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52. Neuropsychological development of children born to patients with systemic lupus erythematosus

Author

Neri, F, Chimini, L, Bonomi, F, Filippini, E, Motta, M, Faden, D, Lojacono, A, Rebaioli, C, Frassi, M, Danieli, E, Tincani, A, NERI, FRANCESCA, Rebaioli, CB, Tincani, A., Neri, F, Chimini, L, Bonomi, F, Filippini, E, Motta, M, Faden, D, Lojacono, A, Rebaioli, C, Frassi, M, Danieli, E, Tincani, A, NERI, FRANCESCA, Rebaioli, CB, and Tincani, A.

Abstract

To verify the neuropsychological development in the offspring of patients with systemic lupus erythematosus (SLE), 47 children (23 male and 24 female) from affected women were studied. The tests applied were related to the children’s ages: Griffiths scale up to four years, WPPSI and metaphonological tests (MP, evaluating the phonological consciousness) from four to six years of age, WISC-R test and Rey test (evaluating the visual-space abilities) from six years onwards; finally, specific tests for the diagnosis of learning disabilities (LD) between the ages of seven and 13. Intelligence levels were always normal (mean IQ score 106.32; median 104; SD 9.05). Three out of eight examined children failed MP, therefore may develop LD and will need further evaluation later. Fourteen children were specifically studied for LD and three reported scores lower than normal, but only two (who were brothers) were defined dyslexic. Antiphospholipid antibodies (aPL) were positive in the mothers of the three children with impaired LD tests. Other maternal autoantibodies or drugs administered during pregnancy did not seem to be related to LD. In conclusion, maternal SLE does not impair intelligence levels, but may increase the occurrence of LD particularly in male children (2/8 males examined, 25%). Both maternal aPL and genetic background may have pathogenetic implications. Lupus (2004) 13, 805–811.

Published
2004

62. Characterization of T-cell population in children with prolonged fetal exposure to dexamethasone for anti-Ro/SS-A antibodies associated congenital heart block

Author

Airó, P, primary, Scarsi, M, additional, Brucato, A, additional, Benicchi, T, additional, Malacarne, F, additional, Cavazzana, I, additional, Danieli, E, additional, LiDestri, M, additional, Motta, M, additional, Caimi, L, additional, Tincani, A, additional, and Imberti, L, additional

Published
2006
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68. Pregnancy and neonatal outcome in primary antiphospholipid syndrome

Author

Tincani, A, primary, Lojacono, A, additional, Taglietti, M, additional, Motta, M, additional, Biasini, C, additional, Decca, L, additional, Zatti, S, additional, Frassi, M, additional, Barbetti, L, additional, Gorla, R, additional, Danieli, E, additional, Balestrieri, G, additional, Chirico, G, additional, and Faden, D, additional

Published
2002
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70. Mobile Low-Field H NMR Spectroscopy Desktop Analysis of Biodiesel Production.

Author

Garro Linck, Yamila, Killner, M., Danieli, E., and Blümich, B.

Abstract

Biodiesel produced mainly by the base-catalyzed transesterification of vegetable oils or animal fats with a short chain alcohol, has become an attractive alternative to petroleum-based diesel fuel. Even though high-field H nuclear magnetic resonance (NMR) is a reliable method for biodiesel quality control, it is restricted by its poor mobility and expensive superconducting coils. As an alternative, this study presents a mobile low-field H NMR spectrometer for the analysis of biodiesel samples derived from different feedstock oils. The low-field H NMR spectra of all the compounds coexisting in a typical transesterification reaction such as rapeseed oil, rapeseed biodiesel, methanol, and glycerol, could be clearly differentiated. Field-dependent characteristic parameters such as relaxation times are provided. The degree of saturation of the different biofuels samples could be reliably estimated via integration of the resolved signals of the spectra. The obtained results agreed well with those measured at high-field H NMR. Since this compositional information is directly related to the biodiesel properties, the presented mobile low-field H NMR device built from permanent magnets arrayed in a Halbach geometry, constitutes an excellent alternative tool for biodiesel quality control. [ABSTRACT FROM AUTHOR]

Published
2013
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71. Cyclic DGR-peptidomimetic containing a bicyclic reverse turn inducer as a selective αvβ5 integrin ligand.

Author

Trabocchi, A., Menchi, G., Danieli, E., Potenza, D., Cini, N., Bottoncetti, A., Raspanti, S., Pupi, A., and Guarna, Antonio

Subjects
AMINO acids, PEPTIDES, BICYCLIC compounds, CONFORMATIONAL analysis, INTERFERON inducers, INTEGRINS, LIGANDS (Biochemistry)
Abstract

3-Aza-6,8-dioxabicyclo[3.2.1]octane-based amino acids as reverse turn inducers have been introduced into cyclic peptidomimetics containing the RGD or DGR retro-sequence, in order to achieve a stereochemical scanning of the binding capability of the resulting molecules towards αvβ3 and αvβ5 integrins, resulting in retro-inverso DGR peptides as micromolar ligands. A comparative analysis between the conformational preferences of 4 and of its isomer 3, having the opposite RGD sequence, was reported with respect to the binding activity, giving insight into the factors affecting the preferential binding of 4 to the αvβ5 integrin. [ABSTRACT FROM AUTHOR]

Published
2010
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72. Impact of in utero environment on the offspring of lupus patients.

Author

Tincani, A., Danieli, E., Nuzzo, M., Scarsi, M., Motta, M., Cimaz, R., Lojacono, A., Nacinovich, R., Taddei, F., Doria, A., Brucato, A., and Meroni, P.

Subjects
*SYSTEMIC lupus erythematosus, *PHOSPHOLIPID antibodies, *AUTOANTIBODIES, *IMMUNOSUPPRESSIVE agents, *LEARNING disabilities, *PREGNANCY complications, *CONGENITAL heart disease, *HEART block, *DIAGNOSIS
Abstract

The number of patients affected by systemic lupus erythematosus (SLE) that decide to have children has greatly increased probably because of recent improvements in the diagnosis and management of the disease. This has stimulated our interest in defining the outcome of children, focusing both on neonatal problems and long term development. SLE patients still carry a risk of pregnancy loss. However, due to careful monitoring and treatment by a multidisciplinary team, the number of losses has dramatically decreased, but an increased number of preterm deliveries is still a problem. Neonatal lupus is linked to the presence of anti-Ro/SS-A and anti-La/SS-B antibodies in the mother, although other factors probably of fetal origin are important. Neonatal lupus is a complex condition whose most serious manifestation is the congenital heart block (CHB). Usually, children with complete CHB need permanent pacing, but apparently do not have neuropsychological problems. Studies focusing on the neuropsychological development of SLE offspring show an increased number of learning disabilities in children with normal intelligence levels. Fetal consequence of maternal treatment need to be considered choosing non teratogenic drugs, but the withdrawal of medications just because the patient is pregnant should be avoided to avoid SLE flares. [ABSTRACT FROM AUTHOR]

Published
2006
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78. Improvement of ALT decay kinetics by all-oral HCV treatment: Role of NS5A inhibitors and differences with IFN-based regimens

Author

Carlo Magni, Barbara Menzaghi, Valeria Cento, Francesca Ceccherini-Silberstein, Giustino Parruti, Antonio Di Biagio, Velia Chiara Di Maio, Sergio Babudieri, Antonella d'Arminio Monforte, Loredana Sarmati, Laura Gianserra, Paolo Casalino, Tiziana Quirino, Elena Danieli, Jeremie Guedj, Dante Romagnoli, Ilaria Lenci, Sergio Bernardini, Laura Ambra Nicolini, Elisa Biliotti, Matteo Bolis, M. Melis, Maddalena Cerrone, Massimo Puoti, Valeria Micheli, Carlo Federico Perno, Vincenza Calvaruso, Thi Huyen Tram Nguyen, Ennio Polilli, Giuliano Rizzardini, Massimo Siciliano, Massimo Andreoni, Mario Angelico, Francesco Paolo Antonucci, Domenico Di Carlo, Caterina Pasquazzi, Antonio Craxì, Daniele Di Paolo, Elisabetta Teti, Gloria Taliani, Roberta Alfieri, Cento, V, Nguyen, T, Di Carlo, D, Biliotti, E, Gianserra, L, Lenci, I, Di Paolo, D, Calvaruso, V, Teti, E, Cerrone, M, Romagnoli, D, Melis, M, Danieli, E, Menzaghi, B, Polilli, E, Siciliano, M, Nicolini, L, Di Biagio, A, Magni, C, Bolis, M, Antonucci, F, Di Maio, V, Alfieri, R, Sarmati, L, Casalino, P, Bernardini, S, Micheli, V, Rizzardini, G, Parruti, G, Quirino, T, Puoti, M, Babudieri, S, Monforte, A, Andreoni, M, Craxì, A, Angelico, M, Pasquazzi, C, Taliani, G, Guedj, J, Perno, C, Ceccherini-Silberstein, F, Cento, V., Nguyen, T., Di Carlo, D., Biliotti, E., Gianserra, L., Lenci, I., Di Paolo, D., Calvaruso, V., Teti, E., Cerrone, M., Romagnoli, D., Melis, M., Danieli, E., Menzaghi, B., Polilli, E., Siciliano, M., Nicolini, L., Di Biagio, A., Magni, C., Bolis, M., Antonucci, F., Di Maio, V., Alfieri, R., Sarmati, L., Casalino, P., Bernardini, S., Micheli, V., Rizzardini, G., Parruti, G., Quirino, T., Puoti, M., Babudieri, S., Monforte, A., Andreoni, M., Craxi, A., Angelico, M., Pasquazzi, C., Taliani, G., Guedj, J., Perno, C., and Ceccherini-Silberstein, F.

Subjects
Genetics and Molecular Biology (all), Simeprevir, Male, Hepacivirus, Pharmacology, Biochemistry, Stiffness, 0302 clinical medicine, Animal Cells, Medicine, Amino Acids, lcsh:Science, Alanine, Organic Compounds, Liver Diseases, 3. Good health, Cirrhosis, Physical Sciences, Administration, Interferon, 030211 gastroenterology & hepatology, Drug Therapy, Combination, Cellular Types, Oligopeptides, Human, Oral, Materials Science, Gastroenterology and Hepatology, Microbiology, Antiviral Agents, 03 medical and health sciences, Drug Therapy, Humans, Aged, Kinetic, Hepaciviru, Biochemistry, Genetics and Molecular Biology (all), Mathematical Modeling, lcsh:R, Chemical Compounds, Biology and Life Sciences, Proteins, medicine.disease, digestive system diseases, Administration, Oral, Alanine Transaminase, Female, Hepatitis C, Interferons, Kinetics, Middle Aged, RNA, Viral, Ribavirin, Sofosbuvir, Treatment Outcome, Viral Nonstructural Proteins, Agricultural and Biological Sciences (all), 030104 developmental biology, chemistry, Aliphatic Amino Acids, lcsh:Q, 0301 basic medicine, lcsh:Medicine, Medicine (all), Telaprevir, chemistry.chemical_compound, Medicine and Health Sciences, Viral, Multidisciplinary, biology, Antimicrobials, Simulation and Modeling, Drugs, Antivirals, Chemistry, Liver, Combination, Oligopeptide, Anatomy, medicine.drug, Research Article, Settore MED/17 - Malattie Infettive, General Science & Technology, Material Properties, Research and Analysis Methods, Microbial Control, Virology, Mechanical Properties, NS5A, Antiviral Agent, business.industry, HCV DAA ALT, Viral Nonstructural Protein, Organic Chemistry, Cell Biology, biology.organism_classification, Alanine transaminase, biology.protein, Hepatocytes, RNA, business
Abstract

Background Intracellular HCV-RNA reduction is a proposed mechanism of action of direct-acting antivirals (DAAs), alternative to hepatocytes elimination by pegylated-interferon plus ribavirin (PR). We modeled ALT and HCV-RNA kinetics in cirrhotic patients treated with currently-used all-DAA combinations to evaluate their mode of action and cytotoxicity compared with telaprevir (TVR)+PR. Study design Mathematical modeling of ALT and HCV-RNA kinetics was performed in 111 HCV-1 cirrhotic patients, 81 treated with all-DAA regimens and 30 with TVR+PR. Kinetic-models and Cox-analysis were used to assess determinants of ALT-decay and normalization. Results HCV-RNA kinetics was biphasic, reflecting a mean effectiveness in blocking viral production >99.8%. The first-phase of viral-decline was faster in patients receiving NS5A-inhibitors compared to TVR+PR or sofosbuvir+simeprevir (p

Published
2017

79. 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

80. 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

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

Author

Kondili, Loreta A., GAETA, Giovanni Battista, Ieluzzi, Donatella, Zignego, Anna Linda, Monti, Monica, Gori, Andrea, Soria, Alessandro, Raimondo, Giovanni, Filomia, Roberto, Leo, Alfredo Di, Iannone, Andrea, Massari, Marco, Corsini, Romina, Gulminetti, Roberto, Comini, Alberto Gatti, Toniutto, Pierluigi, Dissegna, Denis, Russo, Francesco Paolo, Zanetto, Alberto, Rumi, Maria Grazia, Brancaccio, Giuseppina, Danieli, Elena, Brunetto, Maurizia Rossana, Weimer, Liliana Elena, Quaranta, Maria Giovanna, Vella, Stefano, Puoti, Massimo, PITER Cohort Study, FEDERICO, Alessandro, Dallio, M, LOGUERCIO, Carmelina, Kondili, L, Gaeta, G, Ieluzzi, D, Zignego, A, Monti, M, Gori, A, Soria, A, Raimondo, G, Filomia, R, Leo, A, Iannone, A, Massari, M, Corsini, R, Gulminetti, R, Comini, A, Toniutto, P, Dissegna, D, Russo, F, Zanetto, A, Rumi, M, Brancaccio, G, Danieli, E, Brunetto, M, Weimer, L, Quaranta, M, Vella, S, Puoti, M, Kondili, Loreta A., Gaeta, Giovanni Battista, Ieluzzi, Donatella, Zignego, Anna Linda, Monti, Monica, Gori, Andrea, Soria, Alessandro, Raimondo, Giovanni, Filomia, Roberto, Leo, Alfredo Di, Iannone, Andrea, Massari, Marco, Corsini, Romina, Gulminetti, Roberto, Comini, Alberto Gatti, Toniutto, Pierluigi, Dissegna, Deni, Russo, Francesco Paolo, Zanetto, Alberto, Rumi, Maria Grazia, Brancaccio, Giuseppina, Danieli, Elena, Brunetto, Maurizia Rossana, Weimer, Liliana Elena, Quaranta, Maria Giovanna, Vella, Stefano, Puoti, Massimo, PITER Cohort, Study, Federico, Alessandro, Dallio, M, and Loguercio, Carmelina

Subjects
Genetics and Molecular Biology (all), Male, Cirrhosis, Disease, Hepacivirus, Toxicology, Biochemistry, Viral infection, 0302 clinical medicine, 80 and over, Medicine, Prospective Studies, Chronic, lcsh:Science, media_common, Aged, 80 and over, Liver Diseases, Drug Interaction, Italy, Adult, Aged, Antiviral Agents, Drug Administration Schedule, Drug Therapy, Combination, Female, Hepatitis C, Chronic, Humans, Interferons, Liver Cirrhosis, Middle Aged, Risk, Drug Interactions, Medicine (all), Biochemistry, Genetics and Molecular Biology (all), Agricultural and Biological Sciences (all), 030220 oncology & carcinogenesis, Interferon, 030211 gastroenterology & hepatology, Human, Cohort study, Drug, medicine.medical_specialty, media_common.quotation_subject, Drug-Drug Interactions, Gastroenterology and Hepatology, Microbiology, 03 medical and health sciences, Drug Therapy, Pharmacology, Hepaciviru, Flaviviruses, lcsh:R, Organisms, Correction, medicine.disease, Prospective Studie, Regimen, Immunology, lcsh:Q, RNA viruses, lcsh:Medicine, 030204 cardiovascular system & hematology, medicine.disease_cause, Cohort Studies, Liver disease, Drug Metabolism, Medicine and Health Sciences, 030212 general & internal medicine, Prospective cohort study, Pathology and laboratory medicine, Multidisciplinary, HCV DAA, Hepatitis C virus, Antiviral therapy, Medical microbiology, Hepatitis C, Real life data, Research Design, Combination, Viruses, Pathogens, Research Article, Liver Cirrhosi, Biology, Research and Analysis Methods, Chronic hepatitis, Internal medicine, Pharmacokinetics, In patient, Antiviral Agent, Biology and life sciences, Toxicity, business.industry, Interferon free, Viral pathogens, Hepatitis viruses, Microbial pathogens, business
Abstract

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

Published
2018

82. Steatosis in patients with HCV chronic liver disease: Baseline results from patients enrolled in the PITER cohort study

Author

L. Falzano, D. Ieluzzi, L. Nicolini, M.C. Pasetto, V. Rizzo, A. Orlandini, Cappelletti Mattia, B. Stagno, M. Borghi, M. Dallio, F.P. Russo, A. Rocco, M. Massella, L. Cavalletto, V. Donati, M. Milella, Alessia Ciancio, O. Patti, A. Mallano, D. Drenaggi, S. Petta, M.G. Faraci, P. Colombato, F. D’Aversa, Maria Giovanna Quaranta, A. Giammario, T. Tieghi, M. Margotti, S. Camera, Giulia Morsica, S. Zaltron, Mario Masarone, F. Giancotti, A. Iannone, L.E. Weimer, L. Giubilei, P. Blanc, L. Valenti, Loreta A. Kondili, L. Framarin, E.M. Erne, S. Rosato, C. Cerva, Ivan Gentile, M. Gonzo, F. Tamburrini, E. Danieli, M. Vinci, S. Storato, S. Pellicano, R. Filomia, A.R. Capitano, R. Corsini, Laura Staiano, Weimer, L. E., Falzano, L., Mallano, A., Quaranta, M. G., Massella, M., Rosato, S., Colombato, P., Giubilei, L., Ciancio, A., Iannone, A., Filomia, R., Orlandini, A., Petta, S., Tamburrini, F., Blanc, P., D’Aversa, F., Pasetto, M. C., Erne, E. M., Ieluzzi, D., Storato, S., Margotti, M., Vinci, M., Russo, F. P., Patti, O., Rizzo, V., Giammario, A., Gentile, Ivan, Donati, V., Staiano, L., Masarone, M., Cavalletto, L., Gonzo, M., Giancotti, F., Danieli, E., Corsini, R., Faraci, M. G., Valenti, L., Cappelletti, M., Camera, S., Pellicano, S., Stagno, B., Tieghi, T., Milella, M., Dallio, M., Rocco, A., Borghi, M., Drenaggi, D., Zaltron, S., Morsica, G., Framarin, L., Capitano, A. R., Cerva, C., Nicolini, L., and Kondili, L.

Subjects
medicine.medical_specialty, Hepatology, business.industry, Internal medicine, Gastroenterology, medicine, In patient, Steatosis, Chronic liver disease, medicine.disease, Baseline (configuration management), business, Cohort study
Published
2015

83. Impact of in utero environment on the offspring of lupus patients

Author

A Tincani, E Danieli, M Nuzzo, M Scarsi, M Motta, R Cimaz, A Lojacono, R Nacinovich, F Taddei, A Doria, A Brucato, P Meroni, null for the Pregnancy Study Group of Italian Society of Rheumato, Tincani, A, Danieli, E, Nuzzo, M, Scarsi, M, Motta, M, Cimaz, R, Lojacono, A, Nacinovich, R, Taddei, F, Doria, A, and Brucato, A

Subjects
Central Nervous System, Male, Pediatrics, medicine.medical_specialty, Offspring, Disease, Neuropsychological Tests, 030204 cardiovascular system & hematology, Neonatal lupus, 03 medical and health sciences, 0302 clinical medicine, Rheumatology, Pregnancy, medicine, Humans, Lupus Erythematosus, Systemic, Genetic Predisposition to Disease, skin and connective tissue diseases, Neonatal lupu, Learning disabilities, 030203 arthritis & rheumatology, Fetus, Systemic lupus erythematosus, SLE pregnancy, Immunosuppressive drug, business.industry, Antiphospholipid antibodies, Infant, Newborn, Pregnancy Outcome, Neuropsychology, Learning disabilitie, medicine.disease, Settore MED/16 - Reumatologia, Heart Block, MED/39 - NEUROPSICHIATRIA INFANTILE, In utero, Immunosuppressive drugs, Immunology, Female, business, Antiphospholipid antibodie, Psychomotor Performance
Abstract

The number of patients affected by systemic lupus erythematosus (SLE) that decide to have children has greatly increased probably because of recent improvements in the diagnosis and management of the disease. This has stimulated our interest in defining the outcome of children, focusing both on neonatal problems and long term development. SLE patients still carry a risk of pregnancy loss. However, due to careful monitoring and treatment by a multidisciplinary team, the number of losses has dramatically decreased, but an increased number of preterm deliveries is still a problem. Neonatal lupus is linked to the presence of anti-Ro/SS-A and anti-La/SS-B antibodies in the mother, although other factors probably of fetal origin are important. Neonatal lupus is a complex condition whose most serious manifestation is the congenital heart block (CHB). Usually, children with complete CHB need permanent pacing, but apparently do not have neuropsychological problems. Studies focusing on the neuropsychological development of SLE offspring show an increased number of learning disabilities in children with normal intelligence levels. Fetal consequence of maternal treatment need to be considered choosing non teratogenic drugs, but the withdrawal of medications just because the patient is pregnant should be avoided to avoid SLE flares.

Published
2006

84. Neuropsychological development of children born to patients with systemic lupus erythematosus

Author

E Danieli, L Chimini, F Neri, C. Biasini Rebaioli, F Bonomi, Andrea Lojacono, Angela Tincani, D Faden, Mario Motta, E Filippini, M Frassi, Neri, F, Chimini, L, Bonomi, F, Filippini, E, Motta, M, Faden, D, Lojacono, A, Rebaioli, C, Frassi, M, Danieli, E, and Tincani, A

Subjects
Male, Pediatrics, medicine.medical_specialty, Adolescent, learning disabilitie, Offspring, Intelligence, 030204 cardiovascular system & hematology, Neuropsychological Tests, 03 medical and health sciences, 0302 clinical medicine, Child Development, Rheumatology, Child of Impaired Parents, systemic lupus erythematosus, medicine, Humans, Lupus Erythematosus, Systemic, Prospective Studies, Prospective cohort study, Child, Wechsler Intelligence Scale for Children, 030203 arthritis & rheumatology, Pregnancy, Lupus erythematosus, Wechsler Preschool and Primary Scale of Intelligence, Intelligence quotient, business.industry, Learning Disabilities, Incidence, Adolescent Development, medicine.disease, autoantibodie, Child development, Pregnancy Complications, antiphospholipid antibodie, Child, Preschool, Antibodies, Antiphospholipid, Female, pregnancy, business
Abstract

To verify the neuropsychological development in the offspring of patients with systemic lupus erythematosus (SLE), 47 children (23 male and 24 female) from affected women were studied. The tests applied were related to the children’s ages: Griffiths scale up to four years, WPPSI and metaphonological tests (MP, evaluating the phonological consciousness) from four to six years of age, WISC-R test and Rey test (evaluating the visual-space abilities) from six years onwards; finally, specific tests for the diagnosis of learning disabilities (LD) between the ages of seven and 13. Intelligence levels were always normal (mean IQ score 106.32; median 104; SD 9.05). Three out of eight examined children failed MP, therefore may develop LD and will need further evaluation later. Fourteen children were specifically studied for LD and three reported scores lower than normal, but only two (who were brothers) were defined dyslexic. Antiphospholipid antibodies (aPL) were positive in the mothers of the three children with impaired LD tests. Other maternal autoantibodies or drugs administered during pregnancy did not seem to be related to LD. In conclusion, maternal SLE does not impair intelligence levels, but may increase the occurrence of LD particularly in male children (2/8 males examined, 25%). Both maternal aPL and genetic background may have pathogenetic implications. Lupus (2004) 13, 805–811.

Published
2004

85. Obstetrics during the French Revolution: political and medical controversies around the new obstetrical surgery.

Author

Danieli E

Abstract

During the French Revolution, obstetrics underwent substantial transformations in practice, teaching, and the physical spaces where it was conducted. The revolutionary authorities implemented reforms in French medical institutions that promoted an instrument-centred style and the dissemination of novel surgical techniques in obstetrics. The selection of professors for the obstetrics chair at the newly established École de santé and the appointment of chiefs for the new maternity ward in Paris favoured proponents of a mechanistic approach to labour assistance. This essay explores the theoretical principles and societal pressures that guided these transformative reforms and the remarkable changes they introduced in healthcare and in the practise of medicine and surgery. Furthermore, it examines the consolidation of new epistemological, ethical, and professional boundaries within the context of late eighteenth-century French obstetrics. A critical section of this study focuses on the debate ignited by the contemporaries who voiced concerns that the rise of surgical interventions on pregnant women's bodies might result in unwarranted violence, in a diminishing of midwives' roles, and in a departure from the tradition of natural childbirth. These controversies among obstetricians highlight significant contradictions within the Revolutionary medical reforms.

Published
2024
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86. Virtual Behavioural Medicine Program: A Novel Model of Care for Neuropsychiatric Symptoms in Dementia1.

Author

Freedman M, Binns MA, Serediuk F, Wolf MU, Danieli E, Pugh B, Galet D, Abdellah E, Teleg E, Halper M, Masci L, Lee A, and Kirstein A

Subjects
Emergency Service, Hospital, Hospitalization, Humans, Long-Term Care, Behavioral Medicine, Mental Disorders therapy
Abstract

Background: Patients with severe neuropsychiatric symptoms (NPS) due to dementia are often uprooted from their familiar environments in long-term care or the community and transferred to emergency departments, acute care hospitals, or specialized behavioral units which can exacerbate NPS. To address this issue, we developed the Virtual Behavioural Medicine Program (VBM), an innovative model of virtual care designed to support management of patients with NPS in their own environment., Objective: To determine efficacy of VBM in reducing admission to a specialized inpatient neurobehavioral unit for management of NPS., Methods: We reviewed outcomes in the first consecutive 95 patients referred to VBM. Referrals were classified into two groups. In one group, patients were referred to VBM with a simultaneous application to an inpatient Behavioural Neurology Unit (BNU). The other group was referred only to VBM. The primary outcome was reduction in proportion of patients requiring admission to the BNU regardless of whether they were referred to the BNU or to VBM alone., Results: For patients referred to VBM plus the BNU, the proportion needing admission to the BNU was reduced by 60.42%. For patients referred to VBM alone, it was 68.75%., Conclusion: VBM is a novel virtual neurobehavioral unit for treatment of NPS. Although the sample size was relatively small, especially for the VBM group, the data suggest that this program is a game changer that can reduce preventable emergency department visits and acute care hospital admissions. VBM is a scalable model of virtual care that can be adopted worldwide.

Published
2022
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87. Compact low-field NMR spectroscopy and chemometrics applied to the analysis of edible oils.

Author

Galvan D, Tanamati AAC, Casanova F, Danieli E, Bona E, and Killner MHM

Subjects
Least-Squares Analysis, Magnetic Resonance Spectroscopy, Reproducibility of Results, Fatty Acids, Plant Oils
Abstract

Compact nuclear magnetic resonance (NMR) spectroscopy combined with chemometric tools opens new perspectives for NMR use. This work compares the potential of 43, 60 and 400 MHz NMR spectroscopy for quality control of edible oils. Partial least squares regression (PLSR) and support vector regression (SVR) models built on the three NMR devices had equivalent performances for fatty acids and iodine value, and the models built with the low field spectra were equivalent to the high field. Moreover, performances for calibration indicated that most of the models built with medium/or high-resolution fields presented reproducibility values lower than the minimum accepted by the American Oil Chemists' Society (AOCS). Compared to classical methods, this new approach allows the application of medium resolution devices as a sample screening tool in analytical laboratories since it allows the spectrum obtention in a few seconds, without the need for sample preparation or the use of deuterated solvents., (Copyright © 2021 Elsevier Ltd. All rights reserved.)

Published
2021
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88. The DWQ-EMR Embedded Tool to Enhance the Family Physician-Caregiver Connection: A Pilot Case Study.

Author

Kokorelias KM, Danieli E, Dunn S, Feldman S, Ryan DP, and Sadavoy J

Abstract

The number of family caregivers to individuals with dementia is increasing. Family physicians are often the first point of access to the health care system for individuals with dementia and their caregivers. Caregivers are at an increased risk of developing negative physical, cognitive and affective health problems themselves. Caregivers also describe having unmet needs to help them sustain care in the community. Family physicians are in a unique position to help support caregivers and individuals with dementia, but often struggle with keeping up with best practice dementia service knowledge. The Dementia Wellness Questionnaire was designed to serve as a starting point for discussions between caregivers and family physicians by empowering caregivers to communicate their needs and concerns and to enhance family physicians' access to specific dementia support information. The DWQ aims to alert physicians of caregiver and patient needs. This pilot study aimed to explore the experiences of physicians and caregivers of people using the Questionnaire in two family medicine clinics in Ontario, Canada. Interviews with physicians and caregivers collected data on their experiences using the DWQ following a 10-month data gathering period. Data was analyzed using content analysis. Results indicated that family physicians may have an improved efficacy in managing dementia by having dementia care case specific guidelines integrated within electronic medical records. By having time-efficient access to tailored supports, family physicians can better address the needs of the caregiver-patient dyad and help support family caregivers in their caregiving role. Caregivers expressed that the Questionnaire helped them remember concerns to bring up with physicians, in order to receive help in a more efficient manner.

Published
2021
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89. Calibration Transfer of Partial Least Squares Regression Models between Desktop Nuclear Magnetic Resonance Spectrometers.

Author

Galvan D, Bona E, Borsato D, Danieli E, and Montazzolli Killner MH

Abstract

Low-field proton nuclear magnetic resonance (LF- 1 H NMR) devices based on permanent magnets are a promising analytical tool to be extensively applied to the process analytical chemistry scenario. To enhance its analytical applicability in samples where the spectral resolution is compromised, multivariate regression methods are required. However, building a robust calibration model, such as partial least squares (PLS) regression, is a laborious task because (1) the number of measurements required during the calibration process is large and (2) the procedure must be repeated when the instrument is changed or after a certain period due to the long-term stability of the instrument. Thus, the present work describes the application of calibration transfer methodologies (direct standardization (DS), piece-wise direct standardization (PDS), and double-window piece-wise direct standardization (DWPDS)) on LF- 1 H NMR to exempt the necessity of a recalibration procedure when moving from the original spectrometer to a second one with the same, lower, or higher magnetic field. These calibration transfer methodologies were tested with PLS models built on a 60 MHz (for the proton Larmor frequency) spectrometer to predict the specific gravity (SG), distillation temperature (T50%), and final boiling point (FBP) of commercial gasoline. The results showed that the DWPDS method applying only 2 to 7 transference samples enables the transference of all PLS models built on the primary instrument (60 MHz) to other (43, 60, and 80 MHz) different instruments, reaching the same RMSEP values as the primary instrument: 1.2 kg/m 3 for SG, 5.1 °C for FBP, and 1.1 °C for T50%.

Published
2020
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90. Correction: Real-life data on potential drug-drug interactions in patients with chronic hepatitis C viral infection undergoing antiviral therapy with interferon-free DAAs in the PITER Cohort Study.

Author

Kondili LA, Gaeta GB, Ieluzzi D, Zignego AL, Monti M, Gori A, Soria A, Raimondo G, Filomia R, Di Leo A, Iannone A, Massari M, Corsini R, Gulminetti R, Gatti Comini A, Toniutto P, Dissegna D, Russo FP, Zanetto A, Rumi MG, Brancaccio G, Danieli E, Brunetto MR, Weimer LE, Quaranta MG, Vella S, and Puoti M

Abstract

[This corrects the article DOI: 10.1371/journal.pone.0172159.].

Published
2018
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91. Desktop NMR spectroscopy for real-time monitoring of an acetalization reaction in comparison with gas chromatography and NMR at 9.4 T.

Author

Singh K, Danieli E, and Blümich B

Abstract

Monitoring of chemical reactions in real-time is in demand for process control. Different methods such as gas chromatography (GC), mass spectroscopy, infrared spectroscopy, and nuclear magnetic resonance (NMR) are used for that purpose. The current state-of-the-art compact NMR systems provide a useful method to employ with various reaction conditions for studying chemical reactions inside the fume hood at the chemical workplace. In the present study, an acetalization reaction was investigated with compact NMR spectroscopy in real-time. Acetalization is used for multistep synthesis of the variety of organic compounds to protect particular chemical groups. A compact 1 T NMR spectrometer with a permanent magnet was employed to monitor the acid catalyzed acetalization of the p-nitrobenzaldehyde with ethylene glycol. The concentrations of both reactant and product were followed by peak integrals in single-scan 1 H NMR spectra as a function of time. The reaction conditions were varied in terms of temperature, agitation speed, catalyst loading, and feed concentrations in order to determine the activation energy with the help of a pseudo-homogeneous kinetic model. For low molar ratios of aldehyde and glycol, the equilibrium conversions were lower than for the stoichiometric ratio. Increasing catalyst concentration leads to faster conversion. The data obtained with low-field NMR spectroscopy were compared with data from GC and NMR spectroscopy at 9.4 T acquired in batch mode by extracting samples at regular time intervals. The reaction kinetics followed by either method agreed well. The activation energies for forward and backward reactions were determined by real-time monitoring with compact NMR at 1 T were 48 ± 5 and 60 ± 4 kJ/mol, respectively. The activation energies obtained with gas chromatography for forward and backward reactions were 48 ± 4 and 51 ± 4 kJ/mol. The equilibrium constant decreases with increasing temperature as expected for an exothermic reaction. The impact of dense sampling with online NMR and sparse sampling with GC was observed on the kinetic outcome using the same kinetic model. Graphical abstract Acetalization reaction kinetics were monitored with real-time desktop NMR spectroscopy at 1 T. Each data point was obtained at regular intervals with a single shot in 15 s. The kinetics was compared with sparsely sampled data obtained with GC and NMR at 9.4 T.

Published
2017
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92. Improvement of ALT decay kinetics by all-oral HCV treatment: Role of NS5A inhibitors and differences with IFN-based regimens.

Author

Cento V, Nguyen THT, Di Carlo D, Biliotti E, Gianserra L, Lenci I, Di Paolo D, Calvaruso V, Teti E, Cerrone M, Romagnoli D, Melis M, Danieli E, Menzaghi B, Polilli E, Siciliano M, Nicolini LA, Di Biagio A, Magni CF, Bolis M, Antonucci FP, Di Maio VC, Alfieri R, Sarmati L, Casalino P, Bernardini S, Micheli V, Rizzardini G, Parruti G, Quirino T, Puoti M, Babudieri S, D'Arminio Monforte A, Andreoni M, Craxì A, Angelico M, Pasquazzi C, Taliani G, Guedj J, Perno CF, and Ceccherini-Silberstein F

Subjects
Administration, Oral, Aged, Alanine Transaminase metabolism, Antiviral Agents administration & dosage, Drug Therapy, Combination, Female, Hepacivirus genetics, Humans, Interferons pharmacology, Kinetics, Male, Middle Aged, Oligopeptides administration & dosage, Oligopeptides pharmacology, RNA, Viral blood, Ribavirin administration & dosage, Ribavirin pharmacology, Simeprevir administration & dosage, Simeprevir pharmacology, Sofosbuvir administration & dosage, Sofosbuvir pharmacology, Treatment Outcome, Alanine Transaminase blood, Antiviral Agents pharmacology, Hepatitis C drug therapy, Viral Nonstructural Proteins antagonists & inhibitors
Abstract

Background: Intracellular HCV-RNA reduction is a proposed mechanism of action of direct-acting antivirals (DAAs), alternative to hepatocytes elimination by pegylated-interferon plus ribavirin (PR). We modeled ALT and HCV-RNA kinetics in cirrhotic patients treated with currently-used all-DAA combinations to evaluate their mode of action and cytotoxicity compared with telaprevir (TVR)+PR., Study Design: Mathematical modeling of ALT and HCV-RNA kinetics was performed in 111 HCV-1 cirrhotic patients, 81 treated with all-DAA regimens and 30 with TVR+PR. Kinetic-models and Cox-analysis were used to assess determinants of ALT-decay and normalization., Results: HCV-RNA kinetics was biphasic, reflecting a mean effectiveness in blocking viral production >99.8%. The first-phase of viral-decline was faster in patients receiving NS5A-inhibitors compared to TVR+PR or sofosbuvir+simeprevir (p<0.001), reflecting higher efficacy in blocking assembly/secretion. The second-phase, noted δ and attributed to infected-cell loss, was faster in patients receiving TVR+PR or sofosbuvir+simeprevir compared to NS5A-inhibitors (0.27 vs 0.21 d-1, respectively, p = 0.0012). In contrast the rate of ALT-normalization, noted λ, was slower in patients receiving TVR+PR or sofosbuvir+simeprevir compared to NS5A-inhibitors (0.17 vs 0.27 d-1, respectively, p<0.001). There was no significant association between the second-phase of viral-decline and ALT normalization rate and, for a given level of viral reduction, ALT-normalization was more profound in patients receiving DAA, and NS5A in particular, than TVR+PR., Conclusions: Our data support a process of HCV-clearance by all-DAA regimens potentiated by NS5A-inhibitor, and less relying upon hepatocyte death than IFN-containing regimens. This may underline a process of "cell-cure" by DAAs, leading to a fast improvement of liver homeostasis.

Published
2017
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93. Real-life data on potential drug-drug interactions in patients with chronic hepatitis C viral infection undergoing antiviral therapy with interferon-free DAAs in the PITER Cohort Study.

Author

Kondili LA, Gaeta GB, Ieluzzi D, Zignego AL, Monti M, Gori A, Soria A, Raimondo G, Filomia R, Di Leo A, Iannone A, Massari M, Corsini R, Gulminetti R, Gatti Comini A, Toniutto P, Dissegna D, Russo FP, Zanetto A, Rumi MG, Brancaccio G, Danieli E, Brunetto MR, Weimer LE, Quaranta MG, Vella S, and Puoti M

Subjects
Adult, Aged, Aged, 80 and over, Drug Administration Schedule, Drug Therapy, Combination, Female, Hepacivirus, Humans, Interferons, Italy, Liver Cirrhosis chemically induced, Liver Cirrhosis complications, Male, Middle Aged, Prospective Studies, Risk, Antiviral Agents adverse effects, Antiviral Agents therapeutic use, Drug Interactions, Hepatitis C, Chronic drug therapy
Abstract

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

Published
2017
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95. [Not Available].

Author

Danieli E

Subjects
History, 20th Century, History, 21st Century, Ireland, Literature, Modern, Medicine in Literature, Psychology
Published
2016
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96. Differentiation of enantiomers by 2D NMR spectroscopy at 1 T using residual dipolar couplings.

Author

Koos MR, Danieli E, Casanova F, Blümich B, and Luy B

Abstract

Differentiating enantiomers using 2D bench-top NMR spectroscopy. Spectrometers working with permanent magnets at 1 T field strength allow the acquisition of 2D data sets. In conjunction with previously reported chiral alignment media, this setup allows the measurement of enantiomeric excess via residual dipolar couplings in stretched gelatine as a result of the reduced line width obtained by 2D J-resolved spectroscopy., (Copyright © 2015 John Wiley & Sons, Ltd.)

Published
2016
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97. Real-time reaction monitoring by ultrafast 2D NMR on a benchtop spectrometer.

Author

Gouilleux B, Charrier B, Danieli E, Dumez JN, Akoka S, Felpin FX, Rodriguez-Zubiri M, and Giraudeau P

Subjects
Catalysis, Molecular Structure, Palladium chemistry, Time Factors, Chemistry Techniques, Analytical instrumentation, Magnetic Resonance Spectroscopy
Abstract

Reaction monitoring is widely used to follow chemical processes in a broad range of application fields. Recently, the development of robust benchtop NMR spectrometers has brought NMR under the fume hood, making it possible to monitor chemical reactions in a safe and accessible environment. However, these low-field NMR approaches suffer from limited resolution leading to strong peak overlaps, which can limit their application range. Here, we propose an approach capable of recording ultrafast 2D NMR spectra on a compact spectrometer and of following in real time reactions in the synthetic chemistry laboratory. This approach--whose potential is shown here on a Heck-Matsuda reaction--is highly versatile; the duration of the measurement can be optimized to follow reactions whose time scale ranges from between a few tens of seconds to a few hours. It makes it possible to monitor complex reactions in non-deuterated solvents, and to confirm in real time the molecular structure of the compounds involved in the reaction while giving access to relevant kinetic parameters.

Published
2015
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98. [Physician literature puzzle].

Author

Danieli E

Subjects
France, History, 20th Century, History, 21st Century, Humans, Male, Literature, Modern history, Medicine in Literature, Suicide psychology
Published
2015
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99. Desktop MRI as a promising tool for mapping intra-aneurismal flow.

Author

Perlo J, Silletta EV, Danieli E, Cattaneo G, Acosta RH, Blümich B, and Casanova F

Subjects
Blood Flow Velocity, Computer Simulation, Glass, Humans, Imaging, Three-Dimensional, Metals, Phantoms, Imaging, Reproducibility of Results, Silicones chemistry, Software, Stents, Aneurysm physiopathology, Image Processing, Computer-Assisted methods, Intracranial Aneurysm physiopathology, Magnetic Resonance Imaging methods
Abstract

In this work we evaluate the performance of a 40-mm diameter bore 0.2T desktop Halbach tomograph to obtain 2D and 3D velocity maps for studying intra-aneurismal flow in the presence or absence of nitinol meshed implants with the aim of optimizing the flow diverter efficacy. Phantoms with known spatial velocity distribution were used to determine the performance of the MRI system. Maximum velocities of about 200mm/s could be measured with a precision of 1% at a spatial resolution of 0.5×0.5×1mm(3). This accuracy is suitable to evaluate in vitro intra-aneurismal flow under different conditions such as variable flow rates, different vessel-aneurysm geometry, as well as the influence of metallic flow diverters on the intra-aneurismal flow distribution. The information obtained non-invasively with desktop tomographs can be used to complement in vivo studies in order to decide the optimum flow diverter., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Published
2015
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