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1. Metabolic syndrome and body weight in people living with HIV infection: analysis of differences observed in three different cohort studies over a decade

Author

Taramasso L., Bonfanti P., Ricci E., Maggi P., Orofino G., Squillace N., Menzaghi B., Madeddu G., Molteni C., Vichi F., Riguccini E., Saracino A., Santoro C., Guastavigna M., Francisci D., Di Biagio A., De Socio G. V., Sarchi E., Chichino G., Bolla C., Bellacosa C., Angarano G., Calza L., Farinazzo M., Angioni G., Gussio M., Celesia B. M., Falasca K., Mastroianni A., Guadagnino G., Salomoni E., Martinelli C., Dentone C., Bassetti M., Cenderello G., Pellicano G. F., Nunnari G., Valsecchi L., Cordier L., Parisini S., Rizzardini G., Rusconi S., Conti F., Bandera A., Gori A., Motta D., Puoti M., Migliorino G. M., Martini S., Cascio A., Trizzino M., Gulminetti R., Nofri M., Cibelli D., Parruti G., Mameli M. S., Taramasso L., Bonfanti P., Ricci E., Maggi P., Orofino G., Squillace N., Menzaghi B., Madeddu G., Molteni C., Vichi F., Riguccini E., Saracino A., Santoro C., Guastavigna M., Francisci D., Di Biagio A., De Socio G.V., Sarchi E., Chichino G., Bolla C., Bellacosa C., Angarano G., Calza L., Farinazzo M., Angioni G., Gussio M., Celesia B.M., Falasca K., Mastroianni A., Guadagnino G., Salomoni E., Martinelli C., Dentone C., Bassetti M., Cenderello G., Pellicano G.F., Nunnari G., Valsecchi L., Cordier L., Parisini S., Rizzardini G., Rusconi S., Conti F., Bandera A., Gori A., Motta D., Puoti M., Migliorino G.M., Martini S., Cascio A., Trizzino M., Gulminetti R., Nofri M., Cibelli D., Parruti G., Mameli M.S., Taramasso, L, Bonfanti, P, Ricci, E, Maggi, P, Orofino, G, Squillace, N, Menzaghi, B, Madeddu, G, Molteni, C, Vichi, F, Riguccini, E, Saracino, A, Santoro, C, Guastavigna, M, Francisci, D, Di Biagio, A, De Socio, G, Taramasso, Lucia, Bonfanti, Paolo, Ricci, Elena, Maggi, Paolo, Orofino, Giancarlo, Squillace, Nicola, Menzaghi, Barbara, Madeddu, Giordano, Molteni, Chiara, Vichi, Francesca, Riguccini, Erika, Saracino, Annalisa, Santoro, Carmen, Guastavigna, Marta, Francisci, Daniela, Di Biagio, Antonio, and De Socio, Giuseppe Vittorio

Subjects
Adult, Male, dyslipidaemia, antiretroviral therapy, HIV Infections, Overweight, Logistic regression, Body Mass Index, Cohort Studies, Prevalence, medicine, overweight, Humans, Pharmacology (medical), Metabolic Syndrome, business.industry, Health Policy, Incidence (epidemiology), Body Weight, HIV, weight gain, Odds ratio, Middle Aged, medicine.disease, Confidence interval, metabolic syndrome, Cross-Sectional Studies, Infectious Diseases, Metabolic syndrome, medicine.symptom, business, Weight gain, Demography, Cohort study
Abstract

Objectives: The aim of this study was to assess the incidence of being overweight and metabolic syndrome (MS) among people living with HIV (PHIV) in three different cross-sectional studies conducted over three different periods: 2005, 2011 and 2015. Methods: This was a multi-centre, nationwide study. Data were collected in three studies from the CISAI group - SIMOne, HIV-HY and STOPSHIV - and included a total of 3014 PHIV. Logistic regression [odds ratio (OR), 95% confidence interval (CI)] was used to account for age and gender difference among three groups when comparing MS prevalence and being overweight; potential confounders were accounted for by including them in the regression equation. Results: Overall, the mean age was 46.9±10.2years, and men comprised 73.3% of participants. Comparing 2005, 2011 and 2015, MS was present in 34.5%, 33.0% and 29.3% of PHIV, respectively. Adjusted OR for MS was 0.64 (95% CI: 0.52-0.78) in 2011 and 0.56 (95% CI: 0.46-0.69) in 2015 compared with 2005, while BMI (kg/m2 ) increased from 23.6 in 2005, 24.5 in 2011 and 24.5 in 2015, with a concomitant increase of being overweight from 29.4% to 39.5% to 39.6% (p&nbsp

Published
2021

3. Positioning of darunavir/cobicistat-containing antiretroviral regimens in real life: Results from a large multicentre observational prospective cohort (SCOLTA)

Author

Taramasso, L, Ricci, E, Cascio, A, Valsecchi, L, Menzaghi, B, Squillace, N, Maggi, P, De Socio, G, Dentone, C, Madeddu, G, Pellicano, G, Calza, L, Angioni, G, Bonfanti, P, Di Biagio, A, Sarchi, E, Chichino, G, Bellacosa, C, Angarano, G, Farinazzo, M, Gussio, M, Celesia, B, Falasca, K, Mastroianni, A, Guadagnino, G, Vichi, F, Salomoni, E, Martinelli, C, Nicolini, L, Cenderello, G, Molteni, C, Nunnari, G, Cordier, L, Parisini, A, Rizzardini, G, Rusconi, S, Conti, F, Bandera, A, Gori, A, Motta, D, Puoti, M, Migliorino, G, Martini, S, Trizzino, M, Gulminetti, R, Cibelli, D, Parruti, G, Mameli, M, Orofino, G, Guastavigna, M, Taramasso L., Ricci E., Cascio A., Valsecchi L., Menzaghi B., Squillace N., Maggi P., De Socio G. V., Dentone C., Madeddu G., Pellicano G. F., Calza L., Angioni G., Bonfanti P., Di Biagio A., Sarchi E., Chichino G., Bellacosa C., Angarano G., Farinazzo M., Gussio M., Celesia B. M., Falasca K., Mastroianni A., Guadagnino G., Vichi F., Salomoni E., Martinelli C., Nicolini L., Cenderello G., Molteni C., Nunnari G., Cordier L., Parisini A., Rizzardini G., Rusconi S., Conti F., Bandera A., Gori A., Motta D., Puoti M., Migliorino G. M., Martini S., Trizzino M., Gulminetti R., Cibelli D., Parruti G., Mameli M. S., Orofino G., Guastavigna M., Taramasso, L, Ricci, E, Cascio, A, Valsecchi, L, Menzaghi, B, Squillace, N, Maggi, P, De Socio, G, Dentone, C, Madeddu, G, Pellicano, G, Calza, L, Angioni, G, Bonfanti, P, Di Biagio, A, Sarchi, E, Chichino, G, Bellacosa, C, Angarano, G, Farinazzo, M, Gussio, M, Celesia, B, Falasca, K, Mastroianni, A, Guadagnino, G, Vichi, F, Salomoni, E, Martinelli, C, Nicolini, L, Cenderello, G, Molteni, C, Nunnari, G, Cordier, L, Parisini, A, Rizzardini, G, Rusconi, S, Conti, F, Bandera, A, Gori, A, Motta, D, Puoti, M, Migliorino, G, Martini, S, Trizzino, M, Gulminetti, R, Cibelli, D, Parruti, G, Mameli, M, Orofino, G, Guastavigna, M, Taramasso L., Ricci E., Cascio A., Valsecchi L., Menzaghi B., Squillace N., Maggi P., De Socio G. V., Dentone C., Madeddu G., Pellicano G. F., Calza L., Angioni G., Bonfanti P., Di Biagio A., Sarchi E., Chichino G., Bellacosa C., Angarano G., Farinazzo M., Gussio M., Celesia B. M., Falasca K., Mastroianni A., Guadagnino G., Vichi F., Salomoni E., Martinelli C., Nicolini L., Cenderello G., Molteni C., Nunnari G., Cordier L., Parisini A., Rizzardini G., Rusconi S., Conti F., Bandera A., Gori A., Motta D., Puoti M., Migliorino G. M., Martini S., Trizzino M., Gulminetti R., Cibelli D., Parruti G., Mameli M. S., Orofino G., and Guastavigna M.

Abstract

Background: Study aim was to evaluate the safety and durability of darunavir/cobicistat (DRV/c) in a real life setting. Methods: Multicentre prospective cohort study performed in the context of SCOLTA (Surveillance Cohort Long-Term Toxicity Antiretrovirals). Patients were evaluated at baseline, week 24 and 48. Changes were evaluated using the paired t test or signed rank test. The multivariable analysis was performed using a general linear model, after ranking of not normally distributed variables. Results: A total of 249 patients were included, 72 (29%) were in DRV/c-based dual therapies (DT). Hypercholesterolemia, HC, (total cholesterol (TC) ≥ 200 mg/dL or low density-C (LDL-C) ≥ 130 or statin use) was present in 121 (48.6%) and hypertriglyceridemia, (triglycerides (TG) ≥ 200 mg/dl or fibrate use) in 41 (16.5%) patients. Blood lipid profile did not change significantly in either the global population or patients with HC. After a median observation of 17 months (IQR 13-20), 59 (25.3%) patients discontinued DRV/c, of which 13 were in DT. The durability DT resulted higher than that of triple therapy (log-rank test p = 0.01). Main reasons for stopping DRV/c were simplification (15 patients), adverse events (13 patients), planned discontinuation for treatment initiation with DAA (4 patients), treatment failure (2 patients); death (2 patients), other causes (10 patients). Twenty-six were lost to follow-up. Conclusions: DRV/c was safe and well tolerated. Dual therapies showed a better profile of tolerability and a longer durability compared to triple therapies.

Published
2019

4. Positioning of darunavir/cobicistat-containing antiretroviral regimens in real life: results from a large multicentre observational prospective cohort (SCOLTA)

Author

Taramasso L., Ricci E., Cascio A., Valsecchi L., Menzaghi B., Squillace N., Maggi P., De Socio G. V., Dentone C., Madeddu G., Pellicano G. F., Calza L., Angioni G., Bonfanti P., Di Biagio A., Sarchi E., Chichino G., Bellacosa C., Angarano G., Farinazzo M., Gussio M., Celesia B. M., Falasca K., Mastroianni A., Guadagnino G., Vichi F., Salomoni E., Martinelli C., Nicolini L., Cenderello G., Molteni C., Nunnari G., Cordier L., Parisini A., Rizzardini G., Rusconi S., Conti F., Bandera A., Gori A., Motta D., Puoti M., Migliorino G. M., Martini S., Trizzino M., Gulminetti R., Cibelli D., Parruti G., Mameli M. S., Orofino G., Guastavigna M., Lucia Taramasso, Elena Ricci, Antonio Cascio, Laura Valsecchi, Barbara Menzaghi, Nicola Squillace, Paolo Maggi, Giuseppe Vittorio De Socio, Chiara Dentone, Giordano Madeddu, Giovanni F. Pellicanò, Leonardo Calza, Goffredo Angioni, Paolo Bonfanti, Antonio Di Biagio, CISAI Study Group, Taramasso, L, Ricci, E, Cascio, A, Valsecchi, L, Menzaghi, B, Squillace, N, Maggi, P, De Socio, Gv, Dentone, C, Madeddu, G, Pellicanò, Gf, Calza, L, Angioni, G, Bonfanti, P, Di Biagio, A, Sarchi, E, Chichino, G, Bellacosa, C, Angarano, G, Farinazzo, M, Gussio, M, Celesia, B, Falasca, K, Mastroianni, A, Guadagnino, G, Vichi, F, Salomoni, E, Martinelli, C, Nicolini, L, Cenderello, G, Molteni, C, Pellicanò, G, Nunnari, G, Cordier, L, Parisini, A, Rizzardini, G, Rusconi, S, Conti, F, Bandiera, A, Gori, A, Motta, D, Puoti, M, Migliorino, G, Martini, S, Trizzino, M, Gulminetti, R, De Socio, G, Cibelli, D, Parruti, G, Mameli, M, Orofino, G, Guastavigna, M, Pellicano, G, Bandera, A, Taramasso L., Ricci E., Cascio A., Valsecchi L., Menzaghi B., Squillace N., Maggi P., De Socio G.V., Dentone C., Madeddu G., Pellicano G.F., Calza L., Angioni G., Bonfanti P., Di Biagio A., Sarchi E., Chichino G., Bellacosa C., Angarano G., Farinazzo M., Gussio M., Celesia B.M., Falasca K., Mastroianni A., Guadagnino G., Vichi F., Salomoni E., Martinelli C., Nicolini L., Cenderello G., Molteni C., Nunnari G., Cordier L., Parisini A., Rizzardini G., Rusconi S., Conti F., Bandera A., Gori A., Motta D., Puoti M., Migliorino G.M., Martini S., Trizzino M., Gulminetti R., Cibelli D., Parruti G., Mameli M.S., Orofino G., and Guastavigna M.

Subjects
0301 basic medicine, Male, HIV Infections, 0302 clinical medicine, Dual, Medicine, HIV Infection, Pharmacology (medical), 030212 general & internal medicine, Prospective Studies, Prospective cohort study, Darunavir, Cobicistat, Middle Aged, Viral Load, Tolerability, Anti-Retroviral Agents, Cohort, Molecular Medicine, Drug Therapy, Combination, Female, Darunavir/cobicistat, Human, medicine.drug, Adverse event, Adult, lcsh:Immunologic diseases. Allergy, medicine.medical_specialty, 030106 microbiology, Context (language use), Durability, 03 medical and health sciences, Darunavir/cobicistat, Dual, Durability, Tolerability, CISAI, Adverse events, Virology, Internal medicine, Humans, business.industry, Research, Hypertriglyceridemia, medicine.disease, CISAI, Discontinuation, Prospective Studie, Adverse events, HIV-1, Anti-Retroviral Agent, business, lcsh:RC581-607
Abstract

Background Study aim was to evaluate the safety and durability of darunavir/cobicistat (DRV/c) in a real life setting. Methods Multicentre prospective cohort study performed in the context of SCOLTA (Surveillance Cohort Long-Term Toxicity Antiretrovirals). Patients were evaluated at baseline, week 24 and 48. Changes were evaluated using the paired t test or signed rank test. The multivariable analysis was performed using a general linear model, after ranking of not normally distributed variables. Results A total of 249 patients were included, 72 (29%) were in DRV/c-based dual therapies (DT). Hypercholesterolemia, HC, (total cholesterol (TC) ≥ 200 mg/dL or low density-C (LDL-C) ≥ 130 or statin use) was present in 121 (48.6%) and hypertriglyceridemia, (triglycerides (TG) ≥ 200 mg/dl or fibrate use) in 41 (16.5%) patients. Blood lipid profile did not change significantly in either the global population or patients with HC. After a median observation of 17 months (IQR 13–20), 59 (25.3%) patients discontinued DRV/c, of which 13 were in DT. The durability DT resulted higher than that of triple therapy (log-rank test p = 0.01). Main reasons for stopping DRV/c were simplification (15 patients), adverse events (13 patients), planned discontinuation for treatment initiation with DAA (4 patients), treatment failure (2 patients); death (2 patients), other causes (10 patients). Twenty-six were lost to follow-up. Conclusions DRV/c was safe and well tolerated. Dual therapies showed a better profile of tolerability and a longer durability compared to triple therapies.

Published
2019

5. Atazanavir/ritonavir with lamivudine as maintenance therapy in virologically suppressed HIV-infected patients: 96 week outcomes of a randomized trial

Author

Fabbiani, M, Gagliardini, R, Ciccarelli, N, Roldan, E, Latini, A, D'Ettorre, G, Antinori, A, Castagna, A, Orofino, G, Francisci, D, Chinello, P, Madeddu, G, Grima, P, Rusconi, S, Del Pin, B, Lombardi, F, D'Avino, A, Foca, E, Colafigli, M, Cauda, R, Di Giambenedetto, S, De Luca, A, Mondi, A, Borghetti, A, Baldonero, E, Belmonti, S, Lamonica, S, Sidella, L, Tamburrini, E, Visconti, E, Giacometti, A, Barchiesi, F, Castelli, P, Cirioni, O, Mazzocato, S, Di Pietro, M, Blanc, P, Degli Esposti, A, Mariabelli, E, Marini, S, Poggi, A, Quiros Roldan, E, 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, Fabbiani M., Gagliardini R., Ciccarelli N., Roldan E. Q., Latini A., d'Ettorre G., Antinori A., Castagna A., Orofino G., Francisci D., Chinello P., Madeddu G., Grima P., Rusconi S., Del Pin B., Lombardi F., D'Avino A., Foca E., Colafigli M., Cauda R., Di Giambenedetto S., De Luca A., Mondi A., Borghetti A., Baldonero E., Belmonti S., Lamonica S., Sidella L., Tamburrini E., Visconti E., Giacometti A., Barchiesi F., Castelli P., Cirioni O., Mazzocato S., Di Pietro M., Blanc P., Degli Esposti A., Mariabelli E., Marini S., Poggi A., Quiros Roldan E., 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., 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. 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., Fabbiani, M, Gagliardini, R, Ciccarelli, N, Roldan, E, Latini, A, D'Ettorre, G, Antinori, A, Castagna, A, Orofino, G, Francisci, D, Chinello, P, Madeddu, G, Grima, P, Rusconi, S, Del Pin, B, Lombardi, F, D'Avino, A, Foca, E, Colafigli, M, Cauda, R, Di Giambenedetto, S, De Luca, A, Mondi, A, Borghetti, A, Baldonero, E, Belmonti, S, Lamonica, S, Sidella, L, Tamburrini, E, Visconti, E, Giacometti, A, Barchiesi, F, Castelli, P, Cirioni, O, Mazzocato, S, Di Pietro, M, Blanc, P, Degli Esposti, A, Mariabelli, E, Marini, S, Poggi, A, Quiros Roldan, E, 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, Fabbiani M., Gagliardini R., Ciccarelli N., Roldan E. Q., Latini A., d'Ettorre G., Antinori A., Castagna A., Orofino G., Francisci D., Chinello P., Madeddu G., Grima P., Rusconi S., Del Pin B., Lombardi F., D'Avino A., Foca E., Colafigli M., Cauda R., Di Giambenedetto S., De Luca A., Mondi A., Borghetti A., Baldonero E., Belmonti S., Lamonica S., Sidella L., Tamburrini E., Visconti E., Giacometti A., Barchiesi F., Castelli P., Cirioni O., Mazzocato S., Di Pietro M., Blanc P., Degli Esposti A., Mariabelli E., Marini S., Poggi A., Quiros Roldan E., 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., 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. 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., and Valdatta C.

Abstract

Objectives: To investigate the long-term safety and efficacy of a treatment switch to dual ART with atazanavir/ritonavir+lamivudine versus continuing a standard regimen with atazanavir/ritonavir+2NRTI in virologically suppressed patients. Methods: ATLAS-M is a 96 week open-label, randomized, non-inferiority (margin -12%) trial enrolling HIV-infected adults on atazanavir/ritonavir+2NRTI, with stable HIV-RNA < 50 copies/mL and CD4 counts.200 cells/mm3. At baseline, patients were randomized 1:1 to switch to atazanavir/ritonavir+lamivudine or to continue the previous regimen. Here, we report the 96 week efficacy and safety data. The study was registered with ClinicalTrials.gov, number NCT01599364. Results: Overall, 266 subjects were enrolled (133 in each arm). At 96 weeks, in the ITT population, patients free of treatment failure totalled 103 (77.4%) with atazanavir/ritonavir+lamivudine and 87 (65.4%) with triple therapy (difference +12.0%, 95% CI +1.2/+22.8, P=0.030), demonstrating the superiority of dual therapy. Two (1.5%) and 9 (6.8%) virological failures occurred in the dual-therapy arm and the triple-therapy arm, respectively, without development of resistance to any study drug. Clinical adverse events occurred at similar rates in both arms. A higher frequency of grade 3-4 hyperbilirubinemia (66.9% versus 50.4%, P=0.006) and hypertriglyceridaemia (6.8% versus 1.5%, P=0.031) occurred with dual therapy, although this never led to treatment discontinuation. A significant improvement in renal function and lumbar spine bone mineral density occurred in the dual-therapy arm. The evolution of CD4, HIV-DNA levels and neurocognitive performance was similar in both arms. Conclusions: In this randomized study, a treatment switch to atazanavir/ritonavir+lamivudine was superior over the continuation of atazanavir/ritonavir+2NRTI in virologically suppressed patients, with a sustained benefit in terms of improved renal function and bone mineral density.

Published
2018

7. 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, 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, 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. 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., 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. 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, 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. 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., 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. 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., and Valdatta C.

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 <50 copies/mL and CD4+>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 <50 copies/mL at week 48 of the ITT-exposed (ITT-e) analysis with switch"failure. The non-inferiority margin was 12%. This study is registered at ClinicalTrials.gov, number NCT01599364. Results: Between July 2011 and June 2014, 266 patients were randomized (133 to each arm). After 48 weeks, the primary study outcome was met by 119 of 133 patients (89.5%) in the atazanavir/ritonavir+lamivudine arm and 106 of 133 patients (79.7%) in the atazanavir/ritonavir+two NRTIs arm [difference atazanavir/ritonavir+ lamivudine versus atazanavir/ritonavir+two NRTIs arm: +9.8% (95% CI+1.2 to+18.4)], demonstrating non-inferiority and superior efficacy of the atazanavir/ritonavir+lamivudine arm. Virological failure occurred in two (1.5%) patients in the atazanavir/ritonavir+lamivudine arm and six (4.5%) patients in the atazanavir/ritonavir+ two NRTIs arm, without resistance selection. A similar proportion of adverse events occurred in both arms. Conclusions: Treatment simplification to atazanavir/rito

Published
2017

8. Risk of HIV transmission through condomless sex in serodifferent gay couples with the HIV-positive partner taking suppressive antiretroviral therapy (PARTNER): final results of a multicentre, prospective, observational study

Author

Rodger, A. J., Cambiano, V., Phillips, A. N., Bruun, T., Raben, D., Lundgren, J., Vernazza, P., Collins, S., Degen, O., Corbelli, G. M., Estrada, V., Geretti, A. M., Beloukas, A., Coll, P., Antinori, A., Nwokolo, N., Rieger, A., Prins, J. M., Blaxhult, A., Weber, R., Van Eeden, A., Brockmeyer, N. H., Clarke, A., del Romero Guerrero, J., Raffi, F., Bogner, J. R., Wandeler, G., Gerstoft, J., Gutierrez, F., Brinkman, K., Kitchen, M., Ostergaard, L., Leon, A., Ristola, M., Jessen, H., Stellbrink, H. -J., Cobarsi, P., Nieto, A., Meulbroek, M., Carrillo, A., Saz, J., Guerrero, J. D. R., Garcia, M. V., Masia, M., Robledano, C., Leal, L., Redondo, E. G., Estrada, V. P., Marquez, R., Sandoval, R., Viciana, P., Espinosa, N., Lopez-Cortes, L., Podzamczer, D., Tiraboschi, J., Morenilla, S., Antela, A., Losada, E., Sewell, J., Kirk, S., Knott, A., Fernandez, T., Gompels, M., Jennings, L., Ward, L., Fox, J., Lwanga, J., Lee, M., Gilson, R., Leen, C., Morris, S., Clutterbuck, D., Brady, M., Asboe, D., Fedele, S., Fidler, S., Brockmeyer, N., Potthoff, A., Skaletz-Rorowski, A., Bogner, J., Seybold, U., Roider, J., Jessen, A., Ruzicic, S., Kummerle, T., Lehmann, C., Bartel, S., Hufner, A., Rockstroh, J., Mohrmann, K., Boesecke, C., Krznaric, I., Ingiliz, P., Grube, C., Braun, D., Gunthard, H., Furrer, H., Rauch, A., Schmid, P., Rasi, M., Borso, D., Stratmann, M., Caviezel, O., Stoeckle, M., Battegay, M., Tarr, P., Christinet, V., Jouinot, F., Isambert, C., Bernasconi, E., Bernasconi, B., Jensen, L. P., Bayer, A. A., Yehdego, Y., Bach, A., Handberg, P., Kronborg, G., Pedersen, S. S., Bulow, N., Ramskover, B., Debnam, O., Sutinen, J., Ask, R., Hildingsson-Lundh, B., Westling, K., Frisen, E. -M., Cortney, G., O'Dea, S., De Wit, S., Necsoi, C., Vandekerckhove, L., Goffard, J. -C., Henrard, S., Prins, J., Nobel, H. -H., Weijsenfeld, A., Elsenburg, L., Vos, D., Hoijenga, I., Gisolf, E., Van Bentum, P., Verhagen, D., Billaud, E., Ohayon, M., Gosset, D., Fior, A., Pialoux, G., Thibaut, P., Chas, J., Leclercq, V., Pechenot, V., Coquelin, V., Pradier, C., Breaud, S., Touzeau-Romer, V., Kitchen - Maria Geit, M., Sarcletti, M., Gisinger, M., Oellinger, A., Menichetti, S., Bini, T., Mussini, C., Meschiari, M., Di Biagio, A., Taramasso, L., Celesia, B. M., Gussio, M., Janeiro, N., AII - Infectious diseases, Infectious diseases, Imperial College Healthcare NHS Trust- BRC Funding, Department of Medicine, University Management, Clinicum, and HUS Inflammation Center

Subjects
Male, SERODISCORDANT COUPLES, HIV Infections, 030204 cardiovascular system & hematology, Condoms, Sexual and Gender Minorities, 0302 clinical medicine, Unsafe Sex, Antiretroviral Therapy, Highly Active, Epidemiology, INFECTION, HIV Seropositivity, Medicine and Health Sciences, 030212 general & internal medicine, Homosexuality, Prospective Studies, Prospective cohort study, 610 Medicine & health, 11 Medical and Health Sciences, media_common, Transmission (medicine), virus diseases, General Medicine, Middle Aged, Viral Load, Sexual Partners, PARTNER Study Group, Viral load, Life Sciences & Biomedicine, Adult, medicine.medical_specialty, Anti-HIV Agents, media_common.quotation_subject, education, Antiretroviral Therapy, Article, 03 medical and health sciences, Medicine, General & Internal, General & Internal Medicine, medicine, Humans, Highly Active, Seroconversion, SEMEN, Homosexuality, Male, Science & Technology, business.industry, HIV Seropositivity/transmission, HIV, PREVENTION, 3121 General medicine, internal medicine and other clinical medicine, Anti-HIV Agents/therapeutic use, BLOOD-PLASMA, RNA, Observational study, HETEROSEXUAL TRANSMISSION, business, Demography
Abstract

BACKGROUND: The level of evidence for HIV transmission risk through condomless sex in serodifferent gay couples with the HIV-positive partner taking virally suppressive antiretroviral therapy (ART) is limited compared with the evidence available for transmission risk in heterosexual couples. The aim of the second phase of the PARTNER study (PARTNER2) was to provide precise estimates of transmission risk in gay serodifferent partnerships.METHODS: The PARTNER study was a prospective observational study done at 75 sites in 14 European countries. The first phase of the study (PARTNER1; Sept 15, 2010, to May 31, 2014) recruited and followed up both heterosexual and gay serodifferent couples (HIV-positive partner taking suppressive ART) who reported condomless sex, whereas the PARTNER2 extension (to April 30, 2018) recruited and followed up gay couples only. At study visits, data collection included sexual behaviour questionnaires, HIV testing (HIV-negative partner), and HIV-1 viral load testing (HIV-positive partner). If a seroconversion occurred in the HIV-negative partner, anonymised phylogenetic analysis was done to compare HIV-1 pol and env sequences in both partners to identify linked transmissions. Couple-years of follow-up were eligible for inclusion if condomless sex was reported, use of pre-exposure prophylaxis or post-exposure prophylaxis was not reported by the HIV-negative partner, and the HIV-positive partner was virally suppressed (plasma HIV-1 RNA FINDINGS: Between Sept 15, 2010, and July 31, 2017, 972 gay couples were enrolled, of which 782 provided 1593 eligible couple-years of follow-up with a median follow-up of 2·0 years (IQR 1·1-3·5). At baseline, median age for HIV-positive partners was 40 years (IQR 33-46) and couples reported condomless sex for a median of 1·0 years (IQR 0·4-2·9). During eligible couple-years of follow-up, couples reported condomless anal sex a total of 76 088 times. 288 (37%) of 777 HIV-negative men reported condomless sex with other partners. 15 new HIV infections occurred during eligible couple-years of follow-up, but none were phylogenetically linked within-couple transmissions, resulting in an HIV transmission rate of zero (upper 95% CI 0·23 per 100 couple-years of follow-up).INTERPRETATION: Our results provide a similar level of evidence on viral suppression and HIV transmission risk for gay men to that previously generated for heterosexual couples and suggest that the risk of HIV transmission in gay couples through condomless sex when HIV viral load is suppressed is effectively zero. Our findings support the message of the U=U (undetectable equals untransmittable) campaign, and the benefits of early testing and treatment for HIV.FUNDING: National Institute for Health Research.

Published
2019

9. Risk of HIV transmission through condomless sex in serodifferent gay couples with the HIV-positive partner taking suppressive antiretroviral therapy (PARTNER): final results of a multicentre, prospective, observational study

Author

Cambiano, V, Bruun, T, Collins, S, Corbelli, GM, Geretti, AM, Beloukas, A, Raben, D, Prins, JM, Van Eeden, A, Guerrero, JD, Bogner, JR, Phillips, AN, Lundgren, J, Viciana, P, Espinosa, N, Lopez-Cortes, L, Gutierrez, F, Masia, M, Robledano, C, Coll, P, Cobarsi, P, Nieto, A, Podzamczer, D, Tiraboschi, J, Morenilla, S, Meulbroek, M, Carrillo, A, Saz, J, Estrada, V, Marquez, R, Sandoval, R, Antela, A, Losada, E, Leon, A, Leal, L, Redondo, EG, Garcia, MV, Asboe, D, Fedele, S, Nwokolo, N, Gilson, R, Gompels, M, Jennings, L, Ward, L, Brady, M, Clarke, A, Kirk, S, Knott, A, Fox, J, Lwanga, J, Lee, M, Leen, C, Morris, S, Clutterbuck, D, Fidler, S, Rodger, AJ, Fernandez, T, Sewell, J, Degen, O, Bartel, S, Hufner, A, Kummerle, T, Lehmann, C, Bogner, J, Seybold, U, Roider, J, Brockmeyer, NH, Potthoff, A, Skaletz-Rorowski, A, Stellbrink, HJ, Jessen, H, Jessen, A, Ruzicic, S, Rockstroh, J, Mohrmann, K, Boesecke, C, Krznaric, I, Ingiliz, P, Prins, J, Nobel, HE, Weijsenfeld, A, Brinkman, K, Vos, D, Hoijenga, I, Verhagen, D, van Eeden, A, Elsenburg, L, Gisolf, E, van Bentum, P, Weber, R, Grube, C, Braun, D, Wandeler, G, Furrer, H, Rauch, A, Stoeckle, M, Tarr, P, Battegay, M, Vernazza, P, Schmid, P, Rasi, M, Bernasconi, E, Bernasconi, B, Christinet, V, Jouinot, F, Isambert, C, Borso, D, Stratmann, M, Caviezel, O, Bini, T, Antinori, A, Menichetti, S, Celesia, BM, Gussio, M, Mussini, C, Meschiari, M, Di Biagio, A, Taramasso, L, Rieger, A, Touzeau-Romer, V, Kitchen, M, Sarcletti, M, Gisinger, M, Oelinger, A, Geit, M, Gerstoft, J, Jensen, LP, Bayer, AA, Handberg, P, Kronborg, G, Ostergaard, L, Pedersen, SS, Bulow, N, Ramskover, B, Pradier, C, Breaud, S, Raffi, F, Billaud, E, Ohayon, M, Gosset, D, Fior, A, Pialoux, G, Thibaut, P, Chas, J, Leclercq, V, Pechenot, V, Coquelin, V, Westling, K, Frisen, EM, Blaxhult, A, Ask, R, Hildingsson-Lundh, B, Ristola, M, Debnam, O, Sutinen, J, De Wit, S, Necsoi, C, Vandekerckhove, L, Goffard, JC, Henrard, S, Janeiro, N, Cortney, G, and O'Dea, S

Abstract

Background The level of evidence for HIV transmission risk through condomless sex in serodifferent gay couples with the HIV-positive partner taking virally suppressive antiretroviral therapy (ART) is limited compared with the evidence available for transmission risk in heterosexual couples. The aim of the second phase of the PARTNER study (PARTNER2) was to provide precise estimates of transmission risk in gay serodifferent partnerships. Methods The PARTNER study was a prospective observational study done at 75 sites in 14 European countries. The first phase of the study (PARTNER1; Sept 15, 2010, to May 31, 2014) recruited and followed up both heterosexual and gay serodifferent couples (HIV-positive partner taking suppressive ART) who reported condomless sex, whereas the PARTNER2 extension (to April 30, 2018) recruited and followed up gay couples only. At study visits, data collection included sexual behaviour questionnaires, HIV testing (HIV-negative partner), and HIV-1 viral load testing (HIV-positive partner). If a seroconversion occurred in the HIV-negative partner, anonymised phylogenetic analysis was done to compare HIV-1 pol and env sequences in both partners to identify linked transmissions. Couple-years of follow-up were eligible for inclusion if condomless sex was reported, use of pre-exposure prophylaxis or post-exposure prophylaxis was not reported by the HIV-negative partner, and the HIV-positive partner was virally suppressed (plasma HIV-1 RNA < 200 copies per mL) at the most recent visit (within the past year). Incidence rate of HIV transmission was calculated as the number of phylogenetically linked HIV infections that occurred during eligible couple-years of follow-up divided by eligible couple-years of follow-up. Two-sided 95% CIs for the incidence rate of transmission were calculated using exact Poisson methods. Findings Between Sept 15, 2010, and July 31, 2017, 972 gay couples were enrolled, of which 782 provided 1593 eligible couple-years of follow-up with a median follow-up of 2.0 years (IQR 1.1-3.5). At baseline, median age for HIV-positive partners was 40 years (IQR 33-46) and couples reported condomless sex for a median of 1.0 years (IQR 0.4-2.9). During eligible couple-years of follow-up, couples reported condomless anal sex a total of 76 088 times. 288 (37%) of 777 HIV-negative men reported condomless sex with other partners. 15 new HIV infections occurred during eligible couple-years of follow-up, but none were phylogenetically linked within-couple transmissions, resulting in an HIV transmission rate of zero (upper 95% CI 0.23 per 100 couple-years of follow-up). Interpretation Our results provide a similar level of evidence on viral suppression and HIV transmission risk for gay men to that previously generated for heterosexual couples and suggest that the risk of HIV transmission in gay couples through condomless sex when HIV viral load is suppressed is effectively zero. Our findings support the message of the U=U (undetectable equals untransmittable) campaign, and the benefits of early testing and treatment for HIV. Copyright (C) 2019 The Author(s). Published by Elsevier Ltd.

Published
2019

10. 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

12. Early occurrence of hepatocellular carcinoma (HCC) in patients with HCV cirrhosis treated with direct-acting antivirals (DAAs)

Author

Calvaruso, V., primary, Cabibbo, G., additional, Cacciola, I., additional, Petta, S., additional, Madonia, S., additional, Bellia, A., additional, Tinè, F., additional, Distefano, M., additional, Giannitrapani, L., additional, Prestileo, T., additional, Mazzola, G., additional, Davì, A., additional, Larocca, L., additional, Ardiri, A., additional, Digiacomo, A., additional, Gussio, M., additional, Guarneri, L., additional, Magro, A., additional, Averna, A., additional, Iacobello, C., additional, Scalisi, I., additional, Cartabellotta, F., additional, Savalli, F., additional, Russello, M., additional, Scifo, G., additional, Squadrito, G., additional, Cammà, C., additional, Raimondo, G., additional, Craxì, A., additional, and Di Marco, V., additional

Published
2017
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13. Occurrence of hepatocellular carcinoma in patients with hepatitis C virus related liver disease treated with direct-acting antivirals

Author

Calvaruso, V., primary, Cabibbo, G., additional, Cacciola, I., additional, Petta, S., additional, Madonia, S., additional, Bellia, A., additional, Stefano, M.D., additional, Giannitrapani, L., additional, Tinè, F., additional, Magro, A., additional, Davì, A., additional, Larocca, L., additional, Ardiri, A., additional, Digiacomo, A., additional, Gussio, M., additional, Guarneri, L., additional, Scalisi, I., additional, Mazzola, G., additional, Cartabellotta, F., additional, Savalli, F., additional, Russello, M., additional, Scifo, G., additional, Squadrito, G., additional, Cammà, C., additional, Raimondo, G., additional, Craxì, A., additional, and Di Marco, V., additional

Published
2017
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16. HBV reactivation in immunosuppressed patients

Author

Maresca, M, Scibilia, E, Guglielmino, Mr, Bruno, R, Trovato, L, Oliveri, Salvatore, Tedesco, M. C., Gussio, M, Benanti, F, and Cacopardo, B.

Subjects
Hepatitis B virus, HBV, Steroids, Hepatitis B virus, HBV, Reactivation, Steroids, Immunosuppression, Reactivation, Immunosuppression
Published
2015

17. Self-reported sexual dysfunction in HIV-positive subjects: a cross-sectional study

Author

Pinzone, M. R., Gussio, M., Bellissimo, F., Coco, C., Bisicchia, F., Pellicanò, G., Palermo, Francesco, Mughini, M. T., Cacopardo, B., Nunnari, G., and Celesia, B. M.

Subjects
HAART, Anxiety, Erectile dysfunction, HAART, HIV, Sexual dysfunction, HIV, Sexual dysfunction, Erectile dysfunction, Anxiety
Published
2015

19. High prevalence of parotideal abnormalities among HCV infected patients

Author

Cacopardo, Bruno Santi, Pinzone, Mr, Gussio, M, and Nunnari, G.

Subjects
Male, Female, Hepatitis C, Chronic, Humans, Middle Aged, Parotid Diseases, Prevalence, Chronic, Hepatitis C
Abstract

Several salivary diseases, such as Sjogren syndrome (SS), chronic lymphocytic sialadenitis and parotid non-Hodgkin's lymphoma, may occur in the setting of HCV infection. Our aim was to evaluate the prevalence of parotid abnormalities in a cohort of 310 patients with chronic hepatitis C (CHC) attending the Unit of Infectious Diseases of the Garibaldi Nesima Hospital of Catania. Our control group consisted of 188 patients with chronic HBV infection. We found that the prevalence of parotideal diseases was significantly higher among HCV-infected patients in comparison with HBV-infected (17% vs. 1%). Indeed, 53 CHC subjects had parotideal abnormalities: 24 patients (45.3%) had lymphoepithelial cysts of the salivary gland, six patients (11.3%) had a benign tumour, six patients (11.3%) had granulomatous lesions, 12 patients (22.7%) had Sjogren's syndrome and four patients (7.5%) were diagnosed as having chronic lymphocytic sialadenitis. Finally, one patient (1.9%) had parotid non-Hodgkin's lymphoma. In conclusion, parotideal abnormalities are common among HCV-infected individuals and targeted diagnostic protocols may help identify parotid involvement in this population of subjects.

Published
2014

20. Cryptococcal meningitis in an HIV-1-infected person: relapses or IRIS? Case report and review of the literature

Author

Nunnari, G., Gussio, M., Pinzone, M. R., Martellotta, F., Cosentino, S., bruno cacopardo, and Celesia, B. M.

Subjects
Adult, Male, Acquired Immunodeficiency Syndrome, Immune Reconstitution Inflammatory Syndrome, Recurrence, HIV-1, Antiretroviral therapy, Cryptococcal meningitis, HIV, Humans, HIV, Meningitis, Cryptococcal, Antiretroviral therapy, Cryptococcal meningitis
Abstract

After starting highly active antiretroviral therapy (HAART), HIV-infected patients may experience what is termed immune reconstitution inflammatory syndrome (IRIS). IRIS is characterized by a paradoxical inflammatory response to either previously or recently treated infections or unmasked subclinical infections, when the patient regains the ability to mount a suitable immune response against specific antigens or pathogens. Cryptococcal IRIS (C-IRIS) is thought to be mediated by recovery of Cryptococcus-specific immune responses, resulting in exaggerated host inflammatory responses. In HIV-positive subjects, two distinct modes of presentation of C-IRIS are recognized, "paradoxical" and "unmasking" C-IRIS. "Paradoxical" C-IRIS presents as worsening or recurrence of treated cryptococcal disease following HAART initiation, despite microbiological treatment success. In the "unmasking" form, patients with no prior diagnosis may develop acute symptoms of cryptococcosis, such as meningitis or necrotizing lymphadenopathy, after starting HAART. Here, we present the case of an HIV-positive man, who developed cryptococcal meningitis two months after having started HAART and experienced several meningeal relapses and a "paradoxical" C-IRIS during the following year.

Published
2013

22. [Clinical, virological and epidemiological aspects of acute B hepatitis in the Catania area (Italy)]

Author

Scalia, Guido, Russo, Raffaela, Palermo, C. I., Gussio, M, Bellissimo, F, Fatuzzo, F, Montineri, A, Patamia, I, Costanzo, C. M., Zappala', D, Russo, R, and Cacopardo, Bruno Santi

Subjects
Adult, Aged, 80 and over, Male, Hepatitis B virus, Travel, Adolescent, Genotype, Unsafe Sex, Emigrants and Immigrants, Middle Aged, Hepatitis B, Hepatitis B Antigens, Young Adult, Postoperative Complications, Italy, Liver Function Tests, Acute Disease, Humans, Female, Body Piercing, Hepatitis B Antibodies, Child, Substance Abuse, Intravenous, Aged
Abstract

Starting from January 1997 we prospectively evaluated all cases of acute hepatitis B admitted to two of the main Infectious Diseases Units in Catania (eastern Sicily). The survey was extended throughout a 10-year period up to December 2007. Between 1997 and 1999 we observed 21 cases of acute hepatitis B; between 2000 and 2002 18 cases; between 2003 and 2005 22 cases and, finally, 37 cases were reported in the period 2006-2007. We found an increase in acute hepatitis B cases among people aged 26 to 44 years (from 38% in 1997-99 to 70% in 2006-07). A progressive decrease in intravenous drug abuse as a risk factor for acute hepatitis B was also observed (from 61% to 14%) together with a parallel increase in cases due to sexual transmission (from 19% to 56%) and outpatient cosmetic surgical procedures. Mean time to serum HBsAg negativization was longer in the last period (2006-07), with 6 cases out of 37 showing HBsAg persistence beyond 12 months from the clinical onset. Furthermore, in 2006-07 there were 12 cases (42%) of acute hepatitis due to HBV genotypes A and F. In our area, a progressive drop of hepatitis B cases due to intravenous drug abuse occurred, whereas heterosexual and iatrogenic cases increased. Cases due to HBV non-D genotypes may well be related to migration from endemic areas towards Sicily.

Published
2010

26. Description of a rare case of splenic abscess due to spontaneous E. cohi bacteremia in a cirrhotic patient

Author

bruno cacopardo, Sapienza, M., Li Volsi, S., Gussio, M., Benenati, P., Notararrigo, C., and Maiuzzo, S.

Subjects
Male, Liver Cirrhosis, Alcoholic, Splenomegaly, Humans, Bacteremia, Middle Aged, Tomography, X-Ray Computed, Ceftazidime, Abscess, Escherichia coli Infections, Anti-Bacterial Agents, Blood Cell Count, Splenic Diseases
Abstract

We report on a rare case of splenic abscess due to spontaneous Escherichia coli bacteremia in a 49-year old cirrhotic. No other source potentially responsible for bacteremia was found through careful diagnostic research. Splenic abscess appeared from ultrasonography and computerized tomography as a 6-7 cm lesion located at the lower splenic pole. Blood cultures allowed to isolate E. coli which, on the basis of antibiotic susceptibility, was treated by a 21-day intravenous cetazidime course at a dose of 6 g/day. The isolated E. coli strain resulted as quinolone-resistant. Disappearance either of high fever or of abscessual splenic lesion was achieved without surgery after the antibiotic round. Spontaneous bacteremia may occur in cirrhotic patients due to intestinal bacteria traslocation from gut lumen to blood. Nevertheless, isolated splenic localization is a very rare event.

Published
2008

27. Predictors of Costs of Antiretrovirals for HIV Infection in Italy: A Multicentric Retrospection in 2012

Author

Tontodonati, M., primary, Cenderello, G., additional, Celesia, B.M., additional, Trezzi, M., additional, Ursini, T., additional, Costantini, A., additional, Gaggero, D., additional, Gussio, M., additional, Manzoli, L., additional, Polilli, E., additional, Sozio, F., additional, Catalani, C., additional, Butini, L., additional, and Parruti, G., additional

Published
2013
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28. Test for CCR5 tropism and treatment with maraviroc in Sicily: an observational retrospective multicentre study

Author

Celesia, B, primary, Gussio, M, additional, Franco, A, additional, Scifo, G, additional, Prestileo, T, additional, Di Lorenzo, F, additional, La Rosa, R, additional, Nigro, L, additional, Colomba, C, additional, Ingrassia, D, additional, Galvagna, S, additional, Mannino, G, additional, Storaci, N, additional, Migliore, S, additional, Salvo, A, additional, Todaro, G, additional, Portelli, V, additional, Sturniolo, G, additional, Davi’, A, additional, Bruno, S, additional, Bellissima, P, additional, Guarneri, L, additional, Palermo, F, additional, Zagami, A, additional, Nunnari, G, additional, and Cosentino, S, additional

Published
2012
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34. Late presentation of HIV infection: predictors of delayed diagnosis and survival in Eastern Sicily.

Author

CELESIA, B. M., CASTRONUOVO, D., PINZONE, M. R., BELLISSIMO, F., MUGHINI, M. T., LUPO, G., SCARPINO, M. R., GUSSIO, M., PALERMO, F., COSENTINO, S., CACOPARDO, B., and NUNNARI, G.

Abstract

OBJECTIVES: Across Europe, more than one third of patients are diagnosed with HIV infection late. Late presentation for care has been associated with higher risk of clinical progression and mortality. In the present study, we evaluated the prevalence, epidemiological characteristics and survival probability of patients with late and very late presentation, newly diagnosed with HIV infection in Catania, Italy, from 1985 to 2010. PATIENTS AND METHODS: According to the European Consensus definition, Late Presenters (LP) were defined as subjects presenting for care with a CD4+ T-cell count below 350 cells/µl or with an AIDS-defining event, regardless of CD4+ T-cell count; patients with advanced HIV disease (Very Late Presenters) (VLP) were those presenting with a CD4+ T-cell count below 200 cells/µl or with an AIDS-defining event, regardless of CD4+ T-cell count. RESULTS: 620 patients were included in the study. 345 (55.6%) subjects were LP, 35% of them were asymptomatic; 246 (39.7%) were VLP. In univariate analysis, late presentation was related to age (p < 0.001), to heterosexual exposure to HIV infection (70% of heterosexual subjects were LP) (p < 0.005) and to being diagnosed during the calendar period from 1991 to 2000 (p < 0.001). Very late presentation was related to age (p < 0.001), male sex (p < 0.01), heterosexual risk (p < 0.001) and to being diagnosed during the calendar period from 1991 to 2000 (p < 0.001). In multivariate analysis, age (p < 0.0001), being older than 50 years old (p = 0.02), years of diagnosis 1991-1995 (p < 0.005) and 1996-2000 (p < 0.05) in the subgroup of late presenters and age (p < 0.0001), being older than 50 years old (p < 0.005), male sex (p < 0.0001), years of diagnosis 1991-1995 (p < 0.05) and 1996-2000 (p < 0.005) in the subgroup of very late presenters maintained statistical significance. The survival probability within LP and VLP group was statistically lower than no LP/VLP (log rank test p < 0.0005 and p < 0.0001, respectively). For both LP (p < 0.002) and VLP (p < 0.0001), survival probability was significantly lower in the pre-HAART era, in comparison with the period of mono/dual therapy and the HAART era. CONCLUSIONS: More than fifty percent of patients in our setting were diagnosed late with HIV infection and, consequently, treated late. Late and very late presentation were associated with lower survival probability. The implementation of strategies focused on targeted prevention efforts and HIV testing programs appears fundamental to diagnose and treat HIV infection as early as possible. [ABSTRACT FROM AUTHOR]

Published
2013

35. High prevalence of undiagnosed anxiety symptoms among HIV-positive individuals on cART: a cross-sectional study.

Author

CELESIA, B. M., NIGRO, L., PINZONE, M. R., COCO, C., LA ROSA, R., BISICCHIA, F., MAVILLA, S., GUSSIO, M., PELLICANÒ, G., MILIONI, V., PALERMO, F., RUSSO, R., MUGHINI, M. T., MARTELLOTTA, F., TAIBI, R., CACOPARDO, B., and NUNNARI, G.

Abstract

INTRODUCTION: Anxiety disorders are frequent in HIV-infected individuals, can pre-exist or occur during HIV infection. We evaluated with a self-reported questionnaire whether anxiety is related to HIV clinical status and therapeutic success in a cohort of HIV-positive subjects in Sicily. PATIENTS AND METHODS: We enrolled 251 patients on combination antiretroviral therapy (cART) for at least six months; Self Rating Anxiety State SAS 054 was used to diagnose anxiety and a Z score = = 45 points was considered diagnostic. RESULTS: 47% of patients were diagnosed with anxiety. Patients showing symptoms related to anxiety had experienced a high number of therapeutic switches (fourth line or more). CONCLUSIONS: These data confirm a high prevalence of anxiety symptoms among subjects with HIV infection in Eastern Sicily. Physicians should be aware of the extent of the problem and should be able to adequately manage anxiety in the setting of HIV infection. [ABSTRACT FROM AUTHOR]

Published
2013

36. LPS and HIV gp120 modulate monocyte/macrophage CYP27B1 and CYP24A1 expression leading to vitamin D consumption and hypovitaminosis D in HIV-infected individuals.

Author

PINZONE, M. R., DI ROSA, M., CELESIA, B. M., CONDORELLI, F., MALAGUARNERA, M., MADEDDU, G., MARTELLOTTA, F., CASTRONUOVO, D., GUSSIO, M., COCO, C., PALERMO, F., COSENTINO, S., CACOPARDO, B., and NUNNARI, G.

Abstract

AIM: Vitamin D deficiency is very common among HIV-infected subjects. We cross-sectionally evaluated the prevalence and risk factors for hypovitaminosis D in 91 HIV-infected Italian patients. PATIENTS AND METHODS: We studied in a cohort of 91 HIV-infected Italian patients the metabolism of Vitamin D by evaluating the in vitro expression of CYP27B1, CYP24A1 and vitamin D receptor (VDR) by monocytes and macrophages stimulated with the viral envelope protein gp120 or lipopolysaccharide (LPS). RESULTS: The prevalence of vitamin D deficiency (25OHD < 10 ng/ml) and vitamin D insufficiency (25OHD 10-30 ng/ml) was 31% and 57%, respectively. In univariate analysis, female sex (p = 0.01), increasing age (p = 0.05), higher highly sensitive-C reactive protein (p = 0.025), higher parathyroid hormone (PTH) (p = 0.043) and lower BMI (p = 0.04) were associated with vitamin D deficiency. In multivariate analysis, the association was still significant only for PTH (p = 0.03) and female sex (p = 0.03). Monocyte stimulation with LPS (100 ng/ml) or gp120 (1 µg/ml) signif icantly upregulated CYP27B1 mRNA expression. Moreover, gp120 significantly increased VDR mRNA levels. On the contrary, neither LPS nor gp120 modified CYP24A1 levels. Macrophage stimulation with LPS (100 ng/ml) significantly upregulated CYP27B1 and CYP24A1 mRNA expression. When monocytes were cultured in the presence of 25OHD (40 ng/ml) and stimulated with LPS we detected significantly lower levels of 25OHD in the supernatant. CONCLUSIONS: Vitamin D deficiency was very common in our cohort of HIV-infected patients. Chronic inflammation, including residual viral replication, may contribute to hypovitaminosis D, by modulating vitamin D metabolism and catabolism. Systematic screening may help identifying subjects requiring supplementation. [ABSTRACT FROM AUTHOR]

Published
2013

37. Description of a rare case of splenic abscess due to spontaneous E. coli bacteremia in a cirrhotic patient.

Author

CACOPARDO, B., SAPIENZA, M., LI VOLSI, S., GUSSIO, M., BENENATI, P., NOTARARRIGO, C., and MAIUZZO, S.

Abstract

We report on a rare case of splenic abscess due to spontaneous Escherichia coli bacteremia in a 49-year old cirrhotic. No other source potentially responsible for bacteremia was found through careful diagnostic research. Splenic abscess appeared from ultrasonography and computerized tomography as a 6-7 cm lesion located at the lower splenic pole. Blood cultures allowed to isolate E. coli which, on the basis of antibiotic susceptibility, was treated by a 21-day intravenous cetazidime course at a dose of 6 g/day. The isolated E. coli strain resulted as quinolone-resistant. Disappearance either of high fever or of abscessual splenic lesion was achieved without surgery after the antibiotic round. Spontaneous bacteremia may occur in cirrhotic patients due to intestinal bacteria traslocation from gut lumen to blood. Nevertheless, isolated splenic localization is a very rare event. [ABSTRACT FROM AUTHOR]

Published
2008

38. Late presentation of HIV infection: Predictors of delayed diagnosis and survival in Eastern Sicily

Author

benedetto maurizio celesia, Castronuovo, D., Pinzone, M. R., Bellissimo, F., Mughini, M. T., Lupo, G., Scarpino, M. R., Gussio, M., Palermo, F., Cosentino, S., Cacopardo, B., and Nunnari, G.

Subjects
Adult, Male, HAART, Delayed Diagnosis, Time Factors, HIV Infections, HIV, HAART, Late presentation, Late presenter, Sex Factors, Late presenter, Risk Factors, Antiretroviral Therapy, Highly Active, Prevalence, Humans, Heterosexuality, Sicily, Age Factors, HIV, Homosexuality, Middle Aged, Survival Analysis, CD4 Lymphocyte Count, Late presentation, Multivariate Analysis, Disease Progression, Female, Follow-Up Studies
Abstract

Across Europe, more than one third of patients are diagnosed with HIV infection late. Late presentation for care has been associated with higher risk of clinical progression and mortality. In the present study, we evaluated the prevalence, epidemiological characteristics and survival probability of patients with late and very late presentation, newly diagnosed with HIV infection in Catania, Italy, from 1985 to 2010.According to the European Consensus definition, Late Presenters (LP) were defined as subjects presenting for care with a CD4+ T-cell count below 350 cells/µl or with an AIDS-defining event, regardless of CD4+ T-cell count; patients with advanced HIV disease (Very Late Presenters) (VLP) were those presenting with a CD4+ T-cell count below 200 cells/µl or with an AIDS-defining event, regardless of CD4+ T-cell count.620 patients were included in the study. 345 (55.6%) subjects were LP, 35% of them were asymptomatic; 246 (39.7%) were VLP. In univariate analysis, late presentation was related to age (p0.001), to heterosexual exposure to HIV infection (70% of heterosexual subjects were LP) (p0.005) and to being diagnosed during the calendar period from 1991 to 2000 (p0.001). Very late presentation was related to age (p0.001), male sex (p0.01), heterosexual risk (p0.001) and to being diagnosed during the calendar period from 1991 to 2000 (p0.001). In multivariate analysis, age (p0.0001), being older than 50 years old (p = 0.02), years of diagnosis 1991-1995 (p0.005) and 1996-2000 (p0.05) in the subgroup of late presenters and age (p0.0001), being older than 50 years old (p0.005), male sex (p0.0001), years of diagnosis 1991-1995 (p0.05) and 1996-2000 (p0.005) in the subgroup of very late presenters maintained statistical significance. The survival probability within LP and VLP group was statistically lower than no LP/VLP (log rank test p0.0005 and p0.0001, respectively). For both LP (p0.002) and VLP (p0.0001), survival probability was significantly lower in the pre-HAART era, in comparison with the period of mono/dual therapy and the HAART era.More than fifty percent of patients in our setting were diagnosed late with HIV infection and, consequently, treated late. Late and very late presentation were associated with lower survival probability. The implementation of strategies focused on targeted prevention efforts and HIV testing programs appears fundamental to diagnose and treat HIV infection as early as possible.

39. High prevalence of undiagnosed anxiety symptoms among HIV-positive individuals on cART: A cross-sectional study

Author

Celesia, B. M., Nigro, L., Pinzone, M. R., Coco, C., La Rosa, R., Bisicchia, F., Mavilla, S., Gussio, M., Pellicanò, G., Milioni, V., Palermo, F., Russo, R., Mughini, M. T., Martellotta, F., Taibi, R., bruno cacopardo, and Nunnari, G.

Subjects
Adult, Male, Anti-HIV Agents, HIV, HIV Infections, Middle Aged, Anxiety, Ambulatory Care Facilities, Cross-Sectional Studies, HIV Seroprevalence, Surveys and Questionnaires, Prevalence, Humans, CART, Drug Therapy, Combination, Female, Sicily
Abstract

Anxiety disorders are frequent in HIV-infected individuals, can pre-exist or occur during HIV infection. We evaluated with a self-reported questionnaire whether anxiety is related to HIV clinical status and therapeutic success in a cohort of HIV-positive subjects in Sicily.We enrolled 251 patients on combination antiretroviral therapy (cART) for at least six months; Self Rating Anxiety State SAS 054 was used to diagnose anxiety and a Z score ≥ 45 points was considered diagnostic.47% of patients were diagnosed with anxiety. Patients showing symptoms related to anxiety had experienced a high number of therapeutic switches (fourth line or more).These data confirm a high prevalence of anxiety symptoms among subjects with HIV infection in Eastern Sicily. Physicians should be aware of the extent of the problem and should be able to adequately manage anxiety in the setting of HIV infection.

42. Phylogenetic Analysis of isolates from new cases of HBV infection in Southern Italy

Author

M. Gussio, Rosa Di Stefano, Antonio Craxì, Noemi Urone, Salvatore Magliocco, Vito Di Marco, Paola Pizzillo, Donatella Ferraro, Bruno Cacopardo, Ferraro D, Urone N, Pizzillo P, Gussio M, Magliocco S, Cacopardo B, Craxì A, Di Marco V, and Di Stefano, R

Subjects
Microbiology (medical), Adult, Male, medicine.medical_specialty, Hepatitis B virus, Settore MED/07 - Microbiologia E Microbiologia Clinica, Genotype, Biology, medicine.disease_cause, Microbiology, Liver disease, Epidemiology, Genetics, medicine, Humans, Molecular Biology, Ecology, Evolution, Behavior and Systematics, Phylogeny, Aged, Aged, 80 and over, Molecular Epidemiology, Settore MED/12 - Gastroenterologia, Molecular epidemiology, Phylogenetic tree, Sequence Analysis, DNA, Hepatitis B, Middle Aged, medicine.disease, Virology, Infectious Diseases, Italy, Immunology, DNA, Viral, Female, Viral hepatitis, HBV genotypes, molecular epidemiology, Acute HBV infection, phylogenetic analysis
Abstract

The level of endemicity of hepatitis B virus (HBV) infections in Italy is low and genotype D infections predominant. New HBV strains may however be introduced as a result of movements of people from regions of high endemicity. The aim of the present study was to determine whether strains from new cases of acute hepatitis B detected in southern Italy were due to endemic or new HBV strains. We studied 34 isolates from patients with acute hepatitis B infection, and 35 from chronic hepatitis B patients. A phylogenetic analysis of preS/S region was done by comparing the sequences from the acute and chronic cases with references sequences. The study showed that 44% of strain from acute hepatitis B patients were of genotype A, 53% of genotype D, and 3% of genotype E. The molecular analysis of isolates from acute hepatitis B patients from Sicily showed a change in the local epidemiology of this infection, with an increase in HBV/A infections and a clustering effect for HBV D2, possibly correlated to immigration. The introduction of new genotypes , could have an effect on HBV-correlated diseases due to the different association between genotype, liver disease and response to antiviral therapy.

Published
2012

43. Epidemiological and clinical characteristics of nontuberculous mycobacterial infections: A retrospective female cohort study in an Italian population.

Author

Marino A, Raddusa MSP, Gussio M, Sangiorgio G, Moscatt V, Libra A, Spampinato S, Bongiorno D, Cacopardo B, and Nunnari G

Abstract

Objectives: This study aims to assess the characteristics and treatment outcomes of patients diagnosed with non-tuberculous mycobacteria (NTM) diseases at the Infectious Diseases Unit of ARNAS Garibaldi Hospital in Catania, Italy, focusing on demographics, clinical features, and treatment effectiveness., Methods: We conducted a retrospective observational study of 10 patients diagnosed with NTM diseases between 2019 and 2021. Data was collected from electronic medical records, including demographic information, comorbidities, treatment modalities, and outcomes. The study utilized descriptive statistics to analyze continuous and categorical variables. Treatment regimens were based on individual patient needs, incorporating a combination of antibiotics., Results: The median age of the patients was 55.44 years, all female, predominantly suffering from pulmonary NTM diseases. Mycobacterium intracellulare was the most common pathogen. Common comorbidities included COPD, bronchiectasis, GERD, and hypovitaminosis D. Patients showed symptoms like fever, cough, and asthenia. The treatment regimens were diverse, with macrolides, rifampicin, and ethambutol forming the core. Adverse effects were noted in 40 % of patients, including gastrointestinal and neurological disorders. All patients achieved microbiological cure, with 60 % showing clinical improvement and 36 % radiological improvement., Conclusion: The study highlights the complexity of diagnosing and treating NTM diseases, emphasizing the need for personalized treatment plans and vigilant monitoring of adverse effects. Despite achieving microbiological cure, challenges remain in achieving complete clinical and radiological resolution. Further research is needed to enhance the understanding and management of NTM diseases, particularly in diverse populations., Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Published
2024
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44. Mucorales / Fusarium Mixed Infection in Hematologic Patient with COVID-19 Complications: An Unfortunate Combination.

Author

Marino A, Calvo M, Trovato L, Scalia G, Gussio M, Consoli U, Ceccarelli M, Nunnari G, and Cacopardo B

Abstract

Hematological diseases, especially those causing severe neutropenia, represent the main factor in the development of invasive fungal infections (IFIs). Furthermore, COVID-19 has been considerably associated with IFIs due to immunological dysregulation, prolonged hospitalization in intensive care units, and immunomodulatory therapies. Opportunistic molds are correlated with elevated morbidity and mortality rates in these patients, due to immune impairment, diagnostic complexity, and therapeutic challenges. Among opportunistic fungal infections, the Mucorales and Fusarium species are considered particularly aggressive, especially during severe neutropenia. A mixed Mucorales / Fusarium infection has been rarely described in scientific literature. Herein, we report a case of Mucorales and Fusarium co-infection in a patient with acute leukemia whose clinical history was also complicated by COVID-19. Herein, we report a challenging case in order to encourage the clinical suspicion of combined fungal infections in immunosuppressed patients, performing a punctual microbiological diagnosis, and promptly administering the correct empiric and targeted antifungal therapy.

Published
2023
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45. Long-Term Survivors in a Cohort of People Living with HIV Diagnosed between 1985 and 1994: Predictive Factors Associated with More Than 25 Years of Survival.

Author

Cosentino F, Marino A, Anile L, Moscatt V, Gussio M, Boscia V, Bruno R, Nunnari G, Pulvirenti A, Privitera GF, Cacopardo BS, Ceccarelli M, and Celesia BM

Abstract

Although the mortality rate among individuals diagnosed during the pre-Highly Active Antiretroviral Treatment era has been substantial, a considerable number of them survived. Our study aimed to evaluate the prevalence of HIV long-term survivors in a cohort of People Living with HIV diagnosed between 1985 and 1994 and to speculate about potential predictive factors associated to long survival. This is a retrospective single-center study. Subjects surviving more than 300 months (25 years) from HIV diagnosis were defined as Long Term Survivors. Overall, 210 subjects were enrolled. More than 75.24% of the included people living with HIV were males, with a median age of 28 years (IQR 25-34). The prevalent risk factors for HIV infection were injection drug use (47.62%), followed by unprotected sex among heterosexual individuals (23.81%). Ninety-three individuals (44.29%) could be defined as LTS with a median (IQR) survival of 333 (312-377) months. A hazard ratio of 12.45 (95% CI 7.91-19.59) was found between individuals who were exposed to Highly Active AntiRetroviral Treatment (HAART) and individuals who were not, with the latter being at greater risk of death. The availability and accessibility of effective antiretroviral therapy for people living with HIV remain the cornerstone of survival.

Published
2023
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46. Intravenous Fosfomycin: A Potential Good Partner for Cefiderocol. Clinical Experience and Considerations.

Author

Marino A, Stracquadanio S, Campanella E, Munafò A, Gussio M, Ceccarelli M, Bernardini R, Nunnari G, and Cacopardo B

Abstract

Multidrug resistant Gram-negative bacteremia represents a therapeutic challenge clinicians have to deal with. This concern becomes more difficult when causing germs are represented by carbapenem resistant Acinetobacter baumannii or difficult-to-treat Pseudomonas aeruginosa . Few antibiotics are available against these cumbersome bacteria, although literature data are not conclusive, especially for Acinetobacter . Cefiderocol could represent a valid antibiotic choice, being a molecule with an innovative mechanism of action capable of overcoming common resistance pathways, whereas intravenous fosfomycin may be an appropriate partner either enhancing cefiderocol activity or avoiding resistance development. Here we report two patients with MDR Gram negative bacteremia who were successfully treated with a cefiderocol/fosfomycin combination.

Published
2022
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47. Clinical characteristics and predictors of death among hospitalized patients infected with SARS-CoV-2 in Sicily, Italy: A retrospective observational study.

Author

Cosentino F, Moscatt V, Marino A, Pampaloni A, Scuderi D, Ceccarelli M, Benanti F, Gussio M, Larocca L, Boscia V, Vinci G, Zagami A, Onorante A, Lupo G, Torrisi S, Grasso S, Bruno R, Iacobello C, Bonfante S, Guarneri L, Cascio A, Franco A, Del Vecchio RF, Di Rosolini MA, Pulvirenti A, Larnè D, Nunnari G, Celesia BM, and Cacopardo B

Abstract

Since late December 2019, severe acute respiratory syndrome coronavirus 2 has spread across the world, which resulted in the World Health Organization declaring a global pandemic. Coronavirus disease 2019 (COVID-19) presents a highly variable spectrum with regard to the severity of illness. Most infected individuals exhibit a mild to moderate illness (81%); however, 14% have a serious disease and 5% develop severe acute respiratory distress syndrome (ARDS), requiring intensive care support. The mortality rate of COVID-19 continues to rise across the world. Data regarding predictors of mortality in patients with COVID 19 are still scarce but are being actively investigated. The present multicenter retrospective observational study provides a complete description of the demographic and clinical characteristics, comorbidities and laboratory abnormalities in a population of 421 hospitalized patients recruited across eight infectious disease units in Southern Italy (Sicily) with the aim of identifying the baseline characteristics predisposing COVID-19 patients to critical illness or death. In this study, older age, pre-existing comorbidities and certain changes in laboratory markers (such as neutrophilia, lymphocytopenia and increased C-reactive protein levels) at the time of admission were associated with a higher risk of mortality. Male sex, on the other hand, was not significantly associated with increased risk of mortality. Symptoms such as fatigue, older age, a number of co-pathologies and use of continuous positive airway pressure were the most significant contributors in the estimation of clinical prognosis. Further research is required to better characterize the epidemiological features of COVID-19, to understand the related predictors of death and to develop new effective therapeutic strategies., Competing Interests: The authors declare that they have no competing interests., (Copyright: © Cosentino et al.)

Published
2022
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48. Post-infectious ST elevation myocardial infarction following a COVID-19 infection: A case report.

Author

Ceccarelli M, Marino A, Cosentino F, Moscatt V, Celesia BM, Gussio M, Bruno R, Rullo EV, Nunnari G, and Cacopardo BS

Abstract

Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) has been shown to increase the risk of thrombotic events due to a hypercoagulable state caused by several factors. The case of a 59-year-old woman affected by hypertension and metabolic disorders, treated for a COVID-19 infection who developed cardiac symptoms during the first days of hospitalization is reported. Electrocardiogram analysis and cardiac-ultrasound confirmed ST-segment elevation myocardial infarction (STEMI) diagnosis, thus the patient underwent percutaneous coronary intervention, which was successful. This case highlights a possible association between respiratory infection, particularly SARS-CoV-2 infection, and cardiovascular events, in particular Acute Coronary Syndrome. The association between these phenomena seems related to a range of factors, including a proinflammatory state and the hypoxemia. Moreover, the association amongst SARS-CoV-2 and cardiovascular diseases may be also linked to long-term sequelae. Thus, further studies are required to better understand the multifaceted and severe complications of this disease., Competing Interests: The authors declare that they have no competing interests., (Copyright © 2020, Spandidos Publications.)

Published
2022
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49. Successful Extracorporeal Membrane Oxygenation Treatment in an Acquired Immune Deficiency Syndrome (AIDS) Patient with Acute Respiratory Distress Syndrome (ARDS) Complicating Pneumocystis jirovecii Pneumonia: A Challenging Case.

Author

Celesia BM, Marino A, Borracino S, Arcadipane AF, Pantò G, Gussio M, Coniglio S, Pennisi A, Cacopardo B, and Panarello G

Subjects
AIDS-Related Opportunistic Infections microbiology, Adult, Humans, Immunocompromised Host, Male, Pneumocystis carinii, Respiratory Distress Syndrome microbiology, AIDS-Related Opportunistic Infections complications, Acquired Immunodeficiency Syndrome complications, Extracorporeal Membrane Oxygenation, Pneumonia, Pneumocystis complications, Respiratory Distress Syndrome therapy
Abstract

BACKGROUND Patients with HIV infection tend to have poor intensive care unit (ICU) outcomes; however, survival in the modern combination antiretroviral therapy (cART) era has markedly improved, but Pneumocystis jirovecii pneumonia (PJP) still remains a preeminent cause of respiratory failure in AIDS patients. Extracorporeal membrane oxygenation (ECMO) is an adapted cardiopulmonary bypass circuit for temporary life support for patients not responding to conventional treatment. CASE REPORT A 43-year-old male HIV "late presenter" was admitted to our hospital for fever and dyspnea. A chest CT scan revealed bilateral ground-glass opacities. Empiric antibiotic treatment and cART were started. The emergence of ARDS due to PJP dictated urgent veno-venous (VV) ECMO placement. One week later, radiologic findings and respiratory function had improved and the patient was started on a weaning trial from ECMO and removed 12 days after placement. CONCLUSIONS Acute respiratory distress syndrome (ARDS) is a potentially reversible clinical syndrome with a high mortality rate. ECMO is a rescue therapy allowing lung recovery during acute processes and should be considered an adequate treatment option in HIV+ patients with respiratory failure. ECMO should be considered a useful and adequate treatment option in AIDS patients who have a high risk of dying from respiratory failure.

Published
2020
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50. Is it Safe and Cost Saving to Defer the CD4+ Cell Count Monitoring in Stable Patients on Art with More than 350 or 500 cells/μl?

Author

Celesia BM, Marino A, Del Vecchio RF, Bruno R, Palermo F, Gussio M, Nunnari G, and Cacopardo B

Abstract

Background: CD4+ lymphocyte cell count represents the main immunological marker used to monitor HIV infection. However, frequent monitoring may be unnecessary, could cause anxiety to the patient as well as burdening healthcare with extra expenses., Objectives and Methods: A two-step retrospective (safety and cost-saving) analysis was performed to evaluate the probability of maintaining a safe number of more than 350 CD4+ cells/μl in HIV-positive subjects under treatment during a three-year follow up and secondarily to estimate in real life the cost of the CD4+ determinations in a 3 years period, speculating on possible cost-saving strategies. The safety analyses was conducted with Kaplan-Meyer method considering: 1) all patients independently from their viral load (VL); 2) patients with 500 > CD4+ ≥ 350 cells/μl versus (vs) CD4+ ≥ 500 cells/μl at baseline; 3) patients with VL < 20 copies/ml vs VL > 20 copies/ml. The cost-saving analysis measuring the costs of CD4+ determinations was calculated from April 1, 2013, to March 31, 2016., Results: In the safety analysis, 253 subjects were enrolled. The median CD4+ count was 623 (489-805) cells/μl. Subjects maintaining ≥ 350 cells/μl in the first, second, and third year were respectively 238 (94.1%), 229 (90.5%), and 226 (89.3%), independently from VL. Within subjects with ≥ 350 CD4+/μl vs. ≥ 500 CD4+/μl at baseline, those who maintained ≥ 350 cells/μl until the third year were respectively 241 (95.3%) and 158 (98.1%). The probability of maintaining these values in the third year was 89.3% for those who had CD4+ ≥ 350/μl at baseline and 98.1% for those who had CD4+ ≥ 500/μl. This probability was around 90% vs. 99% for subjects with HIV-RNA above or below 20 copies/ml. In the real-life cost saving analysis, we evaluated subjects with a stable value or more than 500 CD4+ (respectively 343, 364 and 383 in the first, second and third period). We observed mean value of about two determinations patient/year (2.41 in 2013/2014; 2.32 in 2014/2015; 2.18 in 2015/2016), with a significant decrease between the first and the last period (p<0.001). The mean cost patient/year was €101.51 in the first year, €97.61 in the second, €92.00 in the third (p<0,001). Assuming to extend these procedures to all our patients with stable CD4+ cells/μl and monitoring CD4+ cell count once in a year, we were able to obtain an overall saving of €19,152/year., Conclusions: A very high percentage of subjects maintained a high and safe number of CD4+ cells (>350 cells/μl) during a three-year follow-up. It could be possible to save up to 66% of the costs by reducing the number of CD4+ count determinations in a year, to have other favorable consequences as well, releasing new resources for patient management., Competing Interests: Competing interests: The authors declare no conflict of Interest.

Published
2019
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