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1. Arterial and venous thrombosis in coronavirus 2019 disease (Covid-19):relationship with mortality

Author

Violi, F., Ceccarelli, G., Cangemi, R., Cipollone, F., D'Ardes, D., Oliva, A., Pirro, M., Rocco, M., Alessandri, F., D'Ettorre, G., Lichtner, M., Pignatelli, P., Ferro, D., Ruberto, F., Lip, G. Y. H., Pugliese, F., Mastroianni, C. M., Albante, A., Auricchio, D., De Lazzaro, F., M. De Lauri D., Di Santo, C., Ianni, S., Magnanimi, E., Ratini, F., Sabani, A., Titi, L., Vaccaro, P., Giordano, G., Manganelli, C., Mancone, M., Bruno, K., Celli, P., Consolo, S., Croce, C., Giannetti, L., Martelli, S., Messina, T., Pattelli, E., Perrella, S., Portieri, M., Ricci, C., Almenrader, N., Arzilla, R., Delia, E., Di Giovanni, C., Laderchi, A., Macri, C., Marandola, M., Nardecchia, G., Pacilli, M., Pacini, F., Araimo Morselli, F., Imperiale, C., Tordiglione, P., Ciardi, M. R., Ajassa, C., D'Agostino, C., Russo, G., Trinchieri, V., Guariglia, P., Antonelli, L., Cuomo, R. M., Carnevalini, M., Mastropietro, C., Iaiani, G., Mezzaroma, I., Falciano, M., Brogi, A., Celani, L., Cavallari, N. E., Rivano Capparuccia, M., Massetti, A. P., Fimiani, C., Santori, M., Bianchi, A., Franchi, C., De Angelis, M., Sereno, S., Furlan, C., De Sanctis, G., Paoletti, F., Pasculli, P., Cogliati Dezza, F., Vassalini, P., Cancelli, F., De Girolamo, G., Savelloni, G., Valeri, S., Siccardi, G., Alessi, F., Recchia, G., Ridolfi, M., Romani, F. E., Aronica, R., Filippi, V., Vera, M., Volpicelli, L., Candy, M., Alban, R., Di Bari, S., Gavaruzzi, F., Casali, E., Carli, M. S., Zingaropoli, A. M., Perri, V., Santinelli, L., Pinacchio, C., Nijhawan, P., Miele, C. M., Innocenti, P. G., and Mengoni, F.

Subjects
Male, covid-19, mortality, sars-cov-2, thrombosis, Coronary Artery Disease, Kaplan-Meier Estimate, 030204 cardiovascular system & hematology, law.invention, Coronary artery disease, 0302 clinical medicine, law, 80 and over, Coronary Artery Disease/epidemiology, Odds Ratio, SARS-cov-2, 030212 general & internal medicine, Prospective Studies, Aged, 80 and over, Thromboembolism/epidemiology, biology, Hazard ratio, Middle Aged, Mortality/trends, Intensive care unit, Thrombosis, Venous thrombosis, Intensive Care Units, C-Reactive Protein, Emergency Medicine, Cardiology, COVID-19/complications, Female, medicine.medical_specialty, Fibrin Fibrinogen Degradation Products/analysis, Fibrin Fibrinogen Degradation Products, 03 medical and health sciences, C-Reactive Protein/analysis, Internal medicine, Thromboembolism, Internal Medicine, medicine, Humans, Mortality, Aged, Proportional Hazards Models, Intensive Care Units/organization & administration, business.industry, C-reactive protein, COVID-19, Odds ratio, medicine.disease, Im - Original, Logistic Models, Heart failure, biology.protein, business
Abstract

Background Patients with coronavirus disease 2019 (Covid-19) may experience venous thrombosis while data regarding arterial thrombosis are sparse. Methods Prospective multicenter study in 5 hospitals including 373 patients with Covid-19-related pneumonia. Demographic data, laboratory findings including coagulation tests and comorbidities were reported. During the follow-up any arterial or venous thrombotic events and death were registered. Results Among 373 patients, 75 (20%) had a thrombotic event and 75 (20%) died. Thrombotic events included 41 venous thromboembolism and 34 arterial thrombosis. Age, cardiovascular disease, intensive care unit treatment, white blood cells, D-dimer, albumin and troponin blood levels were associated with thrombotic events. In a multivariable regression logistic model, intensive care unit treatment (Odds Ratio [OR]: 6.0; 95% Confidence Interval [CI] 2.8–12.6; p p = 0.022); and albumin levels (OR: 0.49; 95% CI 0.28–0.87; p = 0.014) were associated with ischemic events. Age, sex, chronic obstructive pulmonary disease, diabetes, heart failure, coronary heart disease, intensive care unit treatment, in-hospital thrombotic events, D-dimer, C-reactive protein, troponin, and albumin levels were associated with mortality. A multivariable Cox regression analysis showed that in-hospital thrombotic events (hazard ratio [HR]: 2.72; 95% CI 1.59–4.65; p p = 0.001), and albumin (HR: 0.447; 95% CI 0.277–0.723; p = 0.001) predicted morality. Conclusions Covid-19 patients experience an equipollent rate of venous and arterial thrombotic events, that are associated with poor survival. Early identification and appropriate treatment of Covid-19 patients at risk of thrombosis may improve prognosis.

Published
2021
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2. Impact of new DAA therapy on real clinical practice: a multicenter region-wide cohort study

Author

Lanini, Simone, Scognamiglio, Paola, Mecozzi, Alessandra, Lombardozzi, Lorella, Vullo, Vincenzo, Angelico, Mario, Gasbarrini, Antonio, Taliani, Gloria, Attili, Adolfo Francesco, Perno, Carlo Federico, De Santis, Adriano, Puro, Vincenzo, Cerqua, Fabio, D'Offizi, Gianpiero, Pellicelli, Adriano, Armignacco, Orlando, Mennini, Francesco Saverio, Siciliano, Massimo, Girardi, Enrico, Panella, Vincenzo, Ippolito, Giuseppe, Sarrecchia, C., Di Paolo, M. D., Francioso, S., Brega, A., Lenci, I., Sarmati, L., Pompili, Maurizio, Grieco, Antonio, Tamburrini, Enrica, Apaccini, R., Miele, Luca, D'Ettorre, G., Mezzaroma, I., Furlan, C., Accapezzato, D., Paoletti, F., Merili, M., Corradini, S., Sereno, S., Fimiani, C., Mastropietro, C., Labbadia, G., Gentile, Giuseppe, Pasquazzi, C., Marignani, M., Guarisco, R., Puoti, C., Spilabotti, L., Montalbano, M., Boumis, E., Visco-Comandini, U., Zaccarelli, M., Ammassari, A., Lionetti, R., Murachelli, S., Loiacono, L., Antinori, Armando, Noto, P., Palmieri, F., Cicalini, S., Cerilli, S., Sampaolesi, A., Vincenzi, L., Bellagamba, R., Galati, V., Abdeddaim, A., Iacomi, F., Iannicelli, G., Mastroianni, Chiara, Lichtner, M., Ridola, L., Coluzzi, T., Mercurio, V., Del Borgo, C., Fondacaro, L., Cerasari, G., Guarascio, P., D'Ambrosio, C., Starnini, G., Caterini, A., Villani, Emanuele Rocco, Sarracino, L., Casinelli, K., Moretti, A., Vespasiani, U., Galati, G., Cecere, R., Bonaventura, M., and Scudieri, M.

Subjects
Male, Cirrhosis, Investigational, chronic hepatitis c, clinical study, direct acting antiviral, hepatitis c virus, liver cirrhosis, liver damage, mixed effect model, multicenter cohort study, new therapy, treatment efficacy, Logistic regression, Chronic hepatitis C, Cohort Studies, 0302 clinical medicine, Clinical study, Direct acting antiviral, Hepatitis C virus, Liver cirrhosis, Liver damage, Mixed effect model, Multicenter cohort study, New therapy, Treatment efficacy, Adult, Aged, Aged, 80 and over, Antiviral Agents, Drug Therapy, Combination, Drugs, Investigational, Female, Follow-Up Studies, Hepatitis C, Chronic, Humans, Liver Cirrhosis, Middle Aged, Therapies, Investigational, 80 and over, 030212 general & internal medicine, Stage (cooking), Chronic, Confounding, Drugs, Hepatitis C, Infectious Diseases, Cohort, Combination, Settore SECS-P/03 - Scienza delle Finanze, 030211 gastroenterology & hepatology, Cohort study, Research Article, medicine.medical_specialty, Side effect, Hepatitis C virus, Chronic hepatitis C, Liver cirrhosis, Direct acting antiviral, Multicenter cohort study, Mixed effect model, Liver damage, Treatment efficacy, Clinical study, New therapy, lcsh:Infectious and parasitic diseases, 03 medical and health sciences, Drug Therapy, Internal medicine, medicine, lcsh:RC109-216, business.industry, Settore MED/09 - MEDICINA INTERNA, medicine.disease, Clinical trial, Therapies, business
Abstract

Background Management of chronic hepatitis C (CHC) has significantly accelerated in the last few years. Currently, second generation direct acting antivirals (DAAs) promise clearance of infection in most of patients. Here we present the results of the first analysis carried out on data of Lazio clinical network for DAAs. Methods The study was designed as a multicenter cohort: a) to assess the evolution of treatment during the first 24 months of the activity of the Clinical Network; b) to report overall efficacy of treatments; c) to analyze potential factors associated with lack of virological response at 12 weeks after therapy (SVR12); d) to evaluate the variation of ALT at baseline and 12 weeks after therapy in those who achieved SVR12 in comparison to those who did not. Analyses of efficacy were carried out with multilevel mixed effect logistic regression model. ALT temporal variation was assessed by mixed effect model mixed models with random intercept at patient’s level and random slope at the level of the time; i.e. either before or after therapy. Results Between 30 December 2014 and 31 December 2016 5279 patients started a DAA treatment; of those, 5127 (in 14 clinical centers) had completed the 12-week follow-up. Overall proportion of SVR12 was 93.41% (N = 4780) with no heterogeneity between the 14 clinical centers. Interruption as the consequence of severe side effect was very low (only 23 patients). Unadjusted analysis indicates that proportion of SVR12 significantly changes according to patient’s baseline characteristics, however after adjusting for potential confounders only adherence to current guidelines, stage of liver diseases, gender, transplant and HIV status were independently associated with the response to therapy. Analysis of ALT temporal variation showed that ALT level normalized in most, but not, all patients who achieved SVR12. Conclusion Our study confirmed the extraordinary efficacy of DAAs outside clinical trials. The advantage of DAAs was particularly significant for those patients who were previously considered as difficult-to-treat and did not have treatment options before DAAs era. Intervention based on network of select centers and prioritization of patients according to diseases severity was successful. Further studies are needed to establish whether clearance of HCV after DAAs therapy can arrest or even revert liver fibrosis in non-cirrhotic patients and/or improve life quality and expectancy in those who achieve SVR12 with cirrhosis.

Published
2018
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3. Simit Epidemiological Multicentric Study on Hospitalized Immigrants in Italy During 2002

Author

Scotto, G., Saracino, A., Pempinello, R., El Hamad, I., Geraci, S., Panunzio, M., Palumbo, Ernesto, Cibelli, D. C., Angarano, G., Quirino, T., Vigevani, G. M., Balducci, M., Petrelli, E., Bergamasco, A., Cadeo, G., Elhamad, I., Carosi, G., Vitucci, N., Gobbi, M., Allegri, M. P., Toti, M., Piretti, B., De Stefano, C., Mannozzi, P., Mastropietro, C., Paffetti, A., Losappio, R., Fontana, T., Sfara, C., Stagni, G., Salome, G., Soscia, F., Maggi, P., Pastore, G., Miccolis, S., Scalzini, A., Brogi, A., Renda, V., Lancella, L., Ticca, F., Gabbati, A., Mazzotta, A., Villa, M., Viganò, P., Salatino, A., Andreoni, M., Drenaggi, D., Scalise, G., Ciardi, M., D'Elia, S., Limodio, M., Gallo, A. I., Delia, S., Caltabiano, E., Cosentino, G., Raspaglieli, M., Di Gregorio, P., Mariani, R., Paolini, M., Sabbatani, S., Chiodo, F., Casabianca, A., Biglino, A., Galloni, D., Carnevale, G., Pantaleoni, M., Ghinelli, F., Purificato, F., Pompei, A. G., Portelli, V., Chasseur, R., Tassara, A., Benenat, B., Sapienza, M., Sabatini, P., Sabusco, G., Bellardini, G., Zauli, T., Valencic, A., Luzzati, R., Milini, P., Chiodera, A., Sebbia, F., Davi', A., Pizzigallo, E., Scerbo, P., Ferraro, T., Consorte, A., Mariani Toro, G., Gioia, M., Grossi, P., Coviello, G., Sagnelli, E., Azzimi, A., Concia, A., Allegra, M., and Todaro, Gianmarco

Subjects
Adult, Male, medicine.medical_specialty, Pediatrics, Tuberculosis, Adolescent, Epidemiology, HIV Infections, infectious diseases, Communicable Diseases, Article, Hepatitis, HIV, Hospitalization, Immigration, Infectious diseases, Female, Humans, Italy, Middle Aged, Multicenter Studies as Topic, Poverty, Surveys and Questionnaires, Emigration and Immigration, Public Health, Environmental and Occupational Health, medicine, business.industry, Public health, Environmental and Occupational Health, medicine.disease, Country of origin, tuberculosis, Infectious disease (medical specialty), Immunology, Public Health, business, Viral hepatitis, Malaria, immigration
Abstract

The aim of this article is to retrospectively evaluate the patient characteristics and the most common infectious diseases in immigrant patients hospitalized in 46 Italian infectious disease clinics during 2002. The main Italian infectious disease clinics were invited to fill in a questionnaire that regarded the number and type of hospital admissions, the country of origin, and demographic features (age, sex, and resident state) of immigrants. A total of 46 clinics including 2255 patients participated in the study. Most patients were men (63%) with an age between 16 and 40 years (63.4%) covered by the National Health Service (71%) and coming from Africa (44.3%). The main infectious diseases observed were: 378 (16.76%) cases of HIV infection, 303 (13.43%) cases of tuberculosis diseases, 282 (12.5%) cases of various forms of viral hepatitis, 177 (7.84%) cases of respiratory diseases, and 196 (8.69%) gastrointestinal diseases. Tropical diseases found were 134 (5.94%) including 95 cases of malaria (70.9%). In conclusion, a broad range of diseases was noted in immigrants which were directly correlated with conditions of poverty. Only a few tropical diseases were diagnosed and therefore the immigrant should not be considered as an infectious disease carrier.

Published
2005
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4. Pegylated interferon α plus ribavirin for the treatment of chronic hepatitis C: A multicentre independent study supported by the Italian Drug Agency

Author

Rosina, Floriano, Tosti, Maria Elena, Borghesio, Elisabetta, Masocco, Maria, Mele, Alfonso, Coppola, Carmine, Milella, Michele, Borgia, Guglielmo, Andreone, Pietro, Koch, Maurizio, Zignego, Anna Linda, Romano, Mario, Carrara, Maurizio, Almasio, Piero Luigi, Azzola, Emilio, Nardone, Gerardo, Benedetti, Antonio, Carosi, Giampiero, Mazzotta, Francesco, Sagnelli, Evangelista, Rizzetto, Mario, Mascolo, M. C., Cursaro, C., Scuteri, A., Crespi, C., Gianstefani, A., Ranieri, J., Monti, M., Corti, G., Blanc, P. L., Baragli, F., Bellentani, S., Gasbarrini, A., Pompili, M., Mecenate, F., Picardi, A., Vespasiani, U., Nosotti, Null, Null, A. Picardi, Ricci, G. L., Paffetti, A., Mastropietro, C., Moretti, A., Spagnolo, A. L., Puoti, C., Bellis, L., Regazzetti, A., Maffezzini, E., Pietrangelo, A., Abbati, G., Borghi, A., Sardini, C., Raimondo, G., Scribano, L., Martines, D., Svegliati Baroni, G., Faraci, G., Schi anchi, S., Fornaciari, G., Massari, M., Fabris, P., Bertin, T., Salvagnini, M., Madonia, S., Calì, A., Civitavecchia, G., Pirisi, M., Smirne, C., Andreoletti, M., Morisco, F., Caporaso, N., Gentile, I., Brancaccio, G., Gaeta, G. B., Liberti, A., Iannece, M. D., Rocco, A., Federico, A., Loguercio, C., Riegler, G., Esposito, P., Fargion, S., Fatta, E., Masutti, F., Bonaventura, M. E., Autolitano, A., Russello, M., Bellia, A., Toniutto, P., Bitetto, D., Pasulo, L., Lucà, M. G., Grattagliano, I., Palasciano, G., Romagno, D., Giannelli, G., Napoli, N., Plattella, M. S., Cassano, P., Gobbo, G., Monti, V., Raspanti, A., Cuccorese, Null, Colombo, A. E., Mandelli, G., Spinzi, G. C., Floridia, Null, Messina, V., Bonfante, S., Bellissima, P., Toti, M., Vecchiet, J., Falasca, K., Portelli, V., Stefano, G. De, Pietromatera, G., Viganò, P., Re, T., Andreoni, M., Null, G. Raineri, Grossi, P. A., Caputo, S., Cassola, G., Feasi, M., Biagio, A. Di, Nicolini, LAURA AMBRA, Giannini, EDOARDO GIOVANNI, Corbo, M., Foti, G., Kunkar, A., Caterini, L., Migliorini, D., Chiodera, A., Calleri, G., Spezia, C., Framarin, L., Null, M. Berrutti, Ciancio, A., Baiguera, C., Puoti, M., Vento, S., Contini, C., Boccia, S., Casiraghi, M. A., Simone, L., Tacconi, D., Caremani, M., Almi, P., Chimenti, M., Cosco, Null, Messeri, D., Esperti, F. C., Lomonaco, L., Pazzi, P., Fornari, F., Comparato, G., Casetti, T., Foschi, F. G., Samori, A., Ferretti, E., Marin, R., Campo, N., Testa, R., Rizzo, S., Rosina, F, Tosti, ME, Borghesio, E, Masocco, M, Mele, A, Coppola, C, Milella, M, Borgia, G, Andreone, P, Koch, M, Zignego, AL, Romano, M, Carrara, M, Almasio, PL, Azzola, E, Nardone, G, Benedetti, A, Carosi, G, Mazzotta, F, Sagnelli, E, Rizzetto, M, Rosina, F., Tosti, M. E., Borghesio, E., Masocco, M., Mele, A., Coppola, C., Milella, M., Borgia, Guglielmo, Andreone, P., Koch, M., Zignego, A. L., Romano, M., Carrara, M., Almasio, P. L., Azzola, E., Nardone, GERARDO ANTONIO PIO, Benedetti, A., Carosi, G., Mazzotta, F., Sagnelli, E., Rizzetto, M., Aifa, Aisf, Simit, Aigo, Sige, Gentile, Ivan, Morisco, Filomena, Et, Al, Floriano Rosina, Maria Elena Tosti, Elisabetta Borghesio, Maria Masocco, Alfonso Mele, Carmine Coppola, Michele Milella, Guglielmo Borgia, Pietro Andreone, Maurizio Koch, Anna Linda Zignego, Mario Romano, Maurizio Carrara, Piero Luigi Almasio, Emilio Azzola, Gerardo Nardone, Antonio Benedetti, Giampiero Carosi, Francesco Mazzotta, Evangelista Sagnelli, and Mario Rizzetto

Subjects
Registrie, Male, Cirrhosis, medicine.disease_cause, Polyethylene Glycol, Gastroenterology, Polyethylene Glycols, chemistry.chemical_compound, Hepatitis Viruses, Hepatitis Viruse, Prospective Studies, Viral, Registries, Chronic, Prospective cohort study, Drug Carrier, Drug Carriers, Settore MED/12 - Gastroenterologia, Medicine (all), Recombinant Protein, Middle Aged, Hepatitis C, Recombinant Proteins, Treatment Outcome, Italy, Combination, RNA, Viral, Population study, Drug Therapy, Combination, Female, Human, medicine.medical_specialty, Genotype, Hepatitis C virus, Alpha interferon, Ribavirin, Sustained virological response (SVR), Treatment, Antiviral Agents, Follow-Up Studie, Hepatology, Drug Therapy, Internal medicine, medicine, Humans, Antiviral Agent, business.industry, Interferon-alpha, HCV therapy, Hepatitis C, Chronic, medicine.disease, Clinical trial, Prospective Studie, chemistry, Immunology, RNA, Follow-Up Studies, business
Abstract

a b s t r a c t Background: Data on the efficacy of Peg-interferon/ribavirin therapy for chronic hepatitis C are mostly derived from treatment of selected patients enrolled in clinical trials. This study aimed to assess the effectiveness of Peg-interferon/ribavirin therapy in “real world” chronic hepatitis C patients in Italy. Methods: Independent observational multicentre study including consecutive patients receiving Peginterferon/ribavirin in the 18 months before (retrospective phase) and after (prospective phase) the start of the study. Results: 4176 patients were eligible. The final study population consisted of 2051 patients in the retrospective and 2073 in the prospective phase. Sustained virological response was achieved by 1036 patients (50.5%) during the retrospective phase: 325 were genotypes 1/4 (34.1%) and 684 were genotypes 2/3 (67.2%) and by 800 patients (38.6%) during the prospective phase: 300 were genotypes 1/4 (28.4%) and 473 were genotypes 2/3 (51.5%). During multivariate analysis genotypes 2/3 were significantly associated with higher sustained virological response rates; cirrhosis and -glutamil-transpeptidase >2 times the normal limit were associated with poorer response. Conclusions: The response to Peg-interferon/ribavirin therapy in “real world” clinical practice is distinctly lower than in registration trials. The difference in response rates was more pronounced among easy-totreat than among difficult-to-treat hepatitis C virus genotypes.

Published
2014

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