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

Author

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

Abstract

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

Published
2023

3. 2020 position statement and recommendations of the European Liver and Intestine Transplantation Association (ELITA): management of hepatitis B virus-related infection before and after liver transplantation

Author

Duvoux, C, Belli, L, Fung, J, Angelico, M, Buti, M, Coilly, A, Cortesi, P, Durand, F, Feray, C, Fondevila, C, Lebray, P, Martini, S, Nevens, F, Polak, W, Rizzetto, M, Volpes, R, Zoulim, F, Samuel, D, Berenguer, M, Duvoux C., Belli L. S., Fung J., Angelico M., Buti M., Coilly A., Cortesi P., Durand F., Feray C., Fondevila C., Lebray P., Martini S., Nevens F., Polak W. G., Rizzetto M., Volpes R., Zoulim F., Samuel D., Berenguer M., Duvoux, C, Belli, L, Fung, J, Angelico, M, Buti, M, Coilly, A, Cortesi, P, Durand, F, Feray, C, Fondevila, C, Lebray, P, Martini, S, Nevens, F, Polak, W, Rizzetto, M, Volpes, R, Zoulim, F, Samuel, D, Berenguer, M, Duvoux C., Belli L. S., Fung J., Angelico M., Buti M., Coilly A., Cortesi P., Durand F., Feray C., Fondevila C., Lebray P., Martini S., Nevens F., Polak W. G., Rizzetto M., Volpes R., Zoulim F., Samuel D., and Berenguer M.

Abstract

Background: Prophylaxis of HBV recurrence is critical after liver transplantation in HBV patients. Despite new prophylactic schemes, most European LT centres persist on a conservative approach combining hepatitis B immunoglobulin (HBIG) and nucleos(t)ides analogues (NA). Aim: This setting prompted the European Liver Intestine Transplantation Association (ELITA) to look for a consensus on the prevention of HBV recurrence. Methods: Based on a 4-round Delphi process, ELITA investigated 16 research questions and established 50 recommendations. Results: Prophylaxis should be driven according to 3 simplified risk groups: Low and high virological risk patients, with undetectable and detectable HBV DNA pre-LT, respectively, and special populations (HDV, HCC, poorly adherent patients). In low-risk patients, short-term (4 weeks) combination of third-generation NA+ HBIG, or third generation NA monotherapy can be considered as prophylactic options. In high-risk patients, HBIG can be discontinued once HBV DNA undetectable. Combined therapy for 1 year is advised. HBV-HCC patients should be treated according to their virological risk. In HDV/HBV patients, indefinite dual prophylaxis remains the gold standard. Full withdrawal of HBV prophylaxis following or not HBV vaccination should only be attempted in the setting of clinical trials. Organs from HBsAg+ve donors may be considered after assessment of risks, benefits, and patient consent. They should not be used if HDV is present. In poorly adherent patients, dual long-term prophylaxis is recommended. Budget impact analysis should be taken into account to drive prophylactic regimen. Conclusions: These ELITA recommendations should stimulate a more rational and homogeneous approach to HBV prophylaxis across LT programs.

Published
2021

4. 800P Number needed to treat (NNT) and number needed to harm (NNH) to estimate clinical efficacy and safety of new adjuvant (Adj) therapies for resected stage (St) II-III melanoma

Author

Zara, D., primary, Pastò, B., additional, Garutti, M., additional, Bartoletti, M., additional, Palmero, L., additional, Bertoli, E., additional, Noto, C., additional, Cucciniello, L., additional, Totaro, F., additional, Rizzetto, M., additional, Pivetta, T., additional, Membrino, A., additional, Freschi, A., additional, Bolzonello, S., additional, and Puglisi, F., additional

Published
2022
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10. Safety and efficacy of ombitasvir/paritaprevir/ritonavir/dasabuvir plus ribavirin in patients over 65 years with HCV genotype 1 cirrhosis

Author

Ascione, A, De Luca, M, Melazzini, M, Montilla, S, Trotta, M, Petta, S, Puoti, M, Sangiovanni, V, Messina, V, Bruno, S, Izzi, A, Villa, E, Aghemo, A, Zignego, A, Orlandini, A, Fontanella, L, Gasbarrini, A, Marzioni, M, Giannini, E, Craxi, A, Abbati, G, Alberti, A, Andreone, P, Andreoni, M, Angeli, P, Angelico, M, Angarano, G, Angrisani, D, Antinori, A, Antonini, C, Avancini, I, Barone, M, Bruno, R, Benedetti, A, Bernabucci, V, Blanc, P, Boarini, C, Boffa, N, Boglione, L, Borghi, V, Borgia, G, Brancaccio, G, Brunetto, M, Cacciola, I, Calabrese, P, Calvaruso, V, Campagnolo, D, Canovari, B, Caporaso, N, Capra, F, Carolo, G, Cassola, G, Castelli, F, Cauda, R, Silberstein, F, Cecere, R, Chessa, L, Chiodera, A, Chirianni, A, Ciancio, A, Cima, S, Coco, B, Colombo, M, Coppola, N, Corti, G, Cosco, L, Corradori, S, Cozzolongo, R, Cristaudo, A, Danieli, E, Monforte, A, Monache, M, Del Poggio, P, de Luca, A, Dentone, C, Di Biagio, A, Di Leo, A, Di Perri, G, Di Stefano, M, D'Offizi, G, Donato, F, Durante, E, Erne, E, Fagiuoli, S, Falasca, K, Federico, A, Felder, M, Ferrari, C, Gaeta, G, Ganga, R, Gatti, P, Giacomet, V, Giacometti, A, Gianstefani, A, Giordani, M, Giorgini, A, Grieco, A, Guerra, M, Gulminetti, R, Ieluzzi, D, Imparato, M, Iodice, V, La Monica, S, Lazzarin, A, Lenzi, M, Levrero, M, Lichtner, M, Lionetti, R, Guercio, C, Madonna, S, Magnani, S, Maida, I, Marignani, M, Marrone, A, Marsetti, F, Martini, S, Masarone, M, Maserati, R, Mastroianni, C, Memoli, M, Menzaghi, B, Merli, M, Miele, L, Milella, M, Mondelli, M, Montalbano, M, Monti, M, Morelli, O, Morisco, F, Nardone, G, Novara, S, Onnelli, G, Onofrio, M, Paganin, S, Pani, L, Parisi, M, Parruti, G, Pasquazzi, C, Pasulo, L, Perno, C, Persico, M, Piai, G, Picciotto, A, Pigozzi, G, Piovesan, S, Piras, M, Pirisi, M, Piscaglia, A, Ponti, L, Potenza, D, Pravadelli, C, Quartini, M, Quirino, T, Raimondo, G, Rapaccini, G, Rendina, M, Rizzardini, G, Rizzetto, M, Rizzo, S, Romagnoli, D, Romano, A, Rossi, C, Rumi, M, Russello, M, Russo, F, Russo, M, Sansonno, D, Santantonio, T, Saracco, G, Schimizzi, A, Serviddio, G, Simeone, F, Solinas, A, Soria, A, Tabone, M, Taliani, G, Tarantino, G, Tarquini, P, Tavio, M, Termite, A, Teti, E, Toniutto, P, Torti, C, Tundi, P, Vecchiet, G, Verucchi, G, Gentilucci, U, Vinci, M, Vullo, V, Zolfino, T, Zuin, M, Ascione A., De Luca M., Melazzini M., Montilla S., Trotta M. P., Petta S., Puoti M., Sangiovanni V., Messina V., Bruno S., Izzi A., Villa E., Aghemo A., Zignego A. L., Orlandini A., Fontanella L., Gasbarrini A., Marzioni M., Giannini E. G., Craxi A., Abbati G., Alberti A., Andreone P., Andreoni M., Angeli P., Angelico M., Angarano G., Angrisani D., Antinori A., Antonini C., Avancini I., Barone M., Bruno R., Benedetti A., Bernabucci V., Blanc P., Boarini C., Boffa N., Boglione L., Borghi V., Borgia G., Brancaccio G., Brunetto M., Cacciola I., Calabrese P., Calvaruso V., Campagnolo D., Canovari B., Caporaso N., Capra F., Carolo G., Cassola G., Castelli F., Cauda R., Silberstein F. C., Cecere R., Chessa L., Chiodera A., Chirianni A., Ciancio A., Cima S., Coco B., Colombo M., Coppola N., Corti G., Cosco L., Corradori S., Cozzolongo R., Cristaudo A., Danieli E., Monforte A. D. A., Monache M., Del Poggio P., de Luca A., Dentone C., Di Biagio A., Di Leo A., Di Perri G., Di Stefano M., D'Offizi G., Donato F., Durante E., Erne E., Fagiuoli S., Falasca K., Federico A., Felder M., Ferrari C., Gaeta G. B., Ganga R., Gatti P., Giacomet V., Giacometti A., Gianstefani A., Giordani M., Giorgini A., Grieco A., Guerra M., Gulminetti R., Ieluzzi D., Imparato M., Iodice V., La Monica S., Lazzarin A., Lenzi M., Levrero M., Lichtner M., Lionetti R., Guercio C. L., Madonna S., Magnani S., Maida I., Marignani M., Marrone A., Marsetti F., Martini S., Masarone M., Maserati R., Mastroianni C. M., Memoli M., Menzaghi B., Merli M., Miele L., Milella M., Mondelli M., Montalbano M., Monti M., Morelli O., Morisco F., Nardone G., Novara S., Onnelli G., Onofrio M., Paganin S., Pani L., Parisi M. R., Parruti G., Pasquazzi C., Pasulo L., Perno C. F., Persico M., Piai G., Picciotto A., Pigozzi G. M., Piovesan S., Piras M. C., Pirisi M., Piscaglia A. M., Ponti L., Potenza D., Pravadelli C., Quartini M., Quirino T., Raimondo G., Rapaccini G. L., Rendina M., Rizzardini G., Rizzetto M., Rizzo S., Romagnoli D., Romano A., Rossi C., Rumi M. G., Russello M., Russo F. P., Russo M. L., Sansonno D. E., Santantonio T. A., Saracco G., Schimizzi A. M., Serviddio G., Simeone F., Solinas A., Soria A., Tabone M., Taliani G., Tarantino G., Tarquini P., Tavio M., Termite A., Teti E., Toniutto P., Torti C., Tundi P., Vecchiet G., Verucchi G., Gentilucci U. V., Vinci M., Vullo V., Zolfino T., Zuin M., Ascione, A, De Luca, M, Melazzini, M, Montilla, S, Trotta, M, Petta, S, Puoti, M, Sangiovanni, V, Messina, V, Bruno, S, Izzi, A, Villa, E, Aghemo, A, Zignego, A, Orlandini, A, Fontanella, L, Gasbarrini, A, Marzioni, M, Giannini, E, Craxi, A, Abbati, G, Alberti, A, Andreone, P, Andreoni, M, Angeli, P, Angelico, M, Angarano, G, Angrisani, D, Antinori, A, Antonini, C, Avancini, I, Barone, M, Bruno, R, Benedetti, A, Bernabucci, V, Blanc, P, Boarini, C, Boffa, N, Boglione, L, Borghi, V, Borgia, G, Brancaccio, G, Brunetto, M, Cacciola, I, Calabrese, P, Calvaruso, V, Campagnolo, D, Canovari, B, Caporaso, N, Capra, F, Carolo, G, Cassola, G, Castelli, F, Cauda, R, Silberstein, F, Cecere, R, Chessa, L, Chiodera, A, Chirianni, A, Ciancio, A, Cima, S, Coco, B, Colombo, M, Coppola, N, Corti, G, Cosco, L, Corradori, S, Cozzolongo, R, Cristaudo, A, Danieli, E, Monforte, A, Monache, M, Del Poggio, P, de Luca, A, Dentone, C, Di Biagio, A, Di Leo, A, Di Perri, G, Di Stefano, M, D'Offizi, G, Donato, F, Durante, E, Erne, E, Fagiuoli, S, Falasca, K, Federico, A, Felder, M, Ferrari, C, Gaeta, G, Ganga, R, Gatti, P, Giacomet, V, Giacometti, A, Gianstefani, A, Giordani, M, Giorgini, A, Grieco, A, Guerra, M, Gulminetti, R, Ieluzzi, D, Imparato, M, Iodice, V, La Monica, S, Lazzarin, A, Lenzi, M, Levrero, M, Lichtner, M, Lionetti, R, Guercio, C, Madonna, S, Magnani, S, Maida, I, Marignani, M, Marrone, A, Marsetti, F, Martini, S, Masarone, M, Maserati, R, Mastroianni, C, Memoli, M, Menzaghi, B, Merli, M, Miele, L, Milella, M, Mondelli, M, Montalbano, M, Monti, M, Morelli, O, Morisco, F, Nardone, G, Novara, S, Onnelli, G, Onofrio, M, Paganin, S, Pani, L, Parisi, M, Parruti, G, Pasquazzi, C, Pasulo, L, Perno, C, Persico, M, Piai, G, Picciotto, A, Pigozzi, G, Piovesan, S, Piras, M, Pirisi, M, Piscaglia, A, Ponti, L, Potenza, D, Pravadelli, C, Quartini, M, Quirino, T, Raimondo, G, Rapaccini, G, Rendina, M, Rizzardini, G, Rizzetto, M, Rizzo, S, Romagnoli, D, Romano, A, Rossi, C, Rumi, M, Russello, M, Russo, F, Russo, M, Sansonno, D, Santantonio, T, Saracco, G, Schimizzi, A, Serviddio, G, Simeone, F, Solinas, A, Soria, A, Tabone, M, Taliani, G, Tarantino, G, Tarquini, P, Tavio, M, Termite, A, Teti, E, Toniutto, P, Torti, C, Tundi, P, Vecchiet, G, Verucchi, G, Gentilucci, U, Vinci, M, Vullo, V, Zolfino, T, Zuin, M, Ascione A., De Luca M., Melazzini M., Montilla S., Trotta M. P., Petta S., Puoti M., Sangiovanni V., Messina V., Bruno S., Izzi A., Villa E., Aghemo A., Zignego A. L., Orlandini A., Fontanella L., Gasbarrini A., Marzioni M., Giannini E. G., Craxi A., Abbati G., Alberti A., Andreone P., Andreoni M., Angeli P., Angelico M., Angarano G., Angrisani D., Antinori A., Antonini C., Avancini I., Barone M., Bruno R., Benedetti A., Bernabucci V., Blanc P., Boarini C., Boffa N., Boglione L., Borghi V., Borgia G., Brancaccio G., Brunetto M., Cacciola I., Calabrese P., Calvaruso V., Campagnolo D., Canovari B., Caporaso N., Capra F., Carolo G., Cassola G., Castelli F., Cauda R., Silberstein F. C., Cecere R., Chessa L., Chiodera A., Chirianni A., Ciancio A., Cima S., Coco B., Colombo M., Coppola N., Corti G., Cosco L., Corradori S., Cozzolongo R., Cristaudo A., Danieli E., Monforte A. D. A., Monache M., Del Poggio P., de Luca A., Dentone C., Di Biagio A., Di Leo A., Di Perri G., Di Stefano M., D'Offizi G., Donato F., Durante E., Erne E., Fagiuoli S., Falasca K., Federico A., Felder M., Ferrari C., Gaeta G. B., Ganga R., Gatti P., Giacomet V., Giacometti A., Gianstefani A., Giordani M., Giorgini A., Grieco A., Guerra M., Gulminetti R., Ieluzzi D., Imparato M., Iodice V., La Monica S., Lazzarin A., Lenzi M., Levrero M., Lichtner M., Lionetti R., Guercio C. L., Madonna S., Magnani S., Maida I., Marignani M., Marrone A., Marsetti F., Martini S., Masarone M., Maserati R., Mastroianni C. M., Memoli M., Menzaghi B., Merli M., Miele L., Milella M., Mondelli M., Montalbano M., Monti M., Morelli O., Morisco F., Nardone G., Novara S., Onnelli G., Onofrio M., Paganin S., Pani L., Parisi M. R., Parruti G., Pasquazzi C., Pasulo L., Perno C. F., Persico M., Piai G., Picciotto A., Pigozzi G. M., Piovesan S., Piras M. C., Pirisi M., Piscaglia A. M., Ponti L., Potenza D., Pravadelli C., Quartini M., Quirino T., Raimondo G., Rapaccini G. L., Rendina M., Rizzardini G., Rizzetto M., Rizzo S., Romagnoli D., Romano A., Rossi C., Rumi M. G., Russello M., Russo F. P., Russo M. L., Sansonno D. E., Santantonio T. A., Saracco G., Schimizzi A. M., Serviddio G., Simeone F., Solinas A., Soria A., Tabone M., Taliani G., Tarantino G., Tarquini P., Tavio M., Termite A., Teti E., Toniutto P., Torti C., Tundi P., Vecchiet G., Verucchi G., Gentilucci U. V., Vinci M., Vullo V., Zolfino T., and Zuin M.

Abstract

Purpose: To analyse safety and efficacy of treatment based on ombitasvir/paritaprevir/ritonavir/dasabuvir plus ribavirin in the sub-group of GT1 patients older than 65 years. Methods: We collected data extracted from the ABACUS compassionate-use nationwide Italian programme, in patients with cirrhosis due to hepatitis C virus (HCV) Genotype-1 (GT1) or 4 and at high risk of decompensation. GT1-HCV-infected patients received once-daily ombitasvir/paritaprevir, with the pharmacokinetic enhancer ritonavir (25/150/100 mg) and twice-daily dasabuvir (250 mg) plus Ribavirin (RBV) (OBV/PTV/r + DSV + RBV) for 12 (GT1b) or 24 (GT1a) weeks. Endpoints were to evaluate safety and efficacy, the latter defined as HCV RNA negative 12 weeks after the end of treatment (SVR12). Results: Patients who suffered any adverse event (AE) were 74/240 (30.8%); 13/240 (5.4%) discontinued the treatment. A multivariate analysis found albumin < 3.5 g/dL (OR 2.04: 95% CI 1.0–4.2, p < 0.05) and hypertension (OR 4.6: 95% CI 2.3–9.2, p < 0.001) as variables independently associated with AE occurrence. The SVR12 was 95% (228/240). Multivariate analysis identified baseline bilirubin < 2 mg/dL (OR 4.9: 95% CI 1.17–20.71, p = 0.029) as the only variable independently associated with SVR12. Conclusion: Our findings suggest that OBV/PTV/r + DSV + RBV is safe and effective in real-life use in patients with compensated cirrhosis, HCV-GT1 infection, and age over 65.

Published
2018

13. A randomized trial of pegylated-interferon-α2a plus ribavirin with or without amantadine in the re-treatment of patients with chronic hepatitis C not responding to standard interferon and ribavirin

Author

CIANCIO, A., PICCIOTTO, A., GIORDANINO, C., SMEDILE, A., TABONE, M., MANCA, A., MARENCO, G., GARBAGNOLI, P., ANDREONI, M., CARITI, G., CALLERI, G., SARTORI, M., CUSUMANO, S., GRASSO, A., RIZZI, R., GALLO, M., BASSO, M., ANSELMO, M., PERCARIO, G., CICCONE, G., RIZZETTO, M., and SARACCO, G.

Published
2006

16. AISF position paper on HCV in immunocompromised patients

Author

Angelucci, E, Astegiano, M, Baratelli, C, Biancone, L, Bironzo, P, Brancaccio, G, Brunetto, M, Bruno, R, Burra, P, Cabras, M, l Caraceni, P, Chialà, C, Clemente, M, Colli, A, Daniele, B, De Gasperi, E, Di Marco, V, Ditto, M, Fagiuoli, S, Ferri, C, Gaeta, G, Grossi, P, Imperatrice, B, Lampertico, P, Macaluso, F, Madonia, S, Marignani, M, Mazzarelli, C, Mella, A, Missale, G, Parisi, S, Pasulo, L, Puoti, M, Rendina, M, Ribaldone, D, Rossi, G, Toniutto, P, Tucci, A, Vajro, P, Viganò, M, Volpes, R, Zignego, A, Giannini, E, Miele, L, Russo, F, Petta, S, Bonora, S, Brignardello, E, Busca, A, Cariti, G, Cavallo, F, Conforti, M, Coscia, M, Craxì, A, Curci, D, Cusinato, S, Di Maio, M, Valle, R, Fusaro, E, Giacardi, A, Giaccone, L, Lagget, M, Libertucci, D, Minutolo, R, Montrucchio, G, Orlando, A, Orsucci, L, Pasquina, C, Pera, A, Peroni, C, Pirisi, M, Racca, P, Riccardini, F, Rizzetto, M, Salizzoni, M, Salomone, M, Saracco, G, Scaglione, L, Torre, G, Tozzi, R, Vitolo, U, Verme, G, Brunetto, MR, Cabras, MG, Clemente, MG, Ditto, MC, Gaeta, GB, Grossi, PA, Macaluso, FS, Zignego, AL, Giannini, EG, Russo, FP, Valle, RD, Peroni, CL, Saracco, GM, Angelucci, E, Astegiano, M, Baratelli, C, Biancone, L, Bironzo, P, Brancaccio, G, Brunetto, M, Bruno, R, Burra, P, Cabras, M, l Caraceni, P, Chialà, C, Clemente, M, Colli, A, Daniele, B, De Gasperi, E, Di Marco, V, Ditto, M, Fagiuoli, S, Ferri, C, Gaeta, G, Grossi, P, Imperatrice, B, Lampertico, P, Macaluso, F, Madonia, S, Marignani, M, Mazzarelli, C, Mella, A, Missale, G, Parisi, S, Pasulo, L, Puoti, M, Rendina, M, Ribaldone, D, Rossi, G, Toniutto, P, Tucci, A, Vajro, P, Viganò, M, Volpes, R, Zignego, A, Giannini, E, Miele, L, Russo, F, Petta, S, Bonora, S, Brignardello, E, Busca, A, Cariti, G, Cavallo, F, Conforti, M, Coscia, M, Craxì, A, Curci, D, Cusinato, S, Di Maio, M, Valle, R, Fusaro, E, Giacardi, A, Giaccone, L, Lagget, M, Libertucci, D, Minutolo, R, Montrucchio, G, Orlando, A, Orsucci, L, Pasquina, C, Pera, A, Peroni, C, Pirisi, M, Racca, P, Riccardini, F, Rizzetto, M, Salizzoni, M, Salomone, M, Saracco, G, Scaglione, L, Torre, G, Tozzi, R, Vitolo, U, Verme, G, Brunetto, MR, Cabras, MG, Clemente, MG, Ditto, MC, Gaeta, GB, Grossi, PA, Macaluso, FS, Zignego, AL, Giannini, EG, Russo, FP, Valle, RD, Peroni, CL, and Saracco, GM

Abstract

This report summarizes the clinical features and the indications for treating HCV infection in immunocompromised and transplanted patients in the Direct Acting Antiviral drugs era.

Published
2019

22. Portal vein thrombosis relevance on liver cirrhosis: Italian Venous Thrombotic Events Registry

Author

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., 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.

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 ± 12 years) 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 < 0.001), Child–Pugh Class B + C (p < 0.001), hepatocellular carcinoma (p = 0.01), previous upper gastrointestinal bleeding (p = 0.030) and older age (p = 0.012) were independently associated with portal vein thrombosis. Portal vein thrombosis is a frequent complication of cirrhosis, particularly in patients with moderate–severe liver failure. The apparent undertreatment of patients with portal vein thrombosis is a matter of concern and debate, which should be addressed by planning interventional trials especially with newer oral anticoagulants. Clinicaltrials.gov identifier NCT01470547.

Published
2016

24. 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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25. 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

26. 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

32. 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

33. 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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34. 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

35. 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

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

Author

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, Ciancio, A, Stroffolini T, Almasio PL, Sagnelli E, Mele A, Gaeta GB, 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. Italian Hospitals' Collaborating Group., 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, Ciancio, A, Stroffolini T, Almasio PL, Sagnelli E, Mele A, Gaeta GB, 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. Italian Hospitals' Collaborating Group.

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

38. 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

39. 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

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

Author

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, Fagiuoli, S, 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, Fagiuoli, S, 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., and Fagiuoli S.

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

41. 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, M, 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 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, Andorno, E, 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, and Andorno E

Published
2007

42. 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

43. 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

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

Author

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

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

45. Liver transplantation: the Italian experience

Author

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

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 long-term experience of liver transplantation in Italy. Patients and Methods. Data were obtained retrospectively 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

46. Low rates of screening and treatment of chronic hepatitis B, C, D (HBV, HCV, HDV), and hepatocellular carcinoma (HCC), associated barriers, and proposed solutions: results of a survey of physicians from all major provinces of Mongolia

Author

Estevez, J., primary, Kim, Y.A., additional, Le, A., additional, Israelski, D., additional, Baatarkhuu, O., additional, Sarantuya, T., additional, Narantsetseg, S., additional, Nymadawa, P., additional, Le, H., additional, Yuen, M.F., additional, Dusheiko, G., additional, Rizzetto, M., additional, and Nguyen, M.H., additional

Published
2016
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48. HBsAg kinetics in chronic hepatitis D during interferon therapy: on-treatment prediction of response

Author

Niro, G. A., primary, Smedile, A., additional, Fontana, R., additional, Olivero, A., additional, Ciancio, A., additional, Valvano, M. R., additional, Pittaluga, F., additional, Coppola, N., additional, Wedemeyer, H., additional, Zachou, K., additional, Marrone, A., additional, Fasano, M., additional, Lotti, G., additional, Andreone, P., additional, Iacobellis, A., additional, Andriulli, A., additional, and Rizzetto, M., additional

Published
2016
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49. Optimize trial: Non-inferiority of twice-daily telaprevir versus administration every 8 hours in treatment-naive, genotype 1 HCV infected patients.

Author

De Meyer S., Sievert W., Witek J., Luo D., Maieron A., Buti M., Agarwal K., Horsmans Y.J., Janczewska E., Zeuzem S., Nyberg L., Brown R.S., Hezode C., Rizzetto M., Parana R., De Meyer S., Sievert W., Witek J., Luo D., Maieron A., Buti M., Agarwal K., Horsmans Y.J., Janczewska E., Zeuzem S., Nyberg L., Brown R.S., Hezode C., Rizzetto M., and Parana R.

Abstract

Background: The ADVANCE study showed that telaprevir (TVR) every 8 hours (q8h) combined with pIFNalpha-2a (P) and ribavirin (R) had superior efficacy to PR alone. OPTIMIZE, a Phase III, randomized, open-label, international, non-inferiority study compares twice daily (bid) vs q8h TVR (NCT01241760). Method(s): HCV G1 treatment-naive patients were randomized to 750mg q8h or 1125mg bid TVR plus PR for 12 weeks, then PR alone for 12 weeks (RVR) or 36 weeks. The primary endpoint was SVR12. Result(s): 740 patients were treated. 15% had bridging fibrosis, 14% compensated cirrhosis, 85% HCV RNA >=800,000 IU/mL and 29% had IL28B CC. TVR bid vs q8h was non-inferior: difference 1.5% (95% CI: -4.9%, 12.0%). 69% for TVR bid vs 67% for q8h achieved RVR. The adverse event (AE) profile was generally similar between arms, with fatigue (47.3%), pruritus (42.7%), anemia (41.6%), nausea (36.5%) and rash (35.3%) as most frequent AE during the TVR phase. SAE occurred in 8.5%. Conclusion(s): In this study, with a high proportion of patients with bridging fibrosis or compensated cirrhosis, the efficacy of bid TVR was non-inferior to q8h offering the potential of simplified dosing to HCV G1 patients.

Published
2015

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