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1. Hepatic encephalopathy increases the risk for mortality and hospital readmission in decompensated cirrhotic patients: a prospective multicenter study

Author: Riggio, O, Celsa, C, Calvaruso, V, Merli, M, Caraceni, P, Montagnese, S, Mora, V, Milana, M, Saracco, G, Raimondo, G, Benedetti, A, Burra, P, Sacco, R, Persico, M, Schepis, F, Villa, E, Colecchia, A, Fagiuoli, S, Pirisi, M, Barone, M, Azzaroli, F, Soardo, G, Russello, M, Morisco, F, Labanca, S, Fracanzani, A, Pietrangelo, A, Di Maria, G, Nardelli, S, Ridola, L, Gasbarrini, A, Camma, C, Riggio O., Celsa C., Calvaruso V., Merli M., Caraceni P., Montagnese S., Mora V., Milana M., Saracco G. M., Raimondo G., Benedetti A., Burra P., Sacco R., Persico M., Schepis F., Villa E., Colecchia A., Fagiuoli S., Pirisi M., Barone M., Azzaroli F., Soardo G., Russello M., Morisco F., Labanca S., Fracanzani A. L., Pietrangelo A., Di Maria G., Nardelli S., Ridola L., Gasbarrini A., Camma C., Riggio, O, Celsa, C, Calvaruso, V, Merli, M, Caraceni, P, Montagnese, S, Mora, V, Milana, M, Saracco, G, Raimondo, G, Benedetti, A, Burra, P, Sacco, R, Persico, M, Schepis, F, Villa, E, Colecchia, A, Fagiuoli, S, Pirisi, M, Barone, M, Azzaroli, F, Soardo, G, Russello, M, Morisco, F, Labanca, S, Fracanzani, A, Pietrangelo, A, Di Maria, G, Nardelli, S, Ridola, L, Gasbarrini, A, Camma, C, Riggio O., Celsa C., Calvaruso V., Merli M., Caraceni P., Montagnese S., Mora V., Milana M., Saracco G. M., Raimondo G., Benedetti A., Burra P., Sacco R., Persico M., Schepis F., Villa E., Colecchia A., Fagiuoli S., Pirisi M., Barone M., Azzaroli F., Soardo G., Russello M., Morisco F., Labanca S., Fracanzani A. L., Pietrangelo A., Di Maria G., Nardelli S., Ridola L., Gasbarrini A., and Camma C.
Abstract: Introduction: Hepatic encephalopathy (HE) affects the survival and quality of life of patients with cirrhosis. However, longitudinal data on the clinical course after hospitalization for HE are lacking. The aim was to estimate mortality and risk for hospital readmission of cirrhotic patients hospitalized for HE. Methods: We prospectively enrolled 112 consecutive cirrhotic patients hospitalized for HE (HE group) at 25 Italian referral centers. A cohort of 256 patients hospitalized for decompensated cirrhosis without HE served as controls (no HE group). After hospitalization for HE, patients were followed-up for 12 months until death or liver transplant (LT). Results: During follow-up, 34 patients (30.4%) died and 15 patients (13.4%) underwent LT in the HE group, while 60 patients (23.4%) died and 50 patients (19.5%) underwent LT in the no HE group. In the whole cohort, age (HR 1.03, 95% CI 1.01–1.06), HE (HR 1.67, 95% CI 1.08–2.56), ascites (HR 2.56, 95% CI 1.55–4.23), and sodium levels (HR 0.94, 95% CI 0.90–0.99) were significant risk factors for mortality. In the HE group, ascites (HR 5.07, 95% CI 1.39–18.49) and BMI (HR 0.86, 95% CI 0.75–0.98) were risk factors for mortality, and HE recurrence was the first cause of hospital readmission. Conclusion: In patients hospitalized for decompensated cirrhosis, HE is an independent risk factor for mortality and the most common cause of hospital readmission compared with other decompensation events. Patients hospitalized for HE should be evaluated as candidates for LT.
Published: 2023

2. Systematic review and meta-analysis of safety and efficacy of atezolizumab/ bevacizumab in Child-Pugh class B patients with hepatocellular carcinoma

Author: Pasta, A., primary, Calabrese, F., additional, Jaffe, A., additional, Labanca, S., additional, Marenco, S., additional, Pieri, G., additional, Torres, M.C. Plaz, additional, Strazzabosco, M., additional, and Giannini, E.G., additional
Published: 2023
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3. Longer transplant-free and liver-related event-free survival in obeticholic acid-treated patients with primary biliary cholangitis compared to external controls from two large real-world cohorts

Author: Terracciani, F., De Vincentis, A., D'Amato, D., Invernizzi, P., Morgando, A., Vanni, E., Viganò, M., Alvaro, D., Venere, R., Lleo, A., Colapietro, F., Degasperi, E., Viganò, R., Giannini, E.G., Labanca, S., Feletti, V., Mussetto, A., Cozzolongo, R., Losito, F., Pompili, M., Ponziani, F.R., Niro, G.A., Cotugno, R., Pozzoni, P., Chessa, L., Cuccorese, G., Pace Palitti, V., Russello, M., Cannavò, M., Frazzetto, E., Bertino, G., Marzioni, M., Terreni, N., Zolfino, T., Saitta, C., Pellicelli, A., Coco, B., Brunetto, M., Cazzagon, N., Floreani, A., Muratori, L., Rosina, F., Stefano, M. Di, Scifo, G., Baiocchi, L., Grassi, G., Sacco, R., Izzi, A., Crocè, S.L., Fiorini, C., Marra, F., Galli, A., Simone, L., Morelli, O., Abenavoli, L., Pizzolante, F., De Matthaeis, N., Scaravaglio, M., Gimignani, G., Boano, V., Manfredi, G.F., Marignani, M., Fanella, S., Giacchetto, M., Castellaneta, A., Poggi, G., Buzzanca, V., Scivetti, P., Tortora, A., Casella, S., Bellia, V., Omazzi, B.F., Alagna, G., Ricci, C., Poisa, P., Rigamonti, C., Calvaruso, V., Corpechot, C., Carrat, F., Hirschfield, G., Gulamhusein, A., Levy, C., Tananka, A., Montano-Loza, A. J, Londono, M., Eaton, J. E, Dalekos, G. N, Gatselis, N., Abbas, N., Trivedi, P., Thorburn, D., Bonder, A., van der Meer, A., Zigmond, E., Kremer, A. E, Bruns, T., Chazouilleres, O., Hansen, B. E, Carbone, M., and Vespasiani-Gentilucci, U.
Published: 2024
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4. Predictors of serious adverse events and non-response in cirrhotic patients with primary biliary cholangitis treated with obeticholic acid

Author: De Vincentis, A, D'Amato, D, Cristoferi, L, Gerussi, A, Malinverno, F, Lleo, A, Colapietro, F, Marra, F, Galli, A, Fiorini, C, Coco, B, Brunetto, M, Niro, G, Cotugno, R, Saitta, C, Cozzolongo, R, Losito, F, Giannini, E, Labanca, S, Marzioni, M, Marconi, G, Morgando, A, Pellicano, R, Vanni, E, Cazzagon, N, Floreani, A, Chessa, L, Morelli, O, Muratori, L, Pellicelli, A, Pompili, M, Ponziani, F, Tortora, A, Rosina, F, Russello, M, Cannavo, M, Simone, L, Storato, S, Vigano, M, Abenavoli, L, D'Anto, M, De Gasperi, E, Distefano, M, Scifo, G, Zolfino, T, Calvaruso, V, Cuccorese, G, Palitti, V, Sacco, R, Bertino, G, Frazzetto, E, Alvaro, D, Mulinacci, G, Palermo, A, Scaravaglio, M, Terracciani, F, Galati, G, Ronca, V, Zuin, M, Claar, E, Izzi, A, Picardi, A, Invernizzi, P, Vespasiani-Gentilucci, U, Carbone, M, Feletti, V, Mussetto, A, Venere, R, Bernaccioni, G, Graciella Pigozzi, M, Fagiuoli, S, Terreni, N, Pozzoni, P, Baiocchi, L, Grassi, G, Vinci, M, Bellia, V, Boldizzoni, R, Casella, S, Omazzi, B, Poggi, G, De Vincentis A., D'Amato D., Cristoferi L., Gerussi A., Malinverno F., Lleo A., Colapietro F., Marra F., Galli A., Fiorini C., Coco B., Brunetto M., Niro G. A., Cotugno R., Saitta C., Cozzolongo R., Losito F., Giannini E. G., Labanca S., Marzioni M., Marconi G., Morgando A., Pellicano R., Vanni E., Cazzagon N., Floreani A., Chessa L., Morelli O., Muratori L., Pellicelli A., Pompili M., Ponziani F., Tortora A., Rosina F., Russello M., Cannavo M., Simone L., Storato S., Vigano M., Abenavoli L., D'Anto M., De Gasperi E., Distefano M., Scifo G., Zolfino T., Calvaruso V., Cuccorese G., Palitti V. P., Sacco R., Bertino G., Frazzetto E., Alvaro D., Mulinacci G., Palermo A., Scaravaglio M., Terracciani F., Galati G., Ronca V., Zuin M., Claar E., Izzi A., Picardi A., Invernizzi P., Vespasiani-Gentilucci U., Carbone M., Feletti V., Mussetto A., Venere R., Bernaccioni G., Graciella Pigozzi M., Fagiuoli S., Terreni N., Pozzoni P., Baiocchi L., Grassi G., Vinci M., Bellia V., Boldizzoni R., Casella S., Omazzi B., Poggi G., De Vincentis, A, D'Amato, D, Cristoferi, L, Gerussi, A, Malinverno, F, Lleo, A, Colapietro, F, Marra, F, Galli, A, Fiorini, C, Coco, B, Brunetto, M, Niro, G, Cotugno, R, Saitta, C, Cozzolongo, R, Losito, F, Giannini, E, Labanca, S, Marzioni, M, Marconi, G, Morgando, A, Pellicano, R, Vanni, E, Cazzagon, N, Floreani, A, Chessa, L, Morelli, O, Muratori, L, Pellicelli, A, Pompili, M, Ponziani, F, Tortora, A, Rosina, F, Russello, M, Cannavo, M, Simone, L, Storato, S, Vigano, M, Abenavoli, L, D'Anto, M, De Gasperi, E, Distefano, M, Scifo, G, Zolfino, T, Calvaruso, V, Cuccorese, G, Palitti, V, Sacco, R, Bertino, G, Frazzetto, E, Alvaro, D, Mulinacci, G, Palermo, A, Scaravaglio, M, Terracciani, F, Galati, G, Ronca, V, Zuin, M, Claar, E, Izzi, A, Picardi, A, Invernizzi, P, Vespasiani-Gentilucci, U, Carbone, M, Feletti, V, Mussetto, A, Venere, R, Bernaccioni, G, Graciella Pigozzi, M, Fagiuoli, S, Terreni, N, Pozzoni, P, Baiocchi, L, Grassi, G, Vinci, M, Bellia, V, Boldizzoni, R, Casella, S, Omazzi, B, Poggi, G, De Vincentis A., D'Amato D., Cristoferi L., Gerussi A., Malinverno F., Lleo A., Colapietro F., Marra F., Galli A., Fiorini C., Coco B., Brunetto M., Niro G. A., Cotugno R., Saitta C., Cozzolongo R., Losito F., Giannini E. G., Labanca S., Marzioni M., Marconi G., Morgando A., Pellicano R., Vanni E., Cazzagon N., Floreani A., Chessa L., Morelli O., Muratori L., Pellicelli A., Pompili M., Ponziani F., Tortora A., Rosina F., Russello M., Cannavo M., Simone L., Storato S., Vigano M., Abenavoli L., D'Anto M., De Gasperi E., Distefano M., Scifo G., Zolfino T., Calvaruso V., Cuccorese G., Palitti V. P., Sacco R., Bertino G., Frazzetto E., Alvaro D., Mulinacci G., Palermo A., Scaravaglio M., Terracciani F., Galati G., Ronca V., Zuin M., Claar E., Izzi A., Picardi A., Invernizzi P., Vespasiani-Gentilucci U., Carbone M., Feletti V., Mussetto A., Venere R., Bernaccioni G., Graciella Pigozzi M., Fagiuoli S., Terreni N., Pozzoni P., Baiocchi L., Grassi G., Vinci M., Bellia V., Boldizzoni R., Casella S., Omazzi B., and Poggi G.
Abstract: Background & Aims: Obeticholic acid (OCA) has recently been restricted in patients with primary biliary cholangitis (PBC) with “advanced cirrhosis” because of its narrow therapeutic index. We aimed to better define the predicting factors of hepatic serious adverse events (SAEs) and non-response in cirrhotic patients undergoing OCA therapy. Methods: Safety and efficacy of treatment were evaluated in a cohort of consecutive PBC cirrhotic patients started with OCA. OCA response was evaluated according to the Poise criteria. Risk factors for hepatic SAEs and non-response were reported as risk ratios (RR) with 95% confidence intervals (CIs). Results: One hundred PBC cirrhotics were included, 97 Child-Pugh class A and 3 class B. Thirty-one had oesophageal varices and 5 had a history of ascites. Thirty-three per cent and 32% of patients achieved a biochemical response at 6 and 12 months respectively. Male sex (adjusted-RR 1.75, 95%CI 1.42–2.12), INR (1.37, 1.00–1.87), Child-Pugh score (1.79, 1.28–2.50), MELD (1.17, 1.04–1.30) and bilirubin (1.83, 1.11–3.01) were independently associated with non-response to OCA. Twenty-two patients discontinued OCA within 12 months: 10 for pruritus, 9 for hepatic SAEs (5 for jaundice and/or ascitic decompensation; 4 for upper digestive bleeding). INR (adjusted-RR 1.91, 95%CI 1.10–3.36), lower albumin levels (0.18, 0.06–0.51), Child-Pugh score (2.43, 1.50–4.04), history of ascites (3.5, 1.85–6.5) and bilirubin (1.30, 1.05–1.56), were associated with hepatic SAEs. A total bilirubin≥1.4 mg/dl at baseline was the most accurate biochemical predictor of hepatic SAEs under OCA. Conclusions: An accurate baseline assessment is crucial to select cirrhotic patients who can benefit from OCA. Although OCA is effective in one third of cirrhotics, bilirubin level ≥1.4 mg/dl should discourage from its use.
Published: 2022

5. Primary biliary cholangitis: perception and expectation of illness

Author: Floreani, A, Scaffidi, M, Coco, B, Giannini, E, Labanca, S, Bonaiuto, E, De Martin, S, Invernizzi, P, Carbone, M, Alvaro, D, Bragazzi, M, Calvaruso, V, Cossiga, V, Cazzagon, N, Floreani A., Scaffidi M., Coco B., Giannini E. G., Labanca S., Bonaiuto E., De Martin S., Invernizzi P., Carbone M., Alvaro D., Bragazzi M. C., Calvaruso V., Cossiga V., Cazzagon N., Floreani, A, Scaffidi, M, Coco, B, Giannini, E, Labanca, S, Bonaiuto, E, De Martin, S, Invernizzi, P, Carbone, M, Alvaro, D, Bragazzi, M, Calvaruso, V, Cossiga, V, Cazzagon, N, Floreani A., Scaffidi M., Coco B., Giannini E. G., Labanca S., Bonaiuto E., De Martin S., Invernizzi P., Carbone M., Alvaro D., Bragazzi M. C., Calvaruso V., Cossiga V., and Cazzagon N.
Abstract: An important tool to explore personal experience of symptoms, treatment and clinical outcome is stratification of illness perception in patients affected by PBC. Aim: To assess the perception of illness in a cohort of Italian patients with PBC. Methods: Between June and December 2019, a specific questionnaire was administered to a pool of 210 patients from 7 tertiary Italian centers, in order to identify and assess the patient's past history, symptoms and their impact on the quality of life, follow-up, treatment and perceived satisfaction of patients toward the provided care. Results: Fatigue, pruritus, and abdominal discomfort and sicca syndrome were present in 50.4%, 45%, 30.4% and 28.5% of patients, fatigue having the most impacting the daily-life. After a consultation with a specialist, the diagnosis of PBC was met within 18 months for 143 patients. Patients were mostly concerned about possible health problems that occur and in 25% of cases, symptoms had a negative impact on their life. Eighty percent of patients said they were satisfied with efficacy and tolerability of treatment, while 26% requested an improvement in the relationship with the specialist. Conclusions: The results highlight the importance of both promoting timely referral to the specialist and facilitating communication between healthcare professionals and patients.
Published: 2022

6. Long-term results from the Italian real-world experience on obeticholic acid treatment in primary biliary cholangitis: The RECAPITULATE study

Author: Terracciani, F., primary, De Vincentis, A., additional, D'Amato, D., additional, Invernizzi, P., additional, Morgando, A., additional, Vanni, E., additional, Viganò, M., additional, Alvaro, D., additional, Venere, R., additional, Lleo, A., additional, Colapietro, F., additional, Degasperi, E., additional, Viganò, R., additional, Giannini, E.G., additional, Labanca, S., additional, Feletti, V., additional, Mussetto, A., additional, Cozzolongo, R., additional, Losito, F., additional, Pompili, M., additional, Ponziani, F.R., additional, Niro, G.A., additional, Cotugno, R., additional, Pozzoni, P., additional, Chessa, L., additional, Cuccorese, G., additional, Palitti, V. Pace, additional, Russello, M., additional, Cannavò, M., additional, Frazzetto, E., additional, Bertino, G., additional, Marzioni, M., additional, Terreni, N., additional, Zolfino, T., additional, Saitta, C., additional, Pellicelli, A., additional, Coco, B., additional, Brunetto, M., additional, Cazzagon, N., additional, Floreani, A., additional, Muratori, L., additional, Rosina, F., additional, Di Stefano, M., additional, Scifo, G., additional, Baiocchi, L., additional, Grassi, G., additional, Sacco, R., additional, Izzi, A., additional, Crocè, S. Lory, additional, Fiorini, C., additional, Marra, F., additional, Simone, L., additional, Morelli, O., additional, Abenavoli, L., additional, Pizzolante, F., additional, De Matthaeis, N., additional, Scaravaglio, M., additional, Gimignani, G., additional, Boano, V., additional, Manfredi, G.F., additional, Marignani, M., additional, Fanella, S., additional, Giacchetto, M., additional, Castellaneta, A., additional, Poggi, G., additional, Buzzanca, V., additional, Scivetti, P., additional, Tortora, A., additional, Casella, S., additional, Bellia, V., additional, Omazzi, B.F., additional, Alagna, G., additional, Ricci, C., additional, Poisa, P., additional, Rigamonti, C., additional, Calvaruso, V., additional, Carbone, M., additional, and Vespasiani-Gentilucci, U., additional
Published: 2023
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7. Prediction of response to obeticholic acid in primary biliary cholangitis: Development and validation of the OCA response score (ORS)

Author: De Vincentis, A., primary, Terracciani, F., additional, D'Amato, D., additional, Invernizzi, P., additional, Morgando, A., additional, Vanni, E., additional, Viganò, M., additional, Alvaro, D., additional, Venere, R., additional, Lleo, A., additional, Colapietro, F., additional, Degasperi, E., additional, Viganò, R., additional, Giannini, E.G., additional, Labanca, S., additional, Feletti, V., additional, Mussetto, A., additional, Cozzolongo, R., additional, Losito, F., additional, Pompili, M., additional, Ponziani, F.R., additional, Niro, G.A., additional, Cotugno, R., additional, Pozzoni, P., additional, Chessa, L., additional, Cuccorese, G., additional, Palitti, V. Pace, additional, Russello, M., additional, Cannavò, M., additional, Frazzetto, E., additional, Bertino, G., additional, Marzioni, M., additional, Terreni, N., additional, Zolfino, T., additional, Saitta, C., additional, Pellicelli, A., additional, Coco, B., additional, Brunetto, M., additional, Cazzagon, N., additional, Floreani, A., additional, Muratori, L., additional, Rosina, F., additional, Di Stefano, M., additional, Scifo, G., additional, Baiocchi, L., additional, Grassi, G., additional, Sacco, R., additional, Izzi, A., additional, Crocè, Saveria Lory, additional, Fiorini, Cecilia, additional, Marra, Fabio, additional, Simone, Loredana, additional, Morelli, Olivia, additional, Abenavoli, L., additional, Pizzolante, F., additional, De Matthaeis, N., additional, Scaravaglio, M., additional, Gimignani, G., additional, Boano, V., additional, Manfredi, G.F., additional, Marignani, M., additional, Fanella, S., additional, Giacchetto, M., additional, Castellaneta, A., additional, Poggi, G., additional, Buzzanca, V., additional, Scivetti, P., additional, Tortora, A., additional, Casella, S., additional, Bellia, V., additional, Omazzi, B.F., additional, Alagna, G., additional, Ricci, C., additional, Poisa, P., additional, Rigamonti, C., additional, Calvaruso, V., additional, Vespasiani-Gentilucci, U., additional, and Carbone, M., additional
Published: 2023
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8. Real-world experience with obeticholic acid in patients with primary biliary cholangitis

Author: D'Amato, D, De Vincentis, A, Malinverno, F, Vigano, M, Alvaro, D, Pompili, M, Picciotto, A, Palitti, V, Russello, M, Storato, S, Pigozzi, M, Calvaruso, V, De Gasperi, E, Lleo, A, Castellaneta, A, Pellicelli, A, Cazzagon, N, Floreani, A, Muratori, L, Fagiuoli, S, Niro, G, Feletti, V, Cozzolongo, R, Terreni, N, Marzioni, M, Pellicano, R, Pozzoni, P, Baiocchi, L, Chessa, L, Rosina, F, Bertino, G, Vinci, M, Morgando, A, Vanni, E, Scifo, G, Sacco, R, D'Anto, M, Bellia, V, Boldizzoni, R, Casella, S, Omazzi, B, Poggi, G, Cristoferi, L, Gerussi, A, Ronca, V, Venere, R, Ponziani, F, Cannavo, M, Mussetto, A, Fontana, R, Losito, F, Frazzetto, E, Distefano, M, Colapietro, F, Labanca, S, Marconi, G, Grassi, G, Galati, G, O'Donnell, S, Mancuso, C, Mulinacci, G, Palermo, A, Claar, E, Izzi, A, Picardi, A, Invernizzi, P, Carbone, M, Vespasiani-Gentilucci, U, D'Amato D., De Vincentis A., Malinverno F., Vigano M., Alvaro D., Pompili M., Picciotto A., Palitti V. P., Russello M., Storato S., Pigozzi M. G., Calvaruso V., De Gasperi E., Lleo A., Castellaneta A., Pellicelli A., Cazzagon N., Floreani A., Muratori L., Fagiuoli S., Niro G. A., Feletti V., Cozzolongo R., Terreni N., Marzioni M., Pellicano R., Pozzoni P., Baiocchi L., Chessa L., Rosina F., Bertino G., Vinci M., Morgando A., Vanni E., Scifo G., Sacco R., D'Anto M., Bellia V., Boldizzoni R., Casella S., Omazzi B., Poggi G., Cristoferi L., Gerussi A., Ronca V., Venere R., Ponziani F., Cannavo M., Mussetto A., Fontana R., Losito F., Frazzetto E., Distefano M., Colapietro F., Labanca S., Marconi G., Grassi G., Galati G., O'Donnell S. E., Mancuso C., Mulinacci G., Palermo A., Claar E., Izzi A., Picardi A., Invernizzi P., Carbone M., Vespasiani-Gentilucci U., D'Amato, D, De Vincentis, A, Malinverno, F, Vigano, M, Alvaro, D, Pompili, M, Picciotto, A, Palitti, V, Russello, M, Storato, S, Pigozzi, M, Calvaruso, V, De Gasperi, E, Lleo, A, Castellaneta, A, Pellicelli, A, Cazzagon, N, Floreani, A, Muratori, L, Fagiuoli, S, Niro, G, Feletti, V, Cozzolongo, R, Terreni, N, Marzioni, M, Pellicano, R, Pozzoni, P, Baiocchi, L, Chessa, L, Rosina, F, Bertino, G, Vinci, M, Morgando, A, Vanni, E, Scifo, G, Sacco, R, D'Anto, M, Bellia, V, Boldizzoni, R, Casella, S, Omazzi, B, Poggi, G, Cristoferi, L, Gerussi, A, Ronca, V, Venere, R, Ponziani, F, Cannavo, M, Mussetto, A, Fontana, R, Losito, F, Frazzetto, E, Distefano, M, Colapietro, F, Labanca, S, Marconi, G, Grassi, G, Galati, G, O'Donnell, S, Mancuso, C, Mulinacci, G, Palermo, A, Claar, E, Izzi, A, Picardi, A, Invernizzi, P, Carbone, M, Vespasiani-Gentilucci, U, D'Amato D., De Vincentis A., Malinverno F., Vigano M., Alvaro D., Pompili M., Picciotto A., Palitti V. P., Russello M., Storato S., Pigozzi M. G., Calvaruso V., De Gasperi E., Lleo A., Castellaneta A., Pellicelli A., Cazzagon N., Floreani A., Muratori L., Fagiuoli S., Niro G. A., Feletti V., Cozzolongo R., Terreni N., Marzioni M., Pellicano R., Pozzoni P., Baiocchi L., Chessa L., Rosina F., Bertino G., Vinci M., Morgando A., Vanni E., Scifo G., Sacco R., D'Anto M., Bellia V., Boldizzoni R., Casella S., Omazzi B., Poggi G., Cristoferi L., Gerussi A., Ronca V., Venere R., Ponziani F., Cannavo M., Mussetto A., Fontana R., Losito F., Frazzetto E., Distefano M., Colapietro F., Labanca S., Marconi G., Grassi G., Galati G., O'Donnell S. E., Mancuso C., Mulinacci G., Palermo A., Claar E., Izzi A., Picardi A., Invernizzi P., Carbone M., and Vespasiani-Gentilucci U.
Abstract: Background & aims: Obeticholic acid (OCA) is the second-line treatment approved for patients with primary biliary cholangitis (PBC) and an inadequate response or intolerance to ursodeoxycholic acid. We aimed to evaluate the effectiveness and safety of OCA under real-world conditions. Methods: Patients were recruited into the Italian PBC Registry, a multicentre, observational cohort study that monitors patients with PBC at national level. The primary endpoint was the biochemical response according to Poise criteria; the secondary endpoint was the biochemical response according to normal range criteria, defined as normal levels of bilirubin, alkaline phosphatase (ALP), and alanine aminotransferase (ALT) at 12 months. Safety and tolerability were also assessed. Results: We analysed 191 patients until at least 12 months of follow-up. Median age was 57 years, 94% female, 61 (32%) had cirrhosis, 28 (15%) had histologically proven overlap with autoimmune hepatitis (PBC-AIH). At 12 months, significant median reductions of ALP (-32.3%), ALT (-31.4%), and bilirubin (-11.2%) were observed. Response rates were 42.9% according to Poise criteria, and 11% by normal range criteria. Patients with cirrhosis had lower response than patients without cirrhosis (29.5% vs. 49.2%, p = 0.01), owing to a higher rate of OCA discontinuation (30% vs. 12%, p = 0.004), although with similar ALP reduction (29.4% vs. 34%, p = 0.53). Overlap PBC-AIH had a similar response to pure PBC (46.4% vs. 42.3%, p = 0.68), with higher ALT reduction at 6 months (-38% vs. -29%, p = 0.04). Thirty-three patients (17%) prematurely discontinued OCA because of adverse events, of whom 11 experienced serious adverse events. Treatment-induced pruritus was the leading cause of OCA discontinuation (67%). Conclusions: Effectiveness and safety of OCA under real-world conditions mirror those in the Poise trial. Patients with cirrhosis had lower tolerability. Overlap PBC-AIH showed higher ALT reduction at 6 months compare
Published: 2021

9. T.08.4 RELAPSE RATE AND PREDICTORS FOLLOWING IMMUNOSUPPRESSION WITHDRAWAL IN PATIENTS WITH AUTOIMMUNE HEPATITIS

Author: Labanca, S., primary, Buccilli, S., additional, Levo, F., additional, and Giannini, E.G., additional
Published: 2022
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10. T.08.3 CHARACTERISTICS AND SURVIVAL OF PATIENTS WITH PRIMARY BILIARY CHOLANGITIS AND HEPATOCELLULAR CARCINOMA

Author: Giannini, E.G., primary, Pieri, G., additional, Labanca, S., additional, Plaz Torres, M.C., additional, Gasbarrini, A., additional, Biasini, E., additional, Campani, C., additional, Cazzagon, N., additional, Foschi, F.G., additional, Mega, A., additional, Masotto, A., additional, Raimondo, G., additional, Rapaccini, G.L., additional, Sacco, R., additional, Caturelli, E., additional, Guarino, M., additional, Tovoli, F., additional, Vidili, G., additional, Brunetto, M.R., additional, Nardone, G., additional, Svegliati-Baroni, G., additional, Magalotti, D., additional, Azzaroli, F., additional, Cabibbo, G., additional, Di Marco, M., additional, Sangiovanni, A., additional, and Trevisani, F., additional
Published: 2022
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11. Predictors of Serious Adverse Event and Non-response in Cirrhotic Patients With Primary Biliary Cholangitis under Obeticholic Acid

Author: De Vincentis, A., primary, D'Amato, D., additional, Cristoferi, L., additional, Gerussi, A., additional, Malinverno, F., additional, Lleo, A., additional, Colapietro, F., additional, Marra, F., additional, Galli, A., additional, Fiorini, C., additional, Coco, B., additional, Brunetto, M., additional, Niro, G.A., additional, Cotugno, R., additional, Saitta, C., additional, Cozzolongo, R., additional, Losito, F., additional, Giannini, E.G., additional, Labanca, S., additional, Marzioni, M., additional, Marconi, G., additional, Morgando, A., additional, Pellicano, R., additional, Vanni, E., additional, Cazzagon, N., additional, Floreani, A., additional, Chessa, L., additional, Morelli, O., additional, Muratori, L., additional, Pellicelli, A., additional, Pompili, M., additional, Ponziani, F., additional, Rosina, F., additional, Russello, M., additional, Cannavò, M., additional, Simone, L., additional, Storato, S., additional, Viganò, M., additional, Abenavoli, L., additional, D'Antò, M., additional, De Gasperi, E., additional, Distefano, M., additional, Scifo, G., additional, Zolfino, T., additional, Calvaruso, V., additional, Cuccorese, G., additional, Pace Palitti, V., additional, Sacco, R., additional, Bertino, G., additional, Frazzetto, E., additional, Alvaro, D., additional, Mulinacci, G., additional, Palermo, A., additional, Galati, G., additional, Ronca, V., additional, Zuin, M., additional, Claar, E., additional, Izzi, A., additional, Picardi, A., additional, Invernizzi, P., additional, Vespasiani-Gentilucci, U., additional, and Carbone, M., additional
Published: 2022
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12. Clinical features of patients with new onset of autoimmune hepatitis following SARS-CoV-2 vaccination

Author: Rigamonti, C., primary, Coco, B., additional, Brunetto, M., additional, Labanca, S., additional, Giannini, E.G., additional, Magro, B., additional, Fagiuoli, S., additional, Baroni, G. Svegliati, additional, Sgamato, C., additional, Miele, L., additional, Grieco, A., additional, Giuli, L., additional, Manfredi, G.F., additional, and Pirisi, M., additional
Published: 2022
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13. Primary biliary cholangitis: Perception and expectation of illness in Italian patients

Author: Floreani, A., Scaffidi, M., Coco, B., Giannini, E. G., Labanca, S., Bonaiuto, E., De Martin, S., Invernizzi, P., Carbone, M., Alvaro, D., Bragazzi, M. C., Calvaruso, V., Cossiga, V., and Cazzagon, N.
Subjects: Quality of life, Questionnaire, Illness perception, PBC
Published: 2022

14. Accuracy of Liver Stiffness Measurement in assessing liver fibrosis in naïve patients with Primary Biliary Cholangitis

Author: Cristoferi, L, Nardi, A, Viganò, M, Rigamonti, C, Degasperi, E, Cardinale, V, Labanca, S, Zucchini, N, Leutner, M, Venere, R, Picciotto, A, Cazzagon, N, Lucà, M, Overi, D, Gerussi, A, D’Amato, D, O’Donnell, S, Cerini, F, De Benedittis, C, Cadamuro, M, Malinverno, F, Floreani, A, Alvaro, D, Gaudio, E, Invernizzi, P, Carpino, G, Carbone, M, Cristoferi L, Nardi A, Viganò M, Rigamonti C, Degasperi E, Cardinale V, Labanca S, Zucchini N, Leutner M, Venere R, Picciotto A, Cazzagon N, Lucà M, Overi D, Gerussi A, D’Amato D, O’Donnell S, Cerini F, De Benedittis C, Cadamuro M, Malinverno F, Floreani A, Alvaro D, Gaudio E, Invernizzi P, Carpino G, Carbone M, Cristoferi, L, Nardi, A, Viganò, M, Rigamonti, C, Degasperi, E, Cardinale, V, Labanca, S, Zucchini, N, Leutner, M, Venere, R, Picciotto, A, Cazzagon, N, Lucà, M, Overi, D, Gerussi, A, D’Amato, D, O’Donnell, S, Cerini, F, De Benedittis, C, Cadamuro, M, Malinverno, F, Floreani, A, Alvaro, D, Gaudio, E, Invernizzi, P, Carpino, G, Carbone, M, Cristoferi L, Nardi A, Viganò M, Rigamonti C, Degasperi E, Cardinale V, Labanca S, Zucchini N, Leutner M, Venere R, Picciotto A, Cazzagon N, Lucà M, Overi D, Gerussi A, D’Amato D, O’Donnell S, Cerini F, De Benedittis C, Cadamuro M, Malinverno F, Floreani A, Alvaro D, Gaudio E, Invernizzi P, Carpino G, and Carbone M
Abstract: Background and Aims: Non-invasive evaluation of liver fibrosis in primary biliary cholangitis (PBC) with Liver Stiffness Measurements (LSM) by Transient Elastography (TE) is routinely undertaken at diagnosis for disease staging and risk stratification. However, evidence on correlation between LSM and liver fibrosis is based on cross-sectional studies in PBC-treated patients. Moreover, the impact of potential confounders, e.g. cholestasis and steatosis, is unclear. Aim of our study was to investigate the accuracy of LSM to predict moderate to severe fibrosis in newly diagnosed PBC patients naïve to therapy. Method: We collected data from 182 adult patients who underwent liver biopsy (LB) for PBC at diagnosis in five Italian liver centers from Jan 2006 through Aug 2019. TE examinations within 3 months from LB were included. LB were scored centrally by two expert pathologists, blinded to clinical data and disease stage, according to Ludwig staging system. In all patients Fibrosis-4 (FIB-4) and aspartate aminotransferase [AST]/platelet ratio (APRI) score have been calculated. Diagnostic accuracy of LSM, FIB-4 and APRI score was estimated using the area under the receiver operating characteristic curves (AUROCs) for fibrosis. The effects of liver biochemistry and histological parameters were appraised using multivariable logistic model. Results: 123 PBC patients had adequate LB (≥9 portal tracts) and valid LSM values. According to histological assessment, Ludwig stage distribution was as follows: stage I = 38 (30.9%), stage II = 46(37.4%), stage III = 27 (21.9%), stage IV = 12 (9.8%). TE identified patients with Ludwig stage III/IV with an AUROC of 0.83 (95% confidence interval [CI] (0.74, 0.90)) (Fig.1). The optimal threshold was identified at 6.75kPa (CI (6.55, 7.50)), with 85% of sensitivity, 75% of specificity, 78% of accuracy and 6 false negative. TE was superior to APRI and FIB-4 having AUROC of 0.638 (CI = (0.535, 0.740)) and 0.641 (CI = (0.516, 0.766)), respecti
Published: 2020

15. Biochemical response to obeticholic acid drives liver stiffness variation over time and the risk of liver-related events in patients with primary biliary cholangitis

Author: De Vincentis, A., Terracciani, F., D'Amato, D., Scaravaglio, M., Invernizzi, P., Vanni, E., Campion, D., Floreani, A., Cazzagon, N., Alvaro, D., Venere, R., Giannini, E.G., Labanca, S., Lleo, A., Colapietro, F., Degasperi, E., Viganò, M., Pesatori, E., Fagiuoli, S., Marzioni, M., Buzzanca, V., Viganò, R., D'Amico, F., Galli, A., Curto, A., Marra, F., Begini, P., Baiocchi, L., Carnì, P., Muratori, L., Coco, B., Brunetto, M., Pizzolante, F., De Matthaeis, N., Falbo, E., Surace, L., Mattalia, A., Ieluzzi, D., Salomone, F., Delle Monache, G., Tatonetti, R., Cavalli, I., Cossiga, V., Morisco, F., Valiani, V., Gatti, P., Boccaccio, V., Angrisani, D., Vettori, G., Cuffari, B., Moretti, A., Rocco, A., Nardone, G., Scivetti, P., Costanzo, M., Boano, V., Manfredi, G.F., Simone, L., Palitti, V. Pace, Russello, M., Cannavò, M., Frazzetto, E., Bertino, G., Di Stefano, M., Izzi, A., Cerini, F., Chessa, L., Miglianti, M., Feletti, V., Mussetto, A., Cozzolongo, R., Losito, F., Niro, G.A., Cotugno, R., Sacco, R., Ricci, C., Poise, P., Cadamuro, L., Castellaneta, A., Squeo, F., Terreni, N., Bina, N., Pozzoni, P., Casella, S., Zani, F., Morelli, O., Cuccorese, G., Saitta, C., Zolfino, T., Rigamonti, C., Calvaruso, V., Carbone, M., and Vespasiani-Gentilucci, U.
Published: 2024
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16. Economic Consequences of Investing in Anti-HCV Antiviral Treatment from the Italian NHS Perspective: A Real-World-Based Analysis of PITER Data

Author: Marcellusi, Andrea, Viti, Raffaella, Kondili, Loreta A., Rosato, Stefano, Vella, Stefano, Mennini, Francesco Saverio, Kondili, L. A., Vella, S., Quaranta, M. G., Rosato, S., Tosti, M. E., Weimer, L. E., Ferrigno, L., D’Angelo, F., Falzano, L., Benedetti, A., Schiadà, L., Cucco, M., Giacometti, A., Brescini, L., Castelletti, S., Drenaggi, D., Mazzaro, C., Angarano, G., Milella, M., Di Leo, A., Rendina, M., Contaldo, A., Iannone, A., La Fortezza, F., Rizzi, M., Cologni, G., Bolondi, L., Benevento, F., Serio, I., Andreone, P., Caraceni, P., Guarneri, V., Margotti, M., Simonetti, G., Mazzella, G., Verucchi, G., Donati, V., Mian, Peter, Rimenti, G., Rossini, A., Contessi, G. B., Castelli, Fulvio, Zaltron, S., Spinetti, A., Odolini, S., Leandro, G., Cozzolongo, R., Zappimbulso, M., Russello, M., Benigno, R., Coco, C., Torti, C., Costa, C., Greco, G., Mazzitelli, M., Pisani, V., Cosco, Lucia, Quintieri, F., De Siena, Martina, Giancotti, F., Vecchiet, J., Falasca, K., Mastroianni, A., Apuzzo, G., Chidichimo, L., Foschi, F. G., Dall’Aglio, A. C., Libanore, M., Segala, D., Sighinolfi, L., Bartolozzi, D., Salomoni, E., Blanc, P., Baragli, F., DelundefinedPin, B., Mariabelli, E., Mazzotta, F., Poggi, A., Zignego, A. L., Monti, M., Madia, Francesca, Xheka, A., Cela, E. M., Santantonio, T. A., Bruno, S. R., Viscoli, C., Alessandrini, A. I., Curti, C., DiundefinedBiagio, A., Nicolini, L. A., Balletto, E., Mastroianni, Chiara, Blerta, K., Prati, D., Raffaele, L., Andreoletti, M., Perboni, G., Costa, P., Manzini, L., Raimondo, G., Filomia, R., Lazzarin, A., Morsica, G., Salpietro, S., Puoti, M., Baiguera, C., Vassalli, S., Rumi, M. G., Labanca, S., Zuin, M., Giorgini, A., Orellana, D., D’ArminioundefinedMonforte, A., Debona, A., Solaro, S., Fargion, S., Valenti, L., Periti, G., Pelusi, S., Galli, M., Calvi, E., Milazzo, L., Peri, A., Lampertico, P., Borghi, Margherita, D’Ambrosio, R., Degasperi, E., Vinci, Maria Rosaria, Villa, E., Bernabucci, V., Bristot, Luca, Pereira, F., Chessa, L., Pasetto, M. C., Loi, M., Gori, A., Beretta, I., Pastore, V., Soria, A., Strazzabosco, M., Ciaccio, A., Gemma, M., Borgia, G., Foggia, A., Zappulo, E., Gentile, I., Buonomo, A. R., Abrescia, N., Maddaloni, A., Caporaso, N., Morisco, F., Camera, S., Donnarumma, L., Coppola, C., Amoruso, D. C., Staiano, L., Saturnino, M. R., Coppola, N., Martini, S., Monari, C., Federico, Alex, Dallio, M., Loguercio, C., Gaeta, G. B., Brancaccio, G., Nardone, G., Sgamato, C., D’Adamo, G., Alberti, A., Gonzo, M., Piovesan, S., Chemello, L., Buggio, A., Cavalletto, L., Barbaro, F., Castelli, Enrico, Floreani, A., Cazzagon, N., Franceschet, I., Russo, F. P., Zanetto, A., Franceschet, E., Madonia, S., Cannizzaro, Maria Chiara, Montalto, G., Licata, A., Capitano, A. R., Craxì, A., Petta, S., Calvaruso, V., Rini, F., Ferrari, C., Negri, E., Orlandini, A., Pesci, M., Bruno, R., Lombardi, A., Zuccaro, V., Gulminetti, R., Asti, A., Villaraggia, M., Mondelli, M., Ludovisi, S., Baldelli, F., Di Candilo, F., Parruti, G., Di Stefano, Paolo, Sozio, F., Gizzi, M. C., Brunetto, M. R., Colombatto, P., Coco, B., Surace, L., Foti, G., Pellicano, S., Fornaciari, G., Schianchi, S., Vignoli, P., Massari, M., Corsini, R., Garlassi, E., Ballardini, G., Andreoni, M., Cerva, C., Angelico, M., Gasbarrini, Antonio, Siciliano, M., Nosotti, L., Taliani, G., Biliotti, E., Santori, M., Spaziante, M., Tamburini, F., Vullo, V., D’Ettorre, G., Cavallari, E. N., Gebremeskel, T. S., Pavone, P., Cauda, Roberto, Cingolani, Antonella, Lamonica, S., D’Offizi, G., Lionetti, R., Visco Comandini, U., Grieco, Antonio, D’Aversa, F., Picardi, A., De Vincentis, A., Galati, G., Gallo, Patrizia, Dell’Unto, C., Aghemo, A., Gatti Comini, A., Persico, M., Masarone, M., Anselmo, M., De Leo, P., Marturano, Monia, Brunelli, E., Ridolfi, F., Schimizzi, A. M., Ayoubi Khajekini, M., Framarin, L., Di Perri, G., Cariti, G., Boglione, L., Cardellino, C., Marinaro, L., Saracco, G. M., Ciancio, A., Toniutto, P., Alterini, G., Capra, F., Ieluzzi, D., Marcellusi, A, Viti, R, Kondili, L, Rosato, S, Vella, S, Mennini, F, Quaranta, M, Tosti, M, Weimer, L, Ferrigno, L, D'Angelo, F, Falzano, L, Benedetti, A, Schiada, L, Cucco, M, Giacometti, A, Brescini, L, Castelletti, S, Drenaggi, D, Mazzaro, C, Angarano, G, Milella, M, Dileo, A, Rendina, M, Contaldo, A, Iannone, A, La Fortezza, F, Rizzi, M, Cologni, G, Bolondi, L, Benevento, F, Serio, I, Andreone, P, Caraceni, P, Guarneri, V, Margotti, M, Simonetti, G, Mazzella, G, Verucchi, G, Donati, V, Mian, P, Rimenti, G, Rossini, A, Contessi, G, Castelli, F, Zaltron, S, Spinetti, A, Odolini, S, Leandro, G, Cozzolongo, R, Zappimbulso, M, Russello, M, Benigno, R, Coco, C, Torti, C, Costa, C, Greco, G, Mazzitelli, M, Pisani, V, Cosco, L, Quintieri, F, Desiena, M, Giancotti, F, Vecchiet, J, Falasca, K, Mastroianni, A, Apuzzo, G, Chidichimo, L, Foschi, F, Dall'Aglio, A, Libanore, M, Segala, D, Sighinolfi, L, Bartolozzi, D, Salomoni, E, Blanc, P, Baragli, F, Delpin, B, Mariabelli, E, Mazzotta, F, Poggi, A, Zignego, A, Monti, M, Madia, F, Xheka, A, Cela, E, Santantonio, T, Bruno, S, Viscoli, C, Alessandrini, A, Curti, C, Dibiagio, A, Nicolini, L, Balletto, E, Mastroianni, C, Blerta, K, Prati, D, Raffaele, L, Andreoletti, M, Perboni, G, Costa, P, Manzini, L, Raimondo, G, Filomia, R, Lazzarin, A, Morsica, G, Salpietro, S, Puoti, M, Baiguera, C, Vassalli, S, Rumi, M, Labanca, S, Zuin, M, Giorgini, A, Orellana, D, D'Arminiomonforte, A, Debona, A, Solaro, S, Fargion, S, Valenti, L, Periti, G, Pelusi, S, Galli, M, Calvi, E, Milazzo, L, Peri, A, Lampertico, P, Borghi, M, D'Ambrosio, R, Degasperi, E, Vinci, M, Villa, E, Bernabucci, V, Bristot, L, Pereira, F, Chessa, L, Pasetto, M, Loi, M, Gori, A, Beretta, I, Pastore, V, Soria, A, Strazzabosco, M, Ciaccio, A, Gemma, M, Borgia, G, Foggia, A, Zappulo, E, Gentile, I, Buonomo, A, Abrescia, N, Maddaloni, A, Caporaso, N, Morisco, F, Camera, S, Donnarumma, L, Coppola, C, Amoruso, D, Staiano, L, Saturnino, M, Coppola, N, Martini, S, Monari, C, Federico, A, Dallio, M, Loguercio, C, Gaeta, G, Brancaccio, G, Nardone, G, Sgamato, C, D'Adamo, G, Alberti, A, Gonzo, M, Piovesan, S, Chemello, L, Buggio, A, Cavalletto, L, Barbaro, F, Castelli, E, Floreani, A, Cazzagon, N, Franceschet, I, Russo, F, Zanetto, A, Franceschet, E, Madonia, S, Cannizzaro, M, Montalto, G, Licata, A, Capitano, A, Craxi, A, Petta, S, Calvaruso, V, Rini, F, Ferrari, C, Negri, E, Orlandini, A, Pesci, M, Bruno, R, Lombardi, A, Zuccaro, V, Gulminetti, R, Asti, A, Villaraggia, M, Mondelli, M, Ludovisi, S, Baldelli, F, Di Candilo, F, Parruti, G, Di Stefano, P, Sozio, F, Gizzi, M, Brunetto, M, Colombatto, P, Coco, B, Surace, L, Foti, G, Pellicano, S, Fornaciari, G, Schianchi, S, Vignoli, P, Massari, M, Corsini, R, Garlassi, E, Ballardini, G, Andreoni, M, Cerva, C, Angelico, M, Gasbarrini, A, Siciliano, M, De Siena, M, Nosotti, L, Taliani, G, Biliotti, E, Santori, M, Spaziante, M, Tamburini, F, Vullo, V, D'Ettorre, G, Cavallari, E, Gebremeskel, T, Pavone, P, Cauda, R, Cingolani, A, Lamonica, S, D'Offizi, G, Lionetti, R, Visco Comandini, U, Grieco, A, D'Aversa, F, Picardi, A, De Vincentis, A, Galati, G, Gallo, P, Dell'Unto, C, Aghemo, A, Gatti Comini, A, Persico, M, Masarone, M, Anselmo, M, De Leo, P, Marturano, M, Brunelli, E, Ridolfi, F, Schimizzi, A, Ayoubi Khajekini, M, Framarin, L, Di Perri, G, Cariti, G, Boglione, L, Cardellino, C, Marinaro, L, Saracco, G, Ciancio, A, Toniutto, P, Alterini, G, Capra, F, Ieluzzi, D, Kondili LA, Vella S, Quaranta MG, Rosato S, Tosti ME, Weimer LE, Ferrigno L, D'Angelo F, Falzano L, Benedetti A, Schiadà L, Cucco M, Giacometti A, Brescini L, Castelletti S, Drenaggi D, Mazzaro C, Angarano G, Milella M, Di Leo A, Rendina M, Contaldo A, Iannone A, La Fortezza F, Rizzi M, Cologni G, Bolondi L, Benevento F, Serio I, Andreone P, Caraceni P, Guarneri V, Margotti M, Simonetti G, Mazzella G, Verucchi G, Donati V, Mian P, Rimenti G, Rossini A, Contessi GB, Castelli F, Zaltron S, Spinetti A, Odolini S, Leandro G, Cozzolongo R, Zappimbulso M, Russello M, Benigno R, Coco C, Torti C, Costa C, Greco G, Mazzitelli M, Pisani V, Cosco L, Quintieri F, De Siena M, Giancotti F, Vecchiet J, Falasca K, Mastroianni A, Apuzzo G, Chidichimo L, Foschi FG, Dall'Aglio AC, Libanore M, Segala D, Sighinolfi L, Bartolozzi D, Salomoni E, Blanc P, Baragli F, Del Pin B, Mariabelli E, Mazzotta F, Poggi A, Zignego AL, Monti M, Madia F, Xheka A, Cela EM, Santantonio TA, Bruno SR, Viscoli C, Alessandrini AI, Curti C, Di Biagio A, Nicolini LA, Balletto E, Mastroianni C, Blerta K, Prati D, Raffaele L, Andreoletti M, Perboni G, Costa P, Manzini L, Raimondo G, Filomia R, Lazzarin A, Morsica G, Salpietro S, Puoti M, Baiguera C, Vassalli S, Rumi MG, Labanca S, Zuin M, Giorgini A, Orellana D, D'Arminio Monforte A, Debona A, Solaro S, Fargion S, Valenti L, Periti G, Pelusi S, Galli M, Calvi E, Milazzo L, Peri A, Lampertico P, Borghi M, D'Ambrosio R, Degasperi E, Vinci M, Villa E, Bernabucci V, Bristot L, Pereira F, Chessa L, Pasetto MC, Loi M, Gori A, Beretta I, Pastore V, Soria A, Strazzabosco M, Ciaccio A, Gemma M, Borgia G, Foggia A, Zappulo E, Gentile I, Buonomo AR, Abrescia N, Maddaloni A, Caporaso N, Morisco F, Camera S, Donnarumma L, Coppola C, Amoruso DC, Staiano L, Saturnino MR, Coppola N, Martini S, Monari C, Federico A, Dallio M, Loguercio C, Gaeta GB, Brancaccio G, Nardone G, Sgamato C, D'Adamo G, Alberti A, Gonzo M, Piovesan S, Chemello L, Buggio A, Cavalletto L, Barbaro F, Castelli E, Floreani A, Cazzagon N, Franceschet I, Russo FP, Zanetto A, Franceschet E, Madonia S, Cannizzaro M, Montalto G, Licata A, Capitano AR, Craxì A, Petta S, Calvaruso V, Rini F, Ferrari C, Negri E, Orlandini A, Pesci M, Bruno R, Lombardi A, Zuccaro V, Gulminetti R, Asti A, Villaraggia M, Mondelli M, Ludovisi S, Baldelli F, Di Candilo F, Parruti G, Di Stefano P, Sozio F, Gizzi MC, Brunetto MR, Colombatto P, Coco B, Surace L, Foti G, Pellicano S, Fornaciari G, Schianchi S, Vignoli P, Massari M, Corsini R, Garlassi E, Ballardini G, Andreoni M, Cerva C, Angelico M, Gasbarrini A, Siciliano M, De Siena M, Nosotti L, Taliani G, Biliotti E, Santori M, Spaziante M, Tamburini F, Vullo V, D'Ettorre G, Cavallari EN, Gebremeskel TS, Pavone P, Cauda R, Cingolani A, Lamonica S, D'Offizi G, Lionetti R, Visco Comandini U, Grieco A, D'Aversa F, Picardi A, De Vincentis A, Galati G, Gallo P, Dell'Unto C, Aghemo A, Gatti Comini A, Persico M, Masarone M, Anselmo M, De Leo P, Marturano M, Brunelli E, Ridolfi F, Schimizzi AM, Ayoubi Khajekini M, Framarin L, Di Perri G, Cariti G, Boglione L, Cardellino C, Marinaro L, Saracco GM, Ciancio A, Toniutto P, Alterini G, Capra F, Ieluzzi D., Marcellusi, A., Viti, R., Kondili, L. A., Rosato, S., Vella, S., Mennini, F. S., Quaranta, M. G., Tosti, M. E., Weimer, L. E., Ferrigno, L., D'Angelo, F., Falzano, L., Benedetti, A., Schiada, L., Cucco, M., Giacometti, A., Brescini, L., Castelletti, S., Drenaggi, D., Mazzaro, C., Angarano, G., Milella, M., Dileo, A., Rendina, M., Contaldo, A., Iannone, A., La Fortezza, F., Rizzi, M., Cologni, G., Bolondi, L., Benevento, F., Serio, I., Andreone, P., Caraceni, P., Guarneri, V., Margotti, M., Simonetti, G., Mazzella, G., Verucchi, G., Donati, V., Mian, P., Rimenti, G., Rossini, A., Contessi, G. B., Castelli, F., Zaltron, S., Spinetti, A., Odolini, S., Leandro, G., Cozzolongo, R., Zappimbulso, M., Russello, M., Benigno, R., Coco, C., Torti, C., Costa, C., Greco, G., Mazzitelli, M., Pisani, V., Cosco, L., Quintieri, F., Desiena, M., Giancotti, F., Vecchiet, J., Falasca, K., Mastroianni, A., Apuzzo, G., Chidichimo, L., Foschi, F. G., Dall'Aglio, A. C., Libanore, M., Segala, D., Sighinolfi, L., Bartolozzi, D., Salomoni, E., Blanc, P., Baragli, F., Delpin, B., Mariabelli, E., Mazzotta, F., Poggi, A., Zignego, A. L., Monti, M., Madia, F., Xheka, A., Cela, E. M., Santantonio, T. A., Bruno, S. R., Viscoli, C., Alessandrini, A. I., Curti, C., Dibiagio, A., Nicolini, L. A., Balletto, E., Mastroianni, C., Blerta, K., Prati, D., Raffaele, L., Andreoletti, M., Perboni, G., Costa, P., Manzini, L., Raimondo, G., Filomia, R., Lazzarin, A., Morsica, G., Salpietro, S., Puoti, M., Baiguera, C., Vassalli, S., Rumi, M. G., Labanca, S., Zuin, M., Giorgini, A., Orellana, D., D'Arminiomonforte, A., Debona, A., Solaro, S., Fargion, S., Valenti, L., Periti, G., Pelusi, S., Galli, M., Calvi, E., Milazzo, L., Peri, A., Lampertico, P., Borghi, M., D'Ambrosio, R., Degasperi, E., Vinci, M., Villa, E., Bernabucci, V., Bristot, L., Pereira, F., Chessa, L., Pasetto, M. C., Loi, M., Gori, A., Beretta, I., Pastore, V., Soria, A., Strazzabosco, M., Ciaccio, A., Gemma, M., Borgia, G., Foggia, A., Zappulo, E., Gentile, I., Buonomo, A. R., Abrescia, N., Maddaloni, A., Caporaso, N., Morisco, F., Camera, S., Donnarumma, L., Coppola, C., Amoruso, D. C., Staiano, L., Saturnino, M. R., Coppola, N., Martini, S., Monari, C., Federico, A., Dallio, M., Loguercio, C., Gaeta, G. B., Brancaccio, G., Nardone, G., Sgamato, C., D'Adamo, G., Alberti, A., Gonzo, M., Piovesan, S., Chemello, L., Buggio, A., Cavalletto, L., Barbaro, F., Castelli, E., Floreani, A., Cazzagon, N., Franceschet, I., Russo, F. P., Zanetto, A., Franceschet, E., Madonia, S., Cannizzaro, M., Montalto, G., Licata, A., Capitano, A. R., Craxi, A., Petta, S., Calvaruso, V., Rini, F., Ferrari, C., Negri, E., Orlandini, A., Pesci, M., Bruno, R., Lombardi, A., Zuccaro, V., Gulminetti, R., Asti, A., Villaraggia, M., Mondelli, M., Ludovisi, S., Baldelli, F., Di Candilo, F., Parruti, G., Di Stefano, P., Sozio, F., Gizzi, M. C., Brunetto, M. R., Colombatto, P., Coco, B., Surace, L., Foti, G., Pellicano, S., Fornaciari, G., Schianchi, S., Vignoli, P., Massari, M., Corsini, R., Garlassi, E., Ballardini, G., Andreoni, M., Cerva, C., Angelico, M., Gasbarrini, A., Siciliano, M., De Siena, M., Nosotti, L., Taliani, G., Biliotti, E., Santori, M., Spaziante, M., Tamburini, F., Vullo, V., D'Ettorre, G., Cavallari, E. N., Gebremeskel, T. S., Pavone, P., Cauda, R., Cingolani, A., Lamonica, S., D'Offizi, G., Lionetti, R., Visco Comandini, U., Grieco, A., D'Aversa, F., Picardi, A., De Vincentis, A., Galati, G., Gallo, P., Dell'Unto, C., Aghemo, A., Gatti Comini, A., Persico, M., Masarone, M., Anselmo, M., De Leo, P., Marturano, M., Brunelli, E., Ridolfi, F., Schimizzi, A. M., Ayoubi Khajekini, M., Framarin, L., Di Perri, G., Cariti, G., Boglione, L., Cardellino, C., Marinaro, L., Saracco, G. M., Ciancio, A., Toniutto, P., Alterini, G., Capra, F., Ieluzzi, D., Marcellusi, Andrea, Viti, Raffaella, Kondili, Loreta A., Rosato, Stefano, Vella, Stefano, Mennini, Francesco Saverio, Kondili, L.A., Quaranta, M.G., Tosti, M.E., Weimer, L.E., D’Angelo, F., Schiadà, L., Di&nbsp, Leo, A., Contessi, G.B., De&nbsp, Siena, M., Foschi, F.G., Dall’Aglio, A.C., Del&nbsp, Pin, B., Zignego, A.L., Cela, E.M., Santantonio, T.A., Bruno, S.R., Alessandrini, A.I., Biagio, A., Nicolini, L.A., Rumi, M.G., D’Arminio&nbsp, Monforte, A., D’Ambrosio, R., Pasetto, M.C., Buonomo, A.R., Amoruso, D.C., Saturnino, M.R., Gaeta, G.B., D’Adamo, G., Russo, F.P., Capitano, A.R., Craxì, A., Gizzi, M.C., Brunetto, M.R., D’Ettorre, G., Cavallari, E.N., Gebremeskel, T.S., D’Offizi, G., D’Aversa, F., Dell’Unto, C., Schimizzi, A.M., Saracco, G.M., Cosco, Alfredo, Dall’Aglio, A. C., Salomoni, Valentina, Nicolini, Elvira, Calvi, Marta, Soria, Giovanni, D'Adamo, Danilo, ALONSO ALBERTI, MARIA PALOMA CARMEN, Orlandini, Giovanni, DE ASTIS, Fabio, Sozio, Concetta, Terzini, Angelico, DE SIENA, ANDREA URIEL, Taliani, Sabrina, Spaziante, Agata, Lamonica, Emilia, and Capra, Carlo
Subjects: Liver Cirrhosis, Pediatrics, Time Factors, Settore MED/09 - Medicina Interna, National Health Programs, ERADICATION, OUTBREAK, antiviral treatment, anti HCV, economic consequences, Hepacivirus, LIVER FIBROSIS, Severity of Illness Index, Health Services Accessibility, COST-EFFECTIVENESS, Indirect costs, 0302 clinical medicine, Epidemiology, virus infection, 030212 general & internal medicine, health care economics and organizations, cost effectiveness, 030503 health policy & services, Health Policy, Health services research, health, Hepatitis C, Markov Chains, chronic hepatitis C, virus infection, fibrosis progression, cost effectiveness, liver fibrosis, Italy, Pharmacology, Public Health, Environmental and Occupational Health, Cohort, Settore SECS-P/03 - Scienza delle Finanze, Disease Progression, Public Health, 0305 other medical science, Viral hepatitis, Anti-HCV antiviral treatment, CHRONIC HEPATITIS-C, medicine.medical_specialty, Genotype, Settore MED/12 - GASTROENTEROLOGIA, VIRUS-INFECTION, Antiviral Agents, NO, 03 medical and health sciences, Cost Savings, Humans, medicine, MANAGEMENT, chronic hepatitis C, INDUCED DISEASES, METAANALYSIS, Health economics, business.industry, Public health, Environmental and Occupational Health, medicine.disease, FIBROSIS PROGRESSION, business
Abstract: OBJECTIVE:\ud We estimated the cost consequence of Italian National Health System (NHS) investment in direct-acting antiviral (DAA) therapy according to hepatitis C virus (HCV) treatment access policies in Italy.\ud \ud METHODS:\ud A multistate, 20-year time horizon Markov model of HCV liver disease progression was developed. Fibrosis stage, age and genotype distributions were derived from the Italian Platform for the Study of Viral Hepatitis Therapies (PITER) cohort. The treatment efficacy, disease progression probabilities and direct costs in each health state were obtained from the literature. The break-even point in time (BPT) was defined as the period of time required for the cumulative costs saved to recover the Italian NHS investment in DAA treatment. Three different PITER enrolment periods, which covered the full DAA access evolution in Italy, were considered.\ud \ud RESULTS:\ud The disease stages of 2657 patients who consecutively underwent DAA therapy from January 2015 to December 2017 at 30 PITER clinical centres were standardized for 1000 patients. The investment in DAAs was considered to equal €25 million, €15 million, and €9 million in 2015, 2016, and 2017, respectively. For patients treated in 2015, the BPT was not achieved, because of the disease severity of the treated patients and high DAA prices. For 2016 and 2017, the estimated BPTs were 6.6 and 6.2 years, respectively. The total cost savings after 20 years were €50.13 and €55.50 million for 1000 patients treated in 2016 and 2017, respectively.\ud \ud CONCLUSIONS:\ud This study may be a useful tool for public decision makers to understand how HCV clinical and epidemiological profiles influence the economic burden of HCV.
Published: 2019

17. Effectiveness and safety of switching to entecavir hepatitis B patients developing kidney dysfunction during tenofovir

Author: Vigano, M, Loglio, A, Labanca, S, Zaltron, S, Castelli, F, Andreone, P, Messina, V, Ganga, R, Coppola, N, Marrone, A, Russello, M, Marzano, A, Tucci, A, Taliani, G, Fasano, M, Fagiuoli, S, Villa, E, Bronte, F, Santantonio, T, Brancaccio, G, Occhipinti, V, Facchetti, F, Grossi, G, Rumi, M, Lampertico, P, Vigano M., Loglio A., Labanca S., Zaltron S., Castelli F., Andreone P., Messina V., Ganga R., Coppola N., Marrone A., Russello M., Marzano A., Tucci A., Taliani G., Fasano M., Fagiuoli S., Villa E., Bronte F., Santantonio T., Brancaccio G., Occhipinti V., Facchetti F., Grossi G., Rumi M., Lampertico P., Vigano, M, Loglio, A, Labanca, S, Zaltron, S, Castelli, F, Andreone, P, Messina, V, Ganga, R, Coppola, N, Marrone, A, Russello, M, Marzano, A, Tucci, A, Taliani, G, Fasano, M, Fagiuoli, S, Villa, E, Bronte, F, Santantonio, T, Brancaccio, G, Occhipinti, V, Facchetti, F, Grossi, G, Rumi, M, Lampertico, P, Vigano M., Loglio A., Labanca S., Zaltron S., Castelli F., Andreone P., Messina V., Ganga R., Coppola N., Marrone A., Russello M., Marzano A., Tucci A., Taliani G., Fasano M., Fagiuoli S., Villa E., Bronte F., Santantonio T., Brancaccio G., Occhipinti V., Facchetti F., Grossi G., Rumi M., and Lampertico P.
Abstract: Background and Aims: Tenofovir disoproxil fumarate (TDF) is recommended for chronic hepatitis B (CHB) treatment, but it may induce kidney dysfunction whose management is not yet known. This Italian, multicentre, retrospective study aimed to assess the efficacy and safety of switching to entecavir (ETV) patients who developed TDF-associated glomerular and/or tubular dysfunction. Methods: A total of 103 TDF-treated patients were included as follows: age 64 years, 83% male, 49% cirrhotics, 98% with undetectable HBV DNA, 47% with previous lamivudine resistance (LMV-R) and 71% previously treated with adefovir. Twenty-nine (28%) were switched to ETV because estimated glomerular filtration rate (eGFR MDRD ) was <60 mL/min, 37 (36%) because blood phosphate (P) levels were <2.5 mg/dL and 37 (36%) for both reasons. Kidney, liver and virological parameters were recorded every 4 months thereafter. Results: During 46 (4-115) months of ETV treatment, all patients’ renal parameters significantly improved as follows: creatinine from 1.30 to 1.10 mg/dL (P < 0.0001), eGFR MDRD from 54 to 65 mL/min (P = 0.002), P from 2.2 to 2.6 mg/dL (P < 0.0001) and maximal tubule phosphate reabsorption (TmPO4/eGFR) from 0.47 to 0.62 mmol/L (P < 0.0001). Thirteen patients (52%) improved their eGFR MDRD class, P levels were normalised in 13 (35%), and eight (22%) showed improvements in both parameters. Viral suppression was maintained in all but five patients (5%), all of whom had been LMV-R. The 5-year cumulative probability of ETV-R was 0% in LMV-naïve patients, and 11% in LMV-R patients (P = 0.018). Conclusions: Entecavir is an effective and safe rescue strategy for CHB patients who develop renal dysfunction during long-term TDF treatment.
Published: 2019

18. Economic Consequences of Investing in Anti-HCV Antiviral Treatment from the Italian NHS Perspective: A Real-World-Based Analysis of PITER Data

Author: Marcellusi, A, Viti, R, Kondili, L, Rosato, S, Vella, S, Mennini, F, Quaranta, M, Tosti, M, Weimer, L, Ferrigno, L, D'Angelo, F, Falzano, L, Benedetti, A, Schiada, L, Cucco, M, Giacometti, A, Brescini, L, Castelletti, S, Drenaggi, D, Mazzaro, C, Angarano, G, Milella, M, Dileo, A, Rendina, M, Contaldo, A, Iannone, A, La Fortezza, F, Rizzi, M, Cologni, G, Bolondi, L, Benevento, F, Serio, I, Andreone, P, Caraceni, P, Guarneri, V, Margotti, M, Simonetti, G, Mazzella, G, Verucchi, G, Donati, V, Mian, P, Rimenti, G, Rossini, A, Contessi, G, Castelli, F, Zaltron, S, Spinetti, A, Odolini, S, Leandro, G, Cozzolongo, R, Zappimbulso, M, Russello, M, Benigno, R, Coco, C, Torti, C, Costa, C, Greco, G, Mazzitelli, M, Pisani, V, Cosco, L, Quintieri, F, Desiena, M, Giancotti, F, Vecchiet, J, Falasca, K, Mastroianni, A, Apuzzo, G, Chidichimo, L, Foschi, F, Dall'Aglio, A, Libanore, M, Segala, D, Sighinolfi, L, Bartolozzi, D, Salomoni, E, Blanc, P, Baragli, F, Delpin, B, Mariabelli, E, Mazzotta, F, Poggi, A, Zignego, A, Monti, M, Madia, F, Xheka, A, Cela, E, Santantonio, T, Bruno, S, Viscoli, C, Alessandrini, A, Curti, C, Dibiagio, A, Nicolini, L, Balletto, E, Mastroianni, C, Blerta, K, Prati, D, Raffaele, L, Andreoletti, M, Perboni, G, Costa, P, Manzini, L, Raimondo, G, Filomia, R, Lazzarin, A, Morsica, G, Salpietro, S, Puoti, M, Baiguera, C, Vassalli, S, Rumi, M, Labanca, S, Zuin, M, Giorgini, A, Orellana, D, D'Arminiomonforte, A, Debona, A, Solaro, S, Fargion, S, Valenti, L, Periti, G, Pelusi, S, Galli, M, Calvi, E, Milazzo, L, Peri, A, Lampertico, P, Borghi, M, D'Ambrosio, R, Degasperi, E, Vinci, M, Villa, E, Bernabucci, V, Bristot, L, Pereira, F, Chessa, L, Pasetto, M, Loi, M, Gori, A, Beretta, I, Pastore, V, Soria, A, Strazzabosco, M, Ciaccio, A, Gemma, M, Borgia, G, Foggia, A, Zappulo, E, Gentile, I, Buonomo, A, Abrescia, N, Maddaloni, A, Caporaso, N, Morisco, F, Camera, S, Donnarumma, L, Coppola, C, Amoruso, D, Staiano, L, Saturnino, M, Coppola, N, Martini, S, Monari, C, Federico, A, Dallio, M, Loguercio, C, Gaeta, G, Brancaccio, G, Nardone, G, Sgamato, C, D'Adamo, G, Alberti, A, Gonzo, M, Piovesan, S, Chemello, L, Buggio, A, Cavalletto, L, Barbaro, F, Castelli, E, Floreani, A, Cazzagon, N, Franceschet, I, Russo, F, Zanetto, A, Franceschet, E, Madonia, S, Cannizzaro, M, Montalto, G, Licata, A, Capitano, A, Craxi, A, Petta, S, Calvaruso, V, Rini, F, Ferrari, C, Negri, E, Orlandini, A, Pesci, M, Bruno, R, Lombardi, A, Zuccaro, V, Gulminetti, R, Asti, A, Villaraggia, M, Mondelli, M, Ludovisi, S, Baldelli, F, Di Candilo, F, Parruti, G, Di Stefano, P, Sozio, F, Gizzi, M, Brunetto, M, Colombatto, P, Coco, B, Surace, L, Foti, G, Pellicano, S, Fornaciari, G, Schianchi, S, Vignoli, P, Massari, M, Corsini, R, Garlassi, E, Ballardini, G, Andreoni, M, Cerva, C, Angelico, M, Gasbarrini, A, Siciliano, M, De Siena, M, Nosotti, L, Taliani, G, Biliotti, E, Santori, M, Spaziante, M, Tamburini, F, Vullo, V, D'Ettorre, G, Cavallari, E, Gebremeskel, T, Pavone, P, Cauda, R, Cingolani, A, Lamonica, S, D'Offizi, G, Lionetti, R, Visco Comandini, U, Grieco, A, D'Aversa, F, Picardi, A, De Vincentis, A, Galati, G, Gallo, P, Dell'Unto, C, Aghemo, A, Gatti Comini, A, Persico, M, Masarone, M, Anselmo, M, De Leo, P, Marturano, M, Brunelli, E, Ridolfi, F, Schimizzi, A, Ayoubi Khajekini, M, Framarin, L, Di Perri, G, Cariti, G, Boglione, L, Cardellino, C, Marinaro, L, Saracco, G, Ciancio, A, Toniutto, P, Alterini, G, Capra, F, Ieluzzi, D, Marcellusi A., Viti R., Kondili L. A., Rosato S., Vella S., Mennini F. S., Quaranta M. G., Tosti M. E., Weimer L. E., Ferrigno L., D'Angelo F., Falzano L., Benedetti A., Schiada L., Cucco M., Giacometti A., Brescini L., Castelletti S., Drenaggi D., Mazzaro C., Angarano G., Milella M., DiLeo A., Rendina M., Contaldo A., Iannone A., La Fortezza F., Rizzi M., Cologni G., Bolondi L., Benevento F., Serio I., Andreone P., Caraceni P., Guarneri V., Margotti M., Simonetti G., Mazzella G., Verucchi G., Donati V., Mian P., Rimenti G., Rossini A., Contessi G. B., Castelli F., Zaltron S., Spinetti A., Odolini S., Leandro G., Cozzolongo R., Zappimbulso M., Russello M., Benigno R., Coco C., Torti C., Costa C., Greco G., Mazzitelli M., Pisani V., Cosco L., Quintieri F., DeSiena M., Giancotti F., Vecchiet J., Falasca K., Mastroianni A., Apuzzo G., Chidichimo L., Foschi F. G., Dall'Aglio A. C., Libanore M., Segala D., Sighinolfi L., Bartolozzi D., Salomoni E., Blanc P., Baragli F., DelPin B., Mariabelli E., Mazzotta F., Poggi A., Zignego A. L., Monti M., Madia F., Xheka A., Cela E. M., Santantonio T. A., Bruno S. R., Viscoli C., Alessandrini A. I., Curti C., DiBiagio A., Nicolini L. A., Balletto E., Mastroianni C., Blerta K., Prati D., Raffaele L., Andreoletti M., Perboni G., Costa P., Manzini L., Raimondo G., Filomia R., Lazzarin A., Morsica G., Salpietro S., Puoti M., Baiguera C., Vassalli S., Rumi M. G., Labanca S., Zuin M., Giorgini A., Orellana D., D'ArminioMonforte A., Debona A., Solaro S., Fargion S., Valenti L., Periti G., Pelusi S., Galli M., Calvi E., Milazzo L., Peri A., Lampertico P., Borghi M., D'Ambrosio R., Degasperi E., Vinci M., Villa E., Bernabucci V., Bristot L., Pereira F., Chessa L., Pasetto M. C., Loi M., Gori A., Beretta I., Pastore V., Soria A., Strazzabosco M., Ciaccio A., Gemma M., Borgia G., Foggia A., Zappulo E., Gentile I., Buonomo A. R., Abrescia N., Maddaloni A., Caporaso N., Morisco F., Camera S., Donnarumma L., Coppola C., Amoruso D. C., Staiano L., Saturnino M. R., Coppola N., Martini S., Monari C., Federico A., Dallio M., Loguercio C., Gaeta G. B., Brancaccio G., Nardone G., Sgamato C., D'Adamo G., Alberti A., Gonzo M., Piovesan S., Chemello L., Buggio A., Cavalletto L., Barbaro F., Castelli E., Floreani A., Cazzagon N., Franceschet I., Russo F. P., Zanetto A., Franceschet E., Madonia S., Cannizzaro M., Montalto G., Licata A., Capitano A. R., Craxi A., Petta S., Calvaruso V., Rini F., Ferrari C., Negri E., Orlandini A., Pesci M., Bruno R., Lombardi A., Zuccaro V., Gulminetti R., Asti A., Villaraggia M., Mondelli M., Ludovisi S., Baldelli F., Di Candilo F., Parruti G., Di Stefano P., Sozio F., Gizzi M. C., Brunetto M. R., Colombatto P., Coco B., Surace L., Foti G., Pellicano S., Fornaciari G., Schianchi S., Vignoli P., Massari M., Corsini R., Garlassi E., Ballardini G., Andreoni M., Cerva C., Angelico M., Gasbarrini A., Siciliano M., De Siena M., Nosotti L., Taliani G., Biliotti E., Santori M., Spaziante M., Tamburini F., Vullo V., D'Ettorre G., Cavallari E. N., Gebremeskel T. S., Pavone P., Cauda R., Cingolani A., Lamonica S., D'Offizi G., Lionetti R., Visco Comandini U., Grieco A., D'Aversa F., Picardi A., De Vincentis A., Galati G., Gallo P., Dell'Unto C., Aghemo A., Gatti Comini A., Persico M., Masarone M., Anselmo M., De Leo P., Marturano M., Brunelli E., Ridolfi F., Schimizzi A. M., Ayoubi Khajekini M., Framarin L., Di Perri G., Cariti G., Boglione L., Cardellino C., Marinaro L., Saracco G. M., Ciancio A., Toniutto P., Alterini G., Capra F., Ieluzzi D., Marcellusi, A, Viti, R, Kondili, L, Rosato, S, Vella, S, Mennini, F, Quaranta, M, Tosti, M, Weimer, L, Ferrigno, L, D'Angelo, F, Falzano, L, Benedetti, A, Schiada, L, Cucco, M, Giacometti, A, Brescini, L, Castelletti, S, Drenaggi, D, Mazzaro, C, Angarano, G, Milella, M, Dileo, A, Rendina, M, Contaldo, A, Iannone, A, La Fortezza, F, Rizzi, M, Cologni, G, Bolondi, L, Benevento, F, Serio, I, Andreone, P, Caraceni, P, Guarneri, V, Margotti, M, Simonetti, G, Mazzella, G, Verucchi, G, Donati, V, Mian, P, Rimenti, G, Rossini, A, Contessi, G, Castelli, F, Zaltron, S, Spinetti, A, Odolini, S, Leandro, G, Cozzolongo, R, Zappimbulso, M, Russello, M, Benigno, R, Coco, C, Torti, C, Costa, C, Greco, G, Mazzitelli, M, Pisani, V, Cosco, L, Quintieri, F, Desiena, M, Giancotti, F, Vecchiet, J, Falasca, K, Mastroianni, A, Apuzzo, G, Chidichimo, L, Foschi, F, Dall'Aglio, A, Libanore, M, Segala, D, Sighinolfi, L, Bartolozzi, D, Salomoni, E, Blanc, P, Baragli, F, Delpin, B, Mariabelli, E, Mazzotta, F, Poggi, A, Zignego, A, Monti, M, Madia, F, Xheka, A, Cela, E, Santantonio, T, Bruno, S, Viscoli, C, Alessandrini, A, Curti, C, Dibiagio, A, Nicolini, L, Balletto, E, Mastroianni, C, Blerta, K, Prati, D, Raffaele, L, Andreoletti, M, Perboni, G, Costa, P, Manzini, L, Raimondo, G, Filomia, R, Lazzarin, A, Morsica, G, Salpietro, S, Puoti, M, Baiguera, C, Vassalli, S, Rumi, M, Labanca, S, Zuin, M, Giorgini, A, Orellana, D, D'Arminiomonforte, A, Debona, A, Solaro, S, Fargion, S, Valenti, L, Periti, G, Pelusi, S, Galli, M, Calvi, E, Milazzo, L, Peri, A, Lampertico, P, Borghi, M, D'Ambrosio, R, Degasperi, E, Vinci, M, Villa, E, Bernabucci, V, Bristot, L, Pereira, F, Chessa, L, Pasetto, M, Loi, M, Gori, A, Beretta, I, Pastore, V, Soria, A, Strazzabosco, M, Ciaccio, A, Gemma, M, Borgia, G, Foggia, A, Zappulo, E, Gentile, I, Buonomo, A, Abrescia, N, Maddaloni, A, Caporaso, N, Morisco, F, Camera, S, Donnarumma, L, Coppola, C, Amoruso, D, Staiano, L, Saturnino, M, Coppola, N, Martini, S, Monari, C, Federico, A, Dallio, M, Loguercio, C, Gaeta, G, Brancaccio, G, Nardone, G, Sgamato, C, D'Adamo, G, Alberti, A, Gonzo, M, Piovesan, S, Chemello, L, Buggio, A, Cavalletto, L, Barbaro, F, Castelli, E, Floreani, A, Cazzagon, N, Franceschet, I, Russo, F, Zanetto, A, Franceschet, E, Madonia, S, Cannizzaro, M, Montalto, G, Licata, A, Capitano, A, Craxi, A, Petta, S, Calvaruso, V, Rini, F, Ferrari, C, Negri, E, Orlandini, A, Pesci, M, Bruno, R, Lombardi, A, Zuccaro, V, Gulminetti, R, Asti, A, Villaraggia, M, Mondelli, M, Ludovisi, S, Baldelli, F, Di Candilo, F, Parruti, G, Di Stefano, P, Sozio, F, Gizzi, M, Brunetto, M, Colombatto, P, Coco, B, Surace, L, Foti, G, Pellicano, S, Fornaciari, G, Schianchi, S, Vignoli, P, Massari, M, Corsini, R, Garlassi, E, Ballardini, G, Andreoni, M, Cerva, C, Angelico, M, Gasbarrini, A, Siciliano, M, De Siena, M, Nosotti, L, Taliani, G, Biliotti, E, Santori, M, Spaziante, M, Tamburini, F, Vullo, V, D'Ettorre, G, Cavallari, E, Gebremeskel, T, Pavone, P, Cauda, R, Cingolani, A, Lamonica, S, D'Offizi, G, Lionetti, R, Visco Comandini, U, Grieco, A, D'Aversa, F, Picardi, A, De Vincentis, A, Galati, G, Gallo, P, Dell'Unto, C, Aghemo, A, Gatti Comini, A, Persico, M, Masarone, M, Anselmo, M, De Leo, P, Marturano, M, Brunelli, E, Ridolfi, F, Schimizzi, A, Ayoubi Khajekini, M, Framarin, L, Di Perri, G, Cariti, G, Boglione, L, Cardellino, C, Marinaro, L, Saracco, G, Ciancio, A, Toniutto, P, Alterini, G, Capra, F, Ieluzzi, D, Marcellusi A., Viti R., Kondili L. A., Rosato S., Vella S., Mennini F. S., Quaranta M. G., Tosti M. E., Weimer L. E., Ferrigno L., D'Angelo F., Falzano L., Benedetti A., Schiada L., Cucco M., Giacometti A., Brescini L., Castelletti S., Drenaggi D., Mazzaro C., Angarano G., Milella M., DiLeo A., Rendina M., Contaldo A., Iannone A., La Fortezza F., Rizzi M., Cologni G., Bolondi L., Benevento F., Serio I., Andreone P., Caraceni P., Guarneri V., Margotti M., Simonetti G., Mazzella G., Verucchi G., Donati V., Mian P., Rimenti G., Rossini A., Contessi G. B., Castelli F., Zaltron S., Spinetti A., Odolini S., Leandro G., Cozzolongo R., Zappimbulso M., Russello M., Benigno R., Coco C., Torti C., Costa C., Greco G., Mazzitelli M., Pisani V., Cosco L., Quintieri F., DeSiena M., Giancotti F., Vecchiet J., Falasca K., Mastroianni A., Apuzzo G., Chidichimo L., Foschi F. G., Dall'Aglio A. C., Libanore M., Segala D., Sighinolfi L., Bartolozzi D., Salomoni E., Blanc P., Baragli F., DelPin B., Mariabelli E., Mazzotta F., Poggi A., Zignego A. L., Monti M., Madia F., Xheka A., Cela E. M., Santantonio T. A., Bruno S. R., Viscoli C., Alessandrini A. I., Curti C., DiBiagio A., Nicolini L. A., Balletto E., Mastroianni C., Blerta K., Prati D., Raffaele L., Andreoletti M., Perboni G., Costa P., Manzini L., Raimondo G., Filomia R., Lazzarin A., Morsica G., Salpietro S., Puoti M., Baiguera C., Vassalli S., Rumi M. G., Labanca S., Zuin M., Giorgini A., Orellana D., D'ArminioMonforte A., Debona A., Solaro S., Fargion S., Valenti L., Periti G., Pelusi S., Galli M., Calvi E., Milazzo L., Peri A., Lampertico P., Borghi M., D'Ambrosio R., Degasperi E., Vinci M., Villa E., Bernabucci V., Bristot L., Pereira F., Chessa L., Pasetto M. C., Loi M., Gori A., Beretta I., Pastore V., Soria A., Strazzabosco M., Ciaccio A., Gemma M., Borgia G., Foggia A., Zappulo E., Gentile I., Buonomo A. R., Abrescia N., Maddaloni A., Caporaso N., Morisco F., Camera S., Donnarumma L., Coppola C., Amoruso D. C., Staiano L., Saturnino M. R., Coppola N., Martini S., Monari C., Federico A., Dallio M., Loguercio C., Gaeta G. B., Brancaccio G., Nardone G., Sgamato C., D'Adamo G., Alberti A., Gonzo M., Piovesan S., Chemello L., Buggio A., Cavalletto L., Barbaro F., Castelli E., Floreani A., Cazzagon N., Franceschet I., Russo F. P., Zanetto A., Franceschet E., Madonia S., Cannizzaro M., Montalto G., Licata A., Capitano A. R., Craxi A., Petta S., Calvaruso V., Rini F., Ferrari C., Negri E., Orlandini A., Pesci M., Bruno R., Lombardi A., Zuccaro V., Gulminetti R., Asti A., Villaraggia M., Mondelli M., Ludovisi S., Baldelli F., Di Candilo F., Parruti G., Di Stefano P., Sozio F., Gizzi M. C., Brunetto M. R., Colombatto P., Coco B., Surace L., Foti G., Pellicano S., Fornaciari G., Schianchi S., Vignoli P., Massari M., Corsini R., Garlassi E., Ballardini G., Andreoni M., Cerva C., Angelico M., Gasbarrini A., Siciliano M., De Siena M., Nosotti L., Taliani G., Biliotti E., Santori M., Spaziante M., Tamburini F., Vullo V., D'Ettorre G., Cavallari E. N., Gebremeskel T. S., Pavone P., Cauda R., Cingolani A., Lamonica S., D'Offizi G., Lionetti R., Visco Comandini U., Grieco A., D'Aversa F., Picardi A., De Vincentis A., Galati G., Gallo P., Dell'Unto C., Aghemo A., Gatti Comini A., Persico M., Masarone M., Anselmo M., De Leo P., Marturano M., Brunelli E., Ridolfi F., Schimizzi A. M., Ayoubi Khajekini M., Framarin L., Di Perri G., Cariti G., Boglione L., Cardellino C., Marinaro L., Saracco G. M., Ciancio A., Toniutto P., Alterini G., Capra F., and Ieluzzi D.
Abstract: Objective: We estimated the cost consequence of Italian National Health System (NHS) investment in direct-acting antiviral (DAA) therapy according to hepatitis C virus (HCV) treatment access policies in Italy. Methods: A multistate, 20-year time horizon Markov model of HCV liver disease progression was developed. Fibrosis stage, age and genotype distributions were derived from the Italian Platform for the Study of Viral Hepatitis Therapies (PITER) cohort. The treatment efficacy, disease progression probabilities and direct costs in each health state were obtained from the literature. The break-even point in time (BPT) was defined as the period of time required for the cumulative costs saved to recover the Italian NHS investment in DAA treatment. Three different PITER enrolment periods, which covered the full DAA access evolution in Italy, were considered. Results: The disease stages of 2657 patients who consecutively underwent DAA therapy from January 2015 to December 2017 at 30 PITER clinical centres were standardized for 1000 patients. The investment in DAAs was considered to equal €25 million, €15 million, and €9 million in 2015, 2016, and 2017, respectively. For patients treated in 2015, the BPT was not achieved, because of the disease severity of the treated patients and high DAA prices. For 2016 and 2017, the estimated BPTs were 6.6 and 6.2 years, respectively. The total cost savings after 20 years were €50.13 and €55.50 million for 1000 patients treated in 2016 and 2017, respectively. Conclusions: This study may be a useful tool for public decision makers to understand how HCV clinical and epidemiological profiles influence the economic burden of HCV.
Published: 2019

19. Accuracy of Transient Elastography in assessing fibrosis at diagnosis in naïve patients with Primary Biliary Cholangitis: a dual cut-off approach

Author: Cristoferi, L, Calvaruso, V, Overi, D, Viganò, M, Rigamonti, C, Degasperi, E, Cardinale, V, Labanca, S, Zucchini, N, Fichera, A, Di Marco, V, Leutner, M, Venere, R, Picciotto, A, Lucà, M, Mulinacci, G, Palermo, A, Gerussi, A, D'Amato, D, O'Donnell, S, Cerini, F, De Benedittis, C, Malinverno, F, Ronca, V, Mancuso, C, Cazzagon, N, Ciaccio, A, Barisani, D, Marzioni, M, Floreani, A, Alvaro, D, Gaudio, E, Invernizzi, P, Carpino, G, Nardi, A, Carbone, M, Cristoferi, Laura, Calvaruso, Vincenza, Overi, Diletta, Viganò, Mauro, Rigamonti, Cristina, Degasperi, Elisabetta, Cardinale, Vincenzo, Labanca, Sara, Zucchini, Nicola, Fichera, Anna, Di Marco, Vito, Leutner, Monica, Venere, Rosanna, Picciotto, Antonino, Lucà, Martina, Mulinacci, Giacomo, Palermo, Andrea, Gerussi, Alessio, D'Amato, Daphne, O'Donnell, Sarah Elisabeth, Cerini, Federica, De Benedittis, Carla, Malinverno, Federica, Ronca, Vincenzo, Mancuso, Clara, Cazzagon, Nora, Ciaccio, Antonio, Barisani, Donatella, Marzioni, Marco, Floreani, Annarosa, Alvaro, Domenico, Gaudio, Eugenio, Invernizzi, Pietro, Carpino, Guido, Nardi, Alessandra, Carbone, Marco, Cristoferi, L, Calvaruso, V, Overi, D, Viganò, M, Rigamonti, C, Degasperi, E, Cardinale, V, Labanca, S, Zucchini, N, Fichera, A, Di Marco, V, Leutner, M, Venere, R, Picciotto, A, Lucà, M, Mulinacci, G, Palermo, A, Gerussi, A, D'Amato, D, O'Donnell, S, Cerini, F, De Benedittis, C, Malinverno, F, Ronca, V, Mancuso, C, Cazzagon, N, Ciaccio, A, Barisani, D, Marzioni, M, Floreani, A, Alvaro, D, Gaudio, E, Invernizzi, P, Carpino, G, Nardi, A, Carbone, M, Cristoferi, Laura, Calvaruso, Vincenza, Overi, Diletta, Viganò, Mauro, Rigamonti, Cristina, Degasperi, Elisabetta, Cardinale, Vincenzo, Labanca, Sara, Zucchini, Nicola, Fichera, Anna, Di Marco, Vito, Leutner, Monica, Venere, Rosanna, Picciotto, Antonino, Lucà, Martina, Mulinacci, Giacomo, Palermo, Andrea, Gerussi, Alessio, D'Amato, Daphne, O'Donnell, Sarah Elisabeth, Cerini, Federica, De Benedittis, Carla, Malinverno, Federica, Ronca, Vincenzo, Mancuso, Clara, Cazzagon, Nora, Ciaccio, Antonio, Barisani, Donatella, Marzioni, Marco, Floreani, Annarosa, Alvaro, Domenico, Gaudio, Eugenio, Invernizzi, Pietro, Carpino, Guido, Nardi, Alessandra, and Carbone, Marco
Abstract: Background and Aims: Liver fibrosis holds a relevant prognostic meaning in primary biliary cholangitis (PBC). Noninvasive fibrosis evaluation using vibration-controlled transient elastography (VCTE) is routinely performed. However, there is limited evidence on its accuracy at diagnosis in PBC. We aimed to estimate the diagnostic accuracy of VCTE in assessing advanced fibrosis (AF) at disease presentation in PBC. Approach and Results: We collected data from 167 consecutive treatment-naïve PBC patients who underwent liver biopsy (LB) at diagnosis at six Italian centers. VCTE examinations were completed within 12 weeks of LB. Biopsies were scored by two blinded expert pathologists, according to the Ludwig system. Diagnostic accuracy was estimated using the area under the receiver operating characteristic curves (AUROCs) for AF (Ludwig stage ≥III). Effects of biochemical and clinical parameters on liver stiffness measurement (LSM) were appraised. The derivation cohort consisted of 126 patients with valid LSM and LB; VCTE identified patients with AF with an AUROC of 0.89. LSM cutoffs ≤6.5 and >11.0 kPa enabled to exclude and confirm, respectively, AF (negative predictive value [NPV] = 0.94; positive predictive value [PPV] = 0.89; error rate = 5.6%). These values were externally validated in an independent cohort of 91 PBC patients (NPV = 0.93; PPV = 0.89; error rate = 8.6%). Multivariable analysis found that the only parameter affecting LSM was fibrosis stage. No association was found with BMI and liver biochemistry. Conclusions: In a multicenter study of treatment-naïve PBC patients, we identified two cutoffs (LSM ≤6.5 and >11.0 kPa) able to discriminate at diagnosis the absence or presence, respectively, of AF in PBC patients, with external validation. In patients with LSM between these two cutoffs, VCTE is not reliable and liver biopsy should be evaluated for accurate disease staging. BMI and liver biochemistry did not affect LSMs.
Published: 2021

20. Epidemiological and clinical profile of 302 patients with primary biliary cholangitis in Piedmont and Liguria

Author: De Benedittis, C., primary, Labanca, S., additional, Picciotto, A., additional, Morgando, A., additional, Vanni, E., additional, Azzolina, D., additional, Cittone, M.G., additional, Pirisi, M., additional, and Rigamonti, C., additional
Published: 2021
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21. Thromboembolic events in prospectively enrolled series of patients with cirrhosis followed for one year.

Author: Calabrese, F., Pasta, A., Labanca, S., Marenco, S., Pieri, G., Torres, M.C. Plaz, and Giannini, E.G.
Abstract: Coagulation in cirrhosis involves a complex imbalance between procoagulant and anticoagulant factors due to liver dysfunction. This results in a delicate hemostatic equilibrium that increases the risk of both bleeding and thrombosis. To analyze the occurrence of thromboembolic events in a prospective series of patients with liver cirrhosis, and to assess patients' characteristics. We prospectively enrolled 188 patients with cirrhosis admitted to our gastrointestinal ward (December 2021-December 2022). We evaluated general and liver disease-related characteristics as well as the incidence of venous thromboembolism (VTE), and death during the first year following hospital admission. Median age was 63 years, and 72.9% were males. The primary cause of hospitalization was acute decompensation (n=101, 53.7%), followed by hepatocellular carcinoma (n=34, 18.1%) or liver-related elective diagnostic-therapeutic procedures (28, 14.9%). Twenty-five (13.3%) patients were admitted due to non-liver related events. The median length of hospitalization was 9 days (IQR 5-14). Most of patients had decompensated cirrhosis (Child-Pugh B: 41.5%; Child-Pugh C: 26.6%), with median MELD-Na=14, and clinically significant portal-hypertension (CSPH) in 148 (78.7%). Sixty-two (32.9%) patients had hepatocellular carcinoma. Thirty-one patients (16.5%) were on anticoagulants. During a 1-year follow-up, three (1.6%) patients experienced VTE while 26 (13.8%) patients had variceal bleeding. Overall mortality was 42.0% (n=79). Padua and Improve-VTE risk scores, MELD-Na, Child-Pugh class, and presence of CSPH were no different between patients with or without VTE. A competitive-risk model focused on experiencing VTE and risk of death and bleeding as competing events showed no significant association between VTE and use of anticoagulant, Charlson comorbidity index, CSPH, male gender, HCC, length of hospitalization and Improve-VTE, Padua and MELD-Na scores. VTE is a rare event in patients with cirrhosis, occurring in only 1.6% of prospectively evaluated population, and no significant association between VTE and various risk factors was identified. [ABSTRACT FROM AUTHOR]
Published: 2024
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22. Appropriateness of proton pump Inhibitor therapy in patients with cirrhosis: a retrospective study.

Author: Santamorena, G., Pasta, A., Labanca, S., Marenco, S., Pieri, G., Torres, M.C. Plaz, and Giannini, E.G.
Abstract: Proton pump inhibitors (PPIs) are commonly prescribed for gastroesophageal reflux disease (GERD) or prophylaxis of non-steroidal anti-inflammatory drugs and aspirin-induced gastric damage. However, their prolonged use in cirrhotic patients has been linked to complications like spontaneous bacterial peritonitis (SBP) and hepatic encephalopathy (EE). To evaluate the appropriateness of PPI therapy in patients with cirrhosis. We reviewed medical records of 209 cirrhotic patients admitted to our gastrointestinal ward (December 2021-December 2022). Demographics, clinical characteristics, PPI use indications, and incidence of EE and SBP were assessed. The median age was 69 years, and 74.4% were males. Main reasons for hospitalization were hepatocellular carcinoma (n=63, 28.7%), elective diagnostic-therapeutic procedures (n=63, 28.7%), non-liver-related events (n=54, 24.7%), and acute decompensation (n=39, 17.7%). Etiology of liver disease was alcohol in 91 patients (41.6%), virus-related in 77 (35.1%), and metabolic-associated in 30 (13.7%). The median MELD-Na score was 10 (8-14). At admission, 145 patients (66.2%) were on PPIs: of these, 42 patients (29.0%) had confirmed GERD, 12 (8.3%) had esophagitis ≥grade B, and 27 (18.6%) were on aspirin with bleeding risk-factors. Overall, inappropriate PPI use was observed in 74 patients (44.1%). Patients on PPIs were older, with higher MELD-Na and creatinine, and lower hemoglobin and Na compared to those not on PPIs (p<0.05). Multivariate analysis showed that PPI use was independently associated with older age (OR 1.03, IC95% 1.01-1.07) and lower hemoglobin (OR 0.82, IC95% 0.70-0.97). During a median follow-up of 18 months, the incidence of EE and SBP did not differ between PPI users and non-users. A significant proportion of patients with cirrhosis is inappropriately prescribed PPIs. Although this did not correlate with major liver-related events in the short term, proper PPI prescription education is crucial to prevent potential long-term consequences. [ABSTRACT FROM AUTHOR]
Published: 2024
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23. T06.01.17 STAGING OF LIVER FIBROSIS WITH ULTRASOUND MORPHOLOGICAL HEPATIC FEATURES IN PATIENTS AFFECTED BY HCV HEPATITIS AND NAFLD

Author: Ziola, S., primary, Picciotto, A., additional, Labanca, S., additional, Marenco, S., additional, Trombini, M., additional, Dellepiane, S., additional, Pasta, A., additional, Djahandideh Sheijani, A., additional, Pisciotta, L., additional, and Borro, P., additional
Published: 2020
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24. T.12.9: LIVER TRANSPLANTATION IN PATIENTS WITH ALCOHOL RELATED-ACUTE ON CHRONIC LIVER FAILURE.

Author: Mazzia, G., Pasta, A., Dipace, V., Labanca, S., Pieri, G., Marenco, S., and Giannini, E.G.
Published: 2024
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25. Failure of long-term lamivudine prophylaxis in patients with resolved hepatitis B infection undergoing chemotherapy and allogenic hematopoietic stem cell transplantation for hematological malignancies: two case reports

Author: Grossi, G, Viganò, M, Facchetti, F, Labanca, S, Loglio, A, Dodero, A, Montefusco, V, Corradini, P, Cafro, A, Cairoli, R, Colombo, M, Lampertico, P, Grossi G, Viganò M, Facchetti F, Labanca S, Loglio A, Dodero A, Montefusco V, Corradini P, Cafro A, Cairoli R, Colombo M, Lampertico P, Grossi, G, Viganò, M, Facchetti, F, Labanca, S, Loglio, A, Dodero, A, Montefusco, V, Corradini, P, Cafro, A, Cairoli, R, Colombo, M, Lampertico, P, Grossi G, Viganò M, Facchetti F, Labanca S, Loglio A, Dodero A, Montefusco V, Corradini P, Cafro A, Cairoli R, Colombo M, and Lampertico P
Published: 2017

26. Primary biliary cholangitis: histological and clinical liver progression in non responders to ursodeoxycholic acid

Author: Cacciato, V., primary, Benizzelli, G., additional, Grillo, F., additional, Borro, P., additional, Marenco, S., additional, Pasta, A., additional, Picciotto, A., additional, and Labanca, S., additional
Published: 2020
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27. Autoantibody study in Primary Biliary Cholangitis and possible relation with therapeutic response

Author: Cacciato, V., primary, Picciotto, A., additional, Borro, P., additional, Marenco, S., additional, Mobilia, E., additional, Panciroli, M., additional, Pesce, G., additional, and Labanca, S., additional
Published: 2020
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28. L'Italia come modello per l'Europa e per il mondo nelle politiche sanitarie per il trattamento dell'epatite cronica da HCV

Author: Kondili, L. A., Vella, S., Quaranta, M. G., Rosato, S., Tosti, M. E., Weimer, L. E., Ferrigno, L., D'Angelo, F., Falzano, L., Mattei, A., Olivieri, E., Terlizzi, R., Benedetti, A., Faraci, M. G., Giacometti, A., Brescini, L., Castelli, P., Castelletti, S., Drenaggi (Ancona), D., C. Mazzaro (Aviano, P N), Angarano, G., Milella, M., Di Leo, A., Rendina, M., Contaldo, A., Iannone, A., La Fortezza (Bari), F., M. Rizzi, G. Cologni (Bergamo), Bolondi, L., Benevento, F., Gianstefani, A., Serio, I., Vaccà, A., Andreone, P., Caraceni, P., Guarneri, V., Margotti, M., Simonetti, G., Mazzella, G., Verucchi, G., Donati (Bologna), V., P. Mian, G. Rimenti (Bolzano), Rossini, A., Contessi, G. B., Castelli, F., Zaltron, S., Spinetti, A., Odolini (Brescia), S., Leandr o, G., Cozzolongo, R., Zappimbulso (Castellana Grotte, M., BA), Russello, M., Benigno, R., Coco (Catania), C., Torti, C., Costa, C., Greco, G., Mazzitelli, M., Pisani, V., Cosco, L., Quintieri, F., De Siena, M., Giancotti (Catanzaro), F., Vecchiet, J., Pizzigallo, E., Falasca (Chieti), K., Mastroianni, A., Apuzzo, G., Luciani (Cosenza), F., F. G. Foschi, A. C. Dall’Aglio (Faenza), Libanore, M., Segala, D., Sighinolfi (Ferrara), L., Bartolozzi, D., Salomoni, E., Blanc, P., Baragli, F., Del Pin, B., Mariabelli, E., Mazzotta, F., Poggi, A., Zignego, L., Monti, M., Madia, F., Xheka (Firenze), A., Cela, E. M., Santantonio, T. A., Bruno, S., Giammario (Foggia), A., Viscoli, C., Alessandrini, A. I., Curti, C., Di Biagio, A., Nicolini, L. A., Balletto (Genova), E., C. Mastroian ni, K. Blerta (Latina), Prati, D., Raffaele, L., Andreoletti (Lecco), M., Perboni, G., Costa, P., Manzini (Mantova), L., G. Raimondo, R. Filomia (Messina), Lazzarin, A., Morsica, G., Salpietro, S., Puoti, M., Baiguera, C., Rumi, M. R., Labanca, S., Zuin, M., Giorgini, A., Orellana, D., D'Arminio Monfort e, A., Debona, A., Solaro, S., Fargion, S., Borroni, V., Valenti, L., Galli, M., Calvi, E., Milazzo, L., Peri, A., Lampertico, P., Borghi, M., D’Ambrosio, R., Degasperi, E., Vinci (Milano), M., Villa, E., Bernabucci, V., Bristot, L., Pereira (Modena), F., Chessa, L., Pasetto, M. C., Loi (Monserrato, M., CA), Gori, A., Beretta, I., Pastore, V., Soria, A., Strazzabosco, M., Ciaccio, A., Gemma (Monza), M., Borgia, G., Foggia, A., Zappulo, E., Gentile, I., Buonomo, A. R., Abresci a, N., Maddaloni, A., Caporaso, N., Morisco, F., Camera, S., Donnarumma, L., Coppola, C., Amoruso, D. C., Staiano, L., Coppola, N., Martini, S., Federico, A., Dallio, M., Loguercio, C., Gaeta, G. B., Brancaccio, G., Rizzo, V., Nardone, G., Sgamato (Napoli), C., G. D'Adamo (Nocera Inferiore, SA), Alberti, A., Gonzo, M., Piovesan, S., Chemello, L., Angeli, P., Cavalletto, L., Pontisso, P., Gatta, A., Erne, E. M., Castelli, E., Flo reani, A., Cazzagon, N., Franceschet, I., Russo, F. P., Zanetto, A., Franceschet (Padova), E., Madonia, S., Cannizzaro, M., Montalto, G., Licata, A., Capita no, A. R., Craxì, A., Petta, S., Calvaruso (Palermo), V., Ferrari, C., Negri, E., Orlandini, A., Pesci (Parma), M., Bruno, R., Zuccaro, V., Gulminetti, R., Asti, A., Villaraggia, M., Mondelli, M., Ludovisi (Pavia), S., F. Baldelli, F. Di Candilo (Perugia), Parruti, G., Di Stefano, P., Sozio (Pescara), F., Bru netto, M. R., Colombatto, P., Coco, B., Surace (Pisa), L., G. Foti, S. Pellicano (Reggio Calabria), Fornaciari, G., Schianchi, S., Vignoli, P., Massari, M., Cor sini, R., Garlassi (Reggio Emilia), E., Ballardini (Rimini), G., Andreoni, M., Cerva, C., Angelico, M., Gasbarrini, A., Siciliano, M., Nosotti, L., Taliani, G., Bi liotti, E., Santori, M., Spaziante, M., Tamburini, F., Vullo, V., D’Ettorre, G., Cavallari, E. N., Gebremeskel, T. S., Pavone, P., Cauda, R., Cingolani, A., Lam onica, S., D'Offizi, G., Lionetti, R., Visco Comandini, U., Grieco, A., D’Aversa, F., Picardi, A., De Vincentis, A., Galati, G., Gallo, P., Dell’Unto (Roma), C., Aghemo, A., Gatti C omini (Rozzano, A., MI), M. Persico, M. Masarone (Salerno), Anselmo, M., De Leo, P., Marturano (Savona), M., Brunelli, E., Ridolfi, F., Schimizzi (Senigallia, A. M., AN), Ayoubi Khajekini, M., Framarin, L., Di Perri, G., Cariti, G., Boglione, L., Cardellino, C., Marinaro, L., Saracco, G. M., Ciancio (Torino), A., P. Toniutto, G. Alterini (U dine), and F. Capra, D. Ieluzzi (Verona).
Subjects: Hepatitis C, antiviral therapy, cost-effectiveness, NO
Published: 2018

29. Multifactor risk evaluation in patients who have eradicated HCV infection: an interim analysis in the PITER cohort

Author: Kondili, L., primary, Quaranta, M.G., additional, Rosato, S., additional, Monti, M., additional, Coco, B., additional, Filomia, R., additional, Biliotti, E., additional, Iannone, A., additional, Zanetto, A., additional, Bruno, S., additional, Giorgini, A., additional, Loi, M., additional, Baragli, F., additional, Baiguera, C., additional, Vinci, M., additional, Eleonora, C., additional, Ciaccio, A., additional, Corsini, R., additional, D’ambrosio, R., additional, Labanca, S., additional, Dallio, M., additional, Orlandini, A., additional, Ciancio, A., additional, Buonomo, A.R., additional, Guarnieri, V., additional, Cossiga, V., additional, Masarone, M., additional, Ieluzzi, D., additional, Cannizzaro, M., additional, Soria, A., additional, Siciliano, M., additional, Amoruso, D.C., additional, Brancaccio, G., additional, Weimer, L.E., additional, Ferrigno, L., additional, Tosti, M.E., additional, Estes, C., additional, Razavi, H., additional, and Calvaruso, V., additional
Published: 2018
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30. Les villages itinérants ou la démocratisation du « sauvage »

Author: ABBATTISTA, GUIDO, LEMAIRE, S., LABANCA, S., THODE ARORA, Blanchard, Pascal, Boetsch, Gilles, LABANCA, Blanchard Pascal et Snoep Nanette (eds.), Abbattista, Guido, Lemaire, S., Labanca, S., and Thode, Arora
Subjects: colonialism, Esposizioni, communication, colonialismo, cultural studies, studi culturali Exhibition, razza, propaganda, razzismo, spettacoli di massa, antropologia, mass entertainment, anthropology, comunicazione, race, racism
Abstract: This contribution aims at exploring the phenomenon of the ethnic villages in several international exhibitions in different European countries between the end of the 19th and the fist two decades of the 20th century
Published: 2011

31. Validation of the Baveno VI criteria for screening of esophageal varices in patients with metabolic and alcohol related compensated advanced chronic liver disease

Author: Mezzina, N., primary, Viganò, M., additional, Giulia, T., additional, Labanca, S., additional, Lombardi, R., additional, Mainardi, V.L., additional, Fracanzani, A.L., additional, Lampertico, P., additional, Rumi, M., additional, and Primignani, M., additional
Published: 2017
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32. THU-397 - Multifactor risk evaluation in patients who have eradicated HCV infection: an interim analysis in the PITER cohort

Author: Kondili, L., Quaranta, M.G., Rosato, S., Monti, M., Coco, B., Filomia, R., Biliotti, E., Iannone, A., Zanetto, A., Bruno, S., Giorgini, A., Loi, M., Baragli, F., Baiguera, C., Vinci, M., Eleonora, C., Ciaccio, A., Corsini, R., D’ambrosio, R., Labanca, S., Dallio, M., Orlandini, A., Ciancio, A., Buonomo, A.R., Guarnieri, V., Cossiga, V., Masarone, M., Ieluzzi, D., Cannizzaro, M., Soria, A., Siciliano, M., Amoruso, D.C., Brancaccio, G., Weimer, L.E., Ferrigno, L., Tosti, M.E., Estes, C., Razavi, H., and Calvaruso, V.
Published: 2018
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33. Correlation between NK cells and response to triple HCV-therapy with BOC/TVR

Author: Marenco, S., primary, Pieri, G., additional, Mazza, F., additional, Brunacci, M., additional, Labanca, S., additional, Bruzzone, L., additional, Valentina, F., additional, Bozzano, F., additional, Marras, F., additional, De Maria, A., additional, Savarino, V., additional, and Picciotto, A., additional
Published: 2015
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34. Serum SCCA-IgM can predict the development of HCC in patients with HCV-cirrhosis

Author: Pieri, G., primary, Marenco, S., additional, Lantieri, F., additional, Baldissarro, I., additional, Bruzzone, L., additional, Fazio, V., additional, Labanca, S., additional, Sammito, G., additional, Savarino, V., additional, and Picciotto, A., additional
Published: 2015
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35. Real-world experience with obeticholic acid in patients with primary biliary cholangitis

Author: Anna Morgando, Mauro Viganò, Ana Lleo, Maurizio Pompili, Elisabetta De Gasperi, Daphne D’Amato, Alessandro Mussetto, Nora Cazzagon, Pietro Invernizzi, Francesca Colapietro, Vincenzo Ronca, Sara Labanca, Ester Vanni, M.R. Cannavò, Francesco Losito, Ernesto Claar, G. Scifo, Giovanni Galati, Umberto Vespasiani-Gentilucci, Silvia Storato, Alessio Gerussi, Grazia Anna Niro, Antonio Izzi, Barbara Omazzi, Antonio De Vincentis, Valentina Feletti, Giuseppe Grassi, Valeria Pace Palitti, Clara Mancuso, Vincenza Calvaruso, Evelise Frazzetto, Roberto Boldizzoni, Marco Marzioni, Floriano Rosina, Andrea Palermo, Antonino Picciotto, Valentina Bellia, Gaetano Bertino, Italian Pbc Registry, Guido Poggi, Rodolfo Sacco, Domenico Alvaro, Luigi Muratori, Maria Vinci, Marie Graciella Pigozzi, Raffaele Cozzolongo, Natalia Terreni, Annarosa Floreani, Maurizio Russello, Marco Distefano, Rinaldo Pellicano, Maria D'Antò, Marco Carbone, Rosanna Venere, R. Fontana, Antonio Picardi, Silvia Casella, S. E. O'Donnell, Federica Malinverno, Stefano Fagiuoli, Laura Cristoferi, Luchino Chessa, Giacomo Mulinacci, Pietro Pozzoni, Antonino Castellaneta, Giulia Marconi, Adriano M. Pellicelli, Francesca Romana Ponziani, Leonardo Baiocchi, D'Amato, D, De Vincentis, A, Malinverno, F, Vigano, M, Alvaro, D, Pompili, M, Picciotto, A, Palitti, V, Russello, M, Storato, S, Pigozzi, M, Calvaruso, V, De Gasperi, E, Lleo, A, Castellaneta, A, Pellicelli, A, Cazzagon, N, Floreani, A, Muratori, L, Fagiuoli, S, Niro, G, Feletti, V, Cozzolongo, R, Terreni, N, Marzioni, M, Pellicano, R, Pozzoni, P, Baiocchi, L, Chessa, L, Rosina, F, Bertino, G, Vinci, M, Morgando, A, Vanni, E, Scifo, G, Sacco, R, D'Anto, M, Bellia, V, Boldizzoni, R, Casella, S, Omazzi, B, Poggi, G, Cristoferi, L, Gerussi, A, Ronca, V, Venere, R, Ponziani, F, Cannavo, M, Mussetto, A, Fontana, R, Losito, F, Frazzetto, E, Distefano, M, Colapietro, F, Labanca, S, Marconi, G, Grassi, G, Galati, G, O'Donnell, S, Mancuso, C, Mulinacci, G, Palermo, A, Claar, E, Izzi, A, Picardi, A, Invernizzi, P, Carbone, M, Vespasiani-Gentilucci, U, D'Amato D, De Vincentis A, Malinverno F, Viganò M, Alvaro D, Pompili M, Picciotto A, Palitti VP, Russello M, Storato S, Pigozzi MG, Calvaruso V, De Gasperi E, Lleo A, Castellaneta A, Pellicelli A, Cazzagon N, Floreani A, Muratori L, Fagiuoli S, Niro GA, Feletti V, Cozzolongo R, Terreni N, Marzioni M, Pellicano R, Pozzoni P, Baiocchi L, Chessa L, Rosina F, Bertino G, Vinci M, Morgando A, Vanni E, Scifo G, Sacco R, D'Antò M, Bellia V, Boldizzoni R, Casella S, Omazzi B, Poggi G, Cristoferi L, Gerussi A, Ronca V, Venere R, Ponziani F, Cannavò M, Mussetto A, Fontana R, Losito F, Frazzetto E, Distefano M, Colapietro F, Labanca S, Marconi G, Grassi G, Galati G, O'Donnell SE, Mancuso C, Mulinacci G, Palermo A, Claar E, Izzi A, Picardi A, Invernizzi P, Carbone M, Vespasiani-Gentilucci U, and Italian PBC Registry and the Club Epatologi Ospedalieri (CLEO)/Associazione Italiana Gastroenterologi ed Endoscopisti Digestivi Ospedalieri (AIGO) PBC Study Group.
Subjects: upper limit of normal, Cirrhosis, ALT, AMA, Autoimmunity, antinuclear antibodies, ULN, PBC, Gastroenterology, UDCA, Settore MED/12, ULN, upper limit of normal, obeticholic acid, aRR, adjusted risk ratio, CRFs, case record form, AST, aspartate transferase, Clinical endpoint, GGT, gamma-glutamyl transferase, QC, primary biliary cholangitis, Ursodeoxycholic acid, ANA, TCC, Cholestasi, TIPS, Treatment Completer Cohort, ANA, antinuclear antibodie, medicine.medical_specialty, RR, UDCA, ursodeoxycholic acid, TIPS, transjugular intrahepatic portosystemic shunt, OCA, Cirrhosi, ALP, alkaline phosphatase, autoimmune hepatitis, medicine.disease, digestive system diseases, Discontinuation, Keywords: AIH, autoimmune hepatiti, QC, quality control, chemistry, gamma-glutamyl transferase, randomised controlled trial, electronic data capture, antimitochondrial antibodies, aspartate transferase, Autoimmune hepatitis, chemistry.chemical_compound, AIH, CRFs, Immunology and Allergy, adjusted risk ratio, ANA, antinuclear antibodies, RR, risk ratio, Overall cohort, ALT, alanine transferase, AMA, antimitochondrial antibodie, Cholestasis, CRFs, case record forms, Obeticholic acid, Overlap PBC-AIH, ursodeoxycholic acid, OCA, obeticholic acid, Tolerability, alkaline phosphatase, RCT, Research Article, medicine.drug, case record forms, Context (language use), AMA, antimitochondrial antibodies, Internal medicine, EDC, electronic data capture, transjugular intrahepatic portosystemic shunt, Internal Medicine, medicine, RCT, randomised controlled trial, OC, lcsh:RC799-869, quality control, alanine transferase, AST, aRR, Hepatology, business.industry, AIH, autoimmune hepatitis, TCC, Treatment Completer Cohort, PBC, primary biliary cholangiti, GGT, risk ratio, OC, Overall cohort, ALP, lcsh:Diseases of the digestive system. Gastroenterology, PBC, primary biliary cholangitis, business, EDC
Abstract: Background & aims Obeticholic acid (OCA) is the second-line treatment approved for patients with primary biliary cholangitis (PBC) and an inadequate response or intolerance to ursodeoxycholic acid. We aimed to evaluate the effectiveness and safety of OCA under real-world conditions. Methods Patients were recruited into the Italian PBC Registry, a multicentre, observational cohort study that monitors patients with PBC at national level. The primary endpoint was the biochemical response according to Poise criteria; the secondary endpoint was the biochemical response according to normal range criteria, defined as normal levels of bilirubin, alkaline phosphatase (ALP), and alanine aminotransferase (ALT) at 12 months. Safety and tolerability were also assessed. Results We analysed 191 patients until at least 12 months of follow-up. Median age was 57 years, 94% female, 61 (32%) had cirrhosis, 28 (15%) had histologically proven overlap with autoimmune hepatitis (PBC-AIH). At 12 months, significant median reductions of ALP (-32.3%), ALT (-31.4%), and bilirubin (-11.2%) were observed. Response rates were 42.9% according to Poise criteria, and 11% by normal range criteria. Patients with cirrhosis had lower response than patients without cirrhosis (29.5% vs. 49.2%, p = 0.01), owing to a higher rate of OCA discontinuation (30% vs. 12%, p = 0.004), although with similar ALP reduction (29.4% vs. 34%, p = 0.53). Overlap PBC-AIH had a similar response to pure PBC (46.4% vs. 42.3%, p = 0.68), with higher ALT reduction at 6 months (-38% vs. -29%, p = 0.04). Thirty-three patients (17%) prematurely discontinued OCA because of adverse events, of whom 11 experienced serious adverse events. Treatment-induced pruritus was the leading cause of OCA discontinuation (67%). Conclusions Effectiveness and safety of OCA under real-world conditions mirror those in the Poise trial. Patients with cirrhosis had lower tolerability. Overlap PBC-AIH showed higher ALT reduction at 6 months compared with patients with pure PBC. Lay summary Obeticholic acid (OCA) was shown to be effective in more than one-third of patients not responding to ursodeoxycholic acid in a real-world context in Italy. Patients with cirrhosis had more side effects with OCA, and this led to suspension of the drug in one-third of patients. OCA was also effective in patients who had overlap between autoimmune hepatitis and primary biliary cholangitis., Graphical abstract, Highlights • Under real-world conditions, OCA was effective in ~43% of patients who were non-responders to UDCA, according to Poise criteria. • Patients with cirrhosis showed lower efficacy (29.5%), mainly attributed to reduced tolerability and higher discontinuation rate. • Patients with overlap AIH-PBC showed a comparable efficacy to pure PBC, with a higher ALT reduction at 6 months. • Most patients with PBC are still in need of additional therapy if aiming to normalise liver biochemistry.
Published: 2021

36. Effectiveness and safety of switching to entecavir hepatitis B patients developing kidney dysfunction during tenofovir

Author: Erica Villa, Pietro Lampertico, Gloria Taliani, Aldo Marrone, Fabrizio Bronte, Maurizio Russello, G. Grossi, Pietro Andreone, Massimo Fasano, Sara Labanca, Mauro Viganò, Giuseppina Brancaccio, Vincenzo Occhipinti, Alessandra Tucci, Floriana Facchetti, Vincenzo Messina, Roberto Ganga, Alessandro Loglio, Stefano Fagiuoli, Teresa Santantonio, Nicola Coppola, Alfredo Marzano, Maria Grazia Rumi, Serena Zaltron, Francesco Castelli, Vigano, M, Loglio, A, Labanca, S, Zaltron, S, Castelli, F, Andreone, P, Messina, V, Ganga, R, Coppola, N, Marrone, A, Russello, M, Marzano, A, Tucci, A, Taliani, G, Fasano, M, Fagiuoli, S, Villa, E, Bronte, F, Santantonio, T, Brancaccio, G, Occhipinti, V, Facchetti, F, Grossi, G, Rumi, M, Lampertico, P, Vigano M., Loglio A., Labanca S., Zaltron S., Castelli F., Andreone P., Messina V., Ganga R., Coppola N., Marrone A., Russello M., Marzano A., Tucci A., Taliani G., Fasano M., Fagiuoli S., Villa E., Bronte F., Santantonio T., Brancaccio G., Occhipinti V., Facchetti F., Grossi G., Rumi M., Lampertico P., and Viganò, M
Subjects: Male, Time Factors, Sustained Virologic Response, hepatitis B viru, Kidney, Gastroenterology, hepatitis B virus, liver, liver function tests, renal dysfunction, viral hepatitis, chemistry.chemical_compound, 0302 clinical medicine, 80 and over, Adefovir, Chronic, Aged, 80 and over, medicine.diagnostic_test, Drug Substitution, Hepatology, Entecavir, Middle Aged, Hepatitis B, Treatment Outcome, medicine.anatomical_structure, Italy, 030220 oncology & carcinogenesis, Female, Kidney Diseases, 030211 gastroenterology & hepatology, Viral hepatitis, medicine.drug, Adult, medicine.medical_specialty, Guanine, Aged, Antiviral Agents, Hepatitis B, Chronic, Humans, Recovery of Function, Retrospective Studies, Tenofovir, Renal function, 03 medical and health sciences, Internal medicine, medicine, liver function test, Creatinine, business.industry, viral hepatiti, medicine.disease, chemistry, business, Liver function tests
Abstract: Background and Aims: Tenofovir disoproxil fumarate (TDF) is recommended for chronic hepatitis B (CHB) treatment, but it may induce kidney dysfunction whose management is not yet known. This Italian, multicentre, retrospective study aimed to assess the efficacy and safety of switching to entecavir (ETV) patients who developed TDF-associated glomerular and/or tubular dysfunction. Methods: A total of 103 TDF-treated patients were included as follows: age 64years, 83% male, 49% cirrhotics, 98% with undetectable HBV DNA, 47% with previous lamivudine resistance (LMV-R) and 71% previously treated with adefovir. Twenty-nine (28%) were switched to ETV because estimated glomerular filtration rate (eGFR MDRD ) was
Published: 2019

37. Characteristics and survival of patients with primary biliary cholangitis and hepatocellular carcinoma

Author: Edoardo G. Giannini, Giulia Pieri, Sara Labanca, Maria Corina Plaz Torres, Antonio Gasbarrini, Elisabetta Biasini, Claudia Campani, Nora Cazzagon, Francesco Giuseppe Foschi, Andrea Mega, Alberto Masotto, Giovanni Raimondo, Gian Ludovico Rapaccini, Rodolfo Sacco, Eugenio Caturelli, Maria Guarino, Francesco Tovoli, Gianpaolo Vidili, Maurizia Rossana Brunetto, Gerardo Nardone, Gianluca Svegliati-Baroni, Donatella Magalotti, Francesco Azzaroli, Giuseppe Cabibbo, Maria Di Marco, Angelo Sangiovanni, Franco Trevisani, Maurizio Biselli, Paolo Caraceni, Annagiulia Gramenzi, Francesca Benevento, Alessandro Granito, Luca Muratori, Fabio Piscaglia, Federica Bertellini, Fabio Farinati, Giorgio Palano, Filippo Pelizzaro, Barbara Penzo, Elisa Pinto, Gloria Allegrini, Calogero Cammà, Ciro Celsa, Paolo Giuffrida, Caterina Stornello, Mauro Grova, Carmelo Marco Giacchetto, Gabriele Rancatore, Maria Vittoria Grassini, Valentina Adotti, Stefano Gitto, Fabio Marra, Martina Rosi, Vittoria Bevilacqua, Alberto Borghi, Andrea Casadei Gardini, Fabio Conti, Lucia Napoli, Marco Domenicali, Maria Teresa Migliano, Nicoletta de Matthaeis, Francesca Romana Ponziani, Andrea Olivani, Gabriele Missale, Valentina Cossiga, Mario Capasso, Filomena Morisco, Ester Marina Cela, Antonio Facciorusso, Valentina Lauria, Giorgia Ghittoni, Giorgio Pelecca, Fabrizio Chegai, Fabio Coratella, Mariano Ortenzi, Serena Dell'Isola, Maria Stella Franzè, Carlo Saitta, Assunta Sauchella, Elton Dajti, Federico Ravaioli, Filippo Oliveri, Gabriele Ricco, Veronica Romagnoli, Alessandro Inno, Fabiana Marchetti, Pietro Coccoli, Antonio Malerba, Alberta Cappelli, Rita Golfieri, Cristina Mosconi, Matteo Renzulli, Giannini, Edoardo G, Pieri, Giulia, Labanca, Sara, Plaz Torres, Maria Corina, Gasbarrini, Antonio, Biasini, Elisabetta, Campani, Claudia, Cazzagon, Nora, Foschi, Francesco Giuseppe, Mega, Andrea, Masotto, Alberto, Raimondo, Giovanni, Rapaccini, Gian Ludovico, Sacco, Rodolfo, Caturelli, Eugenio, Guarino, Maria, Tovoli, Francesco, Vidili, Gianpaolo, Brunetto, Maurizia Rossana, Nardone, Gerardo, Svegliati-Baroni, Gianluca, Magalotti, Donatella, Azzaroli, Francesco, Cabibbo, Giuseppe, Di Marco, Maria, Sangiovanni, Angelo, Trevisani, Franco, Giannini, E. G., Pieri, G., Labanca, S., Plaz Torres, M. C., Gasbarrini, A., Biasini, E., Campani, C., Cazzagon, N., Foschi, F. G., Mega, A., Masotto, A., Raimondo, G., Rapaccini, G. L., Sacco, R., Caturelli, E., Guarino, M., Tovoli, F., Vidili, G., Brunetto, M. R., Nardone, G., Svegliati-Baroni, G., Magalotti, D., Azzaroli, F., Cabibbo, G., Di Marco, M., Sangiovanni, A., Trevisani, F., Biselli, M., Caraceni, P., Gramenzi, A., Benevento, F., Granito, A., Muratori, L., Piscaglia, F., Bertellini, F., Farinati, F., Palano, G., Pelizzaro, F., Penzo, B., Pinto, E., Allegrini, G., Camma, C., Celsa, C., Giuffrida, P., Stornello, C., Grova, M., Giacchetto, C. M., Rancatore, G., Grassini, M. V., Adotti, V., Gitto, S., Marra, F., Rosi, M., Bevilacqua, V., Borghi, A., Gardini, A. C., Conti, F., Napoli, L., Domenicali, M., Migliano, M. T., de Matthaeis, N., Ponziani, F. R., Olivani, A., Missale, G., Cossiga, V., Capasso, M., Morisco, F., Cela, E. M., Facciorusso, A., Lauria, V., Ghittoni, G., Pelecca, G., Chegai, F., Coratella, F., Ortenzi, M., Dell'Isola, S., Franze, M. S., Saitta, C., Sauchella, A., Dajti, E., Ravaioli, F., Oliveri, F., Ricco, G., Romagnoli, V., Inno, A., Marchetti, F., Coccoli, P., Malerba, A., Cappelli, A., Golfieri, R., Mosconi, C., and Renzulli, M.
Subjects: Male, Carcinoma, Hepatocellular, Cholestatic liver disease, Outcome, Surveillance, Survival, Treatment, Hepatology, Prognosi, Liver Cirrhosis, Biliary, Risk Factor, Settore MED/12 - GASTROENTEROLOGIA, Liver Neoplasms, Gastroenterology, Prognosis, Risk Factors, Humans, Female, Human, Aged
Abstract: Background: Comprehensive and contemporary data pertaining large populations of patients with Primary Biliary Cholangitis (PBC) and hepatocellular carcinoma (HCC) are missing. Aim: To describe main characteristics and outcome of PBC patients with HCC diagnosed in the new millennium. Methods: Analysing the Italian Liver Cancer registry we identified 80 PBC patients with HCC diagnosed after the year 2000, and described their clinical characteristics, access to treatment and survival. Results: Median age of patients was 71 years and 50.0% were males. Cirrhosis was present in 86.3% of patients, being well-compensated in 58.0%. Median HCC diameter was smaller in patients under surveillance (2.6vs 4.0cm, P=0.007). Curative treatment, feasible in 50.0% of patients, was associated with improved survival compared to palliative and supportive care (42vs 33vs 6 months, P
Published: 2022

38. Accuracy of Transient Elastography in Assessing Fibrosis at Diagnosis in Naïve Patients With Primary Biliary Cholangitis: A Dual Cut-Off Approach

Author: Cristina Rigamonti, Rosanna Venere, Carla De Benedittis, Guido Carpino, Pietro Invernizzi, Italian Pbc Registry, Elisabetta Degasperi, Giacomo Mulinacci, Marco Carbone, Sarah Elisabeth O’Donnell, Diletta Overi, Sara Labanca, Vito Di Marco, A. Ciaccio, Vincenzo Cardinale, Mauro Viganò, Andrea Palermo, Annarosa Floreani, Daphne D’Amato, Nora Cazzagon, Vincenzo Ronca, Donatella Barisani, Laura Cristoferi, Federica Malinverno, Marco Marzioni, Domenico Alvaro, Clara Mancuso, Vincenza Calvaruso, Anna Fichera, Martina Lucà, Federica Cerini, Alessandra Nardi, Eugenio Gaudio, Antonino Picciotto, Nicola Zucchini, Monica Leutner, Alessio Gerussi, Laura Cristoferi, Vincenza Calvaruso, Diletta Overi 5 , Mauro Viganò 6 , Cristina Rigamonti 7 , Elisabetta Degasperi 8 , Vincenzo Cardinale 9 , Sara Labanca 10 , Nicola Zucchini 11 , Anna Fichera, Vito Di Marco, Monica Leutner 12 , Rosanna Venere 13 , Antonino Picciotto 10 , Martina Lucà 1 2 , Giacomo Mulinacci 1 2 , Andrea Palermo 1 2 , Alessio Gerussi 1 2 , Daphne D'Amato 1 2 , Sarah Elisabeth O'Donnell 1 2 , Federica Cerini 6 , Carla De Benedittis 7 , Federica Malinverno 1 2 , Vincenzo Ronca 1 2 , Clara Mancuso 1 2 , Nora Cazzagon 14 , Antonio Ciaccio 1 2 , Donatella Barisani 1 , Marco Marzioni 15 , Annarosa Floreani 16 17 , Domenico Alvaro 9 , Eugenio Gaudio 5 , Pietro Invernizzi 1 2 , Guido Carpino # 18 , Alessandra Nardi # 19 , Marco Carbone, Cristoferi, L, Calvaruso, V, Overi, D, Viganò, M, Rigamonti, C, Degasperi, E, Cardinale, V, Labanca, S, Zucchini, N, Fichera, A, Di Marco, V, Leutner, M, Venere, R, Picciotto, A, Lucà, M, Mulinacci, G, Palermo, A, Gerussi, A, D'Amato, D, O'Donnell, S, Cerini, F, De Benedittis, C, Malinverno, F, Ronca, V, Mancuso, C, Cazzagon, N, Ciaccio, A, Barisani, D, Marzioni, M, Floreani, A, Alvaro, D, Gaudio, E, Invernizzi, P, Carpino, G, Nardi, A, and Carbone, M
Subjects: area under curve, 0301 basic medicine, medicine.medical_specialty, liver cirrhosis, Diagnostic accuracy, risk stratification, PBC, Gastroenterology, primary biliary cholangiti, elasticity imaging techniques, female, humans, biliary, male, middle aged, ROC curve, sensitivity and specificity, Therapy naive, 03 medical and health sciences, 0302 clinical medicine, Fibrosis, Internal medicine, medicine, Hepatology, Receiver operating characteristic, medicine.diagnostic_test, Liver Cirrhosis, Biliary, business.industry, Original Articles, medicine.disease, transient elastography, Autoimmune, Cholestatic and Biliary Disease, 030104 developmental biology, Liver biopsy, Cohort, Original Article, 030211 gastroenterology & hepatology, diagnostic accuracy, Cut-off, Transient elastography, business, fibrosi
Abstract: Background & aims Liver fibrosis holds a relevant prognostic meaning in primary biliary cholangitis (PBC). Non-invasive fibrosis evaluation using vibration-controlled transient elastography (VCTE) is routinely performed. However, there is limited evidence on its accuracy at diagnosis in PBC. We aimed to estimate the diagnostic accuracy of VCTE in assessing advanced fibrosis at disease presentation in PBC. Approach & results We collected data from 167 consecutive treatment-naive PBC patients who underwent liver biopsy(LB) at diagnosis at six Italian centers. VCTE examinations were completed within 12 weeks of LB. Biopsies were scored by two blinded expert pathologists, according to Ludwig system. Diagnostic accuracy was estimated using the area under the receiver operating characteristic curves(AUROCs) for advanced fibrosis (Ludwig stage≥III). The effects of biochemical and clinical parameters on liver stiffness measurement (LSM) were appraised. Derivation cohort consisted of 126 patients with valid LSM and LB, VCTE identified patients with advanced fibrosis with AUROC of 0.89. LSM cut-offs ≤6.5kPa and >11.0kPa enabled to exclude and confirm, respectively, advanced fibrosis (negative predictive value[NPV]=0.94, positive predictive value[PPV]=0.89, error rate=5.6%). These values were externally validated in an independent cohort of 91 PBC patients(NPV=0.93, PPV=0.89, error rate=8.6%). Multivariable analysis found the only parameter affecting LSM was fibrosis stage. No association was found with BMI and liver biochemistry. Conclusions In a multicenter study of treatment-naive PBC patients, we identified two cut-offs (LSM≤6.5kPa and>11.0kPa) able to discriminate at diagnosis the presence or the absence, respectively, of advanced fibrosis in PBC patients, with external validation. In patients with LSM between these two cut-offs, VCTE is not reliable and liver biopsy should be evaluated for accurate disease staging. BMI and liver biochemistry did not affect LSMs.
Published: 2021

39. Accuracy of liver stiffness measurement in assessing liver fibrosis in naive patients with primary biliary cholangitis

Author: LAURA CRISTOFERI, Nardi, Alessandra, Vigano, Mauro, Rigamonti, Cristina, Degasperi, Elisabetta, Cardinale, Vincenzo, Labanca, Sara, Zucchini, Nicola, Leutner, Monica, Venere, Rosanna, Picciotto, Antonino, Cazzagon, Nora, Luca, Martina, Overi, Diletta, Gerussi, Alessio, D Amato, Daphne, O Donnell, Sarah Elisabeth, Cerini, Federica, Benedittis, Carla, Cadamuro, Massimiliano, Malinverno, Federica, Floreani, Annarosa, Alvaro, Domenico, Gaudio, Eugenio, Invernizzi, Pietro, Carpino, Guido, Carbone, Marco, Cristoferi, L, Nardi, A, Viganò, M, Rigamonti, C, Degasperi, E, Cardinale, V, Labanca, S, Zucchini, N, Leutner, M, Venere, R, Picciotto, A, Cazzagon, N, Lucà, M, Overi, D, Gerussi, A, D’Amato, D, O’Donnell, S, Cerini, F, De Benedittis, C, Cadamuro, M, Malinverno, F, Floreani, A, Alvaro, D, Gaudio, E, Invernizzi, P, Carpino, G, and Carbone, M
Subjects: Hepatology, Primary biliary cholangiti, Fibrosi, Autoimmune liver disease, Vibration-Controlled Transient Elastography, Risk stratification
Abstract: Background and Aims: Non-invasive evaluation of liver fibrosis in primary biliary cholangitis (PBC) with Liver Stiffness Measurements (LSM) by Transient Elastography (TE) is routinely undertaken at diagnosis for disease staging and risk stratification. However, evidence on correlation between LSM and liver fibrosis is based on cross-sectional studies in PBC-treated patients. Moreover, the impact of potential confounders, e.g. cholestasis and steatosis, is unclear. Aim of our study was to investigate the accuracy of LSM to predict moderate to severe fibrosis in newly diagnosed PBC patients naïve to therapy. Method: We collected data from 182 adult patients who underwent liver biopsy (LB) for PBC at diagnosis in five Italian liver centers from Jan 2006 through Aug 2019. TE examinations within 3 months from LB were included. LB were scored centrally by two expert pathologists, blinded to clinical data and disease stage, according to Ludwig staging system. In all patients Fibrosis-4 (FIB-4) and aspartate aminotransferase [AST]/platelet ratio (APRI) score have been calculated. Diagnostic accuracy of LSM, FIB-4 and APRI score was estimated using the area under the receiver operating characteristic curves (AUROCs) for fibrosis. The effects of liver biochemistry and histological parameters were appraised using multivariable logistic model. Results: 123 PBC patients had adequate LB (≥9 portal tracts) and valid LSM values. According to histological assessment, Ludwig stage distribution was as follows: stage I = 38 (30.9%), stage II = 46(37.4%), stage III = 27 (21.9%), stage IV = 12 (9.8%). TE identified patients with Ludwig stage III/IV with an AUROC of 0.83 (95% confidence interval [CI] (0.74, 0.90)) (Fig.1). The optimal threshold was identified at 6.75kPa (CI (6.55, 7.50)), with 85% of sensitivity, 75% of specificity, 78% of accuracy and 6 false negative. TE was superior to APRI and FIB-4 having AUROC of 0.638 (CI = (0.535, 0.740)) and 0.641 (CI = (0.516, 0.766)), respectively. At multivariable analysis only LSM was associated with liver fibrosis and no significant effect of biochemical measures and steatosis was found. Conclusion: LSM is accurate to predict moderate to severe liver fibrosis at diagnosis in PBC naïve patients using a threshold of 6.75kPa with an AUROC of 0.83. TE outperformed FIB-4 and APRI score and is not confounded by liver biochemistry and steatosis. These data can inform strategies for patient surveillance and trial design in PBC.
Published: 2020
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40. Failure of long-term lamivudine prophylaxis in patients with resolved hepatitis B infection undergoing chemotherapy and allogenic hematopoietic stem cell transplantation for hematological malignancies: two case reports

Author: Pietro Lampertico, Mauro Viganò, Anna Dodero, Paolo Corradini, Massimo Colombo, Floriana Facchetti, Roberto Cairoli, Anna Maria Cafro, Alessandro Loglio, Sara Labanca, G. Grossi, Vittorio Montefusco, Grossi, G, Viganò, M, Facchetti, F, Labanca, S, Loglio, A, Dodero, A, Montefusco, V, Corradini, P, Cafro, A, Cairoli, R, Colombo, M, and Lampertico, P
Subjects: Oncology, Male, medicine.medical_specialty, medicine.medical_treatment, Premedication, Hematopoietic stem cell transplantation, Treatment failure, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, Medicine, In patient, Treatment Failure, Online Only Articles, Hematologic Neoplasm, Antiviral Agent, Chemotherapy, business.industry, Hematopoietic Stem Cell Transplantation, Lamivudine, Hematology, Middle Aged, Hepatitis B infection, 030220 oncology & carcinogenesis, Immunology, 030211 gastroenterology & hepatology, Female, Virus Activation, business, medicine.drug, Human
Published: 2017

41. Second-Line Treatment for Patients With Primary Biliary Cholangitis: A Systematic Review With Network Meta-Analysis.

Author: Giannini EG, Pasta A, Calabrese F, Labanca S, Marenco S, Pieri G, Plaz Torres MC, and Strazzabosco M
Subjects: Humans, Cholagogues and Choleretics therapeutic use, Cholagogues and Choleretics adverse effects, Fibric Acids therapeutic use, Fibric Acids adverse effects, Treatment Outcome, Disease Progression, Salicylates therapeutic use, Salicylates adverse effects, Phosphoric Diester Hydrolases, Propionates, Chalcones, Chenodeoxycholic Acid analogs & derivatives, Chenodeoxycholic Acid therapeutic use, Chenodeoxycholic Acid adverse effects, Liver Cirrhosis, Biliary drug therapy, Liver Cirrhosis, Biliary complications, Ursodeoxycholic Acid therapeutic use, Randomized Controlled Trials as Topic, Network Meta-Analysis, Pruritus drug therapy, Pruritus etiology
Abstract: Background & Aims: Approximately 40% of patients with Primary Biliary Cholangitis (PBC) show incomplete response to ursodeoxycholic acid, thus needing second-line treatment to prevent disease progression. As no head-to-head comparison study is available, we used a network meta-analysis (NMA) to compare efficacy and safety of available second-line therapies., Methods: We performed a systematic literature review including randomised, placebo-controlled trials of patients with PBC and incomplete response, or intolerance, to ursodeoxycholic acid, and compared relative risks (RRs) for primary (biochemical response at 52-week) and secondary outcomes [incidence of new-onset pruritus and serious adverse events (SAEs)]., Results: The NMA included three studies, each testing obeticholic acid (OCA), seladelpar or elafibranor versus placebo (active therapy/placebo: 379/191 patients). All treatments significantly increased the RR for biochemical response with an advantage of elafibranor versus seladelpar (RR: 4.37, 95% CI: 1.01-18.87). OCA 5-10 mg/10 mg was associated with a higher risk of new-onset pruritus compared to placebo (RR: 1.43; 95% CI: 1.09-1.88/RR: 1.79; 95% CI: 1.37-2.33), while seladelpar decreased this risk (RR: 0.30; 95% CI: 0.12-0.80). Compared to placebo, OCA 5-10 mg/10 mg was associated with an increased risk of SAE (RR: 3.82; 95% CI: 1.46-10.02/RR 2.67; 95% CI: 1.00-7.08)., Conclusions: Among second line therapies for patients with PBC, elafibranor is slightly more effective in obtaining biochemical response than seladelpar that, on the other hand, is the only drug associated with a lower incidence of pruritus. While of similar efficacy, OCA was associated with increased pruritus and SAEs. These findings may help personalise second-line treatment in patients with PBC., (© 2024 The Author(s). Liver International published by John Wiley & Sons Ltd.)
Published: 2025
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42. Noninvasive Assessment of portal Hypertension in Patients With Primary Biliary Cholangitis is Affected by Severity of Cholestasis.

Author: Calvaruso V, Celsa C, Cristoferi L, Scaravaglio M, Smith R, Kaur S, Di Maria G, Capodicasa L, Pennisi G, Gerussi A, Nofit E, Malinverno F, Lampertico P, Cazzagon N, Marzioni M, Vespasiani-Gentilucci U, Colapietro F, Andreone P, De Nalda AL, Rigamonti C, Viganò M, Giannini EG, Russello M, Vanni E, Cerini F, Orlandini A, Brunetto M, Niro GA, Vettori G, Castellaneta A, Cardinale V, Alvaro D, Mega A, Palitti VP, Cossiga V, Morisco F, Bellanti F, Baiocchi L, Fabris L, Persico M, Degasperi E, Labanca S, Bonaiuto E, Pezzato F, Federico A, Petta S, Di Marco V, Mells GF, Culver E, Invernizzi P, Cammà C, and Carbone M
Abstract: Background & Aims: Noninvasive tests (NITs) for ruling-out clinical significant portal hypertension (CSPH) and high-risk varices (HRVs) in patients with primary biliary cholangitis (PBC) and compensated advanced chronic liver disease (cACLD) are lacking. We evaluated NITs in these patients and the influence of cholestasis on their performance., Methods: Consecutive patients from the "Italian PBC registry" and 2 United Kingdom large-volume PBC referral centers with upper endoscopy within 6 months from biochemical evaluation and transient elastography were included. Rete Sicilia Selezione Terapia (RESIST), Baveno VI (BVI), and Expanded Baveno VI (EBVI) criteria for ruling out HRV were assessed according to alkaline phosphatase (ALP) levels (< or ≥1.5 × upper limit of normal). Decision curve analysis was performed. Prevalence of any sized esophageal varices among patients fitting Baveno VII (BVII) criteria was also calculated., Results: The final cohort consisted of 293 patients with cACLD. RESIST criteria were associated with the lowest rate of missed HRV (2.5% vs 9.8% for BVI and 8.9% for EBVI). In patients with ALP levels ≥1.5 × upper limit of normal, BVI and EBVI missed a higher rate of HRV (15.5% and 14.5%, respectively) than RESIST (3.1%). Decision curve analysis demonstrated the highest net benefit of RESIST criteria for ruling out HRV, regardless of ALP levels. Among 75 patients classified as low risk of CSPH according to BVII, 14 (18.7%) showed esophageal varices., Conclusions: Biochemical-based RESIST criteria demonstrate the highest net benefit compared with elastography-based criteria for ruling out HRV. The severity of cholestasis affects NITs performance to rule out HRV and CSPH in patients with PBC and cACLD., (Copyright © 2024 AGA Institute. Published by Elsevier Inc. All rights reserved.)
Published: 2024
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43. Development and Validation of a Scoring System to Predict Response to Obeticholic Acid in Primary Biliary Cholangitis.

Author: De Vincentis A, Ampuero J, Terracciani F, D'Amato D, Gerussi A, Cristoferi L, Cazzagon N, Bonaiuto E, Floreani A, Calvaruso V, Cadamuro L, Degasperi E, Morgando A, Vanni E, Lleo A, Colapietro F, Alvaro D, Castellaneta A, Labanca S, Viganò M, Distefano M, Pace Palitti V, Ricci C, De Matthaeis N, Marzioni M, Gómez-Dominguez E, Montero JL, Molina E, Garcia-Buey L, Casado M, Berenguer M, Conde I, Simon MA, Fuentes J, Costa-Moreira P, Macedo G, Jorquera F, Morillas RM, Presa J, Sousa JM, Gomes D, Santos L, Olveira A, Hernandez-Guerra M, Aburruza L, Santos A, Carvalho A, Uriz J, Gutierrez ML, Perez E, Chessa L, Pellicelli A, Marignani M, Muratori L, Niro GA, Brunetto M, Ponziani FR, Pompili M, Marra F, Galli A, Mussetto A, Alagna G, Simone L, Bertino G, Rosina F, Cozzolongo R, Russello M, Baiocchi L, Saitta C, Terreni N, Zolfino T, Rigamonti C, Vigano R, Cuccorese G, Pozzoni P, Pedone C, Grasso S, Picardi A, Invernizzi P, Sacco R, Izzi A, Fernandez-Rodriguez C, Vespasiani-Gentilucci U, and Carbone M
Subjects: Humans, Female, Male, Middle Aged, Prospective Studies, Aged, Liver Cirrhosis, Biliary drug therapy, Treatment Outcome, Adult, Cholagogues and Choleretics therapeutic use, Italy, Chenodeoxycholic Acid analogs & derivatives, Chenodeoxycholic Acid therapeutic use
Abstract: Background & Aims: Obeticholic acid (OCA) is the only licensed second-line therapy for primary biliary cholangitis (PBC). With novel therapeutics in advanced development, clinical tools are needed to tailor the treatment algorithm. We aimed to derive and externally validate the OCA response score (ORS) for predicting the response probability of individuals with PBC to OCA., Methods: We used data from the Italian RECAPITULATE (N = 441) and the IBER-PBC (N = 244) OCA real-world prospective cohorts to derive/validate a score including widely available variables obtained either pre-treatment (ORS) or also after 6 months of treatment (ORS+). Multivariable Cox regressions with backward selection were applied to obtain parsimonious predictive models. The predicted outcomes were biochemical response according to POISE (alkaline phosphatase [ALP]/upper limit of normal [ULN]<1.67 with a reduction of at least 15%, and normal bilirubin), or ALP/ULN<1.67, or normal range criteria (NR: normal ALP, alanine aminotransferase [ALT], and bilirubin) up to 24 months., Results: Depending on the response criteria, ORS included age, pruritus, cirrhosis, ALP/ULN, ALT/ULN, GGT/ULN, and bilirubin. ORS+ also included ALP/ULN and bilirubin after 6 months of OCA therapy. Internally validated c-statistics for ORS were 0.75, 0.78, and 0.72 for POISE, ALP/ULN<1.67, and NR response, which raised to 0.83, 0.88, and 0.81 with ORS+, respectively. The respective performances in validation were 0.70, 0.72, and 0.71 for ORS and 0.80, 0.84, and 0.78 for ORS+. Results were consistent across groups with mild/severe disease., Conclusions: We developed and externally validated a scoring system capable to predict OCA response according to different criteria. This tool will enhance a stratified second-line therapy model to streamline standard care and trial delivery in PBC., (Copyright © 2024 AGA Institute. Published by Elsevier Inc. All rights reserved.)
Published: 2024
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44. Letter to the Editor: Is CAD-LT score as a predictor of coronary artery disease following liver transplantation?

Author: Labanca S, Pasta A, Cariati S, Calabrese F, Pieri G, Plaz Torres MC, Marenco S, and Giannini EG
Subjects: Humans, Coronary Angiography, Risk Factors, Coronary Artery Disease diagnosis, Coronary Artery Disease etiology, Coronary Artery Disease surgery, Liver Transplantation adverse effects
Published: 2024
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45. Safety and Efficacy of Atezolizumab/Bevacizumab in Patients with Hepatocellular Carcinoma and Impaired Liver Function: A Systematic Review and Meta-Analysis.

Author: Pasta A, Calabrese F, Jaffe A, Labanca S, Marenco S, Pieri G, Plaz Torres MC, Strazzabosco M, and Giannini EG
Abstract: Background: Safety and outcome of atezolizumab/bevacizumab in Child-Pugh B patients with hepatocellular carcinoma (HCC) have not been completely characterized., Objectives: In this study, we aimed at addressing safety and efficacy of atezolizumab/bevacizumab in Child-Pugh B patients by reviewing the available data and analyzing them by meta-analysis., Methods: We compared the safety and efficacy of atezolizumab/becavizumab treatment in patients with unresectable HCC and various degrees of liver dysfunction. A total of 8 retrospective, non-randomized, cohort studies were included in this meta-analysis, for a total of 1,071 Child-Pugh A and 225 Child-Pugh B patients. The albumin-bilirubin (ALBI) grade was also used to assess liver function, when available., Results: Grade ≥3 adverse events were observed in 11.8% of Child-Pugh class A and 26.8% class B patients ( p = 0.0001), with an odds ratio (OR) of 0.43 (confidence interval [CI] 0.21-0.90; p = 0.02). Progression-free survival (PFS) at both 6 months (4.90 ± 2.08 vs. 4.75 ± 2.08 months; p = 0.0004) and 12 months (8.83 ± 2.32 vs. 7.26 ± 2.33 months; p = 0.002) was lower in Child-Pugh class B patients. A trend toward a higher objective response rate (ORR) was observed in Child-Pugh class A patients (219/856, 25.6%) as compared to Child-Pugh class B patients (25/138, 18.1%; p = 0.070), while the probability of obtaining an ORR was significantly greater in Child-Pugh A patients (OR 1.79, CI 1.12-2.86; p = 0.02). Median overall survival (OS) was 16.8 ± 2.0 and 6.8 ± 3.2 months in Child-Pugh A and B patients, respectively (mean difference 9.06 months, CI 7.01-11.1, p < 0.0001). Lastly, OS was longer in patients with ALBI grades 1-2 than in those with grade 3 (8.3 ± 11.4 vs. 3.3 ± 5.0 months, p = 0.0008)., Conclusions: Oncological efficacy of atezolizumab/bevacizumab is moderate in Child-Pugh class B patients, and the shorter PFS and OS associated with the greater likelihood of experiencing treatment-related adverse events observed in these patients suggest great caution and individualization of treatment, possibly with the support of the ALBI grade., Competing Interests: Edoardo G. Giannini has participated in consulting and/or advisory boards for Roche, AstraZeneca, Eisai, MSD. Mario Strazzabosco is an advisor for ENGITIX., (© 2023 The Author(s). Published by S. Karger AG, Basel.)
Published: 2023
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46. Excellent outcome in patients with primary biliary cholangitis in Northwest Italy followed up for up to 30 years.

Author: Rigamonti C, De Benedittis C, Labanca S, Vanni E, Morgando A, Manfredi GF, Azzolina D, Cittone MG, Giannini EG, Saracco GM, and Pirisi M
Subjects: Humans, Female, Middle Aged, Male, Cohort Studies, Cholagogues and Choleretics therapeutic use, Retrospective Studies, Prospective Studies, Ursodeoxycholic Acid therapeutic use, Bilirubin, Treatment Outcome, Liver Cirrhosis, Biliary complications, Liver Cirrhosis, Biliary diagnosis, Liver Cirrhosis, Biliary drug therapy
Abstract: Objective: Primary biliary cholangitis (PBC) is a rare chronic autoimmune cholangiopathy, characterized by a variable course and response to treatment. We aimed to describe long-term outcomes of PBC patients referred to three academic centres in Northwest Italy., Methods: This is an ambispective cohort study of PBC patients (retrospective component: diagnosis before 1 January 2019; prospective component: thereafter), including 302 patients: 101 (33%) followed up in Novara, 86 (28%) in Turin, 115 (38%) in Genoa. Clinical features at diagnosis, biochemical response to therapy and survival were analyzed., Results: Among the 302 patients (88% women, median age 55 years, median follow-up 75 months), alkaline phosphatase (ALP) levels significantly decreased during treatment with ursodeoxycholic acid (UDCA, P < 0.0001) and obeticholic acid (P < 0.0001). At multivariate analysis, ALP at diagnosis was predictive of 1-year biochemical response to UDCA [odds ratio 3.57, 95% confidence interval (CI) 1.4-9, P < 0.001]. Estimated median survival free of liver transplantation and hepatic complications was 30 years (95% CI 19-41). Bilirubin level at diagnosis was the only independent risk factor for the combined outcome of death, transplantation or hepatic decompensation (hazard ratio, 1.65, 95% CI 1.66-2.56, P = 0.02). Patients presenting with total bilirubin at diagnosis ≥0.6 times the upper normal limit (ULN) had a significantly lower 10-year survival compared to those with bilirubin <0.6 times ULN (63% vs. 97%, P < 0.0001)., Conclusion: In PBC, both short-term response to UDCA and long-term survival can be predicted by simple conventional biomarkers of disease severity, obtained at diagnosis., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)
Published: 2023
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47. Safety and efficacy of venous thromboembolism prophylaxis in patients with cirrhosis: A systematic review and meta-analysis.

Author: Pasta A, Calabrese F, Labanca S, Marenco S, Pieri G, Plaz Torres MC, Intagliata NM, Caldwell SH, and Giannini EG
Subjects: Humans, Anticoagulants adverse effects, Hemorrhage chemically induced, Liver Cirrhosis drug therapy, Venous Thromboembolism etiology, Venous Thromboembolism prevention & control, Venous Thromboembolism drug therapy
Abstract: Background & Aims: Patients with cirrhosis are considered in a haemostatic balance, though weaker than in normal subjects. In these patients, however, the use of pharmacological prophylaxis for venous thromboembolism (VTE) remains controversial. Therefore, in this study, we aimed to assess the safety and efficacy of VTE prophylaxis in patients with cirrhosis., Methods: We conducted a systematic review of studies reporting the occurrence of bleeding and VTE events in patients with cirrhosis, and controls, undergoing VTE prophylaxis. Meta-regression analysis was conducted to further explore the determinants of heterogeneity in the study of the occurrence of either bleeding or VTE events., Results: In a total of 10 studies, including 5712 patients, of which 2330 undergoing VTE prophylaxis, bleeding (n = 5513) and VTE events occurred in 8.2% and 2.8% patients respectively. A total of 2963 and 3162 patients were included from low-risk of bias studies in bleeding and VTE analysis respectively: while administration of VTE prophylaxis did not seem to reduce VTE (OR = 1.07, CI 0.39-2.96, p = .89), importantly prophylaxis was not associated with increased bleeding risk (OR = 0.56, CI 0.20-1.59, p = .27). Meta-regression analysis showed that no parameter significantly influenced the heterogeneity of data regarding bleeding or VTE events., Conclusions: In patients with cirrhosis, current evidence is insufficient to advise for or against the use of VTE prophylaxis, mainly due to lack of quality and homogeneity of available data. However, its use does not appear to be associated with a significant bleeding risk. Adequately designed studies are required to provide a measure of its overall utility., (© 2023 The Authors. Liver International published by John Wiley & Sons Ltd.)
Published: 2023
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48. Hepatic encephalopathy increases the risk for mortality and hospital readmission in decompensated cirrhotic patients: a prospective multicenter study.

Author: Riggio O, Celsa C, Calvaruso V, Merli M, Caraceni P, Montagnese S, Mora V, Milana M, Saracco GM, Raimondo G, Benedetti A, Burra P, Sacco R, Persico M, Schepis F, Villa E, Colecchia A, Fagiuoli S, Pirisi M, Barone M, Azzaroli F, Soardo G, Russello M, Morisco F, Labanca S, Fracanzani AL, Pietrangelo A, Di Maria G, Nardelli S, Ridola L, Gasbarrini A, and Cammà C
Abstract: Introduction: Hepatic encephalopathy (HE) affects the survival and quality of life of patients with cirrhosis. However, longitudinal data on the clinical course after hospitalization for HE are lacking. The aim was to estimate mortality and risk for hospital readmission of cirrhotic patients hospitalized for HE., Methods: We prospectively enrolled 112 consecutive cirrhotic patients hospitalized for HE (HE group) at 25 Italian referral centers. A cohort of 256 patients hospitalized for decompensated cirrhosis without HE served as controls (no HE group). After hospitalization for HE, patients were followed-up for 12 months until death or liver transplant (LT)., Results: During follow-up, 34 patients (30.4%) died and 15 patients (13.4%) underwent LT in the HE group, while 60 patients (23.4%) died and 50 patients (19.5%) underwent LT in the no HE group. In the whole cohort, age (HR 1.03, 95% CI 1.01-1.06), HE (HR 1.67, 95% CI 1.08-2.56), ascites (HR 2.56, 95% CI 1.55-4.23), and sodium levels (HR 0.94, 95% CI 0.90-0.99) were significant risk factors for mortality. In the HE group, ascites (HR 5.07, 95% CI 1.39-18.49) and BMI (HR 0.86, 95% CI 0.75-0.98) were risk factors for mortality, and HE recurrence was the first cause of hospital readmission., Conclusion: In patients hospitalized for decompensated cirrhosis, HE is an independent risk factor for mortality and the most common cause of hospital readmission compared with other decompensation events. Patients hospitalized for HE should be evaluated as candidates for LT., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Riggio, Celsa, Calvaruso, Merli, Caraceni, Montagnese, Mora, Milana, Saracco, Raimondo, Benedetti, Burra, Sacco, Persico, Schepis, Villa, Colecchia, Fagiuoli, Pirisi, Barone, Azzaroli, Soardo, Russello, Morisco, Labanca, Fracanzani, Pietrangelo, Di Maria, Nardelli, Ridola, Gasbarrini and Cammà.)
Published: 2023
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49. Effect of contrast-enhanced ultrasound (CEUS) on liver stiffness measurements obtained by transient and shear-wave elastography.

Author: Kayali S, Pasta A, Pellicano R, Fagoonee S, Giuliana E, Facchini C, Pili S, Buccilli S, Labanca S, and Borro P
Subjects: Humans, Contrast Media, Retrospective Studies, Liver Cirrhosis diagnostic imaging, Liver diagnostic imaging, Liver pathology, Elasticity Imaging Techniques methods
Abstract: Background: Since liver fibrosis is one of the most accurate predictors of prognosis in hepatopatic patients, its accurate assessment and staging is a major public health issue. Transient elastography (TE) (Fibroscan, Echosens, Paris, France) and shear wave elastography (SWE) represent the gold standard techniques among non-invasive methods to assess liver fibrosis. Contrast-enhanced ultrasound (CEUS) is increasingly used to diagnose the nature of liver lesions and is often performed together with TE and SWE. In this study we evaluated the effect of CEUS on liver stiffness measurements obtained by TE and SWE., Methods: A retrospective analysis of ultrasound (US) exams performed by an expert operator was carried out. TE and SWE were performed 30 seconds before and after the execution of CEUS. Statistical analysis was carried out using the statistical software R. Kolmogorov-Smirnov analysis was performed to test the normality of continuous variables. The pre- and post-CEUS liver stiffness values were compared using the Wilcoxon's Test., Results: Ninety-six patients were enrolled. While the measurements were comparable when performed with TE, those obtained by SWE decreased by 6% after administration of the contrast agent (P=0.0005). Fibrosis stage deviated between pre- and post-CEUS in 16 (17%) patients with Fibroscan and 22 (23%) patients with SWE. Among the latter, in 9 cases (10%) a deviation from absent-low (F0-F2) to high-fibrosis (F3, F4), or vice versa, occurred., Conclusions: Our study, the first to assess the effects of CEUS on US elastography, shows that the contrast agent (Sonovue, Bracco Suisse SA, Cadempino, Switzerland) does not significantly affect liver stiffness measurements obtained by TE, whereas the accuracy decreases when performed by SWE.
Published: 2022
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50. Predictors of serious adverse events and non-response in cirrhotic patients with primary biliary cholangitis treated with obeticholic acid.

Author: De Vincentis A, D'Amato D, Cristoferi L, Gerussi A, Malinverno F, Lleo A, Colapietro F, Marra F, Galli A, Fiorini C, Coco B, Brunetto M, Niro GA, Cotugno R, Saitta C, Cozzolongo R, Losito F, Giannini EG, Labanca S, Marzioni M, Marconi G, Morgando A, Pellicano R, Vanni E, Cazzagon N, Floreani A, Chessa L, Morelli O, Muratori L, Pellicelli A, Pompili M, Ponziani F, Tortora A, Rosina F, Russello M, Cannavò M, Simone L, Storato S, Viganò M, Abenavoli L, D'Antò M, De Gasperi E, Distefano M, Scifo G, Zolfino T, Calvaruso V, Cuccorese G, Palitti VP, Sacco R, Bertino G, Frazzetto E, Alvaro D, Mulinacci G, Palermo A, Scaravaglio M, Terracciani F, Galati G, Ronca V, Zuin M, Claar E, Izzi A, Picardi A, Invernizzi P, Vespasiani-Gentilucci U, and Carbone M
Subjects: Albumins therapeutic use, Ascites drug therapy, Ascites etiology, Bilirubin, Chenodeoxycholic Acid analogs & derivatives, Humans, Liver Cirrhosis complications, Liver Cirrhosis drug therapy, Male, Liver Cirrhosis, Biliary complications, Liver Cirrhosis, Biliary drug therapy
Abstract: Background & Aims: Obeticholic acid (OCA) has recently been restricted in patients with primary biliary cholangitis (PBC) with "advanced cirrhosis" because of its narrow therapeutic index. We aimed to better define the predicting factors of hepatic serious adverse events (SAEs) and non-response in cirrhotic patients undergoing OCA therapy., Methods: Safety and efficacy of treatment were evaluated in a cohort of consecutive PBC cirrhotic patients started with OCA. OCA response was evaluated according to the Poise criteria. Risk factors for hepatic SAEs and non-response were reported as risk ratios (RR) with 95% confidence intervals (CIs)., Results: One hundred PBC cirrhotics were included, 97 Child-Pugh class A and 3 class B. Thirty-one had oesophageal varices and 5 had a history of ascites. Thirty-three per cent and 32% of patients achieved a biochemical response at 6 and 12 months respectively. Male sex (adjusted-RR 1.75, 95%CI 1.42-2.12), INR (1.37, 1.00-1.87), Child-Pugh score (1.79, 1.28-2.50), MELD (1.17, 1.04-1.30) and bilirubin (1.83, 1.11-3.01) were independently associated with non-response to OCA. Twenty-two patients discontinued OCA within 12 months: 10 for pruritus, 9 for hepatic SAEs (5 for jaundice and/or ascitic decompensation; 4 for upper digestive bleeding). INR (adjusted-RR 1.91, 95%CI 1.10-3.36), lower albumin levels (0.18, 0.06-0.51), Child-Pugh score (2.43, 1.50-4.04), history of ascites (3.5, 1.85-6.5) and bilirubin (1.30, 1.05-1.56), were associated with hepatic SAEs. A total bilirubin≥1.4 mg/dl at baseline was the most accurate biochemical predictor of hepatic SAEs under OCA., Conclusions: An accurate baseline assessment is crucial to select cirrhotic patients who can benefit from OCA. Although OCA is effective in one third of cirrhotics, bilirubin level ≥1.4 mg/dl should discourage from its use., (© 2022 The Authors. Liver International published by John Wiley & Sons Ltd.)
Published: 2022
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