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1. Ombitasvir, paritaprevir, and ritonavir, with or without dasabuvir, plus ribavirin for patients with hepatitis C virus genotype 1 or 4 infection with cirrhosis (ABACUS): a prospective observational study

Author

Tabone, Marco, Andreoni, Massimo, Teti, Elisabetta, Angelico, Mario, Persico, Marcello, Masarone, Mario, Chiodera, Aledssandro, Solinas, Attilio, delle Monache, Marco, Cecere, Roberto, Maria Schimizzi, Anna, Piovesan, Sara, Campagnolo, Davide, Chiara Piras, Maria, Zolfino, Teresa, Paolo Russo, Francesca, Morelli, Olivia, Sangiovanni, Vincenzo, Onofrio, Mirella, Iodice, Valentina, Izzi, Antonio, Pirisi, Massimo, Danieli, Elena, Vinci, Maria, Rizzardini, Giuliano, Fagiuoli, Stefano, Pasulo, Luisa, D'Arminio Monforte, Antonella, Zuin, Massimo, Giorgini, Alessia, Simeone, Filomena, Piali, Guido, Lo Guercio, Carmela, Federico, Alessandro, Brancaccio, Giuseppina, Marrone, Aldo, Abbati, Giuseppe, Boarini, Chiara, Borghi, Vanni, Bernabucci, Veronica, Corti, Giampaolo, Monti, Monica, Rizzetto, Mario, Martini, Silvia, Andreone, Pietro, Gianstefani, Alice, Lenzi, Marco, Verucchi, Gabriella, Toniutto, Pierluigi, Borgia, Guglielmo, Caporaso, Nicola, Morisco, Filomena, Nardone, Gaetano, Angrisani, Debora, Giacometti, Andrea, Benedetti, Antonio, Tarantino, Giuseppe, Marsetti, Fabio, Tavio, Marcello, Novara, Sergio, Antonia Santantonio, Teresa, Serviddio, Gaetano, Brunetto, Maurizia, Coco, Barbara, Angarano, Gioacchino, Milella, Michele, Barone, Michele, Di Leo, Alfredo, Ettore Sansonno, Domenico, Cacciola, Irene, Boffa, Nicola, Saracco, Giorgio, Di Biagio, Antonio, Picciotto, Antonino, de Luca, Andrea, Calvaruso, Vincenza, Corradori, Silvia, Ferrari, Carlo, Orlandini, Alessandra, Maida, Ivana, Torti, Carlo, Chessa, Luchino, Felder, Martina, Vespasiani Gentilucci, Umberto, Angeli, Paolo, Romano, Antonietta, Ludovico Rapaccini, Gian, Miele, Luca, Cima, Serena, Luisa Russo, Maria, Cozzolongo, Raffaele, Onnelli, Giovanna, D'Offizi, Giampiero, Lionetti, Raffaella, Montalbano, Marzia, Guerra, Michele, Di Perri, Giovanni, Boglione, Lucio, Capra, Franco, Carolo, Giada, Ieluzzi, Donatella, Antonini, Cinzia, Termite, Antonio, Madonia, Salvatore, Tarquini, Pierluigi, Parruti, Giustino, Vecchiet, Giacomo, Falasca, Katia, Menzaghi, Barbara, Quirino, Tiziana, Dentone, Chiara, Maria Piscaglia, Anna, Rossi, Cristina, Giordani, Maria, Fontanella, Luca, Cassola, Giovanni, Russello, Maurizio, Cristaudo, Antonio, Giacomet, Vania, Colombo, Massimo, Donato, Francesca, Durante, Emanuele, Cosco, Lucio, Marignani, Massimo, Quartini, Mariano, Memoli, Massimo, Ganga, Roberto, Ponti, Laura, Soria, Alessandro, Grazia Rumi, Maria, Gulminetti, Roberto, Maserati, Renato, Mondelli, Mario, Lazzarin, Adriano, Rita Parisi, Maria, Canovari, Benedetta, Avancini, Ivo, Pravadelli, Cecilia, Blanc, Pier, Pasquazzi, Caterina, Maria Mastroianni, Claudio, Lichtner, Myriam, Distefano, Marco, Magnani, Silvia, Paganin, Simona, Erne, Elke, Gatti, Pietro, Tundi, Paolo, Calabrese, Paolo, Gasbarrini, Antonio, Grieco, Antonio, Coppola, Nicola, Del Poggio, Paolo, Levrero, Massimo, Talliani, Gloria, Vullo, Vincenzo, Cauda, Roberto, La Monica, Silvia, Potenza, Domenico, Rizzo, Salvatore, Castelli, Francesco, Marie Pigozzi, Grazielle, Ciancio, Alessia, Romagnoli, Dante, Barchetti, Federica, Ivanovic, Jelena, Longo, Olimpia, Petraglia, Sandra, Paola Trotta, Maria, Petta, Salvatore, Marzioni, Marco, Russo, Pierluigi, Aghemo, Alessio, Alberti, Alfredo, Ascione, Antonio, Antinori, Andrea, Bruno, Raffaele, Bruno, Savino, Chirianni, Antonio, Gaeta, Giovanni Battista, Giannini, Edoardo G, Merli, Manuela, Messina, Vincenzo, Montilla, Simona, Perno, Carlo Federico, Puoti, Massimo, Raimondo, Giovanni, Rendina, Maria, Silberstein, Francesca Ceccherini, Villa, Erica, Zignego, Anna Linda, Pani, Luca, and Craxì, Antonio

Published
2017
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2. The Italian compassionate use of sofosbuvir observational cohort study for the treatment of recurrent hepatitis C: clinical and virological outcomes

Author

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

Published
2017
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6. A nationwide prospective registry of bortezomib-based therapy in light chain (AL) amyloidosis.

Author

Palladini, Giovanni, Celant, Simone, Milani, Paolo, Summa, Valentina, Affronti, Giovanni, Olimpieri, Pier Paolo, Petraglia, Sandra, Foli, Andrea, Nuvolone, Mario, Merlini, Giampaolo, and Russo, Pierluigi

Subjects
AMYLOIDOSIS, PHOTOTHERAPY, OLDER patients, DRUG labeling, KIDNEY failure
Abstract

Until recently, no drug was labeled for AL amyloidosis. In 2011, the Italian Medicines Agency started a program to grant access to upfront bortezomib to patients with AL amyloidosis. All subjects were enrolled in a prospective online registry. Response was evaluated after two cycles to assess the possibility of continuing treatment. A total of 764 patients were included until 2019, and 615 were evaluable. Sixteen percent of patents had advanced (stage-IIIb) heart involvement, and 27% had severe or end-stage renal failure. Bortezomib delivery was possible in stage-IIIb patients at a reduced dose. Bortezomib discontinuation was associated with increasing age, advanced heart involvement and bi-weekly administration. Fifty-nine percent of subjects attained a hematologic response and 14% a cardiac response. Bortezomib-based therapy tends to be discontinued early in elderly patients and in advanced disease. Nevertheless, early response to therapy is possible in this challenging population. [ABSTRACT FROM AUTHOR]

Published
2022
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7. 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

9. Ombitasvir, paritaprevir, and ritonavir, with or without dasabuvir, plus ribavirin for patients with hepatitis C virus genotype 1 or 4 infection with cirrhosis (ABACUS): a prospective observational study

Author

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

Subjects
Cyclopropanes, Compassionate Use Trials, Liver Cirrhosis, Male, chemistry.chemical_compound, 0302 clinical medicine, 2-Naphthylamine, HCV, direct-acting antiviral, mixed cryoglobulinemia, RBV, Anilides, 030212 general & internal medicine, Longitudinal Studies, Prospective Studies, Chronic, Adult, Aged, Antiviral Agents, Carbamates, Drug Therapy, Combination, Female, Genotype, Hepatitis C, Chronic, Humans, Macrocyclic Compounds, Middle Aged, Ribavirin, Ritonavir, Sulfonamides, Treatment Outcome, Uracil, Settore MED/12 - Gastroenterologia, Dasabuvir, HCV DAA, Gastroenterology, virus diseases, Valine, Settore MED/07 - Microbiologia e Microbiologia Clinica, Hepatitis C, Hepatology, Combination, 030211 gastroenterology & hepatology, medicine.drug, medicine.medical_specialty, Proline, Lactams, Macrocyclic, Hepatitis C virus genotype 1, Hepatitis C virus genotype 4, decompensated liver cirrhosis, antiviral therapy, dasabuvir, ombitasvir, paritaprevir, 03 medical and health sciences, Drug Therapy, Internal medicine, medicine, Decompensation, Adverse effect, business.industry, Virology, Ombitasvir, Clinical trial, chemistry, Paritaprevir, business
Abstract

Summary Background We ran a compassionate use nationwide programme (ABACUS) to provide access to ombitasvir, paritaprevir, and ritonavir, with dasabuvir, plus ribavirin for hepatitis C virus (HCV) genotype 1 infection and ombitasvir, paritaprevir, and ritonavir, plus ribavirin for HCV genotype 4 infection in patients with cirrhosis at high risk of decompensation while approval of these regimens was pending in Italy. Methods In this prospective observational study, we collected data from a compassionate use nationwide programme from March 17, 2014, to May 28, 2015. Patients with HCV genotype 1 infection and cirrhosis at high risk of decompensation were given coformulated ombitasvir (25 mg), paritaprevir (150 mg), and ritonavir (100 mg) once daily and dasabuvir (250 mg) twice daily for 12 weeks (patients with HCV genotype 1b infection) or 24 weeks (patients with HCV genotype 1a infection). Patients with HCV genotype 4 infection were given coformulated ombitasvir (25 mg), paritaprevir (150 mg), and ritonavir (100 mg) once per day for 24 weeks. All patients were given weight-based ribavirin. The primary efficacy endpoint was sustained virological response at week 12 after the end of treatment (SVR12), analysed by intention-to-treat. Univariate and multivariate logistic regression analyses were used to identify baseline characteristics associated with SVR12. Adverse events were recorded throughout the study. Findings 728 (96%) of 762 patients with cirrhosis who were given ombitasvir, paritaprevir, and ritonavir, with or without dasabuvir, plus ribavirin therapy for 12 or 24 weeks achieved SVR12. Logistic regression analyses identified that bilirubin concentrations of less than 2 mg/dL were associated with SVR12 (odds ratio [OR] 4·76 [95% CI 1·83–12·3]; p=0·001). 166 (23%) of 734 patients included in safety analyses had an adverse event. 25 (3%) patients discontinued treatment because of adverse events. Asthenia was the most commonly reported adverse event, occurring in 36 (5%) patients. Interpretation Our findings suggest that the safety and effectiveness of ombitasvir, paritaprevir, and ritonavir, with or without dasabuvir, plus ribavirin in patients with HCV genotype 1 or 4 infection and cirrhosis at high risk of decompensation in a real-life setting are similar to those reported in clinical trials. The concordance with clinical trials provides reassurance that the reported efficacy of this treatment in clinical trials will translate to its use in routine clinical practice. Funding Dipartimento Biomedico di Medicina Interna e Specialistica dell'Universita di Palermo.

Published
2017

11. Valacyclovir for prevention and treatment of fetal CMV infection: inclusion in the Law 648/96 list and launch of the Italian multicentre observational prospective study "MEGAL-ITALI".

Author

Zammarchi, Lorenzo, Lazzarotto, Tiziana, Di Tommaso, Mariarosaria, Tomasoni, Lina, Pasquini, Lucia, Galli, Luisa, Simonazzi, Giuliana, Castelli, Francesco, Borchi, Beatrice, Campolmi, Irene, Ornaghi, Sara, Bartoloni, Alessandro, Andreoni, Massimo, Pagano, Immacolata, Petraglia, Sandra, Ramenghi, Luca, Clerici, Pierangelo, Tavio, Marcello, and Trotta, Michele

Published
2021

12. Ombitasvir, paritaprevir, and ritonavir, with or without dasabuvir, plus ribavirin for patients with hepatitis C virus genotype 1 or 4 infection with cirrhosis (ABACUS): a prospective observational study

Author

Petta, Salvatore, primary, Marzioni, Marco, additional, Russo, Pierluigi, additional, Aghemo, Alessio, additional, Alberti, Alfredo, additional, Ascione, Antonio, additional, Antinori, Andrea, additional, Bruno, Raffaele, additional, Bruno, Savino, additional, Chirianni, Antonio, additional, Gaeta, Giovanni Battista, additional, Giannini, Edoardo G, additional, Merli, Manuela, additional, Messina, Vincenzo, additional, Montilla, Simona, additional, Perno, Carlo Federico, additional, Puoti, Massimo, additional, Raimondo, Giovanni, additional, Rendina, Maria, additional, Silberstein, Francesca Ceccherini, additional, Villa, Erica, additional, Zignego, Anna Linda, additional, Pani, Luca, additional, Craxì, Antonio, additional, Tabone, Marco, additional, Andreoni, Massimo, additional, Teti, Elisabetta, additional, Angelico, Mario, additional, Persico, Marcello, additional, Masarone, Mario, additional, Chiodera, Aledssandro, additional, Solinas, Attilio, additional, delle Monache, Marco, additional, Cecere, Roberto, additional, Maria Schimizzi, Anna, additional, Piovesan, Sara, additional, Campagnolo, Davide, additional, Chiara Piras, Maria, additional, Zolfino, Teresa, additional, Paolo Russo, Francesca, additional, Morelli, Olivia, additional, Sangiovanni, Vincenzo, additional, Onofrio, Mirella, additional, Iodice, Valentina, additional, Izzi, Antonio, additional, Pirisi, Massimo, additional, Danieli, Elena, additional, Vinci, Maria, additional, Rizzardini, Giuliano, additional, Fagiuoli, Stefano, additional, Pasulo, Luisa, additional, D'Arminio Monforte, Antonella, additional, Zuin, Massimo, additional, Giorgini, Alessia, additional, Simeone, Filomena, additional, Piali, Guido, additional, Lo Guercio, Carmela, additional, Federico, Alessandro, additional, Brancaccio, Giuseppina, additional, Marrone, Aldo, additional, Abbati, Giuseppe, additional, Boarini, Chiara, additional, Borghi, Vanni, additional, Bernabucci, Veronica, additional, Corti, Giampaolo, additional, Monti, Monica, additional, Rizzetto, Mario, additional, Martini, Silvia, additional, Andreone, Pietro, additional, Gianstefani, Alice, additional, Lenzi, Marco, additional, Verucchi, Gabriella, additional, Toniutto, Pierluigi, additional, Borgia, Guglielmo, additional, Caporaso, Nicola, additional, Morisco, Filomena, additional, Nardone, Gaetano, additional, Angrisani, Debora, additional, Giacometti, Andrea, additional, Benedetti, Antonio, additional, Tarantino, Giuseppe, additional, Marsetti, Fabio, additional, Tavio, Marcello, additional, Novara, Sergio, additional, Antonia Santantonio, Teresa, additional, Serviddio, Gaetano, additional, Brunetto, Maurizia, additional, Coco, Barbara, additional, Angarano, Gioacchino, additional, Milella, Michele, additional, Barone, Michele, additional, Di Leo, Alfredo, additional, Ettore Sansonno, Domenico, additional, Cacciola, Irene, additional, Boffa, Nicola, additional, Saracco, Giorgio, additional, Di Biagio, Antonio, additional, Picciotto, Antonino, additional, de Luca, Andrea, additional, Calvaruso, Vincenza, additional, Corradori, Silvia, additional, Ferrari, Carlo, additional, Orlandini, Alessandra, additional, Maida, Ivana, additional, Torti, Carlo, additional, Chessa, Luchino, additional, Felder, Martina, additional, Vespasiani Gentilucci, Umberto, additional, Angeli, Paolo, additional, Romano, Antonietta, additional, Ludovico Rapaccini, Gian, additional, Miele, Luca, additional, Cima, Serena, additional, Luisa Russo, Maria, additional, Cozzolongo, Raffaele, additional, Onnelli, Giovanna, additional, D'Offizi, Giampiero, additional, Lionetti, Raffaella, additional, Montalbano, Marzia, additional, Guerra, Michele, additional, Di Perri, Giovanni, additional, Boglione, Lucio, additional, Capra, Franco, additional, Carolo, Giada, additional, Ieluzzi, Donatella, additional, Antonini, Cinzia, additional, Termite, Antonio, additional, Madonia, Salvatore, additional, Tarquini, Pierluigi, additional, Parruti, Giustino, additional, Vecchiet, Giacomo, additional, Falasca, Katia, additional, Menzaghi, Barbara, additional, Quirino, Tiziana, additional, Dentone, Chiara, additional, Maria Piscaglia, Anna, additional, Rossi, Cristina, additional, Giordani, Maria, additional, Fontanella, Luca, additional, Cassola, Giovanni, additional, Russello, Maurizio, additional, Cristaudo, Antonio, additional, Giacomet, Vania, additional, Colombo, Massimo, additional, Donato, Francesca, additional, Durante, Emanuele, additional, Cosco, Lucio, additional, Marignani, Massimo, additional, Quartini, Mariano, additional, Memoli, Massimo, additional, Ganga, Roberto, additional, Ponti, Laura, additional, Soria, Alessandro, additional, Grazia Rumi, Maria, additional, Gulminetti, Roberto, additional, Maserati, Renato, additional, Mondelli, Mario, additional, Lazzarin, Adriano, additional, Rita Parisi, Maria, additional, Canovari, Benedetta, additional, Avancini, Ivo, additional, Pravadelli, Cecilia, additional, Blanc, Pier, additional, Pasquazzi, Caterina, additional, Maria Mastroianni, Claudio, additional, Lichtner, Myriam, additional, Distefano, Marco, additional, Magnani, Silvia, additional, Paganin, Simona, additional, Erne, Elke, additional, Gatti, Pietro, additional, Tundi, Paolo, additional, Calabrese, Paolo, additional, Gasbarrini, Antonio, additional, Grieco, Antonio, additional, Coppola, Nicola, additional, Del Poggio, Paolo, additional, Levrero, Massimo, additional, Talliani, Gloria, additional, Vullo, Vincenzo, additional, Cauda, Roberto, additional, La Monica, Silvia, additional, Potenza, Domenico, additional, Rizzo, Salvatore, additional, Castelli, Francesco, additional, Marie Pigozzi, Grazielle, additional, Ciancio, Alessia, additional, Romagnoli, Dante, additional, Barchetti, Federica, additional, Ivanovic, Jelena, additional, Longo, Olimpia, additional, Petraglia, Sandra, additional, and Paola Trotta, Maria, additional

Published
2017
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13. Moving towards a customized approach for drug development: lessons from clinical trials with immune checkpoint inhibitors in lung cancer

Author

Pilotto, Sara, Carbognin, Luisa, Karachaliou, Niki, Garassino, Marina, Cuppone, Federica, Petraglia, Sandra, Rosell, Rafael, Tortora, Giampaolo, and Bria, Emilio

Subjects
Review Article on Lung Cancer Immunotherapy, design, Immunotherapy, cancer, lung, trial
Abstract

Lung cancer has recently been discovered to be an immunological targetable disease, on the basis of the exciting results of the randomized trials with immune checkpoint inhibitors. Nevertheless, the survival benefit appears to not be entirely captured by the usual outcome measures, thus requiring a deep reflection about the appropriateness of the traditional statistical methodologies in this context. The intrinsic biological differences existing both in terms of mechanism of action and kinetic between immunotherapy and chemotherapy or targeted therapy, impact on patients' outcome, requiring a global revolution in the way to design clinical studies with the ideal aim to evolve towards trials carefully 'customized' on the basis of the investigational drug, the specific disease and the biological background. The exciting data recently obtained with immune checkpoint inhibitors, offer an ideal context and background to explore the major questions and future perspectives about the development of immunotherapeutic agents. In this regard, the choice of adequate endpoints, the use of modified statistical methods and the potential introduction of predictive biomarkers for immunotherapy clinical trials, will be discuss in this review in order to provide practical and rationale suggestions aimed to improve the existing model for cancer immunotherapy investigation.

Published
2015

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

Author

the ITACOPS study group, Martini, Silvia, Carrai, Paola, Donato, Maria Francesca, Mazzarelli, Chiara, Rendina, Maria, Visco‐Comandini, Ubaldo, Filì, Daniela, Gianstefani, Alice, Caraceni, Paolo, Fagiuoli, Stefano, Melazzini, Mario, Montilla, Simona, Pani, Luca, Petraglia, Sandra, Russo, Pierluigi, and Trotta, Maria Paola

Subjects
LIVER transplantation, HEPATITIS C diagnosis, LIVER cancer patients, HEPATITIS C treatment, CIRRHOSIS of the liver, LIVER cancer
Abstract

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. [ABSTRACT FROM AUTHOR]

Published
2018
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15. Nivolumab in pretreated pleural mesothelioma: Results from an observational real-world study of patients treated within the AIFA 5% Fund

Author

Cerbone, Luigi, Delfanti, Sara, Crivellari, Stefania, De Angelis, Antonina Maria, Mazzeo, Laura, Proto, Claudia, Occhipinti, Mario, Lo Russo, Giuseppe, Dellepiane, Chiara, Biello, Federica, Alabiso, Irene, Verderame, Francesco, Gauna, Roberta, De Simone, Irene, Cuppone, Federica, Petraglia, Sandra, Pasello, Giulia, Ceresoli, Giovanni Luca, Garassino, Marina Chiara, Torri, Valter, and Grosso, Federica

Abstract

Background: Pleural mesothelioma is a rare cancer with a dismal prognosis and few therapeutic options, especially in the pretreated setting. Immunotherapy with checkpoint inhibitors as single agents yielded interesting results in refractory pleural mesothelioma, achieving a response rate between 10-20%, median progression-free survival of 2-5 months and median overall survival of 7-13 months.Patients and methods: A retrospective, multi-institutional study of pleural mesothelioma patients treated with nivolumab in second and further line was performed. The endpoints of the study are response rate, disease control rate, progression free survival and overall survival.Results: Sixty-five patients with pleural mesothelioma treated with nivolumab in second and further line were enrolled at seven Italian institutions. The response rate was 8%, disease control rate was 37%, median progression free survival was 5.7 months (95% CI: 2.9-9.0) and median overall survival was 11.1 (95% CI 6.2-19.9) months. A higher neutrophils and neutrophils to lymphocytes ratio at baseline were associated with worse prognosis.Conclusion: Nivolumab as a single agent is fairly active in a cohort of unselected pretreated pleural mesothelioma patients. Further investigations on clinical and translational factors are needed to define which patient might benefit most from nivolumab treatment in pleural mesothelioma.

Published
2024
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16. Postsurgical adjuvant therapy for melanoma<FNR HREF="fn1"></FNR><FN ID="fn1">Preliminary results presented at the Annual S.I.D.E.V. (Società Italiana di Dermatologia e Venereologia [Italian Society of Dermatology and Venereology]) Meeting, Rimini, Italy, June 11-14, 1996. </FN>

Author

Rusciani, Luigi, Petraglia, Sandra, Alotto, Massimo, Calvieri, Stefano, and Vezzoni, Giampaolo

Abstract

Early surgical intervention is still the most successful therapy for patients with melanoma. The results obtained with medical therapies are still quite disappointing, with better results observed in soft tissue and lymph node metastasis. There currently is no standardized adjuvant therapy for primary melanoma. On the basis of the activity demonstrated in vitro against melanoma cell lines and the results obtained in many clinical trials in patients with advanced melanoma, the authors chose to study the use of recombinant interferon-α (IFN-α) as adjuvant therapy for patients with Stage I and Stage II melanoma. A randomized multicenter trial based on the use of recombinant IFN-α-2b for 3 years at the dose of 3 MU given intramuscularly 3 times a week for a period of 6 months with a 1-month interval between cycles was conducted in Stage I and Stage II melanoma patients (using the American Joint Committee on Cancer classification). The efficacy of this treatment was evaluated calculating the incidence of recurrence after 3 and 5 years. Results were collected at the end of the treatment period and after 5 years of follow-up for a smaller number of patients. Statistical evaluation showed a significant difference between treated patients and untreated controls with regard to progression of the disease. In particular, IfN-α appears to be more effective in patients with worse prognosis lesions. IFN-α appears to be effective as adjuvant therapy for high risk melanoma patients and the risk/benefit ratio appears to be very favorable. The authors' next goal is to separate those patients who might benefit from adjuvant therapy from those who are cured after the surgical intervention only. Cancer 1997; 79:2354-60. © 1997 American Cancer Society.

Published
1997
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17. The Italian compassionate use of sofosbuvir observational cohort study for the treatment of recurrent hepatitis C: clinical and virological outcomes

Author

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

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

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

Published
2017

18. Valacyclovir for prevention and treatment of fetal CMV infection: inclusion in the Law 648/96 list and launch of the Italian multicentre observational prospective study "MEGAL-ITALI".

Author

Zammarchi L, Lazzarotto T, Di Tommaso M, Tomasoni L, Pasquini L, Galli L, Simonazzi G, Castelli F, Borchi B, Campolmi I, Ornaghi S, Bartoloni A, Andreoni M, Pagano I, Petraglia S, Ramenghi L, Clerici P, Tavio M, and Trotta M

Subjects
Antiviral Agents therapeutic use, Humans, Infant, Newborn, Italy, Cytomegalovirus Infections congenital, Cytomegalovirus Infections drug therapy, Cytomegalovirus Infections prevention & control, Valacyclovir therapeutic use
Abstract

Not available.

Published
2021

19. Moving towards a customized approach for drug development: lessons from clinical trials with immune checkpoint inhibitors in lung cancer.

Author

Pilotto S, Carbognin L, Karachaliou N, Garassino M, Cuppone F, Petraglia S, Rosell R, Tortora G, and Bria E

Abstract

Lung cancer has recently been discovered to be an immunological targetable disease, on the basis of the exciting results of the randomized trials with immune checkpoint inhibitors. Nevertheless, the survival benefit appears to not be entirely captured by the usual outcome measures, thus requiring a deep reflection about the appropriateness of the traditional statistical methodologies in this context. The intrinsic biological differences existing both in terms of mechanism of action and kinetic between immunotherapy and chemotherapy or targeted therapy, impact on patients' outcome, requiring a global revolution in the way to design clinical studies with the ideal aim to evolve towards trials carefully 'customized' on the basis of the investigational drug, the specific disease and the biological background. The exciting data recently obtained with immune checkpoint inhibitors, offer an ideal context and background to explore the major questions and future perspectives about the development of immunotherapeutic agents. In this regard, the choice of adequate endpoints, the use of modified statistical methods and the potential introduction of predictive biomarkers for immunotherapy clinical trials, will be discuss in this review in order to provide practical and rationale suggestions aimed to improve the existing model for cancer immunotherapy investigation.

Published
2015
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