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

Author

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

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

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

Published
2018

60. 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

61. Management of hepatitis C virus infection in patients with chronic kidney disease: position statement of the joint committee of Italian association for the study of the liver (AISF), Italian society of internal medicine (SIMI), Italian society of infectious and tropical disease (SIMIT) and Italian society of nephrology (SIN)

Author

Minutolo, R, Aghemo, A, Chirianni, A, Fabrizi, F, Gesualdo, L, Giannini, E, Maggi, P, Montinaro, V, Paoletti, E, Persico, M, Perticone, F, Petta, S, Puoti, M, Raimondo, G, Rendina, M, Zignego, A, Minutolo R., Aghemo A., Chirianni A., Fabrizi F., Gesualdo L., Giannini E. G., Maggi P., Montinaro V., Paoletti E., Persico M., Perticone F., Petta S., Puoti M., Raimondo G., Rendina M., Zignego A. L., Minutolo, R, Aghemo, A, Chirianni, A, Fabrizi, F, Gesualdo, L, Giannini, E, Maggi, P, Montinaro, V, Paoletti, E, Persico, M, Perticone, F, Petta, S, Puoti, M, Raimondo, G, Rendina, M, Zignego, A, Minutolo R., Aghemo A., Chirianni A., Fabrizi F., Gesualdo L., Giannini E. G., Maggi P., Montinaro V., Paoletti E., Persico M., Perticone F., Petta S., Puoti M., Raimondo G., Rendina M., and Zignego A. L.

Abstract

Hepatitis C virus (HCV) infection is now considered a systemic disease due to the occurrence of extra-hepatic manifestations. Among these, the renal involvement is frequent. HCV infection, in fact, is strongly associated with proteinuria and chronic kidney disease (CKD) and negatively affects the prognosis of renal patients. In the last few years, availability of more specific and effective drugs against HCV has dramatically changed the clinical course of this disease. These drugs may provide further advantages in the CKD population as a whole by reducing progression of renal disease, mortality rate and by increasing the survival of graft in renal transplant recipients. The strict pathogenetic and prognostic link between HCV infection and CKD requires an ongoing relationship among the healthcare professionals involved in the treatment of both HCV infection and CKD. Therefore, Scientific Societies involved in the care of this high-risk population in Italy have organized a joint expert panel. The aim of the panel is to produce a position statement that can be used in daily clinical practice for the management of HCV infected patients across the whole spectrum of renal disease, from the conservative phase to renal replacement treatments (dialysis and transplantation). Sharing specific evidence-based expertise of different professional healthcare is the first step to obtain a common ground of knowledge on which to instate a model for multidisciplinary management of this high-risk population. Statements cover seven areas including epidemiology of CKD, HCV-induced glomerular damage, HCV-related renal risk, staging of liver disease in patients with CKD, prevention of transmission of HCV in hemodialysis units, treatment of HCV infection and management of HCV in kidney transplantation.

Published
2018

62. Current and future challenges in HCV: insights from an Italian experts panel

Author

Andreoni, M, Babudieri, S, Bruno, S, Colombo, M, Zignego, A, Di Marco, V, Di Perri, G, Perno, C, Puoti, M, Taliani, G, Villa, E, Craxi, A, Andreoni M., Babudieri S., Bruno S., Colombo M., Zignego A. L., Di Marco V., Di Perri G., Perno C. F., Puoti M., Taliani G., Villa E., Craxi A., Andreoni, M, Babudieri, S, Bruno, S, Colombo, M, Zignego, A, Di Marco, V, Di Perri, G, Perno, C, Puoti, M, Taliani, G, Villa, E, Craxi, A, Andreoni M., Babudieri S., Bruno S., Colombo M., Zignego A. L., Di Marco V., Di Perri G., Perno C. F., Puoti M., Taliani G., Villa E., and Craxi A.

Abstract

Background: The recent availability of direct acting antiviral drugs (DAAs) has drastically changed hepatitis C virus (HCV) treatment scenarios, due to the exceedingly high rates of sustained virological response (SVR) and excellent tolerability allowing for treatment at all disease stages. Methods: A panel of Italian experts was convened twice, in November 2016 and January 2017, to provide further support on some open issues and provide guidance for personalized HCV care, also in light of forthcoming regimens. Results and conclusions: Treatment recommendations issued by international and national liver societies to guide clinicians in the management of HCV infection are constantly updated due to accumulating new data. Such recommendations may not be applicable to all healthcare settings for a variety of reasons. Moreover, some gaps still remain and the spectrum of patients to be treated is also evolving.

Published
2018

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

Author

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

Abstract

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

Published
2018

64. Forecasting Hepatitis C liver disease burden on real-life data. Does the hidden iceberg matter to reach the elimination goals?

Author

Kondili, L, Robbins, S, Blach, S, Gamkrelidze, I, Zignego, A, Brunetto, M, Raimondo, G, Taliani, G, Iannone, A, Russo, F, Santantonio, T, Zuin, M, Chessa, L, Blanc, P, Puoti, M, Vinci, M, Erne, E, Strazzabosco, M, Massari, M, Lampertico, P, Rumi, M, Federico, A, Orlandini, A, Ciancio, A, Borgia, G, Andreone, P, Caporaso, N, Persico, M, Ieluzzi, D, Madonia, S, Gori, A, Gasbarrini, A, Coppola, C, Brancaccio, G, Andriulli, A, Quaranta, M, Montilla, S, Razavi, H, Melazzini, M, Vella, S, Craxi, A, Kondili L. A., Robbins S., Blach S., Gamkrelidze I., Zignego A. L., Brunetto M. R., Raimondo G., Taliani G., Iannone A., Russo F. P., Santantonio T. A., Zuin M., Chessa L., Blanc P., Puoti M., Vinci M., Erne E. M., Strazzabosco M., Massari M., Lampertico P., Rumi M. G., Federico A., Orlandini A., Ciancio A., Borgia G., Andreone P., Caporaso N., Persico M., Ieluzzi D., Madonia S., Gori A., Gasbarrini A., Coppola C., Brancaccio G., Andriulli A., Quaranta M. G., Montilla S., Razavi H., Melazzini M., Vella S., Craxi A., Kondili, L, Robbins, S, Blach, S, Gamkrelidze, I, Zignego, A, Brunetto, M, Raimondo, G, Taliani, G, Iannone, A, Russo, F, Santantonio, T, Zuin, M, Chessa, L, Blanc, P, Puoti, M, Vinci, M, Erne, E, Strazzabosco, M, Massari, M, Lampertico, P, Rumi, M, Federico, A, Orlandini, A, Ciancio, A, Borgia, G, Andreone, P, Caporaso, N, Persico, M, Ieluzzi, D, Madonia, S, Gori, A, Gasbarrini, A, Coppola, C, Brancaccio, G, Andriulli, A, Quaranta, M, Montilla, S, Razavi, H, Melazzini, M, Vella, S, Craxi, A, Kondili L. A., Robbins S., Blach S., Gamkrelidze I., Zignego A. L., Brunetto M. R., Raimondo G., Taliani G., Iannone A., Russo F. P., Santantonio T. A., Zuin M., Chessa L., Blanc P., Puoti M., Vinci M., Erne E. M., Strazzabosco M., Massari M., Lampertico P., Rumi M. G., Federico A., Orlandini A., Ciancio A., Borgia G., Andreone P., Caporaso N., Persico M., Ieluzzi D., Madonia S., Gori A., Gasbarrini A., Coppola C., Brancaccio G., Andriulli A., Quaranta M. G., Montilla S., Razavi H., Melazzini M., Vella S., and Craxi A.

Abstract

Background & Aims: Advances in direct-acting antiviral treatment of HCV have reinvigorated public health initiatives aimed at identifying affected individuals. We evaluated the possible impact of only diagnosed and linked-to-care individuals on overall HCV burden estimates and identified a possible strategy to achieve the WHO targets by 2030. Methods: Using a modelling approach grounded in Italian real-life data of diagnosed and treated patients, different linkage-to-care scenarios were built to evaluate potential strategies in achieving the HCV elimination goals. Results: Under the 40% linked-to-care scenario, viraemic burden would decline (60%); however, eligible patients to treat will be depleted by 2025. Increased case finding through a targeted screening strategy in 1948-1978 birth cohorts could supplement the pool of diagnosed patients by finding 75% of F0-F3 cases. Under the 60% linked-to-care scenario, viraemic infections would decline by 70% by 2030 but the patients eligible for treatment will run out by 2028. If treatment is to be maintained, a screening strategy focusing on 1958-1978 birth cohorts could capture 55% of F0-F3 individuals. Under the 80% linked-to-care scenario, screening limited in 1968-1978 birth cohorts could sustain treatment at levels required to achieve the HCV elimination goals. Conclusion: In Italy, which is an HCV endemic country, the eligible pool of patients to treat will run out between 2025 and 2028. To maintain the treatment rate and achieve the HCV elimination goals, increased case finding in targeted, high prevalence groups is required.

Published
2018

65. Corrigendum to “Premature ovarian senescence and a high miscarriage rate impair fertility in women with HCV” [J Hepatol 68 (2018) 33–41](S0168827817322596)(10.1016/j.jhep.2017.08.019)

Author

Karampatou A., Karampatou, A, Han, X, Kondili, L, Taliani, G, Ciancio, A, Morisco, F, Critelli, R, Baraldi, E, Bernabucci, V, Troshina, G, Guarino, M, Tagliavini, S, D'Ambrosio, F, Bristot, L, Turco, L, Rosato, S, Vella, S, Trenti, T, Neri, I, La Marca, A, Manthena, S, Goldstein, A, Bruno, S, Bao, Y, Gonzalez, Y, Villa, E, Craxi, A, Petta, S, Calvaruso, V, Brunetto, M, Coco, B, Chessa, L, Pasetto, M, Bigliotti, E, Tamburrini, F, Montalto, G, Capitano, A, Ieluzzi, D, Fattovich, G, Zignego, A, Monti, M, Gragnani, L, Zuin, M, Finati, E, Giorgini, A, Angarano, G, Milella, M, Alessandro, F, Dallio, M, Mazzella, G, Lazzarini, G, Di Fine, M, Russo, F, Zanetto, A, Castelli, F, Zaltron, S, Raimondo, G, Filomia, R, Puoti, M, Danieli, E, Strazzabosco, M, Gemma, M, Angelico, M, De Leonardis, F, Gori, A, Cappelletti, E, Bruno, R, Cima, S, Coppola, C, Amoruso, D, Andreone, P, Simonetti, G, Gaeta, G, Brancaccio, G, Toniutto, P, Dissegna, D, Mondelli, M, Ludovisi, S, Persico, M, Masarone, M, Torti, C, Strazzulla, A, Rosina, F, Framarin, L, Weimer, L, Quaranta, M, Falzano, L, Mallano, A, Karampatou A., Han X., Kondili L. A., Taliani G., Ciancio A., Morisco F., Critelli R. M., Baraldi E., Bernabucci V., Troshina G., Guarino M., Tagliavini S., D'Ambrosio F., Bristot L., Turco L., Rosato S., Vella S., Trenti T., Neri I., La Marca A., Manthena S., Goldstein A. S., Bruno S., Bao Y., Gonzalez Y. S., Villa E., Craxi A., Petta S., Calvaruso V., Brunetto M., Coco B., Chessa L., Pasetto M. C., Bigliotti E., Tamburrini F., Montalto G., Capitano A. R., Ieluzzi D., Fattovich G., Zignego A. L., Monti M., Gragnani L., Zuin M., Finati E., Giorgini A., Angarano G., Milella M., Alessandro F., Dallio M., Mazzella G., Lazzarini G., Di Fine M., Russo F. P., Zanetto A., Castelli F., Zaltron S., Raimondo G., Filomia R., Puoti M., Danieli E., Strazzabosco M., Gemma M., Angelico M., De Leonardis F., Gori A., Cappelletti E., Bruno R., Cima S., Coppola C., Amoruso D. C., Andreone P., Simonetti G., Gaeta G. B., Brancaccio G., Toniutto P., Dissegna D., Mondelli M., Ludovisi S., Persico M., Masarone M., Torti C., Strazzulla A., Rosina F., Framarin L., Weimer L. E., Quaranta M. G., Falzano L., Mallano A., Karampatou A., Karampatou, A, Han, X, Kondili, L, Taliani, G, Ciancio, A, Morisco, F, Critelli, R, Baraldi, E, Bernabucci, V, Troshina, G, Guarino, M, Tagliavini, S, D'Ambrosio, F, Bristot, L, Turco, L, Rosato, S, Vella, S, Trenti, T, Neri, I, La Marca, A, Manthena, S, Goldstein, A, Bruno, S, Bao, Y, Gonzalez, Y, Villa, E, Craxi, A, Petta, S, Calvaruso, V, Brunetto, M, Coco, B, Chessa, L, Pasetto, M, Bigliotti, E, Tamburrini, F, Montalto, G, Capitano, A, Ieluzzi, D, Fattovich, G, Zignego, A, Monti, M, Gragnani, L, Zuin, M, Finati, E, Giorgini, A, Angarano, G, Milella, M, Alessandro, F, Dallio, M, Mazzella, G, Lazzarini, G, Di Fine, M, Russo, F, Zanetto, A, Castelli, F, Zaltron, S, Raimondo, G, Filomia, R, Puoti, M, Danieli, E, Strazzabosco, M, Gemma, M, Angelico, M, De Leonardis, F, Gori, A, Cappelletti, E, Bruno, R, Cima, S, Coppola, C, Amoruso, D, Andreone, P, Simonetti, G, Gaeta, G, Brancaccio, G, Toniutto, P, Dissegna, D, Mondelli, M, Ludovisi, S, Persico, M, Masarone, M, Torti, C, Strazzulla, A, Rosina, F, Framarin, L, Weimer, L, Quaranta, M, Falzano, L, Mallano, A, Karampatou A., Han X., Kondili L. A., Taliani G., Ciancio A., Morisco F., Critelli R. M., Baraldi E., Bernabucci V., Troshina G., Guarino M., Tagliavini S., D'Ambrosio F., Bristot L., Turco L., Rosato S., Vella S., Trenti T., Neri I., La Marca A., Manthena S., Goldstein A. S., Bruno S., Bao Y., Gonzalez Y. S., Villa E., Craxi A., Petta S., Calvaruso V., Brunetto M., Coco B., Chessa L., Pasetto M. C., Bigliotti E., Tamburrini F., Montalto G., Capitano A. R., Ieluzzi D., Fattovich G., Zignego A. L., Monti M., Gragnani L., Zuin M., Finati E., Giorgini A., Angarano G., Milella M., Alessandro F., Dallio M., Mazzella G., Lazzarini G., Di Fine M., Russo F. P., Zanetto A., Castelli F., Zaltron S., Raimondo G., Filomia R., Puoti M., Danieli E., Strazzabosco M., Gemma M., Angelico M., De Leonardis F., Gori A., Cappelletti E., Bruno R., Cima S., Coppola C., Amoruso D. C., Andreone P., Simonetti G., Gaeta G. B., Brancaccio G., Toniutto P., Dissegna D., Mondelli M., Ludovisi S., Persico M., Masarone M., Torti C., Strazzulla A., Rosina F., Framarin L., Weimer L. E., Quaranta M. G., Falzano L., and Mallano A.

Abstract

It has come to our attention that the PITER framework investigator, Alessandro Federico, was incorrectly listed as F. Alessandro in the original manuscript. Please note that the correct name of this author is Alessandro Federico (2nd University of Naples). The correct list of PITER investigators is in the footnote below.

Published
2018

66. Forecasting Hepatitis C liver disease burden on real-life data. Does the hidden iceberg matter to reach the elimination goals?

Author

Kondili, Loreta A., Robbins, Sarah, Blach, Sarah, Gamkrelidze, Ivane, Zignego, Anna L., Brunetto, Maurizia R., Raimondo, Giovanni, Taliani, Gloria, Iannone, Andrea, Russo, Francesco P., Santantonio, Teresa A., Zuin, Massimo, Chessa, Luchino, Blanc, Pierluigi, Puoti, Massimo, Vinci, Maria Rosaria, Erne, Elke M., Strazzabosco, Mario, Massari, Marco, Lampertico, Pietro, Rumi, Maria G., Federico, Alessandro, Orlandini, Alessandra, Ciancio, Alessia, Borgia, Guglielmo, Andreone, Pietro, Caporaso, Nicola, Persico, Marcello, Ieluzzi, Donatella, Madonia, Salvatore, Gori, Andrea, Gasbarrini, Antonio, Coppola, Carmine, Brancaccio, Giuseppina, Andriulli, Angelo, Quaranta, Maria G., Montilla, Simona, Razavi, Homie, Melazzini, Mario, Vella, Stefano, Craxì, Antonio, Vinci, Maria, Gasbarrini, Antonio (ORCID:0000-0002-7278-4823), Kondili, Loreta A., Robbins, Sarah, Blach, Sarah, Gamkrelidze, Ivane, Zignego, Anna L., Brunetto, Maurizia R., Raimondo, Giovanni, Taliani, Gloria, Iannone, Andrea, Russo, Francesco P., Santantonio, Teresa A., Zuin, Massimo, Chessa, Luchino, Blanc, Pierluigi, Puoti, Massimo, Vinci, Maria Rosaria, Erne, Elke M., Strazzabosco, Mario, Massari, Marco, Lampertico, Pietro, Rumi, Maria G., Federico, Alessandro, Orlandini, Alessandra, Ciancio, Alessia, Borgia, Guglielmo, Andreone, Pietro, Caporaso, Nicola, Persico, Marcello, Ieluzzi, Donatella, Madonia, Salvatore, Gori, Andrea, Gasbarrini, Antonio, Coppola, Carmine, Brancaccio, Giuseppina, Andriulli, Angelo, Quaranta, Maria G., Montilla, Simona, Razavi, Homie, Melazzini, Mario, Vella, Stefano, Craxì, Antonio, Vinci, Maria, and Gasbarrini, Antonio (ORCID:0000-0002-7278-4823)

Abstract

Background & Aims: Advances in direct-acting antiviral treatment of HCV have reinvigorated public health initiatives aimed at identifying affected individuals. We evaluated the possible impact of only diagnosed and linked-to-care individuals on overall HCV burden estimates and identified a possible strategy to achieve the WHO targets by 2030. Methods: Using a modelling approach grounded in Italian real-life data of diagnosed and treated patients, different linkage-to-care scenarios were built to evaluate potential strategies in achieving the HCV elimination goals. Results: Under the 40% linked-to-care scenario, viraemic burden would decline (60%); however, eligible patients to treat will be depleted by 2025. Increased case finding through a targeted screening strategy in 1948-1978 birth cohorts could supplement the pool of diagnosed patients by finding 75% of F0-F3 cases. Under the 60% linked-to-care scenario, viraemic infections would decline by 70% by 2030 but the patients eligible for treatment will run out by 2028. If treatment is to be maintained, a screening strategy focusing on 1958-1978 birth cohorts could capture 55% of F0-F3 individuals. Under the 80% linked-to-care scenario, screening limited in 1968-1978 birth cohorts could sustain treatment at levels required to achieve the HCV elimination goals. Conclusion: In Italy, which is an HCV endemic country, the eligible pool of patients to treat will run out between 2025 and 2028. To maintain the treatment rate and achieve the HCV elimination goals, increased case finding in targeted, high prevalence groups is required.

Published
2018

67. IgG cryoglobulinemia

Author

Gulli, F, Basile, Umberto, Gragnani, L, Napodano, Cecilia, Pocino, Krizia, Miele, Luca, Santini, Stefano Angelo, Zignego, A L, Gasbarrini, Antonio, Rapaccini, G L, Basile, U, Napodano, C (ORCID:0000-0002-8720-6284), Pocino, K (ORCID:0000-0003-2456-5308), Miele, L (ORCID:0000-0003-3464-0068), Santini, S A (ORCID:0000-0003-1956-5899), Gasbarrini, A (ORCID:0000-0002-7278-4823), Gulli, F, Basile, Umberto, Gragnani, L, Napodano, Cecilia, Pocino, Krizia, Miele, Luca, Santini, Stefano Angelo, Zignego, A L, Gasbarrini, Antonio, Rapaccini, G L, Basile, U, Napodano, C (ORCID:0000-0002-8720-6284), Pocino, K (ORCID:0000-0003-2456-5308), Miele, L (ORCID:0000-0003-3464-0068), Santini, S A (ORCID:0000-0003-1956-5899), and Gasbarrini, A (ORCID:0000-0002-7278-4823)

Abstract

n/a

Published
2018

69. Modeling cost-effectiveness and health gains of a 'universal' versus 'prioritized' hepatitis C virus treatment policy in a real-life cohort

Author

Kondili, L. A., Romano, F., Rolli, F. R., Ruggeri, M., Rosato, S., Brunetto, M. R., Zignego, A. L., Ciancio, A., Di Leo, A., Raimondo, G., Ferrari, C., Taliani, G., Borgia, G., Santantonio, T. A., Blanc, P., Gaeta, G. B., Gasbarrini, A., Chessa, L., Erne, E. M., Villa, E., Ieluzzi, D., Russo, F. P., Andreone, P., Vinci, M., Coppola, C., Chemello, L., Madonia, S., Verucchi, G., Persico, M., Zuin, M., Puoti, M., Alberti, A., Nardone, G., Massari, M., Montalto, G., Foti, G., Rumi, M. G., Quaranta, M. G., Cicchetti, A., Craxi, A., and Vella, S.

Subjects
Adult, Aged, Aged, 80 and over, Antiviral Agents, Cohort Studies, Cost-Benefit Analysis, Health Policy, Hepatitis C, Humans, Middle Aged, Young Adult, Models, Economic
Published
2017

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

Author

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

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

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

Published
2017

71. 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

73. Interferon-free therapy in hepatitis C virus mixed cryoglobulinaemia: a prospective, controlled, clinical and quality of life analysis

Author

Gragnani, L., primary, Cerretelli, G., additional, Lorini, S., additional, Steidl, C., additional, Giovannelli, A., additional, Monti, M., additional, Petraccia, L., additional, Sadalla, S., additional, Urraro, T., additional, Caini, P., additional, Xheka, A., additional, Simone, A., additional, Arena, U., additional, Matucci-Cerinic, M., additional, Vergani, D., additional, Laffi, G., additional, and Zignego, A. L., additional

Published
2018
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75. Treatment of Hepatitis C virus infection in Italy: A consensus report from an expert panel

Author

Vigano, M, Perno, C, Craxi, A, Aghemo, A, Alberti, A, Andreone, P, Andreoni, M, Bonora, S, Brunetto, M, Bruno, R, Bruno, S, Calvaruso, V, Caporaso, N, Ceccherini-Silberstein, F, Cento, V, Ciancio, A, Colombatto, P, Degasperi, E, Di Marco, V, Di Perri, G, D'Offizi, G, Fagiuoli, S, Ferrari, C, Gaeta, G, Pellicelli, A, Petta, S, Piovesan, S, Puoti, M, Raimondo, G, Russo, F, Taliani, G, Trama, U, Villa, E, Zignego, A, Vigano M., Perno C. F., Craxi A., Aghemo A., Alberti A., Andreone P., Andreoni M., Bonora S., Brunetto M. R., Bruno R., Bruno S., Calvaruso V., Caporaso N., Ceccherini-Silberstein F., Cento V., Ciancio A., Colombatto P., Degasperi E., Di Marco V., Di Perri G., D'offizi G., Fagiuoli S., Ferrari C., Gaeta G. B., Pellicelli A., Petta S., Piovesan S., Puoti M., Raimondo G., Russo F. P., Taliani G., Trama U., Villa E., Zignego A. L., Vigano, M, Perno, C, Craxi, A, Aghemo, A, Alberti, A, Andreone, P, Andreoni, M, Bonora, S, Brunetto, M, Bruno, R, Bruno, S, Calvaruso, V, Caporaso, N, Ceccherini-Silberstein, F, Cento, V, Ciancio, A, Colombatto, P, Degasperi, E, Di Marco, V, Di Perri, G, D'Offizi, G, Fagiuoli, S, Ferrari, C, Gaeta, G, Pellicelli, A, Petta, S, Piovesan, S, Puoti, M, Raimondo, G, Russo, F, Taliani, G, Trama, U, Villa, E, Zignego, A, Vigano M., Perno C. F., Craxi A., Aghemo A., Alberti A., Andreone P., Andreoni M., Bonora S., Brunetto M. R., Bruno R., Bruno S., Calvaruso V., Caporaso N., Ceccherini-Silberstein F., Cento V., Ciancio A., Colombatto P., Degasperi E., Di Marco V., Di Perri G., D'offizi G., Fagiuoli S., Ferrari C., Gaeta G. B., Pellicelli A., Petta S., Piovesan S., Puoti M., Raimondo G., Russo F. P., Taliani G., Trama U., Villa E., and Zignego A. L.

Abstract

Hepatitis C virus (HCV) infection remains one of the main causes of chronic liver disease worldwide. The advent of direct-acting antivirals (DAAs) has significantly improved the course of patients with chronic HCV infection (CHC), due to the ability of these drugs to achieve high rates of sustained virological response (SVR). These exceedingly high rates of SVR and the excellent safety data have been confirmed in real life practice. Evolving guidelines have been issued by national and international scientific societies in accordance with the progression of clinical knowledge and the availability of new DAAs. These recommendations, however, may not be applied universally because of delays in drugs reimbursability in different countries and because some National Health Systems identify only patients with advanced disease as a treatment priority. Italy in this regard is a prototype about DAAs treatment of CHC patients. With the aim to assess the Italian treatment experience with DAAs and to respond to unmet needs in treatment optimization of antiviral therapy in specific settings of CHC patients, a group of Italian experts met in Stresa in February 2017. The summary of the considerations arising from this two-day meeting and some statements regarding a few open issues are reported in this position paper.

Published
2017

76. Real-life data on potential drug-drug interactions in patients with chronic hepatitis C viral infection undergoing antiviral therapy with interferon-free DAAs in the PITER Cohort Study

Author

Kondili, L, Gaeta, G, Ieluzzi, D, Zignego, A, Monti, M, Gori, A, Soria, A, Raimondo, G, Filomia, R, Leo, A, Iannone, A, Massari, M, Corsini, R, Gulminetti, R, Comini, A, Toniutto, P, Dissegna, D, Russo, F, Zanetto, A, Rumi, M, Brancaccio, G, Danieli, E, Brunetto, M, Weimer, L, Quaranta, M, Vella, S, Puoti, M, Kondili L. A., Gaeta G. B., Ieluzzi D., Zignego A. L., Monti M., Gori A., Soria A., Raimondo G., Filomia R., Leo A. D., Iannone A., Massari M., Corsini R., Gulminetti R., Comini A. G., Toniutto P., Dissegna D., Russo F. P., Zanetto A., Rumi M. G., Brancaccio G., Danieli E., Brunetto M. R., Weimer L. E., Quaranta M. G., Vella S., Puoti M., Kondili, L, Gaeta, G, Ieluzzi, D, Zignego, A, Monti, M, Gori, A, Soria, A, Raimondo, G, Filomia, R, Leo, A, Iannone, A, Massari, M, Corsini, R, Gulminetti, R, Comini, A, Toniutto, P, Dissegna, D, Russo, F, Zanetto, A, Rumi, M, Brancaccio, G, Danieli, E, Brunetto, M, Weimer, L, Quaranta, M, Vella, S, Puoti, M, Kondili L. A., Gaeta G. B., Ieluzzi D., Zignego A. L., Monti M., Gori A., Soria A., Raimondo G., Filomia R., Leo A. D., Iannone A., Massari M., Corsini R., Gulminetti R., Comini A. G., Toniutto P., Dissegna D., Russo F. P., Zanetto A., Rumi M. G., Brancaccio G., Danieli E., Brunetto M. R., Weimer L. E., Quaranta M. G., Vella S., and Puoti M.

Abstract

Background There are few real-life data on the potential drug-drug interactions (DDIs) between anti-HCV direct-acting antivirals (DAAs) and the comedications used. Aim To assess the potential DDIs of DAAs in HCV-infected outpatients, according to the severity of liver disease and comedication used in a prospective multicentric study. Methods Data from patients in 15 clinical centers who had started a DAA regimen and were receiving comedications during March 2015 to March 2016 were prospectively evaluated. The DDIs for each regimen and comedication were assigned according to HepC Drug Interactions (www.hep-druginteractions.org). Results Of the 449 patients evaluated, 86 had mild liver disease and 363 had moderate-to-severe disease. The use of a single comedication was more frequent among patients with mild liver disease (p = 0.03), whereas utilization of more than three drugs among those with moderate-to-severe disease (p = 0.05). Of the 142 comedications used in 86 patients with mild disease, 27 (20%) may require dose adjustment/closer monitoring, none was contraindicated. Of the 322 comedications used in 363 patients with moderate-to-severe liver disease, 82 (25%) were classified with potential DDIs that required only monitoring and dose adjustments; 10 (3%) were contraindicated in severe liver disease. In patients with mild liver disease 30% (26/86) used at least one drug with a potential DDI whereas of the 363 patients with moderate-to-severe liver disease, 161 (44%) were at risk for one or more DDI. Conclusions Based on these results, we can estimate that 30-44% of patients undergoing DAA and taking comedications are at risk of a clinically significant DDI. This data indicates the need for increased awareness of potential DDI during DAA therapy, especially in patients with moderate-to-severe liver disease. For several drugs, the recommendation related to the DDI changes from "dose adjustment/closer monitoring" in mild to moderate liver disease, to "the use is co

Published
2017

77. HCV-related mixed cryoglobulinemia: Data from PITER, a nationwide Italian HCV cohort study

Author

Weimer, L. E., Vinci, M., Borgia, G., Brunetto, M., Sturace, L., Gaeta, G. B., Chemello, L., Buggio, A., Andreone, P., Raimondo, G., Filomia, R., Persico, M., Puoti, M., Rumi, M. G., Benedetti, A., Fargion, S., Ieluzzi, D., Nardone, G., Foti, G., Ciancio, A., Taliani, G., Biliotti, E., Madonia, S., Stagno, B., Alberti, A., Massari, M., Rosina, F., Mazzella, G., Di Leo, A., Iannone, A., Ferrari, C., Orlandini, A., Gragnani, L., Santantonio, T. A., Chessa, L., Erne, E. M., Coppola, C., Andreoni, M., Baldelli, F., Mondelli, M., Blanc, P., Gasbarrini, A., D’Aversa, F., Verucchi, G., Colombo, M., Borghi, M., Craxì, A., Petta, S., Villa, E., Patti, O., Russo, F. P., Strazzabosco, M., Mallano, A., Fucili, L., Massella, M., Kondili, L., Vella, S., Zignego, A. L., and it/piter), ISS & AISF & SIMIT collaborating - Group in PITER (available in www. iss.

Subjects
medicine.medical_specialty, Hepatology, business.industry, Internal medicine, Mixed cryoglobulinemia, Gastroenterology, medicine, business, Cohort study
Published
2016

78. Current and future challenges in HCV: insights from an Italian experts panel

Author

Andreoni, Massimo, primary, Babudieri, Sergio, additional, Bruno, Savino, additional, Colombo, Massimo, additional, Zignego, Anna L., additional, Di Marco, Vito, additional, Di Perri, Giovanni, additional, Perno, Carlo F., additional, Puoti, Massimo, additional, Taliani, Gloria, additional, Villa, Erica, additional, and Craxì, Antonio, additional

Published
2017
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79. CRYOGLOBULINEMIC VASCULITIS AND PRIMARY SJOGREN'S SYNDROME ARE INDEPENDENT RISK FACTORS FOR LYMPHOMA IN A LARGE WORLDWIDE POPULATION OF PATIENTS WITH POSITIVE SERUM CRYOGLOBULINS

Author

Quartuccio, L. Corazza, L. Ramos-Casals, M. Retamozo, S. and Ragab, G. M. Ferraccioli, G. Gremese, E. Tzioufas, A. and Voulgarelis, M. Vassilopoulos, D. Koutsianas, C. Scarpato, S. Salvarani, C. Guillevin, L. Terrier, B. Cacoub, P. and Saccardo, F. Gabrielli, A. Fraticelli, P. Tomsic, M. and Tavoni, A. Nishimoto, N. Filippini, D. Scaini, P. and Zignego, A. L. Ferri, C. Sansonno, D. Monti, G. and Pietrogrande, M. Galli, M. Bombardieri, S. De Vita, S.

Published
2015

80. Inhibition of early response genes prevents changes in global joint metabolomic profiles in mouse post-traumatic osteoarthritis.

Author

Haudenschild, D.R., Carlson, A.K., Zignego, D.L., Yik, J.H.N., Hilmer, J.K., June, R.K., Haudenschild, Dominik R, Carlson, Alyssa K, Zignego, Donald L, Yik, Jasper H N, Hilmer, Jonathan K, and June, Ronald K

Abstract

Objective: Although joint injury itself damages joint tissues, a substantial amount of secondary damage is mediated by the cellular responses to the injury. Cellular responses include the production and activation of proteases (MMPs, ADAMTSs, Cathepsins), and the production of inflammatory cytokines. The trajectory of cellular responses is driven by the transcriptional activation of early response genes, which requires Cdk9-dependent RNA Polymerase II phosphorylation. Our objective was to determine whether inhibition of cdk9-dependent early response gene activation affects changes in the joint metabolome.Design: To model post-traumatic osteoarthritis, we subjected mice to non-invasive Anterior Cruciate Ligament (ACL)-rupture joint injury. Following injury, mice were treated with flavopiridol - a potent and selective inhibitor of Cdk9 kinase activity - to inhibit Cdk9-dependent transcriptional activation, or vehicle control. Global joint metabolomics were analyzed 1 h after injury.Results: We found that injury induced metabolomic changes, including increases in Vitamin D3 metabolism, anandamide, and others. Inhibition of primary response gene activation immediately after injury largely prevented the global changes in the metabolomics profiles. Cluster analysis of joint metabolomes identified groups of injury-induced and drug-responsive metabolites.Conclusions: Metabolomic profiling provides an instantaneous snapshot of biochemical activity representing cellular responses. We identified two sets of metabolites that change acutely after joint injury: those that require transcription of primary response genes, and those that do not. These data demonstrate the potential for inhibition of early response genes to alter the trajectory of cell-mediated degenerative changes following joint injury, which may offer novel targets for cell-mediated secondary joint damage. [ABSTRACT FROM AUTHOR]

Published
2019
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81. A randomized, controlled study of peginterferon lambda-1a/ribavirin +/- daclatasvir for hepatitis C virus genotype 2 or 3

Author

University of Helsinki, Clinicum, Foster, Graham R., Chayama, Kazuaki, Chuang, Wan-Long, Fainboim, Hugo, Farkkila, Martti, Gadano, Adrian, Gaeta, Giovanni B., Hezode, Christophe, Inada, Yukiko, Heo, Jeong, Kumada, Hiromitsu, Lu, Sheng-Nan, Marcellin, Patrick, Moreno, Christophe, Roberts, Stuart K., Strasser, Simone I., Thompson, Alexander J., Toyota, Joji, Paik, Seung Woon, Vierling, John M., Zignego, Anna L., Cohen, David, McPhee, Fiona, Wind-Rotolo, Megan, Srinivasan, Subasree, Hruska, Matthew, Myler, Heather, Portsmouth, Simon D., University of Helsinki, Clinicum, Foster, Graham R., Chayama, Kazuaki, Chuang, Wan-Long, Fainboim, Hugo, Farkkila, Martti, Gadano, Adrian, Gaeta, Giovanni B., Hezode, Christophe, Inada, Yukiko, Heo, Jeong, Kumada, Hiromitsu, Lu, Sheng-Nan, Marcellin, Patrick, Moreno, Christophe, Roberts, Stuart K., Strasser, Simone I., Thompson, Alexander J., Toyota, Joji, Paik, Seung Woon, Vierling, John M., Zignego, Anna L., Cohen, David, McPhee, Fiona, Wind-Rotolo, Megan, Srinivasan, Subasree, Hruska, Matthew, Myler, Heather, and Portsmouth, Simon D.

Abstract

Background and purpose: Peginterferon Lambda was being developed as an alternative to alfa interferon for the treatment of chronic hepatitis C virus (HCV) infection. We compared peginterferon Lambda-1a plus ribavirin (Lambda/RBV) and Lambda/RBV plus daclatasvir (DCV; pangenotypic NS5A inhibitor) with peginterferon alfa-2a plus RBV (alfa/RBV) in treatment-naive patients with HCV genotype 2 or 3 infection. Methods: In this multicenter, double-blind, phase 3 randomized controlled trial, patients were assigned 2:2:1 to receive 24 weeks of Lambda/RBV, 12 weeks of Lambda/RBV + DCV, or 24 weeks of alfa/RBV. The primary outcome measure was sustained virologic response at post-treatment Week 12 (SVR12). Results: Overall, 874 patients were treated: Lambda/RBV, n = 353; Lambda/RBV + DCV, n = 349; alfa/RBV, n = 172. Patients were 65 % white and 33 % Asian, 57 % male, with a mean age of 47 years; 52 % were infected with genotype 2 (6 % cirrhotic) and 48 % with genotype 3 (9 % cirrhotic). In the Lambda/RBV + DCV group, 83 % (95 % confidence interval [CI] 78.5, 86.5) achieved SVR12 (90 % genotype 2, 75 % genotype 3) whereas SVR12 was achieved by 68 % (95 % CI 63.1, 72.9) with Lambda/RBV (72 % genotype 2, 64 % genotype 3) and 73 % (95 % CI 66.6, 79.9) with peginterferon alfa/RBV (74 % genotype 2, 73 % genotype 3). Lambda/RBV + DCV was associated with lower incidences of flu-like symptoms, hematological abnormalities, and discontinuations due to adverse events compared with alfa/RBV. Conclusion: The 12-week regimen of Lambda/RBV + DCV was superior to peginterferon alfa/RBV in the combined population of treatment-naive patients with genotype 2 or 3 infection, with an improved tolerability and safety profile compared with alfa/RBV.

Published
2016

82. From current status to optimization of HCV treatment: Recommendations from an expert panel

Author

Craxi, A, Perno, C, Vigano, M, Ceccherini-Silberstein, F, Petta, S, Aghemo, A, Alberti, A, Andreone, P, Andreoni, M, Bonora, S, Brunetto, M, Bruno, S, Caporaso, N, Chirianni, A, Ciancio, A, Degasperi, E, Di Perri, G, Fagiuoli, S, Ferrari, C, Gaeta, G, Pellicelli, A, Puoti, M, Raimondo, G, Taliani, G, Villa, E, Zignego, A, Craxi A., Perno C. F., Vigano M., Ceccherini-Silberstein F., Petta S., Aghemo A., Alberti A., Andreone P., Andreoni M., Bonora S., Brunetto M. R., Bruno S., Caporaso N., Chirianni A., Ciancio A., Degasperi E., Di Perri G., Fagiuoli S., Ferrari C., Gaeta G. B., Pellicelli A., Puoti M., Raimondo G., Taliani G., Villa E., Zignego A. L., Craxi, A, Perno, C, Vigano, M, Ceccherini-Silberstein, F, Petta, S, Aghemo, A, Alberti, A, Andreone, P, Andreoni, M, Bonora, S, Brunetto, M, Bruno, S, Caporaso, N, Chirianni, A, Ciancio, A, Degasperi, E, Di Perri, G, Fagiuoli, S, Ferrari, C, Gaeta, G, Pellicelli, A, Puoti, M, Raimondo, G, Taliani, G, Villa, E, Zignego, A, Craxi A., Perno C. F., Vigano M., Ceccherini-Silberstein F., Petta S., Aghemo A., Alberti A., Andreone P., Andreoni M., Bonora S., Brunetto M. R., Bruno S., Caporaso N., Chirianni A., Ciancio A., Degasperi E., Di Perri G., Fagiuoli S., Ferrari C., Gaeta G. B., Pellicelli A., Puoti M., Raimondo G., Taliani G., Villa E., and Zignego A. L.

Abstract

Chronic hepatitis C virus (HCV) infection is a major public health problem at a global level, causing an enormous burden of hepatic and extra-hepatic morbidity and mortality. Treatment of chronic HCV (CHC) has been revolutionized in the last few years by the introduction of highly effective and well tolerated direct acting antiviral agents (DAAs) able to achieve >90% rates of sustained virological response (SVR) in many groups of patients, including those previously excluded from interferon-based regimens. For such reason interferon-free regimens are now the treatments of choice for all patients. Successful anti-HCV treatment can stop liver disease progression and can solve the HCV-related extra hepatic manifestations, eventually reducing both liver-related and overall mortality. Together with the rapidly accumulating data about the evolution of treatment landscape, different guidelines from national and international Liver Scientific Societies have been published until today. However, these recommendations may not be applied worldwide as, due to high treatment costs, most of them identify as priority groups only patients with advanced liver disease. Moreover some types of patients pose clinical management problems for which even the guidelines do not always provide useful answers. With the aim of treatment optimization by filling some of the gaps of the current guidelines and addressing the remaining unmet needs in practice, a group of Italian experts, experienced on treatment of HCV infection, met in Stresa in February 2016. The summary of all the considerations arising from this two-day meeting and the final statements are reported in this position paper.

Published
2016

83. A randomized, controlled study of peginterferon lambda-1a/ribavirin ± daclatasvir for hepatitis C virus genotype 2 or 3

Author

Foster, Graham R., primary, Chayama, Kazuaki, additional, Chuang, Wan-Long, additional, Fainboim, Hugo, additional, Farkkila, Martti, additional, Gadano, Adrian, additional, Gaeta, Giovanni B., additional, Hézode, Christophe, additional, Inada, Yukiko, additional, Heo, Jeong, additional, Kumada, Hiromitsu, additional, Lu, Sheng-Nan, additional, Marcellin, Patrick, additional, Moreno, Christophe, additional, Roberts, Stuart K., additional, Strasser, Simone I., additional, Thompson, Alexander J., additional, Toyota, Joji, additional, Paik, Seung Woon, additional, Vierling, John M., additional, Zignego, Anna L., additional, Cohen, David, additional, McPhee, Fiona, additional, Wind-Rotolo, Megan, additional, Srinivasan, Subasree, additional, Hruska, Matthew, additional, Myler, Heather, additional, and Portsmouth, Simon D., additional

Published
2016
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84. From meetings

Author

Arias, I. M., Jezequel, A. M., Berg, P. A., Gatta, A., Angeli, P., Galanti, B., Gaeta, G. B., Gallo, C., Giusti, G., Pourcel, C., Zignego, A. L., Bréchot, C., Cantley, L., Rizzetto, M., Mazzanti, R., Moscarella, S., Gentilini, P., Buzzelli, G., Smorlesi, C., Dattolo, P., Focardi, G. P., Laffi, G., Meacci, E., Marra, F., Gentilini, P., Reynolds, T. B., Arroyo, V., Haupert, G. T., Gerbes, A. L., Gentilini, P., Varticovski, L., Villari, N., Bartoletti, S., Strazzabosco, M., Muraca, M., Venuti, M., Varotto, A., Iemmolo, R. M., Fragasso, A., Passera, D., Okolicsanyi, L., Capocaccia, L., Ariosto, F., Merli, M., Riggio, O., Romiti, A., Pagliaro, L., D’Amico, G., Traina, M., Montalbano, L., Gatto, G., Pisa, R., Maisano, S., Politi, F., Colletti, P., Tiné, F., Barbara, L., Corinaldesi, R., De Giorgio, R., Stanghellini, V., Scuro, L. A., Vantini, I., Dobrilla, G., Amplatz, S., Naccarato, R., Di Mario, F., Blasi, A., Mangiameli, A., Bianchi Porro, G., Petrillo, M., Forgac, M. D., Donowitz, M., Rood, R. P., Wesolek, J. H., Emmer, E., Cohen, M., McCullen, J., Braithwaite, R. S., Sharp, G. W. G., Murer, H., Ward, H. D., and Pereira, M. E. A.

Published
1988
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85. IgG cryoglobulinemia.

Author

GRAGNANI, L., GULLI, F., BASILE, U., NAPODANO, C., POCINO, K., SANTINI, S. A., MIELE, L., GASBARRINI, A., RAPACCINI, G. L., and ZIGNEGO, A. L.

Abstract

OBJECTIVE: Mixed Cryoglobulinemia is the most well-known Hepatitis C Virus (HCV)-associated extrahepatic manifestation. MC is both an autoimmune and B-lymphoproliferative disorder. Cryoglobulins (CGs) are classified into three groups according to immunoglobulin (Ig) composition: type I is composed of one isotype or Ig class. Type II and type III mixed CGs are immune complexes composed of polyclonal IgGs acting as autoantigens and mono, polyclonal or oligoclonal IgM with rheumatoid factor activity. IgG1 and IgG3 are the predominant subclasses involved. This study shows the simultaneous presence of IgG-RF and IgG3, supporting the hypothesis of an involvement of this subclass in the initiation of early stages of CGs. PATIENTS AND METHODS: We describe a case series of six HCV-positive patients, all of whom had peripheral neuropathy and transient ischemic attacks, presenting cryoprecipitates formed by IgG3 and IgG1. Cryoprecipitate IgG subclass research was carried out by immunofixation electrophoresis by using antisera against IgG1, IgG2, IgG3, and IgG4. RESULTS: Our six patients presented with an immunochemical pattern characterized by the mere presence of IgG1 and IgG3 subclasses with probable RF activity and one of these six patients exhibited monoclonal IgG3 in his cerebrospinal fluid. CONCLUSIONS: We can hypothesize that the IgG passage through the blood-brain barrier could have contributed to the cause of TIAs, through a mechanism involving the precipitation of circulating immune complexes formed by the two subclasses in the intrathecal vessels. [ABSTRACT FROM AUTHOR]

Published
2018

86. Efficacy and safety of peginterferon alfa-2b plus ribavirin for HCV-positive mixed cryoglobulinemia: a multicentre open-label study

Author

Cesare Mazzaro, Monti, G., Saccardo, F., Zignego, A. L., Ferri, C., Vita, S., Gabrielli, A., Lenzi, M., Donada, C., Galli, M., Pietrogrande, M., Pozzato, G., Mazzaro, C, Monti, G, Saccardo, F, Zignego, Al, Ferri, C, De Vita, S, Gabrielli, A, Lenzi, M, Donada, C, Galli, M, Pietrogrande, M, Pozzato, Gabriele, Mazzaro C, Monti G, Saccardo F, Zignego AL, Ferri C, De Vita S, Gabrielli A, Lenzi M, Donada C, Galli M, Pietrogrande M, and Pozzato G.

Subjects
Adult, Male, mixed cryoglobulinemia, HCV, Non-Hodgkin's lymphomas, Vasculitis, ribavirin, Hepacivirus, Interferon alpha-2, Antiviral Agents, Polyethylene Glycols, Liver Function Tests, IFN Teraphy, Ribavirin, peginterferon, Humans, Aged, Interferon-alpha, virus diseases, CRYOGLOBULINEMIA, Hepatitis C, Chronic, Middle Aged, Recombinant Proteins, digestive system diseases, Treatment Outcome, Drug Therapy, Combination, Female
Abstract

OBJECTIVES: The aim of the present study is to provide information on clinical outcome of the patients affected by HCV-positive mixed cryoglobulinemia (MC) treated with PEG-IFN and Ribavirin for 6 or 12 months according to the HCV genotype. METHODS: Eighty-six patients (42 women and 44 men) were enrolled in 8 Italian centres. All the patients had MC in the active phase of the disease. The patients received Peginterferon alfa-2b 1.5 mcg/kg/once a week (QW) and daily oral Ribavirin (800/1,000/1,200) according to their body weight for 48 weeks for genotype 1 and 4 and for 24 weeks for genotypes 2 and 3. RESULTS: In the 44 patients who underwent 12 months of therapy, 17 cases (39%) could be considered as 'non-responders' and 11 relapsed, therefore only 16 patients (36%) obtained a sustained virological response. In the 42 patients who underwent six months of therapy only 7 cases (17%) could be considered as 'non-responders' and 8 relapsed, therefore 27 patients (64%) obtained a sustained virological response. Purpura score dropped in both group (p

Published
2011

90. The presence of autoimmune thyroiditis in mixed cryoglobulinemia patients is associated with high levels of circulating interleukin-6, but not of tumor necrosis factor-alpha

Author

Antonelli, A., Ferri, C., Ferrari, S. M., Di Domenicantonio, A., Ferrari, P., Pupilli, C., Andrea Nicolini, Zignego, A. L., Marchi, S., and Fallahi, P.

Subjects
Male, mixed cryoglobulinemia, Analysis of Variance, Chi-Square Distribution, Interleukin-6, Tumor Necrosis Factor-alpha, interleukin-6, Thyroiditis, Autoimmune, autoimmune thyroiditis, Hepatitis C, Chronic, Middle Aged, Up-Regulation, Logistic Models, Cryoglobulinemia, Italy, Case-Control Studies, tumor necrosis factor-alpha, Humans, Female, Biomarkers, Aged
Abstract

To our knowledge, no study has evaluated serum levels of interleukin-6 (IL-6), together with tumour necrosis factor-alpha (TNF-α), in a large series of patients with 'mixed cryoglobulinemia and HCV chronic infection' (MC+HCV) in relation to the presence of autoimmune thyroiditis (AT). The aims of the study were to evaluate serum levels of IL-6 in MC+HCV patients and to correlate this parameter with the presence of AT and with circulating levels of TNF-α.Serum IL-6 and TNF-α were assayed in 41 MC+HCV patients, in 41 MC+HCV patients with autoimmune thyroiditis (MC+AT), in 41 sex- and age-matched controls, and 20 AT patients.MC+HCV patients showed significantly (p0.01; Mann-Whitney U-test) higher IL-6 (median 8.1ng/l, range 0.7-651) serum levels than controls (median 0.6ng/l, range 0.5-41), or AT (median 2.8ng/l, range 0.5-67). MC+AT showed significantly (p0.01; Mann-Whitney U-test) higher mean IL-6 (median 15.8ng/l, range 0.5-781) than controls, AT and MC+HCV. Serum TNF-α levels were significantly higher in MC+HCV (median 9.9ng/l, range 1.5-283) or MC+AT (median 11.2ng/l, range 1.6-412) than in controls (median 1.0ng/l, range 0.6-6.4), or AT (median 1.7ng/l, range 0.6-11.8) (p0.01, for each comparison).Our study demonstrates significantly higher serum levels of IL-6 and TNF-α in patients with MC+HCV and MC+AT compared to healthy controls. Furthermore, the study first shows a significant increase in circulating IL-6 observed in MC+AT patients with respect to MC+HCV. Future studies in larger patients' series will be needed to evaluate the relevance of serum IL-6 and TNF-α determination as clinico-prognostic markers of MC+HCV patients and its usefulness in the therapeutic approach to these patients.

Published
2010

91. A randomized, controlled, multicenter phase III study of the efficacy and safety of Rituximab (RTX) monotherapy versus thebest available treatment in patients with mixedcryoglobulinemia syndrome, on behalf of the rituximab studygroup in cryoglobulinemic sindrome

Author

DE VITA, Salvatore, Quartuccio, Luca, Isola, Miriam, Masolini, P., Sacco, S., De Marchi, G., Mazzaro, S., Scaini, P., Lenzi, M., Campanini, M., Scarpato, S., Tavoni, A., Pietrogrande, M., Ferri, C., Mascia, M. T., Roccatello, D., Zignego, A. L., Pioltelli, P., Gabrielli, A., Perella, D. Filippini O., Migliaresi, S., Galli, M., Monti, G., and Bombardieri, S.

Published
2010

92. Retrospective, observational, multicentre study on an Italian population affected by chronic hepatitis C who failed to clear HCV-RNA after the combined therapy (PEG-IFN and ribavirin): NADIR study

Author

Morisco, F, Stroffolini, T, Medda, E, Amoruso, Dc, Almasio, Pl, Villa, E, Zuin, M, Paris, B, Stanzione, M, Caporaso, N, NADIR Study Group, Aceti, A, Amaddeo, G, Ancarani, F, Arcuri, P, Attili, A, Bandiera, F, Bellati, G, Benigno, R, Benini, F, Bombardieri, G, Bruno, S, Capretti, A, Carrara, M, Cottone, C, Cozzolongo, R, Demelia, L, Di Gaetano, G, Esposito, P, Fanelli, G, Gaeta, Gb, Giannini, Eg, Giorgini, A, Grieco, A, Guadagnino, V, Lanzini, A, Lo Bello, S, Lupo, S, Maracci, M, Marchi, S, Martines, D, Mazzella, G, Miele, L, Milan, M, Milani, S, Minoli, G, Montalto, G, Morrone, A, Nosotti, L, Paroli, M, Pastore, G, Persico, Marcello, Piccinino, F, Pinzello, Gb, Pozzi, M, Roffi, L, Russello, M, Russo, M, Sagnelli, E, Savarino, V, Soccorsi, F, Squadrito, G, Tabone, M, Tarsetti, F, Tesini, Em, Testa, R, Tripi, S, Gianfranca, S, Vandelli, C, Zignego, A. L., Morisco, F., Stroffolini, T., Medda, E., Amoruso, D. C., Almasio, P. L., Villa, E., Zuin, M., Paris, B., Stanzione, M., Caporaso, N., Nadir Study Group, Mazzella, Giuseppe, Morisco, F, Stroffolini, T, Medda, E, Amoruso, DC, Almasio, PL, Villa, E, Zuin, M, Paris, B, Stanzione, M, Caporaso, N, Montalto, G, Morisco, Filomena, T., Stroffolini, E., Medda, D. C., Amoruso, P. L., Almasio, E., Villa, M., Zuin, B., Pari, M., Stanzione, and Caporaso, Nicola

Subjects
Adult, Male, non-responders, relapser, Genotype, body mass index, cirrhosis, hepatitis c virus, nonresponder, pegylated-interferon, Infectious Disease, Hepacivirus, virus, Interferon alpha-2, Antiviral Agents, Polyethylene Glycol, Polyethylene Glycols, Medication Adherence, hepatitis C, Risk Factors, Retrospective Studie, Virology, Ribavirin, Humans, Age Factor, Treatment Failure, Retrospective Studies, Aged, Antiviral Agent, Settore MED/12 - Gastroenterologia, HCV, Antiviral therapy, Body mass index, Cirrhosis, Hepatitis C virus, Nonresponder, Pegylated-interferon, Relapser, Cirrhosi, Hepaciviru, Hepatology, Risk Factor, Age Factors, Interferon-alpha, Hepatitis C, Chronic, Middle Aged, Recombinant Protein, Recombinant Proteins, Italy, RNA, Viral, Female, Hepatitis C viru, Human
Abstract

There is a lack of information on the characteristics of patients with chronic hepatitis C virus infection (HCV) who fail to respond to antiviral treatment. We studied HCV-positive subjects with chronic liver diseases treated with pegylated-interferon (PEG-IFN) and ribavirin (RBV) who failed to clear HCV in routine clinical practice. A total of 2150 consecutive adult patients treated with PEG-IFN plus RBV therapy in 46 Italian centres between 1 July 2004, and 30 June 2005, were studied. Of the 2150 patients, 923 (42.9%) (M/F 585/335, mean age 54.8 years) failed to achieve a serum HCV-RNA clearance. Of these 923 patients, 429 (46.5%) were nonresponders, 298 (32.3%) relapsers, 168 (18.2%) drop-outs for noncompliance or adverse events and 28 (3.0%) were lost during follow-up. Overall, 642 (70.6%) patients received adequate therapy (defined as more than 80% of the drug doses for >80% of the time). Genotypes 1-4 were observed in 76.9% of cases; genotypes 2-3 in 21.2% and mixed in 1.9%, respectively. Multiple logistic regression analysis identified genotypes 1 and 4 as the sole independent predictors of the likelihood of nonresponse to therapy compared with relapse (OR: 4.38; 95% CI = 2.28-8.4). Age older than 65 years was the sole independent factor associated with no adherence to therapy (OR: 2.22; 95% CI = 1.36-3.62). Patients who fail to respond to treatment are a nonhomogeneous population with different features, and the sole factor that discriminates nonresponse from relapse is the distribution of genotypes 1-4. Co-morbidities are unable to determine the type of treatment failure and inadequate adherence to therapy mostly affects patients older than 65 years of age. © 2009 Blackwell Publishing Ltd.

Published
2010

94. A randomized, controlled, multicenter phase iii study of the efficacy and safety of rituximab (rtx) monotherapy versus the best available treatment (bat) in patients with mixed cryoglobulinemia syndrome (MC) Ann Rheum Dis 2010;69(Suppl3):93

Author

DE VITA, Salvatore, Quartuccio, Luca, Masolini, P., Stefania, S., De Marchi, G., Zabotti, A., Mazzaro, C., Lenzi, P. Scaini M., Campanini, M., Scarpato, S., Tavoni, A., Pietrogrande, M., Ferri, C., Mascia, M. T., Roccatello, D., Zignego, A. L., Pioltelli, P., Gabrielli, A., Filippini, D., Perrella, O., Migliaresi, S., Galli, M., Monti, G., and Bombardieri, S.

Published
2010

95. Treatment of chronic hepatitis B: recommendations from an Italian workshop

Author

Carosi, G., Rizzetto, M., Andreone, P., Angelico, M., Ascione, A., Caporaso, N., Fagiuolim, S., Fattovich, G., Mondelli, M., Niro, G. A., Pontisso, P., Bonino, F., Perno, C. F., Prati, D., Andreoni, M., Angarano, G., Annicchiarico, E., Boncoraglio, R., Brustia, D., Calabrese, N., Carlotto, A., Cavalletto, L., Cavina, M., Chessa, L., Croce, G., De Sanctis, G., Di Candilo, F., Fabris, P., Fracassetti, O., Lanza, A. G., Giuberti, T., Guazzotti, G., Iacovazzi, T., Iovinella, V., Izzi, A., Loperfido, P., Magni, C. F., Marino, N., Messina, V., Michelone, G., Morante, R., Moretti, A., Nasta, P., Nauri, L., Paffetti, A., Pasino, M., Perboni, G., Petrelli, E., Picciotto, A., Pozzi, M., Purificato, F., Re, T., Rinaldi, R., Sani, S., Santoro, R., Schioppa, O., Scotto, G., Siciliano, M., Sorbello, O., Squadrito, G., Taddei, M. T., Traversa, A., Tundo, P., Venezia, G., Vilardo, L., Zignego, A. L., Zoncada, A., and Zuin, M.

Subjects
Liver Cirrhosis, medicine.medical_specialty, Cirrhosis, Immune suppressed, Human immunodeficiency virus (HIV), HIV Infections, Disease, Antiviral therapy, medicine.disease_cause, Antiviral Agents, Immunocompromised Host, Hepatitis B, Chronic, Chronic hepatitis, Interferon, HDV, Internal medicine, Drug Resistance, Viral, HBV, medicine, Humans, Hepatitis B Antibodies, Liver histology, Hepatitis B virus, HCV, HIV, Hepatology, business.industry, Gastroenterology, Hepatitis B, medicine.disease, Hepatitis C, Hepatitis D, Italy, Immunology, business, medicine.drug
Abstract

The changing scenario of hepatitis B virus therapy has encouraged the organisation of a workshop, endorsed by three Italian scientific societies, aimed at defining the current recommendations for hepatitis B virus treatment. Liver histology and stage of disease remain fundamental for treatment decisions; interferon and nucleoside/nucleotide analogues-based therapy represent different strategies for different phases of the hepatitis B virus disease. The recommendations defined: new and lower cut-off of hepatitis B virus–DNA for eligibility to therapy according to disease stage, how to optimise the use of nucleoside/nucleotide analogues and to individualise the monitoring of response and what to do with treatment failures. Specific recommendations have also been given for cirrhosis patients, those immune suppressed and co-infected with HIV and other hepatitis viruses. © 2008 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

Published
2008

97. Cryoglobulinemia

Author

Ferri, Clodoveo, Zignego, A. L., and Pileri, S. A.

Subjects
mixed cryoglobulinemia
Published
2006

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