melis, Michela, Menzaghi, Barbara, Meregalli, Elisa, Micheli, Valeria, Niero, Fosca, Paoloni, Maurizio, Pieri, Alessandro, Rendina, Maria, Romagnoli, Dante, Rossetti, Barbara, Ruggiero, Tina, Sangiovanni, Vincenzo, Starace, Mario, Sticchi, Laura, Tarquini, Pierluigi, Toniutto, Pierluigi, Vullo, Vincenzo, Zazzi, Maurizio, HCV Virology Italian Resistance Network, Bertoli A1, Sorbo MC1, Aragri M1, Lenci I2, Teti E3, Polilli E4, Di Maio VC1, Gianserra L5, Biliotti E6, Masetti C2, Magni CF7, Babudieri S8, Nicolini LA9, Milana M2, Cacciatore P4, Sarmati L3, Pellicelli A10, Paolucci S11, Craxì A, Morisco F13, Palitti VP14, Siciliano M15, Coppola N16, Iapadre N17, Puoti M18, Rizzardini G7, Taliani G6, Pasquazzi C5, Andreoni M3, Parruti G4, Angelico M2, Perno CF19, Cento V20, Ceccherini-Silberstein F1, HCV Virology Italian Resistance Network (VIRONET-C)., Bertoli, Ada, Sorbo, Maria Chiara, Aragri, Marianna, Lenci, Ilaria, Teti, Elisabetta, Polilli, Ennio, Di Maio, Velia Chiara, Gianserra, Laura, Biliotti, Elisa, Masetti, Chiara, Magni, Carlo F., Babudieri, Sergio, Nicolini, Laura A., Milana, Martina, Cacciatore, Pierluigi, Sarmati, Loredana, Pellicelli, Adriano, Paolucci, Stefania, Craxì, Antonio, Morisco, Filomena, Palitti, Valeria Pace, Siciliano, Massimo, Coppola, Nicola, Iapadre, Nerio, Puoti, Massimo, Rizzardini, Giuliano, Taliani, Gloria, Pasquazzi, Caterina, Andreoni, Massimo, Parruti, Giustino, Angelico, Mario, Perno, Carlo Federico, Cento, Valeria, Ceccherini-Silberstein, Francesca, Andreone, Pietro, Baldanti, Fausto, Barbarini, Giorgio, Boccaccio, Vincenzo, Boglione, Lucio, Bolis, Matteo, Bonora, Stefano, Borghi, Vanni, Brancaccio, Giuseppina, Bruno, Savino, Bruzzone, Bianca, Calvaruso, Vincenza, Caporaso, Nicola, Ciaccio, Antonio, Ciancio, Alessia, Colombatto, Piero, Cozzolongo, Raffaele, D'Ambrosio, Cecilia, D'Ettorre, Gabriella, De Leonardis, Francesco, De Luca, Andrea, Di Biagio, Antonio, Di Perri, Giovanni, Francioso, Simona, Gaeta, Giovanni Battista, Gasbarrini, Antonio, Ghisetti, Valeria, Giorgini, Alessia, Grieco, Antonio, Gubertini, Guido, Gulminetti, Roberto, Lambiase, Lara, Landonio, Simona, Lichtner, Miriam, Maida, Ivana, Marenco, Simona, Marinaro, Letizia, Maserati, Renato, Melis, Michela, Menzaghi, Barbara, Meregalli, Elisa, Micheli, Valeria, Niero, Fosca, Paoloni, Maurizio, Pieri, Alessandro, Rendina, Maria, Romagnoli, Dante, Rossetti, Barbara, Ruggiero, Tina, Sangiovanni, Vincenzo, Starace, Mario, Sticchi, Laura, Tarquini, Pierluigi, Toniutto, Pierluigi, Vullo, Vincenzo, Zazzi, Maurizio, Bertoli, A, Sorbo, M, Aragri, M, Lenci, I, Teti, E, Polilli, E, Di Maio, V, Gianserra, L, Biliotti, E, Masetti, C, Magni, C, Babudieri, S, Nicolini, L, Milana, M, Cacciatore, P, Sarmati, L, Pellicelli, A, Paolucci, S, Craxi, A, Morisco, F, Palitti, V, Siciliano, M, Coppola, N, Iapadre, N, Puoti, M, Rizzardini, G, Taliani, G, Pasquazzi, C, Andreoni, M, Parruti, G, Angelico, M, Perno, C, Cento, V, Ceccherini-Silberstein, F, Andreone, P, Baldanti, F, Barbarini, G, Boccaccio, V, Boglione, L, Bolis, M, Bonora, S, Borghi, V, Brancaccio, G, Bruno, S, Bruzzone, B, Calvaruso, V, Caporaso, N, Ciaccio, A, Ciancio, A, Colombatto, P, Cozzolongo, R, D'Ambrosio, C, D'Ettorre, G, De Leonardis, F, De Luca, A, Di Biagio, A, Di Perri, G, Francioso, S, Gaeta, G, Gasbarrini, A, Ghisetti, V, Giorgini, A, Grieco, A, Gubertini, G, Gulminetti, R, Lambiase, L, Landonio, S, Lichtner, M, Maida, I, Marenco, S, Marinaro, L, Maserati, R, Melis, M, Menzaghi, B, Meregalli, E, Micheli, V, Niero, F, Paoloni, M, Pieri, A, Rendina, M, Romagnoli, D, Rossetti, B, Ruggiero, T, Sangiovanni, V, Starace, M, Sticchi, L, Tarquini, P, Toniutto, P, Vullo, V, Zazzi, M, Sorbo, Mc, Di Maio, Vc, Magni, Cf, Nicolini, La, Craxì, A, Palitti, Vp, Perno, Cf, Gaeta, Gb, and Zazzi, M.

Subjects
Male, 0301 basic medicine, Sofosbuvir, Hepacivirus, Drug Resistance, lcsh:Medicine, Viral Nonstructural Proteins, medicine.disease_cause, Gastroenterology, Hepatitis C Virus, HCV resistance-test, chemistry.chemical_compound, 0302 clinical medicine, Genotype, Prevalence, Viral, lcsh:Science, Multidisciplinary, biology, Hepatitis C, Middle Aged, Settore MED/07 - Microbiologia e Microbiologia Clinica, Italy, Cohort, HCV, Female, 030211 gastroenterology & hepatology, medicine.drug, Adult, medicine.medical_specialty, HCV RAS, Hepatitis C virus, 03 medical and health sciences, Internal medicine, Drug Resistance, Viral, medicine, Humans, Aged, NS5A, NS5B, business.industry, lcsh:R, Hepatitis C Virus, HCV resistance-test, biology.organism_classification, medicine.disease, 030104 developmental biology, chemistry, lcsh:Q, business
Abstract

Natural resistance-associated substitutions (RASs) are reported with highly variable prevalence across different HCV genotypes (GTs). Frequency of natural RASs in a large Italian real-life cohort of patients infected with the 4 main HCV-GTs was investigated. NS3, NS5A and NS5B sequences were analysed in 1445 HCV-infected DAA-naïve patients. Sanger-sequencing was performed by home-made protocols on 464 GT1a, 585 GT1b, 92 GT2c, 199 GT3a, 16 GT4a and 99 GT4d samples. Overall, 20.7% (301/1455) of patients showed natural RASs, and the prevalence of multiclass-resistance was 7.3% (29/372 patients analysed). NS3-RASs were particularly common in GT1a and GT1b (45.2-10.8%, respectively), mainly due to 80K presence in GT1a (17%). Almost all GTs showed high prevalence of NS5A-RASs (range: 10.2–45.4%), and especially of 93H (5.1%). NS5A-RASs with fold-change >100x were detected in 6.8% GT1a (30H/R-31M-93C/H), 10.3% GT1b (31V-93H), 28.4% GT2c (28C-31M-93H), 8.5% GT3a (30K-93H), 45.5% GT4a (28M-30R-93H) and 3.8% GT4d (28V-30S-93H). Sofosbuvir RAS 282T was never detected, while the 159F and 316N RASs were found in GT1b (13.4–19.1%, respectively). Natural RASs are common in Italian patients infected with HCV-GTs 1–4. High prevalence of clinically-relevant RASs (such as Y93H) supports the appropriateness of HCV resistance-test to properly guide DAA-based therapy.

Published
2018

5. Direct-acting antivirals and hepatocellular carcinoma in chronic hepatitis C: A few lights and many shadows

Author

Guarino, Maria, Sessa, Anna, Cossiga, Valentina, Morando, Federica, Caporaso, Nicola, Morisco, Filomena, Luca, Viganó, Romana, Ponziani Francesca, Maurizio, Pompili, Cillo, Umberto, Burra, Patrizia, Mescoli, Claudia, Gambato, Martina, Russo, FRANCESCO PAOLO, Vitale, Alessandro, Giuseppe, Cabibbo, Mauro, Vigano', Giovanni, Galati, Erica, Villa, Lupo, Luigi G., Maria, Rendina, Losito, Francesco, Fucilli, Fabio, Persico, Marcello, D'Ambrosio, Roberta, Sangiovanni, Angelo, Massimo, Iavarone, Brancaccio, Giuseppina, Cucchetti, Alessandro, Renzulli, Matteo, Franco, Trevisani, Miele, Luca, Grieco, Antonio, Rapaccini, Gianlodovico, Gasbarrini, Antonio, Sandri, Giovanni Battisa Levi, Melandro, Fabio, Rossi, Massimo, Quirino, Lai, Lenci, Ilaria, Manzia, Tommaso Maria, Tortora, Raffaella, Di Costanzo, Giovan Giuseppe, Ghinolfi, Davide, Rreka, Erion, Carrai, Paola, Simonetti, Natalia, Rodolfo, Sacco, Sposito, Carlo, Bhoori, Sherrie, Di Sandro, Stefano, Foschi, Francesco Giuseppe, Gardini, Andrea Casadei, Nicolini, Daniele, Mazzocato, Susanna, Alba, Kostandini, Violi, Paola, Baccarani, Umberto, Pravisani, Riccardo, Vincenzi, Valter, Maria, Guarino, Anna, Sessa, Valentina, Cossiga, Federica, Morando, Nicola, Caporaso, Filomena, Morisco, Viganó, Luca, Ponziani Francesca, Romana, Pompili, Maurizio, Umberto, Cillo, Patrizia, Burra, Claudia, Mescoli, Martina, Gambato, Russo Francesco, Paolo, Vitale, Alessandro, Cabibbo, Giuseppe, Vigano', Mauro, Galati, Giovanni, Villa, Erica, Luigi G., Lupo, Rendina, Maria, Francesco, Losito, Fabio, Fucilli, Marcello, Persico, Roberta, D'Ambrosio, Angelo, Sangiovanni, Iavarone, Massimo, Brancaccio, Giuseppina, Alessandro, Cucchetti, Matteo, Renzulli, Trevisani, Franco, Luca, Miele, Antonio, Grieco, Gianlodovico, Rapaccini, Antonio, Gasbarrini, Giovanni Battisa Levi, Sandri, Fabio, Melandro, Massimo, Rossi, Lai, Quirino, Ilaria, Lenci, Tommaso Maria, Manzia, Raffaella, Tortora, Giovan Giuseppe, Di Costanzo, Davide, Ghinolfi, Erion, Rreka, Paola, Carrai, Natalia, Simonetti, Sacco, Rodolfo, Carlo, Sposito, Sherrie, Bhoori, Stefano, Di Sandro, Francesco Giuseppe, Foschi, Andrea Casadei, Gardini, Daniele, Nicolini, Susanna, Mazzocato, Kostandini, Alba, Paola, Violi, Umberto, Baccarani, Riccardo, Pravisani, Valter, Vincenzi, Guarino, Maria, Sessa, Anna, Cossiga, Valentina, Morando, Federica, Caporaso, Nicola, Morisco, Filomena, Luca, Viganó, Romana, Ponziani Francesca, Maurizio, Pompili, Cillo, Umberto, Burra, Patrizia, Mescoli, Claudia, Gambato, Martina, Paolo, Russo Francesco, Alessandro, Vitale, Giuseppe, Cabibbo, Mauro, Vigano', Giovanni, Galati, Erica, Villa, Lupo, Luigi G., Maria, Rendina, Losito, Francesco, Fucilli, Fabio, Persico, Marcello, D'Ambrosio, Roberta, Sangiovanni, Angelo, Massimo, Iavarone, Giuseppina, Brancaccio, Cucchetti, Alessandro, Renzulli, Matteo, Franco, Trevisani, Miele, Luca, Grieco, Antonio, Rapaccini, Gianlodovico, Gasbarrini, Antonio, Sandri, Giovanni Battisa Levi, Melandro, Fabio, Rossi, Massimo, Quirino, Lai, Lenci, Ilaria, Manzia, Tommaso Maria, Tortora, Raffaella, Di Costanzo, Giovan Giuseppe, Ghinolfi, Davide, Rreka, Erion, Carrai, Paola, Simonetti, Natalia, Rodolfo, Sacco, Sposito, Carlo, Bhoori, Sherrie, Di Sandro, Stefano, Foschi, Francesco Giuseppe, Gardini, Andrea Casadei, Nicolini, Daniele, Mazzocato, Susanna, Alba, Kostandini, Violi, Paola, Baccarani, Umberto, Pravisani, Riccardo, and Vincenzi, Valter

Subjects
Oncology, Cirrhosis, Direct-acting antiviral agent, Sustained Virologic Response, Direct-acting antiviral agents, Hepatitis C virus, Hepatocellular carcinoma, Occurrence, Recurrence, Antiviral Agents, Carcinoma, Hepatocellular, Disease Progression, Hepacivirus, Hepatitis C, Chronic, Humans, Incidence, Liver, Liver Neoplasms, Neoplasm Recurrence, Local, Risk Factors, Treatment Outcome, Gastroenterology, medicine.disease_cause, DIRECT ACTING ANTIVIRALS, 0302 clinical medicine, Chronic, biology, Incidence (epidemiology), Minireviews, General Medicine, Hepatitis C, Local, Liver Neoplasm, 030220 oncology & carcinogenesis, 030211 gastroenterology & hepatology, Human, medicine.medical_specialty, Interferon therapy, 03 medical and health sciences, Chronic hepatitis, Internal medicine, medicine, Antiviral Agent, Hepaciviru, business.industry, Risk Factor, Carcinoma, Hepatocellular, medicine.disease, biology.organism_classification, digestive system diseases, Settore MED/18 - Chirurgia Generale, Neoplasm Recurrence, business, Hepatitis C viru
Abstract

With the introduction of direct-acting antiviral agents (DAA), the rate of sustained virological response (SVR) in the treatment of hepatitis C virus (HCV) has radically improved to over 95%. Robust scientific evidence supports a beneficial role of SVR after interferon therapy in the progression of cirrhosis, resulting in a decreased incidence of hepatocellular carcinoma (HCC). However, a debate on the impact of DAAs on the development of HCC is ongoing. This review aimed to analyse the scientific literature regarding the risk of HCC in terms of its recurrence and occurrence after the use of DAAs to eradicate HCV infection. Among 11 studies examining HCC occurrence, the de novo incidence rate ranged from 0 to 7.4% (maximum follow-up: 18 mo). Among 18 studies regarding HCC recurrence, the rate ranged from 0 to 54.4% (maximum "not well-defined" followup: 32 mo). This review highlights the major difficulties in interpreting data and reconciling the results of the included studies. These difficulties include heterogeneous cohorts, potential misclassifications of HCC prior to DAA therapy, the absence of an adequate control group, short follow-up times and different kinds of follow-up. Moreover, no clinical feature-based scoring system accounts for the molecular characteristics and pathobiology of the tumours. Nonetheless, this review does not suggest that there is a higher rate of de novo HCC occurrence or recurrence after DAA therapy in patients with previous HCV infection. © 2018 The Author(s). Published by Baishideng Publishing Group Inc. All rights reserved.

Published
2018

6. Possible application of melatonin treatment in human diseases of the biliary tract

Author

Shannon Glaser, Zhihong Yang, Lenci Ilaria, Lindsey Kennedy, Suthat Liangpunsakul, Praveen Kusumanchi, Leonardo Baiocchi, Ludovica Ceci, Heather Francis, Gianfranco Alpini, Fanyin Meng, Martina Milana, and Tianhao Zhou

Subjects
0301 basic medicine, medicine.medical_specialty, endocrine system, Physiology, Biliary Tract Diseases, Review, Antioxidants, Melatonin, 03 medical and health sciences, 0302 clinical medicine, Physiology (medical), Internal medicine, Medicine, Animals, Humans, Settore MED/12 - Gastroenterologia, Hepatology, business.industry, Liver Diseases, Gastroenterology, Central Nervous System Depressants, Melatonin treatment, Melatonin metabolism, 030104 developmental biology, Endocrinology, Biliary tract, business, 030217 neurology & neurosurgery, hormones, hormone substitutes, and hormone antagonists, medicine.drug
Abstract

Melatonin was discovered in 1958 by Aaron Lerner. Its name comes from the ability of melatonin to change the shape of amphibian melanophores from stellate to roundish. Starting from the 1980s, the role of melatonin in the regulation of mammalian circadian and seasonal clocks has been elucidated. Presently, several other effects have been identified in different organs. For example, the beneficial effects of melatonin in models of liver damage have been described. This review gives first a general background on experimental and clinical data on the use of melatonin in liver damage. The second part of the review focuses on the findings related to the role of melatonin in biliary functions, suggesting a possible use of melatonin therapy in human diseases of the biliary tree.

Published
2019

7. Left adrenal hepatocellular carcinoma recurrence in liver transplanted patient

Author

Parente Alessandro, Lenci Ilaria, Baiocchi Leonardo, Manzia Tommaso Maria, and Tisone Giuseppe

Subjects
medicine.medical_specialty, Cirrhosis, medicine.diagnostic_test, business.industry, Hepatic resection, medicine.medical_treatment, Milan criteria, Liver transplantation, medicine.disease, Gastroenterology, digestive system diseases, Left adrenal gland, Internal medicine, Hepatocellular carcinoma, medicine, Blood test, Lymph, business
Abstract

Hepatocellular carcinoma (HCC) recurrence after liver transplantation (LT) has been reported in less than 20% of patients fulfilling Milan Criteria. Mostly, it occurs within the liver, lungs, lymph nodes, bones and brain. A 45 years old Caucasian man affected by HCV-related liver cirrhosis with HCC, who underwent several multi-modal treatments, including hepatic resection, liver transplantation and loco regional treatment presented in our Department with an unusual mass within the left adrenal gland. No clinical signs were associated. However, considering his blood test and the high risk of HCC recurrence, a mini-invasive left surrenalectomy was performed showing HCC metastases in the left adrenal gland. This case shows that even extremely rare sites of HCC metastases have to be investigated, especially if, despite all available treatments, still persist a clinical or laboratory suspect.

Published
2019
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8. 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
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9. Common issues in the management of patients on the waiting list and after liver transplantation: HCV, HBV, alcoholic liver disease, immunosuppression

Author

Burra, Patrizia, Belli, Luca Saverio, GINANNI CORRADINI, Stefano, Volpes, Riccardo, Marzioni, Marco, Giannini, Edoardo, Toniutto, Pierluigi, Carrai, Paola, Donato, Francesca, Lanza Galeota, Alfonso, Martini, Silvia, Pasulo, Luisa, Ponziani, Francesca, Russo, Francesco Paolo, Coppola, Carmine, Forte, Paolo, Mazzarelli, Chiara, Merli, Manuela, Montalbano, Marzia, Picciotto, Francesco Paolo, Rendina, Maria, Zanetto, Alberto, Angeli, Paolo, Foschi, Francesco, Manini, Matteo, Marzano, Alfredo, Perricone, Giovanni, Pianta, Paolo, Tamè, Mariarosa, De Maria, Nicola, Domenicali, Marco, Germani, Giacomo, Ottobrelli, Antonio, Picciotto, Antonio, Ponti, Laura, Vizzini, Giovanni, Bhoori, Sherrie, Ferri, Flaminia, Gaffuri, Giovanna, Lenci, Ilaria, Mameli, Laura, Morelli, Maria Cristina, and Piras, Maria Rosaria

Subjects
Alcoholic liver disease, DAAs, HBV recurrence, Immunosuppression, Liver transplantation, Hepatology, Gastroenterology
Published
2017

10. Improvement of ALT decay kinetics by all-oral HCV treatment: role of NS5A inhibitors and differences with IFN-based regimens

Author

Cento, Valeria, Nguyen, Thi Huyen Tram, Di Carlo, Domenico, Biliotti, Elisa, Gianserra, Laura, Lenci, Ilaria, Di Paolo, Daniele, Calvaruso, Vincenza, Teti, Elisabetta, Cerrone, Maddalena, Romagnoli, Dante, Melis, Michela, Danieli, Elena, Menzaghi, Barbara, Polilli, Ennio, Siciliano, Massimo, Nicolini, Laura Ambra, Di Biagio, Antonio, Magni, Carlo Federico, Bolis, Matteo, Antonucci, Francesco Paolo, Di Maio, Velia Chiara, Alfieri, Roberta, Sarmati, Loredana, Casalino, Paolo, Bernardini, Sergio, Micheli, Valeria, Rizzardini, Giuliano, Parruti, Giustino, Quirino, Tiziana, Puoti, Massimo, Babudieri, Sergio, D'Arminio Monforte, Antonella, Andreoni, Massimo, Craxì, Antonio, Angelico, Mario, Pasquazzi, Caterina, and Ceccherini-Silberstein, Francesca

Subjects
MED/17 Malattie infettive, digestive system diseases
Abstract

Background: Intracellular HCV-RNA reduction is a proposed mechanism of action of direct-acting antivirals (DAAs), alternative to hepatocytes elimination by pegylated-interferon plus ribavirin (PR). We modeled ALT and HCV-RNA kinetics in cirrhotic patients treated with currently-used all-DAA combinations to evaluate their mode of action and cytotoxicity compared with telaprevir (TVR)+PR. Study design: Mathematical modeling of ALT and HCV-RNA kinetics was performed in 111 HCV-1 cirrhotic patients, 81 treated with all-DAA regimens and 30 with TVR+PR. Kinetic-models and Cox-analysis were used to assess determinants of ALT-decay and normalization. Results: HCV-RNA kinetics was biphasic, reflecting a mean effectiveness in blocking viral production >99.8%. The first-phase of viral-decline was faster in patients receiving NS5A-inhibitors compared to TVR+PR or sofosbuvir+simeprevir (p-1, respectively, p = 0.0012). In contrast the rate of ALT-normalization, noted λ, was slower in patients receiving TVR+PR or sofosbuvir+simeprevir compared to NS5A-inhibitors (0.17 vs 0.27 d-1, respectively, p Conclusions: Our data support a process of HCV-clearance by all-DAA regimens potentiated by NS5A-inhibitor, and less relying upon hepatocyte death than IFN-containing regimens. This may underline a process of “cell-cure” by DAAs, leading to a fast improvement of liver homeostasis.

Published
2017

11. SLOW ACHIEVEMENT OF HCV-RNA UNDETECTABILITY IN CIRRHOTIC PATIENTS TREATED WITH SOFOSBUVIR plus RIBAVIRIN: POSSIBLE CLINICAL IMPLICATIONS IN THE LIVER TRANSPLANT LIST MANAGEMENT

Author

Sforza, Daniele, Lenci, Ilaria, Manuelli, Matteo, Cento, Valeria, Rendina, Maria, Maria, Francesca Donato, Martina, Milana, Marianna, Aragri, Velia, Chiara Di Maio, Amal, Abedrabbo, Federico, Malinverno, Sara, Monico, Maria, Laura Ponti, Roberta, Canu, Roberto, Ganga, Milanesi, Luciano, Di Leo, Alfredo, Perno, Carlo Federico, Ceccherini-Silberstein, Francesca, Colombo, Massimo, Angelico, Mario, and Tisone, Giuseppe

Subjects
Transplantation, HCV-RNA, virus diseases, hepatocellular carcinoma, digestive system diseases
Abstract

Sofosbuvir (SOF) treatment ± ribavirin (RBV) prior to LT has the potential to change the HCV recurrence after Liver Transplantation (LT). This approach has been reported to avoid graft reinfection in compensated patients with hepatocellular carcinoma (HCC), but only among those who reached and maintained undetectable HCV-RNA (TND) before LT. Since the time to obtain this result in decompensated cirrhotics is unknown, we sought to investigate the early HCV-RNA decay in this setting.

Published
2015

14. Virological failures to direct acting antivirals (DAA) regimens in a real life setting show frequent resistance associated variants and may require re-treatment with unconventional strategies

Author

Di Maio, Velia Chiara, Cento, Valeria, Lenci, Ilaria, Aragri, Marianna, Barbaliscia, Silvia, Francioso, Simona, Stefania Paolucci, Melis, Michela, Verucchi, Gabriella, Coppola, Nicola, Magni, Carlo F., Santopaolo, Francesco, Landonio, Simona, Ghisetti, Valeria, Starace, Mario, D Ambrosio, Cecilia, Calvaruso, Vincenzo, Caporasol, Nicola, Pasquazzi, Caterina, Maida, Ivana, Picciotto, Antonino, Di Biagio, Antonio, Sticchi, Laura, Cozzolongo, Raffaele, Romagnoli, Dante, Biolato, Marco, Vecchiet, Jacopo, D Ettorre, Gabriella, Merli, Manuela, Gaeta, Giovanni B., Ciancio, Alessia, Marinaro, Letizia, Andreone, Pietro, Barbarini, Giorgio, Gulminetti, Roberto, Palitti, Valeria Pace, Tarquini, Perluigi, Puoti, Massimo, Sangiovanni, Vincenzo, Paoloni, Maurizio, Babudieri, Sergio, Rizzardini, Giuliano, Bruno, Savino, Andreoni, Massimo, Pellicelli, Adriano M., Parruti, Giustino, Craxi, Antonio, Angelico, Mario, Perno, Carlo F., and Ceccherini-Silberstein, Francesca

15. Resistance-guided retreatment of HCV infected patients with a previous failure to an NS5A inhibitor-containing regimen: Italian real life experience

Author

Di Maio, Velia Chiara, Aragri, Marianna, Masetti, Chiara, Stefania Paolucci, Bruzzone, Bianca, Degasperi, Elisabetta, Barbaliscia, Silvia, Pollicino, Teresa, Minichini, Carmine, Calvaruso, Vincenza, Rendina, Maria Grazia, Cento, Valeria, Teti, Elisabetta, Micheli, Valeria, Ghisetti, Valeria, Polilli, Ennio, Palitti, Valeria Pace, Landonio, Simona, Lenci, Ilaria, Donnarumma, Laura, Nicolini, Laura Ambra, Bertoli, Ada, Pasquazzi, Caterina, Callegaro, Maria Paola, Morisco, Filomena, Cenderrello, Giovanni, Marenco, Simona, Gulminetti, Roberto, Novati, Stefano, Andreone, Pietro, Ciancio, Alessia, Sangiovanni, Vincenzo, Cuomo, Nunzia, Morsica, Giulia, Borghi, Vanni, Maida, Ivana Rita, Brunetto, Maurizia, Cozzolongo, Raffaele, Santis, Adriano, Lichtner, Miriam, Babudieri, Sergio, Taliani, Gloria, Santantonio, Teresa, Paternoster, Claudio, Ganga, Roberto, Puoti, Massimo, Rizzardini, Giuliano, Pellicelli, Adriano, Lampertico, Pietro, Parruti, Giustino, Nicola, Coppola, Zazzi, Maurizio, Raimondo, Giovanni, Andreoni, Massimo, Craxi, Antonio, Mario, Angelico, Perno, Carlo Federico, and Ceccherini, Silberstein Francesca

16. ITALIAN REAL LIFE EXPERIENCE OF RESISTANCE-GUIDED RETREATMENT IN HCV INFECTED PATIENTS WHO PREVIOUSLY FAILED A NS5A INHIBITOR-CONTAINING REGIMEN

Author

Di Maio, Velia Chiara, Aragri, Marianna, Masetti, Chiara, Paolucci, Stefania, Bruzzone, Bianca, Degasperi, Elisabetta, Barbaliscia, Silvia, Pollicino, Teresa, Minichini, Carmine, Calvaruso, Vincenza, Rendina, Maria, Cento, Valeria, Teti, Elisabetta, Valeria Micheli, Ghisetti, Valeria, Polilli, Ennio, Palitti, Valeria Pace, Landonio, Simona, Lenci, Ilaria, Francioso, Simona, Donnarumma, Laura, Nicolini, Laura Ambra, Bertoli, Ada, Starace, Mario, Pasquazzi, Caterina, Callegaro, Annapaola, Morisco, Filomena, Cenderello, Giovanni, Marenco, Simona, Gulminetti, Roberto, Novati, Stefano, Scuteri, Alessandra, Andreone, Pietro, Galli, Silvia, Ciancio, Alessia, Sangiovanni, Vincenzo, Cuomo, Nunzia, Raddi, Adriana, Morsica, Giulia, Hasson, Hamid, Borghi, Vanni, Maida, Ivana, Brunetto, Maurizia R., Colombatto, Piero, Cozzolongo, Raffaele Francesco, Santis, Adriano, Lichtner, Miriam, Babudieri, Sergio, Biliotti, Elisa, Taliani, Gloria, Santantonio, Teresa Antonia, Di Stefano, Mariantonietta, Paternoster, Claudio, Ganga, Roberto, Puoti, Massimo, Rizzardini, Giuliano, Pellicelli, Adriano, Milano, Eugenio, Mastroianni, Claudio, Licata, Anna, Di Lorenzo, Francesco, Giorgini, Alessia, Sighinolfi, Laura, Dentone, Chiara, Lleo, Ana, Rossetti, Barbara, Beretta, Ilaria, Lampertico, Pietro, Parruti, Giustino, Coppola, Nicola, Raimondo, Giovanni, Zazzi, Maurizio, Andreoni, Massimo, Angelico, Mario, Perno, Carlo Federico, Craxi, Antonio, and Silberstein, Francesca Ceccherini

17. DECLINE OF PREVALENCE OF RESISTANCE ASSOCIATED SUBSTITUTIONS TO NS3 AND NS5A INHIBITORS AT DAA-FAILURE IN HEPATITIS C VIRUS IN ITALY OVER THE YEARS 2015 TO 2018

Author

Rossetti, Barbara, Redi, David, Di Maio, Velia Chiara, Aragri, Marianna, Paolucci, Stefania, Paglicci, Lorenzo, Masetti, Chiara, Bruzzone, Bianca, Minichini, Carmine, Montagnani, Francesca, Micheli, Valeria, Landonio, Simona, Zanelli, Giacomo, Degasperi, Elisabetta, Maserati, Renato, Maida, Ivana, Callegaro, Annapaola, Barbaliscia, Silvia, Bertoli, Ada, Paternoster, Claudio, Marenco, Simona, Morisco, Filomena, Calvaruso, Vincenza, Taliani, Gloria, Puoti, Massimo, Cenderello, Giovanni, Santis, Adriano, Lichtner, Miriam, Coppola, Nicola, Gulminetti, Roberto, Cento, Valeria, Rendina, Maria, Teti, Elisabetta, Parruti, Giustino, Ruggiero, Tina, Ghisetti, Valeria, Pasquazzi, Caterina, Nicolini, Laura Ambra, Vullo, Vincenzo, Pellicelli, Adriano, Prestileo, Tullio, Cozzolongo, Raffaele, Sangiovanni, Vincenzo, Biolato, Marco, Lenci, Ilaria, Licata, Anna, Ciaccio, Antonio, Palitti, Valeria Pace, Giorgini, Alessia, Cariti, Giuseppe, Ciancio, Alessia, Aghemo, Alessio, Borghi, Vanni, PIETRO ANDREONE, Brunetto, Maurizia R., Pollicino, Teresa, Santantonio, Teresa Antonia, Cuomo, Nunzia, Caudai, Cinzia, Babudieri, Sergio, Lampertico, Pietro, Gaeta, Giovanni Battista, Raimondo, Giovanni, Andreoni, Massimo, Rizzardini, Giuliano, Angelico, Mario, Perno, Carlo Federico, Craxi, Antonio, Zazzi, Maurizio, and Silberstein, Francesca Ceccherini

18. Natural NS3, NS5A and NS5B HCV resistance is common in real practice, differently associated to HCV genotypes and response to NS5A inhibitors

Author

Cento, Valeria, Sorbo, Maria Chiara, Bertoli, Ada, Lenci, Ilaria, Polilli, Ennio, Masetti, Chiara, Gianserra, Laura, Teti, Elisabetta, Biliotti, Elisa, Magni, Carlo F., Aragri, Marianna, Micheli, Valeria, Melis, Michela, Nicolini, Laura A., Marenco, Simona, Calvaruso, Vincenza, Stefania Paolucci, Baldanti, Fausto, Morisco, Filomena, Siciliano, Massimo, Palitti, Valeria Pace, Andreone, Pietro, Bruzzone, Bianca, Coppola, Nicola, Ruggiero, Tina, Lichtner, Miriam, Menzaghi, Barbara, Romagnoli, Dante, Iapadre, Nerio, Di Maio, Velia Chiara, Leonardis, Francesco, Milana, Martina, Cacciatore, Pierluigi, Pieri, Alessandro, Sarmati, Loredana, Landonio, Simona, Gasbarrini, Antonio, Puoti, Massimo, Craxi, Antonio, Vullo, Vincenzo, Pellicelli, Adriano M., Babudieri, Sergio, Rizzardini, Giuliano, Taliani, Gloria, Andreoni, Massimo, Pasquazzi, Caterina, Parruti, Giustino, Angelico, Mario, Perno, Carlo F., and Ceccherini-Silberstein, Francesca

19. Characteristic and prevalence of NS3, NS5A and NS5B resistance associated substitutions in DAA-naive and DAA-failed HCV-3 patients in Italy

Author

Di Maio, Velia Chiara, Barbaliscia, Silvia, Teti, Elisabetta, Lenci, Ilaria, Aragri, Marianna, Polilli, Ennio, Gianserra, Laura, Palitti, Valeria Pace, Bruzzone, Bianca, Paolucci, Stefania, Coppola, Nicola, Ruggiero, Tina, Pollicino, Teresa, Niero, Fosca, Valeria Micheli, Di Biagio, Antonio, Bertoli, Ada, Sticchi, Laura, Maida, Ivana, Francioso, Simona, Foroghi, Luca, Calvaruso, Vincenza, Morisco, Filomena, Lleo, Ana, Ciancio, Alessia, Maserati, Renato, Brancaccio, Giuseppina, Puoti, Massimo, Toniutto, Pierluigi, Vullo, Vincenzo, Aghemo, Alessio, Cariti, Giuseppe, Bonora, Stefano, Babudieri, Sergio, Gubertini, Guido A., Rendina, Maria, Pellicelli, Adriano M., Sangiovanni, Vincenzo, Ciaccio, Antonio, Taliani, Gloria, Raimondo, Giovanni, Craxi, Antonio, Pasquazzi, Caterina, Sarmati, Loredana, Parruti, Giustino, Angelico, Mario, Andreoni, Massimo, Cento, Valeria, Perno, Carlo Federico, and Ceccherini-Silberstein, Francesca

20. The Italian compassionate use of sofosbuvir observational cohort study for the treatment of recurrent hepatitis C: clinical and virological outcomes

Author

Carrai, P, Morelli, C, Cordone, G, Romano, A, Tamé, M, Lionetti, R, Pietrosi, G, Lenci, I, Piai, G, Russo, F, Coppola, C, Melazzini, M, Montilla, S, Pani, L, Petraglia, S, Russo, P, Trotta, M, Martini, S, Toniutto, P, the ITACOPS study group, Bandiera, F, Bhoori, S, Brillanti, S, Burra, P, Corsale, S, De Luca, A, Fagiuoli, S, Fattovich, G, Fava, G, Felder, M, Forte, P, Galeota-Lanza, A, Gitto, S, Grieco, A, Grossi, P, Ialungo, A, Iemmolo, R, Loiacono, L, Mangia, A, Merli, M, Piacentini, A, Pellicelli, A, Rigamonti, C, Gabriella, V, Zignego, A. L., Carrai, P, Morelli, C, Cordone, G, Romano, A, Tame, M, Lionetti, R, Pietrosi, G, Lenci, I, Piai, G, Russo, F, Coppola, C, Melazzini, M, Montilla, S, Pani, L, Petraglia, S, Russo, P, Trotta, M, Martini, S, Toniutto, P, Bandiera, F, Bhoori, S, Brillanti, S, Burra, P, Corsale, S, De Luca, A, Fagiuoli, S, Fattovich, G, Fava, G, Felder, M, Forte, P, Galeota-Lanza, A, Gitto, S, Grieco, A, Grossi, P, Ialungo, A, Iemmolo, R, Loiacono, L, Mangia, A, Merli, M, Piacentini, A, Pellicelli, A, Rigamonti, C, Gabriella, V, Zignego, A, Carrai, Paola, Cristina, Morelli, Cordone, Gabriella, Romano, Antonietta, Tamã©, Mariarosa, Lionetti, Raffaella, Pietrosi, Giada, Lenci, Ilaria, Piai, Guido, Russo, Francesco Paolo, Coppola, Carmine, Melazzini, Mario, Montilla, Simona, Pani, Luca, Petraglia, Sandra, Russo, Pierluigi, Trotta, Maria Paola, Martini, Silvia, Toniutto, Pierluigi, Bandiera, Francesco, Bhoori, Sherrie, Brillanti, Stefano, Burra, Patrizia, Corsale, Sveva, De Luca, Andrea, Fagiuoli, Stefano, Fattovich, Giovanna, Fava, Gianmarco, Felder, Martina, Forte, Paolo, Galeota-Lanza, Alfonso, Gitto, Stefano, Grieco, Antonio, Grossi, Paolo, Ialungo, A. M., Iemmolo, Rosa Maria, Loiacono, Laura, Mangia, Alessandra, Merli, Manuela, Piacentini, A., Pellicelli, Adriano, Rigamonti, Cristina, Gabriella, Verucchi, and Zignego, Anna Linda

Subjects
Compassionate Use Trials, Liver Cirrhosis, Male, 0301 basic medicine, Simeprevir, cholestatic hepatiti, cholestatic hepatitis, hepatitis C, liver transplantation, sofosbuvir, Analysis of Variance, Antiviral Agents, Cohort Studies, Confidence Intervals, Disease Progression, Dose-Response Relationship, Drug, Drug Administration Schedule, Drug Therapy, Combination, Female, Hepatitis C, Chronic, Humans, Italy, Liver Function Tests, Logistic Models, Multivariate Analysis, Prognosis, Recurrence, Ribavirin, Risk Assessment, Severity of Illness Index, Sofosbuvir, Treatment Outcome, Gastroenterology, chemistry.chemical_compound, 0302 clinical medicine, Chronic, Hepatitis C, Combination, 030211 gastroenterology & hepatology, Drug, Viral hepatitis, medicine.drug, medicine.medical_specialty, Daclatasvir, Transplantation, Dose-Response Relationship, 03 medical and health sciences, Drug Therapy, Internal medicine, medicine, business.industry, medicine.disease, digestive system diseases, Surgery, 030104 developmental biology, chemistry, Liver function, business
Abstract

Direct antivirals are available for treating recurrent hepatitis C (RHC). This study reported outcomes of 424 patients with METAVIR F3–F4 RHC who were treated for 24 weeks with sofosbuvir/ribavirin and followed for 12 weeks within the Italian sofosbuvir compassionate use program. In 55 patients, daclatasvir or simeprevir were added. Child–Pugh class and model of end stage liver disease (MELD) scores were evaluated at baseline and 36 weeks after the start of therapy. The sustained viral response (SVR) was 86.7% (316/365) in patients who received sofosbuvir/ribavirin and 98.3% (58/59) in patients who received a second antiviral (P < 0.01). In patients treated with sofosbuvir/ribavirin, a significant difference in SVR was observed between patients diagnosed with METAVIR F4 (211/250; 84.4%), METAVIR F3 (95/105; 90.5%) and fibrosing cholestatic hepatitis (10/10; 100%) (P = 0.049). A significant association was found between patients who worsened from Child–Pugh class A and who experienced viral relapse (4/26 vs. 8/189, P = 0.02). In patients with a baseline MELD score

Published
2017

21. Prevention of hepatitis C recurrence by bridging sofosbuvir/ribavirin from pre- to post-liver transplant: A real-life strategy

Author

Donato, M. F., Morelli, C., Romagnoli, R., Invernizzi, F., Mazzarelli, C., Iemmolo, R. M., Montalbano, M., Lenci, I., Bhoori, S., Pieri, G., Berardi, S., Caraceni, P., Martini, S., Angeli, P., Belli, L. S., Bernabucci, V., Malinverno, F., Monico, S., Ottobrelli, A., Romano, A., Strona, S., Tame, M. R., Visco-Comandini, U., Cavenago, M., De Carlis, L., Di Benedetto, F., Dondossola, D., Ettorre, G. M., Mazzaferro, V., Montin, U., Pinna, A. D., Rossi, G., Salizzoni, M., Tisone, G., Donato, Maria Francesca, Morelli, Cristina, Romagnoli, Renato, Invernizzi, Federica, Mazzarelli, Chiara, Iemmolo, Rosa Maria, Montalbano, Marzia, Lenci, Ilaria, Bhoori, Sherrie, Pieri, Giulia, Berardi, Sonia, Caraceni, Paolo, Martini, Silvia, Donato, M, Morelli, C, Romagnoli, R, Invernizzi, F, Mazzarelli, C, Iemmolo, R, Montalbano, M, Lenci, I, Bhoori, S, Pieri, G, Berardi, S, Caraceni, P, Martini, S, Angeli, P, Belli, L, Bernabucci, V, Malinverno, F, Monico, S, Ottobrelli, A, Romano, A, Strona, S, Tamè, M, Visco-Comandini, U, Cavenago, M, De Carlis, L, Di Benedetto, F, Dondossola, D, Ettorre, G, Mazzaferro, V, Montin, U, Pinna, A, Rossi, G, Salizzoni, M, and Tisone, G

Subjects
Liver Cirrhosis, Male, Sofosbuvir, Sustained Virologic Response, Hepatocellular carcinoma, medicine.medical_treatment, Hepacivirus, Liver transplantation, medicine.disease_cause, hepatitis C, hepatocellular carcinoma, liver transplant, sofosbuvir therapy, virological response, Adult, Aged, Antiviral Agents, Carcinoma, Hepatocellular, Drug Therapy, Combination, Female, Hepatitis C, Humans, Italy, Liver Neoplasms, Middle Aged, Postoperative Period, Preoperative Period, Recurrence, Retrospective Studies, Ribavirin, Liver Transplantation, Gastroenterology, chemistry.chemical_compound, 0302 clinical medicine, Sofosbuvir therapy, Retrospective Studie, Liver transplant, Virological response, Liver Neoplasm, 030220 oncology & carcinogenesis, Combination, 030211 gastroenterology & hepatology, Viral hepatitis, Human, medicine.drug, medicine.medical_specialty, Liver Cirrhosi, Hepatitis C virus, 03 medical and health sciences, Hepatology, Drug Therapy, Internal medicine, medicine, Antiviral Agent, Hepaciviru, business.industry, Carcinoma, Hepatocellular, medicine.disease, Settore MED/18, Surgery, Regimen, chemistry, business
Abstract

Background and aims Hepatitis C virus (HCV) reinfection following liver transplant (LT) is associated with reduced graft and patients survival. Before transplant, Sofosbuvir/Ribavirin (SOF/R) treatment prevents recurrent HCV in 96% of those patients achieving viral suppression for at least 4 weeks before transplant. We evaluated whether a bridging SOF-regimen from pre to post-transplant is safe and effective to prevent HCV recurrence in those patients with less than 4 week HCV-RNA undetectability at the time of transplant. Material and Methods From July 2014 SOF/R was given in 233 waitlisted HCV cirrhotics with/without hepatocellular carcinoma (HCC) within an Italian Compassionate Program. One-hundred were transplanted and 31 patients (31%) treated by SOF/R bridging therapy were studied Results LT indication in bridge subgroup was HCC in 22 and decompensated cirrhosis in 9. HCV-genotype was 1/4 in 18 patients. SOF 400 mg/day and R (median dosage 800 mg/day) were given for a median of 35 days before LT. At transplant time, 19 patients were still HCV-RNA positive (median HCV-RNA 58 IU/ml). One recipient had a virological breakthrough at week 4 post-transplant; one died, on treatment, 1-month post-transplant for sepsis and 29/31 achieved a 12-week sustained virological response (94%). Acute cellular rejection occurred in 4 recipients. On September 2016, 30 recipients (97%) are alive with a median follow-up of 18 months (range 13-25). Conclusions In patients with suboptimal virological response at LT a bridging SOF/R regimen helps avoiding post-transplant graft reinfection. This article is protected by copyright. All rights reserved.

Published
2017

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