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2. Sarilumab in patients admitted to hospital with severe or critical COVID-19: a randomised, double-blind, placebo-controlled, phase 3 trial

Author

Bazzalo, Ignacio J., Casas, Marcelo M., Nuñez, Sebastián A., Pere, Yael, Ibarrola, Carlos M., Solis Aramayo, Marco A., Cuesta, Maria C., Duarte, Andrea E., Gutierrez Fernandez, Pablo M., Iannantuono, Maria A., Miyazaki, Erica A., Silvio, Javier P., Scublinsky, Dario G., Bales, Alessandra, Catarino, Daniela, Fiss, Elie, Mohrbacher, Sara, Sato, Victor, Baylao, Antonio, Cavalcante, Adilson, Correa, Francini, de Andrade, Celso A., Furtado, Juvencio, Ribeiro Filho, Nelson, Telles, Valéria, Trevelin, Leopoldo T., Vipich, Ricardo, Boldo, Rodrigo, Borges, Paula, Lobo, Suzana, Luckemeyer, Graziela, Machado, Luana, Alves, Maysa B., Iglessias, Ana C., Lago, Marianna M., Santos, Daniel W., Chapdelaine, Hugo, Falcone, Emilia L., Jamal, Rahima, Luong, Me-Linh, Durand, Madeleine, Doucet, Stephane, Carrier, François-Martin, Coburn, Bryan A., Del Sorbo, Lorenzo, Walmsley, Sharon L., Belga, Sara, Chen, Luke Y., Mah, Allison D., Steiner, Theodore, Wright, Alissa J., Hajek, J., Adhikari, Neill, Fowler, Robert A., Daneman, Nick, Khwaja, Kosar A., Shahin, Jason, Gonzalez, Carolina, Silva, Rafael, Lindh, Marcelo, Maluenda, Gabriel, Fernandez, Patricia, Oyonarte, Maite, Lasso, Martin, Boyer, Alexandre, Bronnimann, Didier, Bui, Hoang-Nam, Cazanave, Charles, Chaussade, Helene, Desclaux, Arnaud, Ducours, Mailys, Duvignaud, Alexandre, Malvy, Denis, Martin, Lisa, Neau, Didier, Nguyen, Duc, Pistone, Thierry, Soubrane-Wirth, Gaetane, Leitao, Julie, Allavena, Clotilde, Biron, Charlotte, Bouchez, Sabelline, Gaborit, Benjamin, Gregoire, Antoine, Le Turnier, Paul, Lecompte, Anne-Sophie, Lecomte, Raphael, Lefebvre, Maeva, Raffi, Francois, Boutoille, David, Morineau, Pascale H., Guéry, Romain, Chatelus, Emmanuel, Dumoussaud, Nathalie, Felten, Renaud, Luca, Florina, Goichot, Bernard, Schneider, Francis, Taquet, Marie-Caroline, Groh, Matthieu, Roumier, Mathilde, Neuville, Mathilde, Bachelard, Antoine, Isernia, Valentina, Lescure, F-Xavier, Phung, Bao-Chau, Rachline, Anne, Sautereau, Aurelie, Vallois, Dorothee, Bleher, Yves, Boucher, Delphine, Coudon, Clémentine, Esnault, Jean, Guimard, Thomas, Leautez-Nainville, Sophie, Merrien, Dominique, Morrier, Marine, Motte-Vincent, Pauline, Gabeff, Romain, Leclerc, Hélène, Cozic, Céline, Decours, Romain, Février, Ronan, Colin, Gwenhael, Abgrall, Sophie, Vignes, Dorothee, Sterpu, Raluca, Kuellmar, Mira, Meersch-Dini, Melanie, Weiss, Raphael, Zarbock, Alexander, Antony, Christiane, Berger, Marc, Brenner, Thorsten, Taube, Christian, Herbstreit, Frank, Dolff, Sebastian, Konik, Margarethe, Schmidt, Karsten, Zettler, Markus, Witzke, Oliver, Boell, Boris, Garcia Borrega, Jorge, Koehler, Philipp, Zander, Thomas, Dusse, Fabian, Al-Sawaf, Othman, Köhler, Philipp, Eichenauer, Dennis, Kochanek, Matthias, Shimabukuro-Vornhagen, Alexander, Mellinghoff, Sibylle, Claßen, Annika, Heger, Jan-Michel, Meyer-Schwickerath, Charlotte, Liedgens, Paul, Heindel, Katrin, Belkin, Ana, Biber, Asaf, Gilboa, Mayan, Levy, Itzchak, Litachevsky, Vladislav, Rahav, Galia, Finesod Wiedner, Anat, Zilberman-Daniels, Tal, Oster, Yonatan, Strahilevitz, Jacob, Sviri, Sigal, Baldissera, Elena M., Campochiaro, Corrado, Cavalli, Giulio, Dagna, Lorenzo, De Luca, Giacomo, Della Torre, Emanuel, Tomelleri, Alessandro, Bernasconi De Luca, Davide, Capetti, Amedeo F., Coen, Massimo, Cossu, Maria V., Galli, Massimo, Giacomelli, Andrea, Gubertini, Guido A., Rusconi, Stefano, Burastero, Giulia J., Digaetano, Margherita, Guaraldi, Giovanni, Meschiari, Marianna, Mussini, Cristina, Puzzolante, Cinzia, Volpi, Sara, Aiello, Marina, Ariani, Alarico, Chetta, Alfredo A., Frizzelli, Annalisa, Ticinesi, Andrea, Tuttolomondo, Domenico, Aliberti, Stefano, Blasi, Francesco B., Di Pasquale, Marta F., Misuraca, Sofia, Pilocane, Tommaso, Simonetta, Edoardo, Aghelmo, Alessio M., Angelini, Claudio, Brunetta, Enrico, Canonica, Giorgio W., Ciccarelli, Michele, Dal Farra, Sara, De Santis, Maria, Ferri, Sebastian, Folci, Marco, Guidelli, Giacomo M., Heffler, Enrico M., Loiacono, Ferdinando, Malipiero, Giacomo, Paoletti, Giovanni, Pedale, Rosa, Puggioni, Francesca A., Racca, Francesca, Zumbo, Aurora, Satou, Morihiko, Honda, Hitoshi, Lisun, Tatyana, Protsenko, Denis, Rubtsov, Nikolay, Beloglazova, Irina, Fomina, Daria, Lysenko, Mariana, Serdotetskova, Sofia, Firstov, Vitali, Gordeev, Ivan, Kokorin, Ilia, Komissarova, Ksenia, Lapochkina, Nina, Luchinkina, Elena, Malimon, Valentin, Mamedguseyinova, Sevinch, Polubatonova, Ksenia, Suvorova, Natalia, Arribas, Jose, Borobia Perez, Alberto M., de la Calle Prieto, Fernando, Figueira, Juan Carlos, Motejano Sanchez, Rocio, Mora-Rillo, Marta, Prados Sanchez, Concepcion, Queiruga Parada, Javier, Fernandez Arnalich, Francisco, Guerro Barrientos, Maria, Bendala Estrada, Alejandro, Caballero Marcos, Aranzazu, Garcia Leoni, Maria E., García-Martínez, Rita, Collado, Ana María, Munoz Garcia, Patricia, Torres do Rego, Ana, Villalba García, María V., Burrillo, Almudena, Valerio Minero, Maricela, Gijon Vidaurreta, Paloma, Infante Herrero, Sonsoles, Velilla, Elena, Machado, Marina, Olmedo, Maria, Pinilla, Blanca, Almirante Gragera, Benito, Cañas Ruano, Maria de la Esperanza, Contreras Medina, Sofia, Cortés Herrera, Alejandro, Falcó Ferrer, Vicenç, Ferrer Roca, Ricard, Nuvials Casals, Xavier, Ribera Pascuet, Esteve, Suanzes Diez, Paula, Rebollo Castro, Pedro, Garcia Alcaide, Felipe, Soriano, Alejandro, Oliver Caldes, Aina, González Cordón, Ana, Cardozo, Celia, De la Mora Cañizo, Lorena, Pena López, Romina, Chamorro, Sandra, Crespillo-Andujar, Clara, Escudero Sanchez, Rosa, Fortún-Abete, Jesús, Monge-Maillo, Begoña, Moreno Zamora, Ana, Norman, Francesca, Sanchez Conde, Matilde, Serrano Villar, Sergio, Vizcarra, Pilar, Lescure, François-Xavier, Fowler, Robert A, Lazar, Jennifer Sloane, Shi, Genming, Wung, Peter, Patel, Naimish, and Hagino, Owen

Published
2021
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5. Decay rate of antiS1/S2 IgG serum levels after 6 months of BNT162b2 vaccination in a cohort of COVID-19-naive and COVID-19-experienced subjects

Author

Borgonovo, Fabio, primary, Stangalini, Carlo Alberto, additional, Tinelli, Carmine, additional, Mariani, Chiara, additional, Mileto, Davide, additional, Cossu, Maria Vittoria, additional, Abbati, Laura, additional, Bilardo, Lara, additional, Gagliardi, Gloria, additional, Cutrera, Miriam, additional, Pellicciotta, Martina, additional, Armiento, Luciana, additional, Dedivitiis, Gianfranco, additional, Capetti, Amedeo F., additional, and Rizzardini, Giuliano, additional

Published
2022
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8. Sarilumab in patients admitted to hospital with severe or critical COVID-19: a randomised, double-blind, placebo-controlled, phase 3 trial

Author

Lescure, François-Xavier, primary, Honda, Hitoshi, additional, Fowler, Robert A, additional, Lazar, Jennifer Sloane, additional, Shi, Genming, additional, Wung, Peter, additional, Patel, Naimish, additional, Hagino, Owen, additional, Bazzalo, Ignacio J., additional, Casas, Marcelo M., additional, Nuñez, Sebastián A., additional, Pere, Yael, additional, Ibarrola, Carlos M., additional, Solis Aramayo, Marco A., additional, Cuesta, Maria C., additional, Duarte, Andrea E., additional, Gutierrez Fernandez, Pablo M., additional, Iannantuono, Maria A., additional, Miyazaki, Erica A., additional, Silvio, Javier P., additional, Scublinsky, Dario G., additional, Bales, Alessandra, additional, Catarino, Daniela, additional, Fiss, Elie, additional, Mohrbacher, Sara, additional, Sato, Victor, additional, Baylao, Antonio, additional, Cavalcante, Adilson, additional, Correa, Francini, additional, de Andrade, Celso A., additional, Furtado, Juvencio, additional, Ribeiro Filho, Nelson, additional, Telles, Valéria, additional, Trevelin, Leopoldo T., additional, Vipich, Ricardo, additional, Boldo, Rodrigo, additional, Borges, Paula, additional, Lobo, Suzana, additional, Luckemeyer, Graziela, additional, Machado, Luana, additional, Alves, Maysa B., additional, Iglessias, Ana C., additional, Lago, Marianna M., additional, Santos, Daniel W., additional, Chapdelaine, Hugo, additional, Falcone, Emilia L., additional, Jamal, Rahima, additional, Luong, Me-Linh, additional, Durand, Madeleine, additional, Doucet, Stephane, additional, Carrier, François-Martin, additional, Coburn, Bryan A., additional, Del Sorbo, Lorenzo, additional, Walmsley, Sharon L., additional, Belga, Sara, additional, Chen, Luke Y., additional, Mah, Allison D., additional, Steiner, Theodore, additional, Wright, Alissa J., additional, Hajek, J., additional, Adhikari, Neill, additional, Fowler, Robert A., additional, Daneman, Nick, additional, Khwaja, Kosar A., additional, Shahin, Jason, additional, Gonzalez, Carolina, additional, Silva, Rafael, additional, Lindh, Marcelo, additional, Maluenda, Gabriel, additional, Fernandez, Patricia, additional, Oyonarte, Maite, additional, Lasso, Martin, additional, Boyer, Alexandre, additional, Bronnimann, Didier, additional, Bui, Hoang-Nam, additional, Cazanave, Charles, additional, Chaussade, Helene, additional, Desclaux, Arnaud, additional, Ducours, Mailys, additional, Duvignaud, Alexandre, additional, Malvy, Denis, additional, Martin, Lisa, additional, Neau, Didier, additional, Nguyen, Duc, additional, Pistone, Thierry, additional, Soubrane-Wirth, Gaetane, additional, Leitao, Julie, additional, Allavena, Clotilde, additional, Biron, Charlotte, additional, Bouchez, Sabelline, additional, Gaborit, Benjamin, additional, Gregoire, Antoine, additional, Le Turnier, Paul, additional, Lecompte, Anne-Sophie, additional, Lecomte, Raphael, additional, Lefebvre, Maeva, additional, Raffi, Francois, additional, Boutoille, David, additional, Morineau, Pascale H., additional, Guéry, Romain, additional, Chatelus, Emmanuel, additional, Dumoussaud, Nathalie, additional, Felten, Renaud, additional, Luca, Florina, additional, Goichot, Bernard, additional, Schneider, Francis, additional, Taquet, Marie-Caroline, additional, Groh, Matthieu, additional, Roumier, Mathilde, additional, Neuville, Mathilde, additional, Bachelard, Antoine, additional, Isernia, Valentina, additional, Lescure, F-Xavier, additional, Phung, Bao-Chau, additional, Rachline, Anne, additional, Sautereau, Aurelie, additional, Vallois, Dorothee, additional, Bleher, Yves, additional, Boucher, Delphine, additional, Coudon, Clémentine, additional, Esnault, Jean, additional, Guimard, Thomas, additional, Leautez-Nainville, Sophie, additional, Merrien, Dominique, additional, Morrier, Marine, additional, Motte-Vincent, Pauline, additional, Gabeff, Romain, additional, Leclerc, Hélène, additional, Cozic, Céline, additional, Decours, Romain, additional, Février, Ronan, additional, Colin, Gwenhael, additional, Abgrall, Sophie, additional, Vignes, Dorothee, additional, Sterpu, Raluca, additional, Kuellmar, Mira, additional, Meersch-Dini, Melanie, additional, Weiss, Raphael, additional, Zarbock, Alexander, additional, Antony, Christiane, additional, Berger, Marc, additional, Brenner, Thorsten, additional, Taube, Christian, additional, Herbstreit, Frank, additional, Dolff, Sebastian, additional, Konik, Margarethe, additional, Schmidt, Karsten, additional, Zettler, Markus, additional, Witzke, Oliver, additional, Boell, Boris, additional, Garcia Borrega, Jorge, additional, Koehler, Philipp, additional, Zander, Thomas, additional, Dusse, Fabian, additional, Al-Sawaf, Othman, additional, Köhler, Philipp, additional, Eichenauer, Dennis, additional, Kochanek, Matthias, additional, Shimabukuro-Vornhagen, Alexander, additional, Mellinghoff, Sibylle, additional, Claßen, Annika, additional, Heger, Jan-Michel, additional, Meyer-Schwickerath, Charlotte, additional, Liedgens, Paul, additional, Heindel, Katrin, additional, Belkin, Ana, additional, Biber, Asaf, additional, Gilboa, Mayan, additional, Levy, Itzchak, additional, Litachevsky, Vladislav, additional, Rahav, Galia, additional, Finesod Wiedner, Anat, additional, Zilberman-Daniels, Tal, additional, Oster, Yonatan, additional, Strahilevitz, Jacob, additional, Sviri, Sigal, additional, Baldissera, Elena M., additional, Campochiaro, Corrado, additional, Cavalli, Giulio, additional, Dagna, Lorenzo, additional, De Luca, Giacomo, additional, Della Torre, Emanuel, additional, Tomelleri, Alessandro, additional, Bernasconi De Luca, Davide, additional, Capetti, Amedeo F., additional, Coen, Massimo, additional, Cossu, Maria V., additional, Galli, Massimo, additional, Giacomelli, Andrea, additional, Gubertini, Guido A., additional, Rusconi, Stefano, additional, Burastero, Giulia J., additional, Digaetano, Margherita, additional, Guaraldi, Giovanni, additional, Meschiari, Marianna, additional, Mussini, Cristina, additional, Puzzolante, Cinzia, additional, Volpi, Sara, additional, Aiello, Marina, additional, Ariani, Alarico, additional, Chetta, Alfredo A., additional, Frizzelli, Annalisa, additional, Ticinesi, Andrea, additional, Tuttolomondo, Domenico, additional, Aliberti, Stefano, additional, Blasi, Francesco B., additional, Di Pasquale, Marta F., additional, Misuraca, Sofia, additional, Pilocane, Tommaso, additional, Simonetta, Edoardo, additional, Aghelmo, Alessio M., additional, Angelini, Claudio, additional, Brunetta, Enrico, additional, Canonica, Giorgio W., additional, Ciccarelli, Michele, additional, Dal Farra, Sara, additional, De Santis, Maria, additional, Ferri, Sebastian, additional, Folci, Marco, additional, Guidelli, Giacomo M., additional, Heffler, Enrico M., additional, Loiacono, Ferdinando, additional, Malipiero, Giacomo, additional, Paoletti, Giovanni, additional, Pedale, Rosa, additional, Puggioni, Francesca A., additional, Racca, Francesca, additional, Zumbo, Aurora, additional, Satou, Morihiko, additional, Lisun, Tatyana, additional, Protsenko, Denis, additional, Rubtsov, Nikolay, additional, Beloglazova, Irina, additional, Fomina, Daria, additional, Lysenko, Mariana, additional, Serdotetskova, Sofia, additional, Firstov, Vitali, additional, Gordeev, Ivan, additional, Kokorin, Ilia, additional, Komissarova, Ksenia, additional, Lapochkina, Nina, additional, Luchinkina, Elena, additional, Malimon, Valentin, additional, Mamedguseyinova, Sevinch, additional, Polubatonova, Ksenia, additional, Suvorova, Natalia, additional, Arribas, Jose, additional, Borobia Perez, Alberto M., additional, de la Calle Prieto, Fernando, additional, Figueira, Juan Carlos, additional, Motejano Sanchez, Rocio, additional, Mora-Rillo, Marta, additional, Prados Sanchez, Concepcion, additional, Queiruga Parada, Javier, additional, Fernandez Arnalich, Francisco, additional, Guerro Barrientos, Maria, additional, Bendala Estrada, Alejandro, additional, Caballero Marcos, Aranzazu, additional, Garcia Leoni, Maria E., additional, García-Martínez, Rita, additional, Collado, Ana María, additional, Munoz Garcia, Patricia, additional, Torres do Rego, Ana, additional, Villalba García, María V., additional, Burrillo, Almudena, additional, Valerio Minero, Maricela, additional, Gijon Vidaurreta, Paloma, additional, Infante Herrero, Sonsoles, additional, Velilla, Elena, additional, Machado, Marina, additional, Olmedo, Maria, additional, Pinilla, Blanca, additional, Almirante Gragera, Benito, additional, Cañas Ruano, Maria de la Esperanza, additional, Contreras Medina, Sofia, additional, Cortés Herrera, Alejandro, additional, Falcó Ferrer, Vicenç, additional, Ferrer Roca, Ricard, additional, Nuvials Casals, Xavier, additional, Ribera Pascuet, Esteve, additional, Suanzes Diez, Paula, additional, Rebollo Castro, Pedro, additional, Garcia Alcaide, Felipe, additional, Soriano, Alejandro, additional, Oliver Caldes, Aina, additional, González Cordón, Ana, additional, Cardozo, Celia, additional, De la Mora Cañizo, Lorena, additional, Pena López, Romina, additional, Chamorro, Sandra, additional, Crespillo-Andujar, Clara, additional, Escudero Sanchez, Rosa, additional, Fortún-Abete, Jesús, additional, Monge-Maillo, Begoña, additional, Moreno Zamora, Ana, additional, Norman, Francesca, additional, Sanchez Conde, Matilde, additional, Serrano Villar, Sergio, additional, and Vizcarra, Pilar, additional

Published
2021
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9. Overall Tolerability of Integrase Inhibitors in Clinical Practice: Results from a Multicenter Italian Cohort

Author

Ciccullo, A., Baldin, G., Borghi, V., Sterrantino, G., Madeddu, G., Latini, A., D'Ettorre, G., Lanari, A., Mazzitelli, M., Colafigli, Manuela, Capetti, A. F., Oreni, L., Lagi, F., Rusconi, S., Di Giambenedetto, Simona, Colafigli M., DI Giambenedetto S. (ORCID:0000-0001-6990-5076), Ciccullo, A., Baldin, G., Borghi, V., Sterrantino, G., Madeddu, G., Latini, A., D'Ettorre, G., Lanari, A., Mazzitelli, M., Colafigli, Manuela, Capetti, A. F., Oreni, L., Lagi, F., Rusconi, S., Di Giambenedetto, Simona, Colafigli M., and DI Giambenedetto S. (ORCID:0000-0001-6990-5076)

Abstract

International guidelines recommend the use of integrase strand transfer inhibitor (INI)-based regimens as first-line antiretroviral (ARV) in both naive and experienced HIV-infected patients. We analyzed a multicenter cohort of HIV-infected patients, both naive and experienced, starting an ARV, including an INI. Chi-square test and nonparametric tests were used to assess differences in categorical and continuous variables, respectively. Kaplan-Meier survival analysis was performed to estimate the probability of maintaining the study drug and Cox-regression analysis to evaluate predictors of discontinuation. We enrolled 4,343 patients: 3,143 (72.4%) were males, with a median age of 49 years (interquartile range 41-55). Naive patients were 733 (16.9%), of whom 168 (22.9%) were AIDS presenters. Overall, 2,282 patients (52.5%) started dolutegravir (DTG), 1,426 (32.8%) raltegravir (RAL), and 635 (14.7%) elvitegravir (EVG). During 10,032 patient years of follow-up (PYFU), we observed 1,278 discontinuations (13 per 100 PYFU); 448 of them (35%) due to simplification and 355 (28%) to toxicities (98 for central nervous system toxicity). Reasons of discontinuation were different between INIs. Estimated probability of maintaining DTG at 3 and 4 years were 81.5% [95% confidence interval (CI): 80.5-82.5] and 76.3% (95% CI: 73.9-78.7), respectively; RAL 61.6% (95% CI: 60.2-63.0) and 54.1% (95% CI: 52.7-55.5); EVG 71.6% (95% CI: 69.2-74.0) and 68.3% (95% CI: 65.3-71.3) (p < .001). At a multivariable analysis, being on a RAL-based ARV [vs. DTG, adjusted hazard ratio (aHR) 2.9, 95% CI: 2.3-3.6, p < .001], a EVG-based ARV (vs. DTG, aHR 1.3 95% CI: 1.1-1.7, p = .049), and a peak HIV-RNA >500k cp/mL (aHR 1.3, 95% CI: 1.1-1.6, p = .006) predicted INI discontinuation. Our data confirm the good tolerability of INIs in clinical practice. Differences emerge between the three drugs in reasons for discontinuation.

Published
2021

10. Impressive Boosting of Anti-S1/S2 Immunoglobulin G Production in Coronavirus Disease 2019 (COVID-19)-experienced Patients After the First Shot of the BNT162b2 Messenger RNA COVID-19 Vaccine

Author

Capetti, Amedeo F, primary, Stangalini, Carlo A, additional, Borgonovo, Fabio, additional, Mileto, Davide, additional, Oreni, Letizia, additional, Dedivitiis, Gianfranco, additional, Lupo, Angelica, additional, Cossu, Maria V, additional, Bilardo, Lara, additional, Giacomelli, Andrea, additional, Galli, Massimo, additional, and Rizzardini, Giuliano, additional

Published
2021
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14. Short‐term inhibition of SARS‐CoV‐2 by hydrogen peroxide in persistent nasopharyngeal carriers.

Author

Capetti, Amedeo F., Borgonovo, Fabio, Morena, Valentina, Lupo, Angelica, Cossu, Maria Vittoria, Passerini, Matteo, Dedivitiis, Gianfranco, and Rizzardini, Giuliano

Subjects
COVID-19, SARS-CoV-2, HYDROGEN peroxide, HYPERTONIC solutions, SURFACE cleaning, HYPERTONIC saline solutions
Abstract

Asymptomatic and convalescent coronavirus disease 2019 (COVID‐19) subjects may carry severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) for months in their upper respiratory ways. Desiring to permanently clean the mucosal surfaces, we investigated the chemical agents that fit to rapidly degrade the virus. Among these, hydrogen peroxide, initially tested by two of us for tolerability, showed both good performance and acceptable side effects (burning sensation for 15–20 s). We contacted circles of family physicians and the ATS Milano (Territorial Assistance and Prevention Service), and we tested this procedure on eight persistent carriers of SARS‐CoV‐2, performing swabs before the procedure and after it until the reappearance of the virus or until 14 days (the incubation period), keeping the surfaces clean with a hypertonic solution. Our patients had a median time from exposure or symptom onset of 111 days, and three had relapsed after being declared "cured" (two consecutive negative swabs after quarantine). One patient had a baseline negative swab and was excluded, and two successfully ended the 14 days' course, four suppressed viral elimination for 72 h, and one for 48 h, all rebounding to weak positive (cycle thresholds above 24). Although temporarily effective, such measures may have some place in the control of viral shedding to protect the most fragile subjects. [ABSTRACT FROM AUTHOR]

Published
2021
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16. Durability of dolutegravir plus boosted darunavir as salvage or simplification of salvage regimens in HIV-1 infected, highly treatment-experienced subjects

Author

Capetti, Amedeo F., primary, De Socio, Giuseppe V., additional, Cossu, Maria V., additional, Sterrantino, Gaetana, additional, Cenderello, Giovanni, additional, Cattelan, Annamaria, additional, Baldin, Gian M., additional, Soria, Alessandro, additional, Riccardi, Niccolò, additional, Niero, Fosca P., additional, Celesia, Benedetto M., additional, Barbarini, Giorgio, additional, Rusconi, Stefano, additional, and Rizzardini, Giuliano, additional

Published
2018
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18. Does simplification to dolutegravir-based dual regimens impact on the CD4+/CD8+ T-cell ratio?

Author

Capetti, Amedeo F., Orofino, Giancarlo, Paladini, Laura, Sterrantino, Gaetana, Di Giambenedetto, Simona (ORCID:0000-0001-6990-5076), De Socio, Giuseppe V., Cenderello, Giovanni, Cossu, Maria V., Rizzardini, Giuliano, Capetti, Amedeo F., Orofino, Giancarlo, Paladini, Laura, Sterrantino, Gaetana, Di Giambenedetto, Simona (ORCID:0000-0001-6990-5076), De Socio, Giuseppe V., Cenderello, Giovanni, Cossu, Maria V., and Rizzardini, Giuliano

Abstract

not available

Published
2018

19. Morning dosing for dolutegravir-related insomnia and sleep disorders

Author

Capetti, A. F., Di Giambenedetto, Simona, Latini, A., Sterrantino, G., De Benedetto, I., Cossu, M. V., Gori, A., Di Giambenedetto, S. (ORCID:0000-0001-6990-5076), Capetti, A. F., Di Giambenedetto, Simona, Latini, A., Sterrantino, G., De Benedetto, I., Cossu, M. V., Gori, A., and Di Giambenedetto, S. (ORCID:0000-0001-6990-5076)

Abstract

Dear Sirs, We read with interest the article by Hoffmann et al. 1, reporting unexpected rates of neurological adverse events associated with dolutegravir (DTG)‐based therapy, in particular in women, subjects aged over > 60 years and subjects taking abacavir. Since June 2014, having successfully managed our first case of DTG‐related insomnia (within the ARIA 2 trial) by simply bringing forward the drug dosing from evening to morning, our large Italian outpatients’ clinic has recommended morning dosing to patients starting DTG. The rate of insomnia has been very low since then, and no one has reported dizziness or confusion, unlike those who bring forward efavirenz 3. Other Italian centres implemented the same strategy, suggesting morning dosing to those who were experiencing insomnia after starting DTG. The response was assessed with a dichotomic question (presence or absence of insomnia or sleep disorders) rather than questionnaires as most of the data were retrospective. The significance of the association of the risk factors indicated by Hoffman et al. with the outcome of dosing anticipation and with the proportion of subjects discontinuing DTG was calculated with the two‐tailed Fisher's exact test. Out of 1502 HIV‐1‐infected patients taking DTG, 3.5% had insomnia and sleep disorders. The symptoms were prevalent in > 60‐year‐old subjects and women (P < 0.0001 for both risk factors), while the association with abacavir was not statistically significant (P = 0.3978). Overall, three out of four patients presenting sleep disorders resolved the problem by bringing forward drug dosing, while 15.3% discontinued DTG because of this side effect (0.5% of the whole population). Four of eight patients had additional adverse events motivating discontinuation (agitation in two patients, dyspepsia in one patient and renal colic, a decrease in libido and malaise in one patient). There were no statistically significant differences related to gender, age or concomitant aba

Published
2018

22. A dual regimen of ritonavir/darunavir plus dolutegravir for rescue or simplification of rescue therapy: 48 weeks’ observational data

Author

Capetti, Amedeo F., primary, Cossu, Maria Vittoria, additional, Orofino, Giancarlo, additional, Sterrantino, Gaetana, additional, Cenderello, Giovanni, additional, De Socio, Giuseppe V., additional, Cattelan, Anna Maria, additional, Soria, Alessandro, additional, Rusconi, Stefano, additional, Riccardi, Niccolò, additional, Baldin, Gian Maria, additional, Niero, Fosca P., additional, Barbarini, Giorgio, additional, and Rizzardini, Giuliano, additional

Published
2017
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25. Switch to dolutegravir plus Rilpivirine dual therapy in cART-Experienced subjects: An observational cohort

Author

Capetti, Amedeo F., Sterrantino, Gaetana, Cossu, Maria Vittoria, Orofino, Giancarlo, Barbarini, Giorgio, De Socio, Giuseppe V., Di Giambenedetto, Simona, Di Biagio, Antonio, Celesia, Benedetto M., Argenteri, Barbara, Rizzardini, Giuliano, Di Giambenedetto, Simona (ORCID:0000-0001-6990-5076), Capetti, Amedeo F., Sterrantino, Gaetana, Cossu, Maria Vittoria, Orofino, Giancarlo, Barbarini, Giorgio, De Socio, Giuseppe V., Di Giambenedetto, Simona, Di Biagio, Antonio, Celesia, Benedetto M., Argenteri, Barbara, Rizzardini, Giuliano, and Di Giambenedetto, Simona (ORCID:0000-0001-6990-5076)

Abstract

Introduction: Little information is available on the efficacy and safety of the dual combination of ripivirine plus dolutegravir. This work aims at beginning to fill this gap. Methods: All HIV-1 infected subjects treated with ripivirine plus dolutegravir between October 2014 and September 2015 in eight Italian centres were included in an observational cohort. Data were collected at baseline and at weeks 4, 12, 24 and 48. Results: One hundred and thirty-two subjects were followed for a median of 24 months, mean 33 months. One subject discontinued the study drug at week 24 for headache, one for drug interaction and one died after week 24 of illicit drug abuse. The mean age was 51.8, females 31.7% and non-caucasians 10%. Fifty-seven (43.2%) had at least one failure in their treatment history. Reasons for switching were simplification (53.0%), toxicity (34.8%), drug interactions (n = 7), persistent low-level viremia (n = 4), non-adherence (n = 3) and viral failure (n = 2). Sixty patients (45.5%) had reverse transcriptase (RT) mutations and 69 (44,7%) had protease (PR) mutations. Sixteen had baseline viral replication, 27 had > 50 HIV-1 RNA copies/mL and in 89 (67.4%) no virus was detected (NVD, 0 copies/mL). At w4, 114 (86.4%) had NVD, 15 had 1 to 49 HIV-1 RNA copies/mL and 3 had 50 to 57 copies/mL. At week 24 one subject had viral rebound without mutations due to missed drug refill, 19 had 1 to 49 copies/mL, and 112 had NVD. All 132 subjects were tested at weeks 4 and 24. Of the 50 subjects who had a 48-week follow-up, one had a treatment interruption, four had 1 to 49 copies/mL and 45 had NVD. Among the entire population, one subject had lowlevel, one intermediate and 4 high-level resistance to rilpivirine: none failed by week 48. Mean serum creatinine increased by +0.1 mg/dL. During the follow-up one patient reported headache and insomnia. Conclusions: Ripivirine plus dolutegravir proved safe and effective in this cohort of non-naive HIV-1 infected subjects.

Published
2016

26. Switch to Dolutegravir plus Rilpivirine Dual Therapy in cART-Experienced Subjects: An Observational Cohort

Author

Capetti, Amedeo F., primary, Sterrantino, Gaetana, additional, Cossu, Maria Vittoria, additional, Orofino, GianCarlo, additional, Barbarini, Giorgio, additional, De Socio, Giuseppe V., additional, Di Giambenedetto, Simona, additional, Di Biagio, Antonio, additional, Celesia, Benedetto M., additional, Argenteri, Barbara, additional, and Rizzardini, Giuliano, additional

Published
2016
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27. Salvage Therapy or Simplification of Salvage Regimens with Dolutegravir plus Ritonavir-Boosted Darunavir Dual Therapy in Highly cART-Experienced Subjects: An Italian Cohort

Author

Capetti, Amedeo F, primary, Sterrantino, Gaetana, additional, Cossu, Maria V, additional, Cenderello, Giovanni, additional, Cattelan, Anna M, additional, Socio, Giuseppe V De, additional, Rusconi, Stefano, additional, Riccardi, Niccolò, additional, Baldin, Gian M, additional, Cima, Serena, additional, Niero, Fosca P, additional, Rizzardini, Giuliano, additional, and Sasset, Lolita, additional

Published
2016
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28. An evaluation of elvitegravir plus cobicistat plus tenofovir alafenamide plus emtricitabine as a single-tablet regimen for the treatment of HIV in children and adolescents

Author

Giacomet, Vania, Cossu, Maria V., Capetti, Amedeo F., Zuccotti, GianVincenzo, and Rizzardini, Giuliano

Abstract

ABSTRACTIntroduction: Approximately 2.1 million of the estimated 36 million infected with HIV are children or adolescents. International guidelines for HIV-1 Infection suggest starting antiretrovirals (ARV) at the moment of diagnosis. Many factors limit the optimization of antiretroviral therapy in children and adolescents: lack of pediatric formulations, poor adherence, metabolic and pharmacokinetic changes associated withnormal child development and puberty.Areas covered: Three integrase inhibitors are approved by the US Food and Drug Administration and by European Medical Agency for children and adolescents with HIV-1 infection. Raltegravir is approved for children aged 4 weeks to 18 years, while dolutegravir and elvitegravir co-formulated with cobicistat, emtricitabine, and tenofovir alafenamide (E/C/FTC/TAF) are approved for children from 6 years of age. This article evaluates E/C/FTC/TAF as a treatment option.Expert opinion: E/C/FTC/TAF was well tolerated, and the antiretroviral activity and tolerability data of this combination support the use in children and adolescents. However, the studies regarding E/C/FTC/TAF in children and adolescents are scant. Consequently, additional studies investigating its safety and efficacy in children are paramount.

Published
2019
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29. Correction: Salvage therapy or simplification of salvage regimens with dolutegravir plus ritonavir-boosted darunavir dual therapy in highly cART-experienced subjects: an Italian cohort

Author

Capetti, Amedeo F, primary, Sterrantino, Gaetana, additional, Cossu, Maria V, additional, Cenderello, Giovanni, additional, Cattelan, Anna M, additional, De Socio, Giuseppe V, additional, Rusconi, Stefano, additional, Riccardi, Niccolò, additional, Baldin, Gian M, additional, Cima, Serena, additional, Niero, Fosca P, additional, Rizzardini, Giuliano, additional, and Sasset, Lolita, additional

Published
2016
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30. Dolutegravir plus rilpivirine dual therapy in treating HIV-1 infection

Author

Capetti, Amedeo F., Cossu, Maria V., Paladini, Laura, and Rizzardini, Giuliano

Abstract

ABSTRACTIntroduction: The HIV-infected population is aging and comorbidities and polypharmacological regimens are increasing. To reduce toxicity and drug burden researchers are evaluating the efficacy, safety and durability of dual therapies as a switch option in subjects who have achieved stable virologic suppression. Initially effective dual combinations relied on protease inhibitors but when dolutegravir, the first integrase inhibitor to display a high genetic barrier, became commercially available, many physicians began to use it in a variety of dual regimens, generating several observational cohorts.Areas covered: This review covers the most recent data from observational cohorts and randomized clinical trials concerning the switch to the dual combination of dolutegravir plus rilpivirine and the reasons that lead to consider this option. Also, viral failures, due to poor adherence or to other factors, and drug resistance are investigated. Articles which are searchable on MEDLINE/PubMed and from the main national/international congresses in the field of HIV therapy are reviewed.Expert opinion: The observation period for this regimen is getting longer and data showing its efficacy in maintaining HIV-1 RNA < 50 copies/mL are now consolidated. Metabolic data suggest some benefit in the lipid profile, improvement in bone mineral density and reduced bone reabsorption.

Published
2018
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31. Salvage Therapy or Simplification of Salvage Regimens with Dolutegravir plus Ritonavir-Boosted Darunavir Dual Therapy in Highly cART-Experienced Subjects: An Italian Cohort

Author

Capetti, Amedeo F, Sterrantino, Gaetana, Cossu, Maria V, Cenderello, Giovanni, Cattelan, Anna M, Socio, Giuseppe V De, Rusconi, Stefano, Riccardi, Niccolò, Baldin, Gian M, Cima, Serena, Niero, Fosca P, Rizzardini, Giuliano, and Sasset, Lolita

Abstract

Background Dolutegravir plus darunavir provide a high genetic barrier to HIV-1 resistance and are suitable for simple salvage regimens.Methods All HIV-1-infected subjects treated with dolutegravir plus boosted darunavir dual therapy between March 2011 and September 2015 were included in an observational cohort. Data were collected at baseline and at weeks 4, 12, 24 and 48.Results We enrolled 113 subjects. After week 24, one was lost at follow-up, one dropped out for grade 2 elevation of liver enzymes, one died from illicit drug abuse and one from cancer-related sepsis. The mean age was 51, 26.5% were female and 9.7% were non-Caucasian. Twenty had never experienced failure. A total of 99 had reverse-transcriptase (RT) mutations, 87 had protease inhibitor mutations and 12 had integrase strand transfer inhibitor (INSTI) mutations. Viraemic patients declined from baseline to week 24 from 43.4% to 6.2%, the remainder being due to high baseline viraemia or adherence issues. The proportion of subjects with viraemia 1–49 copies/ml remained at 20.4% while those in whom no virus was detected (NVD) increased from 36.3% to 73.5% by week 24. All the 47 subjects who had a 48-week follow-up had <50 copies/ml and 42 (89.4%) had NVD. 18 subjects had reduced sensitivity to darunavir (Stanford median score 15, range 15–40), but none rebounded, 6 having a 24-week and 7 a 48-week follow-up. The median variation in serum creatinine was -0.01 (range +0.2 to -0.21) mg/dl.Conclusions This dual regimen provides a simple salvage regimen and proved safe and effective in this cohort.

Published
2017
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35. Long-term follow-up of HIV-infected patients in salvage therapy with raltegravir plus optimized background regimens: a multicentre Italian experience.

Author

Landonio, S., Meraviglia, P., Capetti, A. F., Di Biagio, A., Caputo, S. Lo, Sterrantino, G., Ammassari, A., Menzaghi, B., Franzetti, M., De Socio, G., Pellicanò, G., Mazzotta, E., Zucchi, P., and Rizzardini, G.

Subjects
HIV-positive persons, SALVAGE therapy
Abstract

An abstract of the article "Long-term follow-up of HIV-infected patients in salvage therapy with raltegravir plus optimized background regimens: a multicentre Italian experience," by S. Landonio and colleagues is presented.

Published
2010
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36. Maraviroc intensification for HIV-1-positive immunological non-responders (INRs) despite virological suppression during HAART.

Author

Rusconi, S., Vitiello, P., Adorni, F., Colella, E., Focà, E., Capetti, A. F., Meraviglia, P., Abeli, C., Bonora, S., D'Annunzio, M., Di Biagio, A., Di Pietro, A., Butini, L., Orofino, G., Farina, S., d'Ettorre, G., Francisci, D., Soria, A., Buonomini, A. R., and Tommasi, C.

Subjects
HIV infections
Abstract

An abstract of the research paper "Maraviroc Intensification for HIV-1-Positive Immunological Non-Responders (INRs) Despite Virological Suppression During HAART," by S. Rusconi and colleagues which was presented at the Tenth International Congress on Drug Therapy in HIV Infection held at Glasgow, Scotland from November 7-11, 2010 is presented.

Published
2010
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37. Sarilumab in patients admitted to hospital with severe or critical COVID-19: a randomised, double-blind, placebo-controlled, phase 3 trial

Author

François-Xavier Lescure, Hitoshi Honda, Robert A Fowler, Jennifer Sloane Lazar, Genming Shi, Peter Wung, Naimish Patel, Owen Hagino, Ignacio J. Bazzalo, Marcelo M. Casas, Sebastián A. Nuñez, Yael Pere, Carlos M. Ibarrola, Marco A. Solis Aramayo, Maria C. Cuesta, Andrea E. Duarte, Pablo M. Gutierrez Fernandez, Maria A. Iannantuono, Erica A. Miyazaki, Javier P. Silvio, Dario G. Scublinsky, Alessandra Bales, Daniela Catarino, Elie Fiss, Sara Mohrbacher, Victor Sato, Antonio Baylao, Adilson Cavalcante, Francini Correa, Celso A. de Andrade, Juvencio Furtado, Nelson Ribeiro Filho, Valéria Telles, Leopoldo T. Trevelin, Ricardo Vipich, Rodrigo Boldo, Paula Borges, Suzana Lobo, Graziela Luckemeyer, Luana Machado, Maysa B. Alves, Ana C. Iglessias, Marianna M. Lago, Daniel W. Santos, Hugo Chapdelaine, Emilia L. Falcone, Rahima Jamal, Me-Linh Luong, Madeleine Durand, Stephane Doucet, François-Martin Carrier, Bryan A. Coburn, Lorenzo Del Sorbo, Sharon L. Walmsley, Sara Belga, Luke Y. Chen, Allison D. Mah, Theodore Steiner, Alissa J. Wright, J. Hajek, Neill Adhikari, Robert A. Fowler, Nick Daneman, Kosar A. Khwaja, Jason Shahin, Carolina Gonzalez, Rafael Silva, Marcelo Lindh, Gabriel Maluenda, Patricia Fernandez, Maite Oyonarte, Martin Lasso, Alexandre Boyer, Didier Bronnimann, Hoang-Nam Bui, Charles Cazanave, Helene Chaussade, Arnaud Desclaux, Mailys Ducours, Alexandre Duvignaud, Denis Malvy, Lisa Martin, Didier Neau, Duc Nguyen, Thierry Pistone, Gaetane Soubrane-Wirth, Julie Leitao, Clotilde Allavena, Charlotte Biron, Sabelline Bouchez, Benjamin Gaborit, Antoine Gregoire, Paul Le Turnier, Anne-Sophie Lecompte, Raphael Lecomte, Maeva Lefebvre, Francois Raffi, David Boutoille, Pascale H. Morineau, Romain Guéry, Emmanuel Chatelus, Nathalie Dumoussaud, Renaud Felten, Florina Luca, Bernard Goichot, Francis Schneider, Marie-Caroline Taquet, Matthieu Groh, Mathilde Roumier, Mathilde Neuville, Antoine Bachelard, Valentina Isernia, F-Xavier Lescure, Bao-Chau Phung, Anne Rachline, Aurelie Sautereau, Dorothee Vallois, Yves Bleher, Delphine Boucher, Clémentine Coudon, Jean Esnault, Thomas Guimard, Sophie Leautez-Nainville, Dominique Merrien, Marine Morrier, Pauline Motte-Vincent, Romain Gabeff, Hélène Leclerc, Céline Cozic, Romain Decours, Ronan Février, Gwenhael Colin, Sophie Abgrall, Dorothee Vignes, Raluca Sterpu, Mira Kuellmar, Melanie Meersch-Dini, Raphael Weiss, Alexander Zarbock, Christiane Antony, Marc Berger, Thorsten Brenner, Christian Taube, Frank Herbstreit, Sebastian Dolff, Margarethe Konik, Karsten Schmidt, Markus Zettler, Oliver Witzke, Boris Boell, Jorge Garcia Borrega, Philipp Koehler, Thomas Zander, Fabian Dusse, Othman Al-Sawaf, Philipp Köhler, Dennis Eichenauer, Matthias Kochanek, Alexander Shimabukuro-Vornhagen, Sibylle Mellinghoff, Annika Claßen, Jan-Michel Heger, Charlotte Meyer-Schwickerath, Paul Liedgens, Katrin Heindel, Ana Belkin, Asaf Biber, Mayan Gilboa, Itzchak Levy, Vladislav Litachevsky, Galia Rahav, Anat Finesod Wiedner, Tal Zilberman-Daniels, Yonatan Oster, Jacob Strahilevitz, Sigal Sviri, Elena M. Baldissera, Corrado Campochiaro, Giulio Cavalli, Lorenzo Dagna, Giacomo De Luca, Emanuel Della Torre, Alessandro Tomelleri, Davide Bernasconi De Luca, Amedeo F. Capetti, Massimo Coen, Maria V. Cossu, Massimo Galli, Andrea Giacomelli, Guido A. Gubertini, Stefano Rusconi, Giulia J. Burastero, Margherita Digaetano, Giovanni Guaraldi, Marianna Meschiari, Cristina Mussini, Cinzia Puzzolante, Sara Volpi, Marina Aiello, Alarico Ariani, Alfredo A. Chetta, Annalisa Frizzelli, Andrea Ticinesi, Domenico Tuttolomondo, Stefano Aliberti, Francesco B. Blasi, Marta F. Di Pasquale, Sofia Misuraca, Tommaso Pilocane, Edoardo Simonetta, Alessio M. Aghelmo, Claudio Angelini, Enrico Brunetta, Giorgio W. Canonica, Michele Ciccarelli, Sara Dal Farra, Maria De Santis, Sebastian Ferri, Marco Folci, Giacomo M. Guidelli, Enrico M. Heffler, Ferdinando Loiacono, Giacomo Malipiero, Giovanni Paoletti, Rosa Pedale, Francesca A. Puggioni, Francesca Racca, Aurora Zumbo, Morihiko Satou, Tatyana Lisun, Denis Protsenko, Nikolay Rubtsov, Irina Beloglazova, Daria Fomina, Mariana Lysenko, Sofia Serdotetskova, Vitali Firstov, Ivan Gordeev, Ilia Kokorin, Ksenia Komissarova, Nina Lapochkina, Elena Luchinkina, Valentin Malimon, Sevinch Mamedguseyinova, Ksenia Polubatonova, Natalia Suvorova, Jose Arribas, Alberto M. Borobia Perez, Fernando de la Calle Prieto, Juan Carlos Figueira, Rocio Motejano Sanchez, Marta Mora-Rillo, Concepcion Prados Sanchez, Javier Queiruga Parada, Francisco Fernandez Arnalich, Maria Guerro Barrientos, Alejandro Bendala Estrada, Aranzazu Caballero Marcos, Maria E. Garcia Leoni, Rita García-Martínez, Ana María Collado, Patricia Munoz Garcia, Ana Torres do Rego, María V. Villalba García, Almudena Burrillo, Maricela Valerio Minero, Paloma Gijon Vidaurreta, Sonsoles Infante Herrero, Elena Velilla, Marina Machado, Maria Olmedo, Blanca Pinilla, Benito Almirante Gragera, Maria de la Esperanza Cañas Ruano, Sofia Contreras Medina, Alejandro Cortés Herrera, Vicenç Falcó Ferrer, Ricard Ferrer Roca, Xavier Nuvials Casals, Esteve Ribera Pascuet, Paula Suanzes Diez, Pedro Rebollo Castro, Felipe Garcia Alcaide, Alejandro Soriano, Aina Oliver Caldes, Ana González Cordón, Celia Cardozo, Lorena De la Mora Cañizo, Romina Pena López, Sandra Chamorro, Clara Crespillo-Andujar, Rosa Escudero Sanchez, Jesús Fortún-Abete, Begoña Monge-Maillo, Ana Moreno Zamora, Francesca Norman, Matilde Sanchez Conde, Sergio Serrano Villar, Pilar Vizcarra, Lescure, F. -X., Honda, H., Fowler, R. A., Lazar, J. S., Shi, G., Wung, P., Patel, N., Hagino, O., Bazzalo, I. J., Casas, M. M., Nunez, S. A., Pere, Y., Ibarrola, C. M., Solis Aramayo, M. A., Cuesta, M. C., Duarte, A. E., Gutierrez Fernandez, P. M., Iannantuono, M. A., Miyazaki, E. A., Silvio, J. P., Scublinsky, D. G., Bales, A., Catarino, D., Fiss, E., Mohrbacher, S., Sato, V., Baylao, A., Cavalcante, A., Correa, F., de Andrade, C. A., Furtado, J., Ribeiro Filho, N., Telles, V., Trevelin, L. T., Vipich, R., Boldo, R., Borges, P., Lobo, S., Luckemeyer, G., Machado, L., Alves, M. B., Iglessias, A. C., Lago, M. M., Santos, D. W., Chapdelaine, H., Falcone, E. L., Jamal, R., Luong, M. -L., Durand, M., Doucet, S., Carrier, F. -M., Coburn, B. A., Del Sorbo, L., Walmsley, S. L., Belga, S., Chen, L. Y., Mah, A. D., Steiner, T., Wright, A. J., Hajek, J., Adhikari, N., Daneman, N., Khwaja, K. A., Shahin, J., Gonzalez, C., Silva, R., Lindh, M., Maluenda, G., Fernandez, P., Oyonarte, M., Lasso, M., Boyer, A., Bronnimann, D., Bui, H. -N., Cazanave, C., Chaussade, H., Desclaux, A., Ducours, M., Duvignaud, A., Malvy, D., Martin, L., Neau, D., Nguyen, D., Pistone, T., Soubrane-Wirth, G., Leitao, J., Allavena, C., Biron, C., Bouchez, S., Gaborit, B., Gregoire, A., Le Turnier, P., Lecompte, A. -S., Lecomte, R., Lefebvre, M., Raffi, F., Boutoille, D., Morineau, P. H., Guery, R., Chatelus, E., Dumoussaud, N., Felten, R., Luca, F., Goichot, B., Schneider, F., Taquet, M. -C., Groh, M., Roumier, M., Neuville, M., Bachelard, A., Isernia, V., Phung, B. -C., Rachline, A., Sautereau, A., Vallois, D., Bleher, Y., Boucher, D., Coudon, C., Esnault, J., Guimard, T., Leautez-Nainville, S., Merrien, D., Morrier, M., Motte-Vincent, P., Gabeff, R., Leclerc, H., Cozic, C., Decours, R., Fevrier, R., Colin, G., Abgrall, S., Vignes, D., Sterpu, R., Kuellmar, M., Meersch-Dini, M., Weiss, R., Zarbock, A., Antony, C., Berger, M., Brenner, T., Taube, C., Herbstreit, F., Dolff, S., Konik, M., Schmidt, K., Zettler, M., Witzke, O., Boell, B., Garcia Borrega, J., Koehler, P., Zander, T., Dusse, F., Al-Sawaf, O., Kohler, P., Eichenauer, D., Kochanek, M., Shimabukuro-Vornhagen, A., Mellinghoff, S., Classen, A., Heger, J. -M., Meyer-Schwickerath, C., Liedgens, P., Heindel, K., Belkin, A., Biber, A., Gilboa, M., Levy, I., Litachevsky, V., Rahav, G., Finesod Wiedner, A., Zilberman-Daniels, T., Oster, Y., Strahilevitz, J., Sviri, S., Baldissera, E. M., Campochiaro, C., Cavalli, G., Dagna, L., De Luca, Giacomo., Della Torre, E., Tomelleri, A., Bernasconi De Luca, D., Capetti, A. F., Coen, M., Cossu, M. V., Galli, M., Giacomelli, A., Gubertini, G. A., Rusconi, S., Burastero, G. J., Digaetano, M., Guaraldi, G., Meschiari, M., Mussini, C., Puzzolante, C., Volpi, S., Aiello, M., Ariani, A., Chetta, A. A., Frizzelli, A., Ticinesi, A., Tuttolomondo, D., Aliberti, S., Blasi, F. B., Di Pasquale, M. F., Misuraca, S., Pilocane, T., Simonetta, E., Aghelmo, A. M., Angelini, C., Brunetta, E., Canonica, G. W., Ciccarelli, M., Dal Farra, S., De Santis, M., Ferri, S., Folci, M., Guidelli, G. M., Heffler, E. M., Loiacono, F., Malipiero, G., Paoletti, G., Pedale, R., Puggioni, F. A., Racca, F., Zumbo, A., Satou, M., Lisun, T., Protsenko, D., Rubtsov, N., Beloglazova, I., Fomina, D., Lysenko, M., Serdotetskova, S., Firstov, V., Gordeev, I., Kokorin, I., Komissarova, K., Lapochkina, N., Luchinkina, E., Malimon, V., Mamedguseyinova, S., Polubatonova, K., Suvorova, N., Arribas, J., Borobia Perez, A. M., de la Calle Prieto, F., Figueira, J. C., Motejano Sanchez, R., Mora-Rillo, M., Prados Sanchez, C., Queiruga Parada, J., Fernandez Arnalich, F., Guerro Barrientos, M., Bendala Estrada, A., Caballero Marcos, A., Garcia Leoni, M. E., Garcia-Martinez, R., Collado, A. M., Munoz Garcia, P., Torres do Rego, A., Villalba Garcia, M. V., Burrillo, A., Valerio Minero, M., Gijon Vidaurreta, P., Infante Herrero, S., Velilla, E., Machado, M., Olmedo, M., Pinilla, B., Almirante Gragera, B., Canas Ruano, M. D. L. E., Contreras Medina, S., Cortes Herrera, A., Falco Ferrer, V., Ferrer Roca, R., Nuvials Casals, X., Ribera Pascuet, E., Suanzes Diez, P., Rebollo Castro, P., Garcia Alcaide, F., Soriano, A., Oliver Caldes, A., Gonzalez Cordon, A., Cardozo, C., De la Mora Canizo, L., Pena Lopez, R., Chamorro, S., Crespillo-Andujar, C., Escudero Sanchez, R., Fortun-Abete, J., Monge-Maillo, B., Moreno Zamora, A., Norman, F., Sanchez Conde, M., Serrano Villar, S., and Vizcarra, P.

Subjects
Male, Pulmonary and Respiratory Medicine, medicine.medical_specialty, Critical Care, International Cooperation, Population, Antibodies, Monoclonal, Humanized, Placebo, Severity of Illness Index, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, law, Internal medicine, Intensive care, Severity of illness, medicine, Clinical endpoint, Humans, Immunologic Factors, 030212 general & internal medicine, Mortality, education, Respiratory Distress Syndrome, education.field_of_study, Dose-Response Relationship, Drug, SARS-CoV-2, business.industry, Hazard ratio, COVID-19, Articles, Middle Aged, Receptors, Interleukin-6, Sarilumab, Treatment Outcome, 030228 respiratory system, Female, Drug Monitoring, Cytokine Release Syndrome, business
Abstract

Summary Background Elevated proinflammatory cytokines are associated with greater COVID-19 severity. We aimed to assess safety and efficacy of sarilumab, an interleukin-6 receptor inhibitor, in patients with severe (requiring supplemental oxygen by nasal cannula or face mask) or critical (requiring greater supplemental oxygen, mechanical ventilation, or extracorporeal support) COVID-19. Methods We did a 60-day, randomised, double-blind, placebo-controlled, multinational phase 3 trial at 45 hospitals in Argentina, Brazil, Canada, Chile, France, Germany, Israel, Italy, Japan, Russia, and Spain. We included adults (≥18 years) admitted to hospital with laboratory-confirmed SARS-CoV-2 infection and pneumonia, who required oxygen supplementation or intensive care. Patients were randomly assigned (2:2:1 with permuted blocks of five) to receive intravenous sarilumab 400 mg, sarilumab 200 mg, or placebo. Patients, care providers, outcome assessors, and investigators remained masked to assigned intervention throughout the course of the study. The primary endpoint was time to clinical improvement of two or more points (seven point scale ranging from 1 [death] to 7 [discharged from hospital]) in the modified intention-to-treat population. The key secondary endpoint was proportion of patients alive at day 29. Safety outcomes included adverse events and laboratory assessments. This study is registered with ClinicalTrials.gov, NCT04327388; EudraCT, 2020-001162-12; and WHO, U1111-1249-6021. Findings Between March 28 and July 3, 2020, of 431 patients who were screened, 420 patients were randomly assigned and 416 received placebo (n=84 [20%]), sarilumab 200 mg (n=159 [38%]), or sarilumab 400 mg (n=173 [42%]). At day 29, no significant differences were seen in median time to an improvement of two or more points between placebo (12·0 days [95% CI 9·0 to 15·0]) and sarilumab 200 mg (10·0 days [9·0 to 12·0]; hazard ratio [HR] 1·03 [95% CI 0·75 to 1·40]; log-rank p=0·96) or sarilumab 400 mg (10·0 days [9·0 to 13·0]; HR 1·14 [95% CI 0·84 to 1·54]; log-rank p=0·34), or in proportions of patients alive (77 [92%] of 84 patients in the placebo group; 143 [90%] of 159 patients in the sarilumab 200 mg group; difference −1·7 [−9·3 to 5·8]; p=0·63 vs placebo; and 159 [92%] of 173 patients in the sarilumab 400 mg group; difference 0·2 [−6·9 to 7·4]; p=0·85 vs placebo). At day 29, there were numerical, non-significant survival differences between sarilumab 400 mg (88%) and placebo (79%; difference +8·9% [95% CI −7·7 to 25·5]; p=0·25) for patients who had critical disease. No unexpected safety signals were seen. The rates of treatment-emergent adverse events were 65% (55 of 84) in the placebo group, 65% (103 of 159) in the sarilumab 200 mg group, and 70% (121 of 173) in the sarilumab 400 mg group, and of those leading to death 11% (nine of 84) were in the placebo group, 11% (17 of 159) were in the sarilumab 200 mg group, and 10% (18 of 173) were in the sarilumab 400 mg group. Interpretation This trial did not show efficacy of sarilumab in patients admitted to hospital with COVID-19 and receiving supplemental oxygen. Adequately powered trials of targeted immunomodulatory therapies assessing survival as a primary endpoint are suggested in patients with critical COVID-19. Funding Sanofi and Regeneron Pharmaceuticals.

Published
2021

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