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1. Prophylactic heparin and risk of orotracheal intubation or death in patients with mild or moderate COVID-19 pneumonia

Author

Vergori, A., Lorenzini, P., Cozzi-Lepri, A., Donno, D. R., Gualano, G., Nicastri, E., Iacomi, F., Marchioni, L., Campioni, P., Schinina, V., Cicalini, S., Agrati, C., Capobianchi, M. R., Girardi, E., Ippolito, G., Vaia, F., Petrosillo, N., Antinori, A., Taglietti, F., The ReCOVeRI Study Group: Abbonizio, M. A., Abdeddaim, A., Agostini, E., Albarello, F., Amadei, G., Amendola, A., Antonica, M. A., Antonini, M., Bartoli, T. A., Baldini, F., Barbaro, R., Bartolini, B., Bellagamba, R., Benigni, M., Bevilacqua, N., Biava, G., Bibas, M., Bordi, L., Bordoni, V., Boumis, E., Branca, M., Buonomo, R., Busso, D., Camici, M., Canichella, F., Capone, A., Caporale, C., Caraffa, E., Caravella, I., Carletti, F., Castilletti, C., Cataldo, A., Cerilli, S., Cerva, C., Chiappini, R., Chinello, P., Cianfarani, M. A., Ciaralli, C., Cimaglia, C., Cinicola, N., Ciotti, V., Colavita, F., Corpolongo, A., Cristofaro, M., Curiale, S., D'Abramo, A., Dantimi, C., De Angelis, A., De Angelis, G., De Palo, M. G., De Zottis, F., Di Bari, V., Di Lorenzo, R., Di Stefano, F., D'Offizi, G., Evangelista, F., Faraglia, F., Farina, A., Ferraro, F., Fiorentini, L., Frustaci, A., Fusetti, M., Fusto, M., Galati, V., Gagliardini, R., Galli, P., Garotto, G., Gaviano, I., Tekle, S. G., Giancola, M. L., Giansante, F., Giombini, E., Granata, G., Greci, M. C., Grilli, E., Grisetti, S., Iaconi, M., Iannicelli, G., Inversi, C., Lalle, E., Lamanna, M. E., Lanini, S., Lapa, D., Lepore, L., Libertone, R., Lionetti, R., Liuzzi, G., Loiacono, L., Lucia, A., Lufrani, F., Macchione, M., Maffongelli, G., Marani, A., Mariano, A., Marini, M. C., Maritti, M., Mastrobattista, A., Mastrorosa, I., Matusali, G., Mazzotta, V., Mencarini, P., Meschi, S., Messina, F., Micarelli, S., Mogavero, G., Mondi, A., Montalbano, M., Montaldo, C., Mosti, S., Murachelli, S., Musso, M., Nardi, M., Navarra, A., Nocioni, M., Noto, P., Noto, R., Oliva, A., Onnis, I., Ottou, S., Palazzolo, C., Pallini, E., Palmieri, F., Palombi, G., Pareo, C., Passeri, V., Pelliccioni, F., Penna, G., Petrecchia, A., Petrone, A., Pianura, E., Pinnetti, C., Pisciotta, M., Piselli, P., Pittalis, S., Pontarelli, A., Proietti, C., Puro, V., Ramazzini, P. M., Rianda, A., Rinonapoli, G., Rosati, S., Rubino, D., Rueca, M., Ruggeri, A., Sacchi, A., Sampaolesi, A., Sanasi, F., Santagata, C., Scarabello, A., Scarcia, S., Scognamiglio, P., Scorzolini, L., Stazi, G., Strano, G., Taibi, C., Taloni, G., Nardi, T., Tonnarini, R., Topino, S., Tozzi, M., Vairo, F., Valli, M. B., Vincenzi, L., Visco-Comandini, U., Vita, S., Vittozzi, P., Zaccarelli, M., Zanetti, A., Zito, S., Vergori, A., Lorenzini, P., Cozzi-Lepri, A., Donno, D. R., Gualano, G., Nicastri, E., Iacomi, F., Marchioni, L., Campioni, P., Schinina, V., Cicalini, S., Agrati, C., Capobianchi, M. R., Girardi, E., Ippolito, G., Vaia, F., Petrosillo, N., Antinori, A., Taglietti, F., Abbonizio, M. A., Abdeddaim, A., Agostini, E., Albarello, F., Amadei, G., Amendola, A., Antonica, M. A., Antonini, M., Bartoli, T. A., Baldini, F., Barbaro, R., Bartolini, B., Bellagamba, R., Benigni, M., Bevilacqua, N., Biava, G., Bibas, M., Bordi, L., Bordoni, V., Boumis, E., Branca, M., Buonomo, R., Busso, D., Camici, M., Canichella, F., Capone, A., Caporale, C., Caraffa, E., Caravella, I., Carletti, F., Castilletti, C., Cataldo, A., Cerilli, S., Cerva, C., Chiappini, R., Chinello, P., Cianfarani, M. A., Ciaralli, C., Cimaglia, C., Cinicola, N., Ciotti, V., Colavita, F., Corpolongo, A., Cristofaro, M., Curiale, S., D'Abramo, A., Dantimi, C., De Angelis, A., De Angelis, G., De Palo, M. G., De Zottis, F., Di Bari, V., Di Lorenzo, R., Di Stefano, F., D'Offizi, G., Evangelista, F., Faraglia, F., Farina, A., Ferraro, F., Fiorentini, L., Frustaci, A., Fusetti, M., Fusto, M., Galati, V., Gagliardini, R., Galli, P., Garotto, G., Gaviano, I., Tekle, S. G., Giancola, M. L., Giansante, F., Giombini, E., Granata, G., Greci, M. C., Grilli, E., Grisetti, S., Iaconi, M., Iannicelli, G., Inversi, C., Lalle, E., Lamanna, M. E., Lanini, S., Lapa, D., Lepore, L., Libertone, R., Lionetti, R., Liuzzi, G., Loiacono, L., Lucia, A., Lufrani, F., Macchione, M., Maffongelli, G., Marani, A., Mariano, A., Marini, M. C., Maritti, M., Mastrobattista, A., Mastrorosa, I., Matusali, G., Mazzotta, V., Mencarini, P., Meschi, S., Messina, F., Micarelli, S., Mogavero, G., Mondi, A., Montalbano, M., Montaldo, C., Mosti, S., Murachelli, S., Musso, M., Nardi, M., Navarra, A., Nocioni, M., Noto, P., Noto, R., Oliva, A., Onnis, I., Ottou, S., Palazzolo, C., Pallini, E., Palmieri, F., Palombi, G., Pareo, C., Passeri, V., Pelliccioni, F., Penna, G., Petrecchia, A., Petrone, A., Pianura, E., Pinnetti, C., Pisciotta, M., Piselli, P., Pittalis, S., Pontarelli, A., Proietti, C., Puro, V., Ramazzini, P. M., Rianda, A., Rinonapoli, G., Rosati, S., Rubino, D., Rueca, M., Ruggeri, A., Sacchi, A., Sampaolesi, A., Sanasi, F., Santagata, C., Scarabello, A., Scarcia, S., Scognamiglio, P., Scorzolini, L., Stazi, G., Strano, G., Taibi, C., Taloni, G., Nardi, T., Tonnarini, R., Topino, S., Tozzi, M., Vairo, F., Valli, M. B., Vincenzi, L., Visco-Comandini, U., Vita, S., Vittozzi, P., Zaccarelli, M., Zanetti, A., and Zito, S.

Subjects
Male, medicine.medical_treatment, Rome, Kaplan-Meier Estimate, 030204 cardiovascular system & hematology, Severity of Illness Index, 0302 clinical medicine, Retrospective Studie, Coagulopathy, Clinical endpoint, Intubation, Respiratory function, 030212 general & internal medicine, Multidisciplinary, Middle Aged, Medicine, Female, Human, medicine.medical_specialty, Patients, medicine.drug_class, Science, Low molecular weight heparin, Risk Assessment, Article, NO, 03 medical and health sciences, Internal medicine, Severity of illness, medicine, Intubation, Intratracheal, Humans, Retrospective Studies, Aged, business.industry, SARS-CoV-2, COVID-19, Thrombocytopenia, Retrospective cohort study, Heparin, Low-Molecular-Weight, medicine.disease, Respiration, Artificial, COVID-19 Drug Treatment, respiratory tract diseases, Pneumonia, Viral infection, business
Abstract

Prophylactic low molecular weight heparin (pLMWH) is currently recommended in COVID-19 to reduce the risk of coagulopathy. The aim of this study was to evaluate whether the antinflammatory effects of pLMWH could translate in lower rate of clinical progression in patients with COVID-19 pneumonia. Patients admitted to a COVID-hospital in Rome with SARS-CoV-2 infection and mild/moderate pneumonia were retrospectively evaluated. The primary endpoint was the time from hospital admission to orotracheal intubation/death (OTI/death). A total of 449 patients were included: 39% female, median age 63 (IQR, 50–77) years. The estimated probability of OTI/death for patients receiving pLMWH was: 9.5% (95% CI 3.2–26.4) by day 20 in those not receiving pLMWH vs. 10.4% (6.7–15.9) in those exposed to pLMWH; p-value = 0.144. This risk associated with the use of pLMWH appeared to vary by PaO2/FiO2 ratio: aHR 1.40 (95% CI 0.51–3.79) for patients with an admission PaO2/FiO2 ≤ 300 mmHg and 0.27 (0.03–2.18) for those with PaO2/FiO2 > 300 mmHg; p-value at interaction test 0.16. pLMWH does not seem to reduce the risk of OTI/death mild/moderate COVID-19 pneumonia, especially when respiratory function had already significantly deteriorated. Data from clinical trials comparing the effect of prophylactic vs. therapeutic dosage of LMWH at various stages of COVID-19 disease are needed.

Published
2021

2. Risk and predictive factors of prolonged viral RNA shedding in upper respiratory specimens in a large cohort of COVID-19 patients admitted in an Italian Reference Hospital

Author

Annalisa Mondi, Patrizia Lorenzini, Concetta Castilletti, Roberta Gagliardini, Eleonora Lalle, Angela Corpolongo, Maria Beatrice Valli, Fabrizio Taglietti, Stefania Cicalini, Laura Loiacono, Francesco Di Gennaro, Gianpiero D’Offizi, Fabrizio Palmieri, Emanuele Nicastri, Chiara Agrati, Nicola Petrosillo, Giuseppe Ippolito, Francesco Vaia, Enrico Girardi, Maria Rosaria Capobianchi, Andrea Antinori, Sara Zito, Maria Alessandra Abbonizio, Amina Abdeddaim, Elisabetta Agostini, Fabrizio Albarello, Gioia Amadei, Alessandra Amendola, Maria Assunta Antonica, Mario Antonini, Tommaso Ascoli Bartoli, Francesco Baldini, Raffaella Barbaro, Barbara Bartolini, Rita Bellagamba, Martina Benigni, Nazario Bevilacqua, Gianluigi Biava, Michele Bibas, Licia Bordi, Veronica Bordoni, Evangelo Boumis, Marta Branca, Rosanna Buonomo, Donatella Busso, Marta Camici, Paolo Campioni, Flaminia Canichella, Alessandro Capone, Cinzia Caporale, Emanuela Caraffa, Ilaria Caravella, Fabrizio Carletti, Adriana Cataldo, Stefano Cerilli, Carlotta Cerva, Roberta Chiappini, Pierangelo Chinello, Maria Assunta Cianfarani, Carmine Ciaralli, Claudia Cimaglia, Nicola Cinicola, Veronica Ciotti, Francesca Colavita, Massimo Cristofaro, Salvatore Curiale, Alessandra D’Abramo, Cristina Dantimi, Alessia De Angelis, Giada De Angelis, Maria Grazia De Palo, Federico De Zottis, Virginia Di Bari, Rachele Di Lorenzo, Federica Di Stefano, Davide Donno, Francesca Evangelista, Francesca Faraglia, Anna Farina, Federica Ferraro, Lorena Fiorentini, Andrea Frustaci, Matteo Fusetti, Vincenzo Galati, Paola Gallì, Gabriele Garotto, Ilaria Gaviano, Saba Gebremeskel Tekle, Maria Letizia Giancola, Filippo Giansante, Emanuela Giombini, Guido Granata, Maria Cristina Greci, Elisabetta Grilli, Susanna Grisetti, Gina Gualano, Fabio Iacomi, Marta Iaconi, Giuseppina Iannicelli, Carlo Inversi, Maria Elena Lamanna, Simone Lanini, Daniele Lapa, Luciana Lepore, Raffaella Libertone, Raffaella Lionetti, Giuseppina Liuzzi, Andrea Lucia, Franco Lufrani, Manuela Macchione, Gaetano Maffongelli, Alessandra Marani, Luisa Marchioni, Andrea Mariano, Maria Cristina Marini, Micaela Maritti, Annelisa Mastrobattista, Ilaria Mastrorosa, Giulia Matusali, Valentina Mazzotta, Paola Mencarini, Silvia Meschi, Francesco Messina, Sibiana Micarelli, Giulia Mogavero, Marzia Montalbano, Chiara Montaldo, Silvia Mosti, Silvia Murachelli, Maria Musso, Michela Nardi, Assunta Navarra, Martina Nocioni, Pasquale Noto, Roberto Noto, Alessandra Oliva, Ilaria Onnis, Sandrine Ottou, Claudia Palazzolo, Emanuele Pallini, Giulio Palombi, Carlo Pareo, Virgilio Passeri, Federico Pelliccioni, Giovanna Penna, Antonella Petrecchia, Ada Petrone, Elisa Pianura, Carmela Pinnetti, Maria Pisciotta, Pierluca Piselli, Silvia Pittalis, Agostina Pontarelli, Costanza Proietti, Vincenzo Puro, Paolo Migliorisi Ramazzini, Alessia Rianda, Gabriele Rinonapoli, Silvia Rosati, Dorotea Rubino, Martina Rueca, Alberto Ruggeri, Alessandra Sacchi, Alessandro Sampaolesi, Francesco Sanasi, Carmen Santagata, Alessandra Scarabello, Silvana Scarcia, Vincenzo Schininà, Paola Scognamiglio, Laura Scorzolini, Giulia Stazi, Giacomo Strano, Chiara Taibi, Giorgia Taloni, Tetaj Nardi, Roberto Tonnarini, Simone Topino, Martina Tozzi, Francesco Vairo, Alessandra Vergori, Laura Vincenzi, Ubaldo Visco-Comandini, Serena Vita, Pietro Vittozzi, Mauro Zaccarelli, Antonella Zanetti, Mondi, A., Lorenzini, P., Castilletti, C., Gagliardini, R., Lalle, E., Corpolongo, A., Valli, M. B., Taglietti, F., Cicalini, S., Loiacono, L., Di Gennaro, F., D'Offizi, G., Palmieri, F., Nicastri, E., Agrati, C., Petrosillo, N., Ippolito, G., Vaia, F., Girardi, E., Capobianchi, M. R., Antinori, A., Zito, S., Abbonizio, M. A., Abdeddaim, A., Agostini, E., Albarello, F., Amadei, G., Amendola, A., Antonica, M. A., Antonini, M., Bartoli, T. A., Baldini, F., Barbaro, R., Bartolini, B., Bellagamba, R., Benigni, M., Bevilacqua, N., Biava, G., Bibas, M., Bordi, L., Bordoni, V., Boumis, E., Branca, M., Buonomo, R., Busso, D., Camici, M., Campioni, P., Canichella, F., Capone, A., Caporale, C., Caraffa, E., Caravella, I., Carletti, F., Cataldo, A., Cerilli, S., Cerva, C., Chiappini, R., Chinello, P., Cianfarani, M. A., Ciaralli, C., Cimaglia, C., Cinicola, N., Ciotti, V., Colavita, F., Cristofaro, M., Curiale, S., D'Abramo, A., Dantimi, C., De Angelis, A., De Angelis, G., De Palo, M. G., De Zottis, F., Di Bari, V., Di Lorenzo, R., Di Stefano, F., Donno, D., Evangelista, F., Faraglia, F., Farina, A., Ferraro, F., Fiorentini, L., Frustaci, A., Fusetti, M., Galati, V., Galli, P., Garotto, G., Gaviano, I., Tekle, S. G., Giancola, M. L., Giansante, F., Giombini, E., Granata, G., Greci, M. C., Grilli, E., Grisetti, S., Gualano, G., Iacomi, F., Iaconi, M., Iannicelli, G., Inversi, C., Lamanna, M. E., Lanini, S., Lapa, D., Lepore, L., Libertone, R., Lionetti, R., Liuzzi, G., Lucia, A., Lufrani, F., Macchione, M., Maffongelli, G., Marani, A., Marchioni, L., Mariano, A., Marini, M. C., Maritti, M., Mastrobattista, A., Mastrorosa, I., Matusali, G., Mazzotta, V., Mencarini, P., Meschi, S., Messina, F., Micarelli, S., Mogavero, G., Montalbano, M., Montaldo, C., Mosti, S., Murachelli, S., Musso, M., Nardi, M., Navarra, A., Nocioni, M., Noto, P., Noto, R., Oliva, A., Onnis, I., Ottou, S., Palazzolo, C., Pallini, E., Palombi, G., Pareo, C., Passeri, V., Pelliccioni, F., Penna, G., Petrecchia, A., Petrone, A., Pianura, E., Pinnetti, C., Pisciotta, M., Piselli, P., Pittalis, S., Pontarelli, A., Proietti, C., Puro, V., Ramazzini, P. M., Rianda, A., Rinonapoli, G., Rosati, S., Rubino, D., Rueca, M., Ruggeri, A., Sacchi, A., Sampaolesi, A., Sanasi, F., Santagata, C., Scarabello, A., Scarcia, S., Schinina, V., Scognamiglio, P., Scorzolini, L., Stazi, G., Strano, G., Taibi, C., Taloni, G., Nardi, T., Tonnarini, R., Topino, S., Tozzi, M., Vairo, F., Vergori, A., Vincenzi, L., Visco-Comandini, U., Vita, S., Vittozzi, P., Zaccarelli, M., and Zanetti, A.

Subjects
Male, 0301 basic medicine, Time Factors, medicine.medical_treatment, Respiratory System, coronavirus, Infectious and parasitic diseases, RC109-216, Severity of Illness Index, Cohort Studies, 0302 clinical medicine, risk factors, 030212 general & internal medicine, Respiratory disease, General Medicine, Middle Aged, Virus Shedding, Infectious Diseases, symbols, RNA, Viral, Female, Coronavirus, COVID-19, viral clearance, viral shedding, Risk factors, SARS-CoV-2, Cohort study, Adult, Microbiology (medical), medicine.medical_specialty, viral shedding, Coronaviru, 030106 microbiology, Article, NO, 03 medical and health sciences, symbols.namesake, Internal medicine, Severity of illness, medicine, Humans, Poisson regression, Aged, Proportional Hazards Models, Mechanical ventilation, business.industry, Proportional hazards model, COVID-19, Retrospective cohort study, medicine.disease, Respiratory failure, Risk factor, business, viral clearance
Abstract

Background Few data about predictors and outcomes associated with prolonged SARS-CoV-2 RNA shedding (VS) are available. Methods Retrospective study including all patients admitted with COVID-19 in an Italian reference hospital for infectious diseases between March 1 and July 1, 2020. Predictors of viral clearance (VC) and prolonged VS from upper respiratory tract were assessed by Poisson regression and logistic regression analyses. The causal relation between duration of VS and probability of clinical outcomes was evaluated through inverse probability weighted Cox model. Results 536 subjects were included. Median duration of VS from symptoms onset was 18 days (IQR 12-26). The estimated 30-day probability of VC was 70.2% (95%CI:65-75). At multivariable analysis, patients with comorbidities (aIRR = 0.88, p = 0.004), lymphopenia at hospital admission (aIRR = 0.75, p = 0.032) and with moderate/severe respiratory disease (aIRR = 0.42, p 1000 ng/mL at admission (aOR = 1.76, p = 0.035) independently predicted prolonged VS. The achievement of VC doubled the chance of clinical recovery (aHR = 2.17, p

Published
2021

3. Bacterial and CMV pneumonia in a patient treated with alemtuzumab for multiple sclerosis

Author

Ivan Gentile, Emanuela Zappulo, Federico De Zottis, Francesco Saccà, Guglielmo Borgia, Roberta Lanzillo, Antonio Carotenuto, Antonio Riccardo Buonomo, Cinzia Valeria Russo, Buonomo, A. R., Sacca, F., Zappulo, E., De Zottis, F., Lanzillo, R., Gentile, I., Carotenuto, A., Borgia, G., and Russo, C. V.

Subjects
Cytomegalovirus Infection, Male, Multiple Sclerosis, CD52, Pneumonia, Viral, Congenital cytomegalovirus infection, Antibodies, Monoclonal, Humanized, 03 medical and health sciences, Opportunistic infection, 0302 clinical medicine, Immune system, Interferon, Multiple Sclerosi, medicine, Pneumonia, Bacterial, Humans, 030212 general & internal medicine, Alemtuzumab, business.industry, Multiple sclerosis, Bacterial pneumonia, CMV, General Medicine, Middle Aged, medicine.disease, Neurology, Cytomegalovirus Infections, Immunology, Neurology (clinical), Complication, business, 030217 neurology & neurosurgery, medicine.drug, Human
Abstract

Alemtuzumab (a drug highly active in multiple sclerosis) is a humanized monoclonal antibody targeting the surface molecule CD52. It causes a rapid depletion of innate and adaptive immune cells with a peak during the first month after infusion. Infection rates in alemtuzumab-treated patients with multiple sclerosis in clinical trials were higher in than in interferon beta-treated patients. Cytomegalovirus (CMV) primary infections and reactivations have been reported in this setting of patients. We describe the case of a patient that developed both viral (CMV) and bacterial pneumonia one month after alemtuzumab infusion for multiple sclerosis. Physicians dealing with this drug should be aware of this serious but treatable complication.

Published
2019

4. Effectiveness and Tolerability of DOR/3TC/TDF in Experienced People with HIV Switching from RPV/FTC/TDF: A Retrospective, Single Center Cohort Study.

Author

Cicalini S, Lanini S, Gagliardini R, Bellagamba R, Vergori A, Mastrorosa I, Mazzotta V, Esvan R, Plazzi MM, Ottou S, Grilli E, De Zottis F, Fusto M, Paulicelli J, and Antinori A

Abstract

Background: With advances in antiretroviral therapy for HIV treatment, newer drug combinations provide improved efficacy, safety, and compliance. This study evaluates switching to a regimen of doravirine (DOR), tenofovir disoproxil fumarate (TDF), and lamivudine (3TC) in a cohort of people living with HIV (PLWH). Methods: this Italian retrospective study included 426 PLWH who switched from rilpivirine (RPV)/TDF/emtricitabine (FTC) to DOR/3TC/TDF. The analysis focused on treatment effectiveness, safety, and metabolic and renal markers. Results: this study reports a treatment failure (defined as virological failure or discontinuation of the regimen) rate of 2.34% (95% confidence interval, 1.28-4.50%), with significant improvement in CD4 counts (+49.93 cells/µL, p < 0.001). Notably, the switch to DOR/3TC/TDF did not result in adverse metabolic effects or significant changes in renal function. Analysis of lipid profiles showed stabilization in the majority of PLWH. Conclusions: this study indicates that switching to a DOR/3TC/TDF from RPV/TDF/FTC is an effective and well-tolerated option for PLWH, with benefits in terms of maintaining viral suppression, CD4 count recovery, and metabolic health, without evidence of renal impairment. These results support the continued use of DOR/3TC/TDF as part of HIV treatment strategies and highlight the need for ongoing research to refine ART regimens for different populations.

Published
2024
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5. Impact of switching from EFV/F/TDF to B/F/TAF on psychiatric symptoms and neurocognition.

Author

Vergori A, Del Duca G, Lorenzini P, Brita AC, Mastrorosa I, Fusto M, Camici M, Ottou S, Gagliardini R, Paulicelli J, De Zottis F, Grilli E, Esvan R, Plazzi MM, Mazzotta V, Bellagamba R, Antinori A, and Pinnetti C

Abstract

Objectives: The aim was to investigate whether switching from EFV/F/TDF to B/F/TAF may improve neuropsychiatrc symptoms and neurocognition., Design: Pilot, single-arm, prospective study of persons with HIV (PWH) on the efficacy and safety of switching from EFV/F/TDF to B/F/TAF., Methods: Participants underwent neuropsychological assessment (NPA) at switch (T0) and after 48 weeks (T1). NPA was carried out through a standardized battery of 12 tests. Neurocognitive impairment (NCI) was defined by a score ≥1 standard deviation (SD) below the normal mean on at least 2 tests or ≥2 SD below on 1 test. Individual z-scores were determined, NPZ-12 was calculated as the average of 12 test z-scores and change of NPZ-12 was the outcome. HIV-associated Neurocognitive Disorder (HAND) was classified by Frascati's criteria. Beck Anxiety Inventory (BAI), Beck Depression Inventory (BDI-II), and Pittsburgh Sleep Quality Index (PSQI) were administered. Paired-Wilcoxon and McNemar tests were used for comparisons, and logistic regression for associations with NCI changes., Results: Out of 126 participants, BAI, BDI-II, and PSQI questionnaires revealed an improvement at T1. NPA revealed NCI in 40.5% of persons at T0 and 42.1% at T1 (p = 0.746). Specifically, at T0, among participants with NCI, 35% improved; among those without, 26% worsened at T1; NPZ-12 score worsened at T1. 5.6% of ANI was observed at T0 and 7.9% at T1. No factor associated with these changes was found., Conclusions: Our results suggest switching from EFV/F/TDF to B/F/TAF significantly improves psychiatric symptoms and sleep quality. Neurocognitive performance remained stable, although a decline in NPZ-12 and in specific domains was observed., (Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc.)

Published
2024
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6. Rapid ART initiation with bictegravir/emtricitabine/tenofovir alafenamide in individuals presenting with advanced HIV disease (Rainbow study).

Author

Camici M, Gagliardini R, Lanini S, Del Duca G, Mondi A, Ottou S, Plazzi MM, De Zottis F, Pinnetti C, Vergori A, Grilli E, Mastrorosa I, Mazzotta V, Paulicelli J, Bellagamba R, Cimini E, Tartaglia E, Notari S, Tempestilli M, Cicalini S, Amendola A, Abbate I, Forbici F, Fabeni L, Girardi E, Vaia F, Maggi F, and Antinori A

Subjects
Humans, Female, Prospective Studies, Emtricitabine therapeutic use, Adenine therapeutic use, Pyridones therapeutic use, Drug Combinations, Heterocyclic Compounds, 4 or More Rings therapeutic use, HIV Infections drug therapy, Anti-HIV Agents therapeutic use, Piperazines, Tenofovir analogs & derivatives, Alanine, Amides, Heterocyclic Compounds, 3-Ring
Abstract

Background: A rapid ART initiation approach can be beneficial in people with advanced HIV disease, in consideration of their high morbidity and mortality. The aim of our study was to evaluate the feasibility, efficacy and safety of rapid ART start with BIC/FTC/TAF in this setting., Methods: Pilot, single-centre, single-arm, prospective, phase IV clinical trial conducted in a tertiary Italian hospital. Thirty ART-naïve people presenting with advanced HIV-1 diagnosis (defined as the presence of an AIDS-defining event and/or CD4 cell count <200 µL), were enrolled. Main exclusion criteria were active tuberculosis, cryptococcosis and pregnant/breastfeeding women. BIC/FTC/TAF was started within 7 days from HIV diagnosis. The primary endpoint was clinical or virologic failure (VF). Immunological parameters, safety, feasibility, neurocognitive performances and patient-reported outcomes were assessed as well., Results: Over the study period, 40 (34%) of 116 patients diagnosed with HIV infection at INMI Spallanzani had advanced disease, of whom 30 (26%) were enrolled. The proportion of participants with HIV-RNA <50 cp/mL was 9/30 (30%) at week (w) 4, 19/30 (63%) at w12, 24/30 (80%) at w24, 23/30 (77%) at w36 and 27/30 (90%) at w48. Two unconfirmed VF occurred. No ART discontinuation due to toxicity or VF was observed. No ART modification was performed based on the review of genotype and no mutations for the study drugs were detected. Mean CD4 cells count changed by 133 cells/μL at BL to 309 cells/μL at w 48 and 83% of participants had a CD4 > 200 cells/µL at w 48. Two participants developed IRIS and one was diagnosed with disseminated TB and needed an ART switch., Interpretations: Our results support the feasibility, efficacy and safety of BIC/FTC/TAF as a rapid ART strategy in patients with advanced HIV disease., (Copyright © 2023 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

Published
2024
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7. Declining Prevalence of Human Immunodeficiency Virus (HIV)-Associated Neurocognitive Disorders in Recent Years and Associated Factors in a Large Cohort of Antiretroviral Therapy-Treated Individuals With HIV.

Author

Mastrorosa I, Pinnetti C, Brita AC, Mondi A, Lorenzini P, Del Duca G, Vergori A, Mazzotta V, Gagliardini R, Camici M, De Zottis F, Fusto M, Plazzi MM, Grilli E, Bellagamba R, Cicalini S, and Antinori A

Subjects
Humans, Prevalence, Cross-Sectional Studies, Neurocognitive Disorders epidemiology, HIV, HIV Infections complications, HIV Infections drug therapy, HIV Infections epidemiology
Abstract

Background: HIV-associated neurocognitive disorders (HAND) have been suggested as persistent even with effective antiretroviral therapy (ART). Aims were to evaluate HAND prevalence and associated factors, in a large cohort of people-with-HIV (PWH)., Methods: ART-treated PWH, underwent a neuropsychological examination through a battery of 12 tests exploring 5 different domains, between 2009 and 2020, were included in this cross-sectional analysis. HAND were classified according to Frascati's criteria. Participants were defined as complaining or not-complaining if a cognitive complaint was reported or not. Chi-square for trend and multivariable logistic regression were fitted., Results: Overall, 1424 PWH were enrolled during four three-years periods. HAND prevalence was 24%; among complainers (572/1424), it was 38%, higher than among not-complainers (15%). Over the study period, a decreasing HAND prevalence was found in the entire population (P < 0.001) and in complaining (P < 0.001); in not-complaining it remained stable (P = 0.182). Factors associated with HAND were older age, lower educational level, lower current CD4+ T-cell count and HCV co-infection. Compared to nonnucleoside reverse transcriptase inhibitors, receiving dual and integrase strand transfer inhibitor (INSTI)-based therapies was associated with a decreased risk of HAND, as well as being tested in more recent years., Conclusions: In this large cohort of ART-treated PWH, mostly virologically suppressed, a remarkable decreasing HAND prevalence was observed. Besides HIV- and patient-related factors, the reduced risk of HAND found with dual and INSTI-based regimens along with a more recent ART initiation, could suggest a potential role of new treatment strategies in this decline, due to their greater virologic efficacy and better tolerability., Competing Interests: Potential conflicts of interest. Andrea Antinori has served as a paid consultant to and received payment or honoraria from Astra-Zeneca, Gilead Sciences, GlaxoSmithKline, Janssen-Cilag, Merck Sharp and Dohme, Roche, Theratotecnologies, ViiV Healthcare. Rita Bellagamba reports payment or honoraria from Merck Sharp and Dohme, and participation on a Data Safety Monitoring Board or Advisory Board from ViiV Healthcare, Gilead Sciences, and Merck Sharp and Dohme. Marta Camici received institutional grant and support for attending meetings and/or travel from Gilead Sciences. Stefania Cicalini reports consulting fees paid to self from ViiV Healthcare, Jansen-Cilag, Merck Sharp and Dohme, Gilead Sciences; payment or honoraria from ViiV Healthcare, Jansen-Cilag, Merck Sharp and Dohme, and Gilead Sciences. Roberta Gagliardini reports payments to their institution from Gilead Sciences, speakers' honoraria/educational activities for ViiV Healthcare, Merck Sharp and Dohme and Gilead Sciences, support for attending meetings and/or travel from ViiV Healthcare, advisor for Theratechnologies, Janssen-Cilag and Gilead Sciences. Ilaria Mastrorosa received institutional grant and support for attending meetings and/or travel from Gilead Sciences. Carmela Pinnetti received personal fee from Gilead Sciences for a case presentation and a travel grant and served on an advisory board for Janssen-Cilag. Alessandra Vergori received institutional grant from Gilead Sciences, speakers' honoraria/educational activities for Merck Sharp and Dohme and Janssen-Cilag, advisor for Janssen-Cilag. The other co-authors declare no conflicts of interests., (© The Author(s) 2022. Published by Oxford University Press on behalf of Infectious Diseases Society of America.)

Published
2023
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8. Risk and predictive factors of prolonged viral RNA shedding in upper respiratory specimens in a large cohort of COVID-19 patients admitted to an Italian reference hospital.

Author

Mondi A, Lorenzini P, Castilletti C, Gagliardini R, Lalle E, Corpolongo A, Valli MB, Taglietti F, Cicalini S, Loiacono L, Di Gennaro F, D'Offizi G, Palmieri F, Nicastri E, Agrati C, Petrosillo N, Ippolito G, Vaia F, Girardi E, Capobianchi MR, Antinori A, Zito S, Abbonizio MA, Abdeddaim A, Agostini E, Agrati C, Albarello F, Amadei G, Amendola A, Antinori A, Antonica MA, Antonini M, Bartoli TA, Baldini F, Barbaro R, Bartolini B, Bellagamba R, Benigni M, Bevilacqua N, Biava G, Bibas M, Bordi L, Bordoni V, Boumis E, Branca M, Buonomo R, Busso D, Camici M, Campioni P, Canichella F, Capobianchi MR, Capone A, Caporale C, Caraffa E, Caravella I, Carletti F, Castilletti C, Cataldo A, Cerilli S, Cerva C, Chiappini R, Chinello P, Cianfarani MA, Ciaralli C, Cimaglia C, Cinicola N, Ciotti V, Cicalini S, Colavita F, Corpolongo A, Cristofaro M, Curiale S, D'Abramo A, Dantimi C, De Angelis A, De Angelis G, De Palo MG, De Zottis F, Di Bari V, Di Lorenzo R, Di Stefano F, D'Offizi G, Donno D, Evangelista F, Faraglia F, Farina A, Ferraro F, Fiorentini L, Frustaci A, Fusetti M, Galati V, Gagliardini R, Gallì P, Garotto G, Gaviano I, Tekle SG, Giancola ML, Giansante F, Giombini E, Granata G, Greci MC, Grilli E, Grisetti S, Gualano G, Iacomi F, Iaconi M, Iannicelli G, Inversi C, Ippolito G, Lalle E, Lamanna ME, Lanini S, Lapa D, Lepore L, Libertone R, Lionetti R, Liuzzi G, Loiacono L, Lucia A, Lufrani F, Macchione M, Maffongelli G, Marani A, Marchioni L, Mariano A, Marini MC, Maritti M, Mastrobattista A, Mastrorosa I, Matusali G, Mazzotta V, Mencarini P, Meschi S, Messina F, Micarelli S, Mogavero G, Mondi A, Montalbano M, Montaldo C, Mosti S, Murachelli S, Musso M, Nardi M, Navarra A, Nicastri E, Nocioni M, Noto P, Noto R, Oliva A, Onnis I, Ottou S, Palazzolo C, Pallini E, Palmieri F, Palombi G, Pareo C, Passeri V, Pelliccioni F, Penna G, Petrecchia A, Petrone A, Petrosillo N, Pianura E, Pinnetti C, Pisciotta M, Piselli P, Pittalis S, Pontarelli A, Proietti C, Puro V, Ramazzini PM, Rianda A, Rinonapoli G, Rosati S, Rubino D, Rueca M, Ruggeri A, Sacchi A, Sampaolesi A, Sanasi F, Santagata C, Scarabello A, Scarcia S, Schininà V, Scognamiglio P, Scorzolini L, Stazi G, Strano G, Taglietti F, Taibi C, Taloni G, Nardi T, Tonnarini R, Topino S, Tozzi M, Vaia F, Vairo F, Valli MB, Vergori A, Vincenzi L, Visco-Comandini U, Vita S, Vittozzi P, Zaccarelli M, Zanetti A, and Zito S

Subjects
Adult, Aged, Cohort Studies, Female, Humans, Male, Middle Aged, Proportional Hazards Models, Severity of Illness Index, Time Factors, COVID-19 virology, RNA, Viral analysis, Respiratory System virology, SARS-CoV-2 isolation & purification, Virus Shedding
Abstract

Background: Limited data are available about the predictors and outcomes associated with prolonged SARS-CoV-2 RNA shedding (VS)., Methods: A retrospective study including COVID-19 patients admitted to an Italian hospital between March 1 and July 1, 2020. Predictors of viral clearance (VC) and prolonged VS from the upper respiratory tract were assessed by Poisson regression and logistic regression analyses. The causal relation between VS and clinical outcomes was evaluated through an inverse probability weighted Cox model., Results: The study included 536 subjects. The median duration of VS from symptoms onset was 18 days. The estimated 30-day probability of VC was 70.2%. Patients with comorbidities, lymphopenia at hospital admission, or moderate/severe respiratory disease had a lower chance of VC. The development of moderate/severe respiratory failure, delayed hospital admission after symptoms onset, baseline comorbidities, or D-dimer >1000ng/mL at admission independently predicted prolonged VS. The achievement of VC doubled the chance of clinical recovery and reduced the probability of death/mechanical ventilation., Conclusions: Respiratory disease severity, comorbidities, delayed hospital admission and inflammatory markers negatively predicted VC, which resulted to be associated with better clinical outcomes. These findings highlight the importance of prompt hospitalization of symptomatic patients, especially where signs of severity or comorbidities are present., (Copyright © 2021 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Published
2021
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9. COVID-19 in people living with HIV: Clinical implications of dynamics of the immune response to SARS-CoV-2.

Author

Mondi A, Cimini E, Colavita F, Cicalini S, Pinnetti C, Matusali G, Casetti R, Maeurer M, Vergori A, Mazzotta V, Gagliardini R, De Zottis F, Schininà V, Girardi E, Puro V, Ippolito G, Vaia F, Capobianchi MR, Castilletti C, Agrati C, and Antinori A

Subjects
Antibodies, Neutralizing blood, Antibodies, Viral blood, CD4 Lymphocyte Count, Coinfection virology, Cytokines blood, Female, HIV Integrase Inhibitors therapeutic use, Heterocyclic Compounds, 3-Ring therapeutic use, Humans, Immunity, Humoral immunology, Male, Middle Aged, Oxazines therapeutic use, Piperazines therapeutic use, Pyridones therapeutic use, RNA, Viral analysis, Reverse Transcriptase Inhibitors therapeutic use, Risk, Severity of Illness Index, Tenofovir therapeutic use, Transgender Persons, Anti-Retroviral Agents therapeutic use, HIV Infections drug therapy, SARS-CoV-2 drug effects, COVID-19 Drug Treatment
Abstract

Little evidence on coronavirus disease 2019 (COVID-19) in people living with HIV (PLWH) is currently available. We reported clinical and viroimmunological data of all HIV-positive patients admitted to our center with COVID-19 from March 1 to May 12, 2020. Overall, five patients were included: all were virologically-suppressed on antiretroviral therapy and CD4+ count was greater than 350 cell/mm 3 in all but two patients. Although all patients had evidence of pneumonia on admission, only one developed respiratory failure. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RNA was never detected from nasopharyngeal swabs in two patients, whereas in the others, viral clearance occurred within a maximum of 43 days. Immunoglobulin G production was elicited in all patients and neutralizing antibodies in all but one patient. Specific-T-cell response developed in all patients but was stronger in those with the more severe presentations. Similarly, the highest level of proinflammatory cytokines was found in the only patient experiencing respiratory failure. Despite a mild presentation, patients with more pronounced immunosuppression showed high degrees of both cytokines production and immune activation. Our study did not find an increased risk and severity of COVID-19 in PLWH. Adaptative cellular immune response to SARS-CoV-2 appeared to correlate to disease severity. The mild clinical picture showed in advanced HIV patients, despite a significant T-cell activation and inflammatory profile, suggests a potential role of HIV-driven immunological dysregulation in avoiding immune-pathogenetic processes. However, other possible explanations, as a protective role of certain antiretroviral drugs, should be considered. Further larger studies are needed to better clarify the impact of HIV infection on COVID-19., (© 2020 Wiley Periodicals LLC.)

Published
2021
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10. Bacterial and CMV pneumonia in a patient treated with alemtuzumab for multiple sclerosis.

Author

Buonomo AR, Saccà F, Zappulo E, De Zottis F, Lanzillo R, Gentile I, Carotenuto A, Borgia G, and Russo CV

Subjects
Cytomegalovirus Infections immunology, Humans, Male, Middle Aged, Pneumonia, Bacterial immunology, Pneumonia, Viral immunology, Alemtuzumab adverse effects, Antibodies, Monoclonal, Humanized adverse effects, Cytomegalovirus Infections etiology, Multiple Sclerosis drug therapy, Pneumonia, Bacterial etiology, Pneumonia, Viral etiology
Abstract

Alemtuzumab (a drug highly active in multiple sclerosis) is a humanized monoclonal antibody targeting the surface molecule CD52. It causes a rapid depletion of innate and adaptive immune cells with a peak during the first month after infusion. Infection rates in alemtuzumab-treated patients with multiple sclerosis in clinical trials were higher in than in interferon beta-treated patients. Cytomegalovirus (CMV) primary infections and reactivations have been reported in this setting of patients. We describe the case of a patient that developed both viral (CMV) and bacterial pneumonia one month after alemtuzumab infusion for multiple sclerosis. Physicians dealing with this drug should be aware of this serious but treatable complication., (Copyright © 2018. Published by Elsevier B.V.)

Published
2019
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11. Successful treatment of post-surgical osteomyelitis caused by XDR Pseudomonas aeruginosa with ceftolozane/tazobactam monotherapy.

Author

Gentile I, Buonomo AR, Maraolo AE, Scotto R, De Zottis F, Di Renzo G, and Borgia G

Subjects
Anti-Bacterial Agents pharmacology, Drug Resistance, Multiple, Bacterial, Fractures, Bone surgery, Humans, Male, Microbial Sensitivity Tests, Middle Aged, Penicillanic Acid administration & dosage, Pseudomonas aeruginosa isolation & purification, Tazobactam, Treatment Outcome, Anti-Bacterial Agents administration & dosage, Cephalosporins administration & dosage, Fractures, Bone complications, Osteomyelitis drug therapy, Penicillanic Acid analogs & derivatives, Pseudomonas Infections drug therapy, Pseudomonas aeruginosa drug effects, beta-Lactamase Inhibitors administration & dosage
Published
2017
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