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2. Portal Vein Thrombosis Relevance on Liver Cirrhosis: Italian Venous Thrombotic Events Registry

Author

Violi F., Corazza R. G., Caldwell S. H., Perticone F., Gatta A., Angelico M., Farcomeni A., Masotti M., Napoleone L., Vestri A., Raparelli V., Basili S., Palasciano G., D'Alitto F., Palmieri V. O., Santovito D., Di Michele D., Croce G., Sacerdoti D., Brocco S., Fasolato S., Cecchetto L., Bombonato G., Bertoni M., Restuccia R., Andreozzi P., Liguori L. M., Caroleo B., Perticone M., Staltari O., Manfredini R., De Giorgi A., Averna M., Giammanco A., Granito A., Pettinari I., Marinelli S., Bolondi L., Falsetti L., Salvi A., Durante-Mangoni E., Cesaro F., Farinaro V., Ragone E., Morana I., Andriulli A., Ippolito A., Iacobellis A., Niro G., Merla A., Raimondo G., Maimone S., Cacciola I., Varvara D., Drenaggi D., Staffolani S., Picardi A., Vespasiani-Gentilucci U., Galati G., Gallo P., Davi G., Schiavone C., Santilli F., Tana C., Licata A., Soresi M., Bianchi B. G., Carderi I., Pinto A., Tuttolomondo A., Ferrari G., Gresele P., Fierro T., Morelli O., Laffi G., Romanelli R. G., Arena U., Cristina S., Gasbarrini A., Gargovich M., Zocco Z. M., Riccardi L., Ainora M. E., Capeci W., Martino M. G., Lorenzo N., Cavallo M., Frugiuele P., Greco A., Pietrangelo A., Ventura P., Cuoghi C., Marcacci M., Serviddio G., Vendemiale G., Villani R., Gargano R., Vidili G., Di Cesare V., Masala M., Delitala G., Invernizzi P., Di Minno G., Tufano A., Purrello F., Privitera G., Forgione A., Curigliano V., Senzolo M., Rodriguez-Castro K. -I., Giannelli G., Serra C., Neri S., Pignataro P., Rizzetto M., Debernardi V. W., Svegliati B. G., Bergamaschi G., Costanzo F., Angelico F., Del Ben M., Polimeni L., Talerico G., Proietti M., Romiti G. F., Ruscio E., Toriello F., Violi, F., Corazza, R. G., Caldwell, S. H., Perticone, F., Gatta, A., Angelico, M., Farcomeni, A., Masotti, M., Napoleone, L., Vestri, A., Raparelli, V., Basili, S., Palasciano, G., D'Alitto, F., Palmieri, V. O., Santovito, D., Croce, G., Sacerdoti, D., Brocco, S., Fasolato, S., Cecchetto, L., Bombonato, G., Restuccia, R., Andreozzi, P., Liguori, L. M., Perticone, M., Staltari, O., Manfredini, R., De Giorgi, A., Averna, M., Giammanco, A., Granito, A., Marinelli, S., Bolondi, L., Falsetti, L., Salvi, A., Durante-Mangoni, E., Cesaro, F., Farinaro, V., Ragone, E., Morana, I., Andriulli, A., Ippolito, A., Iacobellis, A., Niro, G., Merla, A., Raimondo, G., Maimone, S., Cacciola, I., Varvara, D., Drenaggi, D., Staffolani, S., Picardi, A., Vespasiani-Gentilucci, U., Galati, G., Gallo, P., Davi, G., Schiavone, C., Santilli, F., Tana, C., Licata, A., Soresi, M., Bianchi, B. G., Carderi, I., Pinto, A., Tuttolomondo, A., Ferrari, G., Gresele, P., Fierro, T., Morelli, O., Laffi, G., Romanelli, R. G., Arena, U., Cristina, S., Gasbarrini, A., Gargovich, M., Zocco, Z. M., Riccardi, L., Ainora, M. E., Capeci, W., Martino, M. G., Lorenzo, N., Cavallo, M., Frugiuele, P., Greco, A., Pietrangelo, A., Ventura, P., Cuoghi, C., Marcacci, M., Serviddio, G., Vendemiale, G., Villani, R., Gargano, R., Vidili, G., Di Cesare, V., Masala, M., Delitala, G., Invernizzi, P., Di Minno, G., Tufano, A., Purrello, F., Privitera, G., Forgione, A., Curigliano, V., Senzolo, M., Rodriguez-Castro, K. -I., Giannelli, G., Serra, C., Neri, S., Pignataro, P., Rizzetto, M., Debernardi, V. W., Svegliati, B. G., Bergamaschi, G., Costanzo, F., Angelico, F., Del Ben, M., Polimeni, L., Talerico, G., Proietti, M., Romiti, G. F., Ruscio, E., Toriello, F., Violi, F, Corazza, R, Caldwell, S, Perticone, F, Gatta, A, Angelico, M, Farcomeni, A, Masotti, M, Napoleone, L, Vestri, A, Raparelli, V, Basili, S, Palasciano, G, D'Alitto, F, Palmieri, V, Santovito, D, Di Michele, D, Croce, G, Sacerdoti, D, Brocco, S, Fasolato, S, Cecchetto, L, Bombonato, G, Bertoni, M, Restuccia, R, Andreozzi, P, Liguori, L, Caroleo, B, Perticone, M, Staltari, O, Manfredini, R, De Giorgi, A, Averna, M, Giammanco, A, Granito, A, Pettinari, I, Marinelli, S, Bolondi, L, Falsetti, L, Salvi, A, Durante-Mangoni, E, Cesaro, F, Farinaro, V, Ragone, E, Morana, I, Andriulli, A, Ippolito, A, Iacobellis, A, Niro, G, Merla, A, Raimondo, G, Maimone, S, Cacciola, I, Varvara, D, Drenaggi, D, Staffolani, S, Picardi, A, Vespasiani-Gentilucci, U, Galati, G, Gallo, P, Davi, G, Schiavone, C, Santilli, F, Tana, C, Licata, A, Soresi, M, Bianchi, B, Carderi, I, Pinto, A, Tuttolomondo, A, Ferrari, G, Gresele, P, Fierro, T, Morelli, O, Laffi, G, Romanelli, R, Arena, U, Cristina, S, Gasbarrini, A, Gargovich, M, Zocco, Z, Riccardi, L, Ainora, M, Capeci, W, Martino, M, Lorenzo, N, Cavallo, M, Frugiuele, P, Greco, A, Pietrangelo, A, Ventura, P, Cuoghi, C, Marcacci, M, Serviddio, G, Vendemiale, G, Villani, R, Gargano, R, Vidili, G, Di Cesare, V, Masala, M, Delitala, G, Invernizzi, P, Di Minno, G, Tufano, A, Purrello, F, Privitera, G, Forgione, A, Curigliano, V, Senzolo, M, Rodriguez-Castro, K, Giannelli, G, Serra, C, Neri, S, Pignataro, P, Rizzetto, M, Debernardi, V, Svegliati, B, Bergamaschi, G, Costanzo, F, Angelico, F, Del Ben, M, Polimeni, L, Talerico, G, Proietti, M, Romiti, G, Ruscio, E, Toriello, F, Violi F., Corazza R.G., Caldwell S.H., Perticone F., Gatta A., Angelico M., Farcomeni A., Masotti M., Napoleone L., Vestri A., Raparelli V., Basili S., Palasciano G., D'Alitto F., Palmieri V.O., Santovito D., Di Michele D., Croce G., Sacerdoti D., Brocco S., Fasolato S., Cecchetto L., Bombonato G., Bertoni M., Restuccia R., Andreozzi P., Liguori L.M., Caroleo B., Perticone M., Staltari O., Manfredini R., De Giorgi A., Averna M., Giammanco A., Granito A., Pettinari I., Marinelli S., Bolondi L., Falsetti L., Salvi A., Durante-Mangoni E., Cesaro F., Farinaro V., Ragone E., Morana I., Andriulli A., Ippolito A., Iacobellis A., Niro G., Merla A., Raimondo G., Maimone S., Cacciola I., Varvara D., Drenaggi D., Staffolani S., Picardi A., Vespasiani-Gentilucci U., Galati G., Gallo P., Davi G., Schiavone C., Santilli F., Tana C., Licata A., Soresi M., Bianchi B.G., Carderi I., Pinto A., Tuttolomondo A., Ferrari G., Gresele P., Fierro T., Morelli O., Laffi G., Romanelli R.G., Arena U., Cristina S., Gasbarrini A., Gargovich M., Zocco Z.M., Riccardi L., Ainora M.E., Capeci W., Martino M.G., Lorenzo N., Cavallo M., Frugiuele P., Greco A., Pietrangelo A., Ventura P., Cuoghi C., Marcacci M., Serviddio G., Vendemiale G., Villani R., Gargano R., Vidili G., Di Cesare V., Masala M., Delitala G., Invernizzi P., Di Minno G., Tufano A., Purrello F., Privitera G., Forgione A., Curigliano V., Senzolo M., Rodriguez-Castro K.-I., Giannelli G., Serra C., Neri S., Pignataro P., Rizzetto M., Debernardi V.W., Svegliati B.G., Bergamaschi G., Costanzo F., Angelico F., Del Ben M., Polimeni L., Talerico G., Proietti M., Romiti G.F., Ruscio E., and Toriello F.

Subjects
Registrie, Liver Cirrhosis, Male, Cirrhosis, Hepatocellular carcinoma, 030204 cardiovascular system & hematology, Gastroenterology, 0302 clinical medicine, Esophageal varices, Prevalence, Medicine, Prospective Studies, Registries, Prospective cohort study, Multivariate Analysi, Venous Thrombosis, Portal Vein, Anticoagulants, Liver failure, Splanchnic venous thrombosis, Emergency Medicine, Internal Medicine, Middle Aged, Portal vein thrombosis, Venous thrombosis, Splanchnic venous thrombosis , Anticoagulants , Liver failure , Hepatocellular carcinoma , Esophageal varices, Italy, Liver, Female, 030211 gastroenterology & hepatology, medicine.symptom, Settore SECS-S/01 - Statistica, Human, medicine.medical_specialty, Liver Cirrhosi, Socio-culturale, Asymptomatic, 03 medical and health sciences, Anticoagulants, Esophageal varices, Hepatocellular carcinoma, Liver failure, Splanchnic venous thrombosis, Internal medicine, Humans, Aged, Hepatology, Esophageal varice, business.industry, Anticoagulant, Splanchnic venous thrombosi, medicine.disease, Surgery, Prospective Studie, Splanchnic venous thrombosis, Anticoagulants, Liver failure, Hepatocellular carcinoma, Esophageal varices, Multivariate Analysis, Upper gastrointestinal bleeding, Complication, business
Abstract

Portal vein thrombosis may occur in cirrhosis; nevertheless, its prevalence, and predictors are still elusive. To investigate this issue, the Italian Society of Internal Medicine undertook the “Portal vein thrombosis Relevance On Liver cirrhosis: Italian Venous thrombotic Events Registry” (PRO-LIVER). This prospective multicenter study includes consecutive cirrhotic patients undergoing Doppler ultrasound examination of the portal area to evaluate the prevalence and incidence of portal vein thrombosis over a 2-year scheduled follow-up. Seven hundred and fifty-three (68% men; 64±12years) patients were included in the present analysis. Fifty percent of the cases were cirrhotic outpatients. Viral (44%) etiology was predominant. Around half of the patients had a mild-severity disease according to the Child–Pugh score; hepatocellular carcinoma was present in 20%. The prevalence of ultrasound-detected portal vein thrombosis was 17% (n=126); it was asymptomatic in 43% of the cases. Notably, more than half of the portal vein thrombosis patients (n=81) were not treated with anticoagulant therapy. Logistic step-forward multivariate analysis demonstrated that previous portal vein thrombosis (p&nbsp

Published
2016
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3. A Glossary of Zooarchaeological Methods

Author

Albarella, U., Rizzetto, M., and Albarella, U.

Abstract

This methodological glossary presents brief explanations of the main analytical methods employed by zooarchaeologists and makes reference to those chapters in the Handbook that provide examples of their applications. The aim is to provide non-expert readers with a basic understanding of how the evidence presented in this volume has been obtained. The limitations and biases of each type of analysis are also briefly outlined, as their acknowledgement represents an essential prerequisite to research on archaeological materials. The definitions always refer to zooarchaeological applications of the term, although many of them may be employed in other disciplines with similar or different meanings. Each term makes reference to the chapters where it is mentioned, with the exception of approaches that are invariably adopted (e.g. taxonomic identification, quantification).

Published
2017

4. Impact of Safety-Related Dose Reductions or Discontinuations on Sustained Virologic Response in HCV-Infected Patients: Results from the GUARD-C Cohort

Author

GUARD C, Study Group, Hassanein, T, Bakalos, G, Ahlers, S, Shiffman, Ml, Tallarico, L, Reddy, Kr, Orlandini, A, Ferenci, P, Derbala, M, Coppola, C, Foster, Gr, Basho, J, Shabanaj, G, Harxhi, A, Debzi, N, Afredj, N, Guessab, N, Mahindad, N, Mahiou, H, Aissaoui, M, Al Qameesh, J, Al Ghandoor, Z, Assene, C, Bastens, B, Brixko, C, Cool, M, De Galocsy, C, Delwaide, J, George, C, Laukens, P, Lefebvre, V, Mulkay, Jp, Nevens, F, Servais, B, Van Vlierberghe, H, Horsmans, Y, Henrion, J, Sprengers, D, Michielsen, P, Bourgeois, S, Lasser, L, Langlet, P, Robaeys, G, Martinet, Jp, Warzee, P, Hoste, P, Reynaert, H, Juriens, I, Decaestecker, J, Van Der Meersch, F, Janssens, F, Ahmetagic, S, Verhaz, A, Bevanda, M, Calkic, L, Ibrahimpasic, N, Mesihovic, R, Mello, Ce, Ruiz, Fj, Martins Junior, E, Ferraz, Ml, Silva, G, Mendes, C, Lyra, A, Silva, Mh, Gomide, G, Fernandes, Jc, Pereira, P, Correa, Mc, Teixeira, R, Yousry, A, Hanno, A, Gabr, M, Omar, A, Esmat, G, Karatapanis, S, Nikolopoulou, V, Giannoulis, G, Manolakopoulos, S, Elefsiniotis, I, Drakoulis, C, Dimitroulopoulos, D, Kanatakis, S, Ketikoglou, I, Mimidis, K, Evgenidis, N, Akriviades, E, Vafiadi Zoubouli, I, Tsianos, E, Mela, M, Orfanou, E, Mousoulis, G, Karagiannis, I, Manesis, E, Varga, M, Nemesánszky, E, Fried, K, Schuller, J, Szalay, F, Lengyel, G, Tornai, I, Banyai, T, Lesch, M, Nagy, I, Gervain, J, Tusnadi, A, Schneider, F, Szentgyörgyi, L, Hunyady, B, Vincze, A, Tolvaj, G, Varkonyi, I, Makkai, E, Enyedi, J, Racz, I, Hausinger, P, Váczi, Z, Patai, Á, Ozsvár, Z, Lakner, L, Ribiczey, P, Bhalla, A, Somani, S, Luaia, R, Rao, P, Philip, M, Lawate, P, Nagral, A, Sood, A, Parikh, S, Merat, S, Nassiri Toosi, M, Alavian, Sm, Zali, Mr, Daryani, Ne, Drenaggi, D, Attili, Af, Bandiera, F, Bassi, P, Bellati, G, Bellantani, S, Brunetto, MAURIZIA ROSSANA, Bruno, S, Castelli, F, Castellacci, R, Cattelan, Am, Colombo, M, Craxi, A, D'Angelo, S, Colombo, S, Demelia, L, Di Perri, G, Di Giacomo, A, Ferrari, C, Francisci, D, Casinelli, K, Ganga, R, Costa, C, Mangia, A, Russo, Fp, Matarazzo, F, Mazzella, G, Mazzeo, M, Memoli, M, Montalbano, M, Montalto, G, Pieri, A, Passariello, N, Picciotto, A, Pietrangelo, A, Pirisi, M, Quirino, T, Raimondo, G, Rapaccini, Gl, Rizzardini, G, Rizzetto, M, Russello, M, Sabusco, G, Santantonio, T, Soardo, G, Amedea, A, Verucchi, G, Vinelli, F, Zignego, Al, Zuin, M, Ascione, A, Vinci, M, Pigozzi, Mg, Tundo, P, Saracco, Gm, Amoroso, P, Andreoni, M, Colletta, C, Erne, E, Megna, As, Biglino, A, Chiriaco, P, Foti, G, Spinzi, G, D'Amico, E, Paik, Sw, Ahn, Sh, Lee, Yn, Kim, Y, Yang, J, Han, Sy, Varghese, R, Al Gharabally, A, Askar, H, Sharara, A, Yaghi, C, Rached, Aa, Houmani, Z, Zaarour, F, Dohaibi, A, Ivanovski, L, Joksimovic, N, Abbas, Z, Memon, S, Mohsin, A, Masood, S, Hashmi, Z, Halota, W, Deron, Z, Mazur, W, Flisiak, R, Lipczynski, A, Musialik, J, Piekarska, A, Augustyniak, K, Baka Cwierz, B, Simon, K, Gietka, A, Berak, H, Sieklucki, J, Radowska, D, Szlauer, B, Piekos, T, Olszok, I, Jablkowski, M, Orszulak, G, Warakomska, I, Aleixo, Mj, Valente, C, Macedo, G, Sarmento Castro, R, Roxo, F, Faria, T, Mansinho, K, Velez, J, Ramos, Jp, Guerreiro, H, Alberto, S, Monteverde, C, Serejo, F, Peixe, P, Malhado, J, Curescu, M, Streinu Cercel, A, Caruntu, F, Livia, H, Preotescu, L, Arama, V, Ancuta, I, Gheorghe, L, Stanciu, C, Trifan, A, Acalovschi, M, Andreica, V, Pascu, O, Lencu, M, Sporea, I, Olteanu, D, Ionita Radu, F, Fierbinteanu Braticevici, C, Motoc, A, Silaghi, R, Musat, M, Coman, F, Stan, M, Cijevschi, C, Miftode, E, Delic, D, Jesic, R, Nozic, D, Svorcan, P, Fabri, M, Konstantinovic, L, Pelemis, M, Jankovic, G, Todorovic, Z, Nagorni, A, Kupcova, V, Skladany, L, Szantova, M, Krkoska, D, Jarcuska, P, Schreter, I, Oltman, M, Bocakova, J, Bunganic, I, Holoman, J, Giguere, A, Abdou, A. M., Basic (bio-) Medical Sciences, Gastroenterology, Laboratory of Molecullar and Cellular Therapy, Liver Cell Biology, Michielsen, Peter, GUARD-C Study Group, Graham R. Foster, Carmine Coppola, Moutaz Derbala, Peter Ferenci, Alessandra Orlandini, K. Rajender Reddy, Ludovico Tallarico, Mitchell L. Shiffman, Silke Ahler, Georgios Bakalo, Tarek Hassanein, GUARD-C Study Group: [.., Davide Drenaggi, Adolfo Francesco Attili, Franco Bandiera, Paolo Bassi, Giorgio Bellati, Stefano Bellantani, Maurizia Brunetto, Savino Bruno, Francesco Castelli, Roberto Castellacci, Anna Maria Cattelan, Massimo Colombo, Antonio Craxi, Salvatore D'angelo, Silvia Colombo, Luigi Demelia, Giovanni Di Perri, Antonio Di Giacomo, Carlo Ferrari, Daniela Francisci, Katia Casinelli, Roberto Ganga, Chiara Costa, Alessandra Mangia, Francesco Paolo Russo, Filippo Matarazzo, Giuseppe Mazzella, Maurizio Mazzeo, Massimo Memoli, Marzia Montalbano, Giuseppe Montalto, Alessandro Pieri, Nicola Passariello, Antonio Picciotto, Antonello Pietrangelo, Mario Pirisi, Tiziana Quirino, Giovanni Raimondo, Gian Ludovico Rapaccini, Giuliano Rizzardini, Mario Rizzetto, Maurizio Russello, Giuseppe Sabusco, Teresa Santantonio, Giorgio Soardo, Alessandri Amedea, Gabriella Verucchi, Francesco Vinelli, Anna Linda Zignego, Massimo Zuin, Antonio Ascione, Maria Vinci, Maria Graziella Pigozzi, Paolo Tundo, Giorgio Maria Saracco, Pietro Amoroso, Massimo Andreoni, Cosimo Colletta, Elke Erne, Angelo Salomone Megna, Alberto Biglino, Piergiorgio Chiriaco, Giuseppe Foti, Giancarlo Spinzi, Emilio D'amico, …], Foster G.R., Coppola C., Derbala M., Ferenci P., Orlandini A., Reddy K.R., Tallarico L., Shiffman M.L., Ahlers S., Bakalos G., Hassanein T., Basho J., Shabanaj G., Harxhi A., Debzi N., Afredj N., Guessab N., Mahindad N., Mahiou H., Aissaoui M., Al Qameesh J., Al Ghandoor Z., Assene C., Bastens B., Brixko C., Cool M., De Galocsy C., Delwaide J., George C., Laukens P., Lefebvre V., Mulkay J.-P., Nevens F., Servais B., Van Vlierberghe H., Horsmans Y., Henrion J., Sprengers D., Michielsen P., Bourgeois S., Lasser L., Langlet P., Robaeys G., Martinet J.-P., Warzee P., Hoste P., Reynaert H., Juriens I., Decaestecker J., Van Der Meersch F., Janssens F., Ahmetagic S., Verhaz A., Bevanda M., Calkic L., Ibrahimpasic N., Mesihovic R., Mello C.E., Ruiz F.J., Junior E.M., Ferraz M.L., Silva G., Mendes C., Lyra A., Silva M.H., Gomide G., Fernandes J.C., Pereira P., Correa M.C., Teixeira R., Yousry A., Hanno A., Gabr M., Omar A., Esmat G., Karatapanis S., Nikolopoulou V., Giannoulis G., Manolakopoulos S., Elefsiniotis I., Drakoulis C., Dimitroulopoulos D., Kanatakis S., Ketikoglou I., Mimidis K., Evgenidis N., Akriviades E., Vafiadi-Zoubouli I., Tsianos E., Mela M., Orfanou E., Mousoulis G., Karagiannis I., Manesis E., Varga M., Nemesanszky E., Fried K., Schuller J., Szalay F., Lengyel G., Tornai I., Banyai T., Lesch M., Nagy I., Gervain J., Tusnadi A., Schneider F., Szentgyorgyi L., Hunyady B., Vincze A., Tolvaj G., Varkonyi I., Makkai E., Enyedi J., Racz I., Hausinger P., Vaczi Z., Patai A., Ozsvar Z., Lakner L., Ribiczey P., Bhalla A., Somani S., Luaia R., Rao P., Philip M., Lawate P., Nagral A., Sood A., Parikh S., Merat S., Nassiri-Toosi M., Alavian S.-M., Zali M.R., Daryani N.E., Drenaggi D., Attili A.F., Bandiera F., Bassi P., Bellati G., Bellantani S., Brunetto M., Bruno S., Castelli F., Castellacci R., Cattelan A.M., Colombo M., Craxi A., D'angelo S., Colombo S., Demelia L., Di Perri G., Di Giacomo A., Ferrari C., Francisci D., Casinelli K., Ganga R., Costa C., Mangia A., Russo F.P., Matarazzo F., Mazzella G., Mazzeo M., Memoli M., Montalbano M., Montalto G., Pieri A., Passariello N., Picciotto A., Pietrangelo A., Pirisi M., Quirino T., Raimondo G., Rapaccini G.L., Rizzardini G., Rizzetto M., Russello M., Sabusco G., Santantonio T., Soardo G., Amedea A., Verucchi G., Vinelli F., Zignego A.L., Zuin M., Ascione A., Vinci M., Pigozzi M.G., Tundo P., Saracco G.M., Amoroso P., Andreoni M., Colletta C., Erne E., Megna A.S., Biglino A., Chiriaco P., Foti G., Spinzi G., D'amico E., Paik S.W., Ahn S.-H., Lee Y.N., Kim Y., Yang J., Han S.Y., Varghese R., Al Gharabally A., Askar H., Sharara A., Yaghi C., Abou Rached A., Houmani Z., Zaarour F., Dohaibi A., Ivanovski L., Joksimovic N., Abbas Z., Memon S., Mohsin A., Masood S., Hashmi Z., Halota W., Deron Z., Mazur W., Flisiak R., Lipczynski A., Musialik J., Piekarska A., Augustyniak K., Baka-Cwierz B., Simon K., Gietka A., Berak H., Sieklucki J., Radowska D., Szlauer B., Piekos T., Olszok I., Jablkowski M., Orszulak G., Warakomska I., Aleixo M.J., Valente C., Macedo G., Sarmento-Castro R., Roxo F., Faria T., Mansinho K., Velez J., Ramos J.P., Guerreiro H., Alberto S., Monteverde C., Serejo F., Peixe P., Malhado J., Curescu M., Streinu-Cercel A., Caruntu F., Livia H., Preotescu L., Arama V., Ancuta I., Gheorghe L., Stanciu C., Trifan A., Acalovschi M., Andreica V., Pascu O., Lencu M., Sporea I., Olteanu D., Ionita-Radu F., Fierbinteanu-Braticevici C., Motoc A., Silaghi R., Musat M., Coman F., Stan M., Cijevschi C., Miftode E., Delic D., Jesic R., Nozic D., Svorcan P., Fabri M., Konstantinovic L., Pelemis M., Jankovic G., Todorovic Z., Nagorni A., Kupcova V., Skladany L., Szantova M., Krkoska D., Jarcuska P., Schreter I., Oltman M., Bocakova J., Bunganic I., Holoman J., Giguere A., Abdou A.M.S., UCL - SSS/IREC-Institut de recherche expérimentale et clinique, UCL - SSS/IREC/GAEN-Pôle d'Hépato-gastro-entérologie, and UCL - (SLuc) Service de gastro-entérologie

Subjects
Genetics and Molecular Biology (all), Male, Chronic Hepatitis, Hepacivirus, Ribavirin/adverse effects, Asthenia/chemically induced, Polyethylene Glycol, Biochemistry, Polyethylene Glycols, Body Mass Index, Chronic Liver Disease, 0302 clinical medicine, Neutropenia/chemically induced, Interferon-alpha/adverse effects, Medicine, Chronic, lcsh:Science, Liver Diseases, virus diseases, Antiviral Agents/adverse effects, Cohort, Science & Technology - Other Topics, 030211 gastroenterology & hepatology, Drug Therapy, Combination, Cohort study, Human, medicine.medical_specialty, Alpha interferon, Gastroenterology and Hepatology, Antiviral Agents, Microbiology, Dose-Response Relationship, 03 medical and health sciences, Pharmacotherapy, Hepatitis C, Chronic/drug therapy, Dose Prediction Methods, Drug Therapy, Anemia/chemically induced, Humans, Hemoglobin, Aged, Medicine and health sciences, Biochemistry, Genetics and Molecular Biology (all), Hepaciviru, Science & Technology, Dose-Response Relationship, Drug, Flaviviruses, lcsh:R, Organisms, Biology and Life Sciences, Proteins, medicine.disease, digestive system diseases, chemistry, Agricultural and Biological Sciences (all), Withholding Treatment, Asthenia, Immunology, Proportional Hazards Model, lcsh:Q, Human medicine, RNA viruses, Physiology, lcsh:Medicine, Peginterferon-alfa, Polyethylene Glycols/adverse effects, Adult, Anemia, Cohort Studies, Female, Hepatitis C, Chronic, Host-Pathogen Interactions, Interferon-alpha, Middle Aged, Neutropenia, Outcome Assessment (Health Care), Proportional Hazards Models, RNA, Viral, Recombinant Proteins, Ribavirin, Medicine (all), chemistry.chemical_compound, Outcome Assessment, Health Care, Medicine and Health Sciences, 030212 general & internal medicine, Viral, Pathology and laboratory medicine, Multidisciplinary, biology, Hepatitis C virus, Pharmaceutics, Hepatitis C, Hematology, Recombinant Protein, Outcome Assessment (Health Care)/methods, Medical microbiology, Host-Pathogen Interaction, Multidisciplinary Sciences, Physiological Parameters, Research Design, Combination, Viruses, Drug, Pathogens, Host-Pathogen Interactions/drug effects, Research Article, Clinical Research Design, Research and Analysis Methods, Internal medicine, Recombinant Proteins/adverse effects, RNA, Viral/blood, Antiviral Agent, business.industry, Body Weight, Hepacivirus/drug effects, Viral pathogens, biology.organism_classification, Hepatitis viruses, Microbial pathogens, RNA, Adverse Events, Cohort Studie, business
Abstract

Background: Despite the introduction of direct-acting antiviral agents for chronic hepatitis C virus (HCV) infection, peginterferon alfa/ribavirin remains relevant in many resource-constrained settings. The non-randomized GUARD-C cohort investigated baseline predictors of safety-related dose reductions or discontinuations (sr-RD) and their impact on sustained virologic response (SVR) in patients receiving peginterferon alfa/ribavirin in routine practice. Methods: A total of 3181 HCV-mono-infected treatment-naive patients were assigned to 24 or 48 weeks of peginterferon alfa/ribavirin by their physician. Patients were categorized by time-to-first sr-RD (Week 4/12). Detailed analyses of the impact of sr-RD on SVR24 (HCV RNA

Published
2015

5. Undetectable HCV-RNA at treatment-week 8 results in high-sustained virological response in HCV G1 treatment-experienced patients with advanced liver disease: The International Italian/Spanish Boceprevir/Peginterferon/Ribavirin Name Patients Program

Author

Bruno, S, Bollani, S., Zignego, A. L., Pascasio, J. M., Magni, C., Ciancio, A., Caremani, M., Mangia, A., Marenco, S., Piovesan, S., Chemello, L., Babudieri, S., Moretti, A., Gea, F., Colletta, C., Perez Alvarez, R., Forns, X., Larrubia, J. R., Arenas, J., Crespo, J., Calvaruso, V., Ceccherini Silberstein, F., Maisonneuve, P., Craxì, A., Calleja, J. L., Di Marco, V., Monti, M., Rizzardini, G., Landonio, S., Rizzetto, M., Lapini, L. E., Piazzolla, V., Picciotto, A., Alberti, A., Cavaletto, L., Koch, M., Massari, M., Muratori, L., Cipriano, V., Montineri, A., Iacobello, C., Fangazio, S., Pirisi, M., Colombo, A., Bellati, G., Mazzotta, F., Pierotti, P., Traverso, A., Serviddio, G., Russello, M., Santantonio, T., Drenaggi, D., Marchionne, E., Zuin, M., Delliponti, M., Farina, F., Andreone, P., Scuteri, A., Galli, M., Giannini, EDOARDO GIOVANNI, Nerli, A., Carbonai, S., Coppola, N., Montalbano, M., Portelli, V., Di Biagio, A., Nicolini, LAURA AMBRA, Mastroianni, C., Madonia, S., Licata, A., Montalto, G., Giannitrapani, L., Mondelli, M., Pellicelli, A., Toniutto, P., Borgia, G., Gentile, I., De Luca, M., Di Costanzo, G. G., Corti, G., Sousa, M., Delgado, M. B., De La Revilla, J., Navarro, J. M., Barcena, R., Romero Gomez, M., Fernandez Rodriguez, C. M., Narvaez, I., Erdozain, J. C., Molina, E., Fernandez, I., Cuenca, B., Planas, R., Garcia Samaniego, J., Ladero, J. M., Gonzalez, J. M., Serra, M. A., Castellote, I., Sola, R., Anton, T., Ryan, I., Gonzalez, F., Martinez, E., Portu, J., Bruno, S, Bollani, S., Zignego, A.L., Pascasio, J.M., Magni, C., Ciancio, A., Caremani, M., Mangia, A., Marenco, S., Piovesan, S., Chemello, L., Babudieri, S., Moretti, A., Gea, F., Colletta, C., Perez-Alvarez, R., Forns, X., Larrubia, J.R., Arenas, J., Crespo, J., Calvaruso, V., Ceccherini Silberstein, F., Maisonneuve, P., Craxì, A., Calleja, J.L., Di Marco, V., Monti, M., Rizzardini, G., Landonio, S., Rizzetto, M., Lapini, L.E., Piazzolla, V., Picciotto, A., Alberti, A., Cavaletto, L., Koch, M., Massari, M., Muratori, L., Cipriano, V., Montineri, A., Iacobello, C., Fangazio, S., Pirisi, M., Colombo, A., Bellati, G., Mazzotta, F., Pierotti, P., Traverso, A., Serviddio, G., Russello, M., Santantonio, T., Drenaggi, D., Marchionne, E., Zuin, M., Delliponti, M., Farina, F., Andreone, P., Scuteri, A., Galli, M., Giannini, E.G., Nerli, A., Carbonai, S., Coppola, N., Montalbano, M., Portelli, V., Di Biagio, A., Nicolini, L.A., Mastroianni, C., Madonia, S., Licata, A., Montalto, G., Giannitrapani, L., Mondelli, M., Pellicelli, A., Toniutto, P., Borgia, G., Gentile, I., De Luca, M., Di Costanzo, G.G., Corti, G., Sousa, M., Delgado, M.B., De La Revilla, J., Navarro, J.M., Barcena, R., Romero-Gomez, M., Fernandez-Rodriguez, C.M., Narvaez, I., Erdozain, J.C., Molina, E., Fernandez, I., Cuenca, B., Planas, R., Garcia-Samaniego, J., Ladero, J.M., Gonzalez, J.M., Serra, M.A., Castellote, I., Sola, R., Anton, T., Ryan, I., Gonzalez, F., Martinez, E., Portu, J., Bollani, S, Zignego, A. L, Pascasio, J. M, Magni, C, Ciancio, A, Caremani, M, Mangia, A, Marenco, S, Piovesan, S, Chemello, L, Gentile, Ivan, Borgia, Guglielmo, Et, A, Babudieri, S, Moretti, A, Gea, F, Colletta, C, Perez Alvarez, R, Forns, X, Larrubia, J. R, Arenas, J, Crespo, J, Calvaruso, V, Ceccherini Silberstein, F, Maisonneuve, P, Craxì, A, Calleja, J. L., Bruno, S., Zignego, A., Pascasio, J., Larrubia, J., Calleja, J., Lapini, L., Giannini, E., Nicolini, L., Di Costanzo, G., Delgado, M., Navarro, J., Fernandez-Rodriguez, C., Erdozain, J., Ladero, J., Gonzalez, J., and Serra, M.

Subjects
Male, Settore MED/09 - Medicina Interna, boceprevir, cirrhosis, first-generation protease inhibitors, hepatitis C, IFN-based therapy, Adult, Aged, Antiviral Agents, Drug Therapy, Combination, Female, Hepacivirus, Hepatitis C, Chronic, Humans, Interferon-alpha, Italy, Middle Aged, Proline, RNA, Viral, Ribavirin, Spain, Treatment Outcome, Viral Load, Hepatology, Infectious Diseases, Virology, Medicine (all), Gastroenterology, first-generation protease inhibitor, chemistry.chemical_compound, Liver disease, Medicine, Viral, Chronic, Settore MED/12 - Gastroenterologia, Drug Therapy, Combination, Hepatitis C, RNA, virus diseases, Settore MED/07 - Microbiologia e Microbiologia Clinica, HCV, Viral load, Human, medicine.medical_specialty, Alpha interferon, Infectious Disease, Internal medicine, Boceprevir, hepatitis c, adult, aged, antiviral agents, drug therapy, combination, female, hepacivirus, hepatitis c, chronic, humans, interferon-alpha, italy, male, middle aged, proline, RNA, viral, ribavirin, spain, treatment outcome, viral load, hepatology, infectious diseases, virology, Decompensation, Adverse effect, Antiviral Agent, Hepaciviru, business.industry, medicine.disease, digestive system diseases, chemistry, Immunology, business, cirrhosi
Abstract

In many countries, first-generation protease inhibitors (PIs)/peginterferon/ribavirin (P/R) still represent the only treatment option for HCV-infected patients. Subjects with advanced disease and previous failure to P/R urgently need therapy, but they are under-represented in clinical trials. All treatment-experienced F3/4 Metavir patients who received boceprevir (BOC)+P/R in the Italian-Spanish Name Patient Program have been included in this study. Multivariate logistic regression analysis (MLR) was used to identify baseline and on-treatment predictors of SVR and adverse events (AEs). Four hundred and sixteen patients, mean age 57.7 (range 25-78 years), 70% males, 69.5% (289/416) F4, 14% (41/289) Child-Pugh class A6, 24% (70/289) with varices and 42% (173/416) prior null responders to P/R, were analysed. Overall, SVR rate (all 381 patients who received one dose of BOC) was 49%, (58% in F3, 45% in F4, 61% in relapsers, 51% in partial, 38% in null responders, and 72% in subjects with undetectable HCV-RNA at treatment-week (TW)8. Among patients with TW8 HCV-RNA ≥ 1000 IU/L, SVR was 8% (negative predictive value = 92%). Death occurred in 3 (0.8%) patients, while decompensation and infections were observed in 2.9% and 11%, respectively. At MLR, SVR predictors were TW4 HCV-RNA ≥ 1log10 -decline from baseline, undetectable TW8 HCV-RNA, prior relapse, albumin levels ≥3.5 g/dL and platelet counts ≥100 000/μL. Metavir F4, Child-Pugh A6, albumin, platelets, age and female gender were associated with serious and haematological AEs. Among treatment-experienced patients with advanced liver disease eligible for IFN-based therapy, TW8 HCV-RNA characterised the subset with either high or poor likelihood of achieving SVR. Using TW8 HCV-RNA as a futility rule, BOC/P/R appears to have a favourable benefit-risk profile.

Published
2015

6. Practice guidelines for the treatment of hepatitis C: recommendations from an AISF/SIMIT/SIMAST Expert Opinion Meeting

Author

Prati, D, Gasbarrini, A, Mazzotta, F, Sagnelli, E, Carosi, G, Abrescia, N, Alberti, Alfredo, Ambu, S, Andreone, P, Andriulli, A, Angelico, M, Antonucci, G, Ascione, A, Belli, Ls, Bruno, R, Bruno, S, Burra, Patrizia, Camma, C, Caporaso, N, Cariti, G, Cillo, U, Coppola, N, Craxi, A, DE LUCA, A, DE MARTIN, E, DI MARCO, V, Fagiuoli, S, Ferrari, C, Gaeta, Gb, Galli, M, Grieco, A, Grossi, P, Licata, A, Maida, I, Mangia, A, Marino, N, Maserati, R, Missale, G, Mondelli, M, Nasta, P, Niro, G, Persico, M, Petrelli, E, Picciotto, A, Piscaglia, F, Pollicino, T, Puoti, C, Puoti, M, Raimondo, G, Rumi, Mg, Santantonio, T, Smedile, A, Squadrito, G, Baroni, Gs, Taliani, G, Tavio, M, Toti, M, Bonino, F, Brunetto, Mr, Cacopardo, B, Caremani, M, Cauda, R, Colombo, M, DI PERRI, G, Donato, F, Farci, P, Fattovich, G, Filice, G, Ghinelli, F, Guadagnino, V, Lazzarin, A, Levrero, M, Licata, G, Orani, A, Paffetti, A, Pastore, G, Piccinino, F, Pizzigallo, E, Pontisso, Patrizia, Portelli, V, Rizzetto, M, Rossi, A, Stroffolini, T, Ubaldi, E, Santantanio, T, Alberti, A., Antonucci, Gf, Craxi, A., Prati D, Gasbarrini A, Mazzotta F, Sagnelli E, Carosi G, Abrescia N, Alberti A, Ambu S, Andreone P, Andriulli A, Angelico M, Antonucci GF, Ascione A, Belli LS, Bruno R, Bruno S, Burra P, Cammà, C, Caporaso N, Cariti G, Cillo U, Coppola N, Craxì, A, De Luca A, De Martin E, Di Marco, V, Fagiuoli S, Ferrari C, Gaeta GB, Galli M, Grieco A, Grossi P, Licata, A, Maida I, Mangia A, Marino N, Maserati R, Missale G, Mondelli M, Nasta P, Niro G, Persico M, Petrelli E, Picciotto A, Piscaglia F, Pollicino T, Prati D, Puoti C, Puoti M, Raimondo G, Rumi MG, Sagnelli E, Santantonio T, Smedile A, Squadrito G, Baroni GS, Taliani G, Tavio M, Toti M, Bonino F, Brunetto MR, Cacopardo B, Caremani M, Cauda R, Colombo M, Di Perri G, Donato F, Farci P, Fattovich G, Filice G, Ghinelli F, Guadagnino V, Lazzarin A, Levrero M, Licata G, Orani A, Paffetti A, Pastore G, Piccinino F, Pizzigallo E, Pontisso P, Portelli V, Rizzetto M, Rossi A, Stroffolini T, Ubaldi E., Italian Association for the Study of the Liver, Italian Society of Infectious, Tropical Disease, Italian Society for the Study of Sexually Transmitted Diseases: Prati D., Gasbarrini A., Mazzotta F., Sagnelli E., Carosi G., Abrescia N., Alberti A., Ambu S., Andreone P., Andriulli A., Angelico M., Antonucci G.F., Ascione A., Belli L.S., Bruno R., Bruno S., Burra P., Cammà C., Caporaso N., Cariti G., Cillo U., Coppola N., Craxì A., De Luca A., De Martin E., Di Marco V., Fagiuoli S., Ferrari C., Gaeta G.B., Galli M., Grieco A., Grossi P., Licata A., Maida I., Mangia A., Marino N., Maserati R., Missale G., Mondelli M., Nasta P., Niro G., Persico M., Petrelli E., Picciotto A., Piscaglia F., Pollicino T., Puoti C., Puoti M., Raimondo G., Rumi M.G., Santantonio T., Smedile A., Squadrito G., Baroni G.S., Taliani G., Tavio M., Toti M., Bonino F., Brunetto M.R., Cacopardo B., Caremani M., Cauda R., Colombo M., Di Perri G., Donato F., Farci P., Fattovich G., Filice G., Ghinelli F., Guadagnino V., Lazzarin A., Levrero M., Licata G., Orani A., Paffetti A., Pastore G., Piccinino F., Pizzigallo E., Pontisso P., Portelli V., Rizzetto M., Rossi A., Stroffolini T., Ubaldi E., Prati, D, Gasbarrini, A, Mazzotta, F, Sagnelli, E, Carosi, G, Abrescia, N, Alberti, A, Ambu, S, Andreone, P, Andriulli, A, Angelico, M, Antonucci, G, Ascione, A, Belli, L, Bruno, R, Bruno, S, Burra, P, Caporaso, N, Cariti, G, Cillo, U, Coppola, N, De Luca, A, De Martin, E, Fagiuoli, S, Ferrari, C, Gaeta, G, Galli, M, Grieco, A, Grossi, P, Maida, I, Mangia, A, Marino, N, Maserati, R, Missale, G, Mondelli, M, Nasta, P, Niro, G, Persico, M, Petrelli, E, Picciotto, A, Piscaglia, F, Pollicino, T, Puoti, C, Puoti, M, Raimondo, G, Rumi, M, Santantonio, T, Smedile, A, Squadrito, G, Baroni, G, Taliani, G, Tavio, M, Toti, M, Bonino, F, Brunetto, M, Cacopardo, B, Caremani, M, Cauda, R, Colombo, M, Di Perri, G, Donato, F, Farci, P, Fattovich, G, Filice, G, Ghinelli, F, Guadagnino, V, Lazzarin, A, Levrero, M, Licata, G, Orani, A, Paffetti, A, Pastore, G, Piccinino, F, Pizzigallo, E, Pontisso, P, Portelli, V, Rizzetto, M, Rossi, A, Stroffolini, T, and Ubaldi, E

Subjects
Liver Cirrhosis, ANTIVIRAL TREATMENT, Human immunodeficiency virus (HIV), HIV Infections, Hepacivirus, ANTIVIRAL THERAPY, PEGYLATED INTERFERON-ALPHA-2B, LIVER-TRANSPLANTATION, PEGINTERFERON ALPHA-2A, HIV-INFECTED PATIENTS, VIRUS-COINFECTED PATIENTS, RAPID VIROLOGICAL RESPONSE, Antiviral therapy, medicine.disease_cause, Gastroenterology, Polyethylene Glycols, HBV, guidelines, Acute hepatitis, Chronic hepatitis, Settore MED/12 - Gastroenterologia, liver transplantation, Hepatitis C, Recombinant Proteins, acute hepatitis, antiviral therapy, chronic hepatitis, cirrhosis, elderly patients, hbv, hcv, hdv, hiv, CLINICAL PRACTICE GUIDELINES, Cirrhosis, HCV, Drug Therapy, Combination, Antiviral therapy Acute hepatitis Chronic hepatitis,Cirrhosis, Elderly patients, HBV, HCV, HDV, HIV Liver transplantation, Elderly patient, Acute hepatiti, medicine.medical_specialty, Genotype, Alpha interferon, Interferon alpha-2, CHRONIC HEPATITIS C, Antiviral Agents, Hepatitis B, Chronic, Internal medicine, HDV, Drug Resistance, Viral, Ribavirin, medicine, Humans, Cirrhosi, Hepatology, business.industry, Settore MED/09 - MEDICINA INTERNA, Interferon-alpha, HIV, Hepatitis C, Chronic, medicine.disease, Elderly patients, Family medicine, Expert opinion, Chronic hepatiti, business
Abstract

It is increasingly clear that a tailored therapeutic approach to patients with hepatitis C virus infection is needed. Success rates in difficult to treat and low-responsive hepatitis C virus patients are not completely satisfactory, and there is the need to optimise treatment duration and intensity in patients with the highest likelihood of response. In addition, the management of special patient categories originally excluded from phase III registration trials needs to be critically re-evaluated. This article reports the recommendations for the treatment of hepatitis C virus infection on an individual basis, drafted by experts of three scientific societies.

Published
2010

8. Pegylated interferon α plus ribavirin for the treatment of chronic hepatitis C: A multicentre independent study supported by the Italian Drug Agency

Author

Rosina F, Tosti ME, Borghesio E, Masocco M, Mele A, Coppola C, Milella M, Borgia G, Andreone P, Koch M, Zignego AL, Romano M, Carrara M, Almasio PL, Azzola E, Nardone G, Benedetti A, Carosi G, Mazzotta F, Sagnelli E, Rizzetto M, for the AIFA Study Group, Italian Association for the Study of the Liver, Italian Society for Infectious, Tropical Diseases, Italian Association of Hospital Gastroenterologists, Italian Society of Gastroenterology, LOGUERCIO, Carmelina, Rosina, F, Tosti, Me, Borghesio, E, Masocco, M, Mele, A, Coppola, C, Milella, M, Borgia, G, Andreone, P, Koch, M, Zignego, Al, Romano, M, Carrara, M, Almasio, Pl, Azzola, E, Nardone, G, Benedetti, A, Carosi, G, Mazzotta, F, Sagnelli, E, Rizzetto, M, for the AIFA Study, Group, Italian Association for the Study of the, Liver, Italian Society for, Infectiou, Tropical, Disease, Italian Association of Hospital, Gastroenterologist, Italian Society of, Gastroenterology, and Loguercio, Carmelina

Published
2014

9. Evolving clinical landscape of chronic hepatitis B: A multicenter Italian study

Author

Stroffolini T., Almasio P. L., Sagnelli E., Mele A., Gaeta G. B., Italian Hospitals' Collaborating Group, Scuteri A., Antonucci G., Iacomi F., Babudieri S., Pintus A., Stornaiuolo G., Brancaccio G., Brunetto M., Sasso R., Caporaso N., Morisco F., Chiaramonte M., Lattanzi E., Di Marco V., Venezia G., Fagiuoli S., Boninsegna S., Fattovich G., Olivari N., Ferrari C., Giuberti T., Ferrigno L., Magnani G., Massari M., Mangano C., Caserta C., Messina V., Pastore G., Palattella S., Piccinino F., Stanzione M., Pinzello G., Vinci M., Raimondo G., Caccamo G., Roffi L., Bellia V., Rizzetto M., Smedile A., Ciancio A., ANDREONE, PIETRO, Infectious and Tropical Diseases, Università degli Studi di Roma 'La Sapienza' = Sapienza University [Rome], Gastroenterology, Università degli studi di Palermo - University of Palermo, Public,Clinical and Preventive Medicine, University of Naples Federico II, Laboratory of Epidemiology, Clinical Epidemiology Unit, Istituto Superiore di Sanita [Rome], Infectious Diseases Dept, Stroffolini T., Almasio P.L., Sagnelli E., Mele A., Gaeta G.B., Italian Hospitals' Collaborating Group, Andreone P., Scuteri A., Antonucci G., Iacomi F., Babudieri S., Pintus A., Stornaiuolo G., Brancaccio G., Brunetto M., Sasso R., Caporaso N., Morisco F., Chiaramonte M., Lattanzi E., Di Marco V., Venezia G., Fagiuoli S., Boninsegna S., Fattovich G., Olivari N., Ferrari C., Giuberti T., Ferrigno L., Magnani G., Massari M., Mangano C., Caserta C., Messina V., Pastore G., Palattella S., Piccinino F., Stanzione M., Pinzello G., Vinci M., Raimondo G., Caccamo G., Roffi L., Bellia V., Rizzetto M., Smedile A., Ciancio A., Stroffolini, T, Almasio, P, Sagnelli, E, Mele, A, Gaeta, G, Andreone, P, Scuteri, A, Antonucci, G, Iacomi, F, Babudieri, S, Pintus, A, Stornaiuolo, G, Brancaccio, G, Brunetto, M, Sasso, R, Caporaso, N, Morisco, F, Chiaramonte, M, Lattanzi, E, Di Marco, V, Venezia, G, Fagiuoli, S, Boninsegna, S, Fattovich, G, Olivari, N, Ferrari, C, Giuberti, T, Ferrigno, L, Magnani, G, Massari, M, Mangano, C, Caserta, C, Messina, V, Pastore, G, Palattella, S, Piccinino, F, Stanzione, M, Pinzello, G, Vinci, M, Raimondo, G, Caccamo, G, Roffi, L, Bellia, V, Rizzetto, M, Smedile, A, and Ciancio, A

Subjects
Male, HBsAg, viruses, HIV Infections, Antibodies, Viral, HBeAg, Hepatitis, Liver disease, CHRONIC HEPATITIS B, epidemiology, GEOGRAPHICAL LANDSCAPE, 0302 clinical medicine, 80 and over, Prevalence, Viral, Chronic, Aged, 80 and over, 0303 health sciences, Geography, Age Factors, virus diseases, Hepatitis C, Hepatitis B, Middle Aged, Hepatitis D, 3. Good health, Infectious Diseases, Cirrhosis, Italy, Medicine, 030211 gastroenterology & hepatology, Female, Hepatitis D virus, Human, Adult, Hepatitis, Viral, Human, Adolescent, Antibodies, 03 medical and health sciences, Hepatitis B, Chronic, HDV, Virology, Cirrhosis, HBeAg, HDV, Hepatitis B, Adolescent, Adult, Age Factors, Aged, Aged, 80 and over, Antibodies, Viral, Cross-Sectional Studies, Female, Geography, HIV, HIV Infections, Hepatitis B, Chronic, Hepatitis, Viral, Human, Humans, Italy, Male, Middle Aged, Prevalence, Virology, Infectious Diseases, medicine, Aged, Cross-Sectional Studies, HIV, Humans, 030304 developmental biology, Cirrhosi, business.industry, medicine.disease, digestive system diseases, business
Abstract

The aim of the study was to evaluate the characteristics of chronic hepatitis B with special reference to the geographical origin of the patients and to the prevalence of HBeAg and viral and non-viral co-factors of liver disease. A cross-sectional multicenter survey was undertaken, which enrolled 1,386 HBsAg chronic carriers observed consecutively in 21 referral centers over a 6-month period. The prevalence of HBeAg in patients was 11%; the presence of HBeAg was associated independently with a younger age and co-infection with HIV. Anti-HDV, anti-HCV, or anti-HIV antibodies were detected in 8.1%, 6.5%, and 2%, respectively. However, among the patients first diagnosed during the study period (incident cases), 14.3% were anti-HDV positive. Seven percent of the patients were immigrants; they were younger than Italian patients and 18% were HBeAg positive; no difference was observed in the prevalence of anti-HDV, anti-HCV, or anti-HIV antibodies. The presence of cirrhosis was associated independently with an age >52 years, the presence of anti-HDV or anti-HCV, alcohol use >4 drinks/day, and a high BMI. The clinical epidemiology of chronic hepatitis B virus (HBV) infection shows a dynamic profile, with the potential for re-emergence of cases with HBeAg or anti-HDV and an emerging impact of metabolic factors on the evolution of liver disease.

Published
2009
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11. Clinical outcome of HBeAg-negative chronic hepatitis B in relation to virological response to lamivudine

Author

Di Marco, V., Marzano, A., Lampertico, P., Andreone, Pietro, Santantonio, T., Almasio, P. L., Rizzetto, M., Craxì, A., Italian Association for the Study of the Liver Lamivudine Study Group Italy, DI MARCO, V, MARZANO, A, LAMPERTICO, P, ANDREONE, P, SANTANTONIO, T, ALMASIO, PL, RIZZETTO, M, CRAXI, A, Di Marco V., Marzano A., Lampertico P., Andreone P., Santantonio T., Almasio P.L., Rizzetto M., Craxì A., and Italian Association for the Study of the Liver (AISF) Lamivudine Study Group Italy

Subjects
Adult, Male, medicine.medical_specialty, ANTIVIRAL TREATMENT, Hepatitis B virus, Cirrhosis, Carcinoma, Hepatocellular, medicine.medical_treatment, Epatite cronica da Virus B, trattamento antivirale, LAMIVUDINE, CHRONIC HEPATITIS B, TREATMENT RESISTANCE, Liver transplantation, Gastroenterology, Liver disease, Hepatitis B, Chronic, Internal medicine, Medicine, Humans, Hepatitis B e Antigens, Aged, Retrospective Studies, Hepatology, business.industry, Incidence, Liver Neoplasms, Lamivudine, Middle Aged, medicine.disease, Surgery, Liver Transplantation, Survival Rate, Treatment Outcome, HBeAg, Hepatocellular carcinoma, Multivariate Analysis, Mutation, Reverse Transcriptase Inhibitors, Female, business, Viral load, medicine.drug
Abstract

The effect of lamivudine treatment on the outcome of patients with hepatitis B e antigen (HBeAg)-negative chronic hepatitis is unclear. In a retrospective multicenter study, we have analyzed the virological events observed during lamivudine therapy in patients with HBeAg-negative chronic hepatitis and evaluated the correlation between virological response and clinical outcomes. Among 656 patients (mean age 49.1 years) included in the database, 54% had chronic hepatitis, 30% had Child-Turcotte-Pugh (CTP) A cirrhosis, and 16% had CTP B/C cirrhosis. On therapy (median 22 months, range 1–66), a virological response was obtained in 616 patients (93.9%). The rate of maintained virological response was 39% after 4 years. During follow-up, 47 (7.2%) patients underwent liver transplantation, liver disease worsened in 31 (4.7%), hepatocellular carcinoma (HCC) developed in 31 (4.7%), and 24 patients (3.6%) died of liver-related causes. Patients who had cirrhosis and who maintained virological response were less likely than those with viral breakthrough to develop HCC (P < .001) and disease worsening (P < .001). Survival was better in CTP A patients with cirrhosis and maintained virological response (P = .01 by rank test). Multivariate analysis revealed that presence of cirrhosis and viral breakthrough were independently related to mortality and development of HCC. In conclusion, lamivudine is highly effective in reducing viral load in HBeAg-negative patients. After 4 years of therapy, 39% of patients maintain a virological and biochemical response. Loss of virological response may lead to clinical deterioration in patients with cirrhosis. (Hepatology 2004;40:883–891).

Published
2004

12. Ledipasvir and sofosbuvir plus ribavirin in patients with genotype 1 or 4 hepatitis C virus infection and advanced liver disease: a multicentre, open-label, randomised, phase 2 trial

Author

Manns, M., Samuel, D., Gane, E.J., Mutimer, D., McCaughan, G., Buti, M., Prieto, M., Calleja, J.L., Peck-Radosavljevic, M., Mullhaupt, B., Agarwal, K., Angus, P., Yoshida, E.M., Colombo, M., Rizzetto, M., Dvory-Sobol, H., Denning, J., Arterburn, S., Pang, P.S., Brainard, D., McHutchison, J.G., Dufour, J.F., Vlierberghe, H. van, Hoek, B. van, Forns, X., SOLAR-2 Investigators, University of Zurich, and Manns, Michael

Subjects
Ledipasvir, Liver Cirrhosis, Male, medicine.medical_specialty, Cirrhosis, Time Factors, Sofosbuvir, Genotype, medicine.medical_treatment, 610 Medicine & health, Hepacivirus, Liver transplantation, Global Health, Gastroenterology, Antiviral Agents, 03 medical and health sciences, Liver disease, chemistry.chemical_compound, 0302 clinical medicine, Internal medicine, Ribavirin, medicine, Humans, Fluorenes, business.industry, Hepatitis C, 2725 Infectious Diseases, Hepatitis C, Chronic, Middle Aged, Viral Load, medicine.disease, Transplantation, Infectious Diseases, 10219 Clinic for Gastroenterology and Hepatology, Treatment Outcome, chemistry, 030220 oncology & carcinogenesis, RNA, Viral, 030211 gastroenterology & hepatology, Benzimidazoles, Drug Therapy, Combination, Female, Viral hepatitis, business, Uridine Monophosphate, 11176 Zurich Center for Imaging Science and Technology, medicine.drug
Abstract

Summary Background Treatment options are limited for patients infected by hepatitis C virus (HCV) with advanced liver disease. We assessed the safety and efficacy of ledipasvir, sofosbuvir, and ribavirin in patients with HCV genotype 1 or 4 and advanced liver disease. Methods We did an open-label study at 34 sites in Europe, Canada, Australia, and New Zealand. Cohort A included patients with Child-Turcotte-Pugh class B (CTP-B) or CTP-C cirrhosis who had not undergone liver transplantation. Cohort B included post-transplantation patients who had either no cirrhosis; CTP-A, CTP-B, or CTP-C cirrhosis; or fibrosing cholestatic hepatitis. Patients in each group were randomly assigned (1:1) using a computer-generated randomisation sequence to receive 12 or 24 weeks of ledipasvir (90 mg) and sofosbuvir (400 mg) once daily (combination tablet), plus ribavirin (600–1200 mg daily). The primary endpoint was the proportion of patients achieving a sustained virological response 12 weeks after treatment (SVR12). All patients who received at least one dose of study drug were included in the safety analysis and all patients who received at least one dose of study drug and did not undergo liver transplantation during treatment were included in the efficacy analyses. Estimates of SVR12 and relapse rates and their two-sided 90% CI (Clopper-Pearson method) were provided. This exploratory phase 2 study was not powered for formal comparisons among treatment groups; no statistical hypothesis testing was planned or conducted. The trial is registered with EudraCT (number 2013-002802-30) and ClinicalTrials.gov (number NCT02010255). Findings Between Jan 14, 2014, and Aug 19, 2014, 398 patients were screened. Of 333 patients who received treatment, 296 had genotype 1 HCV and 37 had genotype 4 HCV. In cohort A, among patients with genotype 1 HCV, SVR12 was achieved by 20 (87%, 90% CI 70–96) of 23 CTP-B patients with 12 weeks of treatment; 22 (96%, 81–100) of 23 CTP-B patients with 24 weeks of treatment; 17 (85%, 66–96) of 20 CTP-C patients (12 weeks treatment); and 18 (78%, 60–91) of 23 CTP-C patients (24 weeks treatment). In cohort B, among patients with genotype 1 HCV, SVR12 was achieved by 42 (93%, 84–98) of 45 patients without cirrhosis (12 weeks treatment); 44 (100%, 93–100) of 44 patients without cirrhosis (24 weeks treatment); 30 (100%, 91–100) of 30 CTP-A patients (12 weeks treatment); 27 (96%, 84–100) of 28 CTP-A patients (24 weeks treatment); 19 (95%, 78–100) of 20 CTP-B patients (12 weeks treatment); 20 (100%, 86–100) of 20 CTP-B patients (24 weeks treatment); one (50%, 3–98) of two CTP-C patients (12 weeks treatment); and four (80%, 34–99) of five CTP-C patients (24 weeks treatment). All five patients with fibrosing cholestatic hepatitis achieved SVR12 (100%, 90% CI 55–100). Among all patients with genotype 4 HCV, SVR12 was achieved by 14 (78%, 56–92) of 18 patients (12 weeks treatment) and 16 (94%, 75–100) of 17 patients (24 weeks treatment). Seven patients (2%) discontinued ledipasvir–sofosbuvir prematurely due to adverse events. 17 patients died, mainly from complications of hepatic decompensation. Interpretation Ledipasvir–sofosbuvir and ribavirin provided high rates of SVR12 for patients with advanced liver disease, including those with decompensated cirrhosis before or after liver transplantation. Funding Gilead Sciences.

Published
2015

16. Pharmacokinetics and Pharmacodynamics of Peginterferons

Author

Gonzàlez A, Francesco Scaglione, Soriano, and Rizzetto M

Subjects
Pharmacology, biology, business.industry, Hepacivirus, Alpha interferon, Individualized treatment, Bioinformatics, biology.organism_classification, Clinical Practice, Infectious Diseases, Text mining, Oncology, Chronic hepatitis, Medicine, Pharmacology (medical), business
Published
2006
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17. La gestione nel presente dell’epatite cronica B per risultati a lungo termine

Author

Carosi, G, Gaeta, GB, Fagiuoli, S, Lampertico, P, Levrero, M, Marzano, A, Santantonio, TA, Rizzetto, M, Carosi, G, Gaeta, G, Fagiuoli, S, Lampertico, P, Levrero, M, Marzano, A, Santantonio, T, and Rizzetto, M

Subjects
epatite cronica B
Abstract

L’infezione cronica da virus dell'epatite B (HBV) è un grave problema di salute pubblica che interessa milioni di persone nelle quali il decorso della malattia può portare allo sviluppo di cirrosi, epatocarcinoma, scompenso epatico, riducendo così la sopravvivenza dei pazienti. Nonostante la vaccinazione obbligatoria, nel nostro paese si contano ancora centinaia di migliaia di cittadini italiani e immigrati da aree ad alta endemia con epatite cronica B, contratta alla nascita o nei primi anni di vita, che in molti casi può rimanere misconosciuta e asintomatica per decenni ma che nel tempo può progredire e favorire lo sviluppo di cirrosi ed epatocarcinoma (1). Negli ultimi anni sono molto migliorate l’efficacia e la sicurezza dei trattamenti disponibili, sia per l’avvento dei nuovi farmaci antivirali che per la disponibilità di più accurate tecniche diagnostiche per la stadiazione dell’epatopatia e il monitoraggio della risposta alla terapia. Nonostante i risultati fino a qualche anno fa insperati, sussistono bisogni insoddisfatti e ulteriori margini di miglioramento terapeutico per incrementare l’attesa di vita dei pazienti.

Published
2012

18. 3. HBV DNA suppression and HBsAg clearance in HBeAg negative chronic hepatitis B patients on lamivudine therapy for over 5 years

Author

Fasano M, Lampertico P, Marzano A, Di Marco V, Niro GA, Brancaccio G, Marengo A, Scotto G, Brunetto MR, Rizzetto M, Angarano G, Santantonio T., GAETA, Giovanni Battista, Fasano, M, Lampertico, P, Marzano, A, Di Marco, V, Niro, Ga, Brancaccio, G, Marengo, A, Scotto, G, Brunetto, Mr, Gaeta, Giovanni Battista, Rizzetto, M, Angarano, G, and Santantonio, T.

Abstract

BACKGROUND & AIMS: In long-term responder patients, it is unclear whether lamivudine (LAM) monotherapy should be continued or switched to a high-genetic-barrier analogue. This study aims at assessing LAM efficacy over a 5-year period and the residual risk of drug resistance. The rate of HBsAg clearance and LAM long-term safety profile were also evaluated. METHODS: One hundred and ninety-one patients with chronic HBeAg-negative hepatitis B successfully treated with LAM monotherapy for at least 5 years were included. Biochemical and virological tests were assessed every 3 months in all patients and HBsAg quantification was performed in 45/191. Reverse-transcriptase (RT) region was directly sequenced in virological breakthrough patients. RESULTS: One hundred and ninety-one patients (148 males, median age 53 years, 72 with compensated cirrhosis) responding to 60-month LAM monotherapy continued to receive LAM monotherapy beyond the initial 5 years and were followed for an additional 36-month median period (range 1-108). Virological response was maintained in 128/191 patients (67%) and HBsAg clearance was observed in 15/128 (11.7%) after a 32-month median period (range 1-65). The 63 remaining patients (33%) showed virological breakthrough after a 15-month median treatment (range 1-78). RT region analysis was performed in 38/63 breakthrough patients and LAM resistant mutations were found in 37/38. No significant side effects were observed. CONCLUSIONS: In long-term responder patients, continuation of LAM monotherapy resulted in persistent viral suppression in most cases with undetectable HBV DNA by real-time PCR; moreover, 11.7% of these patients cleared HBsAg. Selection of LAM resistance, however, can still occur even after successful long-term therapy, thus emphasising the importance of a careful virological monitoring.

Published
2012

19. Eltrombopag before procedures in patients with cirrhosis and thrombocytopenia

Author

Afdhal NH, Giannini EG, Tayyab G, Mohsin A, Lee JW, Andriulli A, Jeffers L, McHutchison J, Chen PJ, Han KH, Campbell F, Hyde D, Brainsky A, Theodore D, ELEVATE Study Group […, Akram J, Bessonova E, Bilodeau M, Bloomer J, Botta Fridlund D, Bzowej N, Calmus Y, Carbonell N, Caro Patón A, Cholewinska G, Chuang WL, Colombato L, Colombo M, Craxi A, Di Leo A, Diago M, Dumortier J, Elkasahab M, Everson G, Fallon M, Fedeli G, Finazzi R, Fontanella A, Francavilla A, Gadano A, Gambarin Gelwan M, Gordon F, Graus Morales J, Grieco A, Gugenheim J, Homenda W, Iaquinto G, Kang H, Khan Z, Kuliczkowski K, Kwo P, Lee JH, Lee W, Lee YS, Mazur W, Moreno C, Morozov V, Muñoz A, Navasa Anadón M, Nijhawan S, Pinzello G, Poordad F, Prieto Castillo M, Rafalsky V, Rapaccini G, Regenstein F, Rewak W, Riley T, Ripoll Noiseux C, Rizzetto M, Rodrigo Lopez J, Russo M, Samuel D, Sánchez Antolín G, Satyanaryana R, Savarino V, Shiffman M, Sigal S, Solá Lamoglia R, Sterling R, Tanno H, Te H, Terg R, Thuluvath P, Trepo C, Vargas H, Xiol Quingles X, Zaman A, Fontana R, Kim K, Abrams C, Gish R, Cardenas A, ANDREONE, PIETRO, MAZZELLA, GIUSEPPE, Afdhal, NH, Giannini, EG, Tayyab, G, Mohsin, A, Lee, JW, Andriulli, A, Jeffers, L, McHutchison, J, Chen, PJ, Han, KH, Campbell, F, Hyde, D, Brainsky, A, Theodore, D, Craxi, A, Afdhal NH, Giannini EG, Tayyab G, Mohsin A, Lee JW, Andriulli A, Jeffers L, McHutchison J, Chen PJ, Han KH, Campbell F, Hyde D, Brainsky A, Theodore D, ELEVATE Study Group […, Akram J, Andreone P, Bessonova E, Bilodeau M, Bloomer J, Botta-Fridlund D, Bzowej N, Calmus Y, Carbonell N, Caro Patón A, Cholewinska G, Chuang WL, Colombato L, Colombo M, Craxi A, Di Leo A, Diago M, Dumortier J, Elkasahab M, Everson G, Fallon M, Fedeli G, Finazzi R, Fontanella A, Francavilla A, Gadano A, Gambarin-Gelwan M, Gordon F, Graus Morales J, Grieco A, Gugenheim J, Homenda W, Iaquinto G, Kang H, Khan Z, Kuliczkowski K, Kwo P, Lee JH, Lee W, Lee YS, Mazur W, Mazzella G, Moreno C, Morozov V, Muñoz A, Navasa Anadón M, Nijhawan S, Pinzello G, Poordad F, Prieto Castillo M, Rafalsky V, Rapaccini G, Regenstein F, Rewak W, Riley T, Ripoll Noiseux C, Rizzetto M, Rodrigo Lopez J, Russo M, Samuel D, Sánchez Antolín G, Satyanaryana R, Savarino V, Shiffman M, Sigal S, Solá Lamoglia R, Sterling R, Tanno H, Te H, Terg R, Thuluvath P, Trepo C, Vargas H, Xiol Quingles X, Zaman A, Fontana R, Kim K, Abrams C, Gish R, Cardenas A, and …]

Subjects
Liver Cirrhosis, Male, Cirrhosis, Chronic liver disease, Benzoates, law.invention, chemistry.chemical_compound, Randomized controlled trial, law, Receptors, Clinical endpoint, 80 and over, Medicine, CIRRHOSIS, Aged, 80 and over, Benzoic Acids, General Medicine, CHRONIC LIVER DISEASE, Middle Aged, Hydrazines, Thrombopoietin, Elective Surgical Procedures, Anesthesia, Female, Elective Surgical Procedure, Receptors, Thrombopoietin, Adult, Adolescent, Eltrombopag, ELTROMBOPAG, Hemorrhage, Platelet Transfusion, Placebo, Young Adult, Double-Blind Method, Elective, Surgical Procedures, Elective, Humans, Aged, THROMBOCYTOPENIA, Surgical Procedures, business.industry, Platelet Count, cirrhosis, Settore MED/09 - MEDICINA INTERNA, medicine.disease, Thrombocytopenia, Platelet transfusion, chemistry, Chronic Disease, Pyrazoles, business
Abstract

Eltrombopag is an oral thrombopoietin-receptor agonist. This study evaluated the efficacy of eltrombopag for increasing platelet counts and reducing the need for platelet transfusions in patients with thrombocytopenia and chronic liver disease who are undergoing an elective invasive procedure.We randomly assigned 292 patients with chronic liver disease of diverse causes and platelet counts of less than 50,000 per cubic millimeter to receive eltrombopag, at a dose of 75 mg daily, or placebo for 14 days before a planned elective invasive procedure that was performed within 5 days after the last dose. The primary end point was the avoidance of a platelet transfusion before, during, and up to 7 days after the procedure. A key secondary end point was the occurrence of bleeding (World Health Organization [WHO] grade 2 or higher) during this period.A platelet transfusion was avoided in 104 of 145 patients who received eltrombopag (72%) and in 28 of 147 who received placebo (19%) (P0.001). No significant difference between the eltrombopag and placebo groups was observed in bleeding episodes of WHO grade 2 or higher, which were reported in 17% and 23% of patients, respectively. Thrombotic events of the portal venous system were observed in 6 patients who received eltrombopag, as compared with 1 who received placebo, resulting in the early termination of the study. The incidence and severity of other adverse events were similar in the eltrombopag and placebo groups.Eltrombopag reduced the need for platelet transfusions in patients with chronic liver disease who were undergoing elective invasive procedures, but it was associated with an increased incidence of portal-vein thrombosis, as compared with placebo. (Funded by GlaxoSmithKline; ELEVATE ClinicalTrials.gov number, NCT00678587.).

Published
2012

22. Telaprevir for previously untreated chronic hepatitis C virus infection

Author

Jacobson I. M., McHutchison J. G., Dusheiko G., Di Bisceglie A. M., Reddy K. R., Bzowej N. H., Marcellin P., Muir A. J., Ferenci P., Flisiak R., George J., Rizzetto M., Shouval D., Sola R., Terg R. A., Yoshida E. M., Adda N., Bengtsson L., Sankoh A. J., Kieffer T. L., George S., Kauffman R. S., Zeuzem S., ADVANCE Study Team: Gadano A., Terg R., Bell S., Cheng W., Crawford D., Dore G., MacDonald G., Roberts S., Gschwantler M., Laferl H., Maieron A., Heathcote J., Kaita K., Myers R., Sherman M., Yoshida E., Barange K., Couzigou P., Pawlotsky J. M., Pol S., Serfaty L., Trépo C., Zarski J. P., Berg T., Buggisch P., Diepolder H., Goeser T., Mauss S., Rasenack J., Schmidt W., Wedemeyer H., Baruch Y., Ben Ari Z., Maor Y., Safadi R., Zuckerman E., Colombo M., Baka Cwierz B., Gladysz A., Janczewska Kazek E., Jablkowski M., Krycka W., Diago M., Esteban Mur R., Sanchez Tapias J., Brown A., Fox R., Afdhal N., Arora S., Bennett M., Bernstein D., Bloomer J., Bochan M., Bonkovsky H., Brady C., Brown R., Bzowej N., Cochran J., Chasen R., Davis G., De Jesus E., Di Bisceglie A., Dienstag J., Dieterich D., Etzkorn K., Everson G., Fried M., Freilich B., Ghalib R., Gitlin N., Godofsky E., Gordon S., Hassanein T., Jacobson I., Javadi F., Jonas M., Kilby A., Kwo P., Lawitz E., Lebovics E., Lee W., Luketic V., Maillard M., Monto A., Morgan T., Min A., Murphy M., Nelson D., Northup P., Nyberg L., Pockros P., Poordad F., Poulos J., Reddy R., Rodriguez Torres M., Satyanarayana R., Schiff E., Schwartz H., Shaikh O., Sheikh M., Sherman K., Smith J., Strohecker J., Sulkowski M., Szabo G., Te H., Terrault N., Tsai N., Vargas H., Vierling J., Wruble L., Younossi Z., Zein N., ANDREONE, PIETRO, Jacobson I.M., McHutchison J.G., Dusheiko G., Di Bisceglie A.M., Reddy K.R., Bzowej N.H., Marcellin P., Muir A.J., Ferenci P., Flisiak R., George J., Rizzetto M., Shouval D., Sola R., Terg R.A., Yoshida E.M., Adda N., Bengtsson L., Sankoh A.J., Kieffer T.L., George S., Kauffman R.S., Zeuzem S., ADVANCE Study Team: Gadano A., Terg R., Bell S., Cheng W., Crawford D., Dore G., MacDonald G., Roberts S., Gschwantler M., Laferl H., Maieron A., Heathcote J., Kaita K., Myers R., Sherman M., Yoshida E., Barange K., Couzigou P., Pawlotsky J.M., Pol S., Serfaty L., Trépo C., Zarski J.P., Berg T., Buggisch P., Diepolder H., Goeser T., Mauss S., Rasenack J., Schmidt W., Wedemeyer H., Baruch Y., Ben-Ari Z., Maor Y., Safadi R., Zuckerman E., Andreone P., Colombo M., Baka-Cwierz B., Gladysz A., Janczewska-Kazek E., Jablkowski M., Krycka W., Diago M., Esteban-Mur R., Sanchez-Tapias J., Brown A., Fox R., Afdhal N., Arora S., Bennett M., Bernstein D., Bloomer J., Bochan M., Bonkovsky H., Brady C., Brown R., Bzowej N., Cochran J., Chasen R., Davis G., De Jesus E., Di Bisceglie A., Dienstag J., Dieterich D., Etzkorn K., Everson G., Fried M., Freilich B., Ghalib R., Gitlin N., Godofsky E., Gordon S., Hassanein T., Jacobson I., Javadi F., Jonas M., Kilby A., Kwo P., Lawitz E., Lebovics E., Lee W., Luketic V., Maillard M., Monto A., Morgan T., Min A., Murphy M., Nelson D., Northup P., Nyberg L., Pockros P., Poordad F., Poulos J., Reddy R., Rodriguez-Torres M., Satyanarayana R., Schiff E., Schwartz H., Shaikh O., Sheikh M., Sherman K., Smith J., Strohecker J., Sulkowski M., Szabo G., Te H., Terrault N., Tsai N., Vargas H., Vierling J., Wruble L., Younossi Z., and Zein N.

Subjects
Adult, Male, medicine.medical_specialty, CHRONIC HEPATITIS C, Telaprevir, ANTIVIRAL TREATMENT, Serine Proteinase Inhibitors, Hepatitis C virus, Hepacivirus, Interferon alpha-2, medicine.disease_cause, Gastroenterology, Antiviral Agents, Polyethylene Glycols, chemistry.chemical_compound, Young Adult, Double-Blind Method, Internal medicine, Boceprevir, medicine, Humans, Beclabuvir, Aged, business.industry, Ribavirin, Danoprevir, Interferon-alpha, virus diseases, General Medicine, Hepatitis C, Sequence Analysis, DNA, Hepatitis C, Chronic, Middle Aged, Viral Load, medicine.disease, Ombitasvir, Recombinant Proteins, digestive system diseases, Logistic Models, chemistry, Immunology, RNA, Viral, Drug Therapy, Combination, Female, business, Oligopeptides, medicine.drug
Abstract

A B S T R AC T Background In phase 2 trials, telaprevir, a hepatitis C virus (HCV) genotype 1 protease inhibitor, in combination with peginterferon–ribavirin, as compared with peginterferon–ribavirin alone, has shown improved efficacy, with potential for shortening the duration of treatment in a majority of patients. Methods In this international, phase 3, randomized, double-blind, placebo-controlled trial, we assigned 1088 patients with HCV genotype 1 infection who had not received previous treatment for the infection to one of three groups: a group receiving telaprevir combined with peginterferon alfa-2a and ribavirin for 12 weeks (T12PR group), followed by peginterferon–ribavirin alone for 12 weeks if HCV RNA was undetectable at weeks 4 and 12 or for 36 weeks if HCV RNA was detectable at either time point; a group receiving telaprevir with peginterferon–ribavirin for 8 weeks and placebo with peginterferon–ribavirin for 4 weeks (T8PR group), followed by 12 or 36 weeks of peginterferon–ribavirin on the basis of the same HCV RNA criteria; or a group receiving placebo with peginterferon–ribavirin for 12 weeks, followed by 36 weeks of peginterferon–ribavirin (PR group). The primary end point was the proportion of patients who had undetectable plasma HCV RNA 24 weeks after the last planned dose of study treatment (sustained virologic response). Results Significantly more patients in the T12PR or T8PR group than in the PR group had a sustained virologic response (75% and 69%, respectively, vs. 44%; P

Published
2011

23. PEG-IFN for hepatitis C in clinical practice

Author

Rosina F., Tosti M. E., Borghesio E., Mele A., Minoli G., Gasbarrini A., Pallone f., Carosi G., Mazzotta F., Rizzetto M., the AIFA Study Group, FEDERICO, Alessandro, Rosina, F., Tosti, M. E., Borghesio, E., Mele, A., Minoli, G., Gasbarrini, A., Pallone, F., Carosi, G., Mazzotta, F., Rizzetto, M., the AIFA Study, Group, and Federico, Alessandro

Published
2009

24. Randomised controlled trial of doxorubicin-eluting beads vs conventional chemoembolisation for hepatocellular carcinoma

Author

Golfieri, R., Giampalma, E., Renzulli, M, Cioni, R., Bargellini, I., Bartolozzi, C., Breatta, A. D., Gandini, G., Nani, R., Gasparini, D., Cucchetti, A., Bolondi, L., Trevisani, COLLABORATORS:Mosconi C, F., Cappelli, A, Galaverni, Mc, Pini, P, Piscaglia, F, Benevento, F, Giampaolo, L, Caprara, C, Menichella, R, Lenzi, M, Bernardi, M, Santi, V, Erroi, V, Mazzella, G, Colecchia, A, Montrone, L, Schiumerini, R, Bianchi, G, Zoli, M, Martini, G, Fraticelli, L, Sama, C, Berardi, S, Serra, C, Vignali, C, Bianchi, F, Vallini, V, Carrai, P, Filipponi, F, Moneta, S, Pea, E, Giunta, S, Sacco, R, Ricchiuti, A, di Fluri, G, Coco, B, Rossato, D, Vighetti, C, Battisti, G, Rapellino, A, Carucci, P, Cosso, L, Rizzetto, M, Mirabella, S, Sturniolo, L, Catalano, Giorgia, Salizzoni, M, Agazzi, R, Limonta, S, Fagiuoli, S, Verga, G, Magini, G, Aprile, G, Vit, A., Golfieri, R, Giampalma, E, Renzulli, M, Cioni, R, Bargellini, I, Bartolozzi, C, Breatta, A, Gandini, G, Nani, R, Gasparini, D, Cucchetti, A, Bolondi, L, Trevisani, F, Fagiuoli, S, Golfieri, Rita, Giampalma, Emanuela, Renzulli, Matteo, Cioni, R., Bargellini, I., Bartolozzi, Catia, Breatta, A. D., Gandini, Gualtiero, Nani, R., Gasparini, D., Cucchetti, Alessandro, Bolondi, Luigi, Trevisani, Franco, on behalf of the PRECISION ITALIA STUDY GROUP:, [. . ., Piscaglia, Fabio, Bernardi, Mauro, IBARRA GASPARINI, Daniela, and ], . .

Subjects
Male, medicine.medical_specialty, Abdominal pain, Cancer Research, Carcinoma, Hepatocellular, intra-arterial hepatic therapy, mRECIST, Gastroenterology, survival, law.invention, liver cancer, Randomized controlled trial, law, Antibiotics, Internal medicine, medicine, Carcinoma, Humans, Prospective Studies, HEPATOCELLULAR CARCINOMA, Chemoembolization, Therapeutic, Adverse effect, Prospective cohort study, Survival rate, Aged, Antibiotics, Antineoplastic, business.industry, Liver Neoplasms, Hepatocellular, medicine.disease, Doxorubicin, Female, Survival Rate, Oncology, Antineoplastic, Surgery, Hepatocellular carcinoma, Clinical Study, Chemoembolization, medicine.symptom, Therapeutic, Liver cancer, business
Abstract

Background: Transcatheter arterial chemoembolisation (TACE) is the treatment of choice for intermediate stage hepatocellular carcinoma (HCC). Doxorubicin-loaded drug-eluting beads (DEB)-TACE is expected to improve the performance of conventional TACE (cTACE). The aim of this study was to compare DEB-TACE with cTACE in terms of time-to-tumour progression (TTP), adverse events (AEs), and 2-year survival. Methods: Patients were randomised one-to-one to undergo cTACE or DEB-TACE and followed-up for at least 2 years or until death. Transcatheter arterial chemoembolisation was repeated ‘on-demand'. Results: We enrolled 177 patients: 89 underwent DEB-TACE and 88 cTACE. The median number of procedures was 2 in each arm, and the in-hospital stay was 3 and 4 days, respectively (P=0.323). No differences were found in local and overall tumour response. The median TTP was 9 months in both arms. The AE incidence and severity did not differ between the arms, except for post-procedural pain, more frequent and severe after cTACE (P

Published
2014

26. Pegylated interferon α plus ribavirin for the treatment of chronic hepatitis C: A multicentre independent study supported by the Italian Drug Agency

Author

Rosina, F, Tosti, Me, Borghesio, E, Masocco, M, Mele, A, Coppola, C, Milella, M, Borgia, G, Andreone, P, Koch, M, Zignego, Al, Romano, M, Carrara, M, Almasio, Pl, Azzola, E, Nardone, G, Benedetti, A, Carosi, G, Mazzotta, F, Sagnelli, E, Rizzetto, M, AIFA Study Group, Italian Association for the Study of the Liver, Italian Society for Infectious, Tropical, Diseases, Italian Association of Hospital Gastroenterologists, Italian Society of Gastroenterology, Italian Association for the Study of the Liver AISF, Tropical Diseases SIMIT, Italian Association of Hospital Gastroenterologists AIGO, and Contini, Carlo

Subjects
Peg-interferon/ribavirin, therapy, chronic hepatitis C, hepatitis C virus genotype cC, NO
Published
2014

27. Laparoscopic Cholecystectomy in Cirrhotic Patients

Author

Garino M, Rinaldo Pellicano, Nicola Leone, P. de Paolis, Rizzetto M, and G. R. Fronda

Subjects
Adult, Liver Cirrhosis, Male, medicine.medical_specialty, business.industry, General surgery, Gastroenterology, Middle Aged, Surgery, Cholecystectomy, Laparoscopic, Cholelithiasis, medicine, Humans, Female, business, Laparoscopic cholecystectomy, Aged
Abstract

Background/Aims: Laparoscopic cholecystectomy has become the procedure of choice for symptomatic cholelithiasis. A study to evaluate the benefits and risks of laparoscopic cholecystectomy in cirrhotic patients was performed. Methods: Between January 1994 and December 2000, 1,100 laparoscopic cholecystectomies for symptomatic gallbladder diseases were performed. There were 24 cirrhotic patients (group A) and 72 age- and sex-matched controls (group B). All patients had well-compensated cirrhosis (Child’s class A or B). Results: There was no operative mortality in either group and the postoperative complication rates were 20.8 and 9.72% in groups A and B, respectively (p < 0.000001). Operative time in group A was 89.16 vs. 68.41 min in group B (p < 0.000001). The estimated intraoperative blood loss in group A was 106.25 vs. 37.08 ml in group B (p < 0.000001). The average transfusion requirement was 0.155 and 0.0 units in groups A and B, respectively (p < 0.025). The hospital stay in groups A and B was 4.7 and 3.61 days, respectively (p < 0.0500). Conclusion: Laparoscopic cholecystectomy in patients with compensated cirrhosis is safe and should be the treatment of choice for these patients. Laparotomy should be applied only if the surgeon considers the operation inadequate to be continued laparoscopically.

Published
2001
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28. Long term follow-up of liver transplantation (OLT) for cholestatic and autoimmune end stage liver diseases

Author

Blasone L, Fagiuoli S, Colledan M, Strazzabosco M, Lenzi M, Floreani A, Burra P, Cillo U, Merenda R, Donato MF, Rossi G, Salizzoni M, Franchello A, Rizzetto M, Pinzello G, De Carlis L, Toniutto P, Andorno E, Blasone, L, Fagiuoli, S, Colledan, M, Strazzabosco, M, Lenzi, M, Floreani, A, Burra, P, Cillo, U, Merenda, R, Donato, M, Rossi, G, Salizzoni, M, Franchello, A, Rizzetto, M, Pinzello, G, De Carlis, L, Toniutto, P, and Andorno, E

Subjects
Hepatology, Gastroenterology
Published
2007

29. Adefovir dipivoxil for wait-listed and post-liver transplantation patients with lamivudine-resistant hepatitis B: Final long-term results

Author

Schiff E., Lai C. -L., Hadziyannis S., Nuehaus P., Terrault N., Colombo M., Tillmann H., Samuel D., Zuezem S., Villenueve J. -P., Arteburn S., Borroto-Esoda K., Brosgart C., Chuck S., Shakil A. O., Fung J., Alberti A., Lok A., Picciotto A., Torre F., Riely C., Trepo C., Bizollon T., Bottaa-Fridlund D., Gerolami R., Douglas D., Ranjan D., Faust D., Trojan J., Gane E., Villa E., Boarino M., Sokal E., Starkel P., Bonino F., Maurizio B., Gordon F., Pratt J., Berr F., Schiefke I., McCaughan G., Strasser S., Dusheiko G., Pageaux G. P., Larrey D., Pastore G., Santantonio T., Alexander G., Woodall T., Van Vlierberghe H., Colle I., Harley H., Guggenheim J., Myx-Staccini A., Metreau J. M., Mavier P., Vierling J., Tran T., Girgrah N., Nyberg L., Yuen M. -F., Ma M., Balnco M. D., Merli M., Tanzilli P., Angelico M., Di Paolo D., Rizzetto M., Marzano A., Lampertico P., Prieto M., Berenguer M., Felder M., Sterneck M., Willems M., Charlton M., Gunneson T., Ritter M., Voight M., Swift J., Shiffman M., Tassopoulos N., Klissas I., Naourmov N., Chamouard P., Marcellin P., Durand F., Angus P., Nathan C., Toniutto P., Fumo E., Andreone P., Cursaro C., Barcena R., Hoz F. G., Zachoval R., Christina M., De Man R. A., Metselaar H., Fagiuoli S., Schiff, E, Lai, C, Hadziyannis, S, Nuehaus, P, Terrault, N, Colombo, M, Tillmann, H, Samuel, D, Zuezem, S, Villenueve, J, Arteburn, S, Borroto-Esoda, K, Brosgart, C, Chuck, S, Shakil, A, Fung, J, Alberti, A, Lok, A, Picciotto, A, Torre, F, Riely, C, Trepo, C, Bizollon, T, Bottaa-Fridlund, D, Gerolami, R, Douglas, D, Ranjan, D, Faust, D, Trojan, J, Gane, E, Villa, E, Boarino, M, Sokal, E, Starkel, P, Bonino, F, Maurizio, B, Gordon, F, Pratt, J, Berr, F, Schiefke, I, Mccaughan, G, Strasser, S, Dusheiko, G, Pageaux, G, Larrey, D, Pastore, G, Santantonio, T, Alexander, G, Woodall, T, Van Vlierberghe, H, Colle, I, Harley, H, Guggenheim, J, Myx-Staccini, A, Metreau, J, Mavier, P, Vierling, J, Tran, T, Girgrah, N, Nyberg, L, Yuen, M, Ma, M, Balnco, M, Merli, M, Tanzilli, P, Angelico, M, Di Paolo, D, Rizzetto, M, Marzano, A, Lampertico, P, Prieto, M, Berenguer, M, Felder, M, Sterneck, M, Willems, M, Charlton, M, Gunneson, T, Ritter, M, Voight, M, Swift, J, Shiffman, M, Tassopoulos, N, Klissas, I, Naourmov, N, Chamouard, P, Marcellin, P, Durand, F, Angus, P, Nathan, C, Toniutto, P, Fumo, E, Andreone, P, Cursaro, C, Barcena, R, Hoz, F, Zachoval, R, Christina, M, De Man, R, Metselaar, H, and Fagiuoli, S

Subjects
Male, medicine.medical_treatment, Liver transplantation, medicine.disease_cause, Gastroenterology, lamivudine-resistant, chemistry.chemical_compound, antiviral therapy, Secondary Prevention, Adefovir, Prospective Studies, Adefovir dipivoxil, medicine.diagnostic_test, liver transplantation, Lamivudine, Middle Aged, Hepatitis B, Drug Therapy, Combination, Female, Kidney Diseases, medicine.drug, Adult, medicine.medical_specialty, Waiting Lists, Adenine, Antiviral Agents, DNA, Viral, Drug Resistance, Viral, Hepatitis B virus, Humans, Liver Transplantation, Organophosphonates, Bilirubin, Internal medicine, medicine, wait-listed, hepatitis B virus, Prothrombin time, Transplantation, Hepatology, business.industry, medicine.disease, chemistry, Immunology, Surgery, hepatitis B, business
Abstract

Wait-listed (n = 226) or post-liver transplantation (n = 241) chronic hepatitis B (CHB) patients with lamivudine-resistant hepatitis B virus (HBV) were treated with adefovir dipivoxil for a median of 39 and 99 weeks, respectively. Among wait-listed patients, serum HBV DNA levels became undetectable (

Published
2007

31. Liver transplantation for Wilson's disease: The burden of neurological and psychiatric disorders

Author

Medici V, Mirante VG, Fassati LR, Pompili M, Forti D, Trevisan CP, Cillo U, Sturniolo GC, Fagiuoli S, Andriulli A, Angelico M, Aresu G, Burra P, Caccamo L, Castagneto M, D'Amico DF, Dardano G, Filla A, Gasbarrini A, Gasbarrini G, Gianni S, Grazi GL, Martines D, Marzano A, Melada E, Nardo B, Pevere S, Rapaccini GL, Rizzetto M, Rondinara GF, Salizzoni M, Slim AO, Strazzabosco M, Tisone G, Valente U, Zanus G, Monotematica AISF 2000 OLT Study Group, DEL GAUDIO, MASSIMO, Medici V, Mirante VG, Fassati LR, Pompili M, Forti D, Del Gaudio M, Trevisan CP, Cillo U, Sturniolo GC, Fagiuoli S, Andriulli A, Angelico M, Aresu G, Burra P, Caccamo L, Castagneto M, D'Amico DF, Dardano G, Filla A, Gasbarrini A, Gasbarrini G, Gianni S, Grazi GL, Martines D, Marzano A, Melada E, Nardo B, Pevere S, Rapaccini GL, Rizzetto M, Rondinara GF, Salizzoni M, Slim AO, Strazzabosco M, Tisone G, Valente U, Zanus G, and Monotematica AISF 2000 OLT Study Group.

Subjects
surgical procedures, operative, wilson's disease, LIVER TRANSPLANTATION
Abstract

A retrospective data analysis on liver transplantation for Wilson's disease (WD) was performed among Italian Liver Transplant Centers. Thirty-seven cases were identified. The main indication for liver transplantation was chronic advanced liver disease in 78% of patients. Mixed hepatic and neuropsychiatric symptoms were recorded in 32.3%. Eight patients presented with fulminant liver failure; 44.8% were on medical treatment. Patient and graft survival at 3 months, 12 months, 3 years, 5 years, and 10 years after transplantation were, respectively, 91.8%, 89.1%, 82.9%, 75.6%, and 58.8%, and 85.3%, 83.0%, 77.1%, 70.3%, and 47.2%. Neurological symptoms significantly improved after orthotopic liver transplantation (OLT), but the survival of patients with mixed hepatic and neuropsychiatric involvement was significantly lower than in patients with liver disease alone (P = 0.04). WD characterized by hepatic involvement alone is a rare but good indication for liver transplantation when specific medical therapy fails. Patients with neuropsychiatric signs have a significantly shorter survival even though liver transplantation has a positive impact on neurological symptoms. In conclusion, a combination of hepatic and neuropsychiatric conditions deserves careful neurological evaluation, which should contraindicate OLT in case of severe neurological impairment.

Published
2005

32. Trattamento della Epatite da HCV

Author

Alberti A, Bonino F, Bortolotti F, Colombo M, Craxì A, Mele A, Rizzetto M, Almasio P, Androne P, Ascione A, Benvegnù L, Brunetto M, Bruno S, Cammaà C, Di Marco V, Fattovich G, Ferrari C, Ideo G, Levriero M, Pagliaro L, Pastore G, Piccinino F, Pontisso P, Puoti C, Puoti M, Raimondo G, Rumi MG, Saracco G, Santantonio T, Smedile A, Zignego L., BRILLANTI, STEFANO, MAZZELLA, GIUSEPPE, Alberti A, Bonino F, Bortolotti F, Colombo M, Craxì A, Mele A, Rizzetto M, Almasio P, Androne P, Ascione A, Benvegnù L, Brillanti S, Brunetto M, Bruno S, Cammaà C, Di Marco V, Fattovich G, Ferrari C, Ideo G, Levriero M, Mazzella G, Pagliaro L, Pastore G, Piccinino F, Pontisso P, Puoti C, Puoti M, Raimondo G, Rumi MG, Saracco G, Santantonio T, Smedile A, and Zignego L.

Subjects
TERAPIA, HCV, EPATITE
Published
2004

33. Clinical outcome of HBeAg-negative chronic hepatitis B in relation to virological response to lamivudine

Author

PROMOTING GROUP DI MARCO V, MARZANO A, LAMPERTICO P, ANDREONE P, SANTANTONIO T, ALMASIO PL, RIZZETTO M, CRAXI A, ITALIAN ASSOCIATION FOR THE STUDY OF THE LIVER AISF LAMIVUDINE STUDY GROUP, MARRONE, Aldo, PROMOTING GROUP DI MARCO, V, Marzano, A, Lampertico, P, Andreone, P, Santantonio, T, Almasio, Pl, Rizzetto, M, Craxi, A, ITALIAN ASSOCIATION FOR THE STUDY OF THE LIVER AISF LAMIVUDINE STUDY, Group, and Marrone, Aldo

Published
2004

35. Endoscopic ultrasound in the 2013 preoperative evaluation of gastric cancer

Author

Angelis, C., RINALDO PELLICANO, Manfrè, S. F., and Rizzetto, M.

Subjects
Diagnostic Imaging, Stomach Neoplasms, Preoperative Care, Humans, Endosonography
Abstract

The capacity of endoscopic ultrasound (EUS) to distinguish the different wall layers of the gastrointestinal (GI) tract and the possibility to obtain samples of suspicious lesions or lymph nodes by means of EUS-guided fine-needle aspiration (EUS-FNA), make EUS an ideal staging modality for GI cancers. After an endoscopic and histological diagnosis of gastric cancer (GC), an accurate preoperative evaluation is essential to choose the correct management decision, because for this malignancy various and radically different stage-oriented therapies can be performed. Even if EUS is inserted in the last guidelines for the management of GC as an essential pretherapeutic staging modality, in the literature the reported accuracy, the imaging features and the performances of the technique are variable. In this review, we synthesize the current status and the imaging findings of EUS when describing and staging GC, with a particular attention to the early GC that represents till today a diagnostic and therapeutic challenge. Currently, the EUS study is mandatory for the preoperative staging, to assess with a good accuracy the tumor depth of wall invasion, the presence of suspicious lymph-nodes and of ascites (predictive of peritoneal involvement). The main limitations for a correct EUS staging remain some features of the lesion or its localization, so more attention should be paid when these characteristics are present.

Published
2013

36. Immune ecasion of hepatitis delta from CD8+ t cell immune response

Author

Olivero, A., Hoffmann, D., Buti, M., Frías, F. Rodríguez, Alavian, S.M., Wedemeyer, Heiner, Timm, Jörg, Karimzadeh, H., Rizzetto, M., Keyvani, H., Budeus, B., Kosinska, A., Roggendorf, Michael, Smedile, A., Homs, M., and Fiedler, Melanie

Subjects
Medizin
Published
2013

37. Randomised study comparing 48 and 96 weeks peginterferon α-2a therapy in genotype D HBeAg-negative chronic hepatitis B

Author

Pegbeliver, Study Group, Colombo, M, Facchetti, F, Massetto, B, Regep, L, Iannacone, C, Giuberti, T, Fargion, S, Farci, P, Boninsegna, S, Di Marco, V, Fasano, M, Sagnelli, E, Di Costanzo, Gg, Viganò, M, Lampertico, P, Andreone, P, Riili, A, Scuteri, A, Cursaro, C, Andriulli, A, Niro, Ga, Angarano, G, Santantonio, Ta, Palattella, Ms, Brunetto, MAURIZIA ROSSANA, Colombatto, P, Coco, B, Ciccorossi, P, Oliveri, F, Sacco, R, Bruno, S, Bollani, S, Chiesa, A, Carosi, G, Baiguera, C, Rossi, S, Zaltron, S, Puoti, M, Cozzolongo, R, Giannuzzi, V, Craxì, A, Calvaruso, V, Venezia, G, Lanza, Ag, Di Perri, G, Cariti, G, Mollaretti, O, De Blasi, T, Kulmiye, C, Rostagno, R, Lai, Me, Serra, G, Chessa, L, Balestrieri, C, Cauli, C, Fargion, Sr, Bertelli, C, Fatta, E, Fattovich, G, Pasino, M, Zanni, S, Olivari, N, Zagni, I, Ferrari, C, Schivazappa, S, Laccabue, D, Penna, A, Gaeta, G, Stanzione, M, Stornaiuolo, G, Martines, D, Raimondo, G, Caccamo, G, Squadrito, G, Isgrò, G, Rizzetto, M, Lagget, M, Carenzi, S, Ruggiero, G, Marrone, A, Messina, V, Di Caprio, Du, Selva, V, Toniutto, P., Lampertico, P, Viganò, M, Di Costanzo, GG, Sagnelli, E, Fasano, M, Di Marco, V, Boninsegna, S, Farci, P, Fargion, S, Giuberti, T, Iannacone, C, Regep, L, Massetto, B, Facchetti, F, Colombo, M, and Calvaruso, V

Subjects
Adult, Male, HBsAg, medicine.medical_specialty, Hepatitis B virus, Time Factors, Anti-HIV Agents, medicine.disease_cause, Gastroenterology, Antiviral Agents, Group B, law.invention, Polyethylene Glycols, Pharmacotherapy, Hepatitis B, Chronic, Randomized controlled trial, law, Pegylated interferon, Internal medicine, medicine, Humans, Hepatitis B e Antigens, business.industry, Lamivudine, Interferon-alpha, Alanine Transaminase, Hepatitis B, Middle Aged, medicine.disease, Recombinant Proteins, Treatment Outcome, Immunology, DNA, Viral, Interferon, Drug Therapy, Combination, Female, business, medicine.drug
Abstract

Treatment with peginterferon α-2a (PegIFN) for 48 weeks is the standard of care for selected HBeAg-negative patients chronically infected with hepatitis B virus (HBV), but with limited treatment efficacy. A study was undertaken to investigate whether treatment extension to 96 weeks improves the outcome in this patient population.128 HBeAg-negative patients (120 genotype D) were randomised to weekly 180 μg PegIFN for 48 weeks (group A, n=51), 180 μg PegIFN for 48 weeks followed by 135 μg weekly for an additional 48 weeks (group B, n=52) or 180 μg PegIFN plus lamivudine (100 mg/day) for 48 weeks then 135 μg PegIFN for 48 weeks (group C, n=25). Endpoints were alanine aminotransferase normalisation plus HBV DNA3400 IU/ml (primary), HBV DNA2000 IU/ml and HBsAg clearance at 48 weeks after treatment.Forty-eight weeks after treatment, six patients in group A and 13 in group B achieved alanine aminotransferase normalisation plus HBV DNA3400 IU/ml (11.8% vs 25.0%, p=0.08), 6 vs 15 patients had HBV DNA2000 IU/ml (11.8% vs 28.8%, p=0.03), 0 vs 3 achieved HBsAg clearance (0% vs 5.8%, p=0.24) and 0 vs 5 had HBsAg10 IU/ml (0% vs 9.6%, p=0.06). While extended PegIFN treatment was the strongest independent predictor of response, the combination with lamivudine did not improve responses. Discontinuation rates were similar among the groups (19.6%, 23.1%, 32.0%, p=0.81) and were mostly due to PegIFN-related adverse events.In HBeAg-negative genotype D patients with chronic hepatitis B, PegIFN treatment for 96 weeks was well tolerated and the post-treatment virological response improved significantly compared with 48 weeks of treatment.http://ClinicalTrials.gov registration number: NCT01095835.

Published
2013

38. Inflammatory bowel diseases and primary sclerosing cholangitis: hepatic and pancreatic side effects due to azathioprine

Author

Pallavicino, F., RINALDO PELLICANO, Reggiani, S., Simondi, D., Sguazzini, C., Bonagura, A. G., Cisarò, F., Rizzetto, M., and Astegiano, M.

Subjects
Adult, Male, Adolescent, Liver, Azathioprine, Cholangitis, Sclerosing, Humans, Female, Child, Inflammatory Bowel Diseases, Pancreas, Liver Transplantation, Retrospective Studies
Abstract

In up to 80% of cases primary sclerosing cholangitis (PSC) is associated with inflammatory bowel diseases (IBD). The efficacy of azathioprine (AZA), in the maintenance of remission of IBD has been suggested by several studies. However, AZA tends to exter varied well-known toxicity. Since the rate of hepato-pancreatic side-effects in patients with IBD and PSC is still unclear, we investigated this issue.Consecutive subjects who underwent Outpatient Clinic admission for both IBD and PSC were included. Both conditions were diagnosed according to International Guidelines.Data of 43 patients were elaborated. Twelve of them underwent therapy with AZA. Five (41.7%) presented hepatic (n=4) or pancreatic toxicity. Eighty percent of the patients with hepato-pancreatic reactions versus 28.6% of those without (p0.001) were males, with 60% affected by ulcerative colitis and 40% by Crohn's disease versus 57% and 43%, respectively. Forty percent of patients with reactions versus 43% of those without needed an operation for IBD, and the same percentage underwent orthotopic liver transplantation, with a 100% versus 66.7% (p0.001) need of second transplantation. Colonic neoplasia (20%) was detected only in the former group while cholangiocarcinoma (28.6%) only in the latter.The occurrence of hepato-pancreatic reactions from AZA in our caseload is higher (41.7%) compared to that reported in literature (4%). Therefore, the presence of PSC, in association to IBD, may strongly affect AZA tolerability compared to presence of IBD only.

Published
2013

40. The Italian experience on paediatric liver transplantation: 1988-1999 report

Author

POMPILI M, MIRANTE VG, FAGIUOLI S, BECCARIA S, LEANDRO G, RAPACCINI GL, GASBARRINI A, NACCARATO R, PAGLIARO L, RIZZETTO M, GASBARRINI G, MONOTEMATICA AISF OLT STUDY GROUP., Pompili, M, Mirante, V, Fagiuoli, S, Beccaria, S, Leandro, G, Rapaccini, G, Gasbarrini, A, Naccarato, R, Pagliaro, L, Rizzetto, M, Gasbarrini, G, and MONOTEMATICA AISF OLT STUDY, G

Subjects
medicine.medical_specialty, Pediatrics, Cirrhosis, Liver transplantation, Hepatology, business.industry, medicine.medical_treatment, Gastroenterology, medicine.disease, Surgery, Transplantation, Liver disease, Fulminant hepatic failure, Survival analysi, Biliary atresia, Alagille syndrome, Paediatric age, Medicine, business, Survival rate
Abstract

Background. Liver transplantation is the treatment of choice for end-stage liver disease in both adult and paediatric patients. The Italian experience in paediatric liver transplantation during the period 1988–1999 is reported herein. Patients and methods. This report concerns 228 liver transplantations performed in 207 patients (100 male, 107 female, mean age 5.1±4.4 years) in 11 Italian centres. The mean waiting time on the transplantation list was 6. 1±8.9 months and the main indications for the procedure were biliary atresia, inborn metabolic disorders, liver cirrhosis, liver neoplasms, Alagille syndrome, and fulminant hepatic failure. Results. The cumulative survival rate was 77%, 76%, 73%, and 71 at 1, 3, 5, and 7 years. The overall prevalence of acute rejection was 54%. Survival was significantly affected by re-transplantation (p=0.0002), by United Network for Organ Sharing 4 status at transplantation (p=0.016), and, among the indications for the procedure, by fulminant hepatic failure (p=0.004). Fifty patients (24%) died during the observation period. The main causes of death were primary non-function of the graft and sepsis Conclusions. This study shows that liver transplantation in paediatric age, in Italy, is an effective procedure providing a 5-year survival rate comparable to that attained in the largest published series.

Published
2002

41. Liver transplantation: the Italian experience

Author

Fagiuoli S, Mirante VG, Pompili M, Gianni S, Leandro G, Rapaccini GL, Gasbarrini A, Naccarato R, Pagliaro L, Rizzetto M, Gasbarrini G, Monotematica AISF 2000-OLT Study Group, Fagiuoli, S, Mirante, V, Pompili, M, Gianni, S, Leandro, G, Rapaccini, G, Gasbarrini, A, Naccarato, R, Pagliaro, L, Rizzetto, M, Gasbarrini, G, and Monotematica AISF 2000-OLT Study, G

Subjects
Adult, Graft Rejection, Male, medicine.medical_specialty, Alcoholic liver disease, Cirrhosis, Adolescent, medicine.medical_treatment, Liver transplantation, Gastroenterology, Liver disease, Recurrence, Internal medicine, Prevalence, Medicine, Humans, Aged, Retrospective Studies, Hepatology, business.industry, Liver Diseases, Patient Selection, Hepatitis C, Hepatitis B, Middle Aged, medicine.disease, Transplantation, Survival Rate, Italy, Female, Hepatitis D virus, business
Abstract

Background. Liver transplantation is the standard treatment for patients with end-stage liver disease no longer responsive to conventional medical treatment Aims . To report the longterm experience of liver transplantation in Italy. Patients and Methods . Data were obtained retrospective by means of a multiple-item form collected from 15 Italian liver transplant centres. The filing centre was centralized. Results . A total of 3323 liver transplants were performed on 3026 patients, with a cumulative proportional survival of 72.4%. Three, 5 and 10 years' patient survival rates were 72.3%, 68.8% and 61.3%, respectively. The most common indication for liver transplantation were hepatitis B virus (± hepatitis D virus)- and hepatitis C virus-related cirrhosis (59.4%). Excellent survival rates were observed particularly in controversial indications, such as alcoholic cirrhosis, hepatitis B virus-related cirrhosis and hepatocellular carcinoma. Retransplantation was required in 8.9% of the cases. The overall prevalence of acute cellular rejection episodes was 43.5%. In our study population, primary non-function and disease recurrence were the most common causes of graft failure (28.7% and 25.4%, respectively). Infections and/or sepsis were the most common causes of death after transplantation (42%). Conclusion. This study confirms that patients with controversial indications to liver transplantation such as alcoholic cirrhosis, HBV-related cirrhosis and hepatocellular carcinoma can achieve excellent survival when properly selected.

Published
2002

44. Randomized trial of albinterferon alfa-2b every 4 weeks for chronic hepatitis C virus genotype 2/3

Author

Yin, Y, Pang, M, Li, Y, Rasenack, J, Tanwandee, T, Thongsawat, S, Komolmit, P, Gould, M, George, J, Sood, A, Shah, S, Piratvisuth, T, Andreone, P, Lee, Cm, Flisiak, R, Sarin, Sk, Foster, Gr, Chuang, Wl, Zeuzem, S, Pianko SCrawford, D, Desmond, P, Pianko, S, Sasadeusz, J, Weltman, M, Anderson, F, Fournier, C, Swain, M, Wong, F, Yoshida, E, Berg, T, Buggisch, P, Gerken, G, Goeser, T, Habeeb, A, Kapoor, D, Kar, P, Prabhakar, B, Sarin, S, Brunetto, M, Craxi, A, Mondelli, M, Rizzetto, M, Jablkowski, M, Andrade, R, Barcena, R, Buti, M, Castellano, D, Diago, M, Perez, R, Romero, M, Sola, R, Chang, T, Chuang, W, Kao, J, Lee, C, Sukeepaisarnjaroen, W, Brown, A, Cramp, M, Mills, P, Jacobson, I, and Bain, V.

Published
2012

46. Endoscopic banding for esophageal variceal bleeding: technique and patient outcome

Author

Silvano, S., Elia, C., Alessandria, C., Bruno, M., Musso, A., Giorgio Maria Saracco, Rizzetto, M., and Debernardi Venon, W.

Subjects
Liver Cirrhosis, Treatment Outcome, Recurrence, Humans, Esophagoscopy, Esophageal and Gastric Varices, Gastrointestinal Hemorrhage, Ligation, Retrospective Studies
Abstract

Endoscopic variceal ligation (EVL) is recommended for the treatment of esophageal variceal bleeding. The aim of this study was to assess the most cost-effective timing of endoscopic follow-up after variceal eradication.Cirrhotics with esophageal varices treated between January 2008 and January 2009 until reached variceal obliteration were retrospectively analyzed for technical aspects and for outcomes.Out of 127 patients treated with EVL, 103 were included. Number of sessions to achieve variceal obliteration and number of bands for each session were 2.8±1.3 (range 1-7) and 4.6±1 (range 2-7), respectively. The placement of5 bands per session was not associated with higher incidence of complications (19.6% vs. 17.8%, P=ns). Esophageal ulcers were observed in 42% of patients when the interbanding interval was20 days (versus 15% for interval20 days, P0.05). Once obliteration was achieved, varices reappeared in 28% of patients; the early appearance of small varices was not associated with bleeding.A longer interbanding interval reduces the incidence of procedural-related complications. After variceal obliteration an early endoscopic control is not useful because it does not influence the approach and does not change the patient outcome.

Published
2011

50. The state of hepatitis B and C in Europe: report from the hepatitis B and C summit conference

Author

Hatzakis, A. Wait, S. Bruix, J. Buti, M. Carballo, M. and Cavaleri, M. Colombo, M. Delarocque-Astagneau, E. and Dusheiko, G. Esmat, G. Esteban, R. Goldberg, D. Gore, C. and Lok, A. S. F. Manns, M. Marcellin, P. Papatheodoridis, G. Peterle, A. Prati, D. Piorkowsky, N. Rizzetto, M. and Roudot-Thoraval, F. Soriano, V. Thomas, H. C. Thursz, M. and Valla, D. van Damme, P. Veldhuijzen, I. K. Wedemeyer, H. and Wiessing, L. Zanetti, A. R. Janssen, H. L. A.

Subjects
virus diseases, digestive system diseases
Abstract

Worldwide, the hepatitis B virus (HBV) and the hepatitis C virus (HCV) cause, respectively, 600 000 and 350 000 deaths each year. Viral hepatitis is the leading cause of cirrhosis and liver cancer, which in turn ranks as the third cause of cancer death worldwide. Within the WHO European region, approximately 14 million people are chronically infected with HBV, and nine million people are chronically infected with HCV. Lack of reliable epidemiological data on HBV and HCV is one of the biggest hurdles to advancing policy. Risk groups such as migrants and injecting drug users (IDU) tend to be under-represented in existing prevalence studies; thus, targeted surveillance is urgently needed to correctly estimate the burden of HBV and HCV. The most effective means of prevention against HBV is vaccination, and most European Union (EU) countries have universal vaccination programmes. For both HBV and HCV, screening of individuals who present a high risk of contracting the virus is critical given the asymptomatic, and thereby silent, nature of disease. Screening of migrants and IDUs has been shown to be effective and potentially cost-effective. There have been significant advances in the treatment of HCV and HBV in recent years, but health care professionals remain poorly aware of treatment options. Greater professional training is needed on the management of hepatitis including the treatment of liver cancer to encourage adherence to guidelines and offer patients the best possible outcomes. Viral hepatitis knows no borders. EU Member States, guided by the EU, need to work in a concerted manner to implement lasting, effective policies and programmes and make tackling viral hepatitis a public health priority.

Published
2011

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