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1. Design Thinking Methods to Activate Co-creation Process Among Policymakers, Creative Industries and SMEs

Author

Melazzini, M., Campodall’Orto, S., Carella, G., Vignati, A., Zurlo, F., di Prisco, Marco, Series Editor, Chen, Sheng-Hong, Series Editor, Vayas, Ioannis, Series Editor, Kumar Shukla, Sanjay, Series Editor, Sharma, Anuj, Series Editor, Kumar, Nagesh, Series Editor, Wang, Chien Ming, Series Editor, Abu-Tair, Abid, editor, Lahrech, Abdelmounaim, editor, Al Marri, Khalid, editor, and Abu-Hijleh, Bassam, editor

Published
2020
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3. A phase I/IIa clinical trial of autologous hematopoietic stem cell transplantation in amyotrophic lateral sclerosis

Author

Lunetta, L, Lizio, A, Cabona, C, Gerardi, F, Sansone, V, Corbo, M, Scialo, C, Angelucci, E, Gualandi, F, Marenco, P, Grillo, G, Cairoli, R, Cesana, C, Saccardi, R, Melazzini, M, Mancardi, G, Caponnetto, C, Lunetta L, Lizio A, Cabona C, Gerardi F, Sansone VA, Corbo M, Scialo C, Angelucci E, Gualandi F, Marenco P, Grillo G, Cairoli R, Cesana C, Saccardi R, Melazzini MG, Mancardi G, Caponnetto C., Lunetta, L, Lizio, A, Cabona, C, Gerardi, F, Sansone, V, Corbo, M, Scialo, C, Angelucci, E, Gualandi, F, Marenco, P, Grillo, G, Cairoli, R, Cesana, C, Saccardi, R, Melazzini, M, Mancardi, G, Caponnetto, C, Lunetta L, Lizio A, Cabona C, Gerardi F, Sansone VA, Corbo M, Scialo C, Angelucci E, Gualandi F, Marenco P, Grillo G, Cairoli R, Cesana C, Saccardi R, Melazzini MG, Mancardi G, and Caponnetto C.

Abstract

Objective: To verify the safety and potential effect on ALS progression of a low-intensity immunosuppressive regimen followed by autologous hematopoietic stem cell transplantation (aHSCT) in amyotrophic lateral sclerosis (ALS) patients. Methods: ALS eligible patients underwent a set of clinical and laboratory evaluations at T-4 (screening), T-1 (pre-treatment visit), and for the 12 consecutive months after treatment (T3, T6, T9, T12). We evaluated the tolerability of the procedure, its efficacy on clinical course and quality of life (QoL). Results: Eight of the 11 ALS patients enrolled received the established immunoablative protocol. The procedure was well tolerated and side effects were those expected. One patient died 4 months after the conditioning regimen and another patient underwent tracheotomy just before T3 for a sudden respiratory failure, but he is still alive 4 years after the procedure without being ventilated any more. A third patient died 10 months after conditioning. In the other cases, there was no statistical difference in all functional measures and QoL pre- and post-treatment; however, a transitory slopes’ reduction of ALSFRS-R and seated SVC% after the conditioning procedures was reported. Moreover, although not statistically significant, trends of reduction of CD4 + and increment of CD8 + were found. Conclusions: aHSCT was overall well tolerated, but it was not followed by any significant modification in disease progression. Considering the negative results of this small trial, further studies aimed to evaluate the possible efficacy of the aHSCT using a higher-intensity regimen should be carefully and with caution evaluated.

Published
2022

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

Author

Kondili, La, Robbins, S, Blach, S, Gamkrelidze, I, Zignego, Al, Brunetto, Mr, Raimondo, G, Taliani, G, Iannone, A, Russo, Fp, Santantonio, Ta, Zuin, M, Chessa, L, Blanc, P, Puoti, M, Vinci, M, Erne, Em, Strazzabosco, M, Massari, M, Lampertico, P, Rumi, Mg, Federico, A, Orlandini, A, Ciancio, A, Borgia, G, Andreone, P, Caporaso, N, Persico, M, Ieluzzi, D, Madonia, S, Gori, A, Gasbarrini, A, Coppola, C, Brancaccio, G, Andriulli, A, Quaranta, Mg, Montilla, S, Razavi, H, Melazzini, M, Vella, S, Craxì, A, PITER Collaborating, Group., Kondili LA, Robbins S, Blach S, Gamkrelidze I, Zignego AL, Brunetto MR, Raimondo G, Taliani G, Iannone A, Russo FP, Santantonio TA, Zuin M, Chessa L, Blanc P, Puoti M, Vinci M, Erne EM, Strazzabosco M, Massari M, Lampertico P, Rumi MG, Federico A, Orlandini A, Ciancio A, Borgia G, Andreone P, Caporaso N, Persico M, Ieluzzi D, Madonia S, Gori A, Gasbarrini A, Coppola C, Brancaccio G, Andriulli A, Quaranta MG, Montilla S, Razavi H, Melazzini M, Vella S, Craxì Antonio, Kondili, Loreta A., Robbins, Sarah, Blach, Sarah, Gamkrelidze, Ivane, Zignego, Anna L., Brunetto, Maurizia R., Raimondo, Giovanni, Taliani, Gloria, Iannone, Andrea, Russo, Francesco P., Santantonio, Teresa A., Zuin, Massimo, Chessa, Luchino, Blanc, Pierluigi, Puoti, Massimo, Vinci, Maria, Erne, Elke M., Strazzabosco, Mario, Massari, Marco, Lampertico, Pietro, Rumi, Maria G., Federico, Alessandro, Orlandini, Alessandra, Ciancio, Alessia, Borgia, Guglielmo, Andreone, Pietro, Caporaso, Nicola, Persico, Marcello, Ieluzzi, Donatella, Madonia, Salvatore, Gori, Andrea, Gasbarrini, Antonio, Coppola, Carmine, Brancaccio, Giuseppina, Andriulli, Angelo, Quaranta, Maria G., Montilla, Simona, Razavi, Homie, Melazzini, Mario, Vella, Stefano, Craxì, Antonio, Kondili, L. A., Robbins, S., Blach, S., Gamkrelidze, I., Zignego, A. L., Brunetto, M. R., Raimondo, G., Taliani, G., Iannone, A., Russo, F. P., Santantonio, T. A., Zuin, M., Chessa, L., Blanc, P., Puoti, M., Vinci, M., Erne, E. M., Strazzabosco, M., Massari, M., Lampertico, P., Rumi, M. G., Federico, A., Orlandini, A., Ciancio, A., Borgia, G., Andreone, P., Caporaso, N., Persico, M., Ieluzzi, D., Madonia, S., Gori, A., Gasbarrini, A., Coppola, C., Brancaccio, G., Andriulli, A., Quaranta, M. G., Montilla, S., Razavi, H., Melazzini, M., Vella, S., Craxi, A., Kondili, L, Robbins, S, Blach, S, Gamkrelidze, I, Zignego, A, Brunetto, M, Raimondo, G, Taliani, G, Iannone, A, Russo, F, Santantonio, T, Zuin, M, Chessa, L, Blanc, P, Puoti, M, Vinci, M, Erne, E, Strazzabosco, M, Massari, M, Lampertico, P, Rumi, M, Federico, A, Orlandini, A, Ciancio, A, Borgia, G, Andreone, P, Caporaso, N, Persico, M, Ieluzzi, D, Madonia, S, Gori, A, Gasbarrini, A, Coppola, C, Brancaccio, G, Andriulli, A, Quaranta, M, Montilla, S, Razavi, H, Melazzini, M, Vella, S, and Craxi, A

Subjects
HCV, WHO, chronic infection, linkage to care, Liver Cirrhosis, medicine.medical_specialty, Carcinoma, Hepatocellular, Sustained Virologic Response, Viral Hepatitis, Settore MED/12 - GASTROENTEROLOGIA, World Health Organization, Antiviral Agents, NO, 03 medical and health sciences, Liver disease, 0302 clinical medicine, Pharmacotherapy, Cost of Illness, Cause of Death, Health care, medicine, Humans, 030212 general & internal medicine, Viremia, chronic infection, HCV, linkage to care, WHO, Disease Eradication, Mortality, Intensive care medicine, Cause of death, Hepatology, business.industry, Public health, Carcinoma, Liver Neoplasms, Hepatocellular, Hepatitis C, medicine.disease, Markov Chains, Italy, 030211 gastroenterology & hepatology, business, Viral hepatitis
Abstract

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

Published
2018

9. 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

10. 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

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

Author

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

Abstract

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

Published
2018

12. Worldwide Effects of Coronavirus Disease Pandemic on Tuberculosis Services, January-April 2020

Author

Migliori, GB, Thong, PM, Akkerman, O, Alffenaar, J-W, Alvarez-Navascues, F, Assao-Neino, MM, Bernard, PV, Biala, JS, Blanc, F-X, Bogorodskaya, EM, Borisov, S, Buonsenso, D, Calnan, M, Castellotti, PF, Centis, R, Chakaya, JM, Cho, J-G, Codecasa, LR, D'Ambrosio, L, Denholm, J, Enwerem, M, Ferrarese, M, Galvao, T, Garcia-Clemente, M, Garcia-Garcia, J-M, Gualano, G, Gullon-Blanco, JA, Inwentarz, S, Ippolito, G, Kunst, H, Maryandyshev, A, Melazzini, M, de Queiroz Mello, FC, Munoz-Torrico, M, Njungfiyini, PB, Palmero, DJ, Palmieri, F, Piccioni, P, Piubello, A, Rendon, A, Sabri, J, Saporiti, M, Scognamiglio, P, Sharma, S, Silva, DR, Souleymane, MB, Spanevello, A, Tabernero, E, Tadolini, M, Tchangou, ME, Thornton, ABY, Tiberi, S, Udwadia, ZF, Sotgiu, G, Ong, CWM, Goletti, D, Migliori, GB, Thong, PM, Akkerman, O, Alffenaar, J-W, Alvarez-Navascues, F, Assao-Neino, MM, Bernard, PV, Biala, JS, Blanc, F-X, Bogorodskaya, EM, Borisov, S, Buonsenso, D, Calnan, M, Castellotti, PF, Centis, R, Chakaya, JM, Cho, J-G, Codecasa, LR, D'Ambrosio, L, Denholm, J, Enwerem, M, Ferrarese, M, Galvao, T, Garcia-Clemente, M, Garcia-Garcia, J-M, Gualano, G, Gullon-Blanco, JA, Inwentarz, S, Ippolito, G, Kunst, H, Maryandyshev, A, Melazzini, M, de Queiroz Mello, FC, Munoz-Torrico, M, Njungfiyini, PB, Palmero, DJ, Palmieri, F, Piccioni, P, Piubello, A, Rendon, A, Sabri, J, Saporiti, M, Scognamiglio, P, Sharma, S, Silva, DR, Souleymane, MB, Spanevello, A, Tabernero, E, Tadolini, M, Tchangou, ME, Thornton, ABY, Tiberi, S, Udwadia, ZF, Sotgiu, G, Ong, CWM, and Goletti, D

Abstract

Coronavirus disease has disrupted tuberculosis services globally. Data from 33 centers in 16 countries on 5 continents showed that attendance at tuberculosis centers was lower during the first 4 months of the pandemic in 2020 than for the same period in 2019. Resources are needed to ensure tuberculosis care continuity during the pandemic.

Published
2020

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

Author

Carrai, P, Morelli, C, Cordone, G, Romano, A, Tame, M, Lionetti, R, Pietrosi, G, Lenci, I, Piai, G, Russo, F, Coppola, C, Melazzini, M, Montilla, S, Pani, L, Petraglia, S, Russo, P, Trotta, M, Martini, S, Toniutto, P, Bandiera, F, Bhoori, S, Brillanti, S, Burra, P, Corsale, S, De Luca, A, Fagiuoli, S, Fattovich, G, Fava, G, Felder, M, Forte, P, Galeota-Lanza, A, Gitto, S, Grieco, A, Grossi, P, Ialungo, A, Iemmolo, R, Loiacono, L, Mangia, A, Merli, M, Piacentini, A, Pellicelli, A, Rigamonti, C, Gabriella, V, Zignego, A, Carrai P., Morelli C., Cordone G., Romano A., Tame M., Lionetti R., Pietrosi G., Lenci I., Piai G., Russo F. P., Coppola C., Melazzini M., Montilla S., Pani L., Petraglia S., Russo P., Trotta M. P., Martini S., Toniutto P., Bandiera F., Bhoori S., Brillanti S., Burra P., Corsale S., De Luca A., Fagiuoli S., Fattovich G., Fava G., Felder M., Forte P., Galeota-Lanza A., Gitto S., Grieco A., Grossi P., Ialungo A. M., Iemmolo R. M., Loiacono L., Mangia A., Merli M., Piacentini A., Pellicelli A., Rigamonti C., Gabriella V., Zignego A. L., Carrai, P, Morelli, C, Cordone, G, Romano, A, Tame, M, Lionetti, R, Pietrosi, G, Lenci, I, Piai, G, Russo, F, Coppola, C, Melazzini, M, Montilla, S, Pani, L, Petraglia, S, Russo, P, Trotta, M, Martini, S, Toniutto, P, Bandiera, F, Bhoori, S, Brillanti, S, Burra, P, Corsale, S, De Luca, A, Fagiuoli, S, Fattovich, G, Fava, G, Felder, M, Forte, P, Galeota-Lanza, A, Gitto, S, Grieco, A, Grossi, P, Ialungo, A, Iemmolo, R, Loiacono, L, Mangia, A, Merli, M, Piacentini, A, Pellicelli, A, Rigamonti, C, Gabriella, V, Zignego, A, Carrai P., Morelli C., Cordone G., Romano A., Tame M., Lionetti R., Pietrosi G., Lenci I., Piai G., Russo F. P., Coppola C., Melazzini M., Montilla S., Pani L., Petraglia S., Russo P., Trotta M. P., Martini S., Toniutto P., Bandiera F., Bhoori S., Brillanti S., Burra P., Corsale S., De Luca A., Fagiuoli S., Fattovich G., Fava G., Felder M., Forte P., Galeota-Lanza A., Gitto S., Grieco A., Grossi P., Ialungo A. M., Iemmolo R. M., Loiacono L., Mangia A., Merli M., Piacentini A., Pellicelli A., Rigamonti C., Gabriella V., and Zignego A. L.

Abstract

Direct antivirals are available for treating recurrent hepatitis C (RHC). This study reported outcomes of 424 patients with METAVIR F3–F4 RHC who were treated for 24 weeks with sofosbuvir/ribavirin and followed for 12 weeks within the Italian sofosbuvir compassionate use program. In 55 patients, daclatasvir or simeprevir were added. Child–Pugh class and model of end stage liver disease (MELD) scores were evaluated at baseline and 36 weeks after the start of therapy. The sustained viral response (SVR) was 86.7% (316/365) in patients who received sofosbuvir/ribavirin and 98.3% (58/59) in patients who received a second antiviral (P < 0.01). In patients treated with sofosbuvir/ribavirin, a significant difference in SVR was observed between patients diagnosed with METAVIR F4 (211/250; 84.4%), METAVIR F3 (95/105; 90.5%) and fibrosing cholestatic hepatitis (10/10; 100%) (P = 0.049). A significant association was found between patients who worsened from Child–Pugh class A and who experienced viral relapse (4/26 vs. 8/189, P = 0.02). In patients with a baseline MELD score <15, a significant association was found between maintaining a final MELD score <15 and the achievement of SVR (187/219 vs. 6/10, P = 0.031). This real-world study indicates that sofosbuvir/ribavirin treatment for 24 weeks was effective, and the achievement of SVR was associated with a reduced probability of developing worsening liver function.

Published
2017

18. PITER collaborating group. Forecasting Hepatitis C liver disease burden on real life data. Does the hidden iceberg matter to reach the elimination goals?

Author

Kondili, La, Robbins, S, Blach, S, Gamkrelidze, I, Zignego, Al, Brunetto, Mr, Raimondo, G, Taliani, G, Iannone, A, Russo, Fp, Santantonio, Ta, Zuin, M, Chessa, L, Blanc, P, Puoti, M, Vinci, M, Erne, Em, Strazzabosco, M, Massari, M, Lampertico, P, Rumi, Mg, Federico, A, Orlandini, A, Ciancio, A, Borgia, G, Andreone, P, Caporaso, N, Persico, M, Ieluzzi, D, Madonia, S, Gori, A, Gasbarrini, A, Coppola, C, Brancaccio, G, Andriulli, A, Quaranta, Mg, Montilla, S, Razavi, H, Melazzini, M, Vella, S, and Craxì, A

Published
2018

19. Forecasting liver disease burden based on a real life cohort of the linked to care patients in Italy. Does the ‘underwater portion of the iceberg’ matter to reach the WHO HCV eliminating goals in the high HCV prevalent countries?

Author

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

Published
2018
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20. Forecasting liver disease burden

Author

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

Published
2018
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21. Development of advanced therapies in Italy: Management models and sustainability in six Italian cell factories

Author

Gaipa, G, Introna, M, Golay, J, Nolli, M, Vallanti, G, Parati, E, Giordano, R, Romagnoli, L, Melazzini, M, Biondi, A, Biagi, E, GAIPA, GIUSEPPE, INTRONA, MARTINO, NOLLI, MARIA LUISA, BIONDI, ANDREA, BIAGI, ETTORE, Gaipa, G, Introna, M, Golay, J, Nolli, M, Vallanti, G, Parati, E, Giordano, R, Romagnoli, L, Melazzini, M, Biondi, A, Biagi, E, GAIPA, GIUSEPPE, INTRONA, MARTINO, NOLLI, MARIA LUISA, BIONDI, ANDREA, and BIAGI, ETTORE

Abstract

On November 10, 2014, the representatives of all six certified Good Manufacturing Practices (GMP) cell factories operating in the Lombardy Region of Italy convened a 1-day workshop in Milan titled "Management Models for the Development And Sustainability of Cell Factories: Public-Private Partnership?" The speakers and panelists addressed not only the many scientific, technological and cultural challenges faced by Lombardy Cell Factories, but also the potential impact of advanced therapy medicinal products (ATMPs) on public health and the role played by translational research in this process. Future perspectives for research and development (R&D) and manufacturing processes in the field of regenerative medicine were discussed as well. This report summarizes the most important issues raised by the workshop participants with particular emphasis on strengths and limitations of the R&D and manufacturing processes for innovative therapeutics in Lombardy and what can be improved in this context while maintaining GMP standards. The participants highlighted several strategies to translate patient-specific advanced therapeutics into scaled manufacturing products for clinical application. These included (i) the development of a synergistic interaction between public and private institutions, (ii) better integration with Italian regulatory agencies and (iii) the creation of a network among Lombardy cell factories and other Italian and European institutions.

Published
2016

22. Repeated courses of granulocyte colony-stimulating factor in amyotrophic lateral sclerosis: clinical and biological results from a prospective multicenter study

Author

Chiò, A, Mora, G, Caponnetto, Mancardi, G, Sabatelli, M, Siciliano, G, Silani, V, Corbo, M, Calvo, A, Mutani, R, Rutella, S, Gualandi, F, Melazzini, M, Scimè, R, Petrini, M, Bondesan, P, Garbelli, S, Mantovani, S, Bendotti, C, Tarella, C, STEMALS, Study Group, LA BELLA, Vincenzo, MOGLIA, Cristina, VALENTINO, Francesca, Chiò, A, Mora, G, La Bella, V, Caponnetto, Mancardi, G, Sabatelli, M, Siciliano, G, Silani, V, Corbo, M, Moglia, C, Calvo, A, Mutani, R, Rutella, S, Gualandi, F, Melazzini, M, Scimè, R, Petrini, M, Bondesan, P, Garbelli, S, Mantovani, S, Bendotti, C, Tarella, C, Valentino, F, and STEMALS, Study Group.

Subjects
Keywords:amyotrophic lateral sclerosi, clinical trial, hematopoietic stem cell, Settore MED/26 - Neurologia, granulocyte colony-stimulating factor, neuroinflammation
Abstract

Granulocyte colony-stimulating factor (G-CSF) induces a transient mobilization of hematopoietic progenitor cells from bone marrow to peripheral blood. Our aim was to evaluate safety of repeated courses of G-CSF in patients with amyotrophic lateral sclerosis (ALS), assessing disease progression and changes in chemokine and cytokine levels in serum and cerebrospinal fluid (CSF). Twenty-four ALS patients entered an open-label, multicenter trial in which four courses of G-CSF and mannitol were administered at 3-month intervals. Levels of G-CSF were increased after treatment in the serum and CSF. Few and transitory adverse events were observed. No significant reduction of the mean monthly decrease in ALSFRS-R score and forced vital capacity was observed. A significant reduction in CSF levels of monocyte chemoattractant protein-1 (MCP-1) and interleukin-17 (IL-17) was observed. G-CSF treatment was safe and feasible in a multicenter series of ALS patients. A decrease in the CSF levels of proinflammatory cytokines MCP-1 and IL-17 was found, indicating a G-CSF-induced central anti-inflammatory response

Published
2011

23. A PHASE I-II MULTICENTRE STUDY ON G-CSF IN AMYOTROPHIC LATERAL SCLEROSIS (STEMALS)

Author

CHIÒ A, MORA G, SICILIANO G, SABATELLI M, SILANI V, MOGLIA C, MANCARDI GL, TONALI P, CALVO A, MUTANI R, CORBO M, SCIMÉ R, DONOFRIO G, PETRINI M, MELAZZINI M, GUALANDI F, TARELLA C., CAPONNETTO, Chiara, LA BELLA, Vincenzo, CHIÒ A, MORA G, CAPONNETTO C, SICILIANO G, SABATELLI M, LA BELLA V, SILANI V, MOGLIA C, MANCARDI GL, TONALI P, CALVO A, MUTANI R, CORBO M, SCIMÉ R, DONOFRIO G, PETRINI M, MELAZZINI M, GUALANDI F, and TARELLA C

Published
2008

24. A phase I-II multicentre study on G-CSF in Amyotrophic Lateral Sclerosis

Author

CHIÒ A, MORA G, SICILIANO G, SABATELLI M, SILANI V, MOGLIA C, TONALI P, MANCARDI GL, CALVO A, MUTANI R, CORBO M, SCIMÉ R, LEONE G, PETRINI M, GUALANDI F, MELAZZINI M, TARELLA C., CAPONNETTO, Chiara, LA BELLA, Vincenzo, CHIÒ A, MORA G, CAPONNETTO C, SICILIANO G, SABATELLI M, LA BELLA V, SILANI V, MOGLIA C, TONALI P, MANCARDI GL, CALVO A, MUTANI R, CORBO M, SCIMÉ R, LEONE G, PETRINI M, GUALANDI F, MELAZZINI M, and TARELLA C

Subjects
Settore MED/26 - Neurologia
Published
2007

26. THU-059 - Forecasting liver disease burden based on a real life cohort of the linked to care patients in Italy. Does the ‘underwater portion of the iceberg’ matter to reach the WHO HCV eliminating goals in the high HCV prevalent countries?

Author

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

Published
2018
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27. Malagola M, Skert C, Vignetti M, Piciocchi A, Martinelli G, Alimena G, Mecucci C, Testoni N, Iacobucci I, Clavio M, Gobbi M, Candoni A, Damiani D, Bocchia M, Lauria F, Zaccaria A, Mazza P, Visani G, Peli A, Colombi C, Cancelli V, Mancini M, Foà R, Martelli M, Cantore N, Di Raimondo F, Petrini M, De Fabritiis P, Fioritoni G, Nobile F, Fabbiano F, Specchia G, Baccarani M, Lo Coco F, Amadori S, Mandelli F, Russo D

Author

Chiò, A, Mora, G, La Bella, V, Caponnetto, C, Mancardi, G, Sabatelli, M, Siciliano, G, Silani, V, Corbo, M, Moglia, C, Calvo, A, Mutani, R, Rutella, S, Gualandi, F, Melazzini, M, Scimè, R, Petrini, Mario, Bondesan, P, Garbelli, S, Mantovani, S, Bendotti, C, Tarella, C, and STEMALS Study Group

Published
2011

29. A pilot trial of G-CSF in amyotrophic lateral sclerosis

Author

Chio', Adriano, Mora, G, Caponnetto, C, Siciliano, G, Sabatelli, M, La Bella, V, Silani, V, Moglia, Cristina, Mancardi, Gl, Tonali, P, Calvo, Andrea, Mutani, Roberto, Corbo, M, Scime’, R, D’Onofrio, G, Petrini, M, Gualandi F, Melazzini M., and Tarella, Corrado

Subjects
Settore MED/15 - Malattie del Sangue
Published
2008

40. Worldwide Effects of Coronavirus Disease Pandemic on Tuberculosis Services, January-April 2020

Author

Matteo Saporiti, José-María García-García, Fabrizio Palmieri, Paola Scognamiglio, Fernando Álvarez-Navascués, Luigi Codecasa, Michel Eke Tchangou, Alberto Piubello, Zarir F Udwadia, Fernanda Carvalho de Queiroz Mello, Paola Castellotti, Andrei Maryandyshev, Gina Gualano, Alice Boi Yatta Thornton, José Antonio Gullón-Blanco, Tatiana Senna Galvão, Pascale Valérie Bernard, Joshua Sorba Biala, Giovanni Sotgiu, Rosella Centis, Domingo Palmero, Marina Tadolini, Samridhi Sharma, Eva Tabernero, Catherine W.M. Ong, Heinke Kunst, Adrian Rendon, Jeremiah Chakaya, Maurizio Ferrarese, Antonio Spanevello, Simon Tiberi, Elena M. Bogorodskaya, Pei Min Thong, Mario Melazzini, Martin Enwerem, Patrick Bung Njungfiyini, Marcela Muñoz-Torrico, Delia Goletti, François-Xavier Blanc, Giuseppe Ippolito, Marianne Calnan, Mahamadou Bassirou Souleymane, Giovanni Battista Migliori, Sergey Borisov, Marta García-Clemente, Mourtala Mohamed Assao-Neino, Denise Rossato Silva, Justin T Denholm, Sandra Inwentarz, Jin-Gun Cho, Lia D'Ambrosio, Jan-Willem C. Alffenaar, Onno W. Akkerman, Pavilio Piccioni, Danilo Buonsenso, Josefina Sabriá, Migliori G.B., Thong P.M., Akkerman O., Alffenaar J.-W., Alvarez-Navascues F., Assao-Neino M.M., Bernard P.V., Biala J.S., Blanc F.-X., Bogorodskaya E.M., Borisov S., Buonsenso D., Calnan M., Castellotti P.F., Centis R., Chakaya J.M., Cho J.-G., Codecasa L.R., D'Ambrosio L., Denholm J., Enwerem M., Ferrarese M., Galvao T., Garcia-Clemente M., Garcia-Garcia J.-M., Gualano G., Gullon-Blanco J.A., Inwentarz S., Ippolito G., Kunst H., Maryandyshev A., Melazzini M., Mello F.C.D.Q., Munoz-Torrico M., Njungfiyini P.B., Palmero D.J., Palmieri F., Piccioni P., Piubello A., Rendon A., Sabria J., Saporiti M., Scognamiglio P., Sharma S., Silva D.R., Souleymane M.B., Spanevello A., Tabernero E., Tadolini M., Tchangou M.E., Thornton A.B.Y., Tiberi S., Udwadia Z.F., Sotgiu G., Ong C.W.M., Goletti D., and Microbes in Health and Disease (MHD)

Subjects
Epidemiology, lcsh:Medicine, Disease, medicine.disease_cause, Global Health, 0302 clinical medicine, respiratory infection, Pandemic, wc_505, Global health, 030212 general & internal medicine, health service, Coronavirus, wa_105, biology, Dispatch, Attendance, Continuity of Patient Care, Viral/epidemiology, Infectious Diseases, TB, coronavirus disease, Coronavirus Infections, severe acute respiratory syndrome coronavirus 2, Human, Microbiology (medical), zoonose, Tuberculosis, 030231 tropical medicine, Pneumonia, Viral, lcsh:Infectious and parasitic diseases, 2019 novel coronavirus disease, respiratory infections, 03 medical and health sciences, Betacoronavirus, Environmental health, medicine, Humans, lcsh:RC109-216, viruses, Worldwide Effects of Coronavirus Disease Pandemic on Tuberculosis Services, January–April 2020, health services, Pneumonia, Viral/epidemiology, Pandemics, viruse, Global Health/trends, Betacoronaviru, business.industry, SARS-CoV-2, Coronavirus Infection, lcsh:R, COVID-19, Pneumonia, biology.organism_classification, medicine.disease, zoonoses, tuberculosis and other mycobacteria, wc_518, Continuity of Patient Care/trends, Tuberculosis/epidemiology, Coronavirus Infections/epidemiology, Facilities and Services Utilization/trends, business, Facilities and Services Utilization
Abstract

Coronavirus disease has disrupted tuberculosis services globally. Data from 33 centers in 16 countries on 5 continents showed that attendance at tuberculosis centers was lower during the first 4 months of the pandemic in 2020 than for the same period in 2019. Resources are needed to ensure tuberculosis care continuity during the pandemic.

Published
2020

41. A phase I/IIa clinical trial of autologous hematopoietic stem cell transplantation in amyotrophic lateral sclerosis

Author

Christian Lunetta, Andrea Lizio, Corrado Cabona, Francesca Gerardi, Valeria Ada Sansone, Massimo Corbo, Carlo Scialò, Emanuele Angelucci, Francesca Gualandi, Paola Marenco, Giovanni Grillo, Roberto Cairoli, Clara Cesana, Riccardo Saccardi, Mario Giovanni Melazzini, Gianluigi Mancardi, Claudia Caponnetto, Lunetta, L, Lizio, A, Cabona, C, Gerardi, F, Sansone, V, Corbo, M, Scialo, C, Angelucci, E, Gualandi, F, Marenco, P, Grillo, G, Cairoli, R, Cesana, C, Saccardi, R, Melazzini, M, Mancardi, G, and Caponnetto, C

Subjects
Male, Disease progression, Transplantation Conditioning, Neurology, Amyotrophic Lateral Sclerosis, T-reg, Quality of Life, Humans, Hematopoietic stem cell transplantation, Neurology (clinical), Transplantation, Autologous, Cyclophosphamide, Amyotrophic lateral sclerosi
Abstract

Objective: To verify the safety and potential effect on ALS progression of a low-intensity immunosuppressive regimen followed by autologous hematopoietic stem cell transplantation (aHSCT) in amyotrophic lateral sclerosis (ALS) patients. Methods: ALS eligible patients underwent a set of clinical and laboratory evaluations at T-4 (screening), T-1 (pre-treatment visit), and for the 12 consecutive months after treatment (T3, T6, T9, T12). We evaluated the tolerability of the procedure, its efficacy on clinical course and quality of life (QoL). Results: Eight of the 11 ALS patients enrolled received the established immunoablative protocol. The procedure was well tolerated and side effects were those expected. One patient died 4 months after the conditioning regimen and another patient underwent tracheotomy just before T3 for a sudden respiratory failure, but he is still alive 4 years after the procedure without being ventilated any more. A third patient died 10 months after conditioning. In the other cases, there was no statistical difference in all functional measures and QoL pre- and post-treatment; however, a transitory slopes’ reduction of ALSFRS-R and seated SVC% after the conditioning procedures was reported. Moreover, although not statistically significant, trends of reduction of CD4 + and increment of CD8 + were found. Conclusions: aHSCT was overall well tolerated, but it was not followed by any significant modification in disease progression. Considering the negative results of this small trial, further studies aimed to evaluate the possible efficacy of the aHSCT using a higher-intensity regimen should be carefully and with caution evaluated.

Published
2022

42. 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

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

Author

Giada Carolo, Veronica Bernabucci, Luchino Chessa, Maria Luisa Russo, Giorgio Maria Saracco, Marzia Montalbano, Barbara Menzaghi, Giovanni Di Perri, Adriano Lazzarin, Silvia La Monica, Raffaele Bruno, Gian Ludovico Rapaccini, Mario U. Mondelli, Anna Maria Schimizzi, Caterina Pasquazzi, Maurizia Rossana Brunetto, Antonio Craxì, Filomena Morisco, Carmela Lo Guercio, Vania Giacomet, Alessia Giorgini, Mario Masarone, Francesca Paolo Russo, T. Zolfino, Vincenzo Sangiovanni, Alessia Ciancio, Antonella d'Arminio Monforte, Savino Bruno, E.M. Erne, Antonio Gasbarrini, Francesco Castelli, Sergio Novara, G. Nardone, Andrea De Luca, Claudio Maria Mastroianni, Gioacchino Angarano, Chiara Dentone, Renato Maserati, Anna Maria Piscaglia, Tiziana Quirino, Giuseppe Tarantino, M. Lichtner, Antonio Chirianni, Giuseppina Brancaccio, S. Paganin, Alfredo Alberti, Silvia Corradori, Edoardo G. Giannini, Carlo Torti, Chiara Boarini, Raffaele Cozzolongo, Marco Di Stefano, Alessandro Soria, Paolo Tundi, Giovanni Cassola, Debora Angrisani, Antonio Grieco, Cecilia Pravadelli, Giuliano Rizzardini, Roberto Gulminetti, Vincenzo Messina, Maria Rendina, Massimo Pirisi, Irene Cacciola, Roberto Ganga, Raffaella Lionetti, Paolo Calabrese, Laura Ponti, Filomena Simeone, Maurizio Russello, Monica Monti, Nicola Boffa, Pierluigi Tarquini, Franco Capra, Ivo Avancini, Domenico Sansonno, Stefano Fagiuoli, Michele Barone, Giacomo Vecchiet, Salvatore Rizzo, Carlo Federico Perno, Teresa Santantonio, Pierluigi Toniutto, Massimo Zuin, Nicola Caporaso, Alessandra Orlandini, Grazielle Marie Pigozzi, Martina Felder, Antonio Cristaudo, Roberto Cecere, Massimo Marignani, Vincenza Calvaruso, G. Abbati, Domenico Potenza, Maria Chiara Piras, Mario Rizzetto, Serena Cima, Marco delle Monache, Alessio Aghemo, D. Ieluzzi, Guglielmo Borgia, Giampaolo Corti, Paolo Poggio, Manuela Merli, Elena Danieli, Andrea Giacometti, Massimo Andreoni, Antonino Picciotto, Mario Angelico, Benedetta Canovari, Sara Piovesan, Anna Linda Zignego, Antonio Benedetti, Emanuele Durante, Erica Villa, Marcello Persico, Antonio Patrizio Termite, Barbara Coco, Maria Vinci, Lucio Boglione, Cristina Rossi, Paolo Angeli, Massimo Memoli, Maria Teresa Giordani, Massimo De Luca, Luisa Pasulo, Vincenzo Vullo, Mario Melazzini, Attilio Solinas, Pietro Gatti, Michele Guerra, Silvia Martini, Antonio Ascione, Massimo Puoti, Roberto Cauda, Giovanna Onnelli, Silvia Magnani, Salvatore Madonna, Giovanni Raimondo, Marco Tabone, Gloria Taliani, Dante Romagnoli, Aldo Marrone, Umberto Vespasiani Gentilucci, Luca Miele, Marcello Tavio, Andrea Antinori, Giampiero D'Offizi, Mirella Onofrio, Valentina Iodice, Lucio Cosco, Guido Piai, Luca Pani, Francesca Ceccherini Silberstein, Simona Montilla, Marco Lenzi, Luca Fontanella, Alessandro Federico, Carlo Ferrari, Giustino Parruti, Antonio Di Biagio, Gabriella Verucchi, Fabio Marsetti, Michele Milella, Maria Grazia Rumi, Antonio Izzi, Marco Marzioni, Francesca Donato, Vanni Borghi, Mariano Quartini, Massimo Colombo, Michele Imparato, Giovanni Battista Gaeta, P.L. Blanc, Alfredo Di Leo, Nicola Coppola, Alessandro Chiodera, Ivana Maida, Davide Campagnolo, Cinzia Antonini, Antonietta Romano, A. Gianstefani, Katia Falasca, Massimo Levrero, Gaetano Serviddio, Maria Paola Trotta, Olivia Morelli, Salvatore Petta, Elisabetta Teti, Maria Rita Parisi, Pietro Andreone, Ascione, Antonio, De Luca, Massimo, Melazzini, Mario, Montilla, Simona, Trotta, Maria Paola, Petta, Salvatore, Puoti, Massimo, Sangiovanni, Vincenzo, Messina, Vincenzo, Bruno, Savino, Izzi, Antonio, Villa, Erica, Aghemo, Alessio, Zignego, Anna Linda, Orlandini, Alessandra, Fontanella, Luca, Gasbarrini, Antonio, Marzioni, Marco, Giannini, Edoardo G., Craxì, Antonio, Abbati, Giuseppe, Alberti, Alfredo, Andreone, Pietro, Andreoni, Massimo, Angeli, Paolo, Angelico, Mario, Angarano, Gioacchino, Angrisani, Debora, Antinori, Andrea, Antonini, Cinzia, Avancini, Ivo, Barone, Michele, Bruno, Raffaele, Benedetti, Antonio, Bernabucci, Veronica, Blanc, Pier, Boarini, Chiara, Boffa, Nicola, Boglione, Lucio, Borghi, Vanni, Borgia, Guglielmo, Brancaccio, Giuseppina, Brunetto, Maurizia, Cacciola, Irene, Calabrese, Paolo, Calvaruso, Vincenza, Campagnolo, Davide, Canovari, Benedetta, Caporaso, Nicola, Capra, Franco, Carolo, Giada, Cassola, Giovanni, Castelli, Francesco, Cauda, Roberto, Silberstein, Francesca Ceccherini, Cecere, Roberto, Chessa, Luchino, Chiodera, Alessandro, Chirianni, Antonio, Ciancio, Alessia, Cima, Serena, Coco, Barbara, Colombo, Massimo, Coppola, Nicola, Corti, Giampaolo, Cosco, Lucio, Corradori, Silvia, Cozzolongo, Raffaele, Cristaudo, Antonio, Danieli, Elena, Monforte, Antonella D’Arminio, Monache, Marco delle, Del Poggio, Paolo, de Luca, Andrea, Dentone, Chiara, Di Biagio, Antonio, Di Leo, Alfredo, Di Perri, Giovanni, Di Stefano, Marco, D’Offizi, Giampiero, Donato, Francesca, Durante, Emanuele, Erne, Elke, Fagiuoli, Stefano, Falasca, Katia, Federico, Alessandro, Felder, Martina, Ferrari, Carlo, Gaeta, Giovanni Battista, Ganga, Roberto, Gatti, Pietro, Giacomet, Vania, Giacometti, Andrea, Gianstefani, Alice, Giordani, Maria, Giorgini, Alessia, Grieco, Antonio, Guerra, Michele, Gulminetti, Roberto, Ieluzzi, Donatella, Imparato, Michele, Iodice, Valentina, La Monica, Silvia, Lazzarin, Adriano, Lenzi, Marco, Levrero, Massimo, Lichtner, Myriam, Lionetti, Raffaella, Guercio, Carmela Lo, Madonna, Salvatore, Magnani, Silvia, Maida, Ivana, Marignani, Massimo, Marrone, Aldo, Marsetti, Fabio, Martini, Silvia, Masarone, Mario, Maserati, Renato, Mastroianni, Claudio Maria, Memoli, Massimo, Menzaghi, Barbara, Merli, Manuela, Miele, Luca, Milella, Michele, Mondelli, Mario, Montalbano, Marzia, Monti, Monica, Morelli, Olivia, Morisco, Filomena, Nardone, Gaetano, Novara, Sergio, Onnelli, Giovanna, Onofrio, Mirella, Paganin, Simona, Pani, Luca, Parisi, Maria Rita, Parruti, Giustino, Pasquazzi, Caterina, Pasulo, Luisa, Perno, Carlo Federico, Persico, Marcello, Piai, Guido, Picciotto, Antonino, Pigozzi, Grazielle Marie, Piovesan, Sara, Piras, Maria Chiara, Pirisi, Massimo, Piscaglia, Anna Maria, Ponti, Laura, Potenza, Domenico, Pravadelli, Cecilia, Quartini, Mariano, Quirino, Tiziana, Raimondo, Giovanni, Rapaccini, Gian Ludovico, Rendina, Maria, Rizzardini, Giuliano, Rizzetto, Mario, Rizzo, Salvatore, Romagnoli, Dante, Romano, Antonietta, Rossi, Cristina, Rumi, Maria Grazia, Russello, Maurizio, Russo, Francesca Paolo, Russo, Maria Luisa, Sansonno, Domenico Ettore, Santantonio, Teresa Antonia, Saracco, Giorgio, Schimizzi, Anna Maria, Serviddio, Gaetano, Simeone, Filomena, Solinas, Attilio, Soria, Alessandro, Tabone, Marco, Taliani, Gloria, Tarantino, Giuseppe, Tarquini, Pierluigi, Tavio, Marcello, Termite, Antonio, Teti, Elisabetta, Toniutto, Pierluigi, Torti, Carlo, Tundi, Paolo, Vecchiet, Giacomo, Verucchi, Gabriella, Gentilucci, Umberto Vespasiani, Vinci, Maria, Vullo, Vincenzo, Zolfino, Teresa, Zuin, Massimo, 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, and Zuin, M

Subjects
Cyclopropanes, Liver Cirrhosis, Male, Cirrhosis, Dasabuvir, Elderly, Ombitasvir, Paritaprevir, Aged, 80 and over, Anilides, Antiviral Agents, Biomarkers, Carbamates, Female, Hepacivirus, Hepatitis C, Chronic, Humans, Macrocyclic Compounds, Ribavirin, Ritonavir, Sulfonamides, Treatment Outcome, Uracil, Drug Therapy, Combination, Genotype, Cirrhosis, Dasabuvir, Elderly, Ombitasvir, Paritaprevir, Microbiology (medical), Infectious Diseases, Aged, 80 and over, Hepatitis C, Chronic, Drug Therapy, Combination, Microbiology (medical), Infectious Diseases, Gastroenterology, chemistry.chemical_compound, 0302 clinical medicine, 2-Naphthylamine, Medicine, 030212 general & internal medicine, Valine, General Medicine, 030211 gastroenterology & hepatology, Macrocyclic Compound, medicine.drug, Human, medicine.medical_specialty, Proline, Lactams, Macrocyclic, Settore MED/12 - GASTROENTEROLOGIA, Liver Cirrhosi, Sulfonamide, 03 medical and health sciences, Internal medicine, Decompensation, Hepatitis, Antiviral Agent, Cirrhosi, Hepaciviru, business.industry, Settore MED/09 - MEDICINA INTERNA, Anilide, Biomarker, medicine.disease, chemistry, Carbamate, business
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 65years. 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 (25/150/100mg) and twice-daily dasabuvir (250mg) 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 12weeks 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 < 3.5g/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 < 2mg/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

44. CONSISTENT BONE MARROW-DERIVED CELL MOBILIZATION FOLLOWING REPEATED SHORT COURSES OF GRANULOCYTE-COLONY-STIMULATING FACTOR IN PATIENTS WITH AMYOTROPHIC LATERAL SCLEROSIS: RESULTS FROM A MULTICENTER PROSPECTIVE TRIAL

Author

Corrado, Tarella, Sergio, Rutella, Francesca, Gualandi, Mario, Melazzini, Rosanna, Scimè, Mario, Petrini, Cristina, Moglia, Marco, Ulla, Paola, Omedé, Vincenzo La, Bella, Massimo, Corbo, Vincenzo, Silani, Gabriele, Siciliano, Gabriele, Mora, Claudia, Caponnetto, Mario, Sabatelli, Adriano, Chiò, Giorgio, Lambertenghi Deliliers, Tarella, C., Rutella, S., Gualandi, F., Melazzini, M., Scimè, R., Petrini, M., Moglia, C., Ulla, M., Omedé, P., LA BELLA, V., Corbo, M., Silani, V., Siciliano, G., Mora, G., Caponnetto, C., Sabatelli, M., and Chiò, A.

Subjects
Adult, Male, Cancer Research, medicine.medical_specialty, SLa - trial clinico - C-GSF, Immunology, Antigens, CD34, Bone Marrow Cells, Drug Administration Schedule, Colony-Forming Units Assay, Cell Movement, Internal medicine, Multicenter trial, medicine, Immunology and Allergy, Humans, Cell Lineage, Prospective Studies, Amyotrophic lateral sclerosis, Prospective cohort study, Genetics (clinical), Hematopoietic Stem Cell Mobilization, Neurons, Transplantation, Mobilization, business.industry, Stem Cells, Amyotrophic Lateral Sclerosis, Granulocyte-Macrophage Colony-Stimulating Factor, Cell Differentiation, Cell Biology, Middle Aged, medicine.disease, Hematopoietic Stem Cells, Bone Marrow-Derived Cell, Surgery, Granulocyte colony-stimulating factor, Nerve Regeneration, Settore MED/26 - NEUROLOGIA, Granulocyte macrophage colony-stimulating factor, Treatment Outcome, Oncology, Biological Markers, Female, business, Neuroglia, Biomarkers, medicine.drug
Abstract

Background and aims. The aim of this study was to evaluate and characterize the feasibility and safety of bone marrow-derived cell (BMC) mobilization following repeated courses of granulocyte-colony stimulating factor (G-CSF) in patients with amyotrophic lateral sclerosis (ALS). Methods. Between January 2006 and March 2007, 26 ALS patients entered a multicenter trial that included four courses of BMC mobilization at 3-month intervals. In each course, G-CSF (5 mu g/kg b.i.d.) was administered for four consecutive days; 18% mannitol was also given. Mobilization was monitored by flow cytometry analysis of circulating CD34(+) cells and by in vitro colony assay for clonogenic progenitors. Co-expression by CD34(+) cells of CD133, CD90, CD184, CD117 and CD31 was also assessed. Results. Twenty patients completed the four-course schedule. One patient died and one refused to continue the program before starting the mobilization courses; four discontinued the study protocol because of disease progression. Overall, 89 G-CSF courses were delivered. There were two severe adverse events: one prolactinoma and one deep vein thrombosis. There were no discontinuations as a result of toxic complications. Circulating CD34(+) cells were monitored during 85 G-CSF courses and were always markedly increased; the range of median peak values was 41-57/mu L, with no significant differences among the four G-CSF courses. Circulating clonogenic progenitor levels paralleled CD34(+) cell levels. Most mobilized CD34(+) cells co-expressed stem cell markers, with a significant increase in CD133 co-expression. Conclusions. It is feasible to deliver repeated courses of G-CSF to mobilize a substantial number of CD34(+) cells in patients with ALS; mobilized BMC include immature cells with potential clinical usefulness.

Published
2010

45. New clinical insight in amyotrophic lateral sclerosis and innovative clinical development from the non-profit repurposing trial of the old drug guanabenz.

Author

Ambrosini A, Dalla Bella E, Ravasi M, Melazzini M, and Lauria G

Abstract

Drug repurposing is considered a valid approach to accelerate therapeutic solutions for rare diseases. However, it is not as widely applied as it could be, due to several barriers that discourage both industry and academic institutions from pursuing this path. Herein we present the case of an academic multicentre study that considered the repurposing of the old drug guanabenz as a therapeutic strategy in amyotrophic lateral sclerosis. The difficulties encountered are discussed as an example of the barriers that academics involved in this type of study may face. Although further development of the drug for this target population was hampered for several reasons, the study was successful in many ways. Firstly, because the hypothesis tested was confirmed in a sub-population, leading to alternative innovative solutions that are now under clinical investigation. In addition, the study was informative and provided new insights into the disease, which are now giving new impetus to laboratory research. The message from this example is that even a repurposing study with an old product has the potential to generate innovation and interest from industry partners, provided it is based on a sound rationale, the study design is adequate to ensure meaningful results, and the investigators keep the full clinical development picture in mind., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Ambrosini, Dalla Bella, Ravasi, Melazzini and Lauria.)

Published
2024
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46. The positive impact on translational research of Fondazione italiana di ricerca per la Sclerosi Laterale Amiotrofica (AriSLA), a non-profit foundation focused on amyotrophic lateral sclerosis. Convergence of ex-ante evaluation and ex-post outcomes when goals are set upfront.

Author

Guareschi S, Ravasi M, Baldessari D, Pozzi S, Zaffino T, Melazzini M, and Ambrosini A

Abstract

Charities investing on rare disease research greatly contribute to generate ground-breaking knowledge with the clear goal of finding a cure for their condition of interest. Although the amount of their investments may be relatively small compared to major funders, the advocacy groups' clear mission promotes innovative research and aggregates highly motivated and mission-oriented scientists. Here, we illustrate the case of Fondazione italiana di ricerca per la Sclerosi Laterale Amiotrofica (AriSLA), the main Italian funding agency entirely dedicated to amyotrophic lateral sclerosis research. An international benchmark analysis of publications derived from AriSLA-funded projects indicated that their mean relative citation ratio values (iCite dashboard, National Institutes of Health, U.S.) were very high, suggesting a strong influence on the referring international scientific community. An interesting trend of research toward translation based on the "triangle of biomedicine" and paper citations (iCite) was also observed. Qualitative analysis on researchers' accomplishments was convergent with the bibliometric data, indicating a high level of performance of several working groups, lines of research that speak of progression toward clinical translation, and one study that has progressed from the investigation of cellular mechanisms to a Phase 2 international clinical trial. The key elements of the success of the AriSLA investment lie in: (i) the clear definition of the objectives (research with potential impact on patients, no matter how far), (ii) a rigorous peer-review process entrusted to an international panel of experts, (iii) diversification of the portfolio with ad hoc selection criteria, which also contributed to bringing new experts and younger scientists to the field, and (iv) a close interaction of AriSLA stakeholders with scientists, who developed a strong sense of belonging. Periodic review of the portfolio of investments is a vital practice for funding agencies. Sharing information between funding agencies about their own policies and research assessment methods and outcomes help guide the international debate on funding strategies and research directions to be undertaken, particularly in the field of rare diseases, where synergy is a relevant enabling factor., Competing Interests: SG, MR, TZ, MM, and AA were employed by the company Fondazione AriSLA ETS. DB, SP, and AA were employed by the company Fondazione Telethon ETS., (Copyright © 2023 Guareschi, Ravasi, Baldessari, Pozzi, Zaffino, Melazzini and Ambrosini.)

Published
2023
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47. Worldwide Effects of Coronavirus Disease Pandemic on Tuberculosis Services, January-April 2020.

Author

Migliori GB, Thong PM, Akkerman O, Alffenaar JW, Álvarez-Navascués F, Assao-Neino MM, Bernard PV, Biala JS, Blanc FX, Bogorodskaya EM, Borisov S, Buonsenso D, Calnan M, Castellotti PF, Centis R, Chakaya JM, Cho JG, Codecasa LR, D'Ambrosio L, Denholm J, Enwerem M, Ferrarese M, Galvão T, García-Clemente M, García-García JM, Gualano G, Gullón-Blanco JA, Inwentarz S, Ippolito G, Kunst H, Maryandyshev A, Melazzini M, de Queiroz Mello FC, Muñoz-Torrico M, Njungfiyini PB, Palmero DJ, Palmieri F, Piccioni P, Piubello A, Rendon A, Sabriá J, Saporiti M, Scognamiglio P, Sharma S, Silva DR, Souleymane MB, Spanevello A, Tabernero E, Tadolini M, Tchangou ME, Thornton ABY, Tiberi S, Udwadia ZF, Sotgiu G, Ong CWM, and Goletti D

Subjects
Betacoronavirus, COVID-19, Humans, Pandemics, SARS-CoV-2, Tuberculosis epidemiology, Continuity of Patient Care trends, Coronavirus Infections epidemiology, Facilities and Services Utilization trends, Global Health trends, Pneumonia, Viral epidemiology, Tuberculosis therapy
Abstract

Coronavirus disease has disrupted tuberculosis services globally. Data from 33 centers in 16 countries on 5 continents showed that attendance at tuberculosis centers was lower during the first 4 months of the pandemic in 2020 than for the same period in 2019. Resources are needed to ensure tuberculosis care continuity during the pandemic.

Published
2020
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48. [Establishing the value of new drugs in Italy.]

Author

Villa F, Jommi C, Altamura G, Antignani S, Cangini A, Fortino I, Melazzini M, Trotta F, and Tafuri G

Subjects
Humans, Italy, Reimbursement Mechanisms, State Medicine, Drug Costs, Drug Industry economics, Orphan Drug Production economics, Pharmaceutical Preparations economics
Abstract

Italy was used as a case study to investigate the determinants of the difference between the price proposal for medicines submitted by the industry and the final negotiated price (∆P). Data was gathered through the information system used by Italian Medicines Agency (AIFA) and the time-frame for this analysis is 2013-2017. Factors influencing the delta price were analyzed through a regression analysis. Forty four orphan drugs and 89 new other molecular entities obtained reimbursement in the period considered. Following the negotiation process, prices proposed by Marketing Authorization Holders (MAH) were lowered during the negotiation process by 25.1% and 28.6% on average for orphan drugs and other molecules respectively. The price reduction was higher for innovative drugs (-32.2%). Statistically significant determinants associated to higher price reduction were: i) the implementation of a product specific monitoring registry, ii) the negotiation of a financial-based (FB) Managed Entry Agreement, iii) a target population larger than 20,000 patients, iv) an expected National Health Service expenditure larger than € 200 million. The impact of some variables on the delta price was predictable (e.g. for drugs with an expected higher budget impact and a larger target population), others were more surprising (e.g. a significant price reduction for "innovative" drugs). The implementation of FB agreements, which often rely on confidential arrangements, was one of the determinants with higher impact on price reduction.

Published
2020
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49. Determinants of price negotiations for new drugs. The experience of the Italian Medicines Agency.

Author

Villa F, Tutone M, Altamura G, Antignani S, Cangini A, Fortino I, Melazzini M, Trotta F, Tafuri G, and Jommi C

Subjects
Costs and Cost Analysis, Drug Costs legislation & jurisprudence, Humans, Italy, Orphan Drug Production economics, Technology Assessment, Biomedical, Drug Costs statistics & numerical data, Negotiating
Abstract

Objectives: The aim of this paper is to investigate the determinants of the difference between the price proposal submitted by the industry and the final negotiated price. We used Italy as a case-study., Methods: Data were gathered through the information system used by Italian Medicines Agency. The time-frame for this analysis is 2013-2017. Factors influencing the delta price were analyzed through a regression analysis., Results: 44 orphan drugs and 89 new other molecular entities obtained reimbursement in the last five years. Following the negotiation process, prices were lowered by 25.1% and 28.6% on average for orphan drugs and other molecules respectively. The price reduction was higher for innovative drugs (-32.2%). Statistically significant determinants associated to higher price reduction were: i) the implementation of a product specific monitoring registry, ii) the negotiation of a financial-based Managed Entry Agreement, iii) a target population larger than 20,000 patients, iv) an expected National Health Service expenditure larger than €200 million., Discussion: The impact of some variables on the delta price was predictable (e.g. for drugs with an expected higher budget impact and a larger population target), others were more surprising (e.g. a significant price reduction for "innovative" drugs). The implementation of financial-based agreements, which often rely on confidential arrangements, was one of the determinants with higher impact on price reduction., (Copyright © 2019 Elsevier B.V. All rights reserved.)

Published
2019
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50. [The ICD-ICF clinical model of hospital care].

Author

Traversi E, Springhetti I, Melazzini M, and Giorgi G

Subjects
Critical Pathways, Hospitalization, Humans, International Classification of Diseases, International Classification of Functioning, Disability and Health, Quality of Life, Delivery of Health Care organization & administration, Models, Organizational, Rehabilitation organization & administration
Abstract

Summary: Because of the demographic shift and the increased proportion of patients surviving acute critical illnesses, the number of people living with severely disabling chronic diseases and, consequently, the demand for rehabilitation are expected to increase sharply overtime. As underscored by theWorld Health Organization (WHO), there is substantial evidence that the provision of inpatient rehabilitation in specialized rehabilitation units to people with complex needs is effective in fostering functional recovery, improving health-related quality of life, increasing independence, reducing institutionalization rate, and improving prognosis. Recent studies in the real-world setting reinforce the evidence that patients with ischemic heart disease or stroke benefit from rehabilitation in terms of improved prognosis. In addition, there is evidence of the effectiveness of rehabilitation for the prevention of functional deterioration in patients with complex and/or severe chronic diseases. Given this evidence of effectiveness, rehabilitation should be regarded as an essential part of the continuum of care (transitional care). Nonetheless, rehabilitation still is underdeveloped and underused. A new model based on ICD and ICF WHO disease and disfunctioning classification respectively and on pre-set clinical pathways is described. The aim of this model is to optimize clinical care in times of shortage of resources and huge increase in older chronic multi morbid patients., Competing Interests: The authors of this article have no conflict of interests to disclose., (Copyright© by Aracne Editrice, Roma, Italy.)

Published
2019

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