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1. Personalised management of patients with hepatocellular carcinoma: a multiparametric therapeutic hierarchy concept

Author

Vitale, A, Cabibbo, G, Iavarone, M, Vigano, L, Pinato, D, Ponziani, F, Lai, Q, Casadei-Gardini, A, Celsa, C, Galati, G, Gambato, M, Crocetti, L, Renzulli, M, Giannini, E, Farinati, F, Trevisani, F, Cillo, U, Baccarani, U, Brancaccio, G, Cozzolongo, R, Cucchetti, A, De Matthaeis, N, Di Sandro, S, Famularo, S, Finotti, M, Foschi, F, Ghinolfi, D, Guarracino, M, Gruttadauria, S, Guarino, M, Kostandini, A, Lenci, I, Levi Sandri, G, Manzia, T, Marasco, G, Masarone, M, Mazzarelli, C, Melandro, F, Miele, L, Morisco, F, Nicolini, D, Pagano, D, Pelizzaro, F, Pieri, G, Piscaglia, F, Plaz Torres, M, Pravisani, R, Rendina, M, Romano, F, Russo, F, Sacco, R, Sangiovanni, A, Sposito, C, Tortora, R, Tovoli, F, Vigano, M, Violi, P, Vitale A., Cabibbo G., Iavarone M., Vigano L., Pinato D. J., Ponziani F. R., Lai Q., Casadei-Gardini A., Celsa C., Galati G., Gambato M., Crocetti L., Renzulli M., Giannini E. G., Farinati F., Trevisani F., Cillo U., Baccarani U., Brancaccio G., Cozzolongo R., Cucchetti A., De Matthaeis N., Di Sandro S., Famularo S., Finotti M., Foschi F. G., Ghinolfi D., Guarracino M., Gruttadauria S., Guarino M., Kostandini A., Lenci I., Levi Sandri G. B., Manzia T. M., Marasco G., Masarone M., Mazzarelli C., Melandro F., Miele L., Morisco F., Nicolini D., Pagano D., Pelizzaro F., Pieri G., Piscaglia F., Plaz Torres M. C., Pravisani R., Rendina M., Romano F., Russo F. P., Sacco R., Sangiovanni A., Sposito C., Tortora R., Tovoli F., Vigano M., Violi P., Vitale, A, Cabibbo, G, Iavarone, M, Vigano, L, Pinato, D, Ponziani, F, Lai, Q, Casadei-Gardini, A, Celsa, C, Galati, G, Gambato, M, Crocetti, L, Renzulli, M, Giannini, E, Farinati, F, Trevisani, F, Cillo, U, Baccarani, U, Brancaccio, G, Cozzolongo, R, Cucchetti, A, De Matthaeis, N, Di Sandro, S, Famularo, S, Finotti, M, Foschi, F, Ghinolfi, D, Guarracino, M, Gruttadauria, S, Guarino, M, Kostandini, A, Lenci, I, Levi Sandri, G, Manzia, T, Marasco, G, Masarone, M, Mazzarelli, C, Melandro, F, Miele, L, Morisco, F, Nicolini, D, Pagano, D, Pelizzaro, F, Pieri, G, Piscaglia, F, Plaz Torres, M, Pravisani, R, Rendina, M, Romano, F, Russo, F, Sacco, R, Sangiovanni, A, Sposito, C, Tortora, R, Tovoli, F, Vigano, M, Violi, P, Vitale A., Cabibbo G., Iavarone M., Vigano L., Pinato D. J., Ponziani F. R., Lai Q., Casadei-Gardini A., Celsa C., Galati G., Gambato M., Crocetti L., Renzulli M., Giannini E. G., Farinati F., Trevisani F., Cillo U., Baccarani U., Brancaccio G., Cozzolongo R., Cucchetti A., De Matthaeis N., Di Sandro S., Famularo S., Finotti M., Foschi F. G., Ghinolfi D., Guarracino M., Gruttadauria S., Guarino M., Kostandini A., Lenci I., Levi Sandri G. B., Manzia T. M., Marasco G., Masarone M., Mazzarelli C., Melandro F., Miele L., Morisco F., Nicolini D., Pagano D., Pelizzaro F., Pieri G., Piscaglia F., Plaz Torres M. C., Pravisani R., Rendina M., Romano F., Russo F. P., Sacco R., Sangiovanni A., Sposito C., Tortora R., Tovoli F., Vigano M., and Violi P.

Abstract

Advances in the surgical and systemic therapeutic landscape of hepatocellular carcinoma have increased the complexity of patient management. A dynamic adaptation of the available staging-based algorithms is required to allow flexible therapeutic allocation. In particular, real-world hepatocellular carcinoma management increasingly relies on factors independent of oncological staging, including patients’ frailty, comorbid burden, critical tumour location, multiple liver functional parameters, and specific technical contraindications impacting the delivery of treatment and resource availability. In this Policy Review we critically appraise how treatment allocation strictly based on pretreatment staging features has shifted towards a more personalised treatment approach, in which expert tumour boards assume a central role. We propose an evidence-based framework for hepatocellular carcinoma treatment based on the novel concept of multiparametric therapeutic hierarchy, in which different therapeutic options are ordered according to their survival benefit (ie, from surgery to systemic therapy). Moreover, we introduce the concept of converse therapeutic hierarchy, in which therapies are ordered according to their conversion abilities or adjuvant abilities (ie, from systemic therapy to surgery).

Published
2023

2. The Italian data on SARS-CoV-2 infection in transplanted patients support an organ specific immune response in liver recipients

Author

Rendina, M, Barone, M, Lillo, C, Trapani, S, Masiero, L, Trerotoli, P, Puoti, F, Lupo, L, Tandoi, F, Agnes, S, Grieco, A, Andorno, E, Marenco, S, Giannini, E, Baccarani, U, Toniutto, P, Carraro, A, Colecchia, A, Cescon, M, Morelli, M, Cillo, U, Burra, P, Angeli, P, Colledan, M, Fagiuoli, S, De Carlis, L, Belli, L, De Simone, P, Carrai, P, Di Benedetto, F, De Maria, N, Ettorre, G, Giannelli, V, Gruttadauria, S, Volpes, R, Corsale, S, Mazzaferro, V, Bhoori, S, Romagnoli, R, Martini, S, Rossi, G, Caccamo, L, Donato, M, Rossi, M, Ginanni Corradini, S, Spada, M, Maggiore, G, Tisone, G, Lenci, I, Vennarecci, G, Tortora, R, Vivarelli, M, Svegliati Baroni, G, Zamboni, F, Mameli, L, Tafuri, S, Simone, S, Gesualdo, L, Cardillo, M, Di Leo, A, Rendina M., Barone M., Lillo C., Trapani S., Masiero L., Trerotoli P., Puoti F., Lupo L. G., Tandoi F., Agnes S., Grieco A., Andorno E., Marenco S., Giannini E. G., Baccarani U., Toniutto P., Carraro A., Colecchia A., Cescon M., Morelli M. C., Cillo U., Burra P., Angeli P., Colledan M., Fagiuoli S., De Carlis L., Belli L., De Simone P., Carrai P., Di Benedetto F., De Maria N., Ettorre G. M., Giannelli V., Gruttadauria S., Volpes R., Corsale S., Mazzaferro V., Bhoori S., Romagnoli R., Martini S., Rossi G., Caccamo L., Donato M. F., Rossi M., Ginanni Corradini S., Spada M., Maggiore G., Tisone G., Lenci I., Vennarecci G., Tortora R., Vivarelli M., Svegliati Baroni G., Zamboni F., Mameli L., Tafuri S., Simone S., Gesualdo L., Cardillo M., Di Leo A., Rendina, M, Barone, M, Lillo, C, Trapani, S, Masiero, L, Trerotoli, P, Puoti, F, Lupo, L, Tandoi, F, Agnes, S, Grieco, A, Andorno, E, Marenco, S, Giannini, E, Baccarani, U, Toniutto, P, Carraro, A, Colecchia, A, Cescon, M, Morelli, M, Cillo, U, Burra, P, Angeli, P, Colledan, M, Fagiuoli, S, De Carlis, L, Belli, L, De Simone, P, Carrai, P, Di Benedetto, F, De Maria, N, Ettorre, G, Giannelli, V, Gruttadauria, S, Volpes, R, Corsale, S, Mazzaferro, V, Bhoori, S, Romagnoli, R, Martini, S, Rossi, G, Caccamo, L, Donato, M, Rossi, M, Ginanni Corradini, S, Spada, M, Maggiore, G, Tisone, G, Lenci, I, Vennarecci, G, Tortora, R, Vivarelli, M, Svegliati Baroni, G, Zamboni, F, Mameli, L, Tafuri, S, Simone, S, Gesualdo, L, Cardillo, M, Di Leo, A, Rendina M., Barone M., Lillo C., Trapani S., Masiero L., Trerotoli P., Puoti F., Lupo L. G., Tandoi F., Agnes S., Grieco A., Andorno E., Marenco S., Giannini E. G., Baccarani U., Toniutto P., Carraro A., Colecchia A., Cescon M., Morelli M. C., Cillo U., Burra P., Angeli P., Colledan M., Fagiuoli S., De Carlis L., Belli L., De Simone P., Carrai P., Di Benedetto F., De Maria N., Ettorre G. M., Giannelli V., Gruttadauria S., Volpes R., Corsale S., Mazzaferro V., Bhoori S., Romagnoli R., Martini S., Rossi G., Caccamo L., Donato M. F., Rossi M., Ginanni Corradini S., Spada M., Maggiore G., Tisone G., Lenci I., Vennarecci G., Tortora R., Vivarelli M., Svegliati Baroni G., Zamboni F., Mameli L., Tafuri S., Simone S., Gesualdo L., Cardillo M., and Di Leo A.

Abstract

Introduction: The study of immune response to SARSCoV-2 infection in different solid organ transplant settings represents an opportunity for clarifying the interplay between SARS-CoV-2 and the immune system. In our nationwide registry study from Italy, we specifically evaluated, during the first wave pandemic, i.e., in non-vaccinated patients, COVID-19 prevalence of infection, mortality, and lethality in liver transplant recipients (LTRs), using non-liver solid transplant recipients (NL-SOTRs) and the Italian general population (GP) as comparators. Methods: Case collection started from February 21 to June 22, 2020, using the data from the National Institute of Health and National Transplant Center, whereas the data analysis was performed on September 30, 2020.To compare the sex- and age-adjusted distribution of infection, mortality, and lethality in LTRs, NL-SOTRs, and Italian GP we applied an indirect standardization method to determine the standardized rate. Results: Among the 43,983 Italian SOTRs with a functioning graft, LTRs accounted for 14,168 patients, of whom 89 were SARS-CoV-2 infected. In the 29,815 NL-SOTRs, 361 cases of SARS-CoV-2 infection were observed. The geographical distribution of the disease was highly variable across the different Italian regions. The standardized rate of infection, mortality, and lethality rates in LTRs resulted lower compared to NL-SOTRs [1.02 (95%CI 0.81-1.23) vs. 2.01 (95%CI 1.8-2.2); 1.0 (95%CI 0.5-1.5) vs. 4.5 (95%CI 3.6-5.3); 1.6 (95%CI 0.7-2.4) vs. 2.8 (95%CI 2.2-3.3), respectively] and comparable to the Italian GP. Discussion: According to the most recent studies on SOTRs and SARS-CoV-2 infection, our data strongly suggest that, in contrast to what was observed in NL-SOTRs receiving a similar immunosuppressive therapy, LTRs have the same risk of SARS-CoV-2 infection, mortality, and lethality observed in the general population. These results suggest an immune response to SARS-CoV-2 infection in LTRS that is different fr

Published
2023

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

Author

Cortesi, P, Vigano, R, Conti, S, Lenci, I, Volpes, R, Martini, S, Angelico, M, Fung, J, Buti, M, Coilly, A, Durand, F, Fondevila, C, Lebray, P, Nevens, F, Polak, W, Rizzetto, M, Zoulim, F, Perricone, G, Berenguer, M, Mantovani, L, Duvoux, C, Belli, L, Cortesi P. A., Vigano R., Conti S., Lenci I., Volpes R., Martini S., Angelico M., Fung J., Buti M., Coilly A., Durand F., Fondevila C., Lebray P., Nevens F., Polak W. G., Rizzetto M., Zoulim F., Perricone G., Berenguer M., Mantovani L. G., Duvoux C., Belli L. S., Cortesi, P, Vigano, R, Conti, S, Lenci, I, Volpes, R, Martini, S, Angelico, M, Fung, J, Buti, M, Coilly, A, Durand, F, Fondevila, C, Lebray, P, Nevens, F, Polak, W, Rizzetto, M, Zoulim, F, Perricone, G, Berenguer, M, Mantovani, L, Duvoux, C, Belli, L, Cortesi P. A., Vigano R., Conti S., Lenci I., Volpes R., Martini S., Angelico M., Fung J., Buti M., Coilly A., Durand F., Fondevila C., Lebray P., Nevens F., Polak W. G., Rizzetto M., Zoulim F., Perricone G., Berenguer M., Mantovani L. G., Duvoux C., and Belli L. S.

Abstract

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

Published
2023

4. Prophylaxis of HBV-recurrence after liver transplantation in patients with HCC: Risk of HCC recurrence from a large, multicentre retrospective study from Italy

Author

Battistella, S., primary, Zanetto, A., additional, Turco, L., additional, Manuli, C., additional, Pasulo, L., additional, Giannelli, V., additional, Mameli, L., additional, Ferrarese, A., additional, Marenco, S., additional, Ferri, F., additional, Lenci, I., additional, Scandali, G., additional, Biolato, M., additional, Fornasiere, E., additional, Ponziani, F.R., additional, Baroni, G. Svegliati, additional, Giannini, E., additional, Toniutto, P., additional, Lanza, A. Galeota, additional, Rendina, M., additional, Donato, F., additional, Fagiuoli, S., additional, De Maria, N., additional, Morelli, M. Cristina, additional, Martini, Silvia, additional, Trapani, S., additional, Grossi, P., additional, Aghemo, A., additional, Russo, F.P., additional, and Burra, P., additional

Published
2023
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5. Temporal trends of waitlistings for liver transplantation in Italy: The ECALITA (Evolution of IndiCAtion in LIver transplantation in ITAly) registry study

Author

Manzia, T, Trapani, S, Nardi, A, Ricci, A, Lenci, I, Milana, M, Angelico, R, De Feo, T, Agnes, S, Andorno, E, Baccarani, U, Carraro, A, Cescon, M, Cillo, U, Colledan, M, De Carlis, L, De Simone, P, Di Benedetto, F, Ettorre, G, Gruttadauria, S, Lupo, L, Mazzaferro, V, Romagnoli, R, Rossi, G, Rossi, M, Spada, M, Vennarecci, G, Vivarelli, M, Zamboni, F, Tisone, G, Cardillo, M, Angelico, M, Manzia T. M., Trapani S., Nardi A., Ricci A., Lenci I., Milana M., Angelico R., De Feo T. M., Agnes S., Andorno E., Baccarani U., Carraro A., Cescon M., Cillo U., Colledan M., De Carlis L., De Simone P., Di Benedetto F., Ettorre G. M., Gruttadauria S., Lupo L. G., Mazzaferro V., Romagnoli R., Rossi G., Rossi M., Spada M., Vennarecci G., Vivarelli M., Zamboni F., Tisone G., Cardillo M., Angelico M., Manzia, T, Trapani, S, Nardi, A, Ricci, A, Lenci, I, Milana, M, Angelico, R, De Feo, T, Agnes, S, Andorno, E, Baccarani, U, Carraro, A, Cescon, M, Cillo, U, Colledan, M, De Carlis, L, De Simone, P, Di Benedetto, F, Ettorre, G, Gruttadauria, S, Lupo, L, Mazzaferro, V, Romagnoli, R, Rossi, G, Rossi, M, Spada, M, Vennarecci, G, Vivarelli, M, Zamboni, F, Tisone, G, Cardillo, M, Angelico, M, Manzia T. M., Trapani S., Nardi A., Ricci A., Lenci I., Milana M., Angelico R., De Feo T. M., Agnes S., Andorno E., Baccarani U., Carraro A., Cescon M., Cillo U., Colledan M., De Carlis L., De Simone P., Di Benedetto F., Ettorre G. M., Gruttadauria S., Lupo L. G., Mazzaferro V., Romagnoli R., Rossi G., Rossi M., Spada M., Vennarecci G., Vivarelli M., Zamboni F., Tisone G., Cardillo M., and Angelico M.

Abstract

Background: Over the last decades relevant epidemiological changes of liver diseases have occurred, together with greatly improved treatment opportunities. Aim: To investigate how the indications for elective adult liver transplantation and the underlying disease etiologies have evolved in Italy. Methods: We recruited from the National Transplant Registry a cohort comprising 17,317 adults patients waitlisted for primary liver transplantation from January-2004 to December-2020. Patients were divided into three Eras:1(2004–2011),2(2012–2014) and 3(2015–2020). Results: Waitlistings for cirrhosis decreased from 65.9% in Era 1 to 46.1% in Era 3, while those for HCC increased from 28.7% to 48.7%. Comparing Eras 1 and 3, waitlistings for HCV-related cirrhosis decreased from 35.9% to 12.1%, yet those for HCV-related HCC increased from 8.5% to 26.7%. Waitlistings for HBV-related cirrhosis remained almost unchanged (13.2% and 12.4%), while those for HBV-related HCC increased from 4.0% to 11.6%. ALD-related cirrhosis decreased from 16.9% to 12.9% while ALD-related HCC increased from 1.9% to 3.9%. Conclusions: A sharp increase in liver transplant waitlisting for HCC and a concomitant decrease of waitlisting for cirrhosis have occurred In Italy. Despite HCV infection has noticeably decreased, still remains the primary etiology of waitlisting for HCC, while ALD and HBV represent the main causes for cirrhosis.

Published
2022

6. Safe pregnancy after liver transplantation: Evidence from a multicenter Italian collaborative study

Author

Sciarrone, S, Ferrarese, A, Bizzaro, D, Volpato, S, Donato, F, Invernizzi, F, Trespidi, L, Ramezzana, I, Avolio, A, Nure, E, Pascale, M, Fagiuoli, S, Pasulo, L, Merli, M, Lapenna, L, Toniutto, P, Lenci, I, Di Donato, R, De Maria, N, Villa, E, Galeota Lanza, A, Marenco, S, Bhoori, S, Mameli, L, Cillo, U, Boccagni, P, Russo, F, Bo, P, Cosmi, E, Burra, P, Sciarrone S. S., Ferrarese A., Bizzaro D., Volpato S., Donato F. M., Invernizzi F., Trespidi L., Ramezzana I. G., Avolio A. W., Nure E., Pascale M. M., Fagiuoli S., Pasulo L., Merli M., Lapenna L., Toniutto P., Lenci I., Di Donato R., De Maria N., Villa E., Galeota Lanza A., Marenco S., Bhoori S., Mameli L., Cillo U., Boccagni P., Russo F. P., Bo P., Cosmi E., Burra P., Sciarrone, S, Ferrarese, A, Bizzaro, D, Volpato, S, Donato, F, Invernizzi, F, Trespidi, L, Ramezzana, I, Avolio, A, Nure, E, Pascale, M, Fagiuoli, S, Pasulo, L, Merli, M, Lapenna, L, Toniutto, P, Lenci, I, Di Donato, R, De Maria, N, Villa, E, Galeota Lanza, A, Marenco, S, Bhoori, S, Mameli, L, Cillo, U, Boccagni, P, Russo, F, Bo, P, Cosmi, E, Burra, P, Sciarrone S. S., Ferrarese A., Bizzaro D., Volpato S., Donato F. M., Invernizzi F., Trespidi L., Ramezzana I. G., Avolio A. W., Nure E., Pascale M. M., Fagiuoli S., Pasulo L., Merli M., Lapenna L., Toniutto P., Lenci I., Di Donato R., De Maria N., Villa E., Galeota Lanza A., Marenco S., Bhoori S., Mameli L., Cillo U., Boccagni P., Russo F. P., Bo P., Cosmi E., and Burra P.

Abstract

Background: Women who have undergone liver transplantation (LT) enjoy better health, and possibility of childbearing. However, maternal and graft risks, optimal immunosuppression, and fetal outcome is still to clarify. Aim: Aim of the study was to assess outcomes of pregnancy after LT at national level. Methods: In 2019, under the auspices of the Permanent Transplant Committee of the Italian Association for the Study of the Liver, a multicenter survey including 14 Italian LT-centers was conducted aiming at evaluating the outcomes of recipients and newborns, and graft injury/function parameters during pregnancy in LT-recipients. Results: Sixty-two pregnancies occurred in 60 LT-recipients between 1990 and 2018. Median age at the time of pregnancy was 31-years and median time from transplantation to conception was 8-years. During pregnancy, 4 recipients experienced maternal complications with hospital admission. Live-birth-rate was 100%. Prematurity occurred in 25/62 newborns, and 8/62 newborns had low-birth-weight. Cyclosporine was used in 16 and Tacrolimus in 37 pregnancies, with no different maternal or newborn outcomes. Low-birth-weight was correlated to high values of AST, ALT and GGT. Conclusion: Pregnancy after LT has good outcome; however, maternal complications and prematurity may occur. Compliance with the immunosuppression is fundamental to ensure the stability of graft function and prevent graft-deterioration.

Published
2022

8. Nationwide survey of liver transplantation for Primary Sclerosing Cholangitis in Italy

Author

Morelli, M.C., primary, Gambato, M., additional, Martini, S., additional, Carrai, P., additional, Toniutto, P., additional, Giannelli, V., additional, Donato, F., additional, Lenci, I., additional, Pasulo, L., additional, Mazzarelli, C., additional, Ferrarese, A., additional, Rendina, M., additional, Grieco, A., additional, Lanza, A. Galeota, additional, Svegliati-Baroni, G., additional, De Maria, N., additional, Marenco, S., additional, Mameli, L., additional, and Burra, P., additional

Published
2023
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9. HDV epidemic in Central Italy is stable over the last two decades and is characterized by the circulation of multiple HDV sub-genotypes 1 inducing different inflammatory stimuli

Author

Salpini, R., primary, Piermatteo, L., additional, Torre, G., additional, D'Anna, S., additional, Khan, S., additional, Duca, L., additional, Bertoli, A., additional, Malagnino, V., additional, Paba, P., additional, Ciotti, M., additional, Lenci, I., additional, Francioso, S., additional, Paquazzi, C., additional, Lichtner, M., additional, Mastroianni, C., additional, Santopaolo, F., additional, De Sanctis, G., additional, Marignani, M., additional, Pellicelli, A., additional, Galati, G., additional, Moretti, A., additional, Colucci, G., additional, Casinelli, K., additional, Caterini, L., additional, Iapadre, N., additional, Parruti, G., additional, Vecchiet, I., additional, Paoloni, M., additional, Grelli, S., additional, Ceccherini-Silberstein, F., additional, Sarmati, L., additional, and Svicher, V., additional

Published
2023
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10. Individualized HBIG withdrawal in an historical cohort of liver transplant recipients in Italy

Author

Viganò, R., primary, Lenci, I., additional, Carrai, P., additional, Volpes, R., additional, Martini, S., additional, Donato, MF., additional, Mazzarelli, C., additional, Farina, E., additional, Cocchis, D., additional, Perricone, G., additional, Pasulo, L., additional, Becchetti, C., additional, De Simone, P., additional, Romagnoli, R., additional, Fagiuoli, S., additional, Milana, M., additional, Petruccelli, S., additional, Baiocchi, L., additional, Di Benedetto, C., additional, Loglio, A., additional, D'Amico, F., additional, and Belli, L.S., additional

Published
2023
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11. The role of antiplatelet therapies on incidence and mortality of hepatocellular carcinoma

Author

Lai, Quirino, De Matthaeis, Nicoletta, Finotti, Michele, Galati, Giovanni, Marrone, Giuseppe, Melandro, Fabio, Morisco, Filomena, Nicolini, Daniele, Pravisani, Riccardo, Giannini, Edoardo G, Aglitti, A, Aliberti, C, Baccarani, U, Bhoori, S, Borzio, M, Brancaccio, G, Burra, P, Cabibbo, G, Casadei Gardini, A, Carrai, P, Cillo, U, Conti, F, Cucchetti, A, D'Ambrosio, R, Dell'Unto, C, Di Costanzi, Gg, Di Sandro, S, Foschi, Fg, Fucilli, F, Gambato, M, Gasbarrini, Antonio, Giuliante, Felice, Ghinolfi, D, Grieco, Antonio, Gruttaduria, S, Guarino, M, Kostandini, A, Iavarone, M, Lenci, I, Levi Sandri, Gb, Losito, F, Lupo, Lg, Manzia, Tm, Mazzocato, S, Mescoli, C, Miele, Luca, Muley, M, Persico, M, Plaz Torres, Mc, Pompili, Maurizio, Ponziani, Francesca Romana, Rapaccini, Gian Ludovico, Rendina, M, Renzulli, M, Rossi, Marco, Rreka, E, Russo, Fp, Sacco, R, Sangiovanni, A, Sessa, A, Simonetti, N, Sposito, C, Tortora, R, Trevisani, F, Viganò, L, Viganò, M, Villa, E, Vincenzi, V, Violi, P, Vitale, A, Gasbarrini, A (ORCID:0000-0002-7278-4823), Giuliante, F (ORCID:0000-0001-9517-8220), Grieco, A (ORCID:0000-0002-0544-8993), Miele, L (ORCID:0000-0003-3464-0068), Pompili, M (ORCID:0000-0001-6699-7980), Ponziani, FR (ORCID:0000-0002-5924-6238), Rapaccini, GL (ORCID:0000-0002-6467-857X), Rossi, M (ORCID:0000-0002-4539-5670), Lai, Quirino, De Matthaeis, Nicoletta, Finotti, Michele, Galati, Giovanni, Marrone, Giuseppe, Melandro, Fabio, Morisco, Filomena, Nicolini, Daniele, Pravisani, Riccardo, Giannini, Edoardo G, Aglitti, A, Aliberti, C, Baccarani, U, Bhoori, S, Borzio, M, Brancaccio, G, Burra, P, Cabibbo, G, Casadei Gardini, A, Carrai, P, Cillo, U, Conti, F, Cucchetti, A, D'Ambrosio, R, Dell'Unto, C, Di Costanzi, Gg, Di Sandro, S, Foschi, Fg, Fucilli, F, Gambato, M, Gasbarrini, Antonio, Giuliante, Felice, Ghinolfi, D, Grieco, Antonio, Gruttaduria, S, Guarino, M, Kostandini, A, Iavarone, M, Lenci, I, Levi Sandri, Gb, Losito, F, Lupo, Lg, Manzia, Tm, Mazzocato, S, Mescoli, C, Miele, Luca, Muley, M, Persico, M, Plaz Torres, Mc, Pompili, Maurizio, Ponziani, Francesca Romana, Rapaccini, Gian Ludovico, Rendina, M, Renzulli, M, Rossi, Marco, Rreka, E, Russo, Fp, Sacco, R, Sangiovanni, A, Sessa, A, Simonetti, N, Sposito, C, Tortora, R, Trevisani, F, Viganò, L, Viganò, M, Villa, E, Vincenzi, V, Violi, P, Vitale, A, Gasbarrini, A (ORCID:0000-0002-7278-4823), Giuliante, F (ORCID:0000-0001-9517-8220), Grieco, A (ORCID:0000-0002-0544-8993), Miele, L (ORCID:0000-0003-3464-0068), Pompili, M (ORCID:0000-0001-6699-7980), Ponziani, FR (ORCID:0000-0002-5924-6238), Rapaccini, GL (ORCID:0000-0002-6467-857X), and Rossi, M (ORCID:0000-0002-4539-5670)

Abstract

Aim To evaluate the impact of antiplatelet therapy (APT)on the incidence of hepatocellular carcinoma (HCC) and mortality following its treatment. Methods A systematic literature search was performed using PubMed and Cochrane Central Register of Controlled Trials Databases. Two HCC clinical settings were explored: (i) incidence, and (ii) death after any HCC treatment. Odds ratios (OR) and 95% confidence intervals (95%CI) were calculated to compare the pooled data between patients who received or did not receive APT. Results A total of 20 studies were identified, of whom 15 focused on HCC incidence, including 2,685,009 patients, and five on post-treatment death, including 3281 patients. APT was associated with an overall reduced risk of HCC incidence (OR: 0.63; 95%CI = 0.51-0.79; p < 0.001) as well as of post-treatment mortality (OR: 0.54; 95%CI = 0.35-0.83; p = 0.006). Conclusions Current data suggest that APT correlated with higher HCC incidence and poor overall survival following tumour treatment.

Published
2023

12. The role of antiplatelet therapies on incidence and mortality of hepatocellular carcinoma

Author

Lai, Q., De Matthaeis, N., Finotti, M., Galati, G., Marrone, G., Melandro, F., Morisco, F., Nicolini, D., Pravisani, R., Giannini, E. G., Aglitti, A., Aliberti, C., Baccarani, U., Bhoori, S., Borzio, M., Brancaccio, G., Burra, P., Cabibbo, G., Casadei Gardini, A., Carrai, P., Cillo, U., Conti, F., Cucchetti, A., D'Ambrosio, R., Dell'Unto, C., Di Costanzo, G. G., Di Sandro, S., Foschi, F. G., Fucilli, F., Gambato, M., Gasbarrini, A., Giuliante, F., Ghinolfi, D., Grieco, A., Gruttaduria, S., Guarino, M., Kostandini, A., Iavarone, M., Lenci, I., Levi Sandri, G. B., Losito, F., Lupo, L. G., Manzia, T. M., Mazzocato, S., Mescoli, C., Miele, L., Muley, M., Persico, M., Plaz Torres, M. C., Pompili, M., Ponziani, F. R., Rapaccini, G. L., Rendina, M., Renzulli, M., Rossi, M., Rreka, E., Russo, F. P., Sacco, R., Sangiovanni, A., Sessa, A., Simonetti, N., Sposito, C., Tortora, R., Trevisani, F., Vigano, L., Vigano, M., Villa, E., Vincenzi, V., Violi, P., and Vitale, A.

Subjects
clopidogrel, aspirin, Clinical Biochemistry, incidence, occurrence, survival, General Medicine, Biochemistry, Settore MED/18
Abstract

To evaluate the impact of antiplatelet therapy (APT)on the incidence of hepatocellular carcinoma (HCC) and mortality following its treatment.A systematic literature search was performed using PubMed and Cochrane Central Register of Controlled Trials Databases. Two HCC clinical settings were explored: (i) incidence, and (ii) death after any HCC treatment. Odds ratios (OR) and 95% confidence intervals (95%CI) were calculated to compare the pooled data between patients who received or did not receive APT.A total of 20 studies were identified, of whom 15 focused on HCC incidence, including 2,685,009 patients, and five on post-treatment death, including 3281 patients. APT was associated with an overall reduced risk of HCC incidence (OR: 0.63; 95%CI = 0.51-0.79; p 0.001) as well as of post-treatment mortality (OR: 0.54; 95%CI = 0.35-0.83; p = 0.006).Current data suggest that APT correlated with higher HCC incidence and poor overall survival following tumour treatment.

Published
2023

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

Author

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

Published
2014
Full Text
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14. Resistance analysis and treatment outcomes in hepatitis C virus genotype 3-infected patients within the Italian network VIRONET-C

Author

Di Maio, V, Barbaliscia, S, Teti, E, Fiorentino, G, Milana, M, Paolucci, S, Pollicino, T, Morsica, G, Starace, M, Bruzzone, B, Gennari, W, Micheli, V, Yu La Rosa, K, Foroghi, L, Calvaruso, V, Lenci, I, Polilli, E, Babudieri, S, Aghemo, A, Raimondo, G, Sarmati, L, Coppola, N, Pasquazzi, C, Baldanti, F, Parruti, G, Perno, C, Angelico, M, Craxi, A, Andreoni, M, Ceccherini-Silberstein, F, Andreone, P, Aragri, M, Bertoli, A, Boeri, E, Brancaccio, G, Brunetto, M, Callegaro, A, Cenderello, G, Cento, V, Ciaccio, A, Ciancio, A, Cuomo, N, De Santis, A, Di Biagio, A, Di Marco, V, Di Perri, G, Di Stefano, M, Gaeta, G, Ghisetti, V, Gulminetti, R, Lampertico, P, Landonio, S, Lichtner, M, Lleo, A, Maida, I, Marenco, S, Masetti, C, Mastroianni, C, Minichini, C, Milano, E, Monno, L, Novati, S, Pace Palitti, V, Paternoster, C, Pellicelli, A, Pieri, A, Puoti, M, Rizzardini, G, Ruggiero, T, Rossetti, B, Sangiovanni, V, Santantonio, T, Taliani, G, Toniutto, P, Vullo, V, Zazzi, M, Di Maio V. C., Barbaliscia S., Teti E., Fiorentino G., Milana M., Paolucci S., Pollicino T., Morsica G., Starace M., Bruzzone B., Gennari W., Micheli V., Yu La Rosa K., Foroghi L., Calvaruso V., Lenci I., Polilli E., Babudieri S., Aghemo A., Raimondo G., Sarmati L., Coppola N., Pasquazzi C., Baldanti F., Parruti G., Perno C. F., Angelico M., Craxi A., Andreoni M., Ceccherini-Silberstein F., Andreone P., Aragri M., Bertoli A., Boeri E., Brancaccio G., Brunetto M., Callegaro A. P., Cenderello G., Cento V., Ciaccio A., Ciancio A., Cuomo N., De Santis A., Di Biagio A., Di Marco V., Di Perri G., Di Stefano M. A., Gaeta G. B., Ghisetti V., Gulminetti R., Lampertico P., Landonio S., Lichtner M., Lleo A., Maida I., Marenco S., Masetti C., Mastroianni C., Minichini C., Milano E., Monno L., Novati S., Pace Palitti V., Paternoster C., Pellicelli A., Pieri A., Puoti M., Rizzardini G., Ruggiero T., Rossetti B., Sangiovanni V., Santantonio T., Taliani G., Toniutto P., Vullo V., Zazzi M., Di Maio, V, Barbaliscia, S, Teti, E, Fiorentino, G, Milana, M, Paolucci, S, Pollicino, T, Morsica, G, Starace, M, Bruzzone, B, Gennari, W, Micheli, V, Yu La Rosa, K, Foroghi, L, Calvaruso, V, Lenci, I, Polilli, E, Babudieri, S, Aghemo, A, Raimondo, G, Sarmati, L, Coppola, N, Pasquazzi, C, Baldanti, F, Parruti, G, Perno, C, Angelico, M, Craxi, A, Andreoni, M, Ceccherini-Silberstein, F, Andreone, P, Aragri, M, Bertoli, A, Boeri, E, Brancaccio, G, Brunetto, M, Callegaro, A, Cenderello, G, Cento, V, Ciaccio, A, Ciancio, A, Cuomo, N, De Santis, A, Di Biagio, A, Di Marco, V, Di Perri, G, Di Stefano, M, Gaeta, G, Ghisetti, V, Gulminetti, R, Lampertico, P, Landonio, S, Lichtner, M, Lleo, A, Maida, I, Marenco, S, Masetti, C, Mastroianni, C, Minichini, C, Milano, E, Monno, L, Novati, S, Pace Palitti, V, Paternoster, C, Pellicelli, A, Pieri, A, Puoti, M, Rizzardini, G, Ruggiero, T, Rossetti, B, Sangiovanni, V, Santantonio, T, Taliani, G, Toniutto, P, Vullo, V, Zazzi, M, Di Maio V. C., Barbaliscia S., Teti E., Fiorentino G., Milana M., Paolucci S., Pollicino T., Morsica G., Starace M., Bruzzone B., Gennari W., Micheli V., Yu La Rosa K., Foroghi L., Calvaruso V., Lenci I., Polilli E., Babudieri S., Aghemo A., Raimondo G., Sarmati L., Coppola N., Pasquazzi C., Baldanti F., Parruti G., Perno C. F., Angelico M., Craxi A., Andreoni M., Ceccherini-Silberstein F., Andreone P., Aragri M., Bertoli A., Boeri E., Brancaccio G., Brunetto M., Callegaro A. P., Cenderello G., Cento V., Ciaccio A., Ciancio A., Cuomo N., De Santis A., Di Biagio A., Di Marco V., Di Perri G., Di Stefano M. A., Gaeta G. B., Ghisetti V., Gulminetti R., Lampertico P., Landonio S., Lichtner M., Lleo A., Maida I., Marenco S., Masetti C., Mastroianni C., Minichini C., Milano E., Monno L., Novati S., Pace Palitti V., Paternoster C., Pellicelli A., Pieri A., Puoti M., Rizzardini G., Ruggiero T., Rossetti B., Sangiovanni V., Santantonio T., Taliani G., Toniutto P., Vullo V., and Zazzi M.

Abstract

Aim: This study aimed to investigate the role of resistance-associated substitutions (RASs) to direct-acting-antivirals (DAAs) in HCV genotype 3 (GT3). Methods: Within the Italian VIRONET-C network, a total of 539 GT3-infected patients (417 DAA-naïve and 135 DAA-failures, of them, 13 at both baseline and failure) were analysed. Sanger sequencing of NS3/NS5A/NS5B was performed following home-made protocols. Results: The majority of patients were male (79.4%), 91.4% were injection drug users, 49.3% were cirrhotic and 13.9% were HIV co-infected. Phylogenetic analysis classified sequences as GT3a-b-g-h (98%-0.4%-0.2%-1.2%) respectively. Overall, 135 patients failed a DAA regimen: sofosbuvir (SOF)/daclatasvir (DCV) or velpatasvir (VEL)±ribavirin (RBV) (N = 91/15) and glecaprevir (G)/pibrentasvir (P) (N = 9). Moreover, 14.8% of patients were treated with suboptimal regimens for GT3: 3D ± RBV (Paritaprevir/r + Ombitasvir+Dasabuvir, N = 15), SOF + Simeprevir (SIM) (N = 1) or SOF/Ledipasvir (LDV) ± RBV (N = 4). RAS prevalence was 15.8% in DAA-naïve patients. At failure, 81.5% patients showed at least one RAS: 11/25 (44.0%) in NS3, 109/135 (80.7%) in NS5A, 7/111 (6.3%) in NS5B SOF-failures. In NS5A-failures, Y93H RAS was the most prevalent (68.5% vs 5.1% DAA-naïve, P <.001) followed by A30K (12.7% vs 2.8% in DAA-naïve, P <.001). Analysing baseline samples, a higher prevalence of NS5A-RASs was observed before treatment in DAA-failures (5/13, 38.5%) vs DAA-naïves (61/393, 15.5%, P =.04). Regarding 228 DAA-naïve patients with an available outcome, 93.9% achieved a SVR. Interestingly, patients with baseline Y93H and/or A30K had SVR rate of 72.2% vs 95.7% for patients without NS5A-RASs (P =.002). Conclusions: In this real-life GT3 cohort, the majority of failures harboured resistant variants carrying NS5A-RASs, the most frequent being Y93H. The presence of natu

Published
2021

15. Overview of prognostic systems for hepatocellular carcinoma and ITA.LI.CA external validation of MESH and CNLC classifications

Author

Vitale, A, Farinati, F, Finotti, M, Di Renzo, C, Brancaccio, G, Piscaglia, F, Cabibbo, G, Caturelli, E, Missale, G, Marra, F, Sacco, R, Giannini, E, Trevisani, F, Cillo, U, Bhoori, S, Borzio, M, Burra, P, Casadei Gardini, A, Carrai, P, Conti, F, Cozzolongo, R, Cucchetti, A, D'Ambrosio, R, Dell'Unto, C, De Matthaeis, N, Di Costanzo, G, Di Sandro, S, Famularo, S, Foschi, F, Fucilli, F, Galati, G, Gambato, M, Gasbarrini, A, Giuliante, F, Ghinolfi, D, Grieco, A, Gruttadauria, S, Guarino, M, Iavarone, M, Kostandini, A, Lai, Q, Lenci, I, Levi Sandri, G, Losito, F, Lupo, L, Marasco, G, Manzia, T, Mazzocato, S, Masarone, M, Melandro, F, Mescoli, C, Miele, L, Morisco, F, Muley, M, Nicolini, D, Pagano, D, Persico, M, Pompili, M, Ponziani, F, Pravisani, R, Rapaccini, G, Rendina, M, Renzulli, M, Romano, F, Rossi, M, Rreka, E, Russo, F, Sangiovanni, A, Sessa, A, Simonetti, N, Sposito, C, Tortora, R, Vigano, L, Vigano, M, Villa, E, Vincenzi, V, Violi, P, Azzaroli, F, Brunetto, M, Di Marco, A, Masotto, A, Mega, A, Nardone, G, Oliveri, F, Raimondo, G, Svegliati Baroni, G, Vidili, G, Zoli, M, Vitale A., Farinati F., Finotti M., Di Renzo C., Brancaccio G., Piscaglia F., Cabibbo G., Caturelli E., Missale G., Marra F., Sacco R., Giannini E. G., Trevisani F., Cillo U., Bhoori S., Borzio M., Burra P., Casadei Gardini A., Carrai P., Conti F., Cozzolongo R., Cucchetti A., D'ambrosio R., Dell'unto C., De Matthaeis N., Di Costanzo G. G., Di Sandro S., Famularo S., Foschi F. G., Fucilli F., Galati G., Gambato M., Gasbarrini A., Giuliante F., Ghinolfi D., Grieco A., Gruttadauria S., Guarino M., Iavarone M., Kostandini A., Lai Q., Lenci I., Levi Sandri G. V., Losito F., Lupo L. G., Marasco G., Manzia T. M., Mazzocato S., Masarone M., Melandro F., Mescoli C., Miele L., Morisco F., Muley M., Nicolini D., Pagano D., Persico M., Pompili M., Ponziani F. R., Pravisani R., Rapaccini G. L., Rendina M., Renzulli M., Romano F., Rossi M., Rreka E., Russo F. P., Sangiovanni A., Sessa A., Simonetti N., Sposito C., Tortora R., Vigano L., Vigano M., Villa E., Vincenzi V., Violi P., Azzaroli F., Brunetto M. R., Di Marco A., Masotto A., Mega A., Nardone G., Oliveri F., Raimondo G., Svegliati Baroni G., Vidili G., Zoli M., Vitale, A, Farinati, F, Finotti, M, Di Renzo, C, Brancaccio, G, Piscaglia, F, Cabibbo, G, Caturelli, E, Missale, G, Marra, F, Sacco, R, Giannini, E, Trevisani, F, Cillo, U, Bhoori, S, Borzio, M, Burra, P, Casadei Gardini, A, Carrai, P, Conti, F, Cozzolongo, R, Cucchetti, A, D'Ambrosio, R, Dell'Unto, C, De Matthaeis, N, Di Costanzo, G, Di Sandro, S, Famularo, S, Foschi, F, Fucilli, F, Galati, G, Gambato, M, Gasbarrini, A, Giuliante, F, Ghinolfi, D, Grieco, A, Gruttadauria, S, Guarino, M, Iavarone, M, Kostandini, A, Lai, Q, Lenci, I, Levi Sandri, G, Losito, F, Lupo, L, Marasco, G, Manzia, T, Mazzocato, S, Masarone, M, Melandro, F, Mescoli, C, Miele, L, Morisco, F, Muley, M, Nicolini, D, Pagano, D, Persico, M, Pompili, M, Ponziani, F, Pravisani, R, Rapaccini, G, Rendina, M, Renzulli, M, Romano, F, Rossi, M, Rreka, E, Russo, F, Sangiovanni, A, Sessa, A, Simonetti, N, Sposito, C, Tortora, R, Vigano, L, Vigano, M, Villa, E, Vincenzi, V, Violi, P, Azzaroli, F, Brunetto, M, Di Marco, A, Masotto, A, Mega, A, Nardone, G, Oliveri, F, Raimondo, G, Svegliati Baroni, G, Vidili, G, Zoli, M, Vitale A., Farinati F., Finotti M., Di Renzo C., Brancaccio G., Piscaglia F., Cabibbo G., Caturelli E., Missale G., Marra F., Sacco R., Giannini E. G., Trevisani F., Cillo U., Bhoori S., Borzio M., Burra P., Casadei Gardini A., Carrai P., Conti F., Cozzolongo R., Cucchetti A., D'ambrosio R., Dell'unto C., De Matthaeis N., Di Costanzo G. G., Di Sandro S., Famularo S., Foschi F. G., Fucilli F., Galati G., Gambato M., Gasbarrini A., Giuliante F., Ghinolfi D., Grieco A., Gruttadauria S., Guarino M., Iavarone M., Kostandini A., Lai Q., Lenci I., Levi Sandri G. V., Losito F., Lupo L. G., Marasco G., Manzia T. M., Mazzocato S., Masarone M., Melandro F., Mescoli C., Miele L., Morisco F., Muley M., Nicolini D., Pagano D., Persico M., Pompili M., Ponziani F. R., Pravisani R., Rapaccini G. L., Rendina M., Renzulli M., Romano F., Rossi M., Rreka E., Russo F. P., Sangiovanni A., Sessa A., Simonetti N., Sposito C., Tortora R., Vigano L., Vigano M., Villa E., Vincenzi V., Violi P., Azzaroli F., Brunetto M. R., Di Marco A., Masotto A., Mega A., Nardone G., Oliveri F., Raimondo G., Svegliati Baroni G., Vidili G., and Zoli M.

Abstract

Prognostic assessment in patients with HCC remains an extremely difficult clinical task due to the complexity of this cancer where tumour characteristics interact with degree of liver dysfunction, patient general health status, and a large span of available treatment options. Several prognostic systems have been proposed in the last three decades, both from the Asian and European/North American countries. Prognostic scores, such as the CLIP score and the recent MESH score, have been generated on a solid statistical basis from real life population data, while staging systems, such as the BCLC scheme and the recent CNLC classification, have been created by experts according to recent HCC prognostic evidences from the literature. A third category includes combined prognostic systems that can be used both as prognostic scores and staging systems. A recent example is the ITA.LI.CA prognostic system including either a prognostic score and a simplified staging system. This review focuses first on an overview of the main prognostic systems for HCC classified according to the above three categories, and, second, on a comprehensive description of the methodology required for a correct comparison between different systems in terms of prognostic performance. In this second section the main studies in the literature comparing different prognostic systems are described in detail. Lastly, a formal comparison between the last prognostic systems proposed for each of the above three categories is performed using a large Italian database including 6882 HCC patients in order to concretely apply the comparison rules previously described.

Published
2021

16. Correction to: Immunosuppressive regimens for adult liver transplant recipients in real-life practice: consensus recommendations from an Italian Working Group (Hepatology International, (2020), 14, 6, (930-943), 10.1007/s12072-020-10091-5)

Author

Cillo U., Cillo, U, De Carlis, L, Del Gaudio, M, De Simone, P, Fagiuoli, S, Lupo, F, Tisone, G, Volpes, R, Avolio, A, Bitetto, D, Boccagni, P, Carraro, A, Castellaneta, A, Colledan, M, De Maria, N, Di Benedetto, F, Lanza, A, Gardini, I, Guglielmo, N, Invernizzi, F, Laurenzi, A, Leandro, G, Lenci, I, Lorenzin, D, Mameli, L, Manzia, T, Mariani, A, Mennini, G, Mirabella, S, Morelli, M, Nicolini, D, Petruccelli, S, Regalia, E, Reggiani, P, Roselli, S, Zamboni, F, Cillo U., De Carlis L., Del Gaudio M., De Simone P., Fagiuoli S., Lupo F., Tisone G., Volpes R., Avolio A., Bitetto D., Boccagni P., Carraro A., Castellaneta A., Colledan M., De Maria N., Di Benedetto F., Lanza A. G., Gardini I., Guglielmo N., Invernizzi F., Laurenzi A., Leandro G., Lenci I., Lorenzin D., Mameli L., Manzia T. M., Mariani A., Mennini G., Mirabella S., Morelli M. C., Nicolini D., Petruccelli S., Regalia E., Reggiani P., Roselli S., Zamboni F., Cillo U., Cillo, U, De Carlis, L, Del Gaudio, M, De Simone, P, Fagiuoli, S, Lupo, F, Tisone, G, Volpes, R, Avolio, A, Bitetto, D, Boccagni, P, Carraro, A, Castellaneta, A, Colledan, M, De Maria, N, Di Benedetto, F, Lanza, A, Gardini, I, Guglielmo, N, Invernizzi, F, Laurenzi, A, Leandro, G, Lenci, I, Lorenzin, D, Mameli, L, Manzia, T, Mariani, A, Mennini, G, Mirabella, S, Morelli, M, Nicolini, D, Petruccelli, S, Regalia, E, Reggiani, P, Roselli, S, Zamboni, F, Cillo U., De Carlis L., Del Gaudio M., De Simone P., Fagiuoli S., Lupo F., Tisone G., Volpes R., Avolio A., Bitetto D., Boccagni P., Carraro A., Castellaneta A., Colledan M., De Maria N., Di Benedetto F., Lanza A. G., Gardini I., Guglielmo N., Invernizzi F., Laurenzi A., Leandro G., Lenci I., Lorenzin D., Mameli L., Manzia T. M., Mariani A., Mennini G., Mirabella S., Morelli M. C., Nicolini D., Petruccelli S., Regalia E., Reggiani P., Roselli S., and Zamboni F.

Abstract

In the original publication of this article, after the name of the last author, the wording on behalf of the Italian Liver Transplant Working Group is missing.

Published
2021

17. Resistance analysis and treatment outcomes in hepatitis C virus genotype 3-infected patients within the Italian network VIRONET-C

Author

Di Maio, V. C., Barbaliscia, S., Teti, E., Fiorentino, G., Milana, M., Paolucci, S., Pollicino, T., Morsica, G., Starace, M., Bruzzone, B., Gennari, W., Micheli, V., Yu La Rosa, K., Foroghi, L., Calvaruso, V., Lenci, I., Polilli, E., Babudieri, S., Aghemo, A., Raimondo, G., Sarmati, L., Coppola, N., Pasquazzi, C., Baldanti, F., Parruti, G., Perno, C. F., Angelico, M., Craxi, A., Andreoni, M., Ceccherini-Silberstein, F., Andreone, P., Aragri, M., Bertoli, A., Boeri, E., Brancaccio, G., Brunetto, M., Callegaro, A. P., Cenderello, G., Cento, V., Ciaccio, A., Ciancio, A., Cuomo, N., De Santis, A., Di Biagio, A., Di Marco, V., Di Perri, G., Di Stefano, M. A., Gaeta, G. B., Ghisetti, V., Gulminetti, R., Lampertico, P., Landonio, S., Lichtner, M., Lleo, A., Maida, I., Marenco, S., Masetti, C., Mastroianni, C., Minichini, C., Milano, E., Monno, L., Novati, S., Pace Palitti, V., Paternoster, C., Pellicelli, A., Pieri, A., Puoti, M., Rizzardini, G., Ruggiero, T., Rossetti, B., Sangiovanni, V., Santantonio, T., Taliani, G., Toniutto, P., Vullo, V., Zazzi, M., Di Maio, V, Barbaliscia, S, Teti, E, Fiorentino, G, Milana, M, Paolucci, S, Pollicino, T, Morsica, G, Starace, M, Bruzzone, B, Gennari, W, Micheli, V, Yu La Rosa, K, Foroghi, L, Calvaruso, V, Lenci, I, Polilli, E, Babudieri, S, Aghemo, A, Raimondo, G, Sarmati, L, Coppola, N, Pasquazzi, C, Baldanti, F, Parruti, G, Perno, C, Angelico, M, Craxi, A, Andreoni, M, Ceccherini-Silberstein, F, Andreone, P, Aragri, M, Bertoli, A, Boeri, E, Brancaccio, G, Brunetto, M, Callegaro, A, Cenderello, G, Cento, V, Ciaccio, A, Ciancio, A, Cuomo, N, De Santis, A, Di Biagio, A, Di Marco, V, Di Perri, G, Di Stefano, M, Gaeta, G, Ghisetti, V, Gulminetti, R, Lampertico, P, Landonio, S, Lichtner, M, Lleo, A, Maida, I, Marenco, S, Masetti, C, Mastroianni, C, Minichini, C, Milano, E, Monno, L, Novati, S, Pace Palitti, V, Paternoster, C, Pellicelli, A, Pieri, A, Puoti, M, Rizzardini, G, Ruggiero, T, Rossetti, B, Sangiovanni, V, Santantonio, T, Taliani, G, Toniutto, P, Vullo, V, Zazzi, M, Di Maio, Vc, Perno, Cf, Craxì, A, Di Maio V.C., Barbaliscia S., Teti E., Fiorentino G., Milana M., Paolucci S., Pollicino T., Morsica G., Starace M., Bruzzone B., Gennari W., Micheli V., Yu La Rosa K., Foroghi L., Calvaruso V., Lenci I., Polilli E., Babudieri S., Aghemo A., Raimondo G., Sarmati L., Coppola N., Pasquazzi C., Baldanti F., Parruti G., Perno C.F., Angelico M., Craxi A., Andreoni M., Ceccherini-Silberstein F., Andreone P., Aragri M., Bertoli A., Boeri E., Brancaccio G., Brunetto M., Callegaro A.P., Cenderello G., Cento V., Ciaccio A., Ciancio A., Cuomo N., De Santis A., Di Biagio A., Di Marco V., Di Perri G., Di Stefano M.A., Gaeta G.B., Ghisetti V., Gulminetti R., Lampertico P., Landonio S., Lichtner M., Lleo A., Maida I., Marenco S., Masetti C., Mastroianni C., Minichini C., Milano E., Monno L., Novati S., Pace Palitti V., Paternoster C., Pellicelli A., Pieri A., Puoti M., Rizzardini G., Ruggiero T., Rossetti B., Sangiovanni V., Santantonio T., Taliani G., Toniutto P., Vullo V., and Zazzi M.

Subjects
Male, Sofosbuvir, Sustained Virologic Response, Drug Resistance, Hepacivirus, Viral Nonstructural Proteins, Gastroenterology, Settore MED/06, direct-acting antivirals, failure, genotype 3, HCV, resistance, chemistry.chemical_compound, 0302 clinical medicine, Medicine, Viral, Chronic, Phylogeny, Dasabuvir, hcv, virus diseases, Hepatitis C, Pibrentasvir, Italy, 030220 oncology & carcinogenesis, Combination, Drug Therapy, Combination, 030211 gastroenterology & hepatology, Female, medicine.drug, Ledipasvir, medicine.medical_specialty, Daclatasvir, Genotype, Antiviral Agents, Drug Resistance, Viral, Humans, Hepatitis C, Chronic, 03 medical and health sciences, Drug Therapy, Internal medicine, Antiviral Agent, direct-acting antiviral, Hepaciviru, Hepatology, business.industry, Viral Nonstructural Protein, Glecaprevir, direct acting antivirals, Regimen, chemistry, Paritaprevir, business
Abstract

Aim: This study aimed to investigate the role of resistance-associated substitutions (RASs) to direct-acting-antivirals (DAAs) in HCV genotype 3 (GT3). Methods: Within the Italian VIRONET-C network, a total of 539 GT3-infected patients (417 DAA-naïve and 135 DAA-failures, of them, 13 at both baseline and failure) were analysed. Sanger sequencing of NS3/NS5A/NS5B was performed following home-made protocols. Results: The majority of patients were male (79.4%), 91.4% were injection drug users, 49.3% were cirrhotic and 13.9% were HIV co-infected. Phylogenetic analysis classified sequences as GT3a-b-g-h (98%-0.4%-0.2%-1.2%) respectively. Overall, 135 patients failed a DAA regimen: sofosbuvir (SOF)/daclatasvir (DCV) or velpatasvir (VEL)±ribavirin (RBV) (N=91/15) and glecaprevir (G)/pibrentasvir (P) (N=9). Moreover, 14.8% of patients were treated with suboptimal regimens for GT3: 3D±RBV (Paritaprevir/r+Ombitasvir+Dasabuvir, N=15), SOF+Simeprevir (SIM) (N=1) or SOF/Ledipasvir (LDV)±RBV (N=4). RAS prevalence was 15.8% in DAA-naïve patients. At failure, 81.5% patients showed at least one RAS: 11/25 (44.0%) in NS3, 109/135 (80.7%) in NS5A, 7/111 (6.3%) in NS5B SOF-failures. In NS5A-failures, Y93H RAS was the most prevalent (68.5% vs 5.1% DAA-naïve, P&nbsp

Published
2021

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

Author

Di Maio, V. C., Cento, V., Di Paolo, D., Aragri, M., De Leonardis, F., Tontodonati, M., Micheli, V., Bellocchi, M. C., Antonucci, F. P., Bertoli, A., Lenci, I., Milana, M., Gianserra, L., Melis, M., Di Biagio, A., Sarrecchia, C., Sarmati, L., Landonio, S., Francioso, S., Lambiase, L., Nicolini, L. A., Marenco, S., Nosotti, L., Giannelli, V., Siciliano, M., Romagnoli, D., Pellicelli, A., Vecchiet, J., Magni, C. F., Babudieri, S., Mura, M. S., Taliani, G., Mastroianni, C., Vespasiani-Gentilucci, U., Romano, M., Morisco, F., Gasbarrini, A., Vullo, V., Bruno, S., Baiguera, C., Pasquazzi, C., Tisone, G., Picciotto, A., Andreoni, M., Parruti, G., Rizzardini, G., Angelico, M., Perno, C. F., Ceccherini-Silberstein, F., Mariani, R., Paoloni, M., Iapadre, N., Grimaldi, A., Menzaghi, B., Quirino, T., Vecchiet, J., Bruzzone, B., De Maria, A., Di Biagio, A., Marenco, S., Nicolini, L. A., Picciotto, A., Viscoli, C., Casinelli, K., Monache, M. Delle, Lichtner, M., Mastroianni, C., Aghemo, A., Bruno, S., Cerrone, M., Colombo, M., Monforte, A. DʼArminio, Danieli, E., Donato, F., Gubertini, G., Landonio, S., Magni, C. F., Mancon, A., Micheli, V., Monico, S., Niero, F., Puoti, M., Rizzardini, G., Russo, M. L., Alfieri, R., Gnocchi, M., Orro, A., Milanesi, L., Baldelli, E., Bertolotti, M., Borghi, V., Mussini, C., Romagnoli, D., Brancaccio, G., Caporaso, N., Gaeta, G. B., Lembo, V., Morisco, F., Calvaruso, V., Craxì, A., Di Marco, V., Mazzola, A., Petta, S., DʼAmico, E., Cacciatore, P., Consorte, A., Palitti, V. Pace, Parruti, G., Pieri, A., Polilli, E., Tontodonati, M., Andreoni, M., Angelico, M., Antenucci, F., Antonucci, F. P., Aragri, M., Armenia, D., Baiocchi, L., Bellocchi, M., Bertoli, A., Biliotti, E., Biolato, M., Carioti, L., Ceccherini-Silberstein, F., Cento, V., Cerasari, G., Cerva, C., Ciotti, M., DʼAmbrosio, C., DʼEttorre, G., De Leonardis, F., De Sanctis, A., Di Maio, V. C., Di Paolo, D., Francioso, S., Furlan, C., Gallo, P., Gasbarrini, A., Giannelli, V., Gianserra, L., Grieco, A., Grieco, S., Lambiase, L., Lattanzi, B., Lenci, I., Malagnino, V., Manuelli, M., Merli, M., Miglioresi, L., Milana, M., Nosotti, L., Palazzo, D., Pasquazzi, C., Pellicelli, A., Perno, C. F., Romano, M., Santopaolo, F., Santoro, M. M., Sarmati, L., Sarrecchia, C., Sforza, D., Siciliano, M., Sorbo, M. C., Spaziante, M., Svicher, V., Taliani, G., Teti, E., Tisone, G., Vespasiani-Gentilucci, U., Vullo, V., Mangia, A., Babudieri, S., Maida, I., Melis, M., Mura, M. S., Falconi, L., Di Giammartino, D., and Tarquini, P.

Published
2016
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19. Long‐term outcomes of direct acting antivirals in post‐transplant advanced hepatitis C virus recurrence and fibrosing cholestatic hepatitis

Author

Vukotic, R., Conti, F., Fagiuoli, S., Morelli, M. C., Pasulo, L., Colpani, M., Foschi, F. G., Berardi, S., Pianta, P., Mangano, M., Donato, M. F., Malinverno, F., Monico, S., Tamè, M., Mazzella, G., Belli, L. S., Viganò, R., Carrai, P., Burra, P., Russo, F. P., Lenci, I., Toniutto, P., Merli, M., Loiacono, L., Iemmolo, R., Degli Antoni, A. M., Romano, A., Picciotto, A., Rendina, M., and Andreone, P.

Published
2017
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20. SARS-CoV-2 infection in liver transplantation is associated with favorable outcomes: an Italian transplant registry study

Author

Rendina, M., primary, Barone, M., additional, Trapani, S., additional, Masiero, L., additional, Trerotoli, P., additional, Puoti, F., additional, Lupo, L.G., additional, Agnes, S., additional, Grieco, A., additional, Andorno, E., additional, Marenco, S., additional, Baccarani, U., additional, Toniutto, P., additional, Carraro, A., additional, Colecchia, A., additional, Cescon, M., additional, Morelli, M.C., additional, Cillo, U., additional, Burra, P., additional, Angeli, P., additional, Colledan, M., additional, Fagiuoli, S., additional, De Carlis, L., additional, Belli, L., additional, De Simone, P., additional, Carrai, P., additional, Di Benedetto, F., additional, De Maria, N., additional, Ettorre, G.M., additional, Giannelli, V., additional, Gruttadauria, S., additional, Volpes, R., additional, Mazzaferro, V., additional, Bhoori, S., additional, Romagnoli, R., additional, Martini, S., additional, Rossi, G., additional, Donato, F., additional, Rossi, M., additional, Ginanni Corradini, S., additional, Spada, M., additional, Maggiore, G., additional, Tisone, G., additional, Lenci, I., additional, Vennarecci, G., additional, Di Costanzo, G.G., additional, Vivarelli, M., additional, Svegliati Baroni, G., additional, Zamboni, F. o, additional, Mameli, L., additional, Tafuri, S., additional, Simone, S., additional, Gesualdo, L., additional, Cardillo, M., additional, and Di Leo, A., additional

Published
2022
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21. Renal Function, Adherence and Quality of Life Improvement After Conversion From Immediate to Prolonged-Release Tacrolimus in Liver Transplantation: Prospective Ten-Year Follow-Up Study

Author

Toti, L, Manzia, Tm, Blasi, F, Lenci, I, Baiocchi, L, Toschi, N, and Tisone, G

Subjects
Transplantation, immunosuppression, liver transplantation, quality of life, adherence, Tacrolimus, Settore MED/18
Abstract

Immunosuppression non-adherence is a major cause of graft failure after liver transplantation. The aim of this study was to evaluate practice surrounding conversion from immediate-release to prolonged-release Tacrolimus formulation and to assess patient adherence and quality of life (QoL). One hundred and seven adult liver transplant recipients, receiving immediate-release Tacrolimus for a minimum of 6 months, were converted to prolonged-release formulation, based on a dose ratio of one (1:1). The median follow-up was 120 [IQR, 120–123] months. Tacrolimus dosage and blood level, liver and renal function, lipid and glucose profiles were recorded. In addition, questionnaires were submitted to evaluate adherence and QoL following conversion. No rejection was recorded. The median serum Tacrolimus blood level decreased over 1 month (5.80, [IQR, 2.0–10.8] vs. 3.8 [IQR, 1.4–8.7]; p < 0.0005). Significant improvement in renal function was noted (median GFR was 81.7 [IQR, 43.4–128.6] vs. 73.9 [IQR, 27.1–130.2]; p = 0.0002). At the end of the follow-up, conversion resulted in an overall decrease in non-adherence of 53.3% (p = 0.0001) and an improvement in QoL was reported by 76.2% of patients. Thus, 1:1 conversion from immediate to prolonged-release Tacrolimus is safe, feasible and efficient, avoiding under-therapeutic and toxic peak concentrations, improving renal function, adherence to immunosuppression and overall patient QoL.

Published
2022

24. Development of a model based on case-mix analysis to predict 6-month patient survival after liver transplantation: a multicenter Italian study

Author

Avolio, A, Lai, Q, Franco, A, Bianco, G, Calia, R, Spoletini, G, Agnes, S, Grieco, A, Rossi, M, Corradini, S, Vivarelli, M, Benedetti, A, Lupo, L, Rendina, M, Colledan, M, Fagiuoli, S, Cescon, M, Donato, C, Zamboni, F, Mameli, L, De Carlis, L, Belli, L, Rossi, G, Donato, F, Mazzaferro, V, Bhoori, S, Di Benedetto, F, De Maria, N, Santaniello, W, Di Costanzo, G, Gruttadauria, S, Volpes, R, De Simone, P, Carrai, P, Spada, M, Nobile, V, Ettorre, G, Giannelli, V, Tisone, G, Lenci, I, Romagnoli, R, Martini, S, Risaliti, A, Toniutto, P, Tedeschi, U, Carraro, A, Burra, P, Cillo, U, Avolio A, Lai Q, Franco A, Bianco G, Calia R, Spoletini G, Agnes S, Grieco A, Rossi M, Corradini SG, Vivarelli M, Benedetti A, Lupo L, Rendina M, Colledan M, Fagiuoli S, Cescon M, Donato C, Zamboni F, Mameli L, De Carlis L, Belli L, Rossi G, Donato F, Mazzaferro V, Bhoori S, Di Benedetto F, De Maria N, Santaniello W, Di Costanzo G, Gruttadauria S, Volpes R, De Simone P, Carrai P, Spada M, Nobile V, Ettorre G, Giannelli V, Tisone G, Lenci I, Romagnoli R, Martini S, Risaliti A, Toniutto P, Tedeschi U, Carraro A, Burra P, Cillo U, Avolio, A, Lai, Q, Franco, A, Bianco, G, Calia, R, Spoletini, G, Agnes, S, Grieco, A, Rossi, M, Corradini, S, Vivarelli, M, Benedetti, A, Lupo, L, Rendina, M, Colledan, M, Fagiuoli, S, Cescon, M, Donato, C, Zamboni, F, Mameli, L, De Carlis, L, Belli, L, Rossi, G, Donato, F, Mazzaferro, V, Bhoori, S, Di Benedetto, F, De Maria, N, Santaniello, W, Di Costanzo, G, Gruttadauria, S, Volpes, R, De Simone, P, Carrai, P, Spada, M, Nobile, V, Ettorre, G, Giannelli, V, Tisone, G, Lenci, I, Romagnoli, R, Martini, S, Risaliti, A, Toniutto, P, Tedeschi, U, Carraro, A, Burra, P, Cillo, U, Avolio A, Lai Q, Franco A, Bianco G, Calia R, Spoletini G, Agnes S, Grieco A, Rossi M, Corradini SG, Vivarelli M, Benedetti A, Lupo L, Rendina M, Colledan M, Fagiuoli S, Cescon M, Donato C, Zamboni F, Mameli L, De Carlis L, Belli L, Rossi G, Donato F, Mazzaferro V, Bhoori S, Di Benedetto F, De Maria N, Santaniello W, Di Costanzo G, Gruttadauria S, Volpes R, De Simone P, Carrai P, Spada M, Nobile V, Ettorre G, Giannelli V, Tisone G, Lenci I, Romagnoli R, Martini S, Risaliti A, Toniutto P, Tedeschi U, Carraro A, Burra P, and Cillo U

Published
2019

25. Different perceptions of sustainable case-mix for liver transplantation between surgeons and hepatologists: an Italian multicenter study

Author

Calia, R, Avolio, A, Luciani, M, Franco, A, Lai, Q, Vivarelli, M, Benedetti, A, Lupo, L, Rendina, M, Colledan, M, Fagiuoli, S, Cescon, M, Morelli, C, Zamboni, F, Mameli, L, De Carlis, L, Belli, L, Rossi, G, Donato, F, Mazzaferro, V, Bhoori, S, Di Benedetto, F, De Maria, N, Santaniello, W, Costanzo, G, Gruttadauria, S, Volpes, R, De Simone, P, Carrai, P, Spada, M, Nobile, V, Agnes, S, Grieco, A, Spoletini, G, Ettorre, G, Giannelli, V, Tisone, G, Lenci, I, Rossi, M, Corradini, S, Romagnoli, R, Martini, S, Risaliti, A, Toniutto, P, Tedeschi, U, Carrao, A, Burra, P, Cillo, U, Calia R, Avolio A, Luciani M, Franco A, Lai Q, Vivarelli M, Benedetti A, Lupo L, Rendina M, Colledan M, Fagiuoli S, Cescon M, Morelli C, Zamboni F, Mameli L, De Carlis L, Belli L, Rossi G, Donato F, Mazzaferro V, Bhoori S, Di Benedetto F, De Maria N, Santaniello W, Costanzo G, Gruttadauria S, Volpes R, De Simone P, Carrai P, Spada M, Nobile V, Agnes S, Grieco A, Spoletini G, Ettorre G, Giannelli V, Tisone G, Lenci I, Rossi M, Corradini SG, Romagnoli R, Martini S, Risaliti A, Toniutto P, Tedeschi U, Carrao A, Burra P, Cillo U, Calia, R, Avolio, A, Luciani, M, Franco, A, Lai, Q, Vivarelli, M, Benedetti, A, Lupo, L, Rendina, M, Colledan, M, Fagiuoli, S, Cescon, M, Morelli, C, Zamboni, F, Mameli, L, De Carlis, L, Belli, L, Rossi, G, Donato, F, Mazzaferro, V, Bhoori, S, Di Benedetto, F, De Maria, N, Santaniello, W, Costanzo, G, Gruttadauria, S, Volpes, R, De Simone, P, Carrai, P, Spada, M, Nobile, V, Agnes, S, Grieco, A, Spoletini, G, Ettorre, G, Giannelli, V, Tisone, G, Lenci, I, Rossi, M, Corradini, S, Romagnoli, R, Martini, S, Risaliti, A, Toniutto, P, Tedeschi, U, Carrao, A, Burra, P, Cillo, U, Calia R, Avolio A, Luciani M, Franco A, Lai Q, Vivarelli M, Benedetti A, Lupo L, Rendina M, Colledan M, Fagiuoli S, Cescon M, Morelli C, Zamboni F, Mameli L, De Carlis L, Belli L, Rossi G, Donato F, Mazzaferro V, Bhoori S, Di Benedetto F, De Maria N, Santaniello W, Costanzo G, Gruttadauria S, Volpes R, De Simone P, Carrai P, Spada M, Nobile V, Agnes S, Grieco A, Spoletini G, Ettorre G, Giannelli V, Tisone G, Lenci I, Rossi M, Corradini SG, Romagnoli R, Martini S, Risaliti A, Toniutto P, Tedeschi U, Carrao A, Burra P, and Cillo U

Published
2019

26. THE CASE-MIX IN LIVER TRANSPLANTATION. DIFFERENT PERCEPTIONS (TRANSPLANT SURGEONS AND TRANSPLANT HEPATOLOGISTS) AND DIFFERENT CONCORDANCE LEVELS WITHIN CENTERS

Author

Calia, R, Avolio, A, Luciani, M, Franco, A, Lai, Q, Vivarelli, M, Benedetti, A, Lupo, L, Rendina, M, Colledan, M, Fagiuoli, S, Cescon, M, Morelli, C, Zamboni, F, Mameli, L, De Carlis, L, Belli, L, Rossi, G, Donato, F, Mazzaferro, V, Bhoori, S, Di Benedetto, F, De Maria, N, Santaniello, W, Di Costanzo, G, Gruttadauria, S, Volpes, R, De Simone, P, Carrai, P, Spada, M, Nobile, V, Agnes, S, Grieco, A, Spoletini, G, Ettorre, G, Giannelli, V, Tisone, G, Lenci, I, Rossi, M, Corradini, S, Romagnoli, R, Martini, S, Risaliti, A, Toniutto, P, Tedeschi, U, Carraro, A, Burra, P, Cillo, U, Calia R, Avolio A, Luciani M, Franco A, Lai Q, Vivarelli M, Benedetti A, Lupo L, Rendina M, Colledan M, Fagiuoli S, Cescon M, Morelli C, Zamboni F, Mameli L, De Carlis L, Belli LS, Rossi G, Donato F, Mazzaferro V, Bhoori S, Di Benedetto F, De Maria N, Santaniello W, Di Costanzo G, Gruttadauria S, Volpes R, De Simone P, Carrai P, Spada M, Nobile V, Agnes S, Grieco A, Spoletini G, Ettorre G, Giannelli V, Tisone G, Lenci I, Rossi M, Corradini SG, Romagnoli R, Martini S, Risaliti A, Toniutto P, Tedeschi U, Carraro A, Burra P, Cillo U, Calia, R, Avolio, A, Luciani, M, Franco, A, Lai, Q, Vivarelli, M, Benedetti, A, Lupo, L, Rendina, M, Colledan, M, Fagiuoli, S, Cescon, M, Morelli, C, Zamboni, F, Mameli, L, De Carlis, L, Belli, L, Rossi, G, Donato, F, Mazzaferro, V, Bhoori, S, Di Benedetto, F, De Maria, N, Santaniello, W, Di Costanzo, G, Gruttadauria, S, Volpes, R, De Simone, P, Carrai, P, Spada, M, Nobile, V, Agnes, S, Grieco, A, Spoletini, G, Ettorre, G, Giannelli, V, Tisone, G, Lenci, I, Rossi, M, Corradini, S, Romagnoli, R, Martini, S, Risaliti, A, Toniutto, P, Tedeschi, U, Carraro, A, Burra, P, Cillo, U, Calia R, Avolio A, Luciani M, Franco A, Lai Q, Vivarelli M, Benedetti A, Lupo L, Rendina M, Colledan M, Fagiuoli S, Cescon M, Morelli C, Zamboni F, Mameli L, De Carlis L, Belli LS, Rossi G, Donato F, Mazzaferro V, Bhoori S, Di Benedetto F, De Maria N, Santaniello W, Di Costanzo G, Gruttadauria S, Volpes R, De Simone P, Carrai P, Spada M, Nobile V, Agnes S, Grieco A, Spoletini G, Ettorre G, Giannelli V, Tisone G, Lenci I, Rossi M, Corradini SG, Romagnoli R, Martini S, Risaliti A, Toniutto P, Tedeschi U, Carraro A, Burra P, and Cillo U

Published
2019

27. Platelets and hepatocellular cancer: Bridging the bench to the clinics

Author

Lai, aEmail Author, Q., Vitale, bEmail Author, A., Manzia, cEmail Author, T. M., Foschi, dEmail Author, F. G., Sandri, eEmail Author, G. B. L., Gambato, bEmail Author, M., Melandro, fEmail Author, F., Russo, bEmail Author, F. P., Miele, gEmail Author, L., Viganò, hEmail Author, L., Burra, bEmail Author, P., Giannini, iEmail Author, E. G., Aliberti, C., Baccarani, U., Bhoori, S., Borzio, M., Brancaccio, G., Cabibbo, G., Casadei, Gardini, Carrai, A., Cillo, P., Conti, U., Cucchetti, F., D’Ambrosio, A., Dell’Unto, R., Dematthaeis, C., Costanzo, Di, G. G., Di Sandro, S., Fucilli, F., Galati, G., Gasbarrini, A., Giuliante, F., Ghinolfi, D., Grieco, A., Gruttaduria, S., Guarino, M., Kostandini, A., Iavarone, M., Lenci, I., Losito, F., Lupo, L. G., Mazzocato, S., Mescoli, C., Miele, L., Morisco, F., Muley, M., Nicolini, D., Persico, M., Pompili, M., Ponziani, F. R., Pravisani, R., Rapaccini, G. L., Rendina, M., Renzulli, M., Rossi, M., Rreka, E., Sacco, R., Sangiovanni, A., Sessa, A., Simonetti, N., Sposito, C., Tortora, R., Trevisani, F., Viganò, M., Villa, E., Vincenzi, V., Violi, P., Associazione Italiana per lo Studio del Fegato (AISF) HCC Special Interest Group, Lai, Q., aEmail Author, Vitale, A., bEmail Author, Manzia, T. M., cEmail Author, Foschi, F. G., dEmail Author, Sandri, G. B. L., eEmail Author, Gambato, M., bEmail Author, Melandro, F., fEmail Author, Russo, F. P., bEmail Author, Miele, L., gEmail Author, Viganò, L., hEmail Author, Burra, P., bEmail Author, Giannini, E. G., iEmail Author, Aliberti, C., Baccarani, U., Bhoori, S., Borzio, M., Brancaccio, G., Cabibbo, G., Casadei, Gardini, A., Carrai, P., Cillo, U., Conti, F., Cucchetti, A., D’Ambrosio, R., Dell’Unto, C., Dematthaei, Di, Costanzo, G., G., Di Sandro, S., Fucilli, F., Galati, G., Gasbarrini, A., Giuliante, F., Ghinolfi, D., Grieco, A., Gruttaduria, S., Guarino, M., Kostandini, A., Iavarone, M., Lenci, I., Losito, F., Lupo, L. G., Mazzocato, S., Mescoli, C., Miele, L., Morisco, F., Muley, M., Nicolini, D., Persico, M., Pompili, M., Ponziani, F. R., Pravisani, R., Rapaccini, G. L., Rendina, M., Renzulli, M., Rossi, M., Rreka, E., Sacco, R., Sangiovanni, A., Sessa, A., Simonetti, N., Sposito, C., Tortora, R., Trevisani, F., Viganò, M., Villa, E., Vincenzi, V., Violi, P., Associazione Italiana per lo Studio del Fegato (AISF) HCC Special Interest, Group, Lai Q., Vitale A., Manzia T.M., Foschi F.G., Sandri G.B.L., Gambato M., Melandro F., Russo F.P., Miele L., Vigano L., Burra P., Giannini E.G., Aglitti A., Aliberti C., Baccarani U., Bhoori S., Borzio M., Brancaccio G., Cabibbo G., Casadei Gardini A., Carrai P., Cillo U., Conti F., Cucchetti A., D'ambrosio R., Dell'unto C., Dematthaeis N., Di Costanzo G.G., Di Sandro S., Fucilli F., Galati G., Gasbarrini A., Giuliante F., Ghinolfi D., Grieco A., Gruttaduria S., Guarino M., Kostandini A., Iavarone M., Lenci I., Losito F., Lupo L.G., Mazzocato S., Mescoli C., Morisco F., Muley M., Nicolini D., Persico M., Pompili M., Ponziani F.R., Pravisani R., Rapaccini G.L., Rendina M., Renzulli M., Rossi M., Rreka E., Sacco R., Sangiovanni A., Sessa A., Simonetti N., Sposito C., Tortora R., Trevisani F., Vigano M., Villa E., Vincenzi V., Violi P., Lai, Q., Vitale, A., Manzia, T. M., Foschi, F. G., Sandri, G. B. L., Gambato, M., Melandro, F., Russo, F. P., Vigano, L., Burra, P., Giannini, E. G., Casadei Gardini, A., Carrai, P., Cillo, U., Conti, F., Cucchetti, A., D'Ambrosio, R., Dell'Unto, C., Dematthaeis, N., Di Costanzo, G. G., and Vigano, M.

Subjects
Cancer Research, Integrins, Platelet-derived growth factor, Endothelium, Settore MED/12 - GASTROENTEROLOGIA, medicine.medical_treatment, Integrin, Review, lcsh:RC254-282, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Platelet-to-lymphocyte ratio, Selectins, Vascular endothelial growth factor, medicine, Platelet, Selectin, business.industry, Growth factor, lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens, Extravasation, Settore MED/01, medicine.anatomical_structure, Oncology, chemistry, Tumor progression, 030220 oncology & carcinogenesis, Cancer research, 030211 gastroenterology & hepatology, business
Abstract

Growing interest is recently being focused on the role played by the platelets in favoring hepatocellular cancer (HCC) growth and dissemination. The present review reports in detail both the experimental and clinical evidence published on this topic. Several growth factors and angiogenic molecules specifically secreted by platelets are directly connected with tumor progression and neo-angiogenesis. Among them, we can list the platelet-derived growth factor, the vascular endothelial growth factor, the endothelial growth factor, and serotonin. Platelets are also involved in tumor spread, favoring endothelium permeabilization and tumor cells' extravasation and survival in the bloodstream. From the bench to the clinics, all of these aspects were also investigated in clinical series, showing an evident correlation between platelet count and size of HCC, tumor biological behavior, metastatic spread, and overall survival rates. Moreover, a better understanding of the mechanisms involved in the platelet-tumor axis represents a paramount aspect for optimizing both current tumor treatment and development of new therapeutic strategies against HCC. Growing interest is recently being focused on the role played by the platelets in favoring hepatocellular cancer (HCC) growth and dissemination. The present review reports in detail both the experimental and clinical evidence published on this topic. Several growth factors and angiogenic molecules specifically secreted by platelets are directly connected with tumor progression and neo-angiogenesis. Among them, we can list the platelet-derived growth factor, the vascular endothelial growth factor, the endothelial growth factor, and serotonin. Platelets are also involved in tumor spread, favoring endothelium permeabilization and tumor cells’ extravasation and survival in the bloodstream. From the bench to the clinics, all of these aspects were also investigated in clinical series, showing an evident correlation between platelet count and size of HCC, tumor biological behavior, metastatic spread, and overall survival rates. Moreover, a better understanding of the mechanisms involved in the platelet–tumor axis represents a paramount aspect for optimizing both current tumor treatment and development of new therapeutic strategies against HCC.

Published
2019

29. Sarco-Model: A score to predict the dropout risk in the perspective of organ allocation in patients awaiting liver transplantation

Author

Lai, Q., Magistri, P., Lionetti, R., Avolio, A. W., Lenci, I., Giannelli, V., Pecchi, A., Ferri, F., Marrone, G., Angelico, M., Milana, M., Schinnina, V., Menozzi, R., Di Martino, M., Grieco, A., Manzia, T. M., Tisone, G., Agnes, S., Rossi, M., Di Benedetto, F., Ettorre, G. M., Curci, F. P., Giovanardi, F., Mennini, G., Ginanni Corradini, S., Merli, M., Guidetti, C., Assirati, G., Po, L., Prampolini, F., De Maria, N., D'Offizi, G., Cina, A., Barbieri, P., Biolato, M., Pascale, M. M., Pellicelli, A., Falasca, F., Colasanti, M., and Levi Sandri, G. B.

Subjects
MELDNa, Adult, Liver Cirrhosis, Futile transplant, medicine.medical_specialty, futility, Sarcopenia, Cirrhosis, Waiting Lists, medicine.medical_treatment, Settore MED/18 - CHIRURGIA GENERALE, Allocation, Futility, malnutrition, Liver transplantation, Liver Transplant, dropout, Severity of Illness Index, sarcopenia, End Stage Liver Disease, 03 medical and health sciences, Liver disease, 0302 clinical medicine, allocation, Internal medicine, medicine, Humans, Dropout (neural networks), Outcome, Hepatology, business.industry, cirrhosis, Area under the curve, Score, Prognostic Index, medicine.disease, Prognosis, MELD, Liver Transplantation, Transplantation, 030220 oncology & carcinogenesis, Population study, 030211 gastroenterology & hepatology, adult, humans, liver cirrhosis, prognosis, severity of illness index, waiting lists, end stage liver disease, liver transplantation, business
Abstract

BACKGROUND & AIMS Sarcopenia in liver transplantation (LT) cirrhotic candidates has been connected with higher dropouts and graft losses after transplant. The study aims to create an 'urgency' model combining sarcopenia and Model for End-stage Liver Disease Sodium (MELDNa) to predict the risk of dropout and identify an appropriate threshold of post-LT futility. METHODS A total of 1087 adult cirrhotic patients were listed for a first LT during January 2012 to December 2018. The study population was split into a training (n = 855) and a validation set (n = 232). RESULTS Using a competing-risk analysis of cause-specific hazards, we created the Sarco-Model2 . According to the model, one extra point of MELDNa was added for each 0.5 cm2 /m2 reduction of total psoas area (TPA)

Published
2021

30. Correction to: Immunosuppressive regimens for adult liver transplant recipients in real-life practice: consensus recommendations from an Italian Working Group (Hepatology International, (2020), 14, 6, (930-943), 10.1007/s12072-020-10091-5)

Author

Cillo, U, De Carlis, L, Del Gaudio, M, De Simone, P, Fagiuoli, S, Lupo, F, Tisone, G, Volpes, R, Avolio, A, Bitetto, D, Boccagni, P, Carraro, A, Castellaneta, A, Colledan, M, De Maria, N, Di Benedetto, F, Lanza, Ag, Gardini, I, Guglielmo, N, Invernizzi, F, Laurenzi, A, Leandro, G, Lenci, I, Lorenzin, D, Mameli, L, Manzia, Tm, Mariani, A, Mennini, G, Mirabella, S, Morelli, Mc, Nicolini, D, Petruccelli, S, Regalia, E, Reggiani, P, Roselli, S, and Zamboni, F

Subjects
Settore MED/18
Published
2021

33. THE CASE-MIX IN LIVER TRANSPLANTATION. DIFFERENT PERCEPTIONS (TRANSPLANT SURGEONS AND TRANSPLANT HEPATOLOGISTS) AND DIFFERENT CONCORDANCE LEVELS WITHIN CENTERS

Author

Calia, R., Avolio, A., Luciani, M., Franco, Antonio, Lai, Q., Vivarelli, M., Benedetti, A., Lupo, L., Rendina, M., Colledan, Michele, Fagiuoli, S., Cescon, M., Morelli, C., Zamboni, F., Mameli, L., Carlis, Luciano, Belli, Luca Saverio, Rossi, G., Donato, F., Mazzaferro, V., Bhoori, S., Di Benedetto, Fabrizio, Maria, N., Santaniello, W., Di Costanzo, G., Gruttadauria, Salvatore, Volpes, R., Paolo De Simone, Carrai, Paola, Spada, M., Nobile, V., Agnes, S., Grieco, Antonio, Spoletini, G., Ettorre, G., Giannelli, Valerio, Tisone, G., Lenci, I., Rossi, M., Corradini, S. Ginanni, Romagnoli, R., Martini, S., Risaliti, A., Toniutto, P., Tedeschi, U., Carraro, A., Burra, Patrizia, Cillo, Umberto, Calia, R, Avolio, A, Luciani, M, Franco, A, Lai, Q, Vivarelli, M, Benedetti, A, Lupo, L, Rendina, M, Colledan, M, Fagiuoli, S, Cescon, M, Morelli, C, Zamboni, F, Mameli, L, De Carlis, L, Belli, L, Rossi, G, Donato, F, Mazzaferro, V, Bhoori, S, Di Benedetto, F, De Maria, N, Santaniello, W, Di Costanzo, G, Gruttadauria, S, Volpes, R, De Simone, P, Carrai, P, Spada, M, Nobile, V, Agnes, S, Grieco, A, Spoletini, G, Ettorre, G, Giannelli, V, Tisone, G, Lenci, I, Rossi, M, Corradini, S, Romagnoli, R, Martini, S, Risaliti, A, Toniutto, P, Tedeschi, U, Carraro, A, Burra, P, and Cillo, U

Subjects
LIVER TRANSPLANTATION
Published
2019

34. Pregnancy after liver transplantation: a survey from Italian liver transplants centres

Author

Sciarrone, S.S., primary, Ferrarese, A., additional, Volpato, S., additional, Donato, M.F., additional, Invernizzi, F., additional, Trespidi, L., additional, Ramezzana, I.G., additional, Avolio, A.W., additional, Nure, E., additional, Pascale, M.M., additional, Fagiuoli, S., additional, Pasulo, L., additional, Merli, M., additional, Lapenna, L., additional, Toniutto, P., additional, Lenci, I., additional, Donato, R. Di, additional, De Maria, N., additional, Villa, E., additional, Lanza, A. Galeota, additional, Marenco, S., additional, Bhoori, S., additional, Mameli, L., additional, Cillo, U., additional, Boccagni, P., additional, Russo, F.P., additional, Bo, P., additional, Cosmi, E., additional, and Burra, P., additional

Published
2021
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35. Prevalence of Single and Multiple Natural NS3, NS5A and NS5B Resistance-Associated Substitutions in Hepatitis C Virus Genotypes 1-4 in Italy

Author

Bertoli, A, Sorbo, M, Aragri, M, Lenci, I, Teti, E, Polilli, E, Di Maio, V, Gianserra, L, Biliotti, E, Masetti, C, Magni, C, Babudieri, S, Nicolini, L, Milana, M, Cacciatore, P, Sarmati, L, Pellicelli, A, Paolucci, S, Craxi, A, Morisco, F, Palitti, V, Siciliano, M, Coppola, N, Iapadre, N, Puoti, M, Rizzardini, G, Taliani, G, Pasquazzi, C, Andreoni, M, Parruti, G, Angelico, M, Perno, C, Cento, V, Ceccherini-Silberstein, F, Andreone, P, Baldanti, F, Barbarini, G, Boccaccio, V, Boglione, L, Bolis, M, Bonora, S, Borghi, V, Brancaccio, G, Bruno, S, Bruzzone, B, Calvaruso, V, Caporaso, N, Ciaccio, A, Ciancio, A, Colombatto, P, Cozzolongo, R, D'Ambrosio, C, D'Ettorre, G, De Leonardis, F, De Luca, A, Di Biagio, A, Di Perri, G, Francioso, S, Gaeta, G, Gasbarrini, A, Ghisetti, V, Giorgini, A, Grieco, A, Gubertini, G, Gulminetti, R, Lambiase, L, Landonio, S, Lichtner, M, Maida, I, Marenco, S, Marinaro, L, Maserati, R, Melis, M, Menzaghi, B, Meregalli, E, Micheli, V, Niero, F, Paoloni, M, Pieri, A, Rendina, M, Romagnoli, D, Rossetti, B, Ruggiero, T, Sangiovanni, V, Starace, M, Sticchi, L, Tarquini, P, Toniutto, P, Vullo, V, Zazzi, M, Bertoli A., Sorbo M. C., Aragri M., Lenci I., Teti E., Polilli E., Di Maio V. C., Gianserra L., Biliotti E., Masetti C., Magni C. F., Babudieri S., Nicolini L. A., Milana M., Cacciatore P., Sarmati L., Pellicelli A., Paolucci S., Craxi A., Morisco F., Palitti V. P., Siciliano M., Coppola N., Iapadre N., Puoti M., Rizzardini G., Taliani G., Pasquazzi C., Andreoni M., Parruti G., Angelico M., Perno C. F., Cento V., Ceccherini-Silberstein F., Andreone P., Baldanti F., Barbarini G., Boccaccio V., Boglione L., Bolis M., Bonora S., Borghi V., Brancaccio G., Bruno S., Bruzzone B., Calvaruso V., Caporaso N., Ciaccio A., Ciancio A., Colombatto P., Cozzolongo R., D'Ambrosio C., D'Ettorre G., De Leonardis F., De Luca A., Di Biagio A., Di Perri G., Francioso S., Gaeta G. B., Gasbarrini A., Ghisetti V., Giorgini A., Grieco A., Gubertini G., Gulminetti R., Lambiase L., Landonio S., Lichtner M., Maida I., Marenco S., Marinaro L., Maserati R., Melis M., Menzaghi B., Meregalli E., Micheli V., Niero F., Paoloni M., Pieri A., Rendina M., Romagnoli D., Rossetti B., Ruggiero T., Sangiovanni V., Starace M., Sticchi L., Tarquini P., Toniutto P., Vullo V., Zazzi M., Bertoli, A, Sorbo, M, Aragri, M, Lenci, I, Teti, E, Polilli, E, Di Maio, V, Gianserra, L, Biliotti, E, Masetti, C, Magni, C, Babudieri, S, Nicolini, L, Milana, M, Cacciatore, P, Sarmati, L, Pellicelli, A, Paolucci, S, Craxi, A, Morisco, F, Palitti, V, Siciliano, M, Coppola, N, Iapadre, N, Puoti, M, Rizzardini, G, Taliani, G, Pasquazzi, C, Andreoni, M, Parruti, G, Angelico, M, Perno, C, Cento, V, Ceccherini-Silberstein, F, Andreone, P, Baldanti, F, Barbarini, G, Boccaccio, V, Boglione, L, Bolis, M, Bonora, S, Borghi, V, Brancaccio, G, Bruno, S, Bruzzone, B, Calvaruso, V, Caporaso, N, Ciaccio, A, Ciancio, A, Colombatto, P, Cozzolongo, R, D'Ambrosio, C, D'Ettorre, G, De Leonardis, F, De Luca, A, Di Biagio, A, Di Perri, G, Francioso, S, Gaeta, G, Gasbarrini, A, Ghisetti, V, Giorgini, A, Grieco, A, Gubertini, G, Gulminetti, R, Lambiase, L, Landonio, S, Lichtner, M, Maida, I, Marenco, S, Marinaro, L, Maserati, R, Melis, M, Menzaghi, B, Meregalli, E, Micheli, V, Niero, F, Paoloni, M, Pieri, A, Rendina, M, Romagnoli, D, Rossetti, B, Ruggiero, T, Sangiovanni, V, Starace, M, Sticchi, L, Tarquini, P, Toniutto, P, Vullo, V, Zazzi, M, Bertoli A., Sorbo M. C., Aragri M., Lenci I., Teti E., Polilli E., Di Maio V. C., Gianserra L., Biliotti E., Masetti C., Magni C. F., Babudieri S., Nicolini L. A., Milana M., Cacciatore P., Sarmati L., Pellicelli A., Paolucci S., Craxi A., Morisco F., Palitti V. P., Siciliano M., Coppola N., Iapadre N., Puoti M., Rizzardini G., Taliani G., Pasquazzi C., Andreoni M., Parruti G., Angelico M., Perno C. F., Cento V., Ceccherini-Silberstein F., Andreone P., Baldanti F., Barbarini G., Boccaccio V., Boglione L., Bolis M., Bonora S., Borghi V., Brancaccio G., Bruno S., Bruzzone B., Calvaruso V., Caporaso N., Ciaccio A., Ciancio A., Colombatto P., Cozzolongo R., D'Ambrosio C., D'Ettorre G., De Leonardis F., De Luca A., Di Biagio A., Di Perri G., Francioso S., Gaeta G. B., Gasbarrini A., Ghisetti V., Giorgini A., Grieco A., Gubertini G., Gulminetti R., Lambiase L., Landonio S., Lichtner M., Maida I., Marenco S., Marinaro L., Maserati R., Melis M., Menzaghi B., Meregalli E., Micheli V., Niero F., Paoloni M., Pieri A., Rendina M., Romagnoli D., Rossetti B., Ruggiero T., Sangiovanni V., Starace M., Sticchi L., Tarquini P., Toniutto P., Vullo V., and Zazzi M.

Abstract

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

Published
2018

36. Sofosbuvir plus daclatasvir with or without ribavirin is safe and effective for post-transplant hepatitis C recurrence and severe fibrosis and cirrhosis: A prospective study

Author

Lionetti, R, Calvaruso, V, Piccolo, P, Mancusi, R, Mazzarelli, C, Fagiuoli, S, Montalbano, M, Lenci, I, Carrai, P, Guaraldi, G, Visco-Comandini, U, Milana, M, Biolato, M, Loiacono, L, Valente, G, Craxi, A, Angelico, M, D'Offizi, G, Lionetti R., Calvaruso V., Piccolo P., Mancusi R. L., Mazzarelli C., Fagiuoli S., Montalbano M., Lenci I., Carrai P., Guaraldi G., Visco-Comandini U., Milana M., Biolato M., Loiacono L., Valente G., Craxi A., Angelico M., D'offizi G., Lionetti, R, Calvaruso, V, Piccolo, P, Mancusi, R, Mazzarelli, C, Fagiuoli, S, Montalbano, M, Lenci, I, Carrai, P, Guaraldi, G, Visco-Comandini, U, Milana, M, Biolato, M, Loiacono, L, Valente, G, Craxi, A, Angelico, M, D'Offizi, G, Lionetti R., Calvaruso V., Piccolo P., Mancusi R. L., Mazzarelli C., Fagiuoli S., Montalbano M., Lenci I., Carrai P., Guaraldi G., Visco-Comandini U., Milana M., Biolato M., Loiacono L., Valente G., Craxi A., Angelico M., and D'offizi G.

Abstract

Background: In 2012, an Italian Named Patient Program began for hepatitis C virus (HCV)-infected liver transplant (LT) recipients with advanced fibrosis, before approval of direct antiviral agents (DAA), to benefit severely ill patients. The aim of this “real-life” study was to assess treatment efficacy and safety with an extended course of daclatasvir (DCV) plus sofosbuvir (SOF) with or without ribavirin (RBV). Methods: All HCV LT recipients with severe fibrosis in 15 Italian transplant centers were treated with DCV+SOF±RBV for 24 weeks; sustained virological response was assessed at 12 weeks post-treatment (SVR12). Results: Eighty-seven patients were enrolled (75.9% males, mean age 58.4 ± 7.2 years, 83.9% genotype 1, 81.6% cirrhosis); 52 (59.8%) received RBV. Overall, 79 obtained SVR12 (90.8%): 100% in F3 and 88.7% in cirrhotics (91.5% in Child-Pugh A, 83.3% in Child-Pugh B and C). According to the treatment group, SVR was 80% in DCV + SOF group and 98.1% in SOF + DCV + RBV. Two virological relapses occurred during follow-up in cirrhotic patients who received DCV + SOF. Four cirrhotic patients in DCV + SOF group and 1 in DCV + SOF + RBV group died on treatment. Conclusion: An extended course of SOF plus DCV for 24 weeks, with or without RBV, is effective and well tolerated for the treatment of post-LT HCV recurrence with severe fibrosis.

Published
2018

37. The Italian compassionate use of sofosbuvir in HCV patients waitlisted for liver transplantation: A national real-life experience

Author

Martini, S, Donato, M, Mazzarelli, C, Rendina, M, Visco-Comandini, U, Fili, D, Gianstefani, A, Fagiuoli, S, Melazzini, M, Montilla, S, Pani, L, Petraglia, S, Russo, P, Trotta, M, Carrai, P, Caraceni, P, Angeli, P, Ballardini, G, Bernabucci, V, Bhoori, S, Burra, P, Civolani, A, D'Offizi, G, Felder, M, Gaeta, G, Ganga, R, Ginanni Corradini, S, Iemmolo, R, Lenci, I, Lionetti, R, Montalbano, M, Morelli, M, Picciotto, A, Sapere, C, Serviddio, G, Tame, M, Verucchi, G, Zignego, A, Martini S., Donato M. F., Mazzarelli C., Rendina M., Visco-Comandini U., Fili D., Gianstefani A., Fagiuoli S., Melazzini M., Montilla S., Pani L., Petraglia S., Russo P., Trotta M. P., Carrai P., Caraceni P., Angeli P., Ballardini G., Bernabucci V., Bhoori S., Burra P., Civolani A., D'Offizi G., Felder M., Gaeta G. B., Ganga R., Ginanni Corradini S., Iemmolo R. M., Lenci I., Lionetti R., Montalbano M., Morelli M. C., Picciotto A., Sapere C., Serviddio G., Tame M., Verucchi G., Zignego A. L., Martini, S, Donato, M, Mazzarelli, C, Rendina, M, Visco-Comandini, U, Fili, D, Gianstefani, A, Fagiuoli, S, Melazzini, M, Montilla, S, Pani, L, Petraglia, S, Russo, P, Trotta, M, Carrai, P, Caraceni, P, Angeli, P, Ballardini, G, Bernabucci, V, Bhoori, S, Burra, P, Civolani, A, D'Offizi, G, Felder, M, Gaeta, G, Ganga, R, Ginanni Corradini, S, Iemmolo, R, Lenci, I, Lionetti, R, Montalbano, M, Morelli, M, Picciotto, A, Sapere, C, Serviddio, G, Tame, M, Verucchi, G, Zignego, A, Martini S., Donato M. F., Mazzarelli C., Rendina M., Visco-Comandini U., Fili D., Gianstefani A., Fagiuoli S., Melazzini M., Montilla S., Pani L., Petraglia S., Russo P., Trotta M. P., Carrai P., Caraceni P., Angeli P., Ballardini G., Bernabucci V., Bhoori S., Burra P., Civolani A., D'Offizi G., Felder M., Gaeta G. B., Ganga R., Ginanni Corradini S., Iemmolo R. M., Lenci I., Lionetti R., Montalbano M., Morelli M. C., Picciotto A., Sapere C., Serviddio G., Tame M., Verucchi G., and Zignego A. L.

Abstract

Background & Aims: This study aimed to assess the real-life clinical and virological outcomes of HCV waitlisted patients for liver transplantation (LT) who received sofosbuvir/ribavirin (SOF/R) within the Italian compassionate use program. Methods: Clinical and virological data were collected in 224 patients with decompensated cirrhosis and/or hepatocellular carcinoma (HCC) receiving daily SOF/R until LT or up a maximum of 48 weeks. Results: Of 100 transplanted patients, 51 were HCV-RNA negative for >4 weeks before LT (SVR12: 88%) and 49 negative for <4 weeks or still viraemic at transplant: 34 patients continued treatment after LT (bridging therapy) (SVR12: 88%), while 15 stopped treatment (SVR12: 53%). 98 patients completed SOF/R without LT (SVR12: 73%). In patients with advanced decompensated cirrhosis (basal MELD ≥15 and/or C-P ≥B8), a marked improvement of the scores occurred in about 50% of cases and almost 20% of decompensated patients without HCC reached a condition suitable for inactivation and delisting. Conclusions: These real-life data indicate that in waitlisted patients: (i) bridging antiviral therapy can be an option for patients still viraemic or negative <4 weeks at LT; and (ii) clinical improvement to a condition suitable for delisting can occur even in patients with advanced decompensated cirrhosis.

Published
2018

38. Frequent NS5A and multiclass resistance in almost all HCV genotypes at DAA failures: What are the chances for second-line regimens?

Author

Di Maio, V, Cento, V, Aragri, M, Paolucci, S, Pollicino, T, Coppola, N, Bruzzone, B, Ghisetti, V, Zazzi, M, Brunetto, M, Bertoli, A, Barbaliscia, S, Galli, S, Gennari, W, Baldanti, F, Raimondo, G, Perno, C, Ceccherini-Silberstein, F, Andreone, P, Andreoni, M, Angelico, M, Babudieri, S, Barbarini, G, Boccaccio, V, Boglione, L, Bolis, M, Bonora, S, Borghi, V, Brancaccio, G, Bruno, S, Cacciatore, P, Calvaruso, V, Caporaso, N, Ciaccio, A, Ciancio, A, Colombatto, P, Cozzolongo, R, Craxi, A, D'Ambrosio, C, D'Ettorre, G, De Luca, A, Di Biagio, A, Di Perri, G, Francioso, S, Gaeta, G, Giorgini, A, Grieco, A, Gubertini, G, Gulminetti, R, Lambiase, L, Lenci, I, Lichtner, M, Maida, I, Marenco, S, Marinaro, L, Maserati, R, Masetti, C, Melis, M, Meregalli, E, Micheli, V, Morisco, F, Niero, F, Nicolini, L, Palitti, V, Paoloni, M, Parruti, G, Pasquazzi, C, Pellicelli, A, Polilli, E, Ponti, M, Puoti, M, Rendina, M, Rizzardini, G, Rossetti, B, Ruggiero, T, Sangiovanni, V, Starace, M, Sticchi, L, Tarquini, P, Toniutto, P, Vullo, V, Di Maio V. C., Cento V., Aragri M., Paolucci S., Pollicino T., Coppola N., Bruzzone B., Ghisetti V., Zazzi M., Brunetto M., Bertoli A., Barbaliscia S., Galli S., Gennari W., Baldanti F., Raimondo G., Perno C. F., Ceccherini-Silberstein F., Andreone P., Andreoni M., Angelico M., Babudieri S., Barbarini G., Boccaccio V., Boglione L., Bolis M., Bonora S., Borghi V., Brancaccio G., Bruno S., Cacciatore P., Calvaruso V., Caporaso N., Ciaccio A., Ciancio A., Colombatto P., Cozzolongo R., Craxi A., D'Ambrosio C., D'Ettorre G., De Luca A., Di Biagio A., Di Perri G., Francioso S., Gaeta G. B., Giorgini A., Grieco A., Gubertini G., Gulminetti R., Lambiase L., Lenci I., Lichtner M., Maida I., Marenco S., Marinaro L., Maserati R., Masetti C., Melis M., Meregalli E., Micheli V., Morisco F., Niero F., Nicolini L. A., Palitti V. P., Paoloni M., Parruti G., Pasquazzi C., Pellicelli A., Polilli E., Ponti M. L., Puoti M., Rendina M., Rizzardini G., Rossetti B., Ruggiero T., Sangiovanni V., Starace M., Sticchi L., Tarquini P., Toniutto P., Vullo V., Di Maio, V, Cento, V, Aragri, M, Paolucci, S, Pollicino, T, Coppola, N, Bruzzone, B, Ghisetti, V, Zazzi, M, Brunetto, M, Bertoli, A, Barbaliscia, S, Galli, S, Gennari, W, Baldanti, F, Raimondo, G, Perno, C, Ceccherini-Silberstein, F, Andreone, P, Andreoni, M, Angelico, M, Babudieri, S, Barbarini, G, Boccaccio, V, Boglione, L, Bolis, M, Bonora, S, Borghi, V, Brancaccio, G, Bruno, S, Cacciatore, P, Calvaruso, V, Caporaso, N, Ciaccio, A, Ciancio, A, Colombatto, P, Cozzolongo, R, Craxi, A, D'Ambrosio, C, D'Ettorre, G, De Luca, A, Di Biagio, A, Di Perri, G, Francioso, S, Gaeta, G, Giorgini, A, Grieco, A, Gubertini, G, Gulminetti, R, Lambiase, L, Lenci, I, Lichtner, M, Maida, I, Marenco, S, Marinaro, L, Maserati, R, Masetti, C, Melis, M, Meregalli, E, Micheli, V, Morisco, F, Niero, F, Nicolini, L, Palitti, V, Paoloni, M, Parruti, G, Pasquazzi, C, Pellicelli, A, Polilli, E, Ponti, M, Puoti, M, Rendina, M, Rizzardini, G, Rossetti, B, Ruggiero, T, Sangiovanni, V, Starace, M, Sticchi, L, Tarquini, P, Toniutto, P, Vullo, V, Di Maio V. C., Cento V., Aragri M., Paolucci S., Pollicino T., Coppola N., Bruzzone B., Ghisetti V., Zazzi M., Brunetto M., Bertoli A., Barbaliscia S., Galli S., Gennari W., Baldanti F., Raimondo G., Perno C. F., Ceccherini-Silberstein F., Andreone P., Andreoni M., Angelico M., Babudieri S., Barbarini G., Boccaccio V., Boglione L., Bolis M., Bonora S., Borghi V., Brancaccio G., Bruno S., Cacciatore P., Calvaruso V., Caporaso N., Ciaccio A., Ciancio A., Colombatto P., Cozzolongo R., Craxi A., D'Ambrosio C., D'Ettorre G., De Luca A., Di Biagio A., Di Perri G., Francioso S., Gaeta G. B., Giorgini A., Grieco A., Gubertini G., Gulminetti R., Lambiase L., Lenci I., Lichtner M., Maida I., Marenco S., Marinaro L., Maserati R., Masetti C., Melis M., Meregalli E., Micheli V., Morisco F., Niero F., Nicolini L. A., Palitti V. P., Paoloni M., Parruti G., Pasquazzi C., Pellicelli A., Polilli E., Ponti M. L., Puoti M., Rendina M., Rizzardini G., Rossetti B., Ruggiero T., Sangiovanni V., Starace M., Sticchi L., Tarquini P., Toniutto P., and Vullo V.

Published
2018

39. Genetic Determinants in a Critical Domain of NS5A Correlate with Hepatocellular Carcinoma in Cirrhotic Patients Infected with HCV Genotype 1b

Author

Alkhatib M, Di Maio VC, De Murtas V, Polilli E, Milana M, Teti E, Fiorentino G, Calvaruso V, Barbaliscia S, Bertoli A, Scutari R, Carioti L, Cento V, Santoro MM, Orro A, Maida I, Lenci I, Sarmati L, Craxi A, Pasquazzi C, Parruti G, Babudieri S, Milanesi L, Andreoni M, Angelico M, Perno CF, Ceccherini-Silberstein F, Svicher V, Salpini R, On Behalf Of Hirma Hepatocarcinoma Innovative Research MArkers And Fondazione Vironet C Hcv Virology Italian Resistance., and Alkhatib M, Di Maio VC, De Murtas V, Polilli E, Milana M, Teti E, Fiorentino G, Calvaruso V, Barbaliscia S, Bertoli A, Scutari R, Carioti L, Cento V, Santoro MM, Orro A, Maida I, Lenci I, Sarmati L, Craxi A, Pasquazzi C, Parruti G, Babudieri S, Milanesi L, Andreoni M, Angelico M, Perno CF, Ceccherini-Silberstein F, Svicher V, Salpini R, On Behalf Of Hirma Hepatocarcinoma Innovative Research MArkers And Fondazione Vironet C Hcv Virology Italian Resistance.

Subjects
hepatitis C virus, Liver Cirrhosis, Male, Cirrhosis, viruses, Hepacivirus, Viral Nonstructural Proteins, NS5A, medicine.disease_cause, Severity of Illness Index, genetic variability, Medicine, Liver Neoplasms, virus diseases, hepatocellular carcinoma, Middle Aged, Hepatitis C, QR1-502, Infectious Diseases, Hepatocellular carcinoma, HCV, Host-Pathogen Interactions, Female, Disease Susceptibility, Carcinoma, Hepatocellular, Genotype, Hepatitis C virus, Viremia, Microbiology, Article, Structure-Activity Relationship, Virology, Genetic variation, Humans, Genetic variability, neoplasms, Aged, business.industry, cirrhosis, Sequence Analysis, DNA, biochemical phenomena, metabolism, and nutrition, genotype 1b, medicine.disease, Settore MED/17, digestive system diseases, Mutation, Cancer research, business, Carcinogenesis, Biomarkers
Abstract

HCV is an important cause of hepatocellular carcinoma (HCC). HCV NS5A domain-1 interacts with cellular proteins inducing pro-oncogenic pathways. Thus, we explore genetic variations in NS5A domain-1 and their association with HCC, by analyzing 188 NS5A sequences from HCV genotype-1b infected DAA-naïve cirrhotic patients: 34 with HCC and 154 without HCC. Specific NS5A mutations significantly correlate with HCC: S3T (8.8% vs. 1.3%, p = 0.01), T122M (8.8% vs. 0.0%, p &lt, 0.001), M133I (20.6% vs. 3.9%, p &lt, 0.001), and Q181E (11.8% vs. 0.6%, p &lt, 0.001). By multivariable analysis, the presence of &gt, 1 of them independently correlates with HCC (OR (95%CI): 21.8 (5.7–82.3), p &lt, 0.001). Focusing on HCC-group, the presence of these mutations correlates with higher viremia (median (IQR): 5.7 (5.4–6.2) log IU/mL vs. 5.3 (4.4–5.6) log IU/mL, p = 0.02) and lower ALT (35 (30–71) vs. 83 (48–108) U/L, p = 0.004), suggesting a role in enhancing viral fitness without affecting necroinflammation. Notably, these mutations reside in NS5A regions known to interact with cellular proteins crucial for cell-cycle regulation (p53, p85-PIK3, and β-catenin), and introduce additional phosphorylation sites, a phenomenon known to ameliorate NS5A interaction with cellular proteins. Overall, these results provide a focus for further investigations on molecular bases of HCV-mediated oncogenesis. The role of theseNS5A domain-1 mutations in triggering pro-oncogenic stimuli that can persist also despite achievement of sustained virological response deserves further investigation.

Published
2021
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40. Impact of new DAA therapy on real clinical practice: a multicenter region-wide cohort study

Author

Lanini, Simone, Scognamiglio, Paola, Mecozzi, Alessandra, Lombardozzi, Lorella, Vullo, Vincenzo, Angelico, Mario, Gasbarrini, Antonio, Taliani, Gloria, Attili, Adolfo Francesco, Perno, Carlo Federico, De Santis, Adriano, Puro, Vincenzo, Cerqua, Fabio, D'Offizi, Gianpiero, Pellicelli, Adriano, Armignacco, Orlando, Mennini, Francesco Saverio, Siciliano, Massimo, Girardi, Enrico, Panella, Vincenzo, Ippolito, Giuseppe, Sarrecchia, C., Di Paolo, M. D., Francioso, S., Brega, A., Lenci, I., Sarmati, L., Pompili, Maurizio, Grieco, Antonio, Tamburrini, Enrica, Apaccini, R., Miele, Luca, D'Ettorre, G., Mezzaroma, I., Furlan, C., Accapezzato, D., Paoletti, F., Merili, M., Corradini, S., Sereno, S., Fimiani, C., Mastropietro, C., Labbadia, G., Gentile, Giuseppe, Pasquazzi, C., Marignani, M., Guarisco, R., Puoti, C., Spilabotti, L., Montalbano, M., Boumis, E., Visco-Comandini, U., Zaccarelli, M., Ammassari, A., Lionetti, R., Murachelli, S., Loiacono, L., Antinori, Armando, Noto, P., Palmieri, F., Cicalini, S., Cerilli, S., Sampaolesi, A., Vincenzi, L., Bellagamba, R., Galati, V., Abdeddaim, A., Iacomi, F., Iannicelli, G., Mastroianni, Chiara, Lichtner, M., Ridola, L., Coluzzi, T., Mercurio, V., Del Borgo, C., Fondacaro, L., Cerasari, G., Guarascio, P., D'Ambrosio, C., Starnini, G., Caterini, A., Villani, Emanuele Rocco, Sarracino, L., Casinelli, K., Moretti, A., Vespasiani, U., Galati, G., Cecere, R., Bonaventura, M., and Scudieri, M.

Subjects
Male, Cirrhosis, Investigational, chronic hepatitis c, clinical study, direct acting antiviral, hepatitis c virus, liver cirrhosis, liver damage, mixed effect model, multicenter cohort study, new therapy, treatment efficacy, Logistic regression, Chronic hepatitis C, Cohort Studies, 0302 clinical medicine, Clinical study, Direct acting antiviral, Hepatitis C virus, Liver cirrhosis, Liver damage, Mixed effect model, Multicenter cohort study, New therapy, Treatment efficacy, Adult, Aged, Aged, 80 and over, Antiviral Agents, Drug Therapy, Combination, Drugs, Investigational, Female, Follow-Up Studies, Hepatitis C, Chronic, Humans, Liver Cirrhosis, Middle Aged, Therapies, Investigational, 80 and over, 030212 general & internal medicine, Stage (cooking), Chronic, Confounding, Drugs, Hepatitis C, Infectious Diseases, Cohort, Combination, Settore SECS-P/03 - Scienza delle Finanze, 030211 gastroenterology & hepatology, Cohort study, Research Article, medicine.medical_specialty, Side effect, Hepatitis C virus, Chronic hepatitis C, Liver cirrhosis, Direct acting antiviral, Multicenter cohort study, Mixed effect model, Liver damage, Treatment efficacy, Clinical study, New therapy, lcsh:Infectious and parasitic diseases, 03 medical and health sciences, Drug Therapy, Internal medicine, medicine, lcsh:RC109-216, business.industry, Settore MED/09 - MEDICINA INTERNA, medicine.disease, Clinical trial, Therapies, business
Abstract

Background Management of chronic hepatitis C (CHC) has significantly accelerated in the last few years. Currently, second generation direct acting antivirals (DAAs) promise clearance of infection in most of patients. Here we present the results of the first analysis carried out on data of Lazio clinical network for DAAs. Methods The study was designed as a multicenter cohort: a) to assess the evolution of treatment during the first 24 months of the activity of the Clinical Network; b) to report overall efficacy of treatments; c) to analyze potential factors associated with lack of virological response at 12 weeks after therapy (SVR12); d) to evaluate the variation of ALT at baseline and 12 weeks after therapy in those who achieved SVR12 in comparison to those who did not. Analyses of efficacy were carried out with multilevel mixed effect logistic regression model. ALT temporal variation was assessed by mixed effect model mixed models with random intercept at patient’s level and random slope at the level of the time; i.e. either before or after therapy. Results Between 30 December 2014 and 31 December 2016 5279 patients started a DAA treatment; of those, 5127 (in 14 clinical centers) had completed the 12-week follow-up. Overall proportion of SVR12 was 93.41% (N = 4780) with no heterogeneity between the 14 clinical centers. Interruption as the consequence of severe side effect was very low (only 23 patients). Unadjusted analysis indicates that proportion of SVR12 significantly changes according to patient’s baseline characteristics, however after adjusting for potential confounders only adherence to current guidelines, stage of liver diseases, gender, transplant and HIV status were independently associated with the response to therapy. Analysis of ALT temporal variation showed that ALT level normalized in most, but not, all patients who achieved SVR12. Conclusion Our study confirmed the extraordinary efficacy of DAAs outside clinical trials. The advantage of DAAs was particularly significant for those patients who were previously considered as difficult-to-treat and did not have treatment options before DAAs era. Intervention based on network of select centers and prioritization of patients according to diseases severity was successful. Further studies are needed to establish whether clearance of HCV after DAAs therapy can arrest or even revert liver fibrosis in non-cirrhotic patients and/or improve life quality and expectancy in those who achieve SVR12 with cirrhosis.

Published
2018
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42. Multiclass HCV resistance to direct-acting antiviral failure in real-life patients advocates for tailored second-line therapies

Author

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

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

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

Published
2017
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43. VIRONET-C real life experience of resistance-guided retreatment in HCV infected patients who previously failed a NS5A inhibitor-containing regimen

Author

Di Maio, V.C., primary, Aragri, M., additional, Masetti, C., additional, Paolucci, S., additional, Bruzzone, B., additional, Degasperi, E., additional, Barbaliscia, S., additional, Pollicino, T., additional, Minichini, C., additional, Calvaruso, V., additional, Rendina, M., additional, Cento, V., additional, Teti, E., additional, Micheli, V., additional, Allice, T., additional, Polilli, E., additional, Palitti, V. Pace, additional, Landonio, S., additional, Lenci, I., additional, Francioso, S., additional, Donnarumma, L., additional, Nicolini, L.A., additional, Bertoli, A., additional, Starace, M., additional, Pasquazzi, C., additional, Callegaro, A.P., additional, Morisco, F., additional, Cenderello, G., additional, Marenco, S., additional, Gulminetti, R., additional, Novati, S., additional, Scuteri, A., additional, Andreone, P., additional, Galli, S., additional, Ciancio, A., additional, Sangiovanni, V., additional, Cuomo, N., additional, Raddi, A., additional, Gennari, W., additional, Boeri, E., additional, Morsica, G., additional, Hasson, H., additional, Borghi, V., additional, Maida, I., additional, Brunetto, M., additional, Colombatto, P., additional, Cozzolongo, R., additional, De Santis, A., additional, Lichtner, M., additional, Babudieri, S., additional, Biliotti, E., additional, Taliani, G., additional, Santantonio, T., additional, Di Stefano, M., additional, Paternoster, C., additional, Ganga, R., additional, Merli, M., additional, Rizzardini, G., additional, Pellicelli, A., additional, Giannelli, V., additional, Milano, E., additional, Mastroianni, C., additional, Licata, A., additional, Di Lorenzo, F., additional, Giorgini, A., additional, Sighinolfi, L., additional, Dentone, C., additional, Lleo, A., additional, Rossetti, B., additional, Beretta, I., additional, Cariti, G., additional, Ghisetti, V., additional, Lampertico, P., additional, Parruti, G., additional, Coppola, N., additional, Baldanti, F., additional, Gaeta, G.B., additional, Raimondo, G., additional, Puoti, M., additional, Zazzi, M., additional, Andreoni, M., additional, Angelico, M., additional, Perno, C.F., additional, Craxì, A., additional, and Ceccherini-Silberstein, F., additional

Published
2020
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44. Sarco-model, a novel score to better predict the risk of death in cirrhotic patients awaiting liver transplantation

Author

Lai, Q., primary, Magistri, P., additional, Lionetti, R., additional, Avolio, A., additional, Lenci, I., additional, Giannelli, V., additional, Pecchi, A., additional, Ferri, F., additional, Marrone, G., additional, Milana, M., additional, Schinniná, V., additional, Menozzi, R., additional, Di Martino, M., additional, Grieco, A., additional, Manzia, T.M., additional, Tisone, G., additional, Agnes, S., additional, Rossi, M., additional, Di Benedetto, F., additional, and Ettorre., G.M., additional

Published
2020
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45. The Italian compassionate use of sofosbuvir in HCV patients waitlisted for liver transplantation: A national real-life experience

Author

Martini, Silvia, Donato, Maria Francesca, Mazzarelli, Chiara, Rendina, Maria, Visco-Comandini, Ubaldo, Filì, Daniela, Gianstefani, Alice, Fagiuoli, Stefano, Melazzini, Mario, Montilla, Simona, Pani, Luca, Petraglia, Sandra, Russo, Pierluigi, Trotta, Maria Paola, Carrai, Paola, Caraceni, Paolo, ITACOPS study group, Angeli, P, Ballardini, G, Bernabucci, V, Bhoori, S, Burra, P, Civolani, A, D'Offizi, G, Felder, M, Gaeta, Gb, Ganga, R, Ginanni Corradini, S, Iemmolo, Rm, Lenci, I, Lionetti, R, Montalbano, M, Morelli, Mc, Picciotto, A, Sapere, C, Serviddio, G, Tamè, M, Verucchi, G, Zignego, A. L., Martini, Silvia, Donato, Maria Francesca, Mazzarelli, Chiara, Rendina, Maria, Visco-Comandini, Ubaldo, Filì, Daniela, Gianstefani, Alice, Fagiuoli, Stefano, Melazzini, Mario, Montilla, Simona, Pani, Luca, Petraglia, Sandra, Russo, Pierluigi, Trotta, Maria Paola, Carrai, Paola, Caraceni, Paolo, Martini, S, Donato, M, Mazzarelli, C, Rendina, M, Visco-Comandini, U, Fili, D, Gianstefani, A, Fagiuoli, S, Melazzini, M, Montilla, S, Pani, L, Petraglia, S, Russo, P, Trotta, M, Carrai, P, Caraceni, P, Angeli, P, Ballardini, G, Bernabucci, V, Bhoori, S, Burra, P, Civolani, A, D'Offizi, G, Felder, M, Gaeta, G, Ganga, R, Ginanni Corradini, S, Iemmolo, R, Lenci, I, Lionetti, R, Montalbano, M, Morelli, M, Picciotto, A, Sapere, C, Serviddio, G, Tame, M, Verucchi, G, and Zignego, A

Subjects
Compassionate Use Trials, Liver Cirrhosis, Male, Cirrhosis, Sofosbuvir, bridging therapy, decompensated cirrhosis, delisting, direct-acting antivirals, hepatitis C, liver transplantation, Adult, Aged, Antiviral Agents, Carcinoma, Hepatocellular, Drug Therapy, Combination, Female, Hepacivirus, Hepatitis C, Chronic, Humans, Italy, Kaplan-Meier Estimate, Liver Neoplasms, Middle Aged, Prospective Studies, Ribavirin, Liver Transplantation, Waiting Lists, Hepatology, medicine.medical_treatment, Liver transplantation, chemistry.chemical_compound, 0302 clinical medicine, Chronic, Hepatitis C, 030220 oncology & carcinogenesis, Combination, 030211 gastroenterology & hepatology, medicine.drug, medicine.medical_specialty, 03 medical and health sciences, Drug Therapy, Internal medicine, medicine, direct-acting antiviral, business.industry, decompensated cirrhosi, Carcinoma, Hepatocellular, medicine.disease, Surgery, Transplantation, chemistry, business
Abstract

Background & aims This study aimed to assess the real-life clinical and virological outcomes of HCV waitlisted patients for liver transplantation (LT) who received sofosbuvir/ribavirin (SOF/R) within the Italian compassionate use program. Methods Clinical and virological data were collected in 224 patients with decompensated cirrhosis and/or hepatocellular carcinoma (HCC) receiving daily SOF/R until LT or up a maximum of 48 weeks. Results Of 100 transplanted patients, 51 were HCV-RNA negative for >4 weeks before LT (SVR12: 88%) and 49 negative for

Published
2018

46. Long-term outcomes of direct acting antivirals in post-transplant advanced hepatitis C virus recurrence and fibrosing cholestatic hepatitis

Author

Vukotic, R, Conti, F, Fagiuoli, S, Morelli, M, Pasulo, L, Colpani, M, Foschi, F, Berardi, S, Pianta, P, Mangano, M, Donato, M, Malinverno, F, Monico, S, Tame, M, Mazzella, G, Belli, L, Vigano, R, Carrai, P, Burra, P, Russo, F, Lenci, I, Toniutto, P, Merli, M, Loiacono, L, Iemmolo, R, Degli Antoni, A, Romano, A, Picciotto, A, Rendina, M, Andreone, P, Vukotic R., Conti F., Fagiuoli S., Morelli M. C., Pasulo L., Colpani M., Foschi F. G., Berardi S., Pianta P., Mangano M., Donato M. F., Malinverno F., Monico S., Tame M., Mazzella G., Belli L. S., Vigano R., Carrai P., Burra P., Russo F. P., Lenci I., Toniutto P., Merli M., Loiacono L., Iemmolo R., Degli Antoni A. M., Romano A., Picciotto A., Rendina M., Andreone P., Vukotic, R, Conti, F, Fagiuoli, S, Morelli, M, Pasulo, L, Colpani, M, Foschi, F, Berardi, S, Pianta, P, Mangano, M, Donato, M, Malinverno, F, Monico, S, Tame, M, Mazzella, G, Belli, L, Vigano, R, Carrai, P, Burra, P, Russo, F, Lenci, I, Toniutto, P, Merli, M, Loiacono, L, Iemmolo, R, Degli Antoni, A, Romano, A, Picciotto, A, Rendina, M, Andreone, P, Vukotic R., Conti F., Fagiuoli S., Morelli M. C., Pasulo L., Colpani M., Foschi F. G., Berardi S., Pianta P., Mangano M., Donato M. F., Malinverno F., Monico S., Tame M., Mazzella G., Belli L. S., Vigano R., Carrai P., Burra P., Russo F. P., Lenci I., Toniutto P., Merli M., Loiacono L., Iemmolo R., Degli Antoni A. M., Romano A., Picciotto A., Rendina M., and Andreone P.

Abstract

Long-term functional outcomes of sofosbuvir-based antiviral treatment were evaluated in a cohort study involving 16 Italian centres within the international compassionate use programme for post-transplant hepatitis C virus (HCV) recurrence. Seventy-three patients with cirrhosis (n=52) or fibrosing cholestatic hepatitis (FCH, n=21) received 24-week sofosbuvir with ribavirin±pegylated interferon or interferon-free sofosbuvir-based regimen with daclatasvir/simeprevir+ribavirin. The patients were observed for a median time of 103 (82-112) weeks. Twelve of 73 (16.4%) died (10 non-FCH, 2 FCH) and two underwent re-LT. Sustained virological response was achieved in 46 of 66 (69.7%): 31 of 47 (66%) non-FCH and 15 of 19 (79%) FCH patients. All relapsers were successfully retreated. Comparing the data of baseline with last follow-up, MELD and Child-Turcotte-Pugh scores improved both in non-FCH (15.3±6.5 vs 10.5±3.8, P<.0001 and 8.4±2.1 vs 5.7±1.3, P<.0001, respectively) and FCH (17.3±5.9 vs 10.1±2.8, P=.001 and 8.2±1.6 vs 5.5±1, P=.001, respectively). Short-treatment mortality was higher in patients with baseline MELD≥25 than in those with MELD<25 (42.9% vs 4.8%, P=.011). Long-term mortality was 53.3% among patients with baseline MELD≥20 and 7.5% among those with MELD<20 (P<.0001). Among deceased patients 75% were Child-Turcotte-Pugh class C at baseline, while among survivors 83.9% were class A or B (P<.0001). Direct acting antivirals-based treatments for severe post-transplant hepatitis C recurrence, comprising fibrosing cholestatic hepatitis, significantly improve liver function, even without viral clearance and permit an excellent long-term survival. The setting of severe HCV recurrence may require the identification of “too-sick-to-treat patients” to avoid futile treatments.

Published
2017

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

Author

Carrai, P, Morelli, C, Cordone, G, Romano, A, Tame, M, Lionetti, R, Pietrosi, G, Lenci, I, Piai, G, Russo, F, Coppola, C, Melazzini, M, Montilla, S, Pani, L, Petraglia, S, Russo, P, Trotta, M, Martini, S, Toniutto, P, Bandiera, F, Bhoori, S, Brillanti, S, Burra, P, Corsale, S, De Luca, A, Fagiuoli, S, Fattovich, G, Fava, G, Felder, M, Forte, P, Galeota-Lanza, A, Gitto, S, Grieco, A, Grossi, P, Ialungo, A, Iemmolo, R, Loiacono, L, Mangia, A, Merli, M, Piacentini, A, Pellicelli, A, Rigamonti, C, Gabriella, V, Zignego, A, Carrai P., Morelli C., Cordone G., Romano A., Tame M., Lionetti R., Pietrosi G., Lenci I., Piai G., Russo F. P., Coppola C., Melazzini M., Montilla S., Pani L., Petraglia S., Russo P., Trotta M. P., Martini S., Toniutto P., Bandiera F., Bhoori S., Brillanti S., Burra P., Corsale S., De Luca A., Fagiuoli S., Fattovich G., Fava G., Felder M., Forte P., Galeota-Lanza A., Gitto S., Grieco A., Grossi P., Ialungo A. M., Iemmolo R. M., Loiacono L., Mangia A., Merli M., Piacentini A., Pellicelli A., Rigamonti C., Gabriella V., Zignego A. L., Carrai, P, Morelli, C, Cordone, G, Romano, A, Tame, M, Lionetti, R, Pietrosi, G, Lenci, I, Piai, G, Russo, F, Coppola, C, Melazzini, M, Montilla, S, Pani, L, Petraglia, S, Russo, P, Trotta, M, Martini, S, Toniutto, P, Bandiera, F, Bhoori, S, Brillanti, S, Burra, P, Corsale, S, De Luca, A, Fagiuoli, S, Fattovich, G, Fava, G, Felder, M, Forte, P, Galeota-Lanza, A, Gitto, S, Grieco, A, Grossi, P, Ialungo, A, Iemmolo, R, Loiacono, L, Mangia, A, Merli, M, Piacentini, A, Pellicelli, A, Rigamonti, C, Gabriella, V, Zignego, A, Carrai P., Morelli C., Cordone G., Romano A., Tame M., Lionetti R., Pietrosi G., Lenci I., Piai G., Russo F. P., Coppola C., Melazzini M., Montilla S., Pani L., Petraglia S., Russo P., Trotta M. P., Martini S., Toniutto P., Bandiera F., Bhoori S., Brillanti S., Burra P., Corsale S., De Luca A., Fagiuoli S., Fattovich G., Fava G., Felder M., Forte P., Galeota-Lanza A., Gitto S., Grieco A., Grossi P., Ialungo A. M., Iemmolo R. M., Loiacono L., Mangia A., Merli M., Piacentini A., Pellicelli A., Rigamonti C., Gabriella V., and Zignego A. L.

Abstract

Direct antivirals are available for treating recurrent hepatitis C (RHC). This study reported outcomes of 424 patients with METAVIR F3–F4 RHC who were treated for 24 weeks with sofosbuvir/ribavirin and followed for 12 weeks within the Italian sofosbuvir compassionate use program. In 55 patients, daclatasvir or simeprevir were added. Child–Pugh class and model of end stage liver disease (MELD) scores were evaluated at baseline and 36 weeks after the start of therapy. The sustained viral response (SVR) was 86.7% (316/365) in patients who received sofosbuvir/ribavirin and 98.3% (58/59) in patients who received a second antiviral (P < 0.01). In patients treated with sofosbuvir/ribavirin, a significant difference in SVR was observed between patients diagnosed with METAVIR F4 (211/250; 84.4%), METAVIR F3 (95/105; 90.5%) and fibrosing cholestatic hepatitis (10/10; 100%) (P = 0.049). A significant association was found between patients who worsened from Child–Pugh class A and who experienced viral relapse (4/26 vs. 8/189, P = 0.02). In patients with a baseline MELD score <15, a significant association was found between maintaining a final MELD score <15 and the achievement of SVR (187/219 vs. 6/10, P = 0.031). This real-world study indicates that sofosbuvir/ribavirin treatment for 24 weeks was effective, and the achievement of SVR was associated with a reduced probability of developing worsening liver function.

Published
2017

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

Author

Di Maio, V, Cento, V, Lenci, I, Aragri, M, Rossi, P, Barbaliscia, S, Melis, M, Verucchi, G, Magni, C, Teti, E, Bertoli, A, Antonucci, F, Bellocchi, M, Micheli, V, Masetti, C, Landonio, S, Francioso, S, Santopaolo, F, Pellicelli, A, Calvaruso, V, Gianserra, L, Siciliano, M, Romagnoli, D, Cozzolongo, R, Grieco, A, Morisco, F, Merli, M, Brancaccio, G, Di Biagio, A, Loggi, E, Mastroianni, C, Pace Palitti, V, Tarquini, P, Puoti, M, Taliani, G, Sarmati, L, Picciotto, A, Vullo, V, Caporaso, N, Paoloni, M, Pasquazzi, C, Rizzardini, G, Parruti, G, Craxì, A, Babudieri, S, Andreoni, M, Angelico, M, Perno, C, Ceccherini-Silberstein, F, Di Maio, V. C. a, Cento V. a, Lenci I. b, Aragri, M. a, Rossi P. b, Barbaliscia S. a, Melis M. c, Verucchi G. d, Magni, C. F. e, Teti E. f, Bertoli A, Bellocchi, MC, Pellicelli, AM, Mastroianni, CM, Perno, CF, Di Maio, V, Cento, V, Lenci, I, Aragri, M, Rossi, P, Barbaliscia, S, Melis, M, Verucchi, G, Magni, C, Teti, E, Bertoli, A, Antonucci, F, Bellocchi, M, Micheli, V, Masetti, C, Landonio, S, Francioso, S, Santopaolo, F, Pellicelli, A, Calvaruso, V, Gianserra, L, Siciliano, M, Romagnoli, D, Cozzolongo, R, Grieco, A, Morisco, F, Merli, M, Brancaccio, G, Di Biagio, A, Loggi, E, Mastroianni, C, Pace Palitti, V, Tarquini, P, Puoti, M, Taliani, G, Sarmati, L, Picciotto, A, Vullo, V, Caporaso, N, Paoloni, M, Pasquazzi, C, Rizzardini, G, Parruti, G, Craxì, A, Babudieri, S, Andreoni, M, Angelico, M, Perno, C, Ceccherini-Silberstein, F, Di Maio, V. C. a, Cento V. a, Lenci I. b, Aragri, M. a, Rossi P. b, Barbaliscia S. a, Melis M. c, Verucchi G. d, Magni, C. F. e, Teti E. f, Bertoli A, Bellocchi, MC, Pellicelli, AM, Mastroianni, CM, and Perno, CF

Abstract

Background & Aims: Despite the excellent efficacy of direct-acting antivirals (DAA) reported in clinical trials, virological failures can occur, often associated with the development of resistance-associated substitutions (RASs). This study aimed to characterize the presence of clinically relevant RASs to all classes in real-life DAA failures. Methods: Of the 200 virological failures that were analyzed in 197 DAA-treated patients, 89 with pegylated-interferon+ribavirin (PegIFN+RBV) and 111 without (HCV-1a/1b/1g/2/3/4=58/83/1/6/24/25; 56.8% treatment experienced; 65.5% cirrhotic) were observed. Sanger sequencing of NS3/NS5A/NS5B was performed by home-made protocols, at failure (N=200) and whenever possible at baseline (N=70). Results: The majority of the virological failures were relapsers (57.0%), 22.5% breakthroughs, 20.5% non-responders. RAS prevalence varied according to IFN/RBV use, DAA class, failure type and HCV genotype/subtype. It was 73.0% in IFN group vs 49.5% in IFN free, with the highest prevalence of NS5A-RASs (96.1%), compared to NS3-RASs (75.9% with IFN, 70.5% without) and NS5B-RASs (66.6% with IFN, 20.4% without, in sofosbuvir failures). In the IFN-free group, RASs were higher in breakthrough/non-responders than in relapsers (90.5% vs 40.0%, P<.001). Interestingly, 57.1% of DAA IFN-free non-responders had a misclassified genotype, and 3/4 sofosbuvir breakthroughs showed the major-RAS-S282T, while RAS-L159F was frequently found in sofosbuvir relapsers (18.2%). Notably, 9.0% of patients showed also extra target RASs, and 47.4% of patients treated with ≥2 DAA classes showed multiclass resistance, including 11/11 NS3+NS5A failures. Furthermore, 20.0% of patients had baseline-RASs, which were always confirmed at failure. Conclusions: In our failure setting, RAS prevalence was remarkably high in all genes, with a partial exception for NS5B, whose limited resistance is still higher than previously reported. This multiclass resistance advocates for HC

Published
2017

50. Common issues in the management of patients in the waiting list and after liver transplantation

Author

Burra, P, Belli, L, Ginanni, Corradini, S, Volpes, R, Marzioni, M, Giannini, E, Toniutto, P, Carrai, P, Donato, F, Lanza-Galeota, A, Martini, S, Pasulo, L, Ponziani, F, Russo, F, Coppola, C, Forte, P, Mazzarelli, C, Merli, M, Montalbano, M, Picciotto, F, Rendina, M, Zanetto, A, Angeli, P, Foschi, F, Manini, M, Marzano, A, Perricone, G, Pianta, P, Tamè, M, De Maria, N, Domenicali, M, Ottobrelli, A, Picciotto, A, Ponti, L, Vizzini, G, Corradini, S, Bhoori, S, Ferri, F, Gaffuri, G, Lenci, I, Mameli, L, Morelli, M, and Piras, M. R.

Subjects
medicine.medical_specialty, Alcoholic liver disease, DAAs, HBV recurrence, Immunosuppression, Liver transplantation, Antiviral Agents, Hepatitis C, Chronic, Humans, Italy, Liver Diseases, Alcoholic, Recurrence, Societies, Medical, Disease Management, Liver Transplantation, Waiting Lists, Hepatology, Gastroenterology, medicine.medical_treatment, 030230 surgery, 03 medical and health sciences, 0302 clinical medicine, Medical, Internal medicine, medicine, In patient, Chronic, Disease management (health), business.industry, Liver Diseases, General surgery, Hcv recurrence, Evidence-based medicine, Alcoholic, medicine.disease, Hepatitis C, surgical procedures, operative, Waiting list, 030211 gastroenterology & hepatology, Societies, business
Abstract

The present document contains the recommendations of an expert panel of transplant hepatologists, appointed by the Italian Association for the Study of the Liver (AISF), on how to manage the most common aspects of liver transplantation: the topics covered include: new treatments for HCV in patients on the waiting list for liver transplantation; antiviral treatments in patients with HCV recurrence after liver transplantation; prophylaxis for HBV recurrence after liver transplantation; indications for liver transplantation in alcoholic liver disease; and Immunosuppressive therapy. The statements on each topic were approved by participants at the AISF Transplant Hepatologist Expert Meeting (organized by the Permanent Committee on Liver Transplantation in Mondello on 4–5 October 2015), and are graded according to the Oxford classification of levels of evidence.

Published
2017
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