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3. 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

8. Preliminary classification criteria for the cryoglobulinaemic vasculitis

Author

De Vita, S, Soldano, F, Isola, M, Monti, G, Gabrielli, A, Tzioufas, A, Ferri, C, Ferraccioli, G F, Quartuccio, L, Corazza, L, De Marchi, G, Casals, M Ramos, Voulgarelis, M, Lenzi, M, Saccardo, F, Fraticelli, P, Mascia, M T, Sansonno, D, Cacoub, P, Tomsic, M, Tavoni, A, Pietrogrande, M, Zignego, A L, Scarpato, S, Mazzaro, C, Pioltelli, P, Steinfeld, S, Lamprecht, P, Bombardieri, S, and Galli, M

Published
2011
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20. [Therapeutic decisions and treatment with sorafenib in hepatocellular carcinoma: final analysis of GIDEON study in Italy]

Author

D'Angelo, S, Germano, D, Zolfino, T, Sansonno, D, Giannitrapani, L, Benedetti, A, Montesarchio, V, Attili, A, Buonadonna, A, Barni, S, Gasbarrini, A, Burlone, Me, Cillo, U, Marenco, S, Villa, Eleonora, Giovanis, P, Proserpio, I, Saitta, C, Magini, G, Cengarle, R, Fava, G, Cuttone, F, Calvani, N, Angelico, M, Di Costanzo, F, Noto, A, Poggi, G, Marignani, M, Cascinu, S, Amoroso, D, Palmieri, V, Massa, E, Crocè, Ls, Picardi, A, Tumulo, S, Erminero, C, Lencioni, R, Lorusso, V., D'Angelo, S., Germano, D., Zolfino, T., Sansonno, D., Giannitrapani, L., Benedetti, A., Montesarchio, V., Attili, A., Buonadonna, A., Barni, S., Gasbarrini, A., Burlone, M. E., Cillo, U., Marenco, S., Villa, E., Giovanis, P., Proserpio, I., Saitta, C., Magini, G., Cengarle, R., Fava, G., Cuttone, F., Calvani, N., Angelico, M., Di Costanzo, F., Noto, A., Poggi, G., Marignani, M., Cascinu, S., Amoroso, D., Palmieri, V., Massa, E., Croce, L. S., Picardi, A., Tumulo, S., Erminero, C., Lencioni, R., and Lorusso, V.

Subjects
GIDEON study, Hepatocellular carcinoma, Sorafenib, Adult, Aged, 80 and over, Male, Niacinamide, Carcinoma, Hepatocellular, Aged, Antineoplastic Agents, Female, Humans, Italy, Liver Neoplasms, Middle Aged, Phenylurea Compounds, Prospective Studies, Settore MED/12 - GASTROENTEROLOGIA, Carcinoma, Hepatocellular, 80 and over
Abstract

Introduction. Sorafenib, an oral multikinase inhibitor, is the only targeted agent approved for the treatment of patients with hepatocellular carcinoma (HCC) after demonstration to increase overall survival compared to placebo in two randomized phase III study. GIDEON (Global Investigation of therapeutic DEcisions in HCC and Of its treatment with sorafeNib) is the largest, global, non-interventional, prospective study of patients with uHCC (n>3200) treated with sorafenib in real-life clinical practice conditions. Here we report the final analysis of safety and efficacy in the Italian cohort of patients. Methods. Patients with unresectable HCC who are candidates for systemic therapy, and for whom a decision has been made to treat with sorafenib, are eligible for inclusion. Patients demographics disease characteristics and treatment history were recorded at baseline visit. Sorafenib dose, concomitant medications, performance status, liver function, adverse events and efficacy (survival and response rate) were collected throughout the study. Results. In the Italian cohort of the GIDEON study 278 patients were included in 36 centers. The global rate of adverse events was 81%. Drug-related events accounted for 67%, mostly of grade 1 and 2, and only 8% were classified as serious. The most common were diarrhea (24%), fatigue (23%), dermatological (14%), rash/exfoliation (10%), hypertension (9%), hemorrage/bleeding of gastrointestinal tract (6%). Overall survival was 14.4 months and time to progression 6.2 months. Objective responses were observed in 14 patients (5%) with 3 complete responses (1%). Stable diseases of at least 6 weeks were observed in 113 patients (41%) with a 30% of disease control rate. Discussion. The safety profile of sorafenib in terms of rate and type of adverse events is similar to that emerged in the global international GIDEON study as well as in the pivotal registration studies.

Published
2015

21. Italy GIDEON final analysis Sorafenib-treated patients: prognostic value of baseline characteristics and staging systems

Author

D'Angelo, S, Lorusso, V, Piras, MR, Sansonno, D, Benedetti, A, Montesarchio, V, Attili, AF, Frustaci, S, Barni, S, Pirisi, M, Carpani, D, Magini, G, Daniele, B., GIANNITRAPANI, Lydia, D'Angelo, S, Lorusso, V, Piras, MR, Sansonno, D, Giannitrapani, L, Benedetti, A, Montesarchio, V, Attili, AF, Frustaci, S, Barni, S, Pirisi, M, Carpani, D, Magini, G, and Daniele, B

Subjects
Settore MED/09 - Medicina Interna, HCC, Sorafenib, clinical practice
Published
2014

22. HCC management with Sorafenib and TACE: Italian experience from GIDEON (Global Investigational Of Therapeutic Decisions in HCC and of its Treatment with Sorafenib)

Author

Lorusso, V, Germano, D, Zolfino, MT, Sansonno, D, Benedetti, A, Montesarchio, V, Attili, AF, Frustaci, S, Gasbarrini, A, Cillo, U, Carpani, D. Picciotto A, D’Angelo S., MONTALTO, Giuseppe, Lorusso, V, Germano, D, Zolfino, MT, Sansonno, D, Montalto, G, Benedetti, A, Montesarchio, V, Attili, AF, Frustaci, S, Gasbarrini, A, Cillo, U, and Carpani, D Picciotto A, D’Angelo S

Subjects
Hepatocellular carcinoma, Sorafenib, Management
Published
2014

24. Cryoglobulinemic Vasculitis and Primary sjögren'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, Ragab, Gm, Ferraccioli, G, Gremese, E, Tzioufas, A, Voulgarelis, M, Vassilopoulos, D, Koutsianas, C, Scarpato, S, Salvarani, Carlo, Guillevin, L, Terrier, B, Cacoub, P, Saccardo, F, Gabrielli, A, Fraticelli, P, Tomsic, M, Tavoni, A, Nishimoto, N, Filippini, D, Scaini, P, Zignego, Al, Ferri, Clodoveo, Sansonno, D, Monti, G, Pietrogrande, M, Galli, M, Bombardieri, S, and Vita, S. De

Published
2015

25. 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

26. Sorafenib in clinical practice: Pooled analysis of two prospective observational studies in hepatocellular carcinoma (HCC)

Author

Di Costanzo, G.G., primary, D’Angelo, S., additional, Zolfino, T., additional, Lorusso, V., additional, Montesarchio, V., additional, de Stefano, G., additional, Sacco, R., additional, Attili, A.F., additional, Benedetti, A., additional, Sansonno, D., additional, Giannitrapani, L., additional, Buonadonna, A., additional, Giovanis, P., additional, Cabibbo, G., additional, De Vita, F., additional, Carucci, P., additional, Pirisi, M., additional, Moscovici, M., additional, Pisconti, S., additional, and Daniele, B., additional

Published
2016
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27. HCV RNA Genomic sequences and HCV-E2 glycoprotein in sural nerve biopsies from HCV-infected patients with peripheral neuropathy.

Author

Russi, S., Sansonno, D., Monaco, S., Mariotto, S., Ferrari, S., Pavone, F., Lauletta, G., and Dammacco, F.

Subjects
*GLYCOPROTEIN analysis, *HEPATITIS C virus, *CRYOGLOBULINEMIA, *PERIPHERAL neuropathy, *IN situ hybridization
Abstract

Aims: Peripheral neuropathy (PN), the major neurological complication of chronic HCV infection, is frequently associated with mixed cryoglobulinaemia (MC) and small-vessel systemic vasculitis. While humoral and cellmediated immune mechanisms are suspected to act together in an aberrant immune response that results in peripheral nerve damage, the role of HCV remains largely speculative. The possible demonstration of HCV in peripheral nerve tissue would obviously assume important pathogenic implications. Methods: We studied sural nerve biopsies from 11 HCV-positive patients with neuropathic symptoms: five with and six without MC. In situ hybridization (ISH) and immunofluorescence studies were carried out to detect genomic and antigenomic HCV RNA sequences and HCV-encoded E2-glycoprotein, respectively. Results: Epineurial vascular deposits of E2- glycoprotein were found in four (80%) MC and in two (33.3%) non-MC patients, respectively. These findings were enhanced by the perivascular deposition of positive-, though not negative-strand replicative RNA, as also found in the nerve extracts of all patients. Mild inflammatory cell infiltrates with no deposits of immunoglobulins and/or complement proteins were revealed around small vessels, without distinct vasculitis changes between MC and non-MC patients. Conclusions: These results indicate that nerve vascular HCV RNA/E2 deposits associated to perivascular inflammatory infiltrates were similar in chronically HCV-infected patients, regardless of cryoglobulin occurrence. Given the failure to demonstrate HCV productive infection in the examined sural nerve biopsies, nerve damage is likely to result from virus-triggered immune-mediated mechanisms. [ABSTRACT FROM AUTHOR]

Published
2018
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28. Preliminary classification criteria for the cryoglobulinaemic vasculitis

Author

De Vita, S. Soldano, F. Isola, M. Monti, G. Gabrielli, A. Tzioufas, A. Ferri, C. Ferraccioli, G.F. Quartuccio, L. Corazza, L. De Marchi, G. Ramos Casals, M. Voulgarelis, M. Lenzi, M. Saccardo, F. Fraticelli, P. Mascia, M.T. Sansonno, D. Cacoub, P. Tomsic, M. Tavoni, A. Pietrogrande, M. Zignego, A.L. Scarpato, S. Mazzaro, C. Pioltelli, P. Steinfeld, S. Lamprecht, P. Bombardieri, S. Galli, M.

Abstract

Background: To develop preliminary classification criteria for the cryoglobulinaemic syndrome or cryoglobulinaemic vasculitis (CV). Methods: Study part I developed a questionnaire for CV to be included in the formal, second part (study part II). Positivity of serum cryoglobulins was defined by experts as an essential condition for CV classification. In study part II, a core set of classification items (questionnaire, clinical and laboratory items, as agreed) was tested in three groups of patients and controls - that is, group A (new patients with the CV), group B (controls with serum cryoglobulins but lacking CV) and group C (controls without serum cryoglobulins but with features which can be observed in CV). Results: In study part I (188 cases, 284 controls), a positive response to at least two of three selected questions showed a sensitivity of 81.9% and a specificity of 83.5% for CV. This questionnaire was employed and validated in study part II, which included 272 patients in group A and 228 controls in group B. The final classification criteria for CV, by pooling data from group A and group B, required the positivity of questionnaire plus clinical, questionnaire plus laboratory, or clinical plus laboratory items, or all the three, providing a sensitivity of 88.5% and a specificity of 93.6% for CV. By comparing data in group A versus group C (425 controls), the same classification criteria showed a sensitivity 88.5% and a specificity 97.0% for CV. Conclusion: Classification criteria for CV were developed, and now need validation.

Published
2011

29. Final results of the gideon study according to patient etiology: The italian experience

Author

D'Angelo, S., primary, Germano, D., additional, Zolfino, T., additional, Sansonno, D., additional, Montalto, G., additional, Benedetti, A., additional, Montesarchio, V., additional, Attili, A.F., additional, Buonadonna, A., additional, Barni, S., additional, Gasbarrini, A., additional, Pirisi, M., additional, Cillo, U., additional, Marenco, S., additional, Villa, E., additional, Giovanis, P., additional, Pinotti, G., additional, Saitta, C., additional, Erminero, C., additional, de Giorgio, M., additional, and Lorusso, V., additional

Published
2015
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30. Hepatocellular Carcinoma In Elderly Patients: final results of The Italian Cohort Of GIDEON (Global Investigational of therapeutic DEcisions in HCC and of its treatment with sorafeNib) Study

Author

Zolfino, T., primary, Lorusso, V., additional, D'Angelo, S., additional, Sansonno, D., additional, Giannitrapani, L., additional, Benedetti, A., additional, Montesarchio, V., additional, Attili, A.F., additional, Buonadonna, A., additional, Barni, S., additional, Gasbarrini, A., additional, Pirisi, M., additional, Cillo, U., additional, Picciotto, A., additional, Villa, E., additional, Giovanis, P., additional, Pinotti, G., additional, Saitta, C., additional, Erminero, C., additional, de Giorgio, M., additional, and Daniele, B., additional

Published
2015
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31. OP0274 Cryoglobulinemic Vasculitis and Primary sjögren's Syndrome are Independent Risk Factors for Lymphoma in a Large Worldwide Population of Patients with Positive Serum Cryoglobulins

Author

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

Published
2015
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32. P-111 Final results of the GIDEON (Global Investigational of therapeutic DEcisions in HCC and Of its treatment with sorafeNib) study according to patient etiology: The Italian experience

Author

D'Angelo, S., primary, Germano, D., additional, Zolfino, T., additional, Sansonno, D., additional, Montalto, G., additional, Benedetti, A., additional, Montesarchio, V., additional, Attili, A., additional, Buonadonna, A., additional, Barni, S., additional, Gasbarrini, A., additional, Pirisi, M., additional, Cillo, U., additional, Marenco, S., additional, Villa, E., additional, Giovanis, P., additional, Pinotti, G., additional, Raimondo, G., additional, Erminero, C., additional, De Giorgio, M., additional, and Lorusso, V., additional

Published
2015
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33. P-110 Hepatocellular carcinoma in elderly patients: Final results of the Italian cohort of GIDEON study

Author

Zolfino, T., primary, Lorusso, V., additional, D'Angelo, S., additional, Sansonno, D., additional, Giannitrapani, L., additional, Benedetti, A., additional, Montesarchio, V., additional, Attili, A., additional, Buonadonna, A., additional, Barni, S., additional, Gasbarrini, A., additional, Pirisi, M., additional, Cillo, U., additional, Picciotto, A., additional, Villa, E., additional, Giovanis, P., additional, Pinotti, G., additional, Raimondo, G., additional, Erminero, C., additional, De Giorgio, M., additional, and Daniele, B., additional

Published
2015
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34. Validation of the classification criteria for cryoglobulinaemic vasculitis

Author

Quartuccio, L, Isola, M, Corazza, L, Ramos Casals, M, Retamozo, S, Ragab, Gm, Zoheir, Mn, El Menyawi, Ma, Salem, Mn, Sansonno, D, Ferraccioli, Gianfranco, Gremese, Elisa, Tzioufas, A, Voulgarelis, M, Vassilopoulos, D, Scarpato, S, Pipitone, N, Salvarani, C, Guillevin, L, Terrier, B, Cacoub, P, Filippini, D, Saccardo, F, Gabrielli, A, Fraticelli, P, Sebastiani, M, Tomsic, M, Tavoni, A, Mazzaro, C, Pioltelli, P, Nishimoto, N, Zignego, Al, Ferri, C, Monti, G, Pietrogrande, M, Bombardieri, S, Galli, M, De Vita, S., Ferraccioli, Gianfranco (ORCID:0000-0001-6246-2428), Gremese, Elisa (ORCID:0000-0002-2248-1058), Quartuccio, L, Isola, M, Corazza, L, Ramos Casals, M, Retamozo, S, Ragab, Gm, Zoheir, Mn, El Menyawi, Ma, Salem, Mn, Sansonno, D, Ferraccioli, Gianfranco, Gremese, Elisa, Tzioufas, A, Voulgarelis, M, Vassilopoulos, D, Scarpato, S, Pipitone, N, Salvarani, C, Guillevin, L, Terrier, B, Cacoub, P, Filippini, D, Saccardo, F, Gabrielli, A, Fraticelli, P, Sebastiani, M, Tomsic, M, Tavoni, A, Mazzaro, C, Pioltelli, P, Nishimoto, N, Zignego, Al, Ferri, C, Monti, G, Pietrogrande, M, Bombardieri, S, Galli, M, De Vita, S., Ferraccioli, Gianfranco (ORCID:0000-0001-6246-2428), and Gremese, Elisa (ORCID:0000-0002-2248-1058)

Abstract

The aim of this study was to validate the classification criteria for cryoglobulinaemic vasculitis (CV).

Published
2014

35. Multidisciplinary approach for HCC patients: hepatology for the oncologists

Author

Barone, Carlo Antonio, Koeberle, D, Metselaar, H, Parisi, G, Sansonno, D, Spinzi, G., Barone, Carlo Antonio, Koeberle, D, Metselaar, H, Parisi, G, Sansonno, D, and Spinzi, G.

Abstract

Hepatocellular carcinoma (HCC) is a complex and heterogeneous disease, often associated with underlying conditions, like cirrhosis or other relevant co-morbidities that worsen the prognosis and make the clinical management more challenging. Current recommendations emphasize the importance of a multidisciplinary approach for the management of HCC patients and stress the crucial role of careful prevention and the management of cirrhosis-associated complications. This article discusses the importance of a multidisciplinary approach in the treatment of HCC patients. Current recommendations for the treatment of cirrhotic patients with HCC are also reviewed.

Published
2013

37. Performance of the preliminary classification criteria for cryoglobulinaemic vasculitis and clinical manifestations in hepatitis C virus-unrelated cryoglobulinaemic vasculitis

Author

Quartuccio, L, Isola, M, Corazza, L, Maset, M, Monti, G, Gabrielli, A, Tzioufas, Ag, Ferri, C, Ferraccioli, Gianfranco, Ramos Casals, M, Voulgarelis, M, Lenzi, M, Mascia, Mt, Sansonno, D, Cacoub, P, Tomsic, M, Tavoni, A, Pietrogrande, M, Zignego, Al, Scarpato, S, Pioltelli, P, Steinfeld, S, Lamprecht, P, Galli, M, Bombardieri, S, De Vita, S., Ferraccioli, Gianfranco (ORCID:0000-0001-6246-2428), Quartuccio, L, Isola, M, Corazza, L, Maset, M, Monti, G, Gabrielli, A, Tzioufas, Ag, Ferri, C, Ferraccioli, Gianfranco, Ramos Casals, M, Voulgarelis, M, Lenzi, M, Mascia, Mt, Sansonno, D, Cacoub, P, Tomsic, M, Tavoni, A, Pietrogrande, M, Zignego, Al, Scarpato, S, Pioltelli, P, Steinfeld, S, Lamprecht, P, Galli, M, Bombardieri, S, De Vita, S., and Ferraccioli, Gianfranco (ORCID:0000-0001-6246-2428)

Abstract

Cryoglobulinaemic vasculitis (CV) is often related to hepatitis C virus (HCV) infection, but it can develop in other diseases (e.g. other infections, connective tissue diseases, malignancies) in the absence of HCV infection. A comparison of the performance of the recently published classification criteria for the CV was made between HCV-positive and HCV negative patients with serum cryoglobulins.

Published
2012

38. Recommendations for the management of mixed cryoglobulinemia syndrome in hepatitis C virus-infected patients

Author

Pietrogrande, M, De Vita, S, Zignego, A, Pioltelli, P, Sansonno, D, Sollima, S, Atzeni, F, Saccardo, F, Quartuccio, L, Bruno, S, Bruno, R, Campanini, M, Candela, M, Castelnovo, L, Gabrielli, A, Gaeta, G, Marson, P, Mascia, M, Mazzaro, C, Mazzotta, F, Meroni, P, Montecucco, C, Ossi, E, Piccinino, F, Prati, D, Puoti, M, Riboldi, P, Riva, A, Roccatello, D, Sagnelli, E, Scaini, P, Scarpato, S, Sinico, R, Taliani, G, Tavoni, A, Bonacci, E, Renoldi, P, Filippini, D, Sarzi Puttini, P, Ferri, C, Monti, G, Galli, M, Galli, M., PIOLTELLI, PIETRO ENRICO, SINICO, RENATO ALBERTO, Pietrogrande, M, De Vita, S, Zignego, A, Pioltelli, P, Sansonno, D, Sollima, S, Atzeni, F, Saccardo, F, Quartuccio, L, Bruno, S, Bruno, R, Campanini, M, Candela, M, Castelnovo, L, Gabrielli, A, Gaeta, G, Marson, P, Mascia, M, Mazzaro, C, Mazzotta, F, Meroni, P, Montecucco, C, Ossi, E, Piccinino, F, Prati, D, Puoti, M, Riboldi, P, Riva, A, Roccatello, D, Sagnelli, E, Scaini, P, Scarpato, S, Sinico, R, Taliani, G, Tavoni, A, Bonacci, E, Renoldi, P, Filippini, D, Sarzi Puttini, P, Ferri, C, Monti, G, Galli, M, Galli, M., PIOLTELLI, PIETRO ENRICO, and SINICO, RENATO ALBERTO

Abstract

Objective: The objective of this review was to define a core set of recommendations for the treatment of HCV-associated mixed cryoglobulinemia syndrome (MCS) by combining current evidence from clinical trials and expert opinion. Methods: Expert physicians involved in studying and treating patients with MCS formulated statements after discussing the published data. Their attitudes to treatment approaches (particularly those insufficiently supported by published data) were collected before the consensus conference by means of a questionnaire, and were considered when formulating the statements. Results: An attempt at viral eradication using pegylated interferon plus ribavirin should be considered the first-line therapeutic option in patients with mild-moderate HCV-related MCS. Prolonged treatment (up to 72. weeks) may be considered in the case of virological non-responders showing clinical and laboratory improvements. Rituximab (RTX) should be considered in patients with severe vasculitis and/or skin ulcers, peripheral neuropathy or glomerulonephritis. High-dose pulsed glucocorticoid (GC) therapy is useful in severe conditions and, when necessary, can be considered in combination with RTX; on the contrary, the majority of conference participants discouraged the chronic use of low-medium GC doses. Apheresis remains the elective treatment for severe, life-threatening hyper-viscosity syndrome; its use should be limited to patients who do not respond to (or who are ineligible for) other treatments, and emergency situations. Cyclophosphamide can be considered in combination with apheresis, but the data supporting its use are scarce. Despite the limited available data, colchicine is used by many of the conference participants, particularly in patients with mild-moderate MCS refractory to other therapies. Careful monitoring of the side effects of each drug, and its effects on HCV replication and liver function tests is essential. A low-antigen-content diet can be considered

Published
2011

40. SAT0175 Results of the Classification Criteria for Cryoglobulinemic Vasculitis Validation Study

Author

De Vita, S., primary, Quartuccio, L., additional, Isola, M., additional, Corazza, L., additional, Ramos-Casals, M., additional, Retamozo, S., additional, Ragab, G., additional, Zoheir, N., additional, El Menyawi, M. M., additional, Salem, M., additional, Sansonno, D., additional, Conteduca, V., additional, Ferraccioli, G., additional, Gremese, E., additional, Tzioufas, A., additional, Voulgarelis, M., additional, Vassilopoulos, D., additional, Koutsianas, C., additional, Zignego, A. L., additional, Urraro, T., additional, Pipitone, N., additional, Salvarani, C., additional, Ghinoi, A., additional, Guillevin, L., additional, Terrier, B., additional, Cacoub, P., additional, Filippini, D., additional, Saccardo, F., additional, Gabrielli, A., additional, Fraticelli, P., additional, Tomsic, M., additional, Ferri, C., additional, Sebastiani, M., additional, Tavoni, A., additional, Catarsi, E., additional, Mazzaro, C., additional, Pioltelli, P., additional, Nishimoto, N., additional, Scaini, P., additional, Monti, G., additional, Pietrogrande, M., additional, Galli, M., additional, and Bombardieri, S., additional

Published
2013
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42. Patients with Mixed Cryoglobulinemia and HCV Infection, in Presence or Absence of Autoimmune Thyroiditis, Have High Serum Levels of (CXC MOTIF) Ligand (CXCL)9 and CXCL11 Chemokines

Author

Antonelli, A., primary, Fallahi, P., additional, Ferrari, S.M., additional, Frascerra, S., additional, Corrado, A., additional, Colaci, M., additional, Manfredi, A., additional, Maccheroni, M., additional, Sansonno, D., additional, Zignego, A.L., additional, Centanni, M., additional, and Ferri, C., additional

Published
2012
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46. Role of the HLA Class II: HCV-Related Disorders

Author

DE RE, V., primary, CAGGIARI, L., additional, SIMULA, M. P., additional, DE VITA, S., additional, MAZZARO, C., additional, LENZI, M., additional, MASSIMO, G. M., additional, MONTI, G., additional, FERRI, C., additional, ZIGNEGO, A. L., additional, GABRIELLI, A., additional, SANSONNO, D., additional, DAMMACCO, F., additional, LIBRA, M., additional, SACCHI, N., additional, TALAMINI, R., additional, SPINA, M., additional, TIRELLI, U., additional, CANNIZZARO, R., additional, and DOLCETTI, R., additional

Published
2007
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