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2. Evolution of endoscopic management for anastomotic biliary strictures after liver transplantation: a two-decade retrospective study

Author

De Lucia, S. S., additional, Birligea, M. M., additional, Schepis, T., additional, Perri, V., additional, Familiari, P., additional, Boskoski, I., additional, Landi, R., additional, Bove, V., additional, Montalbano, M., additional, Ettorre, G. M., additional, Guglielmo, N., additional, Avolio, A. W., additional, Agnes, S., additional, Costamagna, G., additional, Spada, C., additional, and Tringali, A., additional

Published
2024
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3. Active Coated PLA-PHB Film with Formulations Containing a Commercial Olive Leaf Extract to Improve Quality Preservation of Fresh Pork Burgers

Author

Fiorentini, Cecilia, Bassani, Andrea, Zaccone, M., Montalbano, M. L., De Apodaca, E. D., Spigno, Giorgia, Fiorentini C., Bassani A. (ORCID:0000-0001-8258-4369), Spigno G. (ORCID:0000-0003-1636-6851), Fiorentini, Cecilia, Bassani, Andrea, Zaccone, M., Montalbano, M. L., De Apodaca, E. D., Spigno, Giorgia, Fiorentini C., Bassani A. (ORCID:0000-0001-8258-4369), and Spigno G. (ORCID:0000-0003-1636-6851)

Abstract

Since fresh meat is often subject to several degradation reactions that decrease its safety and quality until it is considered unacceptable, the release of bioactive compounds into meat products may be a good option to slow down oxidation and extend its shelf-life by a few days. Therefore, this study aimed to test the application on fresh pork burgers of a PLA-PHB film coated with two different coating formulations (methylcellulose, MC and chitosan, CT), both containing a commercial olive leaf extract OL, to evaluate their effect on meat quality preservation. Samples were tested at 0, 2, 5, 7, 9, 12, and 14 days after packing for microbial, chemical, and sensory evaluations. Except for the chitosan-only formulation, all tested formulations (MC, MC+OL and CT+OL) adhered well to the PLA-PHB base without the use of specific treatments. Meat packed with the different coatings maintained a slightly brighter red colour than the control samples and, as a result, deteriorated more slowly. In the evaluation of lipid oxidation, the CT+OL coating showed lower mean values of mg MDA/kg meat, which were significantly different from the other samples, especially on the 7th and 9th day of storage. Moreover, the CT+OL coating showed a slight slowdown in Enterobacteriaceae growth, revealing promising results in maintaining the meat quality longer.

Published
2023

6. Prophylactic heparin and risk of orotracheal intubation or death in patients with mild or moderate COVID-19 pneumonia

Author

Vergori, A., Lorenzini, P., Cozzi-Lepri, A., Donno, D. R., Gualano, G., Nicastri, E., Iacomi, F., Marchioni, L., Campioni, P., Schinina, V., Cicalini, S., Agrati, C., Capobianchi, M. R., Girardi, E., Ippolito, G., Vaia, F., Petrosillo, N., Antinori, A., Taglietti, F., The ReCOVeRI Study Group: Abbonizio, M. A., Abdeddaim, A., Agostini, E., Albarello, F., Amadei, G., Amendola, A., Antonica, M. A., Antonini, M., Bartoli, T. A., Baldini, F., Barbaro, R., Bartolini, B., Bellagamba, R., Benigni, M., Bevilacqua, N., Biava, G., Bibas, M., Bordi, L., Bordoni, V., Boumis, E., Branca, M., Buonomo, R., Busso, D., Camici, M., Canichella, F., Capone, A., Caporale, C., Caraffa, E., Caravella, I., Carletti, F., Castilletti, C., Cataldo, A., Cerilli, S., Cerva, C., Chiappini, R., Chinello, P., Cianfarani, M. A., Ciaralli, C., Cimaglia, C., Cinicola, N., Ciotti, V., Colavita, F., Corpolongo, A., Cristofaro, M., Curiale, S., D'Abramo, A., Dantimi, C., De Angelis, A., De Angelis, G., De Palo, M. G., De Zottis, F., Di Bari, V., Di Lorenzo, R., Di Stefano, F., D'Offizi, G., Evangelista, F., Faraglia, F., Farina, A., Ferraro, F., Fiorentini, L., Frustaci, A., Fusetti, M., Fusto, M., Galati, V., Gagliardini, R., Galli, P., Garotto, G., Gaviano, I., Tekle, S. G., Giancola, M. L., Giansante, F., Giombini, E., Granata, G., Greci, M. C., Grilli, E., Grisetti, S., Iaconi, M., Iannicelli, G., Inversi, C., Lalle, E., Lamanna, M. E., Lanini, S., Lapa, D., Lepore, L., Libertone, R., Lionetti, R., Liuzzi, G., Loiacono, L., Lucia, A., Lufrani, F., Macchione, M., Maffongelli, G., Marani, A., Mariano, A., Marini, M. C., Maritti, M., Mastrobattista, A., Mastrorosa, I., Matusali, G., Mazzotta, V., Mencarini, P., Meschi, S., Messina, F., Micarelli, S., Mogavero, G., Mondi, A., Montalbano, M., Montaldo, C., Mosti, S., Murachelli, S., Musso, M., Nardi, M., Navarra, A., Nocioni, M., Noto, P., Noto, R., Oliva, A., Onnis, I., Ottou, S., Palazzolo, C., Pallini, E., Palmieri, F., Palombi, G., Pareo, C., Passeri, V., Pelliccioni, F., Penna, G., Petrecchia, A., Petrone, A., Pianura, E., Pinnetti, C., Pisciotta, M., Piselli, P., Pittalis, S., Pontarelli, A., Proietti, C., Puro, V., Ramazzini, P. M., Rianda, A., Rinonapoli, G., Rosati, S., Rubino, D., Rueca, M., Ruggeri, A., Sacchi, A., Sampaolesi, A., Sanasi, F., Santagata, C., Scarabello, A., Scarcia, S., Scognamiglio, P., Scorzolini, L., Stazi, G., Strano, G., Taibi, C., Taloni, G., Nardi, T., Tonnarini, R., Topino, S., Tozzi, M., Vairo, F., Valli, M. B., Vincenzi, L., Visco-Comandini, U., Vita, S., Vittozzi, P., Zaccarelli, M., Zanetti, A., Zito, S., Vergori, A., Lorenzini, P., Cozzi-Lepri, A., Donno, D. R., Gualano, G., Nicastri, E., Iacomi, F., Marchioni, L., Campioni, P., Schinina, V., Cicalini, S., Agrati, C., Capobianchi, M. R., Girardi, E., Ippolito, G., Vaia, F., Petrosillo, N., Antinori, A., Taglietti, F., Abbonizio, M. A., Abdeddaim, A., Agostini, E., Albarello, F., Amadei, G., Amendola, A., Antonica, M. A., Antonini, M., Bartoli, T. A., Baldini, F., Barbaro, R., Bartolini, B., Bellagamba, R., Benigni, M., Bevilacqua, N., Biava, G., Bibas, M., Bordi, L., Bordoni, V., Boumis, E., Branca, M., Buonomo, R., Busso, D., Camici, M., Canichella, F., Capone, A., Caporale, C., Caraffa, E., Caravella, I., Carletti, F., Castilletti, C., Cataldo, A., Cerilli, S., Cerva, C., Chiappini, R., Chinello, P., Cianfarani, M. A., Ciaralli, C., Cimaglia, C., Cinicola, N., Ciotti, V., Colavita, F., Corpolongo, A., Cristofaro, M., Curiale, S., D'Abramo, A., Dantimi, C., De Angelis, A., De Angelis, G., De Palo, M. G., De Zottis, F., Di Bari, V., Di Lorenzo, R., Di Stefano, F., D'Offizi, G., Evangelista, F., Faraglia, F., Farina, A., Ferraro, F., Fiorentini, L., Frustaci, A., Fusetti, M., Fusto, M., Galati, V., Gagliardini, R., Galli, P., Garotto, G., Gaviano, I., Tekle, S. G., Giancola, M. L., Giansante, F., Giombini, E., Granata, G., Greci, M. C., Grilli, E., Grisetti, S., Iaconi, M., Iannicelli, G., Inversi, C., Lalle, E., Lamanna, M. E., Lanini, S., Lapa, D., Lepore, L., Libertone, R., Lionetti, R., Liuzzi, G., Loiacono, L., Lucia, A., Lufrani, F., Macchione, M., Maffongelli, G., Marani, A., Mariano, A., Marini, M. C., Maritti, M., Mastrobattista, A., Mastrorosa, I., Matusali, G., Mazzotta, V., Mencarini, P., Meschi, S., Messina, F., Micarelli, S., Mogavero, G., Mondi, A., Montalbano, M., Montaldo, C., Mosti, S., Murachelli, S., Musso, M., Nardi, M., Navarra, A., Nocioni, M., Noto, P., Noto, R., Oliva, A., Onnis, I., Ottou, S., Palazzolo, C., Pallini, E., Palmieri, F., Palombi, G., Pareo, C., Passeri, V., Pelliccioni, F., Penna, G., Petrecchia, A., Petrone, A., Pianura, E., Pinnetti, C., Pisciotta, M., Piselli, P., Pittalis, S., Pontarelli, A., Proietti, C., Puro, V., Ramazzini, P. M., Rianda, A., Rinonapoli, G., Rosati, S., Rubino, D., Rueca, M., Ruggeri, A., Sacchi, A., Sampaolesi, A., Sanasi, F., Santagata, C., Scarabello, A., Scarcia, S., Scognamiglio, P., Scorzolini, L., Stazi, G., Strano, G., Taibi, C., Taloni, G., Nardi, T., Tonnarini, R., Topino, S., Tozzi, M., Vairo, F., Valli, M. B., Vincenzi, L., Visco-Comandini, U., Vita, S., Vittozzi, P., Zaccarelli, M., Zanetti, A., and Zito, S.

Subjects
Male, medicine.medical_treatment, Rome, Kaplan-Meier Estimate, 030204 cardiovascular system & hematology, Severity of Illness Index, 0302 clinical medicine, Retrospective Studie, Coagulopathy, Clinical endpoint, Intubation, Respiratory function, 030212 general & internal medicine, Multidisciplinary, Middle Aged, Medicine, Female, Human, medicine.medical_specialty, Patients, medicine.drug_class, Science, Low molecular weight heparin, Risk Assessment, Article, NO, 03 medical and health sciences, Internal medicine, Severity of illness, medicine, Intubation, Intratracheal, Humans, Retrospective Studies, Aged, business.industry, SARS-CoV-2, COVID-19, Thrombocytopenia, Retrospective cohort study, Heparin, Low-Molecular-Weight, medicine.disease, Respiration, Artificial, COVID-19 Drug Treatment, respiratory tract diseases, Pneumonia, Viral infection, business
Abstract

Prophylactic low molecular weight heparin (pLMWH) is currently recommended in COVID-19 to reduce the risk of coagulopathy. The aim of this study was to evaluate whether the antinflammatory effects of pLMWH could translate in lower rate of clinical progression in patients with COVID-19 pneumonia. Patients admitted to a COVID-hospital in Rome with SARS-CoV-2 infection and mild/moderate pneumonia were retrospectively evaluated. The primary endpoint was the time from hospital admission to orotracheal intubation/death (OTI/death). A total of 449 patients were included: 39% female, median age 63 (IQR, 50–77) years. The estimated probability of OTI/death for patients receiving pLMWH was: 9.5% (95% CI 3.2–26.4) by day 20 in those not receiving pLMWH vs. 10.4% (6.7–15.9) in those exposed to pLMWH; p-value = 0.144. This risk associated with the use of pLMWH appeared to vary by PaO2/FiO2 ratio: aHR 1.40 (95% CI 0.51–3.79) for patients with an admission PaO2/FiO2 ≤ 300 mmHg and 0.27 (0.03–2.18) for those with PaO2/FiO2 > 300 mmHg; p-value at interaction test 0.16. pLMWH does not seem to reduce the risk of OTI/death mild/moderate COVID-19 pneumonia, especially when respiratory function had already significantly deteriorated. Data from clinical trials comparing the effect of prophylactic vs. therapeutic dosage of LMWH at various stages of COVID-19 disease are needed.

Published
2021

7. Plasmonic Metasurfaces for Specific SERS Detection of Shiga Toxins

Author

Rippa, M., primary, Sagnelli, D., additional, Vestri, A., additional, Marchesano, V., additional, Munari, B., additional, Carnicelli, D., additional, Varrone, E., additional, Brigotti, M., additional, Tozzoli, R., additional, Montalbano, M., additional, Morabito, S., additional, Zhou, J., additional, Zyss, J., additional, and Petti, L., additional

Published
2022
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8. Daclatasvir-based regimens in HCV cirrhosis: experience from the Italian early access program

Author

Calvaruso, V, Mazzarelli, C, Milazzo, L, Badia, L, Pasulo, L, Guaraldi, G, Lionetti, R, Villa, E, Borghi, V, Carrai, P, Alberti, A, Biolato, M, Piai, G, Persico, M, Santantonio, T, Felder, M, Angelico, M, Montalbano, M, Mancusi, R, Grieco, A, Angeli, E, D'Offizi, G, Fagiuoli, S, Belli, L, Verucchi, G, Puoti, M, Craxi, A, Calvaruso V., Mazzarelli C., Milazzo L., Badia L., Pasulo L., Guaraldi G., Lionetti R., Villa E., Borghi V., Carrai P., Alberti A., Biolato M., Piai G., Persico M., Santantonio T., Felder M., Angelico M., Montalbano M., Mancusi R. L., Grieco A., Angeli E., D'Offizi G., Fagiuoli S., Belli L., Verucchi G., Puoti M., Craxi A., Calvaruso, V, Mazzarelli, C, Milazzo, L, Badia, L, Pasulo, L, Guaraldi, G, Lionetti, R, Villa, E, Borghi, V, Carrai, P, Alberti, A, Biolato, M, Piai, G, Persico, M, Santantonio, T, Felder, M, Angelico, M, Montalbano, M, Mancusi, R, Grieco, A, Angeli, E, D'Offizi, G, Fagiuoli, S, Belli, L, Verucchi, G, Puoti, M, Craxi, A, Calvaruso V., Mazzarelli C., Milazzo L., Badia L., Pasulo L., Guaraldi G., Lionetti R., Villa E., Borghi V., Carrai P., Alberti A., Biolato M., Piai G., Persico M., Santantonio T., Felder M., Angelico M., Montalbano M., Mancusi R. L., Grieco A., Angeli E., D'Offizi G., Fagiuoli S., Belli L., Verucchi G., Puoti M., and Craxi A.

Abstract

We reported the efficacy and safety data for daclatasvir (DCV)-based all-oral antiviral therapy in patients treated in the Italian compassionate-use program. 275 patients were included (202 male-73.5%, mean age: 57.4 years, 62 HIV-coinfected, 94 with recurrence of hepatitis C post-OLT). Forty-nine patients (17.8%) had Child-Pugh B, Genotype(G) distribution was: G1a:72 patients (26.2%), G1b:137 (49.8%); G3:40 (14.5%) and G4:26 (9.5%). Patients received DCV with sofosbuvir(SOF) (n = 221, 129 with ribavirin(RBV) or with simeprevir (SMV) or asunaprevir (ASU) (n = 54, 19 with RBV) for up to 24 weeks. Logistic regression was used to identify baseline characteristics associated with sustained virological response at week 12 post-treatment (SVR12). Liver function changes between baseline and follow up were assessed in 228 patients. 240 patients achieved SVR12 (87.3%), post transplant and HIV co-infected patients were equally distributed among SVR and no SVR (35% vs 34.3%; p = 0.56 and 24.2% vs 11.4%, p = 0.13, respectively). SVR rate was significantly higher with the combination DCV + SOF compared with DCV + SIM or ASU (93.2% vs 63.0%, p < 0.0001). Bilirubin value (OR: 0.69, CI95%: 0.54–0.87, p = 0.002) and regimen containing SOF (OR: 9.99, CI95%: 4.09–24.40; p < 0.001) were independently related with SVR. Mean albumin and bilirubin values significantly improved between baseline and follow-up week 12. DCV-based antiviral therapy was well tolerated and resulted in a high SVR when combined with SOF either in pre-transplant and in OLT patients and in “difficult to treat” HCV genotypes. Regimens containing DCV in combination with NS3 protease inhibitors obtained suboptimal results.

Published
2019

9. Preexisting and treatment-emergent autoimmune cytopenias in patients with CLL treated with targeted drugs

Author

Vitale, C., Salvetti, Maria Cristina, Griggio, V., Porrazzo, M., Schiattone, L., Zamprogna, G., Visentin, A., Vassallo, F., Cassin, R., Rigolin, G. M., Murru, R., Laurenti, Luca, Rivela, P., Marchetti, M., Pennese, E., Gentile, Marino, Boccellato, E., Perutelli, F., Montalbano, M. C., De Paoli, L., Reda, G., Orsucci, L., Trentin, L., Cuneo, A., Tedeschi, Alessandra, Scarfo, L., Gaidano, G., Mauro, F. R., Foa, Robin, Boccadoro, M., Coscia, M., Salvetti C., Laurenti L. (ORCID:0000-0002-8327-1396), Gentile M., Tedeschi A., Foa R., Vitale, C., Salvetti, Maria Cristina, Griggio, V., Porrazzo, M., Schiattone, L., Zamprogna, G., Visentin, A., Vassallo, F., Cassin, R., Rigolin, G. M., Murru, R., Laurenti, Luca, Rivela, P., Marchetti, M., Pennese, E., Gentile, Marino, Boccellato, E., Perutelli, F., Montalbano, M. C., De Paoli, L., Reda, G., Orsucci, L., Trentin, L., Cuneo, A., Tedeschi, Alessandra, Scarfo, L., Gaidano, G., Mauro, F. R., Foa, Robin, Boccadoro, M., Coscia, M., Salvetti C., Laurenti L. (ORCID:0000-0002-8327-1396), Gentile M., Tedeschi A., and Foa R.

Abstract

Autoimmune cytopenias (AICs) affect 5% to 9% of patients with chronic lymphocytic leukemia (CLL). Targeted drugs—ibrutinib, idelalisib, and venetoclax—have a prominent role in the treatment of CLL, but their impact on CLL-associated AICs is largely unknown. In this study, we evaluated the characteristics and outcome of preexisting AICs and described the incidence, quality, and management of treatment-emergent AICs during therapy with targeted drugs in patients with CLL. We collected data from 572 patients treated with ibrutinib (9% in combination with an anti-CD20 monoclonal antibody), 143 treated with idelalisib-rituximab, and 100 treated with venetoclax (12% in combination with an anti-CD20 monoclonal antibody). A history of preexisting AICs was reported in 104 (13%) of 815 patients. Interestingly, 80% of patients whose AICs had not resolved when treatment with a targeted drug was started experienced an improvement or a resolution during therapy. Treatment-emergent AICs occurred in 1% of patients during ibrutinib therapy, in 0.9% during idelalisib therapy, and in 7% during venetoclax therapy, with an estimated incidence rate of 5, 6, and 69 episodes per 1000 patients per year of exposure in the 3 treatment groups, respectively. The vast majority of patients who developed treatment-emergent AICs had unfavorable biological features such as an unmutated IGHV and a del(17p) and/or TP53 mutation. Notably, despite AICs, 83% of patients were able to continue the targeted drug, in some cases in combination with additional immunosuppressive agents. Overall, treatment with ibrutinib, idelalisib, or venetoclax seems to have a beneficial impact on CLL-associated AICs, inducing an improvement or even a resolution of preexisting AICs in most cases and eliciting treatment-emergent AICs in a negligible portion of patients.

Published
2021

11. 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

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

Author

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

Abstract

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

Published
2018

13. 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

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

Author

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

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

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

Published
2018

15. 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

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

Author

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

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

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

Published
2017

19. Survival after the diagnosis of de novo malignancy in liver transplant recipients

Author

Taborelli, M, Piselli, P, Ettorre, Gm, Baccarani, U, Burra, P, Lauro, A, Galatioto, L, Rendina, M, Shalaby, S, Petrara, R, Nudo, F, Toti, L, Fantola, G, Cimaglia, C, Agresta, A, Vennarecci, G, Pinna, Ad, Gruttadauria, S, Risaliti, A, Di Leo, A, Rossi, M, Tisone, G, Zamboni, F, Serraino, D, Zanus, G, Zanini, S, Rigotti, P, Schena, Fp, Grandaliano, G, Fiorentino, M, Di Gioia, P, Pellegrini, S, Zanfi, C, Scolari, Mp, Stefoni, S, Todeschini, P, Panicali, L, Valentini, C, Adani, Gl, Lorenzin, D, Colasanti, M, Coco, M, Ettorre, F, Santoro, R, Miglioresi, L, Mennini, G, Casella, A, Fazzolari, L, Sforza, D, Iaria, G, Gazia, C, Belardi, C, D'Offizi, G, Comandini, Uv, Lionetti, R, Montalbano, M, Taibi, C, Piredda, Gb, Michittu, Mb, Murgia, Mg, Onano, B, Fratino, L, Maso, Ld, De Paoli, P, Verdirosi, D, Vaccher, E, Pisani, F, Famulari, A, Delreno, F, Iesari, S, De Luca, L, Iaria, M, Capocasale, E, Cremaschi, E, Sandrini, S, Valerio, F, Mazzucotelli, V, Bossini, N, Setti, G, Veroux, M, Veroux, P, Giuffrida, G, Giaquinta, A, Zerbo, D, Busnach, G, Di Leo, L, Perrino, Ml, Querques, M, Colombo, V, Sghirlanzoni, Mc, Messa, P, Leoni, A, Sparacino, V, Caputo, F, Buscemi, B, Citterio, F, Spagnoletti, G, Salerno, Mp, Favi, E, Segoloni, Gp, Biancone, L, Lavacca, A, Maresca, Mc, Cascone, C, Virgilio, B, Donati, D, Dossi, F, Fontanella, A, Ambrosini, A, and Di Cicco, M.

Published
2019

21. Increased cancer risk in patients undergoing dialysis: A population-based cohort study in North-Eastern Italy

Author

Taborelli, M., Toffolutti, F., Del Zotto, S., Clagnan, E., Furian, L., Piselli, P., Citterio, Franco, Zanier, L., Boscutti, G., Serraino, D., Shalaby, S., Petrara, R., Burra, P., Zanus, G., Zanini, S., Rigotti, P., Rendina, M., Di Leo, A., Schena, F. P., Grandaliano, Giuseppe, Fiorentino, M., Lauro, A., Pinna, A. D., Di Gioia, P., Pellegrini, S., Zanfi, C., Scolari, M. P., Stefoni, S., Todeschini, P., Panicali, L., Valentini, C., Baccarani, U., Risaliti, A., Adani, G. L., Lorenzin, D., Ettorre, G. M., Vennarecci, G., Colasanti, M., Coco, M., Ettorre, F., Santoro, R., Miglioresi, L., Nudo, F., Rossi, M., Mennini, G., Toti, L., Tisone, G., Casella, A., Fazzolari, L., Sforza, D., Iaria, G., Gazia, C., Belardi, C., Cimaglia, C., Agresta, A., D'Offizi, G., Comandini, U. V., Lionetti, R., Montalbano, M., Taibi, C., Fantola, G., Zamboni, F., Piredda, G. B., Michittu, M. B., Murgia, M. G., Onano, B., Fratino, L., Maso, L. D., De Paoli, P., Verdirosi, D., Vaccher, E., Pisani, F., Famulari, A., Delreno, F., Iesari, S., De Luca, L., Iaria, M., Capocasale, E., Cremaschi, E., Sandrini, S., Valerio, F., Mazzucotelli, V., Bossini, N., Setti, G., Veroux, M., Veroux, P., Giaquinta, A., Zerbo, D., Busnach, G., Di Leo, L., Perrino, M. L., Querques, M., Colombo, V., Sghirlanzoni, M. C., Messa, P., Leoni, A., Galatioto, L., Gruttadauria, S., Sparacino, V., Caputo, F., Buscemi, B., Spagnoletti, Gionata, Salerno, Maria Paola, Favi, E., Segoloni, G. P., Biancone, L., Lavacca, A., Maresca, M. C., Cascone, C., Virgilio, B., Donati, D., Dossi, F., Fontanella, A., Ambrosini, A., Di Cicco, M., Citterio F. (ORCID:0000-0003-0489-6337), Grandaliano G. (ORCID:0000-0003-1213-2177), Spagnoletti G. (ORCID:0000-0003-2626-8147), Salerno M. P., Taborelli, M., Toffolutti, F., Del Zotto, S., Clagnan, E., Furian, L., Piselli, P., Citterio, Franco, Zanier, L., Boscutti, G., Serraino, D., Shalaby, S., Petrara, R., Burra, P., Zanus, G., Zanini, S., Rigotti, P., Rendina, M., Di Leo, A., Schena, F. P., Grandaliano, Giuseppe, Fiorentino, M., Lauro, A., Pinna, A. D., Di Gioia, P., Pellegrini, S., Zanfi, C., Scolari, M. P., Stefoni, S., Todeschini, P., Panicali, L., Valentini, C., Baccarani, U., Risaliti, A., Adani, G. L., Lorenzin, D., Ettorre, G. M., Vennarecci, G., Colasanti, M., Coco, M., Ettorre, F., Santoro, R., Miglioresi, L., Nudo, F., Rossi, M., Mennini, G., Toti, L., Tisone, G., Casella, A., Fazzolari, L., Sforza, D., Iaria, G., Gazia, C., Belardi, C., Cimaglia, C., Agresta, A., D'Offizi, G., Comandini, U. V., Lionetti, R., Montalbano, M., Taibi, C., Fantola, G., Zamboni, F., Piredda, G. B., Michittu, M. B., Murgia, M. G., Onano, B., Fratino, L., Maso, L. D., De Paoli, P., Verdirosi, D., Vaccher, E., Pisani, F., Famulari, A., Delreno, F., Iesari, S., De Luca, L., Iaria, M., Capocasale, E., Cremaschi, E., Sandrini, S., Valerio, F., Mazzucotelli, V., Bossini, N., Setti, G., Veroux, M., Veroux, P., Giaquinta, A., Zerbo, D., Busnach, G., Di Leo, L., Perrino, M. L., Querques, M., Colombo, V., Sghirlanzoni, M. C., Messa, P., Leoni, A., Galatioto, L., Gruttadauria, S., Sparacino, V., Caputo, F., Buscemi, B., Spagnoletti, Gionata, Salerno, Maria Paola, Favi, E., Segoloni, G. P., Biancone, L., Lavacca, A., Maresca, M. C., Cascone, C., Virgilio, B., Donati, D., Dossi, F., Fontanella, A., Ambrosini, A., Di Cicco, M., Citterio F. (ORCID:0000-0003-0489-6337), Grandaliano G. (ORCID:0000-0003-1213-2177), Spagnoletti G. (ORCID:0000-0003-2626-8147), and Salerno M. P.

Abstract

Background: In southern Europe, the risk of cancer in patients with end-stage kidney disease receiving dialysis has not been well quantified. The aim of this study was to assess the overall pattern of risk for de novo malignancies (DNMs) among dialysis patients in the Friuli Venezia Giulia region, north-eastern Italy. Methods: A population-based cohort study among 3407 dialysis patients was conducted through a record linkage between local healthcare databases and the cancer registry (1998-2013). Person-years (PYs) were calculated from 30 days after the date of first dialysis to the date of DNM diagnosis, kidney transplant, death, last follow-up or December 31, 2013, whichever came first. The risk of DNM, as compared to the general population, was estimated using standardized incidence ratios (SIRs) and 95% confidence intervals (CIs). Results: During 10,798 PYs, 357 DNMs were diagnosed in 330 dialysis patients. A higher than expected risk of 1.3-fold was found for all DNMs combined (95% CI: 1.15-1.43). The risk was particularly high in younger dialysis patients (SIR = 1.88, 95% CI: 1.42-2.45 for age 40-59 years), and it decreased with age. Moreover, significantly increased DNM risks emerged during the first 3 years since dialysis initiation, especially within the first year (SIR = 8.52, 95% CI: 6.89-10.41). Elevated excess risks were observed for kidney (SIR = 3.18; 95% CI: 2.06-4.69), skin non-melanoma (SIR = 1.81, 95% CI: 1.46-2.22), oral cavity (SIR = 2.42, 95% CI: 1.36-4.00), and Kaposi's sarcoma (SIR = 10.29, 95% CI: 1.25-37.16). Conclusions: The elevated risk for DNM herein documented suggest the need to implement a targeted approach to cancer prevention and control in dialysis patients.

Published
2019

23. Prevention of hepatitis C recurrence by bridging sofosbuvir/ribavirin from pre- to post-liver transplant: A real-life strategy

Author

Donato, M. F., Morelli, C., Romagnoli, R., Invernizzi, F., Mazzarelli, C., Iemmolo, R. M., Montalbano, M., Lenci, I., Bhoori, S., Pieri, G., Berardi, S., Caraceni, P., Martini, S., Angeli, P., Belli, L. S., Bernabucci, V., Malinverno, F., Monico, S., Ottobrelli, A., Romano, A., Strona, S., Tame, M. R., Visco-Comandini, U., Cavenago, M., De Carlis, L., Di Benedetto, F., Dondossola, D., Ettorre, G. M., Mazzaferro, V., Montin, U., Pinna, A. D., Rossi, G., Salizzoni, M., Tisone, G., Donato, Maria Francesca, Morelli, Cristina, Romagnoli, Renato, Invernizzi, Federica, Mazzarelli, Chiara, Iemmolo, Rosa Maria, Montalbano, Marzia, Lenci, Ilaria, Bhoori, Sherrie, Pieri, Giulia, Berardi, Sonia, Caraceni, Paolo, Martini, Silvia, Donato, M, Morelli, C, Romagnoli, R, Invernizzi, F, Mazzarelli, C, Iemmolo, R, Montalbano, M, Lenci, I, Bhoori, S, Pieri, G, Berardi, S, Caraceni, P, Martini, S, Angeli, P, Belli, L, Bernabucci, V, Malinverno, F, Monico, S, Ottobrelli, A, Romano, A, Strona, S, Tamè, M, Visco-Comandini, U, Cavenago, M, De Carlis, L, Di Benedetto, F, Dondossola, D, Ettorre, G, Mazzaferro, V, Montin, U, Pinna, A, Rossi, G, Salizzoni, M, and Tisone, G

Subjects
Liver Cirrhosis, Male, Sofosbuvir, Sustained Virologic Response, Hepatocellular carcinoma, medicine.medical_treatment, Hepacivirus, Liver transplantation, medicine.disease_cause, hepatitis C, hepatocellular carcinoma, liver transplant, sofosbuvir therapy, virological response, Adult, Aged, Antiviral Agents, Carcinoma, Hepatocellular, Drug Therapy, Combination, Female, Hepatitis C, Humans, Italy, Liver Neoplasms, Middle Aged, Postoperative Period, Preoperative Period, Recurrence, Retrospective Studies, Ribavirin, Liver Transplantation, Gastroenterology, chemistry.chemical_compound, 0302 clinical medicine, Sofosbuvir therapy, Retrospective Studie, Liver transplant, Virological response, Liver Neoplasm, 030220 oncology & carcinogenesis, Combination, 030211 gastroenterology & hepatology, Viral hepatitis, Human, medicine.drug, medicine.medical_specialty, Liver Cirrhosi, Hepatitis C virus, 03 medical and health sciences, Hepatology, Drug Therapy, Internal medicine, medicine, Antiviral Agent, Hepaciviru, business.industry, Carcinoma, Hepatocellular, medicine.disease, Settore MED/18, Surgery, Regimen, chemistry, business
Abstract

Background and aims Hepatitis C virus (HCV) reinfection following liver transplant (LT) is associated with reduced graft and patients survival. Before transplant, Sofosbuvir/Ribavirin (SOF/R) treatment prevents recurrent HCV in 96% of those patients achieving viral suppression for at least 4 weeks before transplant. We evaluated whether a bridging SOF-regimen from pre to post-transplant is safe and effective to prevent HCV recurrence in those patients with less than 4 week HCV-RNA undetectability at the time of transplant. Material and Methods From July 2014 SOF/R was given in 233 waitlisted HCV cirrhotics with/without hepatocellular carcinoma (HCC) within an Italian Compassionate Program. One-hundred were transplanted and 31 patients (31%) treated by SOF/R bridging therapy were studied Results LT indication in bridge subgroup was HCC in 22 and decompensated cirrhosis in 9. HCV-genotype was 1/4 in 18 patients. SOF 400 mg/day and R (median dosage 800 mg/day) were given for a median of 35 days before LT. At transplant time, 19 patients were still HCV-RNA positive (median HCV-RNA 58 IU/ml). One recipient had a virological breakthrough at week 4 post-transplant; one died, on treatment, 1-month post-transplant for sepsis and 29/31 achieved a 12-week sustained virological response (94%). Acute cellular rejection occurred in 4 recipients. On September 2016, 30 recipients (97%) are alive with a median follow-up of 18 months (range 13-25). Conclusions In patients with suboptimal virological response at LT a bridging SOF/R regimen helps avoiding post-transplant graft reinfection. This article is protected by copyright. All rights reserved.

Published
2017

26. Mitochondrial DNA damage and subsequent activation of Z-DNA binding protein 1 links oxidative stress to inflammation in epithelial cells

Author

Szczesny, B. Marcatti, M. Ahmad, A. Montalbano, M. Brunyánszki, A. Bibli, S.-I. Papapetropoulos, A. Szabo, C.

Abstract

This report identifies mitochondrial DNA (mtDNA) as a target and active mediator that links low-level oxidative stress to inflammatory response in pulmonary epithelial cells. Extrusion of mtDNA into the bronchoalveolar lavage fluid occurs as an early event in mice subjected to cigarette smoke injury, concomitantly with the depletion of mtDNA in the lung tissue. In cultured lung epithelial cells, prolonged, low-level oxidative stress damages the mtDNA, without any detectable damage to the nuclear DNA. In turn, cellular depletion of the mtDNA occurs, together with a transient remodeling of cellular bioenergetics and morphology - all without any detectable impairment in overall cell viability. Damaged mtDNA first enters the cytoplasm, where it binds to Z-DNA binding protein 1 (ZBP1) and triggers inflammation via the TANK-binding kinase 1 /interferon regulatory factor 3 signaling pathway. Fragments of the mtDNA are subsequently released into the extracellular space via exosomes. MtDNA-containing exosomes are capable of inducing an inflammatory response in naïve (non-oxidatively stressed) epithelial cells. In vivo, administration of isolated mtDNA into the in lungs of naïve mice induces the production of pro-inflammatory mediators, without histopathologic evidence of tissue injury. We propose that mtDNA-specific damage, and subsequent activation of the ZBP1 pathway, is a mechanism that links prolonged, low-level oxidative stress to autocrine and paracrine inflammation during the early stages of inflammatory lung disease. © 2018 The Author(s).

Published
2018

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

Author

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

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

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

Published
2015

28. 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

29. Non-canonical roles of caspase-8 in MDA-MB-231 breast cancer cell line

Author

De Blasio, A., Di Fiore, R., Morreale, M., Montalbano, M., Carlisi, D., Vento, R., De Blasio, A, Di Fiore, R, Morreale, M, Montalbano, M, Carlisi, D, and Vento, R

Subjects
caspase-8, breast cancer, metastatic capacity
Abstract

Caspase-8 (casp-8) is well known as an initiator caspase involved in cell death signalling, although its activity in many cancer cell types seems to work under non-apoptotic conditions. Moreover, in several types of cancer, casp-8 is only rarely mutated and often its expression is very elevated. Since cancer cell growth also depends on evasion of apoptosis, the upregulation of casp-8 in tumours may suggest one or more non-apoptotic roles (1). Here we report our recent studies carried out in MDA-MB-231 cells, derived from clinically aggressive forms of Triple-Negative Breast Cancer, where we have assessed the non-canonical roles of casp-8. Firstly, we evaluated casp-8 mRNA and protein levels in MDA-MB-231 cells, demonstrating that they were upregulated with respect to HMEC (normal Human Mammalian Epithelial Cells). Thereafter, to assess the role of casp-8, we silenced it by small interfering-RNA. Interestingly casp-8-knockdown, strongly decreased MDA-MB-231 cell growth by delaying G0/G1- to S-phase transition and increasing p21, p27 and hypophosphorylated/active form of pRb levels. No effects were evidenced on cell viability. To assess the metastatic capacity of MDA-MB-231 cells, the gene expression profiles of the relative markers after casp-8 knockdown were also measured. Surprisingly the expression of a number of genes and/or proteins such as VEGFA, C-MYC, CTNNB1, HMGA2, CXCR4, KLF4, VERSICAN V1 and MMP2 potently increased accompanied by migratory and metastatic capacities of cells, as shown by wound healing and matrigel assays. We suggest that among these genes, KLF4, a transcriptional factor with a dual role (activator and repressor), and responsible for p21 and p27 induction, could play critical roles (2). Casp-8 through KLF4 down-regulation, could manage the expression of critical proliferative and migratory/invasive genes. We suggest that these unusual roles played by casp-8 in MDA-MB-231 cells, should be better explored, in order to identify it as a molecular therapeutic target. References 1. Stupack DG. Caspase-8 as a Therapeutic Target in Cancer. Cancer Lett 332:133–140, 2013. 2. Tiwari N et al. Klf4 Is a Transcriptional Regulator of Genes Critical for EMT, Including Jnk1 (Mapk8). PLoS One 8, 2013.

Published
2015

31. Lack of reduction of serum alphafetoprotein during treatment with direct antiviral agents predicts hepatocellular carcinoma development in a large cohort of patients with HCV-related cirrhosis

Author

Masetti, C., primary, Lionetti, R., additional, Lupo, M., additional, Siciliano, M., additional, Giannelli, V., additional, Ponziani, F., additional, Teti, E., additional, Dell’unto, C., additional, Francioso, S., additional, Brega, A., additional, Montalbano, M., additional, Comandini, U.V., additional, Taibi, C., additional, Galati, G., additional, Gentilucci, U.V., additional, Picardi, A., additional, Andreoni, M., additional, Pompili, M., additional, Pellicelli, A., additional, D’offizi, G., additional, Gasbarrini, A., additional, De Santis, A., additional, and Mario, A., additional

Published
2018
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32. Prevention of hepatitis C recurrence by bridging sofosbuvir/ribavirin from pre- to post-liver transplant: A real-life strategy

Author

Donato, M, Morelli, C, Romagnoli, R, Invernizzi, F, Mazzarelli, C, Iemmolo, R, Montalbano, M, Lenci, I, Bhoori, S, Pieri, G, Berardi, S, Caraceni, P, Martini, S, Angeli, P, Belli, L, Bernabucci, V, Malinverno, F, Monico, S, Ottobrelli, A, Romano, A, Strona, S, Tamè, M, Visco-Comandini, U, Cavenago, M, De Carlis, L, Di Benedetto, F, Dondossola, D, Ettorre, G, Mazzaferro, V, Montin, U, Pinna, A, Rossi, G, Salizzoni, M, Tisone, G, Donato, Maria Francesca, Morelli, Cristina, Romagnoli, Renato, Invernizzi, Federica, Mazzarelli, Chiara, Iemmolo, Rosa Maria, Montalbano, Marzia, Lenci, Ilaria, Bhoori, Sherrie, Pieri, Giulia, Berardi, Sonia, Caraceni, Paolo, Martini, Silvia, Angeli, Paolo, Belli, Luca Saverio, Bernabucci, Veronica, Malinverno, Federica, Monico, Sara, Ottobrelli, Antonio, Romano, Antonietta, Strona, Silvia, Tamè, Maria Rosa, Visco-Comandini, Ubaldo, Cavenago, Margherita, De Carlis, Luciano, Di Benedetto, Fabrizio, Dondossola, Daniele, Ettorre, Giuseppe Maria, Mazzaferro, Vincenzo, Montin, Umberto, Pinna, Antonio Daniele, Rossi, Giorgio, Salizzoni, Mauro, Tisone, Giuseppe, Donato, M, Morelli, C, Romagnoli, R, Invernizzi, F, Mazzarelli, C, Iemmolo, R, Montalbano, M, Lenci, I, Bhoori, S, Pieri, G, Berardi, S, Caraceni, P, Martini, S, Angeli, P, Belli, L, Bernabucci, V, Malinverno, F, Monico, S, Ottobrelli, A, Romano, A, Strona, S, Tamè, M, Visco-Comandini, U, Cavenago, M, De Carlis, L, Di Benedetto, F, Dondossola, D, Ettorre, G, Mazzaferro, V, Montin, U, Pinna, A, Rossi, G, Salizzoni, M, Tisone, G, Donato, Maria Francesca, Morelli, Cristina, Romagnoli, Renato, Invernizzi, Federica, Mazzarelli, Chiara, Iemmolo, Rosa Maria, Montalbano, Marzia, Lenci, Ilaria, Bhoori, Sherrie, Pieri, Giulia, Berardi, Sonia, Caraceni, Paolo, Martini, Silvia, Angeli, Paolo, Belli, Luca Saverio, Bernabucci, Veronica, Malinverno, Federica, Monico, Sara, Ottobrelli, Antonio, Romano, Antonietta, Strona, Silvia, Tamè, Maria Rosa, Visco-Comandini, Ubaldo, Cavenago, Margherita, De Carlis, Luciano, Di Benedetto, Fabrizio, Dondossola, Daniele, Ettorre, Giuseppe Maria, Mazzaferro, Vincenzo, Montin, Umberto, Pinna, Antonio Daniele, Rossi, Giorgio, Salizzoni, Mauro, and Tisone, Giuseppe

Abstract

Background & Aims: Hepatitis C virus (HCV) re-infection following liver transplant (LT) is associated with reduced graft and patient survival. Before transplant, Sofosbuvir/ Ribavirin (SOF/R) treatment prevents recurrent HCV in 96% of those patients achieving viral suppression for at least 4 weeks before transplant. We evaluated whether a bridging SOF-regimen from pre- to post-transplant is safe and effective to prevent HCV recurrence in those patients with less than 4 weeks of HCV-RNA undetectability at the time of transplant. Methods: From July 2014 SOF/R was given in 233 waitlisted HCV cirrhotics with/ without hepatocellular carcinoma (HCC) within an Italian Compassionate Program. One hundred patients were transplanted and 31 patients (31%) treated with SOF/R bridging therapy were studied. Results: Liver transplant indication in bridge subgroup was HCC in 22 and decompensated cirrhosis in 9. HCV-genotype was 1/4 in 18 patients. SOF 400 mg/day and R (median dosage 800 mg/day) were given for a median of 35 days before LT. At transplant time, 19 patients were still HCV-RNA positive (median HCV-RNA 58 IU/mL). One recipient had a virological breakthrough at week 4 post-transplant; one died, on treatment, 1-month post-transplant for sepsis and 29/31 achieved a 12-week sustained virological response (94%). Acute cellular rejection occurred in three recipients. On September 2016, 30 recipients (97%) were alive with a median follow-up of 18 months (range 13-25). Conclusions: In patients with suboptimal virological response at LT, a bridging SOF/R regimen helps avoiding post-transplant graft reinfection.

Published
2017

33. Improved virological outcomes and excellent safety profile in genotype 3 HCV-infected cirrhotic patients after an extended 24-weeks course of daclatasvir, sofosbuvir + ribavirin: insights from a real-life multicenter study

Author

Lionetti, R., primary, Lenci, I., additional, Siciliano, M., additional, Pompili, M., additional, Comandini, U.V., additional, Milana, M., additional, Taibi, C., additional, Montalbano, M., additional, Garbuglia, A.R., additional, Begini, P., additional, Imperatrice, B., additional, Angelico, M., additional, and D’Offizi, G., additional

Published
2017
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35. L'emergenza-urgenza psichiatrica nell'ospedale generale. Indagine epidemiologica e raffronto tra il Policlinico Universitario e l'SPDC dell'Ospedale 'V. Cervello' di Palermo nella progettualità di un collegamento tra le diverse strutture nella gestione di servizi acuzie, post-acuzie, e non-acuzie

Author

FRANCOMANO, Antonio, LA PLACA, Maddalena, BONANNO, Barbara, MANGIAPANE, David, LA BARBERA, Daniele, Montalbano, M, Cavalieri, V, Varia, S, Francomano, A, La Placa, M, Bonanno, B, Mangiapane, D, Montalbano, M, Cavalieri, V, Varia, S, and La Barbera, D

Subjects
emergenza psichiatrica, urgenza psichiatrica, ospedale generale
Published
2011

38. FRI-379 - Lack of reduction of serum alphafetoprotein during treatment with direct antiviral agents predicts hepatocellular carcinoma development in a large cohort of patients with HCV-related cirrhosis

Author

Masetti, C., Lionetti, R., Lupo, M., Siciliano, M., Giannelli, V., Ponziani, F., Teti, E., Dell’unto, C., Francioso, S., Brega, A., Montalbano, M., Comandini, U.V., Taibi, C., Galati, G., Gentilucci, U.V., Picardi, A., Andreoni, M., Pompili, M., Pellicelli, A., D’offizi, G., Gasbarrini, A., De Santis, A., and Mario, A.

Published
2018
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39. Lack of reduction of serum alphafetoprotein during treatment with direct antiviral agents predicts hepatocellular carcinoma development in a large cohort of patients with HCV-related cirrhosis

Author

Masetti, C., Lionetti, R., Lupo, M., Siciliano, M., Giannelli, V., Ponziani, F.R., Teti, E., Dell’Unto, C., Francioso, S., Brega, A., Montalbano, M., Visco-Comandini, U., Taibi, C., Galati, G., Gentilucci, U. Vespasiani, Picardi, A., Andreoni, M., Pompili, M., Pellicelli, A.M., D’Offizi, G., Gasbarrini, A., De Santis, A., and Angelico, M.

Published
2018
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42. P0546 : In vivo impact of precore mutations of HBV on viral replicative capacity, viral protein processing, and virion assembly. molecular correlates of histologic and immunohistochemical aspects in liver tissue from patients with chronic hepatitis B

Author

Minosse, C., primary, Baiocchini, A., additional, Coen, S., additional, Zaccaro, P., additional, Visco Comandini, U., additional, Lionetti, R., additional, Montalbano, M., additional, Del Nonno, F., additional, Vivarelli, M., additional, D’Offizi, G., additional, Capobianchi, M.R., additional, and Menzo, S., additional

Published
2015
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43. HBV genetic compartimentalization, variability and molecular correlates of histologic and immunohistochemical aspects in liver tissue: implications for the clinical management of patients with chronic hepatitis B

Author

Minosse, C., primary, Baiocchini, A., additional, Selleri, M., additional, Giombini, E., additional, Coen, S., additional, Zaccaro, P., additional, Rozera, G., additional, Vincenti, D., additional, Del Nonno, F., additional, Comandini, U. Visco, additional, Lionetti, R., additional, Montalbano, M., additional, D’Offizi, G., additional, Vivarelli, M., additional, Capobianchi, M.R., additional, and Menzo, S., additional

Published
2015
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46. P1312 SOFOSBUVIR AND DACLATASVIR FOR RECURRENT HEPATITIS C AFTER LIVER TRANSPLANTATION: POTENT ANTIVIRAL ACTIVITY BUT LACK OF CLINICAL BENEFIT IF TREATMENT IS GIVEN TOO LATE

Author

Pellicelli, A.M., primary, Lionetti, R., additional, Montalbano, M., additional, Durand, C., additional, Ferenci, P., additional, D'Offizi, G., additional, Knop, V., additional, Telese, A., additional, Lenci, I., additional, Andreoli, A., additional, Zeuzem, S., additional, and Angelico, M., additional

Published
2014
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47. Strategia energetica nazionale (Sen)

Author

Antoncecchi, I, Di Dontantonio, L, Mastrella, R, Montalbano, M, Coppi, O, Santoncchi, N, Ligato, A, Orlandi, A, Pellegrini, M, Di Donatantonio, L, ANTONCECCHI, ILARIA, Montalbano, MG, Antoncecchi, I, Di Dontantonio, L, Mastrella, R, Montalbano, M, Coppi, O, Santoncchi, N, Ligato, A, Orlandi, A, Pellegrini, M, Di Donatantonio, L, ANTONCECCHI, ILARIA, and Montalbano, MG

Abstract

Obiettivi e priorità di Azione Riduzione dei costi dell’energia, pieno raggiungimento e superamento di tutti gli obiettivi europei in materia ambientale, maggiore sicurezza di approvvigionamento e sviluppo industriale del settore energia: sono questi gli obiettivi del documento di Strategia Energetica Nazionale, pensati ad oltre vent’anni dall’ultimo Piano Energetico Nazionale. Con riferimento al settore dell’upstream, l’Italia ha a disposizione ingenti riserve provate di gas e petrolio, le più importanti dell’ Europa continentale dopo i paesi nordici. In particolare, dagli ultimi dati disponibili al 31.12.2011, circa il 60% delle riserve di gas si trova nelle zone marine (in modo specifico nella zona A) e proprio dal mare proviene anche il 70% della produzione italiana (zone A e B). Secondo il documento di Strategia Energetica Nazionale al 2020 verrà sviluppata l’attuale produzione annuale italiana, sia onshore che offshore, ritornando sostanzialmente ai livelli degli anni novanta. E’ prevista infatti ulteriore produzione di idrocarburi pari a circa 24 milioni di boe/anno (barili di olio equivalente) di gas e 57 di olio, portando dal 7 al 14% il contributo al fabbisogno energetico totale. Questo consentirà non solo di mobilitare investimenti e creare ulteriore occupazione ma soprattutto di conseguire un risparmio sulla bolletta energetica di circa 5 miliardi di euro l’anno. La realizzazione dei progetti legati alle attività estrattive prevedono comunque un impegno del Governo a non perseguirne lo sviluppo in aree sensibili in mare o in terraferma, ponendo quindi la massima attenzione alle tematiche ambientali e rispettando i più elevati standard internazionali in termini di sicurezza. Tutti gli sforzi del Paese devono essere infatti orientati verso la ripresa di una crescita sostenibile. Coerentemente con queste necessità, la nuova Strategia Energetica Nazionale si incentra sui quattro obiettivi principali citati in premessa: 1. ridurre significativamente il gap di

Published
2013

48. Treatment with pegylated interferon and ribavirin for hepatitis C virus-associated severe cryoglobulinemia in a liver/kidney transplant recipient

Author

Montalbano, M, Pasulo, L, Sonzogni, A, Remuzzi, G, Colledan, M, Strazzabosco, M, STRAZZABOSCO, MARIO, Montalbano, M, Pasulo, L, Sonzogni, A, Remuzzi, G, Colledan, M, Strazzabosco, M, and STRAZZABOSCO, MARIO

Abstract

End-stage liver disease after hepatitis C virus (HCV) infection is the most common indication for liver transplantation, accounting for over 40% of liver transplants performed. Combined liver/kidney transplantation is being performed more frequently, in part because HCV infection may coexist with conditions that damage the kidney, such as diabetes and cryoglobulinemia. Unfortunately, HCV hepatitis and cryoglobulinemia may recur after liver transplantation and adversely affect graft and patient survival. In immunocompetent patients, interferon (IFN) and ribavirin (RBV) combination therapy is often able to control cryoglobulinemic syndrome. Very little data are available on liver transplant recipients, whereas IFN usually is not indicated in kidney transplant recipients because of early reports of steroid-induced rejection after its administration. Successful treatment of cryoglobulinemia with IFN/RBV in recipients of combined liver/kidney transplant has not been previously reported. We treated 1 recipient of a combined liver and kidney transplant with pegylated-IFN/RBV combination therapy. The patient developed HCV recurrence associated with cryoglobulinemia and severe cutaneous peripheral and neurologic manifestations. Treatment with pegylated-IFN-alpha2b and RBV for 12 months cured the cryoglobulinemic vasculitis and allowed the sustained eradication of HCV with no significant changes in kidney function.

Published
2007

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