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15 results on '"Bellagamba R"'

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. 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

3. Treatment simplification to atazanavir/ritonavir+lamivudine versus maintenance of atazanavir/ritonavir+two NRTIs in virologically suppressed HIV-1-infected patients: 48 week results from a randomized trial (ATLAS-M)

Author

Di Giambenedetto, S., Fabbiani, M., Quiros Roldan, E., Latini, A., D'Ettorre, G., Antinori, A., Castagna, A., Orofino, G., Francisci, D., Chinello, P., Madeddu, G., Grima, P., Rusconi, S., Di Pietro, M., Mondi, A., Ciccarelli, N., Borghetti, A., Focà, E., Colafigli, M., De Luca, A., Cauda, R., Baldonero, E., Belmonti, S., D'Avino, A., Gagliardini, R., Lamonica, S., Lombardi, F., Sidella, L., Tamburrini, E., Visconti, E., Giacometti, A., Barchiesi, F., Castelli, P., Cirioni, O., Mazzocato, S., Blanc, P., Degli Esposti, A., Del Pin, B., Mariabelli, E., Marini, S., Poggi, A., Amadasi, S., Apostoli, A., Biasi, L., Bonito, A., Brianese, N., Compostella, S., Ferraresi, A., Motta, D., Mughini, M. T., Celesia, B. M., Gussio, M., Sofia, S., Tana, M., Tundo, P., Viscoli, C., De Hoffer, L., Di Biagio, A., Grignolo, S., Parisini, A., Schenone, E., Taramasso, L., Manconi, P. E., Boccone, A., Ortu, F., Piano, P., Serusi, L., Puoti, M., Moioli, M. C., Rossotti, R., Travi, G., Ventura, F., Galli, M., Di Nardo Stuppino, S., Di Cristo, V., Giacomelli, A., Vimercati, V., Viale, P., Gori, A., Rizzardini, G., Capetti, A., Carenzi, L., Mazza, F., Meraviglia, P., Rosa, S., Zucchi, P., Mineo, M., Giuliani, M., Pacifici, A., Pimpinelli, F., Solivetti, F., Stivali, F., Angelici, F., Bellagamba, R., Delle Rose, D., Fezza, R., Libertone, R., Mosti, S., Narciso, P., Nicastri, E., Ottou, S., Tomassi, C., Vlassi, C., Zaccarelli, M., Zoppè, F., Vullo, V., Altavilla, F., Ceccarelli, G., Fantauzzi, A., Gebremeskel, S., Lo Menzo, S., Mezzaroma, I., Tierno, F., Petrosillo, N., Boumis, E., Cicalini, S., Grilli, E., Musso, M., Stella, C., Mura, M. S., Bagella, P., Mannazzu, M., Soddu, V., Caramello, P., Carcieri, C., Carosella, S., Farenga, M., Scotton, P. G., Rossi, M. C., Concia, E., Corsini, F., Gricolo, C., Lanzafame, M., Lattuada, E., Leonardi, S., Rigo, F., Lazzarin, A., Bigoloni, A., Carini, E., Nozza, S., Spagnuolo, V., Belfiori, B., Malincarne, L., Schiaroli, E., Sfara, C., Tosti, A., Sacchini, D., Ruggieri, A., Valdatta, C., Di Giambenedetto, S, Fabbiani, M, Quiros Roldan, E, Latini, A, D'Ettorre, G, Antinori, A, Castagna, A, Orofino, G, Francisci, D, Chinello, P, Madeddu, G, Grima, P, Rusconi, S, Di Pietro, M, Mondi, A, Ciccarelli, N, Borghetti, A, Foca, E, Colafigli, M, De Luca, A, Cauda, R, Baldonero, E, Belmonti, S, D'Avino, A, Gagliardini, R, Lamonica, S, Lombardi, F, Sidella, L, Tamburrini, E, Visconti, E, Giacometti, A, Barchiesi, F, Castelli, P, Cirioni, O, Mazzocato, S, Blanc, P, Degli Esposti, A, Del Pin, B, Mariabelli, E, Marini, S, Poggi, A, Amadasi, S, Apostoli, A, Biasi, L, Bonito, A, Brianese, N, Compostella, S, Ferraresi, A, Motta, D, Mughini, M, Celesia, B, Gussio, M, Sofia, S, Tana, M, Tundo, P, Viscoli, C, De Hoffer, L, Di Biagio, A, Grignolo, S, Parisini, A, Schenone, E, Taramasso, L, Manconi, P, Boccone, A, Ortu, F, Piano, P, Serusi, L, Puoti, M, Moioli, M, Rossotti, R, Travi, G, Ventura, F, Galli, M, Di Nardo Stuppino, S, Di Cristo, V, Giacomelli, A, Vimercati, V, Viale, P, Gori, A, Rizzardini, G, Capetti, A, Carenzi, L, Mazza, F, Meraviglia, P, Rosa, S, Zucchi, P, Mineo, M, Giuliani, M, Pacifici, A, Pimpinelli, F, Solivetti, F, Stivali, F, Angelici, F, Bellagamba, R, Delle Rose, D, Fezza, R, Libertone, R, Mosti, S, Narciso, P, Nicastri, E, Ottou, S, Tomassi, C, Vlassi, C, Zaccarelli, M, Zoppe, F, Vullo, V, Altavilla, F, Ceccarelli, G, Fantauzzi, A, Gebremeskel, S, Lo Menzo, S, Mezzaroma, I, Tierno, F, Petrosillo, N, Boumis, E, Cicalini, S, Grilli, E, Musso, M, Stella, C, Mura, M, Bagella, P, Mannazzu, M, Soddu, V, Caramello, P, Carcieri, C, Carosella, S, Farenga, M, Scotton, P, Rossi, M, Concia, E, Corsini, F, Gricolo, C, Lanzafame, M, Lattuada, E, Leonardi, S, Rigo, F, Lazzarin, A, Bigoloni, A, Carini, E, Nozza, S, Spagnuolo, V, Belfiori, B, Malincarne, L, Schiaroli, E, Sfara, C, Tosti, A, Sacchini, D, Ruggieri, A, Valdatta, C, Roldan, Eq, Focà, E, and on behalf of the Atlas-M Study, Group

Subjects
Male, 0301 basic medicine, HIV Infections, ART HIV, Gastroenterology, law.invention, 0302 clinical medicine, Randomized controlled trial, immune system diseases, law, Antiretroviral Therapy, Highly Active, HIV Infection, Pharmacology (medical), Viral, 030212 general & internal medicine, Adult, Atazanavir Sulfate, Coinfection, Drug Therapy, Combination, Female, HIV-1, Humans, Lamivudine, Middle Aged, RNA, Viral, Ritonavir, Viral Load, Young Adult, Pharmacology, Infectious Diseases, virus diseases, dual therapy, Combination, Viral load, Human, medicine.drug, Microbiology (medical), medicine.medical_specialty, 030106 microbiology, Antiretroviral Therapy, Settore MED/17 - MALATTIE INFETTIVE, 03 medical and health sciences, Drug Therapy, Internal medicine, medicine, Highly Active, Adverse effect, business.industry, Surgery, Atazanavir, Regimen, RNA, business
Abstract

Background: Combination ART (cART)-related toxicities and costs have prompted the need for treatment simplification. The ATLAS-M trial explored 48 week non-inferior efficacy of simplification to atazanavir/ritonavir + lamivudine versus maintaining three-drug atazanavir/ritonavir-based cART in virologically suppressed patients. Methods: We performed an open-label, multicentre, randomized, non-inferiority study, enrolling HIV-infected adults on atazanavir/ritonavir+two NRTIs, with stable HIV-RNA 200 cells/mm3. Main exclusion criteria were hepatitis B virus coinfection, past virological failure on or resistance to study drugs, recent AIDS and pregnancy. Patients were randomly assigned 1:1 to either switch to 300mg of atazanavir/ 100mg of ritonavir once daily and 300mg of lamivudine once daily (atazanavir/ritonavir+lamivudine arm) or to continue the previous regimen (atazanavir/ritonavir+two NRTIs arm). The primary study outcome was the maintenance of HIV-RNA

Published
2017

4. Response to raltegravir-based salvage therapy in HIV-infected patients with hepatitis C virus or hepatitis B virus coinfection

Author

Weimer, L. E., Fragola, V., Floridia, M., Guaraldi, G., Ladisa, N., Francisci, D., Bellagamba, R., Degli Antoni, A., Parruti, G., Giacometti, A., Manconi, P. E., Vivarelli, A., D'Ettorre, G., Mura, M. S., Cicalini, S., Preziosi, R., Sighinolfi, L., Verucchi, G., Libertone, R., Tavio, M., Sarmati, L., Bucciardini, R., Angarano, G., Volpe, A., Vullo, V., Ceccarelli, G., Andreoni, M., Delle Rose, D., Tozzi, V., Narciso, P., Petrosillo, N., Pucillo, V., Tommasi, C., Segala, D., Armignacco, O., Ferrari, C., Cavalli, A., Sozio, F., Cosentino, L., Ortu, F., Viale, P., Tedeschi, S., Manfredi, R., Mannazzu, M., Cattari, G., Del Gobbo, R., Mataloni Paggi, A., Cirioni, O., Marchionni, E., Silvestri, C., Brescini, L., Sebastianelli, S., Baldelli, F., Mercuri, A., Bastianelli, S., Nardini, G., Massella, M., Baroncelli, S., Galluzzo, C. M., Pirillo, M. F., Mancini, M. G., Amici, R., Cara, A., Bona, R., Leone, P., Filati, P., Franco, M., Donnini, S., Weimer LE, Fragola V, Floridia M, Guaraldi G, Ladisa N, Francisci D, Bellagamba R, Degli Antoni A, Parruti G, Giacometti A, Manconi PE, Vivarelli A, D'Ettorre G, Mura MS, Cicalini S, Preziosi R, Sighinolfi L, Verucchi G, Libertone R, Tavio M, Sarmati L, and Bucciardini R on behalf of the ISS-NIA Study Group

Subjects
Male, HAART, maraviroc, viruses, HIV Infections, darunavir, hiv-1, Hepacivirus, medicine.disease_cause, Cohort Studies, hiv resistance, Pharmacology (medical), cd4 response, Original Research, Aged, 80 and over, Coinfection, virus diseases, Hepatitis C, Middle Aged, Hepatitis B, viral load, Treatment Outcome, integrase inhibitors, Infectious Diseases, hbv, Female, liver disease, Viral hepatitis, Viral load, medicine.drug, Adult, Microbiology (medical), Hepatitis B virus, Hepatitis C virus, HIV infection, HCV infection, HBV infection, antiretroviral therapy, viral hepatitis, etravirine, hcv, NO, Young Adult, Antiretroviral therapy, CD4 response, Darunavir, Etravirine, HBV, HCV, HIV resistance, HIV-1, Integrase inhibitors, Liver disease, Maraviroc, medicine, Humans, Aged, Salvage Therapy, Pharmacology, business.industry, Raltegravir, HIV, medicine.disease, Virology, digestive system diseases, Immunology, business, Follow-Up Studies
Abstract

OBJECTIVES: To define the impact of coinfection with hepatitis B virus (HBV) or hepatitis C virus (HCV) on viroimmunological response to raltegravir-based salvage regimens that also include new HIV inhibitors such as maraviroc, darunavir and etravirine. METHODS: We used data from a national observational study of patients starting raltegravir-based regimens to compare virological suppression and CD4 cell change from baseline in patients with and without concomitant HBV or HCV infection. RESULTS: Overall, 275 patients (107 coinfected and 168 non-coinfected) were evaluated. Coinfected patients were more commonly former intravenous drug users and had a longer history of HIV infection and higher baseline aminotransferase levels. Both HIV-RNA and CD4 response were similar in the two groups. Mean time to first HIV-RNA copy number

Published
2012

5. The potential impact of routine testing of individuals with HIV indicator diseases in order to prevent late HIV diagnosis

Author

Scognamiglio, Paola, Chiaradia, Giacomina, De Carli, Gabriella, Giuliani, Massimo, Mastroianni, Claudio Maria, Aviani Barbacci, Stefano, Buonomini, Anna R., Grisetti, Susanna, Sampaolesi, Alessandro, Corpolongo, Angela, Orchi, Nicoletta, Puro, Vincenzo, Ippolito, Giuseppe, Girardi, Enrico, Girardi, E., Orchi, N., Angeletti, C., Balzano, R., Elia, P., Navarra, A., Nurra, G., Palummieri, A., Alba, L., Ammassari, A., Antinori, A., Baldini, F., Bellagamba, R., Bevilacqua, N., Boumis, E., Capobianchi, M. R., Cerilli, S., Chinello, P., Corpolongo, A., D'Arrigo, R., De Carli, G., Null, D'Offizig, Forbici, F., Fusco, F. M., Galati, V., Ghirga, P., Giancola, L., Gori, C., Grisetti, S., Lauria, F. N., Liuzzi, G., Marconi, P., Mariano, A., Narciso, P., Nicastri, E., Noto, P., Palmieri, A. F., Perno, C. F., Petrosillo, N., Pisapia, R., Pittalis, S., Puro, V., Sampaolesi, A., Scognamiglio, P., Sciarrone, M. R., Selleri, M., Sias, C., Topino, S., Tozzi, V., Vincenzi, L., Visco Comandini, U., Vlassi, C., Zaccarelli, M., Zaniratti, S., Vullo, Vincenzo, Falciano, Mario, Andreoni, M., Sarmati, L., Buonomini, A. R., Di Carlo, A., Giuliani, M., Brancatella, R., Maggi, T., Errico, F., De Filippis, A., Di Bacco, R., Schito, S., Gattari, P., Spizzichino, L., Francesconi, M., Pace, G., Gallo, I., Anzalone, E., Tacconi, L., Mercurio, V. S., Lichtner, Miriam, Natalini Raponi, G., Pitorri, A., Caterini, A., and Aviani Barbacci, S.

Subjects
Adult, Male, Pediatrics, medicine.medical_specialty, Delayed Diagnosis, Tuberculosis, Adolescent, HIV Infections, Disease, HIV testing, Indicator diseases, Late diagnosis, Sexually transmitted infections, Aged, Aged, 80 and over, CD4 Lymphocyte Count, Diagnostic Tests, Routine, Female, Humans, Italy, Middle Aged, Retrospective Studies, Risk Factors, Young Adult, Infectious Diseases, Medical microbiology, Diagnostic Tests, 80 and over, Medicine, Routine, Young adult, business.industry, virus diseases, Seborrhoeic dermatitis, Retrospective cohort study, medicine.disease, Settore MED/17, Surgery, Population study, business, Viral hepatitis, Research Article
Abstract

Background The aim of our work was to evaluate the potential impact of the European policy of testing for HIV all individuals presenting with an indicator disease, to prevent late diagnosis of HIV. We report on a retrospective analysis among individuals diagnosed with HIV to assess whether a history of certain diseases prior to HIV diagnosis was associated with the chance of presenting late for care, and to estimate the proportion of individuals presenting late who could have been diagnosed earlier if tested when the indicator disease was diagnosed. Methods We studied a large cohort of individuals newly diagnosed with HIV infection in 13 counselling and testing sites in the Lazio Region, Italy (01/01/2004-30/04/2009). Considered indicator diseases were: viral hepatitis infection (HBV/HCV), sexually transmitted infections, seborrhoeic dermatitis and tuberculosis. Logistic regression analysis was performed to estimate association of occurrence of at least one indicator disease with late HIV diagnosis. Results In our analysis, the prevalence of late HIV diagnosis was 51.3% (890/1735). Individuals reporting at least one indicator disease before HIV diagnosis (29% of the study population) had a lower risk of late diagnosis (OR = 0.7; 95%CI: 0.5-0.8) compared to those who did not report a previous indicator disease. 52/890 (5.8%) late presenters were probably already infected at the time the indicator disease was diagnosed, a median of 22.6 months before HIV diagnosis. Conclusions Our data suggest that testing for HIV following diagnosis of an indicator disease significantly decreases the probability of late HIV diagnosis. Moreover, for 5.5% of late HIV presenters, diagnosis could have been anticipated if they had been tested when an HIV indicator disease was diagnosed. However, this strategy for enhancing early HIV diagnosis needs to be complemented by client-centred interventions that aim to increase awareness in people who do not perceive themselves as being at risk for HIV.

Published
2013

6. TB Meningitis in HIV-Positive Patients in Europe and Argentina: Clinical Outcome and Factors Associated with Mortality

Author

Efsen, A. M. W., Panteleev, A. M., Grint, D., Podlekareva, D. N., Vassilenko, A., Rakhmanova, A., Zeltina, I., Losso, M. H., Miller, R. F., Girardi, E., Cayla, J., Post, F. A., Miro, J. M., Bruyand, M., Furrer, H., Obel, N., Lundgren, J. D., Mocroft, A., Kirk, O., Toibaro, J. J., Warley, E., Tamayo, N., Cristina Ortiz, M., Scapelatto, P., Bottaro, E., Murano, F., Miachans, M., Contarelli, J., Massera, L., Corral, J., Hualde, M., Miglioranza, C., Corti, M., Metta, H., Casiro, A., Cuini, R., Laplume, H., David, D., Marson, C., Lupo, S., Trape, L., Garcia Messina, O., Gear, O., Bruguera, J. M., Karpov, I., Skrahina, E., Skrahin, A., Zhavoronok, S., Mitsura, V., Ruzanov, D., Bondarenko, V., Suetnov, O., Paduto, D., Gerstoft, J., Kronborg, G., Pedersen, C., Larsen, C. S., Pedersen, G., Laursen, A. L., Nielsen, L., Jensen, J., Dabis, F., Chene, G., Lawson-Ayayi, S., Thiebaut, R., Wittkop, L., Morlat, P., Bonnet, F., Bernard, N., Hessamfar, M., Lacoste, D., Vandenhende, M. A., Dupon, M., Dauchy, F. A., Dutronc, H., Longy-Boursier, M., Mercie, P., Duffau, P., Roger Schmeltz, J., Malvy, D., Pistone, T., Receveur, M. C., Neau, D., Cazanave, C., Ochoa, A., Vareil, M. O., Pellegrin, J. L., Viallard, J. F., Greib, C., Lazaro, E., Fleury, H., Lafon, M. E., Reigadas, S., Trimoulet, P., Breilh, D., Molimard, M., Bouchet, S., Titier, K., Moreau, J. F., Pellegrin, I., Haramburu, F., Arcachon, G., Dupont, A., Gerard, Y., Caunegre, L., Andre, K., Bonnal, F., Farbos, S., Gemain, M. C., Ceccaldi, J., Tchamgoue, S., De Witte, S., Courtault, K., Monlun, E., Gaborieau, V., Lataste, P., Meraud, J. P., Chossat, I., Carvalho, A. C., Basche, R., Hamad, I. E., Ricci, B. A., Maggiolo, F., Ravasio, V., Mussini, C., Prati, F., Castelletti, S., Ammassari, A., Antinori, A., Bellagamba, R., Busi Rizzi, E., Cicalini, S., Corpolongo, A., Capaldo, A., Di Caro, A., Goletti, D., Grisetti, S., Gualano, G., Lauria, F. N., Parracino, L., Palmieri, F., Petrosillo, N., Pinetti, C., Sampaolesi, A., Moroni, M., Angarano, G., Armignacco, O., d'Arminio Monforte, A., Castelli, F., Cauda, R., Di Perri, G., Galli, M., Iardino, R., Guzzinati, Ippolito, Lazzarin, A., Perno, C. F., von Schloesser, F., Viale, P., Castagna, A., Ceccherini-Silberstein, F., Cozzi-Lepri, A., Lo Caputo, S., Puoti, M., Andreoni, M., Balotta, C., Bonfanti, P., Bonora, S., Borderi, M., Capobianchi, M. R., Cingolani, A., Cinque, P., De Luca, A., Di Biagio, A., Gianotti, N., Gori, A., Guaraldi, G., Lapadula, G., Lichtner, M., Madeddu, G., Marchetti, G., Marcotullio, S., Monno, L., Quiros Roldan, E., Rusconi, S., Cicconi, P., Fanti, I., Formenti, T., Galli, L., Lorenzini, P., Giacometti, A., Costantini, A., Carrisa, C., Suardi, C., Vanino, E., Verucchi, G., Minardi, C., Quirino, T., Abeli, C., Manconi, P. E., Piano, P., Vecchiet, J., Falasca, K., Sighinolfi, L., Segala, D., Mazzotta, F., Cassola, G., Viscoli, G., Alessandrini, A., Piscopo, R., Mazzarello, G., Mastroianni, C., Belvisi, V., Caramma, I., Castelli, A. P., Rizzardini, G., Ridolfo, A. L., Piolini, R., Salpietro, S., Carenzi, L., Moioli, M. C., Puzzolante, C., Abrescia, N., Chirianni, A., Guida, M. G., Gargiulo, M., Baldelli, F., Francisci, D., Parruti, G., Ursini, T., Magnani, G., Ursitti, M. A., Vullo, V., D'Avino, A., Gallo, L., Nicastri, E., Acinapura, R., Capozzi, M., Libertone, R., Tebano, G., Cattelan, A., Mura, M. S., Caramello, P., Orofino, G. C., Sciandra, M., Pellizzer, G., Manfrin, V., Riekstina, V., Aldins, P., Duiculescu, D., Malashenkov, E., Kozlov, A., Buzunova, S., Garcia-Goez, J. F., Moreno Camacho, A., Martinez, J. A., Gonzalez, J., Garcia-Alcaide, F., de Lazzari, E., Gatell, J. M., Sanchez, P., Lopezcolomes, J. L., Martinez-Lacasa, X., Falco, V., Imaz, A., Ocana, I., Vidal, R., Sambeat, M. A., Moreno-Martinez, A., Orcau, A., Weber, R., Battegay, M., Hirschel, B., Cavassini, M., Bernasconi, E., Schmid, P., Rickenbach, M., Campbell, L., Arenas-Pinto, A., Chentsova, N., Kjaer, J., Efsen, Anne Marie W., Panteleev, Alexander M., Grint, Daniel, Podlekareva, Daria N., Vassilenko, Anna, Rakhmanova, Aza, Zeltina, Indra, Losso, Marcelo H., Miller, Robert F., Girardi, Enrico, Caylã¡, Joan, Post, Frank A., Miro, Jose M., Bruyand, Mathia, Furrer, Hansjakob, Obel, Niel, Lundgren, Jens D., Mocroft, Amanda, Kirk, Ole, Hiv/tb Study, Group, Castagna, Antonella, Efsen, A, Panteleev, A, Grint, D, Podlekareva, D, Vassilenko, A, Rakhmanova, A, Zeltina, I, Losso, M, Miller, R, Girardi, E, Caylá, J, Post, F, Miro, J, Bruyand, M, Furrer, H, Obel, N, Lundgren, J, Mocroft, A, Kirk, O, and Gori, A

Subjects
Genetics and Molecular Biology (all), Male, Pediatrics, Meningeal, Immunology and Microbiology (all), lcsh:Medicine, HIV Infections, Kaplan-Meier Estimate, Rate ratio, Biochemistry, Risk Factors, Adult, Argentina, CD4 Lymphocyte Count, Europe, Female, HIV, Humans, Treatment Outcome, Tuberculosis, Meningeal, Biochemistry, Genetics and Molecular Biology (all), HIV Infection, Mortality rate, General Medicine, symbols, Meningitis, Human, Research Article, medicine.medical_specialty, Tuberculosis, Settore MED/17 - Malattie Infettive, Article Subject, General Biochemistry, Genetics and Molecular Biology, Tuberculous meningitis, NO, symbols.namesake, Pharmacotherapy, medicine, Poisson regression, General Immunology and Microbiology, business.industry, Public health, Risk Factor, lcsh:R, medicine.disease, Immunology, business
Abstract

Objectives.The study aimed at describing characteristics and outcome of tuberculous meningitis (TBM) in HIV-positive patients and comparing these parameters with those of extrapulmonary TB (TBEP) and pulmonary TB (TBP).Methods.Kaplan-Meier estimation and Poisson regression models were used to assess the mortality following TB diagnosis and to evaluate potential prognostic factors for the 3 groups of TB patients separately.Results.A total of 100 patients with TBM, 601 with TBEP, and 371 TBP were included. Patients with TBM had lower CD4 cell counts and only 17.0% received antiretroviral therapy (ART) at TB diagnosis. The cumulative probability of death at 12 months following TB was 51.2% for TBM (95% CI 41.4–61.6%), 12.3% for TBP (8.9–15.7%), and 19.4% for TBEP (16.1–22.6) (P<0.0001; log-rank test). For TBM, factors associated with a poorer prognosis were not being on ART (adjusted incidence rate ratio (aIRR) 4.00 (1.72–9.09), a prior AIDS diagnosis (aIRR=4.82(2.61–8.92)), and receiving care in Eastern Europe (aIRR=5.41(2.58–11.34))).Conclusions.TBM among HIV-positive patients was associated with a high mortality rate, especially for patients from Eastern Europe and patients with advanced HIV-infection, which urgently calls for public health interventions to improve both TB and HIV aspects of patient management.

Published
2013
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7. Determinants of virologic and immunologic outcomes in chronically HIV-infected subjects undergoing repeated treatment interruptions: The Istituto Superiore di Sanità-Pulsed Antiretroviral Therapy (ISS-PART) study

Author

Palmisano, L., Giuliano, M., Bucciardini, R., Fragola, V., Andreotti, M., Galluzzo, C. M., Pirillo, M. F., Weimer, L. E., Arcieri, R., Germinario, E. A. P., Amici, R., Mancini, M. G., D'Arminio Monforte, A., Castelli, F., Caramello, P., Vella, S., Abrescia, N., Figoni, M., Viglietti, R., Angarano, G., Saracino, A., Anselmo, M., Antinori, A., Sette, P., Zaccarelli, M., Liuzzi, G., Arlotti, M., Martelli, L. T., Ortolani, P., Bassetti, D., Di Biagio, A., Bisio, F., Bellissima, P., Branz, F., Dorigoni, N., Cadeo, G., Vangi, D., Bertelli, D., Bergamasco, A., Caggese, L., Volonterio, A., Orofino, G. C., Carosella, S., Gennero, L., Caremani, M., Tacconi, D., Carosi, G., Tomasoni, L., Patroni, A., Chiodo, F., Borderi, M., Calza, L., Gritti, F., Fasulo, G., Chirianni, A., Gargiulo, M., Colomba, A., Dalle Nogare, E. R., Di Lorenzo, F., Prestileo, T., Bini, T., Cicconi, P., De Lalla, F., Giordani, M. T., De Stefano, C., De Stefano, G., Delia, S., Ciardi, M., Di Perri, G., Sinicco, A., Sales, P., Dini, M., Simeone, M., Esposito, R., Guaraldi, G., Beghetto, B., Fatuzzo, F., La Rosa, R., Ferrari, C., Calzetti, C., Ferraro, T., Cosco, L., Ghinelli, F., Sighinolfi, L., Guadagnino, V., Caroleo, B., Izzi, A., Izzo, C., Franco, A., Lazzarin, A., Castagna, A., Fusetti, G., Leoncini, F., Pozzi, M., Sbaragli, S., Marzetti, M., Magnani, G., Bonazzi, L., Barchi, E., Zoboli, G., Pintus, A., Mandas, A., Soddu, M. L., Zucca, F., Mannucci, P. M., Gringeri, A., Marani Toro, G., Graziani, R. V., Consorti, A., Mazzotta, F., Di Pietro, M., Ble, C., Meneghetti, F., Sasset, L., Cattelan, A. M., Menichetti, F., Savalli, E., Mian, P., Pristera, R., Mignani, E., Artioli, S., Mura, M. S., Mannazzu, M., Narciso, P., Bellagamba, R., Orani, A., Perini, P., Ortona, L., De Luca, A., Murri, R., Pagano, G., Alessandrini, A., Paladini, A., Vinattieri, M. A., Carbonai, S., Pastore, G., Ladina, N., Tateo, M., Piersantelli, N., Penco, G., Petrelli, E., Balducci, M., Pippi, L., Gonnelli, A., Puppo, F., Murdaca, G., Raise, E., Pasquirucci, A., Riccio, G., Bartolacci, V., Carrega, G., Rizzardini, G., Migliorino, G., Russo, R., Casentino, S., Celesia, M., Soranzo, M. L., Macor, A., Salassa, B., Soscia, F., Roberti, L., Di Toro, M. T., Stagno, A., Beltrami, C., Suter, F., Maggiolo, F., Ripamonti, D., Tantimonaco, G., Grisorio, B., Tassara, A., Rossi, P., Tinelli, M., Regazzetti, A., Tirelli, U., Voltaggio, G., Cinelli, R., Toti, M., Baldari, M., Carli, T., Ricciardi, B., Trezzi, M., Vigevani, G. M., Capetti, A., Landonio, S., Vullo, V., Massetti, P., Zauli, T., and Casolari, S.

Subjects
Adult, Male, medicine.medical_specialty, Anti-HIV Agents, medicine.medical_treatment, HIV Infections, Drug resistance, Drug Administration Schedule, law.invention, Randomized controlled trial, Drug Resistance, Multiple, Viral, law, Internal medicine, medicine, Humans, Pharmacology (medical), Protease inhibitor (pharmacology), Structured treatment interruptions, Chemotherapy, Reverse-transcriptase inhibitor, biology, business.industry, HIV, Middle Aged, biology.organism_classification, CD4 Lymphocyte Count, Clinical trial, Chronic infection, Regimen, Infectious Diseases, Immunology, Lentivirus, RNA, Viral, Female, business, medicine.drug
Abstract

Background: Factors influencing the outcome of structured treatment interruptions (STIs) in HIV chronic infection are not fully elucidated. Methods: In ISS-PART, 273 subjects were randomly assigned to arm A (137 assigned to continuous highly active antiretroviral therapy [HAART]) and arm B (136 assigned to 5 STIs of 1, 1, 2, 2, and 3 months'duration, each followed by 3 months of therapy). Main outcome measures were the proportion of subjects with a CD4 count >500 cells/mm 3 , the rate of virologic failure, and the emergence of resistance at 24 months. Results: The proportion of subjects with a CD4 count >500 cells/mm 3 was higher in arm A than in arm B (86.5% vs. 69.1%; P = 0.0075). Pre-HAART CD4 cell count and male gender were independent predictors of a CD4 count >500 cells/mm 3 in arm B. The overall risk of virologic failure was not increased in arm B; however, it was higher in the 38 subjects who had resistance mutations in the rebounding virus. Archived mutations at baseline and the use of a regimen that included an unboosted protease inhibitor (PI), compared with nonnucleoside reverse transcriptase inhibitor-based HAART, independently predicted the emergence of plasma mutations during STI (P = 0.002 for DNA mutations and P = 0.048 for PI-based HAART). Conclusions: Our results suggest that patients with preexisting mutations and treated with unboosted PI-based HAART should not be enrolled in studies of time-fixed treatment interruptions, being at higher risk of developing plasma mutations during STI and virologic failure at therapy reinstitution.

Published
2007

8. 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

9. Simultaneous determination of maraviroc and raltegravir in human plasma by HPLC-UV

Author

Paolo Ascenzi, Rita Bellagamba, Stefania Notari, Massimo Tempestilli, Leopoldo Paolo Pucillo, Emanuele Nicastri, Pasquale Narciso, Chiara Tommasi, Notari, S, Tommasi, C, Nicastri, E, Bellagamba, R, Tempestilli, M, Pucillo, Lp, Narciso, P, and Ascenzi, Paolo

Subjects
Analyte, Anti-HIV Agents, Ultraviolet Rays, Calibration curve, Clinical Biochemistry, Biochemistry, Maraviroc, chemistry.chemical_compound, Cyclohexanes, Raltegravir Potassium, Genetics, medicine, Humans, Molecular Biology, Chromatography, High Pressure Liquid, Chromatography, medicine.diagnostic_test, Chemistry, Elution, Extraction (chemistry), Cell Biology, Triazoles, Raltegravir, Divinylbenzene, Pyrrolidinones, Therapeutic drug monitoring, Drug Monitoring, medicine.drug
Abstract

Therapeutic drug monitoring is pivotal to improve the management of HIV infection. Here, a new HPLC–UV method to quantify simultaneously maraviroc and raltegravir levels in human plasma is reported. Remarkably, this is the first method for maraviroc determination in human plasma. The volume of the plasma sample was 600 μL. This method involved automated solid-phase extraction with Oasis HLB Cartridge 1 cc (30 mg divinylbenzene and N-vinylpyrrolidone) and evaporation in a water bath under nitrogen stream. The extracted samples were reconstituted with 200 μL 50/50 of mobile-phase solution (0.01 M KH2PO4 and acetonitrile). Twenty microliters of these samples were injected into a HPLC–UV system, the analytes were eluted on an analytical dC18 Atlantis column (150 mm × 4.6 mm I.D.) with a particle size of 5 μm. The mobile phase (0.01 M KH2PO4 and acetonitrile) was delivered at 1.0 mL/min with isocratic elution. The total run time for a single analysis was 10 min; maraviroc and raltegravir were detected by UV at 197 and 300 nm. The calibration curves were linear up to 2,500 ng/mL. The absolute recovery ranged between 93 and 100%. The HPLC–UV method reported here has been validated and is currently applied to monitor plasma levels of maraviroc and raltegravir in HIV-infected patients. © 2009 IUBMB IUBMB Life, 61(4):470–475, 2009

Published
2009

10. The problem of renal function monitoring in patients treated with the novel antiretroviral drugs

Author

Paolo Bonfanti, Stefano Rusconi, Antonio Di Biagio, Rita Bellagamba, Vincenzo Montinaro, Paolo Maggi, Paola Corsi, Cristina Mussini, Leonardo Calza, Francesco Montella, Maggi, P, Montinaro, V, Rusconi, S, Di Biagio, A, Bellagamba, R, Bonfanti, P, Calza, L, Corsi, P, Montella, F, Mussini, C., and Mussini, C

Subjects
Glycosuria, medicine.medical_specialty, kidney, Urology, HIV Infections, Pharmacology, Excretion, rilpivirine, chemistry.chemical_compound, medicine, Humans, Pharmacology (medical), HIV Infection, Renal Insufficiency, Chronic, Monitoring, Physiologic, renal toxicity, Creatinine, Proteinuria, new drug, business.industry, Cobicistat, HIV, cobicistat, medicine.disease, dolutegravir, monitoring, Infectious Diseases, chemistry, Anti-Retroviral Agents, Rilpivirine, Dolutegravir, Anti-Retroviral Agent, antiretroviral drug, medicine.symptom, business, Kidney disease, Human, Glomerular Filtration Rate
Abstract

Chronic kidney disease (CKD) is currently considered a major comorbidity in patients affected by HIV infection. In addition, new generation antiretroviral drugs that interact with creatinine transporters were recently introduced. Rilpivirine, dolutegravir, and cobicistat, with different mechanisms, inhibit the amount of tubular secretion of creatinine causing a slight increase in serum creatinine levels and consensual eGFRcreat reduction. This will require an unprecedented attention to renal issues, because the new drugs can also be associated to old antiretroviral drugs that may exert renal toxic effects. Owing to the interference of these drugs with creatinine secretion, an alternative way of estimating GFR would be desirable. At the moment, methods of direct GFR measurement have a high impact on the patient, are not readily available, or are not reliable in HIV patients. Consequently, use of classic formulas to estimate GFR is still recommended, considering the apparent reduction of eGFRcreat due to these drugs. Tubular function needs to be carefully monitored with simple tests such as proteinuria, phosphatemia, urinary excretion of phosphate, normoglycemic glycosuria, and excretion of uric acid. More specific and sensitive markers of tubular damage are still not readily available in all clinical labs. HIV patients treated by the novel drugs need to be monitored on a monthly basis for the first 3 months. Subsequent monitoring should be performed on a quarterly basis or guided by comorbidities. © 2014 Thomas Land Publishers, Inc.

Published
2014

11. Prospective evaluation of bone markers, parathormone and 1,25-(OH)2 vitamin D in HIV-positive patients after the initiation of tenofovir/emtricitabine with atazanavir/ritonavir or efavirenz

Author

Carlo Torti, Maria Carla Re, Ilaria Izzo, Pasquale Narciso, Laura Albini, Emanuele Focà, Laura Sighinolfi, Alessandra Calabresi, Rita Bellagamba, Davide Gibellini, Bruno Mario Cesana, Nigritella Brianese, Davide Motta, Alberto Clò, Daria Gotti, Eugenia Quiros-Roldan, Marco Borderi, Focà E, Motta D, Borderi M, Gotti D, Albini L, Calabresi A, Izzo I, Bellagamba R, Narciso P, Sighinolfi L, Clò A, Gibellini D, Quiros-Roldan E, Brianese N, Cesana BM, Re MC, and Torti C.

Subjects
Oncology, Adult, Male, medicine.medical_specialty, Efavirenz, Anti-HIV Agents, Osteoporosis, Parathyroid hormone, HIV Infections, Emtricitabine, OSTEOPOROSIS, bone, Bone and Bones, Bone remodeling, lcsh:Infectious and parasitic diseases, chemistry.chemical_compound, ANTIRETROVIRAL THERAPY, Internal medicine, Antiretroviral Therapy, Highly Active, BONE TURNOVER, Vitamin D and neurology, Medicine, Humans, lcsh:RC109-216, Prospective Studies, Vitamin D, Prospective cohort study, business.industry, HIV, Middle Aged, medicine.disease, Ergocalciferol, Infectious Diseases, chemistry, Parathyroid Hormone, Immunology, Ergocalciferols, Female, business, Biomarkers, medicine.drug, Research Article
Abstract

Background Increased risk of fractures and osteoporosis have been associated with the use of antiretroviral drugs. There is a paucity of prospective evaluations of bone markers after the initiation of drugs currently recommended to treat HIV infection and results on the evolution of these markers are conflicting. Lastly, the effect of tenofovir on 1,25-(OH)2 vitamin D is uncertain. Methods We performed a prospective study on the evolution of bone markers, parathormone and 1,25-(OH)2 vitamin D before and after standard antiretroviral regimens. This was a sub-study of a trial conducted in antiretroviral-naïve patients randomized to tenofovir + emtricitabine in combination with either atazanavir/ritonavir (ATV/r) or efavirenz (EFV). Follow-up lasted 48 weeks. The following bone markers were analyzed: C-terminal cross-laps (CTx), osteocalcin (OC), osteoprotegerin (OPG), and receptor activator of nuclear factor κB ligand (RANKL). Mixed-factorial analysis of variance with random-coefficient general linear model was used to compare their trends over time and linear multivariable regression was performed with a backward selection method to assess predictors of their variations from baseline to week 48. Trends of parathormone and 1,25-(OH)2 vitamin D were also evaluated. Results Seventy-five patients were studied: 33 received EFV and 42 ATV/r. Significant increases were found for all markers except for RANKL. There was a significant direct association between CTx and OC increases. Multivariable analysis showed that higher glomerular filtration rate (estimated through cystatin C clearance) predicted greater OPG increase, while older age, higher HIV RNA at baseline and use of ATV/r predicted greater CTx increase. A significant increase of parathormone accompanied the evolution of the study markers. 1,25-(OH)2 vitamin D remained stable, though a seasonality variation was demonstrated. Conclusions These data demonstrate CTx increase (bone resorption marker) corresponding to OC increase (bone formation marker) early upon HAART initiation. Moreover, predictors of bone marker increases have been suggested, possibly indicating that a stricter monitoring of bone health and pro-active interventions are needed in older patients, those with higher HIV RNA, prescribed ATV/r rather than EFV, and with decreased renal function at baseline. Further studies are needed to clarify the mechanisms responsible for up-regulation of bone turnover markers, as well as to understand if and what markers are best correlated or predictive of pathological fractures.

Published
2012

12. A randomized, pilot trial to evaluate glomerular filtration rate by creatinine or cystatin C in naïve HIV-infected patients after tenofovir/emtricitabine in combination with atazanavir/ritonavir or efavirenz

Author

Luigi Manili, Paolo Maggi, Rita Bellagamba, Eugenia Quiros-Roldan, Laura Sighinolfi, Laura Albini, Emanuele Focà, Rita Fezza, Davide Motta, Daria Gotti, Pasquale Narciso, Giovanni Guaraldi, Giuseppe Lapadula, Alessandra Calabresi, Ilaria Izzo, Carlo Torti, Bruno Mario Cesana, Albini, L, Cesana, Bm, Motta, D, Focà, E, Gotti, D, Calabresi, A, Izzo, I, Bellagamba, R, Fezza, R, Narciso, P, Sighinolfi, L, Maggi, P, Quiros-Roldan, E, Manili, L, Guaraldi, G, Lapadula, G, Torti, C, Cesana, B, and Foca, E

Subjects
Cyclopropanes, Male, Pyridines, Pyridine, HIV Infections, Pilot Projects, urologic and male genital diseases, Deoxycytidine, chemistry.chemical_compound, Organophosphonate, Emtricitabine, Pharmacology (medical), HIV Infection, Alkyne, HIV, glomerular filtration rate, HAART, creatinine, cystatin C, biology, Cyclopropane, Middle Aged, female genital diseases and pregnancy complications, Infectious Diseases, Alkynes, Creatinine, Oligopeptide, Female, Oligopeptides, medicine.drug, Human, Glomerular Filtration Rate, Benzoxazine, Adult, medicine.medical_specialty, Efavirenz, Anti-HIV Agents, antiretroviral therapy, Atazanavir Sulfate, Urology, Organophosphonates, Renal function, medicine, Humans, Pilot Project, Cystatin C, Tenofovir, Ritonavir, business.industry, Adenine, Anti-HIV Agent, medicine.disease, Atazanavir, Benzoxazines, chemistry, biology.protein, business, Kidney disease
Abstract

Background: Glomerular filtration rate (GFR) estimated by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation based on creatinine or cystatine C may be more accurate methods especially in patients without chronic kidney disease. There is lack of data on GFR estimated by these methods in patients on highly active antiretroviral therapy. Methods: Antiretroviral-naive HIV-infected patients were randomized to tenofovir/emtricitabine in association with atazanavir/ritonavir (ATV/r) or efavirenz (EFV) Patients had to have an actual creatinine clearance >50 mL/minute (24-hour urine collection) and were followed for 48 weeks. RESULTS: Ninety-one patients (48 ATV/r, 43 EFV) were recruited. Using the CKD-EPI creatinine formula, there was a significant decrease in GFR up to week 48 in patients receiving ATV/r (4.9 mL/minute/m, P = 0.02) compared with a not statistically significant increment in patients prescribed EFV. Using the cystatin C-based equation, we found greater decrease in GFR in both arms, although, in the EFV arm, the decrease was not statistically significant (5.8 mL/minute/m, P = 0.92). At multivariable analysis, ATV/r was a significant predictor of greater decrease in estimated glomerular filtration rate (eGFR) (P = 0.0046) only with CKD-EPI creatinine. Conclusions: ATV/r plus tenofovir caused greater GFR decreases compared with EFV. The evaluation of eGFR by cystatin C confirmed this result, but this method seemed to be more stringent, probably precluding the possibility to detect a significant difference in the pattern of eGFR evolution between the two arms over time. More studies are needed to understand the clinical relevance of these alterations and whether cystatin C is a more appropriate method for monitoring GFR in clinical practice.

Published
2012

13. Increase in Standard Cholesterol and Large HDL Particle Subclasses in Antiretroviral-Naïve Patients Prescribed Efavirenz Compared to Atazanavir/Ritonavir

Author

Rita Fezza, Daria Gotti, Emanuele Focà, Laura Albini, Ilaria Izzo, Giovanni Guaraldi, Rita Bellagamba, Bruno Mario Cesana, Pasquale Narciso, Carlo Torti, Paolo Maggi, Nigritella Brianese, Eugenia Quiros-Roldan, Davide Motta, Alessandra Calabresi, Laura Sidhinolfi, Gotti, D, Cesana, Bm, Albini, L, Calabresi, A, Izzo, I, Focà, E, Motta, D, Bellagamba, R, Fezza, R, Narciso, P, Sidhinolfi, L, Maggi, P, Brianese, N, Quiros-Roldan, E, Guaraldi, G, and Torti, C

Subjects
Adult, Cyclopropanes, Male, medicine.medical_specialty, Efavirenz, HDL, Anti-HIV Agents, Pyridines, HIV infection, cholesterol, antiretroviral therapy, Atazanavir Sulfate, Hypercholesterolemia, Pharmacology, Emtricitabine, Gastroenterology, chemistry.chemical_compound, immune system diseases, Internal medicine, medicine, Humans, Pharmacology (medical), HDL particle, Atazanavir/ritonavir, Ritonavir, business.industry, Cholesterol, Cholesterol, HDL, virus diseases, Middle Aged, Confidence interval, Benzoxazines, Atazanavir, Infectious Diseases, chemistry, Alkynes, Drug Therapy, Combination, Female, lipids (amino acids, peptides, and proteins), business, Oligopeptides, medicine.drug
Abstract

Cardiovascular risk in HIV-infected patients is related, at least in part, to serum lipid alterations before and after HAART. Lipoprotein-particle subclasses may also have an effect, but comparative data after standard HAART regimens are limited.This was a substudy of a trial in 91 antiretroviral-naïve patients randomized to tenofovir + emtricitabine + atazanavir/ritonavir (ATV/r) or efavirenz (EFV). Over-time trends from baseline to week 48 in total cholesterol (TC), triglycerides (TG), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), HDL particles (HDLp), and TC:HDL-C and TG:HDL-C ratios were analyzed by analysis of covariance (ANCOVA). Furthermore, confidence intervals for differences between the 2 groups at week 48 were calculated. Indications for lipid-lowering interventions and low HDL-C were also studied.ANCOVA showed that, with respect to patients receiving ATV/r, those prescribed efavirenz (EFV) had greater increases reported as mean differences in lipid values at week 48: 14 mg/dL (95% CI, 0.2 to 27) for TC, 14 mg/dL (95% CI, 4 to 25) for LDL-C, 5 mg/dL (95% CI, 2 to 9) for HDL-C, and 2.2 mg/dL (95% CI, 0.4 to 4) for large HDLp. Proportions of subjects with indications for lipid-lowering interventions and with HDL-C40 mg/dL did not differ significantly.Patients prescribed EFV had greater increases in TC, LDL-C, and HDL-C. Although no significant differences were detected between the 2 groups for the TC:HDL ratio and for indications to start lipid-lowering interventions, large HDLp increased more in the EFV group compared to the ATV/r group, suggesting a protective effect associated with EFV use.

Published
2012

14. Univariate and multivariate analysis of prognostic factors in the surgical treatment of hilar cholangiocarcinoma

Author

Antonio Daniele Pinna, Massimo Del Gaudio, Giorgio Ercolani, Niccolò Petrucciani, Nicola Cautero, Matteo Cescon, Charles Miller, Augusto Lauro, Fabrizio Di Benedetto, Matteo Ravaioli, Alessandro Cucchetti, Riccardo Bellagamba, Giovanni Ramacciato, Cristiano Quintini, Giuseppe Nigri, Ramacciato G., Nigri G., Bellagamba R., Petrucciani N., Ravaioli M., Cescon M., Del Gaudio M., Ercolani G., Di Benedetto F., Cautero N., Quintini C., Cucchetti A., Lauro A., Miller C., and Pinna A.D.

Subjects
Adult, Male, medicine.medical_specialty, Multivariate analysis, NEOPLASM, medicine.medical_treatment, Bile duct cancer, Cholangiocarcinoma, Adult, Aged, Bile Duct Neoplasms, diagnosis/drug therapy/surgery, Bile Ducts, Intrahepatic, Chemotherapy, Adjuvant, Cholangiocarcinoma, diagnosis/drug therapy/surgery, Female, Hepatectomy, Humans, Male, Middle Aged, Prognosis, Proportional Hazards Models, Retrospective Studies, Survival Rate, Treatment Outcome, Tumor Markers, Biological, analysis, medicine, Biomarkers, Tumor, HEPATIC SURGERY, Hepatectomy, Humans, Survival rate, Aged, Proportional Hazards Models, Retrospective Studies, BILIARY TRACT, Proportional hazards model, business.industry, Medical record, Retrospective cohort study, General Medicine, Perioperative, Middle Aged, medicine.disease, Prognosis, Surgery, Survival Rate, Bile Ducts, Intrahepatic, Treatment Outcome, Bile Duct Neoplasms, Chemotherapy, Adjuvant, Female, business
Abstract

Surgery is the only effective treatment able to improve survival of patients with hilar cholangiocarcinoma (CCA). However, the significance of prognostic factors on overall survival is still debated. We evaluated early and long-term outcomes of patients resected for hilar cholangiocarcinoma over a 3-year period to determine the role of prognostic factors and their effect on overall survival. Medical records of patients with hilar CCA who underwent resection between January 2001 and December 2004 were retrospectively reviewed. Univariate and multivariate analysis was performed to identify prognostic factors associated with survival. Thirty-two of 45 patients underwent surgical resection with curative intent. Morbidity was 24.4 per cent; perioperative mortality was 0 per cent. Overall median survival was 22.3 months. Well-differentiated tumor grading and R0 resection were independently associated with better survival at multivariate analysis. Aggressive surgery, including biliary resection combined with major hepatectomy, is a safe procedure with low morbidity and mortality in a tertiary referral hepatobiliary center. The main aim of an aggressive surgical approach is to obtain a microscopic margin-negative resection, which is associated with better prognosis. Another important prognostic factor is tumor grading, which is independently associated with survival.

Published
2010

15. Hepatocellular carcinomas and primary liver tumors as predictive factors for postoperative mortality after liver resection: a meta-analysis of more than 35,000 hepatic resections

Author

Niccolò Petrucciani, Massimo Del Gaudio, Riccardo Bellagamba, Paolo Aurello, Francesca Pezzoli, Matteo Cescon, Albert Balesh, Giuseppe Nigri, Laura Antolino, Antonio Daniele Pinna, Francesco D'Angelo, Giovanni Ramacciato, Matteo Ravaioli, Alessandro Cucchetti, Rossella Baldini, Ramacciato G., D'Angelo F., Baldini R., Petrucciani N., Antolino L., Aurello P., Nigri G., Bellagamba R., Pezzoli F., Balesh A., Cucchetti A., Cescon M., Del Gaudio M., Ravaioli M., and Pinna A.D.

Subjects
Oncology, medicine.medical_specialty, Carcinoma, Hepatocellular, Metastatic lesions, Gastroenterology, Resection, Postoperative Complications, Overdispersion, Models, Internal medicine, HEPATIC SURGERY, medicine, Hepatectomy, Humans, HEPATOCELLULAR CARCINOMA, Models, Statistical, business.industry, Carcinoma, Liver Neoplasms, Gold standard, Hepatocellular, General Medicine, Statistical, META-ANALYSIS, medicine.disease, Treatment Outcome, Postoperative mortality, Meta-analysis, Hepatocellular carcinoma, Hepatic surgery, business
Abstract

Liver resection is considered the therapeutic gold standard for primary and metastatic liver neoplasms. The reduction of postoperative complications and mortality has resulted in a more aggressive approach to hepatic malignancies. For the most part, results of liver surgery have been published by highly experienced institutions, but the observations of highly specialized units results may not reflect the current status of hepatic surgery, underestimating mortality and complications. The objective of this study is to evaluate morbidity and mortality as a result of liver resection for primary and metastatic lesions, analyzing a large number of studies with a meta-analytic process taking into account the overdispersion of data. An extensive literature search has been conducted, and 148 papers published between January 2000 and April 2008, including a total of 36,629 patients from both high-volume and low volume institutions, were included in the meta-analysis. A beta binomial model was used to provide a robust estimate of the summary event rate by pooling overdispersion binomial data from different studies. Overall morbidity and mortality after liver surgery were 29.32 per cent and 3.15 per cent, respectively. Significantly higher postoperative mortality was observed after liver resection for hepatocellular carcinomas and primary hepatic tumors. The application of a beta binomial model to correct for overdispersion of liver surgery data showed significantly higher postoperative mortality rates in patients with hepatocellular carcinomas or primary hepatic tumors after liver resection.

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