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1. Burden of Disease in PWH Harboring a Multidrug-Resistant Virus: Data from the PRESTIGIO Registry

Author

Galli, L, Parisi, M, Poli, A, Menozzi, M, Fiscon, M, Garlassi, E, Francisci, D, DI Biagio, A, Sterrantino, G, Fornabaio, C, Degli Antoni, A, Angarano, G, Fusco, F, D'Arminio Monforte, A, Corbelli, G, Santoro, M, Zazzi, M, Castagna, A, Gianotti, N, Maggiolo, F, Calza, L, Foca, E, Cenderello, G, Rusconi, S, Mussini, C, Antinori, A, Gagliardini, R, Bonora, S, Ferrara, M, Galli, A, Carini, E, Bigoloni, A, Tavio, M, Butini, L, Giacometti, A, Vaccher, E, Martellotta, F, Da Ros, V, Saracino, A, Balena, F, Comi, L, DI Filippo, E, Valenti, D, Suardi, C, Mazzola, B, Viale, P, Del Turco, E, Ramirez, M, Castelli, F, Celotti, A, Brognoli, F, Bonoldi, G, Menzaghi, B, Abeli, C, Farinazzo, M, Ortu, F, Campus, M, Cacopardo, B, Celesia, M, Pan, A, Bartoloni, A, Rinaldi, F, Giache, S, Pierluigi, B, Vichi, F, Santantonio, T, Ferrara, S, Bruno, S, Cassola, G, Marcello, F, Calautti, F, Bassetti, M, Bruzzone, B, Artioli, S, Lazzarin, A, Canetti, D, Galli, M, Formenti, T, Morena, V, Gabrieli, A, Gazzola, L, Merlini, E, Minieri, V, Gori, A, Bandera, A, Pastore, V, Ferroni, V, Puoti, M, Moioli, C, Vassalli, S, Enrica, R, Giulia, N, Beghetto, B, Manzillo, E, Franco, A, Cattelan, A, Marinello, S, Cavinato, S, Macario, A, Cascio, A, Mazzola, G, Antoni, A, Ferrari, C, Laccabue, D, Filice, G, Gulminetti, R, Pagnucco, L, Asti, A, Schiaroli, E, Papalini, C, Italiani, F, DI Pietro, M, Magnani, G, Elisa, G, Barchi, E, Corsini, R, Vergori, A, Cicalini, S, Onnelli, G, Giannetti, A, Cauda, R, Ciccullo, A, La Monica, S, Vullo, V, Dettorre, G, Cavallari, E, Andreoni, M, Malagnino, V, Ceccarelli, L, Viviani, F, Sasset, L, Dentone, C, Rossetti, B, Modica, S, Borgo, V, DI Perri, G, Carcieri, C, Malena, M, Padovani, B, Luzzati, R, Centonze, S, Valentinotti, R, Galli L., Parisi M. R., Poli A., Menozzi M., Fiscon M., Garlassi E., Francisci D., DI Biagio A., Sterrantino G., Fornabaio C., Degli Antoni A., Angarano G., Fusco F. M., D'Arminio Monforte A., Corbelli G. M., Santoro M. M., Zazzi M., Castagna A., Gianotti N., Maggiolo F., Calza L., Foca E., Cenderello G., Rusconi S., Mussini C., Antinori A., Gagliardini R., Bonora S., Ferrara M., Santoro M., Galli A., Carini E., Bigoloni A., Tavio M., Butini L., Giacometti A., Vaccher E., Martellotta F., Da Ros V., Saracino A., Balena F., Comi L., DI Filippo E., Valenti D., Suardi C., Mazzola B., Viale P., Del Turco E. R., Ramirez M. V., Castelli F., Celotti A., Brognoli F., Bonoldi G., Menzaghi B., Abeli C., Farinazzo M., Ortu F., Campus M., Cacopardo B., Celesia M., Pan A., Bartoloni A., Rinaldi F., Giache S., Pierluigi B., Vichi F., Santantonio T., Ferrara S., Bruno S. R., Cassola G., Marcello F., Calautti F., Bassetti M., Bruzzone B., Artioli S., Lazzarin A., Canetti D., Galli M., Formenti T., Morena V., Gabrieli A., Gazzola L., Merlini E., Minieri V., Gori A., Bandera A., Pastore V., Ferroni V., Puoti M., Moioli C., Vassalli S., Enrica R., Giulia N., Beghetto B., Manzillo E., Franco A., Cattelan A. M., Marinello S., Cavinato S., MacArio A., Cascio A., Mazzola G., Antoni A. M. D., Ferrari C., Laccabue D., Filice G., Gulminetti R., Pagnucco L., Asti A., Schiaroli E., Papalini C., Italiani F., DI Pietro M., Magnani G., Elisa G., Barchi E., Corsini R., Vergori A., Cicalini S., Onnelli G., Giannetti A., Cauda R., Ciccullo A., La Monica S., Vullo V., Dettorre G., Cavallari E. N., Andreoni M., Malagnino V., Ceccarelli L., Viviani F., Sasset L., Dentone C., Rossetti B., Modica S., Borgo V., DI Perri G., Carcieri C., Malena M., Padovani B., Luzzati R., Centonze S., Valentinotti R., Galli, L, Parisi, M, Poli, A, Menozzi, M, Fiscon, M, Garlassi, E, Francisci, D, DI Biagio, A, Sterrantino, G, Fornabaio, C, Degli Antoni, A, Angarano, G, Fusco, F, D'Arminio Monforte, A, Corbelli, G, Santoro, M, Zazzi, M, Castagna, A, Gianotti, N, Maggiolo, F, Calza, L, Foca, E, Cenderello, G, Rusconi, S, Mussini, C, Antinori, A, Gagliardini, R, Bonora, S, Ferrara, M, Galli, A, Carini, E, Bigoloni, A, Tavio, M, Butini, L, Giacometti, A, Vaccher, E, Martellotta, F, Da Ros, V, Saracino, A, Balena, F, Comi, L, DI Filippo, E, Valenti, D, Suardi, C, Mazzola, B, Viale, P, Del Turco, E, Ramirez, M, Castelli, F, Celotti, A, Brognoli, F, Bonoldi, G, Menzaghi, B, Abeli, C, Farinazzo, M, Ortu, F, Campus, M, Cacopardo, B, Celesia, M, Pan, A, Bartoloni, A, Rinaldi, F, Giache, S, Pierluigi, B, Vichi, F, Santantonio, T, Ferrara, S, Bruno, S, Cassola, G, Marcello, F, Calautti, F, Bassetti, M, Bruzzone, B, Artioli, S, Lazzarin, A, Canetti, D, Galli, M, Formenti, T, Morena, V, Gabrieli, A, Gazzola, L, Merlini, E, Minieri, V, Gori, A, Bandera, A, Pastore, V, Ferroni, V, Puoti, M, Moioli, C, Vassalli, S, Enrica, R, Giulia, N, Beghetto, B, Manzillo, E, Franco, A, Cattelan, A, Marinello, S, Cavinato, S, Macario, A, Cascio, A, Mazzola, G, Antoni, A, Ferrari, C, Laccabue, D, Filice, G, Gulminetti, R, Pagnucco, L, Asti, A, Schiaroli, E, Papalini, C, Italiani, F, DI Pietro, M, Magnani, G, Elisa, G, Barchi, E, Corsini, R, Vergori, A, Cicalini, S, Onnelli, G, Giannetti, A, Cauda, R, Ciccullo, A, La Monica, S, Vullo, V, Dettorre, G, Cavallari, E, Andreoni, M, Malagnino, V, Ceccarelli, L, Viviani, F, Sasset, L, Dentone, C, Rossetti, B, Modica, S, Borgo, V, DI Perri, G, Carcieri, C, Malena, M, Padovani, B, Luzzati, R, Centonze, S, Valentinotti, R, Galli L., Parisi M. R., Poli A., Menozzi M., Fiscon M., Garlassi E., Francisci D., DI Biagio A., Sterrantino G., Fornabaio C., Degli Antoni A., Angarano G., Fusco F. M., D'Arminio Monforte A., Corbelli G. M., Santoro M. M., Zazzi M., Castagna A., Gianotti N., Maggiolo F., Calza L., Foca E., Cenderello G., Rusconi S., Mussini C., Antinori A., Gagliardini R., Bonora S., Ferrara M., Santoro M., Galli A., Carini E., Bigoloni A., Tavio M., Butini L., Giacometti A., Vaccher E., Martellotta F., Da Ros V., Saracino A., Balena F., Comi L., DI Filippo E., Valenti D., Suardi C., Mazzola B., Viale P., Del Turco E. R., Ramirez M. V., Castelli F., Celotti A., Brognoli F., Bonoldi G., Menzaghi B., Abeli C., Farinazzo M., Ortu F., Campus M., Cacopardo B., Celesia M., Pan A., Bartoloni A., Rinaldi F., Giache S., Pierluigi B., Vichi F., Santantonio T., Ferrara S., Bruno S. R., Cassola G., Marcello F., Calautti F., Bassetti M., Bruzzone B., Artioli S., Lazzarin A., Canetti D., Galli M., Formenti T., Morena V., Gabrieli A., Gazzola L., Merlini E., Minieri V., Gori A., Bandera A., Pastore V., Ferroni V., Puoti M., Moioli C., Vassalli S., Enrica R., Giulia N., Beghetto B., Manzillo E., Franco A., Cattelan A. M., Marinello S., Cavinato S., MacArio A., Cascio A., Mazzola G., Antoni A. M. D., Ferrari C., Laccabue D., Filice G., Gulminetti R., Pagnucco L., Asti A., Schiaroli E., Papalini C., Italiani F., DI Pietro M., Magnani G., Elisa G., Barchi E., Corsini R., Vergori A., Cicalini S., Onnelli G., Giannetti A., Cauda R., Ciccullo A., La Monica S., Vullo V., Dettorre G., Cavallari E. N., Andreoni M., Malagnino V., Ceccarelli L., Viviani F., Sasset L., Dentone C., Rossetti B., Modica S., Borgo V., DI Perri G., Carcieri C., Malena M., Padovani B., Luzzati R., Centonze S., and Valentinotti R.

Abstract

Background: Currently, no data are available on the burden of morbidity and mortality in people with HIV-1 (PWH) harboring a 4-class drug-resistant (4DR) virus (nucleoside reverse transcriptase inhibitors, non-nucleoside reverse transcriptase inhibitors, protease inhibitors, integrase strand transfer inhibitors). The study aimed to assess the incidence of clinical events and death in this population. Methods: This was a cohort study on PWH from the PRESTIGIO Registry with a documented 4DR virus. Burden of disease was defined as the occurrence of any new event including an AIDS-defining event (ADE) or non-AIDS-defining event (NADE) or death from any cause after 4DR evidence (baseline). Cox regression models evaluated factors associated with the risk of new clinical events/death. Results: Among 148 PWH followed for a median (interquartile range) of 47 (32-84) months after 4DR evidence, 38 PWH had 62 new events or died from any cause (incidence rate, 9.12/100 person-years of follow-up; 95% CI = 6.85-11.39): 12 deaths (6 AIDS-related and 6 non-AIDS-related), 18 ADEs, 32 NADEs; 20 of the 38 NADEs (45%) of the incident clinical events were malignancies. The 4-year cumulative incidence of death was 6% (95% CI, 3%-13%), and that of ≥1 event or death was 22% (95% CI, 16%-31%). A higher risk of new clinical events/death was more likely in PWH with previous clinical events (adjusted hazard ratio [aHR], 2.67; 95% CI, 1.07-6.67) and marginally associated with lower baseline CD4+/CD8+ ratio (aHR, 0.82; 95% CI, 0.65-1.02). Conclusions: PWH harboring 4DR have a high burden of disease with a worrying incidence of malignancies, strongly advising for close prevention and monitoring interventions as well as access to innovative therapeutic strategies, especially in people with a history of clinical events and low CD4+/CD8+ ratio.

Published
2020

2. The burden of clostridioides difficile infection during the COVID-19 pandemic: A retrospective case-control study in Italian hospitals (CloVid)

Author

Granata, G, Bartoloni, A, Codeluppi, M, Contadini, I, Cristini, F, Fantoni, M, Ferraresi, A, Fornabaio, C, Grasselli, S, Lagi, F, Masucci, L, Puoti, M, Raimondi, A, Taddei, E, Trapani, F, Viale, P, Johnson, S, Petrosillo, N, Granata G., Bartoloni A., Codeluppi M., Contadini I., Cristini F., Fantoni M., Ferraresi A., Fornabaio C., Grasselli S., Lagi F., Masucci L., Puoti M., Raimondi A., Taddei E., Trapani F. F., Viale P., Johnson S., Petrosillo N., Granata, G, Bartoloni, A, Codeluppi, M, Contadini, I, Cristini, F, Fantoni, M, Ferraresi, A, Fornabaio, C, Grasselli, S, Lagi, F, Masucci, L, Puoti, M, Raimondi, A, Taddei, E, Trapani, F, Viale, P, Johnson, S, Petrosillo, N, Granata G., Bartoloni A., Codeluppi M., Contadini I., Cristini F., Fantoni M., Ferraresi A., Fornabaio C., Grasselli S., Lagi F., Masucci L., Puoti M., Raimondi A., Taddei E., Trapani F. F., Viale P., Johnson S., and Petrosillo N.

Abstract

Data on the burden of Clostridioides difficile infection (CDI) in Coronavirus Disease 2019 (COVID-19) patients are scant. We conducted an observational, retrospective, multicenter, 1:3 case (COVID-19 patients with CDI)-control (COVID-19 patients without CDI) study in Italy to assess incidence and outcomes, and to identify risk factors for CDI in COVID-19 patients. From February through July 2020, 8402 COVID-19 patients were admitted to eight Italian hospitals; 38 CDI cases were identified, including 32 hospital-onset-CDI (HO-CDI) and 6 community-onset, healthcare-associated-CDI (CO-HCA-CDI). HO-CDI incidence was 4.4 × 10,000 patient-days. The percentage of cases recovering without complications at discharge (i.e., pressure ulcers, chronic heart decompensation) was lower than among controls (p = 0.01); in-hospital stays was longer among cases, 35.0 versus 19.4 days (p = 0.0007). The presence of a previous hospitalisation (p = 0.001), previous steroid administration (p = 0.008) and the administration of antibiotics during the stay (p = 0.004) were risk factors associated with CDI. In conclusions, CDI complicates COVID-19, mainly in patients with co-morbidities and previous healthcare exposures. Its association with antibiotic usage and hospital acquired bacterial infections should lead to strengthen antimicrobial stewardship programmes and infection prevention and control activities.

Published
2020

3. Burden of Disease in PWH Harboring a Multidrug-Resistant Virus: Data from the PRESTIGIO Registry

Author

Galli, L., Parisi, M. R., Poli, A., Menozzi, M., Fiscon, M., Garlassi, E., Francisci, D., DI Biagio, A., Sterrantino, G., Fornabaio, C., Degli Antoni, A., Angarano, G., Fusco, F. M., D'Arminio Monforte, A., Corbelli, G. M., Santoro, M. M., Zazzi, M., Castagna, A., Gianotti, N., Maggiolo, F., Calza, L., Foca, E., Cenderello, G., Rusconi, S., Mussini, C., Antinori, A., Gagliardini, R., Bonora, S., Ferrara, M., Santoro, M., Galli, A., Carini, E., Bigoloni, A., Tavio, M., Butini, L., Giacometti, A., Vaccher, E., Martellotta, F., Da Ros, V., Saracino, A., Balena, F., Comi, L., DI Filippo, E., Valenti, D., Suardi, C., Mazzola, B., Viale, P., Del Turco, E. R., Ramirez, M. V., Castelli, F., Celotti, A., Brognoli, F., Bonoldi, G., Menzaghi, B., Abeli, C., Farinazzo, M., Ortu, F., Campus, M., Cacopardo, B., Celesia, M., Pan, A., Bartoloni, A., Rinaldi, F., Giache, S., Pierluigi, B., Vichi, F., Santantonio, T., Ferrara, S., Bruno, S. R., Cassola, G., Marcello, F., Calautti, F., Bassetti, M., Bruzzone, B., Artioli, S., Lazzarin, A., Canetti, D., Galli, M., Formenti, T., Morena, V., Gabrieli, A., Gazzola, L., Merlini, E., Minieri, V., Gori, A., Bandera, A., Pastore, V., Ferroni, V., Puoti, M., Moioli, C., Vassalli, S., Enrica, R., Giulia, N., Beghetto, B., Manzillo, E., Franco, A., Cattelan, A. M., Marinello, S., Cavinato, S., Macario, A., Cascio, A., Mazzola, G., Antoni, A. M. D., Ferrari, C., Laccabue, D., Filice, G., Gulminetti, R., Pagnucco, L., Asti, A., Schiaroli, E., Papalini, C., Italiani, F., DI Pietro, M., Magnani, G., Elisa, G., Barchi, E., Corsini, R., Vergori, A., Cicalini, S., Onnelli, G., Giannetti, A., Cauda, R., Ciccullo, A., La Monica, S., Vullo, V., Dettorre, G., Cavallari, E. N., Andreoni, M., Malagnino, V., Ceccarelli, L., Viviani, F., Sasset, L., Dentone, C., Rossetti, B., Modica, S., Borgo, V., DI Perri, G., Carcieri, C., Malena, M., Padovani, B., Luzzati, R., Centonze, S., Valentinotti, R., Galli L., Parisi M.R., Poli A., Menozzi M., Fiscon M., Garlassi E., Francisci D., DI Biagio A., Sterrantino G., Fornabaio C., Degli Antoni A., Angarano G., Fusco F.M., D'Arminio Monforte A., Corbelli G.M., Santoro M.M., Zazzi M., Castagna A., Gianotti N., Maggiolo F., Calza L., Foca E., Cenderello G., Rusconi S., Mussini C., Antinori A., Gagliardini R., Bonora S., Ferrara M., Santoro M., Galli A., Carini E., Bigoloni A., Tavio M., Butini L., Giacometti A., Vaccher E., Martellotta F., Da Ros V., Saracino A., Balena F., Comi L., DI Filippo E., Valenti D., Suardi C., Mazzola B., Viale P., Del Turco E.R., Ramirez M.V., Castelli F., Celotti A., Brognoli F., Bonoldi G., Menzaghi B., Abeli C., Farinazzo M., Ortu F., Campus M., Cacopardo B., Celesia M., Pan A., Bartoloni A., Rinaldi F., Giache S., Pierluigi B., Vichi F., Santantonio T., Ferrara S., Bruno S.R., Cassola G., Marcello F., Calautti F., Bassetti M., Bruzzone B., Artioli S., Lazzarin A., Canetti D., Galli M., Formenti T., Morena V., Gabrieli A., Gazzola L., Merlini E., Minieri V., Gori A., Bandera A., Pastore V., Ferroni V., Puoti M., Moioli C., Vassalli S., Enrica R., Giulia N., Beghetto B., Manzillo E., Franco A., Cattelan A.M., Marinello S., Cavinato S., MacArio A., Cascio A., Mazzola G., Antoni A.M.D., Ferrari C., Laccabue D., Filice G., Gulminetti R., Pagnucco L., Asti A., Frsdi E., Schiaroli E., Papalini C., Italiani F., DI Pietro M., Magnani G., Elisa G., Barchi E., Corsini R., Vergori A., Cicalini S., Onnelli G., Giannetti A., Cauda R., Ciccullo A., La Monica S., Vullo V., Dettorre G., Cavallari E.N., Andreoni M., Malagnino V., Ceccarelli L., Viviani F., Sasset L., Dentone C., Rossetti B., Modica S., Borgo V., DI Perri G., Carcieri C., Malena M., Padovani B., Luzzati R., Centonze S., Valentinotti R., Galli, L, Parisi, M, Poli, A, Menozzi, M, Fiscon, M, Garlassi, E, Francisci, D, DI Biagio, A, Sterrantino, G, Fornabaio, C, Degli Antoni, A, Angarano, G, Fusco, F, D'Arminio Monforte, A, Corbelli, G, Santoro, M, Zazzi, M, Castagna, A, Gianotti, N, Maggiolo, F, Calza, L, Foca, E, Cenderello, G, Rusconi, S, Mussini, C, Antinori, A, Gagliardini, R, Bonora, S, Ferrara, M, Galli, A, Carini, E, Bigoloni, A, Tavio, M, Butini, L, Giacometti, A, Vaccher, E, Martellotta, F, Da Ros, V, Saracino, A, Balena, F, Comi, L, DI Filippo, E, Valenti, D, Suardi, C, Mazzola, B, Viale, P, Del Turco, E, Ramirez, M, Castelli, F, Celotti, A, Brognoli, F, Bonoldi, G, Menzaghi, B, Abeli, C, Farinazzo, M, Ortu, F, Campus, M, Cacopardo, B, Celesia, M, Pan, A, Bartoloni, A, Rinaldi, F, Giache, S, Pierluigi, B, Vichi, F, Santantonio, T, Ferrara, S, Bruno, S, Cassola, G, Marcello, F, Calautti, F, Bassetti, M, Bruzzone, B, Artioli, S, Lazzarin, A, Canetti, D, Galli, M, Formenti, T, Morena, V, Gabrieli, A, Gazzola, L, Merlini, E, Minieri, V, Gori, A, Bandera, A, Pastore, V, Ferroni, V, Puoti, M, Moioli, C, Vassalli, S, Enrica, R, Giulia, N, Beghetto, B, Manzillo, E, Franco, A, Cattelan, A, Marinello, S, Cavinato, S, Macario, A, Cascio, A, Mazzola, G, Antoni, A, Ferrari, C, Laccabue, D, Filice, G, Gulminetti, R, Pagnucco, L, Asti, A, Schiaroli, E, Papalini, C, Italiani, F, DI Pietro, M, Magnani, G, Elisa, G, Barchi, E, Corsini, R, Vergori, A, Cicalini, S, Onnelli, G, Giannetti, A, Cauda, R, Ciccullo, A, La Monica, S, Vullo, V, Dettorre, G, Cavallari, E, Andreoni, M, Malagnino, V, Ceccarelli, L, Viviani, F, Sasset, L, Dentone, C, Rossetti, B, Modica, S, Borgo, V, DI Perri, G, Carcieri, C, Malena, M, Padovani, B, Luzzati, R, Centonze, S, Valentinotti, R, Galli, Laura, Parisi, Maria Rita, Poli, Andrea, Menozzi, Marianna, Fiscon, Marta, Garlassi, Elisa, Francisci, Daniela, Di Biagio, Antonio, Sterrantino, Gaetana, Fornabaio, Chiara, Degli Antoni, Anna, Angarano, Gioacchino, Fusco, Francesco Maria, D'Arminio Monforte, Antonella, Corbelli, Giulio Maria, Santoro, Maria Mercede, Zazzi, Maurizio, and Castagna, Antonella

Subjects
0301 basic medicine, medicine.medical_specialty, 4-class drug resistance, AIDS-defining event, cancer, death, non-AIDS-defining event, Population, Major Articles, Settore MED/07, 03 medical and health sciences, 0302 clinical medicine, Interquartile range, Internal medicine, medicine, Cumulative incidence, 030212 general & internal medicine, education, Disease burden, education.field_of_study, Proportional hazards model, business.industry, Incidence (epidemiology), Hazard ratio, 030112 virology, AcademicSubjects/MED00290, Infectious Diseases, Oncology, business, Cohort study
Abstract

BackgroundCurrently, no data are available on the burden of morbidity and mortality in people with HIV-1 (PWH) harboring a 4-class drug-resistant (4DR) virus (nucleoside reverse transcriptase inhibitors, non-nucleoside reverse transcriptase inhibitors, protease inhibitors, integrase strand transfer inhibitors). The study aimed to assess the incidence of clinical events and death in this population.MethodsThis was a cohort study on PWH from the PRESTIGIO Registry with a documented 4DR virus. Burden of disease was defined as the occurrence of any new event including an AIDS-defining event (ADE) or non-AIDS-defining event (NADE) or death from any cause after 4DR evidence (baseline). Cox regression models evaluated factors associated with the risk of new clinical events/death.ResultsAmong 148 PWH followed for a median (interquartile range) of 47 (32–84) months after 4DR evidence, 38 PWH had 62 new events or died from any cause (incidence rate, 9.12/100 person-years of follow-up; 95% CI = 6.85–11.39): 12 deaths (6 AIDS-related and 6 non-AIDS-related), 18 ADEs, 32 NADEs; 20 of the 38 NADEs (45%) of the incident clinical events were malignancies. The 4-year cumulative incidence of death was 6% (95% CI, 3%–13%), and that of ≥1 event or death was 22% (95% CI, 16%–31%). A higher risk of new clinical events/death was more likely in PWH with previous clinical events (adjusted hazard ratio [aHR], 2.67; 95% CI, 1.07–6.67) and marginally associated with lower baseline CD4+/CD8+ ratio (aHR, 0.82; 95% CI, 0.65–1.02).ConclusionsPWH harboring 4DR have a high burden of disease with a worrying incidence of malignancies, strongly advising for close prevention and monitoring interventions as well as access to innovative therapeutic strategies, especially in people with a history of clinical events and low CD4+/CD8+ ratio.

Published
2020

4. Susceptibility to HIV-1 integrase strand transfer inhibitors (INSTIs) in highly treatment-experienced patients who failed an INSTI-based regimen

Author

Santoro, M, Fornabaio, C, Malena, M, Galli, L, Poli, A, Menozzi, M, Zazzi, M, White, K, Castagna, A, PRESTIGIO Study, G, Santoro, M. M., Fornabaio, C., Malena, M., Galli, L., Poli, A., Menozzi, M., Zazzi, M., White, K. L., and Castagna, A.

Subjects
0301 basic medicine, Male, HIV Infections, Drug resistance, HIV Integrase, Quinolones, Resistance phenotypes, Piperazines, Settore MED/07, chemistry.chemical_compound, 0302 clinical medicine, Interquartile range, Genotype, Pharmacology (medical), 030212 general & internal medicine, Drug susceptibility, Elvitegravir, General Medicine, Middle Aged, Antiretroviral therapy, Infectious Diseases, Treatment Outcome, Dolutegravir, Female, Heterocyclic Compounds, 3-Ring, medicine.drug, Microbiology (medical), Pyridones, 030106 microbiology, Heterocyclic Compounds, 4 or More Rings, 03 medical and health sciences, Drug Resistance, Multiple, Viral, Raltegravir Potassium, Oxazines, medicine, Humans, HIV Integrase Inhibitors, HIV, Bictegravir, business.industry, Raltegravir, Virology, Amides, Regimen, chemistry, HIV-1, business
Abstract

The aim of this study was to characterize the genotypic and phenotypic resistance profile to the integrase strand transfer inhibitor (INSTI) bictegravir (BIC) and other INSTIs in patients who previously failed twice-daily raltegravir (RAL)-based or twice-daily dolutegravir (DTG)-based regimens. Twenty-two samples were collected after failure on an INSTI-based regimen in 17 highly treatment-experienced patients with HIV-1 with multi-drug-resistant virus, recorded in the Italian PRESTIGIO registry. Genotypic resistance mutations and phenotypic susceptibility to INSTIs were detected by GeneSeqIN and PhenoSenseIN assays, respectively (Monogram Biosciences, San Francisco, CA, USA). The primary INSTI resistance substitutions E138A/K, G140S, Y143C/H/R, Q148H and N155H were detected in 14 of 22 samples and were associated with resistance to one or more INSTIs, with G140S+Q148H present in 11 of 22 samples. Of these 14 samples, all showed high levels of resistance to elvitegravir (EVG) and RAL. Two isolates contained L74M, E138K, G140S and Q148H, or L74M, T97A, S119T, E138K, G140S, Y143R and Q148H, and had high-level resistance to all INSTIs, including BIC and DTG. Intermediate resistance was reported for eight of 14 isolates for BIC and nine of 14 isolates for DTG. Overall, for the 14 INSTI-resistant isolates, the median fold-change values in phenotypic susceptibility were: BIC 3.2 [interquartile range (IQR) 0.6–66], DTG 6.3 (IQR 0.8–>186), EVG >164 (IQR 2.6–>164) and RAL >188 (IQR 2.7–>197). In conclusion, the study findings supported the in-vitro activity of BIC and DTG against most isolates derived from highly treatment-experienced patients who failed INSTI regimens.

Published
2020

6. Long-term efficacy of dolutegravir in treatment-experienced subjects failing therapy with HIV-1 integrase strand inhibitor-resistant virus

Author

Castagna, A., Ferrara, M., Galli, L., Comi, L., Sterrantino, G., Cenderello, G., Zaccarelli, M., Focà, E., Roncadori, A., Lazzarin, A., Chichino, G., Mantia, E., Butini, L., Costantini, A., Giacometti, A., Tavio, M., Grassini, M., Valle, M., Vaccher, E., Martellotta, F., Schioppa, O., Maggiolo, F., Viale, P., Borderi, M., Calza, L., Moratello, L., Magistrelli, E., Castelli, F., Festa, E., Quirino, T., Campus, M., Businco, F., Celesia, B. M., La Rosa, R., Pan, A., Fornabaio, C., Mazzotta, F., Di Pietro, M., Bartoloni, A., Ferrara, S., Mastroianni, A., Di Cesare, S., Viscoli, C., Di Biagio, A., Cassola, G., Penco, G., Cericola, A, Nencioni, C., Carli, T., Viganò, P., Re, T., Del Fiorentino, A., Gattuso, G., Palvarini, L., Taurozzi, M., Gianotti, N., Galizzi, N., Poli, A., Rusconi, S., Salvaggio, S. E., Galli, M., Rizzardini, G., Mussini, C., Menozzi, M., Gori, A., Muscatello, A., Cappelletti, E., Gargiulo, M., Garavelli, P. L., Bargiacchi, O., Prestileo, T., Di Lorenzo, F., Bonanno, S., Ferrari, C., degli Antoni, A. M., Cattelan, A. M., Gulminetti, R., Pagnucco, L., Menichetti, F., Iapoce, R., Baldelli, F., Schiaroli, E., Italiani, F., Aquilini, D., Magnani, G., Corsini, R., Barchi, E., Ferrari, E., Antinori, A., Cristaudo, A., Latini, A., Cauda, R., Vullo, V., Maffongelli, G., Andreoni, M., Sassett, L., Viviani, F., De Luca, A., Rossetti, B., Franco, A., Resta, F., Di Perri, G., Bonora, S., Bassetti, M., Londero, A., Malena, M., Luzzati, Roberto, Castagna, A., Ferrara, M., Galli, L., Comi, L., Sterrantino, G., Cenderello, G., Zaccarelli, M., Focà, E., Roncadori, A., Lazzarin, A., Chichino, G., Mantia, E., Butini, L., Costantini, A., Giacometti, A., Tavio, M., Grassini, M., Valle, M., Vaccher, E., Martellotta, F., Schioppa, O., Maggiolo, F., Viale, P., Borderi, M., Calza, L., Moratello, L., Magistrelli, E., Castelli, F., Festa, E., Quirino, T., Campus, M., Businco, F., Celesia, B. M., La Rosa, R., Pan, A., Fornabaio, C., Mazzotta, F., Di Pietro, M., Bartoloni, A., Ferrara, S., Mastroianni, A., Di Cesare, S., Viscoli, C., Di Biagio, A., Cassola, G., Penco, G., Cericola, A, Nencioni, C., Carli, T., Viganò, P., Re, T., Del Fiorentino, A., Gattuso, G., Palvarini, L., Taurozzi, M., Gianotti, N., Galizzi, N., Poli, A., Rusconi, S., Salvaggio, S. E., Galli, M., Rizzardini, G., Mussini, C., Menozzi, M., Gori, A., Muscatello, A., Cappelletti, E., Gargiulo, M., Garavelli, P. L., Bargiacchi, O., Prestileo, T., Di Lorenzo, F., Bonanno, S., Ferrari, C., degli Antoni, A. M., Cattelan, A. M., Gulminetti, R., Pagnucco, L., Menichetti, F., Iapoce, R., Baldelli, F., Schiaroli, E., Italiani, F., Aquilini, D., Magnani, G., Corsini, R., Barchi, E., Ferrari, E., Antinori, A., Cristaudo, A., Latini, A., Cauda, R., Vullo, V., Maffongelli, G., Andreoni, M., Sassett, L., Viviani, F., De Luca, A., Rossetti, B., Franco, A., Resta, F., Di Perri, G., Bonora, S., Bassetti, M., Londero, A., Malena, M., and Luzzati, Roberto

Subjects
HIV, dolutegravir, efficacy, Male, Anti-HIV Agents, Pyridones, Drug Resistance, HIV Infections, HIV Integrase, 3-Ring, Piperazines, Coinfection, Drug Resistance, Viral, Drug Therapy, Combination, Female, HIV Integrase Inhibitors, HIV-1, Hepatitis C, Chronic, Heterocyclic Compounds, 3-Ring, Humans, Middle Aged, Treatment Outcome, Viral Load, Drug Therapy, Heterocyclic Compounds, Oxazines, Pharmacology (medical), Viral, Chronic, Pharmacology, Pharmacology, Pharmacology (medical), Infectious Diseases, Hepatitis C, Infectious Diseases, Combination
Abstract

OBJECTIVES: This study evaluated the virological efficacy of dolutegravir 50 mg twice daily in 190 HIV-1 failing antiretroviral-experienced patients with previous exposure to first-generation integrase strand transfer inhibitor (INSTI) over a 5 year follow-up using data from clinical practice. PATIENTS AND METHODS: This analysis included HIV-1-infected patients who were ≥18 years of age, treatment experienced, had HIV-1 RNA >50 copies/mL, with INSTI-resistant virus, who started dolutegravir 50 mg twice daily plus optimized background therapy (OBT), recorded in the national prospective database PRESTIGIO (www.progettoprestigio.it). Follow-up accrued from the start of dolutegravir 50 mg twice daily + OBT until virological failure (VF) or dolutegravir discontinuation for any reason or the last treatment visit on dolutegravir 50 mg twice daily treatment. VF was defined by the lack of achievement of HIV-1 RNA 100000 copies/mL (adjusted HR = 4.73, 95% CI = 1.33-16.78, P = 0.016) and with ≥1 INSTI mutations plus Q148H/K/R/N and the G140S/A/C as compared with other subjects (adjusted HR = 4.18, 95% CI = 1.32-13.23, P = 0.015). CONCLUSIONS: Our data showed a favourable long-term efficacy of dolutegravir 50 mg twice daily in association with OBT in treatment-experienced failing subjects, with INSTI-resistant virus, in the real world. A close monitoring of adherence is crucial for maintenance of virological response in this fragile subgroup of subjects.

Published
2018

8. Cancer incidence and mortality for all causes in HIV-infected patients over a quarter century: A multicentre cohort study Disease epidemiology - Infectious

Author

Raffetti, E, Albini, L, Gotti, D, Segala, D, Maggiolo, F, Di Filippo, E, Saracino, A, Ladisa, N, Lapadula, G, Fornabaio, C, Castelnuovo, F, Casari, S, Fabbiani, M, Pierotti, P, Donato, F, Quiros-Roldan, E, Raffetti E., Albini L., Gotti D., Segala D., Maggiolo F., Di Filippo E., Saracino A., Ladisa N., Lapadula G., Fornabaio C., Castelnuovo F., Casari S., Fabbiani M., Pierotti P., Donato F., Quiros-Roldan E., Raffetti, E, Albini, L, Gotti, D, Segala, D, Maggiolo, F, Di Filippo, E, Saracino, A, Ladisa, N, Lapadula, G, Fornabaio, C, Castelnuovo, F, Casari, S, Fabbiani, M, Pierotti, P, Donato, F, Quiros-Roldan, E, Raffetti E., Albini L., Gotti D., Segala D., Maggiolo F., Di Filippo E., Saracino A., Ladisa N., Lapadula G., Fornabaio C., Castelnuovo F., Casari S., Fabbiani M., Pierotti P., Donato F., and Quiros-Roldan E.

Abstract

Background: We aimed to assess cancer incidence and mortality for all-causes and factors related to risk of death in an Italian cohort of HIV infected unselected patients as compared to the general population. Methods: We conducted a retrospective (1986-2012) cohort study on 16 268 HIV infected patients enrolled in the MASTER cohort. The standardized incidence ratios (SIRs) and standardized mortality ratios (SMRs) were computed using cancer incidence rates of Italian Cancer Registries and official national data for overall mortality. The risk factors for death from all causes were assessed using Poisson regression models. Results: 1,195 cancer cases were diagnosed from 1986 to 2012: 700 AIDS-defining-cancers (ADCs) and 495 non-AIDS-defining-cancers (NADCs). ADC incidence was much higher than the Italian population (SIR∈=∈30.8, 95% confidence interval 27.9-34.0) whereas NADC incidence was similar to the general population (SIR∈=∈0.9, 95% CI 0.8-1.1). The SMR for all causes was 11.6 (11.1-12.0) in the period, and it decreased over time, mainly after 1996, up to 3.53 (2.5-4.8) in 2012. Male gender, year of enrolment before 1993, older age at enrolment, intravenous drug use, low CD4 cell count, AIDS event, cancer occurrence and the absence of antiretroviral therapy were all associated independently with risk of death. Conclusions: In HIV infected patients, ADC but not NADC incidence rates were higher than the general population. Although overall mortality in HIV infected subjects decreased over time, it is about three-fold higher than the general population at present.

Published
2015

9. Cancer incidence and mortality for all causes in HIV-infected patients over a quarter century: A multicentre cohort study Disease epidemiology - Infectious

Author

Raffetti E., Albini L., Gotti D., Segala D., Maggiolo F., Di Filippo E., Saracino A., Ladisa N., Lapadula G., Fornabaio C., Castelnuovo F., Casari S., Fabbiani M., Pierotti P., Donato F., Quiros-Roldan E., Raffetti, E, Albini, L, Gotti, D, Segala, D, Maggiolo, F, Di Filippo, E, Saracino, A, Ladisa, N, Lapadula, G, Fornabaio, C, Castelnuovo, F, Casari, S, Fabbiani, M, Pierotti, P, Donato, F, and Quiros-Roldan, E

Subjects
Adult, Male, Registrie, Adolescent, Epidemiology, Sex Factor, Substance Abuse, Intravenou, NO, Young Adult, Retrospective Studie, Age Factor, HIV Infection, Mortality, HIV-infection, Aged, Cancer, Acquired Immunodeficiency Syndrome, Incidence, Risk Factor, Middle Aged, CD4 Lymphocyte Count, Italy, Neoplasm, Anti-Retroviral Agent, Female, Cohort Studie, Human
Abstract

Background: We aimed to assess cancer incidence and mortality for all-causes and factors related to risk of death in an Italian cohort of HIV infected unselected patients as compared to the general population. Methods: We conducted a retrospective (1986-2012) cohort study on 16 268 HIV infected patients enrolled in the MASTER cohort. The standardized incidence ratios (SIRs) and standardized mortality ratios (SMRs) were computed using cancer incidence rates of Italian Cancer Registries and official national data for overall mortality. The risk factors for death from all causes were assessed using Poisson regression models. Results: 1,195 cancer cases were diagnosed from 1986 to 2012: 700 AIDS-defining-cancers (ADCs) and 495 non-AIDS-defining-cancers (NADCs). ADC incidence was much higher than the Italian population (SIR∈=∈30.8, 95% confidence interval 27.9-34.0) whereas NADC incidence was similar to the general population (SIR∈=∈0.9, 95% CI 0.8-1.1). The SMR for all causes was 11.6 (11.1-12.0) in the period, and it decreased over time, mainly after 1996, up to 3.53 (2.5-4.8) in 2012. Male gender, year of enrolment before 1993, older age at enrolment, intravenous drug use, low CD4 cell count, AIDS event, cancer occurrence and the absence of antiretroviral therapy were all associated independently with risk of death. Conclusions: In HIV infected patients, ADC but not NADC incidence rates were higher than the general population. Although overall mortality in HIV infected subjects decreased over time, it is about three-fold higher than the general population at present.

Published
2015

10. Cohort Profile: Standardized Management of Antiretroviral Therapy Cohort (MASTER Cohort)

Author

Torti, C, Raffetti, E, Donato, F, Castelli, F, Maggiolo, F, Angarano, G, Mazzotta, F, Gori, A, Sighinolfi, L, Pan, A, Cauda, R, Scalzini, A, Quiros-Roldan, E, Nasta, P, Gregis, G, Benatti, S, Digiambenedetto, S, Ladisa, N, Giralda, M, Saracino, A, Castelnuovo, F, Di Pietro, M, Lo Caputo, S, Lapadula, G, Costarelli, S, Lorenzotti, S, Mazzini, N, Paraninfo, G, Casari, S, Focà, E, Pezzoli, C, Fabbiani, M, Monno, L, Pierotti, P, Ble, C, Leone, S, Postorino, M, Fornabaio, C, Zacchi, F, Zoncada, A, Carosi, G, Torti, C, Raffetti, E, Donato, F, Castelli, F, Maggiolo, F, Angarano, G, Mazzotta, F, Gori, A, Sighinolfi, L, Pan, A, Cauda, R, Scalzini, A, Quiros-Roldan, E, Nasta, P, Gregis, G, Benatti, S, Digiambenedetto, S, Ladisa, N, Giralda, M, Saracino, A, Castelnuovo, F, Di Pietro, M, Lo Caputo, S, Lapadula, G, Costarelli, S, Lorenzotti, S, Mazzini, N, Paraninfo, G, Casari, S, Focà, E, Pezzoli, C, Fabbiani, M, Monno, L, Pierotti, P, Ble, C, Leone, S, Postorino, M, Fornabaio, C, Zacchi, F, Zoncada, A, and Carosi, G

Published
2017

11. Mycobacterium tuberculosis in ospedale: è patogeno nosocomiale? oppure occupazionale?

Author

AROSIO, MARCO ENRICO, DE VITO, GIOVANNI, Fornabaio, C, Mattelli, A, RIVA, MICHELE AUGUSTO, Tortoli, E., Arosio, M, DE VITO, G, Fornabaio, C, Mattelli, A, Riva, M, and Tortoli, E

Subjects
Tuberculosis, healthcare workers’ disease, nosocomial disease, MED/44 - MEDICINA DEL LAVORO, Tubercolosi, rischio biologico, patologia nosocomiale
Abstract

La tubercolosi costituisce una emergenza sanitaria per la salute pubblica, oltre che una problematica confinata agli ambienti lavorativi. Per tale ragione le autorità sanitarie redigono ed aggiornano costantemente linee guida di notevole valore scientifico e pratico. Recenti episodi di cronaca hanno riportato alla ribalta la tubercolosi come patologia nosocomiale, la cui trasmissione può avvenire da operatore sanitario a paziente. Per quanto concerne gli operatori sanitari, una recente revisione della letteratura ha confermato che il rischio di infezione tubercolare latente e di tubercolosi sono maggiori in questa categoria rispetto alla popolazione generale. Gli strumenti di riduzione del rischio di tubercolosi in ambito nosocomiale si basano innanzitutto sull’adozione di misure di isolamento respiratorio; tuttavia tali procedure richiedono il rapido riconoscimento del sospetto clinico. La diagnosi microbiologica di tubercolosi si basa sul reperto di bacilli tubercolari nel campione clinico. La ricerca di tali microrganismi può essere eseguita con l’esame microscopico, colturale e con tecniche rapide di biologia molecolare. Tuberculosis is an emergency for public health, as well as an issue confined to working environments. For this reason, the health authorities draw up and regularly update guidelines of considerable scientific and practical value. Recent reports have shown tuberculosis as a nosocomial disease whose transmission can occur from healthcare environment to patient. With regard to healthcare workers, a recent literature review confirmed that the risk of latent TB infection and tuberculosis is greater in this category of workers than in the general population. The tools for risk reduction in nosocomial TB are based primarily on respiratory isolation measures. However such procedures require the rapid recognition of clinical suspicion. The microbiological diagnosis of tuberculosis is based on the detection of tubercular bacilli in clinical specimens. The research of these microorganisms can be done using microscopic and coltural examination as well as rapid molecular biology techniques.

Published
2014

12. Low-level viraemia, measured as viraemia copy-years, as a prognostic factor for medium-long-term all-cause mortality: A MASTER cohort study

Author

Quiros-Roldan, E, Raffetti, E, Castelli, F, Focà, E, Castelnuovo, F, Di Pietro, M, Gagliardini, R, Gori, A, Saracino, A, Fornabaio, C, Sighinolfi, L, Di Filippo, E, Maggiolo, F, Donato, F, Quiros-Roldan, E, Raffetti, E, Castelli, F, Focà, E, Castelnuovo, F, Di Pietro, M, Gagliardini, R, Gori, A, Saracino, A, Fornabaio, C, Sighinolfi, L, Di Filippo, E, Maggiolo, F, and Donato, F

Abstract

Objectives: We investigated the association between persistent low-level viraemia, measured as viraemia copy-years (VCY), and all-cause mortality. Methods: We included 3271 HIV-infected patients who initiated their first combined ART (cART) during 1998- 2012 enrolled in the multicentre Italian MASTER cohort. VCY was defined as the area under the curve of plasma viral load (pVL) and expressed in log10 copies.years/mL. VCY was evaluated from cART initiation until the end of follow-up [VCY-overall (VCY-o)], and stratified into before [VCY-early (VCY-e)] and after [VCY-late (VCY-l)] the eighth month from starting cART, and as the ratio of VCY-l to follow-up duration (VCY-l/FUD). Results: The risk of death increased of about 40% for higher than the median levels of VCY-o and VCY-e. Compared with subjects with permanently suppressed pVL after the eighth month from starting cART, mortality increased by 70% for those with VCY-l =≥3 log10 copies.years/mL, and by about 20-fold for those with VCY-l/FUD =≥2.3 log10 copies/mL. Patients who maintained low levels of VCY-l (<,3 log10 copies.years/mL) or VCY-l/FUD (<,2.3 log10 copies/mL) had a risk of death similar to patients with permanently suppressed pVL. CD4 cell count at baseline was predictive of high risk of death only in subjects with VCY-l =≥3 log10 copies.years/mL. Conclusions: The risk of death did not increase in HIV-infected patients with low levels of VCY-l compared with patients with permanent virological suppression.

Published
2016

13. Pediatric tuberculosis in Italian children: Epidemiological and clinical data from the Italian register of pediatric tuberculosis

Author

Galli, Lavinia Maddalena, Lancella, L., Tersigni, Chiara, Venturini, Elena, Chiappini, Elisabetta, Bergamini, B., Codifava, M., Venturelli, Chiara, Tosetti, Giovanni, Marabotto, C., Cursi, L., Boccuzzi, E., Garazzino, S., Tovo, P., Pinon, M., Serre, D., Castiglioni, L., Vecchio, A., Guarino, A., Bruzzese, E., Losurdo, G., Castagnola, E., Bossi, Giuliana, Marseglia, G., Esposito, S., Bosis, S., Grandolfo, R., Fiorito, V., Valentini, Piero, Buonsenso, Danilo, Domenici, R., Montesanti, M., Salvini, F., Riva, E., Dodi, I., Maschio, F., Abbagnato, L., Fiumana, E., Fornabaio, C., Ballista, P., Portelli, V., Bottone, G., Palladino, N., Valenzise, M., Vecchi, B., Gangi, M., Lupi, C., Villani, Andrea, De Martino, M., Galli L., Tersigni C., Venturini E., Chiappini E. (ORCID:0000-0002-9782-0712), Venturelli C., Tosetti G., Bossi G., Valentini P. (ORCID:0000-0001-6095-9510), Buonsenso D., Villani A., Galli, Lavinia Maddalena, Lancella, L., Tersigni, Chiara, Venturini, Elena, Chiappini, Elisabetta, Bergamini, B., Codifava, M., Venturelli, Chiara, Tosetti, Giovanni, Marabotto, C., Cursi, L., Boccuzzi, E., Garazzino, S., Tovo, P., Pinon, M., Serre, D., Castiglioni, L., Vecchio, A., Guarino, A., Bruzzese, E., Losurdo, G., Castagnola, E., Bossi, Giuliana, Marseglia, G., Esposito, S., Bosis, S., Grandolfo, R., Fiorito, V., Valentini, Piero, Buonsenso, Danilo, Domenici, R., Montesanti, M., Salvini, F., Riva, E., Dodi, I., Maschio, F., Abbagnato, L., Fiumana, E., Fornabaio, C., Ballista, P., Portelli, V., Bottone, G., Palladino, N., Valenzise, M., Vecchi, B., Gangi, M., Lupi, C., Villani, Andrea, De Martino, M., Galli L., Tersigni C., Venturini E., Chiappini E. (ORCID:0000-0002-9782-0712), Venturelli C., Tosetti G., Bossi G., Valentini P. (ORCID:0000-0001-6095-9510), Buonsenso D., and Villani A.

Abstract

Tuberculosis (TB) is one of the leading causes of death worldwide. Over the last decades, TB has also emerged in the pediatric population. Epidemiologic data of childhood TB are still limited and there is an urgent need of more data on very large cohorts. A multicenter study was conducted in 27 pediatric hospitals, pediatric wards, and public health centers in Italy using a standardized form, covering the period of time between 1 January 2010 and 31 December 2012. Children with active TB, latent TB, and those recently exposed to TB or recently adopted/immigrated from a high TB incidence country were enrolled. Overall, 4234 children were included; 554 (13.1%) children had active TB, 594 (14.0%) latent TB and 3086 (72.9%) were uninfected. Among children with active TB, 481 (86.8%) patients had pulmonary TB. The treatment of active TB cases was known for 96.4% (n = 534) of the cases. Overall, 210 (39.3%) out of these 534 children were treated with three and 216 (40.4%) with four first-line drugs. Second-line drugs where used in 87 (16.3%) children with active TB. Drug-resistant strains of Mycobacterium tuberculosis were reported in 39 (7%) children. Improving the surveillance of childhood TB is important for public health care workers and pediatricians. A non-negligible proportion of children had drug-resistant TB and was treated with second-line drugs, most of which are off-label in the pediatric age. Future efforts should concentrate on improving active surveillance, diagnostic tools, and the availability of antitubercular pediatric formulations, also in low-endemic countries.

Published
2016

14. Cohort Profile: Standardized Management of Antiretroviral Therapy Cohort (MASTER Cohort)

Author

Torti, C, Raffetti, E, Donato, F, Castelli, F, Maggiolo, F, Angarano, G, Mazzotta, F, Gori, A, Sighinolfi, L, Pan, A, Cauda, Roberto, Scalzini, A, Quiros Roldan, E, Nasta, P, Gregis, G, Benatti, S, Di Giambenedetto, Simona, Ladisa, N, Giralda, M, Saracino, A, Castelnuovo, F, Di Pietro, M, Lo Caputo, S, Lapadula, G, Costarelli, S, Lorenzotti, S, Mazzini, N, Paraninfo, G, Casari, S, Focà, E, Pezzoli, C, Fabbiani, Massimiliano, Monno, L, Pierotti, P, Ble, C, Leone, S, Postorino, M, Fornabaio, C, Zacchi, F, Zoncada, A, Carosi, G., Cauda, Roberto (ORCID:0000-0002-1498-4229), Di Giambenedetto, Simona (ORCID:0000-0001-6990-5076), Torti, C, Raffetti, E, Donato, F, Castelli, F, Maggiolo, F, Angarano, G, Mazzotta, F, Gori, A, Sighinolfi, L, Pan, A, Cauda, Roberto, Scalzini, A, Quiros Roldan, E, Nasta, P, Gregis, G, Benatti, S, Di Giambenedetto, Simona, Ladisa, N, Giralda, M, Saracino, A, Castelnuovo, F, Di Pietro, M, Lo Caputo, S, Lapadula, G, Costarelli, S, Lorenzotti, S, Mazzini, N, Paraninfo, G, Casari, S, Focà, E, Pezzoli, C, Fabbiani, Massimiliano, Monno, L, Pierotti, P, Ble, C, Leone, S, Postorino, M, Fornabaio, C, Zacchi, F, Zoncada, A, Carosi, G., Cauda, Roberto (ORCID:0000-0002-1498-4229), and Di Giambenedetto, Simona (ORCID:0000-0001-6990-5076)

Abstract

The Italian MASTER (MAnagement Standardizzato di TErapia antiRetrovirale, standardized management of antiretroviral therapy) cohort is a hospital-based multicentre, open, dynamic HIV cohort established in the mid 1990s, with retrospective patient enrolment from 1986 to 1997 and subsequent prospective recruitment. At that time, no institutional system of surveillance of HIV infection was available, apart from the registration of AIDS cases. Accurate, precise and up-to-date data on HIV infection were therefore needed. To this end, we established a network of various HIV infection treatment centres in Italy, using a common clinical chart and an electronic database for data collection and management. The MASTER cohort enrols all HIV-infected patients, both treatment naïve and treatment experienced, in care at several HIV clinics throughout the country in order to represent the epidemiological and clinical scenario of HIV infection in Italy. A Steering Committee guarantees the scientific accuracy of the cohort. The Committee is made up of members from each centre and controls data quality by verifying the completeness, accuracy and updating of data collected by each centre. Furthermore, a working group proposes new studies, carries them out, analyses and discusses the findings and writes the final papers, under the supervision of the Steering Committee. The committee also verifies the consistency of the final paper with the initial proposal before its submission to a journal for publication. In performing these activities, the working group is supported by a data manager, a statistician and an epidemiologist. The main objectives of this cohort study are: (i) to create a hospital-based database of HIV-positive subjects for clinical and epidemiological research projects; (ii) to monitor the epidemiological pattern of HIV infection in Italy; (iii) to monitor highly active antiretroviral therapy (HAART) effectiveness and safety, and HIV drug resistance emergence; (iv) to in

Published
2015

15. Systemic Inflammation-Based Biomarkers and Survival in HIV-Positive Subject With Solid Cancer in an Italian Multicenter Study

Author

Raffetti, E, Donato, F, Pezzoli, C, Di Giambenedetto, Simona, Bandera, A, Di Pietro, M, Di Filippo, E, Maggiolo, F, Sighinolfi, L, Fornabaio, C, Castelnuovo, F, Ladisa, N, Castelli, F, Quiros Roldan, E., Di Giambenedetto, Simona (ORCID:0000-0001-6990-5076), Raffetti, E, Donato, F, Pezzoli, C, Di Giambenedetto, Simona, Bandera, A, Di Pietro, M, Di Filippo, E, Maggiolo, F, Sighinolfi, L, Fornabaio, C, Castelnuovo, F, Ladisa, N, Castelli, F, Quiros Roldan, E., and Di Giambenedetto, Simona (ORCID:0000-0001-6990-5076)

Abstract

Recently, some systemic inflammation-based biomarkers have been demonstrated useful for predicting risk of death in patients with solid cancer independently of tumor characteristics. This study aimed to investigate the prognostic role of systemic inflammation-based biomarkers in HIV-infected patients with solid tumors and to propose a risk score for mortality in these subjects.

Published
2015

16. Mycobacterium tuberculosis in ospedale: è patogeno nosocomiale? oppure occupazionale?

Author

Arosio, M, DE VITO, G, Fornabaio, C, Mattelli, A, Riva, M, Tortoli, E, AROSIO, MARCO ENRICO, DE VITO, GIOVANNI, RIVA, MICHELE AUGUSTO, Tortoli, E., Arosio, M, DE VITO, G, Fornabaio, C, Mattelli, A, Riva, M, Tortoli, E, AROSIO, MARCO ENRICO, DE VITO, GIOVANNI, RIVA, MICHELE AUGUSTO, and Tortoli, E.

Abstract

La tubercolosi costituisce una emergenza sanitaria per la salute pubblica, oltre che una problematica confinata agli ambienti lavorativi. Per tale ragione le autorità sanitarie redigono ed aggiornano costantemente linee guida di notevole valore scientifico e pratico. Recenti episodi di cronaca hanno riportato alla ribalta la tubercolosi come patologia nosocomiale, la cui trasmissione può avvenire da operatore sanitario a paziente. Per quanto concerne gli operatori sanitari, una recente revisione della letteratura ha confermato che il rischio di infezione tubercolare latente e di tubercolosi sono maggiori in questa categoria rispetto alla popolazione generale. Gli strumenti di riduzione del rischio di tubercolosi in ambito nosocomiale si basano innanzitutto sull’adozione di misure di isolamento respiratorio; tuttavia tali procedure richiedono il rapido riconoscimento del sospetto clinico. La diagnosi microbiologica di tubercolosi si basa sul reperto di bacilli tubercolari nel campione clinico. La ricerca di tali microrganismi può essere eseguita con l’esame microscopico, colturale e con tecniche rapide di biologia molecolare., Tuberculosis is an emergency for public health, as well as an issue confined to working environments. For this reason, the health authorities draw up and regularly update guidelines of considerable scientific and practical value. Recent reports have shown tuberculosis as a nosocomial disease whose transmission can occur from healthcare environment to patient. With regard to healthcare workers, a recent literature review confirmed that the risk of latent TB infection and tuberculosis is greater in this category of workers than in the general population. The tools for risk reduction in nosocomial TB are based primarily on respiratory isolation measures. However such procedures require the rapid recognition of clinical suspicion. The microbiological diagnosis of tuberculosis is based on the detection of tubercular bacilli in clinical specimens. The research of these microorganisms can be done using microscopic and coltural examination as well as rapid molecular biology techniques.

Published
2014

17. Early and sustained virological response in non-responders with chronic hepatitis C: a randomized open-label study of pegylated interferon-alpha-2a versus pegylated interferon-alpha-2b.

Author

Scotto G, Fazio V, Fornabaio C, Tartaglia A, Di Tullio R, Saracino A, and Angarano G

Abstract

OBJECTIVES: The purpose of this randomized open-label study was to assess the efficacy of treatment with pegylated interferon-alpha-2a versus pegylated interferon-alpha-2b, both plus ribavirin, in inducing early and sustained virological response (EVR and SVR) in chronic hepatitis C non-responders. PATIENTS AND METHODS: A total of 108 patients with chronic hepatitis C who were non-responders to previous combined therapy (standard interferon-alpha plus ribavirin for >/=3 months) were enrolled and equally randomized into two groups in this intention-to-treat analysis. The patients exhibited similar baseline features. One group received subcutaneous pegylated interferon-alpha-2a 180 mug once weekly, while the other was treated with subcutaneous pegylated interferon-alpha-2b 1.5 mug/kg once weekly. Ribavirin 15 mg/kg/day was included in both protocols. Treatment duration for EVR was 12 weeks. Patients who demonstrated non-detectable hepatitis C virus (HCV) RNA or a >/=2 log(10) reduction in viral load at week 12 continued therapy up to 48 weeks, with assessments every 3 months during a follow-up of 24 weeks. RESULTS: All patients in both groups completed the EVR study, then seven patients receiving pegylated interferon-alpha-2a and seven patients receiving pegylated interferon-alpha2b discontinued treatment as a result of severe adverse effects. After 12 weeks of treatment, viral load reduction was >2 log(10) with both pegylated interferon-alpha-2a (-2.53) and pegylated interferon-alpha-2b (-2.48) with no significant difference. At the end of week 48, HCV RNA was undetectable in 14 of 54 patients (25.9%) receiving pegylated interferon-alpha-2a and in 15 of 54 patients (27.7%) receiving pegylated interferon-alpha-2b. When terminating follow-up, an SVR was observed in 11 of 54 patients (20.4%) who received pegylated interferon-alpha-2a and 10 of 54 patients (18.4%) receiving pegylated interferon-alpha-2b. The incidence and severity of adverse events was similar in both groups. CONCLUSIONS: Our results seem to show that in chronic hepatitis C patients who are non-responsive to previous therapy, EVR to the two pegylated interferons did not significantly differ with a similar therapeutic efficacy defined as SVR. [ABSTRACT FROM AUTHOR]

Published
2008
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23. The Burden of Clostridioides Difficile Infection during the COVID-19 Pandemic: A Retrospective Case-Control Study in Italian Hospitals (CloVid)

Author

Guido Granata, Alessandro Bartoloni, Mauro Codeluppi, Ilaria Contadini, Francesco Cristini, Massimo Fantoni, Alice Ferraresi, Chiara Fornabaio, Sara Grasselli, Filippo Lagi, Luca Masucci, Massimo Puoti, Alessandro Raimondi, Eleonora Taddei, Filippo Fabio Trapani, Pierluigi Viale, Stuart Johnson, Nicola Petrosillo, on behalf of the CloVid Study Group, Granata, G, Bartoloni, A, Codeluppi, M, Contadini, I, Cristini, F, Fantoni, M, Ferraresi, A, Fornabaio, C, Grasselli, S, Lagi, F, Masucci, L, Puoti, M, Raimondi, A, Taddei, E, Trapani, F, Viale, P, Johnson, S, and Petrosillo, N

Subjects
medicine.medical_specialty, Coronavirus disease 2019 (COVID-19), genetic structures, medicine.drug_class, Clostridioides difficile infection, case-control study, Antibiotics, lcsh:Medicine, Article, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, Pandemic, medicine, Antimicrobial stewardship, Infection control, risk factors, hospital-onset, 0303 health sciences, 030306 microbiology, business.industry, Incidence (epidemiology), lcsh:R, Case-control study, General Medicine, 030211 gastroenterology & hepatology, Observational study, coronavirus disease 2019 pandemic, Risk factor, business
Abstract

Data on the burden of Clostridioides difficile infection (CDI) in Coronavirus Disease 2019 (COVID-19) patients are scant. We conducted an observational, retrospective, multicenter, 1:3 case (COVID-19 patients with CDI)-control (COVID-19 patients without CDI) study in Italy to assess incidence and outcomes, and to identify risk factors for CDI in COVID-19 patients. From February through July 2020, 8402 COVID-19 patients were admitted to eight Italian hospitals, 38 CDI cases were identified, including 32 hospital-onset-CDI (HO-CDI) and 6 community-onset, healthcare-associated-CDI (CO-HCA-CDI). HO-CDI incidence was 4.4 × 10,000 patient-days. The percentage of cases recovering without complications at discharge (i.e., pressure ulcers, chronic heart decompensation) was lower than among controls (p = 0.01), in-hospital stays was longer among cases, 35.0 versus 19.4 days (p = 0.0007). The presence of a previous hospitalisation (p = 0.001), previous steroid administration (p = 0.008) and the administration of antibiotics during the stay (p = 0.004) were risk factors associated with CDI. In conclusions, CDI complicates COVID-19, mainly in patients with co-morbidities and previous healthcare exposures. Its association with antibiotic usage and hospital acquired bacterial infections should lead to strengthen antimicrobial stewardship programmes and infection prevention and control activities.

Published
2020

24. Pediatric Tuberculosis in Italian Children: Epidemiological and Clinical Data from the Italian Register of Pediatric Tuberculosis

Author

Alberto Villani, Patrizia Ballista, Luisa Galli, Laura Castiglioni, Elena Chiappini, Daniele Le Serre, Samantha Bosis, Gian Luigi Marseglia, Maurizio de Martino, Giuseppe Losurdo, Laura Lancella, Maria Di Gangi, Filippo Salvini, Cristina Venturelli, Andrea Lo Vecchio, Barbara Maria Bergamini, Eugenia Bruzzese, Elena Boccuzzi, Caterina Marabotto, Susanna Esposito, Michele Pinon, Piero Valentini, Laura Cursi, Elisa Fiumana, Elio Castagnola, Grazia Bossi, Marco Montesanti, Francesca Maschio, Chiara Fornabaio, Giulia Tosetti, Elisabetta Venturini, Alfredo Guarino, Margherita Codifava, Gabriella Bottone, Icilio Dodi, Rita Grandolfo, Carla Lupi, Nicola Palladino, Mariella Valenzise, Raffaele Domenici, V. Portelli, Danilo Buonsenso, Valentina Fiorito, Barbara Vecchi, Luisa Abbagnato, Pier-Angelo Tovo, Enrica Riva, Silvia Garazzino, Chiara Tersigni, Galli, L, Lancella, L, Tersigni, C, Venturini, E, Chiappini, E, Bergamini, Bm, Codifava, M, Venturelli, C, Tosetti, G, Marabotto, C, Cursi, L, Boccuzzi, E, Garazzino, S, Tovo, Pa, Pinon, M, Le Serre, D, Castiglioni, L, LO VECCHIO, Andrea, Guarino, Alfredo, Bruzzese, Eugenia, Losurdo, G, Castagnola, E, Bossi, G, Marseglia, Gl, Esposito, S, Bosis, S, Grandolfo, R, Fiorito, V, Valentini, P, Buonsenso, D, Domenici, R, Montesanti, M, Salvini, Fm, Riva, E, Dodi, I, Maschio, F, Abbagnato, L, Fiumana, E, Fornabaio, C, Ballista, P, Portelli, V, Bottone, G, Palladino, N, Valenzise, M, Vecchi, B, Di Gangi, M, Lupi, C, Villani, A, and de Martino, M.

Subjects
Male, Pediatrics, Children, Italian, Register, Tuberculosis, Antitubercular Agents, Drug resistance, Ambulatory Care Facilities, Catalysi, lcsh:Chemistry, 0302 clinical medicine, Health care, Epidemiology, Tuberculosis, Multidrug-Resistant, 030212 general & internal medicine, Registries, Child, lcsh:QH301-705.5, Spectroscopy, Pediatric, register, biology, Incidence (epidemiology), Computer Science Applications1707 Computer Vision and Pattern Recognition, Pulmonary, General Medicine, Multidrug-Resistant, Hospitals, Pediatric, Settore MED/38, Hospitals, Computer Science Applications, Pediatric tuberculosis, Settore MED/38 - PEDIATRIA GENERALE E SPECIALISTICA, Italy, tuberculosis, Child, Preschool, Catalysis, Molecular Biology, Physical and Theoretical Chemistry, Organic Chemistry, Inorganic Chemistry, Female, medicine.medical_specialty, Adolescent, Tuberculosi, Humans, Infant, Tuberculosis, Pulmonary, Article, Mycobacterium tuberculosis, 03 medical and health sciences, children, 030225 pediatrics, medicine, Preschool, business.industry, Public health, medicine.disease, biology.organism_classification, Children, Italian, Register, Tuberculosis, lcsh:Biology (General), lcsh:QD1-999, business
Abstract

Tuberculosis (TB) is one of the leading causes of death worldwide. Over the last decades, TB has also emerged in the pediatric population. Epidemiologic data of childhood TB are still limited and there is an urgent need of more data on very large cohorts. A multicenter study was conducted in 27 pediatric hospitals, pediatric wards, and public health centers in Italy using a standardized form, covering the period of time between 1 January 2010 and 31 December 2012. Children with active TB, latent TB, and those recently exposed to TB or recently adopted/immigrated from a high TB incidence country were enrolled. Overall, 4234 children were included; 554 (13.1%) children had active TB, 594 (14.0%) latent TB and 3086 (72.9%) were uninfected. Among children with active TB, 481 (86.8%) patients had pulmonary TB. The treatment of active TB cases was known for 96.4% (n = 534) of the cases. Overall, 210 (39.3%) out of these 534 children were treated with three and 216 (40.4%) with four first-line drugs. Second-line drugs where used in 87 (16.3%) children with active TB. Drug-resistant strains of Mycobacterium tuberculosis were reported in 39 (7%) children. Improving the surveillance of childhood TB is important for public health care workers and pediatricians. A non-negligible proportion of children had drug-resistant TB and was treated with second-line drugs, most of which are off-label in the pediatric age. Future efforts should concentrate on improving active surveillance, diagnostic tools, and the availability of antitubercular pediatric formulations, also in low-endemic countries.

Published
2016

25. Cohort Profile: Standardized Management of Antiretroviral Therapy Cohort (MASTER Cohort)

Author

Francesco Castelli, Maria Concetta Postorino, Silvia Lorenzotti, Gioacchino Angarano, Giampiero Carosi, Mariarosaria Giralda, Giuseppe Paraninfo, Nicola Mazzini, Fabio Zacchi, Elena Raffetti, Alessia Zoncada, Francesco Mazzotta, Roberto Cauda, Silvia Costarelli, Chiara Fornabaio, Eugenia Quiros-Roldan, Simona Digiambenedetto, Simone Benatti, Alfredo Scalzini, Emanuele Focà, Angelo Pan, Salvatore Casari, Massimo Di Pietro, Franco Maggiolo, Giampietro Gregis, Laura Monno, Filippo Castelnuovo, Paola Nasta, Sergio Lo Caputo, Piera Pierotti, Francesco Donato, Sebastiano Leone, Laura Sighinolfi, Carlo Torti, Massimiliano Fabbiani, Claudio Ble, Nicoletta Ladisa, Chiara Pezzoli, Annalisa Saracino, Andrea Gori, Giuseppe Lapadula, Torti, C, Raffetti, E, Donato, F, Castelli, F, Maggiolo, F, Angarano, G, Mazzotta, F, Gori, A, Sighinolfi, L, Pan, A, Cauda, R, Scalzini, A, Quiros-Roldan, E, Nasta, P, Gregis, G, Benatti, S, Digiambenedetto, S, Ladisa, N, Giralda, M, Saracino, A, Castelnuovo, F, Di Pietro, M, Lo Caputo, S, Lapadula, G, Costarelli, S, Lorenzotti, S, Mazzini, N, Paraninfo, G, Casari, S, Focà, E, Pezzoli, C, Fabbiani, M, Monno, L, Pierotti, P, Ble, C, Leone, S, Postorino, M, Fornabaio, C, Zacchi, F, Zoncada, A, and Carosi, G

Subjects
Adult, Male, medicine.medical_specialty, Sustained Virologic Response, Epidemiology, Alternative medicine, Human immunodeficiency virus (HIV), HIV Infections, hiv, medicine.disease_cause, Settore MED/17 - MALATTIE INFETTIVE, Drug Prescriptions, Young Adult, Age Distribution, Internal medicine, Antiretroviral Therapy, Highly Active, medicine, Humans, Multicenter Studies as Topic, Prospective Studies, Sex Distribution, Aged, Retrospective Studies, business.industry, Retrospective cohort study, General Medicine, Middle Aged, Antiretroviral therapy, Antiretroviral, Italy, Cohort, Female, Therapy, business
Published
2015

26. Polypharmacy, anticholinergic burden and drug-drug interaction assessment in people with four-class-resistant HIV: data from the PRESTIGIO registry.

Author

Mazzitelli M, Pontillo D, Clemente T, Di Biagio A, Cenderello G, Rusconi S, Menzaghi B, Fornabaio C, Garlassi E, Zazzi M, Castagna A, and Cattelan AM

Subjects
Humans, Male, Female, Middle Aged, Cross-Sectional Studies, Drug Resistance, Viral, Adult, Drug Interactions, Polypharmacy, HIV Infections drug therapy, Anti-HIV Agents therapeutic use, Registries, Cholinergic Antagonists administration & dosage
Abstract

Objectives: To evaluate polypharmacy, anticholinergic burden (ACB) and drug-drug interactions (DDIs) in people with four-class-resistant HIV (4DR-PWH)., Methods: We performed a cross-sectional study, including 4DR-PWH from the PRESTIGIO Registry taking at least one non-antiretroviral drug. Polypharmacy was defined as taking five or more non-antiretroviral drugs. ACB was calculated using the ACB scale: 0 = no AC effect, 1-2 = low/moderate risk, ≥3 = high AC risk. Participants' characteristics by ACB score were compared using the Kruskal-Wallis test, and Spearman's correlation coefficient was used to assess linear relationships. DDIs were evaluated using the Liverpool database., Results: Overall, 172 4DR-PLWH were evaluated: 75.6% males, median age 49.9 years (IQR = 45.6-56), 62 (27.1%) on polypharmacy, 124 (72.1%) using a boosting agent and 72 (41.8%) with four or more antiretrovirals. Based on ACB, 128 (74.45%), 33 (19.2%) and 11 (6.4%) had a no, low/moderate and high AC risk, respectively. The most common AC drugs were β-blockers (12.2%), diuretics (8.7%) and antidepressants (8.7%). The high ACB was significantly related to the number of drugs/person (r = 0.33, P < 0.0001) and the number of clinical events (r = 0.222, P = 0.004). Overall, 258 DDIs were found between antiretrovirals and co-medications in 115 (66.8%) PWH, and 14 (8.1%) PWH received contraindicated drug combinations., Conclusions: In 4DR-PWH, polypharmacy, DDIs and the proportion of people with moderate/high AC burden were high. In 4DR-PWH undetectability achievement and maintenance is the priority and use of boosted PIs is common. A strict collaboration (infectious diseases specialists, virologists, pharmacologists) is needed to limit the risk of ACB and DDIs and to explore the advantages of new antiretrovirals., (© The Author(s) 2024. Published by Oxford University Press on behalf of British Society for Antimicrobial Chemotherapy. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)

Published
2024
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28. Convenience, efficacy, safety, and durability of INSTI-based antiretroviral therapies: evidence from the Italian MaSTER cohort.

Author

Rich SN, Nasta P, Quiros-Roldan E, Fusco P, Tondinelli A, Costa C, Fornabaio C, Mazzini N, Prosperi M, Torti C, and Carosi G

Subjects
Humans, Male, Middle Aged, Italy epidemiology, Coinfection, Substance Abuse, Intravenous, HIV Infections drug therapy
Abstract

Background: Integrase strand transferase inhibitors (INSTI), including raltegravir (RAL), elvitegravir (ELV), and dolutegravir (DTG), have demonstrated better efficacy and tolerability than other combination antiretroviral therapy (cART) classes in clinical trials; however, studies of sustainability of INSTI-containing therapy in the long-term are sparse. The purpose of this study was to provide an epidemiological overview comparing the outcome performance of different INSTI-based regimens longitudinally, including the metrics of efficacy, safety, convenience, and durability among a large, nationally representative cohort of persons living with HIV in Italy., Methods: We selected subjects in the MaSTER cohort (an Italian multicenter, hospital-based cohort established in the mid-1990s that currently has enrolled over 24,000 PLWH) who initiated an INSTI-based regimen either when naïve or following a regimen switch. Cox proportional hazards regression models were fitted to evaluate associations between therapy interruptions and age, sex, nationality, transmission risk group, viral suppression status, CD4 + T-cell count, diagnosis year, cART status (naïve or experienced), and hepatitis coinfection. Results were stratified by cART INSTI type., Results: There were 8173 participants who initiated an INSTI-based cART regimen in the MaSTER cohort between 2009 and 2017. The population was majority male (72.6%), of Italian nationality (88.6%), and cART-experienced (83.0%). Mean age was 49.7 (standard deviation: 13.9) years. In total, interruptions of the 1st INSTI-based treatment were recorded in 34% of cases. The most frequently cited reason for interruption among all three drug types was safety problems. In the survival analysis, past history of cART use was associated with higher hazards of interruption due to poor efficacy for all three drug types when compared to persons who were cART naïve. Non-viral suppression and CD4 + T-cell count < 200/mm 3 at baseline were associated with higher hazards of interruption due to efficacy, safety, and durability reasons. Non-Italian nationality was linked to higher hazards of efficacy interruption for RAL and EVG. Age was negatively associated with interruption due to convenience and positively associated with interruption due to safety reasons. People who injects drugs (PWID) were associated with higher hazards of interruption due to convenience problems. Hepatitis coinfection was linked to higher hazards of interruption due to safety concerns for people receiving RAL., Conclusion: One-third of the population experienced an interruption of any drugs included in INSTI therapy in this study. The most frequent reason for interruption was safety concerns which accounted for one-fifth of interruptions among the full study population, mainly switched to DTG. The hazard for interruption was higher for low baseline CD4 + T-cell counts, higher baseline HIV-RNA, non-Italian nationality, older age, PWID and possible co-infections with hepatitis viruses. The risk ratio was higher for past history of cART use compared to persons who were cART naive, use of regimens containing 3 drugs compared to regimens containing 2 drugs. Durability worked in favor of DTG which appeared to perform better in this cohort compared to RAL and EVG, though length of follow-up was significantly shorter for DTG. These observational results need to be confirmed in further perspective studies with longer follow-up., (© 2023. BioMed Central Ltd., part of Springer Nature.)

Published
2023
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29. Efficacy, Convenience, Safety and Durability of DTG-Based Antiretroviral Therapies: Evidence from a Prospective Study by the Italian MaSTER Cohort.

Author

Fusco P, Nasta P, Quiros-Roldan E, Tondinelli A, Costa C, Fornabaio C, Mazzini N, Prosperi M, Torti C, and Carosi G

Subjects
Humans, Male, Middle Aged, Female, Prospective Studies, Treatment Outcome, Heterocyclic Compounds, 3-Ring therapeutic use, RNA, Lamivudine therapeutic use, Anti-HIV Agents adverse effects, HIV Infections drug therapy
Abstract

Background : Dolutegravir (DTG) is recommended by international guidelines as a main component of an optimal initial regimen of cART (combination antiretroviral treatment) in people living with HIV (PLWH) and in case of switching for failure or optimization strategies. However, studies on the performance of DTG-containing regimens and indications for switching therapies in the long term are sparse. The purpose of this study was to evaluate prospectively the performance of DTG-based regimens, using the metrics of "efficacy", "safety", "convenience" and ''durability'', among a nationally representative cohort of PLWH in Italy. Methods : We selected all PLWH in four centers of the MaSTER cohort who initiated a DTG-based regimen either when naïve or following a regimen switch between 11 July 2018 and 2 July 2021. Participants were followed until the outcomes were recorded or until the end of the study on 4 August 2022, whichever occurred first. Interruption was reported even when a participant switched to another DTG-containing regimen. Survival regression models were fitted to evaluate associations between therapy performance and age, sex, nationality, risk of HIV transmission, HIV RNA suppression status, CD4+ T-cell count, year of HIV diagnosis, cART status (naïve or experienced), cART backbone and viral hepatitis coinfection. Results : There were 371 participants in our cohort who initiated a DTG-based cART regimen in the time frame of the study. The population was predominantly male (75.2%), of Italian nationality (83.3%), with a history of cART use (80.9%), and the majority initiated a DTG-based regimen following a switch strategy in 2019 (80.1%). Median age was 53 years (interquartile range (IQR): 45-58). Prior cART regimen was based mostly on a combination of NRTI drugs plus a PI-boosted drug (34.2%), followed by a combination of NRTIs plus an NNRTI (23.5%). Concerning the NRTI backbone, the majority comprised 3TC plus ABC (34.5%), followed by 3TC alone (28.6%). The most reported transmission risk factor was heterosexual intercourse (44.2%). Total interruptions of the first DTG-based regimen were registered in 58 (15.6%) participants. The most frequent reason for interruption was due to cART simplification strategies, which accounted for 52%. Only 1 death was reported during the study period. The median time of total follow-up was 556 days (IQR: 316.5-722.5). Risk factors for poor performance of DTG-containing-regimens were found to be: a backbone regimen containing tenofovir, being cART naïve, having detectable HIV RNA at baseline, FIB-4 score above 3.25 and having a cancer diagnosis. By contrast, protective factors were found to be: higher CD4+ T-cell counts and higher CD4/CD8 ratio at baseline. Conclusion: DTG-based regimens were used mainly as a switching therapy in our cohort of PLWH who had undetectable HIV RNA and a good immune status. In this type of population, the durability of DTG-based regimens was maintained in 84.4% of participants with a modest incidence of interruptions mostly due to cART simplification strategies. The results of this prospective real-life study confirm the apparent low risk of changing DTG-containing regimens due to virological failure. They may also help physicians to identify people with increased risk of interruption for different reasons, suggesting targeted medical interventions.

Published
2023
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30. A case of mumps encephalitis imported to Italy from India.

Author

Baggieri M, Rovida F, Marchi A, Zoncada A, Fornabaio C, Bucci P, Nicoletti L, Baldanti F, and Magurano F

Subjects
Humans, Antibodies, Viral blood, Communicable Diseases, Imported virology, Communicable Diseases, Imported diagnosis, Encephalitis, Viral virology, Encephalitis, Viral diagnosis, India, Italy, Mumps diagnosis, Mumps virus genetics, Mumps virus isolation & purification
Published
2020
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31. The Burden of Clostridioides Difficile Infection during the COVID-19 Pandemic: A Retrospective Case-Control Study in Italian Hospitals (CloVid).

Author

Granata G, Bartoloni A, Codeluppi M, Contadini I, Cristini F, Fantoni M, Ferraresi A, Fornabaio C, Grasselli S, Lagi F, Masucci L, Puoti M, Raimondi A, Taddei E, Trapani FF, Viale P, Johnson S, Petrosillo N, and On Behalf Of The CloVid Study Group

Abstract

Data on the burden of Clostridioides difficile infection (CDI) in Coronavirus Disease 2019 (COVID-19) patients are scant. We conducted an observational, retrospective, multicenter, 1:3 case (COVID-19 patients with CDI)-control (COVID-19 patients without CDI) study in Italy to assess incidence and outcomes, and to identify risk factors for CDI in COVID-19 patients. From February through July 2020, 8402 COVID-19 patients were admitted to eight Italian hospitals; 38 CDI cases were identified, including 32 hospital-onset-CDI (HO-CDI) and 6 community-onset, healthcare-associated-CDI (CO-HCA-CDI). HO-CDI incidence was 4.4 × 10,000 patient-days. The percentage of cases recovering without complications at discharge (i.e., pressure ulcers, chronic heart decompensation) was lower than among controls ( p = 0.01); in-hospital stays was longer among cases, 35.0 versus 19.4 days ( p = 0.0007). The presence of a previous hospitalisation ( p = 0.001), previous steroid administration ( p = 0.008) and the administration of antibiotics during the stay ( p = 0.004) were risk factors associated with CDI. In conclusions, CDI complicates COVID-19, mainly in patients with co-morbidities and previous healthcare exposures. Its association with antibiotic usage and hospital acquired bacterial infections should lead to strengthen antimicrobial stewardship programmes and infection prevention and control activities.

Published
2020
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32. Burden of Disease in PWH Harboring a Multidrug-Resistant Virus: Data From the PRESTIGIO Registry.

Author

Galli L, Parisi MR, Poli A, Menozzi M, Fiscon M, Garlassi E, Francisci D, Di Biagio A, Sterrantino G, Fornabaio C, Degli Antoni A, Angarano G, Fusco FM, D'Arminio Monforte A, Corbelli GM, Santoro MM, Zazzi M, and Castagna A

Abstract

Background: Currently, no data are available on the burden of morbidity and mortality in people with HIV-1 (PWH) harboring a 4-class drug-resistant (4DR) virus (nucleoside reverse transcriptase inhibitors, non-nucleoside reverse transcriptase inhibitors, protease inhibitors, integrase strand transfer inhibitors). The study aimed to assess the incidence of clinical events and death in this population., Methods: This was a cohort study on PWH from the PRESTIGIO Registry with a documented 4DR virus. Burden of disease was defined as the occurrence of any new event including an AIDS-defining event (ADE) or non-AIDS-defining event (NADE) or death from any cause after 4DR evidence (baseline). Cox regression models evaluated factors associated with the risk of new clinical events/death., Results: Among 148 PWH followed for a median (interquartile range) of 47 (32-84) months after 4DR evidence, 38 PWH had 62 new events or died from any cause (incidence rate, 9.12/100 person-years of follow-up; 95% CI = 6.85-11.39): 12 deaths (6 AIDS-related and 6 non-AIDS-related), 18 ADEs, 32 NADEs; 20 of the 38 NADEs (45%) of the incident clinical events were malignancies. The 4-year cumulative incidence of death was 6% (95% CI, 3%-13%), and that of ≥1 event or death was 22% (95% CI, 16%-31%). A higher risk of new clinical events/death was more likely in PWH with previous clinical events (adjusted hazard ratio [aHR], 2.67; 95% CI, 1.07-6.67) and marginally associated with lower baseline CD4+/CD8+ ratio (aHR, 0.82; 95% CI, 0.65-1.02)., Conclusions: PWH harboring 4DR have a high burden of disease with a worrying incidence of malignancies, strongly advising for close prevention and monitoring interventions as well as access to innovative therapeutic strategies, especially in people with a history of clinical events and low CD4+/CD8+ ratio., (© The Author(s) 2020. Published by Oxford University Press on behalf of Infectious Diseases Society of America.)

Published
2020
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33. Susceptibility to HIV-1 integrase strand transfer inhibitors (INSTIs) in highly treatment-experienced patients who failed an INSTI-based regimen.

Author

Santoro MM, Fornabaio C, Malena M, Galli L, Poli A, Menozzi M, Zazzi M, White KL, and Castagna A

Subjects
Amides, Drug Resistance, Multiple, Viral genetics, Female, HIV Integrase drug effects, HIV-1 genetics, HIV-1 isolation & purification, Humans, Male, Middle Aged, Quinolones therapeutic use, Raltegravir Potassium therapeutic use, Treatment Outcome, HIV Infections drug therapy, HIV Integrase Inhibitors therapeutic use, HIV-1 drug effects, Heterocyclic Compounds, 3-Ring therapeutic use, Heterocyclic Compounds, 4 or More Rings therapeutic use, Oxazines therapeutic use, Piperazines therapeutic use, Pyridones therapeutic use
Abstract

The aim of this study was to characterize the genotypic and phenotypic resistance profile to the integrase strand transfer inhibitor (INSTI) bictegravir (BIC) and other INSTIs in patients who previously failed twice-daily raltegravir (RAL)-based or twice-daily dolutegravir (DTG)-based regimens. Twenty-two samples were collected after failure on an INSTI-based regimen in 17 highly treatment-experienced patients with HIV-1 with multi-drug-resistant virus, recorded in the Italian PRESTIGIO registry. Genotypic resistance mutations and phenotypic susceptibility to INSTIs were detected by GeneSeqIN and PhenoSenseIN assays, respectively (Monogram Biosciences, San Francisco, CA, USA). The primary INSTI resistance substitutions E138A/K, G140S, Y143C/H/R, Q148H and N155H were detected in 14 of 22 samples and were associated with resistance to one or more INSTIs, with G140S+Q148H present in 11 of 22 samples. Of these 14 samples, all showed high levels of resistance to elvitegravir (EVG) and RAL. Two isolates contained L74M, E138K, G140S and Q148H, or L74M, T97A, S119T, E138K, G140S, Y143R and Q148H, and had high-level resistance to all INSTIs, including BIC and DTG. Intermediate resistance was reported for eight of 14 isolates for BIC and nine of 14 isolates for DTG. Overall, for the 14 INSTI-resistant isolates, the median fold-change values in phenotypic susceptibility were: BIC 3.2 [interquartile range (IQR) 0.6-66], DTG 6.3 (IQR 0.8->186), EVG >164 (IQR 2.6->164) and RAL >188 (IQR 2.7->197). In conclusion, the study findings supported the in-vitro activity of BIC and DTG against most isolates derived from highly treatment-experienced patients who failed INSTI regimens., (Copyright © 2020 Elsevier B.V. and International Society of Chemotherapy. All rights reserved.)

Published
2020
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34. Cohort Profile: Standardized Management of Antiretroviral Therapy Cohort (MASTER Cohort).

Author

Torti C, Raffetti E, Donato F, Castelli F, Maggiolo F, Angarano G, Mazzotta F, Gori A, Sighinolfi L, Pan A, Cauda R, Scalzini A, Quiros-Roldan E, Nasta P, Gregis G, Benatti S, Digiambenedetto S, Ladisa N, Giralda M, Saracino A, Castelnuovo F, Di Pietro M, Lo Caputo S, Lapadula G, Costarelli S, Lorenzotti S, Mazzini N, Paraninfo G, Casari S, Focà E, Pezzoli C, Fabbiani M, Monno L, Pierotti P, Ble C, Leone S, Postorino MC, Fornabaio C, Zacchi F, Zoncada A, and Carosi G

Subjects
Adult, Age Distribution, Aged, Antiretroviral Therapy, Highly Active adverse effects, Female, Humans, Italy epidemiology, Male, Middle Aged, Multicenter Studies as Topic, Prospective Studies, Retrospective Studies, Sex Distribution, Sustained Virologic Response, Young Adult, Antiretroviral Therapy, Highly Active methods, Drug Prescriptions statistics & numerical data, HIV Infections drug therapy, HIV Infections epidemiology
Published
2017
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35. Systemic inflammation-based scores and mortality for all causes in HIV-infected patients: a MASTER cohort study.

Author

Raffetti E, Donato F, Casari S, Castelnuovo F, Sighinolfi L, Bandera A, Maggiolo F, Ladisa N, di Pietro M, Fornabaio C, Digiambenedetto S, and Quiros-Roldan E

Subjects
Adult, Biomarkers blood, Cause of Death, Female, Follow-Up Studies, Humans, Inflammation blood, Inflammation diagnosis, Italy epidemiology, Lymphocyte Count, Male, Middle Aged, Neutrophils metabolism, Platelet Count, Proportional Hazards Models, Prospective Studies, Retrospective Studies, HIV Infections immunology, HIV Infections mortality, Inflammation mortality, Inflammation virology
Abstract

Background: Two biomarkers, the neutrophil to lymphocyte ratio (NLR) and platelet to lymphocyte ratio (PLR), have been shown to be indicative of systemic inflammation and predictive of mortality in general population. We aimed to assess the association of NLR and PLR, with risk of death in HIV-infected subjects when also taking account of HIV-related factors., Methods: We conducted a multicenter Italian cohort study from 2000 to 2012 including HIV-infected subjects naïve at antiretroviral treatment. The associations of NLR and PLR with all-cause mortality were tested by univariate and multivariate analyses using both time independent and dependent Cox proportional hazard models. We also fitted models with a cubic-spline for PLR and NLR to evaluate the possible non-linear relationship between biomarkers values and risk of death., Results: Eight-thousand and two hundred thirty patients (73.1% males) with a mean age of 38.4 years (SD 10.1) were enrolled. During a median follow-up of 3.9 years, 539 patients died. PLR < 100 and ≥ 200, as compared to PLR of 100-200, and NLR ≥ 2, as compared to < 2, were associated with risk of death at both univariate and multivariate analyses. Using multivariate models with restricted cubic-splines, we found a linear relationship of increasing risk of death with increasing values for NRL over 1.1, and an U-shape curve for PLR, with higher mortality risk for values higher or lower than 120., Conclusions: Our data suggest that NLR and PLR can reflect the severity of the underlying systemic disturbance of the inflammatory process and coagulation leading to augmented mortality in HIV positive subjects.

Published
2017
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36. Low-level viraemia, measured as viraemia copy-years, as a prognostic factor for medium-long-term all-cause mortality: a MASTER cohort study.

Author

Quiros-Roldan E, Raffetti E, Castelli F, Focà E, Castelnuovo F, Di Pietro M, Gagliardini R, Gori A, Saracino A, Fornabaio C, Sighinolfi L, Di Filippo E, Maggiolo F, and Donato F

Subjects
Adult, Anti-Retroviral Agents therapeutic use, Cohort Studies, Female, HIV Infections drug therapy, Humans, Italy, Male, Middle Aged, Prognosis, Risk Assessment, Survival Analysis, Time Factors, Young Adult, HIV Infections mortality, Viral Load, Viremia mortality
Abstract

Objectives: We investigated the association between persistent low-level viraemia, measured as viraemia copy-years (VCY), and all-cause mortality., Methods: We included 3271 HIV-infected patients who initiated their first combined ART (cART) during 1998-2012 enrolled in the multicentre Italian MASTER cohort. VCY was defined as the area under the curve of plasma viral load (pVL) and expressed in log 10 copies · years/mL. VCY was evaluated from cART initiation until the end of follow-up [VCY-overall (VCY-o)], and stratified into before [VCY-early (VCY-e)] and after [VCY-late (VCY-l)] the eighth month from starting cART, and as the ratio of VCY-l to follow-up duration (VCY-l/FUD)., Results: The risk of death increased of about 40% for higher than the median levels of VCY-o and VCY-e. Compared with subjects with permanently suppressed pVL after the eighth month from starting cART, mortality increased by 70% for those with VCY-l ≥3 log 10 copies·years/mL, and by about 20-fold for those with VCY-l/FUD ≥2.3 log 10 copies/mL. Patients who maintained low levels of VCY-l (<3 log 10 copies · years/mL) or VCY-l/FUD (<2.3 log 10 copies/mL) had a risk of death similar to patients with permanently suppressed pVL. CD4 cell count at baseline was predictive of high risk of death only in subjects with VCY-l ≥3 log 10 copies · years/mL., Conclusions: The risk of death did not increase in HIV-infected patients with low levels of VCY-l compared with patients with permanent virological suppression., (© The Author 2016. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.)

Published
2016
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37. Pediatric Tuberculosis in Italian Children: Epidemiological and Clinical Data from the Italian Register of Pediatric Tuberculosis.

Author

Galli L, Lancella L, Tersigni C, Venturini E, Chiappini E, Bergamini BM, Codifava M, Venturelli C, Tosetti G, Marabotto C, Cursi L, Boccuzzi E, Garazzino S, Tovo PA, Pinon M, Le Serre D, Castiglioni L, Lo Vecchio A, Guarino A, Bruzzese E, Losurdo G, Castagnola E, Bossi G, Marseglia GL, Esposito S, Bosis S, Grandolfo R, Fiorito V, Valentini P, Buonsenso D, Domenici R, Montesanti M, Salvini FM, Riva E, Dodi I, Maschio F, Abbagnato L, Fiumana E, Fornabaio C, Ballista P, Portelli V, Bottone G, Palladino N, Valenzise M, Vecchi B, Di Gangi M, Lupi C, Villani A, and de Martino M

Subjects
Adolescent, Ambulatory Care Facilities statistics & numerical data, Antitubercular Agents therapeutic use, Child, Child, Preschool, Female, Hospitals, Pediatric statistics & numerical data, Humans, Infant, Italy, Male, Registries statistics & numerical data, Tuberculosis, Multidrug-Resistant diagnosis, Tuberculosis, Multidrug-Resistant drug therapy, Tuberculosis, Pulmonary diagnosis, Tuberculosis, Pulmonary drug therapy, Tuberculosis, Multidrug-Resistant epidemiology, Tuberculosis, Pulmonary epidemiology
Abstract

Tuberculosis (TB) is one of the leading causes of death worldwide. Over the last decades, TB has also emerged in the pediatric population. Epidemiologic data of childhood TB are still limited and there is an urgent need of more data on very large cohorts. A multicenter study was conducted in 27 pediatric hospitals, pediatric wards, and public health centers in Italy using a standardized form, covering the period of time between 1 January 2010 and 31 December 2012. Children with active TB, latent TB, and those recently exposed to TB or recently adopted/immigrated from a high TB incidence country were enrolled. Overall, 4234 children were included; 554 (13.1%) children had active TB, 594 (14.0%) latent TB and 3086 (72.9%) were uninfected. Among children with active TB, 481 (86.8%) patients had pulmonary TB. The treatment of active TB cases was known for 96.4% (n = 534) of the cases. Overall, 210 (39.3%) out of these 534 children were treated with three and 216 (40.4%) with four first-line drugs. Second-line drugs where used in 87 (16.3%) children with active TB. Drug-resistant strains of Mycobacterium tuberculosis were reported in 39 (7%) children. Improving the surveillance of childhood TB is important for public health care workers and pediatricians. A non-negligible proportion of children had drug-resistant TB and was treated with second-line drugs, most of which are off-label in the pediatric age. Future efforts should concentrate on improving active surveillance, diagnostic tools, and the availability of antitubercular pediatric formulations, also in low-endemic countries.

Published
2016
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38. Systemic Inflammation-Based Biomarkers and Survival in HIV-Positive Subject With Solid Cancer in an Italian Multicenter Study.

Author

Raffetti E, Donato F, Pezzoli C, Digiambenedetto S, Bandera A, Di Pietro M, Di Filippo E, Maggiolo F, Sighinolfi L, Fornabaio C, Castelnuovo F, Ladisa N, Castelli F, and Quiros Roldan E

Subjects
Adult, Cohort Studies, Female, HIV Infections blood, HIV Infections pathology, Humans, Italy epidemiology, Male, Middle Aged, Neoplasms blood, Neoplasms pathology, Prognosis, Retrospective Studies, Risk Factors, Biomarkers blood, HIV Infections complications, HIV Infections mortality, Neoplasms complications, Neoplasms mortality
Abstract

Background: Recently, some systemic inflammation-based biomarkers have been demonstrated useful for predicting risk of death in patients with solid cancer independently of tumor characteristics. This study aimed to investigate the prognostic role of systemic inflammation-based biomarkers in HIV-infected patients with solid tumors and to propose a risk score for mortality in these subjects., Methods: Clinical and pathological data on solid AIDS-defining cancer (ADC) and non-AIDS-defining cancer (NADC), diagnosed between 1998 and 2012 in an Italian cohort, were analyzed. To evaluate the prognostic role of systemic inflammation- and nutrition-based markers, univariate and multivariable Cox regression models were applied. To compute the risk score equation, the patients were randomly assigned to a derivation and a validation sample., Results: A total of 573 patients (76.3% males) with a mean age of 46.2 years (SD = 10.3) were enrolled. 178 patients died during a median of 3.2 years of follow-up. For solid NADCs, elevated Glasgow Prognostic Score, modified Glasgow Prognostic Score, neutrophil/lymphocyte ratio, platelet/lymphocyte ratio, and Prognostic Nutritional Index were independently associated with risk of death; for solid ADCs, none of these markers was associated with risk of death. For solid NADCs, we computed a mortality risk score on the basis of age at cancer diagnosis, intravenous drug use, and Prognostic Nutritional Index. The areas under the receiver operating characteristic curve were 0.67 (95% confidence interval: 0.58 to 0.75) in the derivation sample and 0.66 (95% confidence interval: 0.54 to 0.79) in the validation sample., Conclusions: Inflammatory biomarkers were associated with risk of death in HIV-infected patients with solid NADCs but not with ADCs.

Published
2015
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39. Cancer incidence and mortality for all causes in HIV-infected patients over a quarter century: a multicentre cohort study.

Author

Raffetti E, Albini L, Gotti D, Segala D, Maggiolo F, di Filippo E, Saracino A, Ladisa N, Lapadula G, Fornabaio C, Castelnuovo F, Casari S, Fabbiani M, Pierotti P, Donato F, and Quiros-Roldan E

Subjects
Acquired Immunodeficiency Syndrome drug therapy, Acquired Immunodeficiency Syndrome epidemiology, Adolescent, Adult, Age Factors, Aged, Anti-Retroviral Agents therapeutic use, CD4 Lymphocyte Count, Cohort Studies, Female, HIV Infections drug therapy, Humans, Incidence, Italy epidemiology, Male, Middle Aged, Neoplasms epidemiology, Registries, Retrospective Studies, Risk Factors, Sex Factors, Substance Abuse, Intravenous epidemiology, Young Adult, HIV Infections epidemiology, Neoplasms mortality
Abstract

Background: We aimed to assess cancer incidence and mortality for all-causes and factors related to risk of death in an Italian cohort of HIV infected unselected patients as compared to the general population., Methods: We conducted a retrospective (1986-2012) cohort study on 16 268 HIV infected patients enrolled in the MASTER cohort. The standardized incidence ratios (SIRs) and standardized mortality ratios (SMRs) were computed using cancer incidence rates of Italian Cancer Registries and official national data for overall mortality. The risk factors for death from all causes were assessed using Poisson regression models., Results: 1,195 cancer cases were diagnosed from 1986 to 2012: 700 AIDS-defining-cancers (ADCs) and 495 non-AIDS-defining-cancers (NADCs). ADC incidence was much higher than the Italian population (SIR = 30.8, 95% confidence interval 27.9-34.0) whereas NADC incidence was similar to the general population (SIR = 0.9, 95% CI 0.8-1.1). The SMR for all causes was 11.6 (11.1-12.0) in the period, and it decreased over time, mainly after 1996, up to 3.53 (2.5-4.8) in 2012. Male gender, year of enrolment before 1993, older age at enrolment, intravenous drug use, low CD4 cell count, AIDS event, cancer occurrence and the absence of antiretroviral therapy were all associated independently with risk of death., Conclusions: In HIV infected patients, ADC but not NADC incidence rates were higher than the general population. Although overall mortality in HIV infected subjects decreased over time, it is about three-fold higher than the general population at present.

Published
2015
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40. Cervical human papillomavirus infection and shedding of human immunodeficiency virus in cervicovaginal fluids: a cross-sectional study.

Author

Fornabaio C, Carvalho AC, Lillo F, Fiore JR, Bergamaschi V, Bigoni S, Puzzi PR, Cristini G, Comelli M, Parisi MR, and Matteelli A

Subjects
Adult, Anti-Retroviral Agents therapeutic use, Blood virology, Cervix Uteri virology, Cross-Sectional Studies, Female, HIV Infections drug therapy, Humans, Italy, Middle Aged, Vagina virology, Viral Load, Young Adult, Body Fluids virology, HIV isolation & purification, HIV Infections complications, HIV Infections virology, Papillomavirus Infections complications, Papillomavirus Infections virology, Virus Shedding
Abstract

We evaluated the association between human papillomavirus cervical infection and HIV shedding in cervicovaginal lavage fluid (CVL), studying 89 HIV-infected women recruited at the Department of Infectious Diseases of Brescia (Italy). HIV shedding in CVL was found in a similar proportion of women with (30%; 21/70) and without (31.6%; 6/19) cervical human papillomavirus infection. A statistically significant correlation was found between HIV viral load in serum and CVL among the 27 women with detectable HIV in CVL (r = 0.4; P = 0.04). However, women on highly active antiretroviral therapy were more likely to have detectable HIV-RNA in CVL despite negative viremia (80% vs. 8%; P < 0.005).

Published
2012
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41. Differential diagnosis of cervical mycobacterial lymphadenitis in children.

Author

Carvalho AC, Codecasa L, Pinsi G, Ferrarese M, Fornabaio C, Bergamaschi V, Lacchini C, Ekema G, Stefini S, Comelli M, and Matteelli A

Subjects
Adolescent, Child, Child, Preschool, Diagnosis, Differential, Female, Humans, Infant, Italy, Lymphadenitis epidemiology, Lymphadenitis pathology, Male, Mycobacterium Infections epidemiology, Mycobacterium Infections microbiology, Mycobacterium Infections pathology, Radiography, Thoracic, Risk Factors, Lymphadenitis microbiology, Mycobacterium classification, Mycobacterium isolation & purification, Mycobacterium Infections diagnosis, Neck pathology
Abstract

Background and Aims: The differential diagnosis between tuberculosis (TB) and lymphadenitis caused by nontuberculous mycobacteria (NTM) in children is often based on epidemiologic and clinical data. The aim of this study was to identify epidemiologic and clinical variables associated with TB lymphadenitis in children attending 2 TB out-patient clinics in northern Italy during a 10-year period., Patients and Methods: All children less than 16 years of age attending the study sites suspected of mycobacterial disease from 1999 through 2008 were included in the analysis. Logistic regression was used to evaluate the variables independently associated with TB lymphadenitis., Results: From 299 children diagnosed with mycobacterial disease 121 children (40%) had a clinical diagnosis of cervical mycobacterial lymphadenitis: 38 TB (31%) and 83 NTM lymphadenitis (69%) cases. Increasing age (OR, 1.29; 95% CI, 1.02-1.69; P = 0.04), being foreign born (OR, 11.60; 95% CI, 1.37-114.20; P = 0.02), and having an abnormal chest radiograph (OR, 18.32; 95% CI, 2.37-201.68; P = 0.008) were independently associated with TB lymphadenitis. In the selected model, a 5-year-old foreign born child with cervical lymphadenitis and abnormal findings on chest radiograph has an estimated 0.90 probability of having TB disease. On the other hand, an Italy born child of the same age with cervical lymphadenitis and normal chest radiograph has a 0.04 probability of having TB., Conclusion: Epidemiologic and clinical data are useful tools in the differential diagnosis between TB and NTM lymphadenitis when etiologic diagnosis is not available.

Published
2010
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42. QuantiFERON-TB Gold In-Tube test (QFT-GIT) for the screening of latent tuberculosis in recent immigrants to Italy.

Author

Saracino A, Scotto G, Fornabaio C, Martinelli D, Faleo G, Cibelli D, Tartaglia A, Di Tullio R, Fazio V, Prato R, Monno L, and Angarano G

Subjects
Adult, Female, Humans, Italy, Latent Tuberculosis epidemiology, Male, Mycobacterium tuberculosis immunology, Skin Tests, Tuberculosis, Pulmonary diagnosis, Tuberculosis, Pulmonary epidemiology, Young Adult, Emigrants and Immigrants, Interferon-gamma blood, Latent Tuberculosis diagnosis, Mass Screening methods, Reagent Kits, Diagnostic
Abstract

To evaluate the agreement between QuantiFERON-TB Gold In-Tube test (QFT-GIT) and tuberculin skin test (TST) for the screening of latent tuberculosis infection (LTBI) in recent immigrants to Italy, 279 subjects were submitted to concomitant TST and QFT-GIT. The agreement was analyzed using k statistics. A total of 72/279 (25.8%) individuals were TST positive, while 107/279 (38.3%) were QFT-GIT positive. The overall agreement between QFT-GIT and TST was 70.9%, with k statistic of 0.35. Using different TST and QFT-GIT cut-offs, the best concordance value was obtained for QFT-GIT at > 2.64 IU/ml and TST at > 10mm (k = 0.409). Discordant results were found for 58 subjects (21%) with QFT-GIT positive/TST negative and 23 (8%) with QFT-GIT negative/TST positive. A high amount of discordance QFT-GIT+/TST- was described. QFT-GIT might increase the identification of LTBI cases among recent immigrants.

Published
2009

43. Tuberculosis and immigrants: a SIMIT (Italian Society of Infectious Diseases) clinical, epidemiological multicentric research investigation.

Author

Scotto G, Fornabaio C, Prato R, Saracino A, Tartaglia A, Di Tullio R, Carbonara S, and Angarano G

Subjects
AIDS-Related Opportunistic Infections diagnosis, AIDS-Related Opportunistic Infections epidemiology, Adolescent, Adult, Aged, Child, Child, Preschool, Female, HIV Infections complications, HIV Infections epidemiology, Hospitalization statistics & numerical data, Humans, Incidence, Infant, Italy epidemiology, Male, Middle Aged, Patient Compliance, Young Adult, Antitubercular Agents pharmacology, Antitubercular Agents therapeutic use, Drug Resistance, Bacterial, Emigrants and Immigrants statistics & numerical data, Mycobacterium classification, Mycobacterium drug effects, Mycobacterium isolation & purification, Mycobacterium tuberculosis drug effects, Mycobacterium tuberculosis isolation & purification, Tuberculosis drug therapy, Tuberculosis epidemiology, Tuberculosis microbiology, Tuberculosis physiopathology
Abstract

The aim of the study was to evaluate the epidemiology and the diagnostic, clinical and therapeutic aspects of immigrants affected by tuberculosis, hospitalized in 35 Italian Infectious Diseases Clinics during 2003. The data obtained showed that 300/2392 (12.5%) patients had active tuberculosis, 10.3% of whom had concomitant HIV infection. 53% of the patients were legal residents and were assisted by the National Health Service; 48.3% came from African regions. The mean length of residency in Italy at the time of hospitalization was 4 years. The main clinical forms were pulmonary (66%), lymph nodal (15.3%) and bone TB (5.3%). Drug resistance was demonstrated in 16% of cases with 9% cases of resistance to isoniazid, 8.2% to streptomycin, 5.1% to pyrazinamide, 2.6% to ethambutol, 2.6% to rifampicin; in 5.3% of cases a multiple resistance was demonstrated. A complete adherence to treatment was achieved in 213 patients. Statistical analysis disclosed a significant correlation between compliance with treatment and legal citizenship status. In conclusion, TB still represents an important disease among immigrants. Improved living conditions, both in countries of origin and in Italy, especially in the first few years, would certainly decrease the incidence of TB.

Published
2009

44. Peg-interferon alpha-2a versus Peg-interferon alpha-2b in nonresponders with HCV active chronic hepatitis: a pilot study.

Author

Scotto G, Fazio V, Fornabaio C, Tartaglia A, Di Tullio R, Saracino A, and Angarano G

Subjects
Adult, Antiviral Agents administration & dosage, Cohort Studies, Drug Therapy, Combination, Female, Hepacivirus drug effects, Hepacivirus immunology, Hepatitis C, Chronic immunology, Hepatitis C, Chronic virology, Humans, Interferon alpha-2, Interferon-alpha administration & dosage, Interferon-alpha immunology, Interferon-alpha toxicity, Male, Middle Aged, Pilot Projects, Polyethylene Glycols administration & dosage, Polyethylene Glycols toxicity, Recombinant Proteins, Ribavirin administration & dosage, Antiviral Agents therapeutic use, Hepatitis C, Chronic drug therapy, Interferon-alpha therapeutic use, Polyethylene Glycols therapeutic use, Ribavirin therapeutic use
Abstract

Background: The efficacy and tolerability of Peg-Interferon alpha-2a (Peg-IFNalpha-2a) versus Peg-Interferon alpha-2b (Peg-IFNalpha-2b) were compared in a patient cohort with hepatitis C virus (HCV)-related active chronic hepatitis, unresponsive to previous antiviral treatment with standard IFN (6 MU three times/week) plus ribavirin (10.6 mg/kg/day) for a period of at least 3 months., Patients and Methods: A total of 143 patients were enrolled and randomized into two treatment groups (A-B). Group A (71 patients) received one vial of Peg-IFNalpha-2a weekly (180 microg) subcutaneously whereas Group B (72 patients) received 1.5 microg/kg of Peg-IFNalpha-2b weekly subcutaneously. Interferon was combined with ribavirin (15 mg/kg/day) in both groups and all patients who demonstrated nondetectable HCV-RNA or a >or=2(log) reduction in viral load at week 12, were treated for 48 weeks, with a 24-week follow up., Results: Group A (10/71) and Group B (8/72) patients discontinued treatment due to severe side effects. At the end of therapy, HCV-RNA was undetectable in 17/71 (23.9%) Group A and in 19/72 (26.4%) of Group B patients. When terminating follow up, a sustained virological response was observed in 14/71 in Group A (19.7%) and 13/72 in Group B (18.0%)., Conclusions: Within the limits of the relatively small sample size, Peg-IFNalpha-2a and Peg-IFNalpha-2b demonstrated nonstatistically significant differences in effectiveness in patients nonresponsive to previous antiviral treatment.

Published
2008
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