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3. Effects of the Emissions of Vehicles Ahead on In‐Car Exposure to Traffic‐Related Air Pollutants: A Multiple Statistical Analysis Approach.

Author

Campagnolo, Davide, Cattaneo, Andrea, Iodice, Simona, Favero, Chiara, Lioi, Simone, Boniardi, Luca, Borghi, Francesca, Fanti, Giacomo, Keller, Marta, Rovelli, Sabrina, Zellino, Carolina, De Vito, Giovanni, Spinazzè, Andrea, Fustinoni, Silvia, Bollati, Valentina, Cavallo, Domenico M., and Yang, Xiaohu

Subjects
*AUTOMOBILE emissions, *GENERALIZED estimating equations, *TRAFFIC safety, *PARTICULATE matter, *CAMCORDERS
Abstract

Traffic‐related air pollutants inside vehicle cabins are often extremely high compared to background pollution concentrations. The study of the determinants of these concentrations is particularly important for professional drivers and commuters who spend long periods in vehicles. This study is aimed at identifying and quantifying the effect of several exposure determinants on carbon monoxide (CO), equivalent black carbon (eBC), two particulate matter (PM) fractions (PM0.3–1 and PM1–2.5), and ultrafine particle (UFP) concentrations inside a passenger car cabin. The novelty of this work consists in examining the effects of the emissions of the first vehicle ahead (henceforth called "leading vehicle") on pollutant concentrations inside the cabin of the following vehicle (i.e., the car that was equipped with the air monitoring devices), with particular emphasis on the role of the leading vehicle characteristics (e.g., emission reduction technologies). The real‐time instrumentation was placed inside the cabin of a petrol passenger car, which was driven by the same operator two times per day on the same route in real driving conditions. The in‐cabin ventilation settings were set as follows: windows closed, air conditioning and recirculation modes off, and the fanned ventilation system on. The measurements were conducted over a total of 10 weekdays during two different seasons (i.e., summer and autumn). A video camera fixed to the windscreen was used to retrieve information about traffic conditions and leading vehicle characteristics through careful video analysis. The associations among pollutant concentrations and their potential determinants were evaluated using generalized estimating equation univariate and multiple models. The results confirmed the significant impact of several well‐known determinants such as seasonality, microclimatic parameters, traffic jam situations, and route characteristics. Moreover, the outcomes shed light on the key role of leading vehicle emissions as determinant factors of the pollutant concentrations inside car cabins. Indeed, in the tested cabin ventilation conditions, it was demonstrated that in‐cabin pollutant concentrations were significantly higher with leading vehicles ahead (from +14.6% to +67.5%) compared to empty road conditions, even though the introduction of newer technologies with better emissions reduction helped mitigate their effect. Additionally, diesel‐fuelled leading vehicles compared to petrol‐fuelled leading vehicles were impactful on in‐cabin CO (−7.2%) and eBC (+45.3%) concentrations. An important effect (+30.4%) on in‐vehicle PM1–2.5 concentrations was found with heavy‐duty compared to light‐duty leading vehicles. Finally, this research pointed out that road‐scale factors are more important determinant factors of in‐cabin concentrations than local pollution and meteorological conditions. [ABSTRACT FROM AUTHOR]

Published
2024
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4. First in-Lab Testing of a Cost-Effective Prototype for PM 2.5 Monitoring: The P.ALP Assessment.

Author

Fanti, Giacomo, Borghi, Francesca, Wolfe, Cody, Campagnolo, Davide, Patts, Justin, Cattaneo, Andrea, Spinazzè, Andrea, Cauda, Emanuele, and Cavallo, Domenico Maria

Subjects
AIR pollution, AIR quality, DATA warehousing, REGRESSION analysis, LINEAR statistical models, BLAND-Altman plot
Abstract

The goal of the present research was to assess, under controlled laboratory conditions, the accuracy and precision of a prototype device (named 'P.ALP': Ph.D. Air-quality Low-cost Project) developed for PM2.5 concentration level monitoring. Indeed, this study follows a complementary manuscript (previously published) focusing on the in-field evaluation of the device's performance. Four P.ALP prototypes were co-located with the reference instrument in a calm-air aerosol chamber at the NIOSH laboratories in Pittsburgh, PA (USA), used by the Center for Direct Reading and Sensor Technologies. The devices were tested for 10 monitoring days under several exposure conditions. To evaluate the performance of the prototypes, different approaches were employed. After the data from the devices were stored and prepared for analysis, to assess the accuracy (comparing the reference instrument with the prototypes) and the precision (comparing all the possible pairs of devices) of the P.ALPs, linear regression analysis was performed. Moreover, to find out the applicability field of this device, the US EPA's suggested criteria were adopted, and to assess error trends of the prototype in the process of data acquisition, Bland–Altman plots were built. The findings show that, by introducing ad hoc calibration factors, the P.ALP's performance needs to be further implemented, but the device can monitor the concentration trend variations with satisfying accuracy. Overall, the P.ALP can be involved in and adapted to a wide range of applications because of the inexpensive nature of the components, the small dimensions, and the high data storage capacity. [ABSTRACT FROM AUTHOR]

Published
2024
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5. Exposure to airborne particulate matter in working from office and working from home employees

Author

Borghi, Francesca, primary, Spinazzè, Andrea, additional, Fanti, Giacomo, additional, Albareda, Angelica, additional, Ghiraldini, Jacopo, additional, Campagnolo, Davide, additional, Carminati, Alessio, additional, Keller, Marta, additional, Rovelli, Sabrina, additional, Zellino, Carolina, additional, Giovanni, De Vito, additional, Cattaneo, Andrea, additional, and Cavallo, Domenico Maria, additional

Published
2024
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7. Influence of Time–Activity Patterns on Indoor Air Quality in Italian Restaurant Kitchens.

Author

Keller, Marta, Campagnolo, Davide, Borghi, Francesca, Carminati, Alessio, Fanti, Giacomo, Rovelli, Sabrina, Zellino, Carolina, Del Vecchio, Rocco Loris, De Vito, Giovanni, Spinazzé, Andrea, Mihucz, Viktor Gábor, Dossi, Carlo, Carrieri, Mariella, Cattaneo, Andrea, and Cavallo, Domenico Maria

Subjects
*INDOOR air quality, *SURFACE cleaning, *HAND washing, *DISHWASHING liquids, *VOLATILE organic compounds
Abstract

This study aims to delve deeper into the relationship between the professional activities carried out in restaurant kitchens and some key air pollutants. The ultrafine particles (UFPs), nitrogen dioxide (NO2), ozone (O3), Total Volatile Organic Compounds (TVOCs) and formaldehyde (HCHO) indoor air concentrations were determined using real-time monitors. Simultaneously, the kitchen environment was characterized using video recordings with the aim to retrieve information pertaining to cooking, cookware washing and surface cleaning activities. Statistical analysis was carried out separately for the winter and summer campaigns. The obtained results confirmed that the professional activities carried out in restaurant kitchens had a significant impact on the concentrations of all the selected pollutants. Specifically, this study revealed the following key results: (i) indoor UFPs and NO2 concentrations were significantly higher during cooking than during washing activities (e.g., about +60% frying vs. handwashing and dishwasher running), mainly in the winter; (ii) washing activity had a statistically significant impact on the TVOC (+39% on average) and HCHO (+67% on average) concentrations compared to other activities; (iii) some specific sources of short-term pollutant emissions have been identified, such as the different types of cooking and opening the dishwasher; and (iv) in some restaurants, a clear time-dependent relationship between O3 and UFP, TVOC and HCHO has been observed, underlining the occurrence of ozonolysis reactions. [ABSTRACT FROM AUTHOR]

Published
2024
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9. An In-Field Assessment of the P.ALP Device in Four Different Real Working Conditions: A Performance Evaluation in Particulate Matter Monitoring.

Author

Fanti, Giacomo, Borghi, Francesca, Campagnolo, Davide, Rovelli, Sabrina, Carminati, Alessio, Zellino, Carolina, Cattaneo, Andrea, Cauda, Emanuele, Spinazzè, Andrea, and Cavallo, Domenico Maria

Subjects
BLAND-Altman plot, PARTICULATE matter, JOB performance, DATA scrubbing, AIR quality, DATA warehousing, SHARED workspaces
Abstract

This study aimed to assess the performance, in terms of precision and accuracy, of a prototype (called "P.ALP"—Ph.D. Air Quality Low-cost Project) developed for monitoring PM2.5 concentration levels. Four prototypes were co-located with reference instrumentation in four different microenvironments simulating real-world and working conditions, namely (i) office, (ii) home, (iii) outdoor, and (iv) occupational environments. The devices were evaluated for a total of 20 monitoring days (approximately 168 h) under a wide range of PM2.5 concentrations. The performances of the prototypes (based on the light-scattering working principle) were tested through different statistical methods. After the data acquisition and data cleaning processes, a linear regression analysis was performed to assess the precision (by comparing all possible pairs of devices) and the accuracy (by comparing the prototypes against the reference instrumentation) of the P.ALP. Moreover, the United States Environmental Protection Agency (US EPA) criteria were applied to assess the possible usage of this instrumentation, and to evaluate the eventual error trends of the P.ALP in the data storage process, Bland–Altman plots were also adopted. The outcomes of this study underlined that the P.ALP performed differently depending on the microenvironment in which it was tested and, consequently, on the PM2.5 concentrations. The device can monitor PM2.5 variations with acceptable results, but the performance cannot be considered satisfactory at extremely low and remarkably high PM2.5 concentrations. Thanks to modular components and open-source software, the tested device has the potential to be customized and adapted to better fit specific study design needs, but it must be implemented with ad hoc calibration factors depending on the application before being used in field. [ABSTRACT FROM AUTHOR]

Published
2024
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10. 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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12. VOCs and aldehydes source identification in European office buildings - The OFFICAIR study

Author

Campagnolo, Davide, Saraga, Dikaia E., Cattaneo, Andrea, Spinazzè, Andrea, Mandin, Corinne, Mabilia, Rosanna, Perreca, Erica, Sakellaris, Ioannis, Canha, Nuno, Mihucz, Victor G., Szigeti, Tamás, Ventura, Gabriela, Madureira, Joana, de Oliveira Fernandes, Eduardo, de Kluizenaar, Yvonne, Cornelissen, Eric, Hänninen, Otto, Carrer, Paolo, Wolkoff, Peder, Cavallo, Domenico M., and Bartzis, John G.

Published
2017
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13. Multi-proxy signatures in deep-water fine-grained sediments: Inherited versus syn-sedimentary factors controlling sediment compositions within a foredeep basin (Paleogene Adriatic foredeep – Northern Italy)

Author

Di Capua, A, Miano, S, Campagnolo, D, Bonomo, S, Caruso, A, Carugati, G, Cavallo, A, Livio, F, Vezzoli, G, Di Capua, Andrea, Miano, Samuele, Campagnolo, Davide, Bonomo, Sergio, Caruso, Antonio, Carugati, Gabriele, Cavallo, Alessandro, Livio, Franz A., Vezzoli, Giovanni, Di Capua, A, Miano, S, Campagnolo, D, Bonomo, S, Caruso, A, Carugati, G, Cavallo, A, Livio, F, Vezzoli, G, Di Capua, Andrea, Miano, Samuele, Campagnolo, Davide, Bonomo, Sergio, Caruso, Antonio, Carugati, Gabriele, Cavallo, Alessandro, Livio, Franz A., and Vezzoli, Giovanni

Abstract

This work explores the significance of sedimentary proxies recorded within the Paleogene fine-grained detritus of the Adriatic foredeep (Northern Italy). Such sequences represent the only sedimentary record describing the source-to-sink system delivering detritus from the growing Alpine belt to the basin during the Eocene – Oligocene boundary. The combination of x-ray powder diffractometric, petrographic, SEM-EDS and biostratigraphic analyses on more than twenty samples from the Ternate-Travedona Formation, the Chiasso Formation, and the Villa Olmo Conglomerate allowed to identify the source areas of detritus and potential fluvial paleo-drainages, possibly ascribable to two different sectors of the Southalpine domain. Comparison between these results and the petrographic composition of the Cretaceous wedge in the same area opens to the possibility that Cenozoic drainages were inherited from more limited paleo-drainages developed during the end of the Mesozoic. Results of provenance analysis also gives new insights on how detrital compositions may vary in function of grain-size in tropical-subtropical environments.

Published
2023

14. Occupational Exposure to Halogenated Anaesthetic Gases in Hospitals: A Systematic Review of Methods and Techniques to Assess Air Concentration Levels

Author

Keller, Marta, primary, Cattaneo, Andrea, additional, Spinazzè, Andrea, additional, Carrozzo, Letizia, additional, Campagnolo, Davide, additional, Rovelli, Sabrina, additional, Borghi, Francesca, additional, Fanti, Giacomo, additional, Fustinoni, Silvia, additional, Carrieri, Mariella, additional, Moretto, Angelo, additional, and Cavallo, Domenico Maria, additional

Published
2022
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20. How to obtain large amounts of location- and time-specific PM2.5 with homogeneous mass and composition? A possible approach, from particulate collection to chemical characterization

Author

Rovelli, Sabrina, primary, Cattaneo, Andrea, additional, Binda, Gilberto, additional, Borghi, Francesca, additional, Spinazzè, Andrea, additional, Campagnolo, Davide, additional, Keller, Marta, additional, Fanti, Giacomo, additional, Ferrari, Luca, additional, Biggeri, Annibale, additional, Monticelli, Damiano, additional, Fermo, Paola, additional, Bollati, Valentina, additional, and Cavallo, Domenico M., additional

Published
2021
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32. Applicazione della norma UNI EN 689:2019 per la valutazione dell'esposizione occupazionale ad agenti chimici: caso-studio in una fonderia

Author

Keller, M, Rovelli, S, Bonacina, F, Campagnolo, D, Fanti, G, Spinazzè, A, Borghi, F, Recchia, S, Cattaneo, A, De Vito, G, Cavallo, D, Keller, Marta, Rovelli, Sabrina, Bonacina, Fabio, Campagnolo, Davide, Fanti, Giacomo, Spinazzè, Andrea, Borghi, Francesca, Recchia, Sandro, Cattaneo, Andrea, De Vito, Giovanni, Cavallo, Domenico M., Keller, M, Rovelli, S, Bonacina, F, Campagnolo, D, Fanti, G, Spinazzè, A, Borghi, F, Recchia, S, Cattaneo, A, De Vito, G, Cavallo, D, Keller, Marta, Rovelli, Sabrina, Bonacina, Fabio, Campagnolo, Davide, Fanti, Giacomo, Spinazzè, Andrea, Borghi, Francesca, Recchia, Sandro, Cattaneo, Andrea, De Vito, Giovanni, and Cavallo, Domenico M.

Published
2021

33. Exposure to airborne particles associated with the handling of graphene nanoplatelets

Author

Spinazzè, Andrea, Cattaneo, Andrea, Borghi, Francesca, DEL BUONO, Luca, Campagnolo, Davide, Rovelli, Sabrina, and Cavallo, Domenico M.

Subjects
Inhalation Exposure, Occupational Exposure, graphene, Humans, Nanoparticles, Original Article, Graphite, Air Pollutants, Occupational, Respiratory Protective Devices, Nanomaterial, occupational exposure
Abstract

Background: It is recognized that engineering control measures are needed to reduce occupational exposure to engineered nanomaterials (NMs): of these, fume hoods are among the most widespread collective protection equipment used while handling NMs in occupational settings. It is known that in some circumstances, handling NMs in fume hoods can result in a significant release of NMs. Objective: To assess the effectiveness of fume hoods in reducing exposure while handling graphene nanoplatelets and to define the conditions that result in a lower dispersion of particles and thus less operator exposure. Methods: An experimental protocol was established to monitor the variations of airborne particle concentrations while handling graphene in fume hoods (transferring and pouring). The measurement locations were at the laboratory, inside the hood and at operator’s breathing zone. Handling tasks were performed under different operating conditions: the variable factors included hood face velocity and sash height. Results: Results of this study indicate that the handling of graphene nanoplatelets may pose a potential risk of contamination of the work environment and hence exposure of the involved operators, if adequate control measures are not taken. In fact, when inadequate or not sufficiently cautionary operational conditions were utilized, non-negligible increases in airborne graphene particle concentrations during the nanomaterial manipulation phases were observed. Conclusions: Some operating conditions (e.g., face velocity, sash height) can be adjusted to avoid relevant personal exposure conditions and contamination of the work environment by NMs, thus ensuring safer conditions.

Published
2018

41. 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

44. Indoor gaseous air pollutants determinants in office buildings—The OFFICAIR project

Author

Spinazzè, Andrea, primary, Campagnolo, Davide, additional, Cattaneo, Andrea, additional, Urso, Patrizia, additional, Sakellaris, Ioannis A., additional, Saraga, Dikaia E., additional, Mandin, Corinne, additional, Canha, Nuno, additional, Mabilia, Rosanna, additional, Perreca, Erica, additional, Mihucz, Victor G., additional, Szigeti, Tamás, additional, Ventura, Gabriela, additional, Oliveira Fernandes, Eduardo, additional, Kluizenaar, Yvonne, additional, Cornelissen, Eric, additional, Hänninen, Otto, additional, Carrer, Paolo, additional, Wolkoff, Peder, additional, Cavallo, Domenico M., additional, and Bartzis, John G., additional

Published
2019
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48. Safety and efficacy of ombitasvir/paritaprevir/ritonavir/dasabuvir plus ribavirin in patients over 65 years with HCV genotype 1 cirrhosis

Author

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, Gasbarrini, Antonio (ORCID:0000-0002-7278-4823), Cauda, Roberto (ORCID:0000-0002-1498-4229), de Luca, Andrea (ORCID:0000-0002-8311-6935), Grieco, Antonio (ORCID:0000-0002-0544-8993), Miele, Luca (ORCID:0000-0003-3464-0068), Rapaccini, Gian Ludovico (ORCID:0000-0002-6467-857X), 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, Gasbarrini, Antonio (ORCID:0000-0002-7278-4823), Cauda, Roberto (ORCID:0000-0002-1498-4229), de Luca, Andrea (ORCID:0000-0002-8311-6935), Grieco, Antonio (ORCID:0000-0002-0544-8993), Miele, Luca (ORCID:0000-0003-3464-0068), and Rapaccini, Gian Ludovico (ORCID:0000-0002-6467-857X)

Abstract

Purpose: To analyse safety and efficacy of treatment based on ombitasvir/paritaprevir/ritonavir/dasabuvir plus ribavirin in the sub-group of GT1 patients older than 65 years. Methods: We collected data extracted from the ABACUS compassionate-use nationwide Italian programme, in patients with cirrhosis due to hepatitis C virus (HCV) Genotype-1 (GT1) or 4 and at high risk of decompensation. GT1-HCV-infected patients received once-daily ombitasvir/paritaprevir, with the pharmacokinetic enhancer ritonavir (25/150/100 mg) and twice-daily dasabuvir (250 mg) plus Ribavirin (RBV) (OBV/PTV/r + DSV + RBV) for 12 (GT1b) or 24 (GT1a) weeks. Endpoints were to evaluate safety and efficacy, the latter defined as HCV RNA negative 12 weeks after the end of treatment (SVR12). Results: Patients who suffered any adverse event (AE) were 74/240 (30.8%); 13/240 (5.4%) discontinued the treatment. A multivariate analysis found albumin < 3.5 g/dL (OR 2.04: 95% CI 1.0–4.2, p < 0.05) and hypertension (OR 4.6: 95% CI 2.3–9.2, p < 0.001) as variables independently associated with AE occurrence. The SVR12 was 95% (228/240). Multivariate analysis identified baseline bilirubin < 2 mg/dL (OR 4.9: 95% CI 1.17–20.71, p = 0.029) as the only variable independently associated with SVR12. Conclusion: Our findings suggest that OBV/PTV/r + DSV + RBV is safe and effective in real-life use in patients with compensated cirrhosis, HCV-GT1 infection, and age over 65.

Published
2018

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