Search

Your search keyword '"Barchi E"' showing total 26 results
Start Over Author "Barchi E"
26 results on '"Barchi E"'

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. 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

3. Dolutegravir plus lamivudine versus dolutegravir plus tenofovir disoproxil fumarate and emtricitabine in antiretroviral-naive adults with HIV-1 infection (GEMINI-1 and GEMINI-2): week 48 results from two multicentre, double-blind, randomised, non-inferiority, phase 3 trials

Author

Cahn, P, Madero, J, Arribas, J, Antinori, A, Ortiz, R, Clarke, A, Hung, C, Rockstroh, J, Girard, P, Sievers, J, Man, C, Currie, A, Underwood, M, Tenorio, A, Pappa, K, Wynne, B, Fettiplace, A, Gartland, M, Aboud, M, Smith, K, Cassetti, L, David, D, Figueras, L, Losso, M, Lopardo, G, Lupo, S, Porteiro, N, Sanchez, M, Bloch, M, Cooper, D, Finlayson, R, Kelleher, A, Koh, K, Lewis, D, Mcmahon, J, Moore, R, Roth, N, Shields, M, De Wit, S, Florence, E, Goffard, J, Demeester, R, Lacor, P, Vandercam, B, Vandekerckhove, L, Angel, J, Baril, J, Conway, B, De Pokomandy, A, Szabo, J, Walmsley, S, Bouchaud, O, Chidiac, C, Delobel, P, Goujard, C, Katlama, C, Molina, J, Pialoux, G, Philibert, P, Bogner, J, Esser, S, Krznaric, I, Lehmann, C, Spinner, C, Stellbrink, H, Stephan, C, Stoehr, A, Barchi, E, Caramello, P, Castelli, F, Cattelan, A, D'Arminio Monforte, A, Di Biagio, A, Di Perri, G, Gori, A, Maggiolo, F, Menzaghi, B, Migliorino, G, Mussini, C, Penco, G, Puoti, M, Rizzardini, G, Gulminetti, R, Lazzarin, A, Quirino, T, Sighinolfi, L, Viale, P, Amaya Tapia, G, Andrade Villanueva, J, Granados Reyes, E, Perez Rios, A, Santoscoy Gomez, M, Den Hollander, J, Rijnders, B, Hidalgo, J, Hercilla Vasquez, L, Illescas, L, Olczak, A, Mansinho, K, Correia Pacheco, P, Teofilo, E, Saraiva da Cunha, J, Sarmento e Castro, R, Serrao, R, Arbune, M, Jianu, C, Oprea, A, Preotescu, L, Prisacariu, L, Belonosova, E, Borodkina, O, Chernova, O, Gankina, N, Kizhlo, S, Kulagin, V, Kurina, N, Nagimova, F, Pokrovsky, V, Ryamova, E, Voronin, E, Yakovlev, A, Kaplan, R, Lee, S, Kim, S, Kim, W, Antela Lopez, A, Casado Osorio, J, Castano Carracedo, M, De Los Santos Gil, I, Estrada Perez, V, Falco Ferrer, V, Force, L, Galinda Puerto, M, Garcia Deltoro, M, Gatell, J, Goenaga Sanchez, M, Gonzalez Cordon, A, Knobel, H, Lopez Bernaldo de Quiros, J, Losa Garcia, J, Masia, M, Montero-Alsonso, M, Ocampo Hermida, A, Pasquau Liano, J, Portilla Sogorb, J, Pulido Ortega, F, Rivera Roman, A, Santos Fernandez, J, Torres Perea, R, Troya Garcia, J, Viciana Fernandez, P, Calmy, A, Hauser, C, Fehr, J, Cheng, S, Ko, W, Lin, H, Lu, P, Tseng, Y, Wang, N, Wong, W, Yang, C, Arduino, R, Benson, P, Berhe, M, Bredeek, F, Brinson, C, Campbell, T, Crofoot, G, Cunningham, D, Dejesus, E, Dretler, R, Eron, J, Fife, K, Fichtenbaum, C, Flamm, J, Goldstein, D, Gupta, S, Hagins, D, Hoffman-Terry, M, Jayaweera, D, Kinder, C, Klein, D, Mcdonald, C, Mills, A, Nahass, R, Osiyemi, O, Overton, E, Parks, D, Prelutsky, D, Ramgopal, M, Schrader, S, Sha, B, Simon, G, Sims, J, Skiest, D, Slim, J, Tashima, K, Thedinger, B, Gazzard, B, Fox, J, Johnson, M, Kegg, S, Khoo, S, Mazhude, C, Orkin, C, Schembri, G, Ustianowski, A, Cahn P., Madero J. S., Arribas J. R., Antinori A., Ortiz R., Clarke A. E., Hung C. -C., Rockstroh J. K., Girard P. -M., Sievers J., Man C., Currie A., Underwood M., Tenorio A. R., Pappa K., Wynne B., Fettiplace A., Gartland M., Aboud M., Smith K., Cassetti L., David D., Figueras L., Losso M., Lopardo G., Lupo S., Porteiro N., Sanchez M., Bloch M., Cooper D., Finlayson R., Kelleher A., Koh K., Lewis D., McMahon J., Moore R., Roth N., Shields M., De Wit S., Florence E., Goffard J. -C., Demeester R., Lacor P., Vandercam B., Vandekerckhove L., Angel J., Baril J. -G., Conway B., De Pokomandy A., Szabo J., Walmsley S., Bouchaud O., Chidiac C., Delobel P., Goujard C., Katlama C., Molina J. -M., Pialoux G., Philibert P., Bogner J., Esser S., Krznaric I., Lehmann C., Spinner C., Stellbrink H. -J., Stephan C., Stoehr A., Barchi E., Caramello P., Castelli F., Cattelan A. M., D'Arminio Monforte A., Di Biagio A., Di Perri G., Gori A., Maggiolo F., Menzaghi B., Migliorino G., Mussini C., Penco G., Puoti M., Rizzardini G., Gulminetti R., Lazzarin A., Quirino T., Sighinolfi L., Viale P., Amaya Tapia G., Andrade Villanueva J., Granados Reyes E. R., Perez Rios A., Santoscoy Gomez M., Den Hollander J., Rijnders B., Hidalgo J. A., Hercilla Vasquez L., Illescas L., Olczak A., Mansinho K., Correia Pacheco P. P., Teofilo E., Saraiva da Cunha J., Sarmento e Castro R., Serrao R., Arbune M., Jianu C., Oprea A., Preotescu L., Prisacariu L. -J., Belonosova E., Borodkina O., Chernova O., Gankina N., Kizhlo S., Kulagin V., Kurina N., Nagimova F., Pokrovsky V., Ryamova E., Voronin E., Yakovlev A., Kaplan R., Lee S. H., Kim S. -W., Kim S. -I., Kim W. J., Antela Lopez A., Casado Osorio J. L., Castano Carracedo M. A., De Los Santos Gil I., Estrada Perez V., Falco Ferrer V., Force L., Galinda Puerto M. J., Garcia Deltoro M., Gatell J. M., Goenaga Sanchez M. A., Gonzalez Cordon A., Knobel H., Lopez Bernaldo de Quiros J. C., Losa Garcia J. E., Masia M., Montero-Alsonso M., Ocampo Hermida A., Pasquau Liano J., Portilla Sogorb J., Pulido Ortega F., Rivera Roman A., Santos Fernandez J. R., Torres Perea R., Troya Garcia J., Viciana Fernandez P., Calmy A., Hauser C., Fehr J., Cheng S. -H., Ko W. -C., Lin H. -H., Lu P. -L., Tseng Y. -T., Wang N. -C., Wong W. -W., Yang C. -J., Arduino R., Benson P., Berhe M., Bredeek F., Brinson C., Campbell T., Crofoot G., Cunningham D., DeJesus E., Dretler R., Eron J., Fife K., Fichtenbaum C., Flamm J., Goldstein D., Gupta S., Hagins D., Hoffman-Terry M., Jayaweera D., Kinder C., Klein D., McDonald C., Mills A., Nahass R., Osiyemi O., Overton E., Parks D., Prelutsky D., Ramgopal M., Schrader S., Sha B., Simon G., Sims J., Skiest D., Slim J., Tashima K., Thedinger B., Gazzard B., Fox J., Johnson M., Kegg S., Khoo S., Mazhude C., Orkin C., Schembri G., Ustianowski A., Cahn, P, Madero, J, Arribas, J, Antinori, A, Ortiz, R, Clarke, A, Hung, C, Rockstroh, J, Girard, P, Sievers, J, Man, C, Currie, A, Underwood, M, Tenorio, A, Pappa, K, Wynne, B, Fettiplace, A, Gartland, M, Aboud, M, Smith, K, Cassetti, L, David, D, Figueras, L, Losso, M, Lopardo, G, Lupo, S, Porteiro, N, Sanchez, M, Bloch, M, Cooper, D, Finlayson, R, Kelleher, A, Koh, K, Lewis, D, Mcmahon, J, Moore, R, Roth, N, Shields, M, De Wit, S, Florence, E, Goffard, J, Demeester, R, Lacor, P, Vandercam, B, Vandekerckhove, L, Angel, J, Baril, J, Conway, B, De Pokomandy, A, Szabo, J, Walmsley, S, Bouchaud, O, Chidiac, C, Delobel, P, Goujard, C, Katlama, C, Molina, J, Pialoux, G, Philibert, P, Bogner, J, Esser, S, Krznaric, I, Lehmann, C, Spinner, C, Stellbrink, H, Stephan, C, Stoehr, A, Barchi, E, Caramello, P, Castelli, F, Cattelan, A, D'Arminio Monforte, A, Di Biagio, A, Di Perri, G, Gori, A, Maggiolo, F, Menzaghi, B, Migliorino, G, Mussini, C, Penco, G, Puoti, M, Rizzardini, G, Gulminetti, R, Lazzarin, A, Quirino, T, Sighinolfi, L, Viale, P, Amaya Tapia, G, Andrade Villanueva, J, Granados Reyes, E, Perez Rios, A, Santoscoy Gomez, M, Den Hollander, J, Rijnders, B, Hidalgo, J, Hercilla Vasquez, L, Illescas, L, Olczak, A, Mansinho, K, Correia Pacheco, P, Teofilo, E, Saraiva da Cunha, J, Sarmento e Castro, R, Serrao, R, Arbune, M, Jianu, C, Oprea, A, Preotescu, L, Prisacariu, L, Belonosova, E, Borodkina, O, Chernova, O, Gankina, N, Kizhlo, S, Kulagin, V, Kurina, N, Nagimova, F, Pokrovsky, V, Ryamova, E, Voronin, E, Yakovlev, A, Kaplan, R, Lee, S, Kim, S, Kim, W, Antela Lopez, A, Casado Osorio, J, Castano Carracedo, M, De Los Santos Gil, I, Estrada Perez, V, Falco Ferrer, V, Force, L, Galinda Puerto, M, Garcia Deltoro, M, Gatell, J, Goenaga Sanchez, M, Gonzalez Cordon, A, Knobel, H, Lopez Bernaldo de Quiros, J, Losa Garcia, J, Masia, M, Montero-Alsonso, M, Ocampo Hermida, A, Pasquau Liano, J, Portilla Sogorb, J, Pulido Ortega, F, Rivera Roman, A, Santos Fernandez, J, Torres Perea, R, Troya Garcia, J, Viciana Fernandez, P, Calmy, A, Hauser, C, Fehr, J, Cheng, S, Ko, W, Lin, H, Lu, P, Tseng, Y, Wang, N, Wong, W, Yang, C, Arduino, R, Benson, P, Berhe, M, Bredeek, F, Brinson, C, Campbell, T, Crofoot, G, Cunningham, D, Dejesus, E, Dretler, R, Eron, J, Fife, K, Fichtenbaum, C, Flamm, J, Goldstein, D, Gupta, S, Hagins, D, Hoffman-Terry, M, Jayaweera, D, Kinder, C, Klein, D, Mcdonald, C, Mills, A, Nahass, R, Osiyemi, O, Overton, E, Parks, D, Prelutsky, D, Ramgopal, M, Schrader, S, Sha, B, Simon, G, Sims, J, Skiest, D, Slim, J, Tashima, K, Thedinger, B, Gazzard, B, Fox, J, Johnson, M, Kegg, S, Khoo, S, Mazhude, C, Orkin, C, Schembri, G, Ustianowski, A, Cahn P., Madero J. S., Arribas J. R., Antinori A., Ortiz R., Clarke A. E., Hung C. -C., Rockstroh J. K., Girard P. -M., Sievers J., Man C., Currie A., Underwood M., Tenorio A. R., Pappa K., Wynne B., Fettiplace A., Gartland M., Aboud M., Smith K., Cassetti L., David D., Figueras L., Losso M., Lopardo G., Lupo S., Porteiro N., Sanchez M., Bloch M., Cooper D., Finlayson R., Kelleher A., Koh K., Lewis D., McMahon J., Moore R., Roth N., Shields M., De Wit S., Florence E., Goffard J. -C., Demeester R., Lacor P., Vandercam B., Vandekerckhove L., Angel J., Baril J. -G., Conway B., De Pokomandy A., Szabo J., Walmsley S., Bouchaud O., Chidiac C., Delobel P., Goujard C., Katlama C., Molina J. -M., Pialoux G., Philibert P., Bogner J., Esser S., Krznaric I., Lehmann C., Spinner C., Stellbrink H. -J., Stephan C., Stoehr A., Barchi E., Caramello P., Castelli F., Cattelan A. M., D'Arminio Monforte A., Di Biagio A., Di Perri G., Gori A., Maggiolo F., Menzaghi B., Migliorino G., Mussini C., Penco G., Puoti M., Rizzardini G., Gulminetti R., Lazzarin A., Quirino T., Sighinolfi L., Viale P., Amaya Tapia G., Andrade Villanueva J., Granados Reyes E. R., Perez Rios A., Santoscoy Gomez M., Den Hollander J., Rijnders B., Hidalgo J. A., Hercilla Vasquez L., Illescas L., Olczak A., Mansinho K., Correia Pacheco P. P., Teofilo E., Saraiva da Cunha J., Sarmento e Castro R., Serrao R., Arbune M., Jianu C., Oprea A., Preotescu L., Prisacariu L. -J., Belonosova E., Borodkina O., Chernova O., Gankina N., Kizhlo S., Kulagin V., Kurina N., Nagimova F., Pokrovsky V., Ryamova E., Voronin E., Yakovlev A., Kaplan R., Lee S. H., Kim S. -W., Kim S. -I., Kim W. J., Antela Lopez A., Casado Osorio J. L., Castano Carracedo M. A., De Los Santos Gil I., Estrada Perez V., Falco Ferrer V., Force L., Galinda Puerto M. J., Garcia Deltoro M., Gatell J. M., Goenaga Sanchez M. A., Gonzalez Cordon A., Knobel H., Lopez Bernaldo de Quiros J. C., Losa Garcia J. E., Masia M., Montero-Alsonso M., Ocampo Hermida A., Pasquau Liano J., Portilla Sogorb J., Pulido Ortega F., Rivera Roman A., Santos Fernandez J. R., Torres Perea R., Troya Garcia J., Viciana Fernandez P., Calmy A., Hauser C., Fehr J., Cheng S. -H., Ko W. -C., Lin H. -H., Lu P. -L., Tseng Y. -T., Wang N. -C., Wong W. -W., Yang C. -J., Arduino R., Benson P., Berhe M., Bredeek F., Brinson C., Campbell T., Crofoot G., Cunningham D., DeJesus E., Dretler R., Eron J., Fife K., Fichtenbaum C., Flamm J., Goldstein D., Gupta S., Hagins D., Hoffman-Terry M., Jayaweera D., Kinder C., Klein D., McDonald C., Mills A., Nahass R., Osiyemi O., Overton E., Parks D., Prelutsky D., Ramgopal M., Schrader S., Sha B., Simon G., Sims J., Skiest D., Slim J., Tashima K., Thedinger B., Gazzard B., Fox J., Johnson M., Kegg S., Khoo S., Mazhude C., Orkin C., Schembri G., and Ustianowski A.

Abstract

Background: Effective two-drug regimens could decrease long-term drug exposure and toxicity with HIV-1 antiretroviral therapy (ART). We therefore aimed to evaluate the efficacy and safety of a two-drug regimen compared with a three-drug regimen for the treatment of HIV-1 infection in ART-naive adults. Methods: We conducted two identically designed, multicentre, double-blind, randomised, non-inferiority, phase 3 trials: GEMINI-1 and GEMINI-2. Both studies were done at 192 centres in 21 countries. We included participants (≥18 years) with HIV-1 infection and a screening HIV-1 RNA of 500 000 copies per mL or less, and who were naive to ART. We randomly assigned participants (1:1) to receive a once-daily two-drug regimen of dolutegravir (50 mg) plus lamivudine (300 mg) or a once-daily three-drug regimen of dolutegravir (50 mg) plus tenofovir disoproxil fumarate (300 mg) and emtricitabine (200 mg). Both drug regimens were administered orally. We masked participants and investigators to treatment assignment: dolutegravir was administered as single-entity tablets (similar to its commercial formulation, except with a different film colour), and lamivudine tablets and tenofovir disoproxil fumarate and emtricitabine tablets were over-encapsulated to visually match each other. Primary endpoint was the proportion of participants with HIV-1 RNA of less than 50 copies per mL at week 48 in the intention-to-treat-exposed population, using the Snapshot algorithm and a non-inferiority margin of −10%. Safety analyses were done on the safety population. GEMINI-1 and GEMINI-2 are registered with ClinicalTrials.gov, numbers NCT02831673 and NCT02831764, respectively. Findings: Between July 18, 2016, and March 31, 2017, 1441 participants across both studies were randomly assigned to receive either the two-drug regimen (n=719) or three-drug regimen (n=722). At week 48 in the GEMINI-1 intention-to-treat-exposed population, 320 (90%) of 356 participants receiving the two-drug regimen and 332

Published
2019

5. 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

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

Author

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

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

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

Published
2007

7. Conflicting interpretations of the prevalence of mutations associated with drug resistance in antiviral na{\'i}ve HIV-1 patients with acute and chronic infection

Author

M. C., Re, Monari, P., Bon, I., Borderi, M., Chiodo, F., Alberici, F., Sacchini, D., Arlotti, M., Mori, F., Cancellieri, C., Allegrini, F., Mastroianni, A., Esposito, R., Guaraldi, G., Ferrari, C., Sacchelli, L., Gibellini, D., Gorini, R., Schiavone, P., Furlini, G., Ghinelli, F., Sighinolfi, L., Gritti, F., Dentale, N., Magnani, G., Barchi, E., Stagno, A., Brighi, S., Zauli, T., Catania, A., RE MC, MONARI P, BON I, Borderi M, and CHIODO F

Subjects
Adult, Male, Microbiology (medical), Anti-HIV Agents, HIV Infections, Drug resistance, Biology, Cohort Studies, drug-resistance, HIV Protease, Drug Resistance, Viral, Genotype, drug-resistance, HIV-1, interpretation, Prevalence, Humans, Pharmacology (medical), Seroconversion, Genotyping, interpretation, Genotyping assay, HIV-1 naïve, Virtual phenotype, Sequence Analysis, DNA, General Medicine, biology.organism_classification, Virology, HIV Reverse Transcriptase, Reverse transcriptase, Chronic infection, Infectious Diseases, Amino Acid Substitution, Acute Disease, Chronic Disease, Lentivirus, Immunology, HIV-1, Female, Reagent Kits, Diagnostic, Viral disease
Abstract

The routine determination of drug resistance in newly HIV-1 infected individuals records a potential increase in transmissions of drug-resistant variants. Plasma samples from 38 individuals classified as newly infected (seroconversion time

Published
2004

8. CD4-Guided treatment interruptions: a new possibile therapeutic strategy

Author

Mussini, Cristina, Cozzi Lepri, A., Borghi, V., D’Arminio Monforte, A., De Luca, A., Sighinolfi, L., Ortolani, P., Barchi, E., Guaraldi, Giovanni, Bedini, A., Bratt, G., Erikson, L., Antinori, A., Cossarizza, Andrea, and Esposito, Roberto

Subjects
antiretroviral therapy, HIV, CD4 cell
Published
2003

9. Dolutegravir plus lamivudine versus dolutegravir plus tenofovir disoproxil fumarate and emtricitabine in antiretroviral-naive adults with HIV-1 infection (GEMINI-1 and GEMINI-2): week 48 results from two multicentre, double-blind, randomised, non-inferiority, phase 3 trials

Author

Pedro Cahn, Juan Sierra Madero, José Ramón Arribas, Andrea Antinori, Roberto Ortiz, Amanda E Clarke, Chien-Ching Hung, Jürgen K Rockstroh, Pierre-Marie Girard, Jörg Sievers, Choy Man, Alexander Currie, Mark Underwood, Allan R Tenorio, Keith Pappa, Brian Wynne, Anna Fettiplace, Martin Gartland, Michael Aboud, Kimberly Smith, Lidia Cassetti, Daniel David, Laura Figueras, Marcelo Losso, Gustavo Lopardo, Sergio Lupo, Norma Porteiro, Marisa Sánchez, Mark Bloch, David Cooper, Robert Finlayson, Anthony Kelleher, Kenneth Koh, David Lewis, James McMahon, Richard Moore, Norman Roth, Matthew Shields, Stephane De Wit, Eric Florence, Jean-Christophe Goffard, Remy Demeester, Patrick Lacor, Bernard Vandercam, Linos Vandekerckhove, Jonathan Angel, Jean-Guy Baril, Brian Conway, Alexandra De Pokomandy, Jason Szabo, Sharon Walmsley, Olivier Bouchaud, Christian Chidiac, Pierre Delobel, Cecile Goujard, Christine Katlama, Jean-Michel Molina, Gilles Pialoux, Patrick Philibert, Johannes Bogner, Stefan Esser, Ivanka Krznaric, Clara Lehmann, Christoph Spinner, Hans-Jurgen Stellbrink, Christoph Stephan, Albrecht Stoehr, Enrico Barchi, Pietro Caramello, Francesco Castelli, Anna Maria Cattelan, Antonella D'Arminio Monforte, Antonio Di Biagio, Giovanni Di Perri, Andrea Gori, Franco Maggiolo, Barbara Menzaghi, Guglielmo Migliorino, Cristina Mussini, Giovanni Penco, Massimo Puoti, Giuliano Rizzardini, Roberto Gulminetti, Adriano Lazzarin, Tiziano Quirino, Laura Sighinolfi, Pierluigi Viale, Gerardo Amaya Tapia, Jaime Andrade Villanueva, Enrique R Granados Reyes, Alma Perez Rios, Mario Santoscoy Gomez, Jan Den Hollander, Bart Rijnders, José A Hidalgo, Luis Hercilla Vasquez, Luis Illescas, Anita Olczak, Kamal Mansinho, Patricia Paula Correia Pacheco, Eugénio Teófilo, Jose Saraiva da Cunha, Rui Sarmento e Castro, Rosário Serrão, Manuela Arbune, Cristian Jianu, Anca Oprea, Liliana Preotescu, Liviu-Jany Prisacariu, Elena Belonosova, Olga Borodkina, Oxana Chernova, Natalia Gankina, Svetlana Kizhlo, Valeriy Kulagin, Nadezhda Kurina, Firaya Nagimova, Vadim Pokrovsky, Elena Ryamova, Evgeny Voronin, Alexey Yakovlev, Richard Kaplan, Sun Hee Lee, Shin-Woo Kim, Sang-Il Kim, Woo Joo Kim, Antonio Antela Lopez, Jose L Casado Osorio, Manuel A Castaño Carracedo, Ignacio De Los Santos Gil, Vicente Estrada Perez, Vicenç Falco Ferrer, Luis Force, Maria Jose Galinda Puerto, Miguel Garcia Deltoro, Josep M Gatell, Miguel A Goenaga Sanchez, Ana González Cordón, Hernando Knobel, Juan Carlos Lopez Bernaldo de Quiros, Juan E Losa Garcia, Mar Masia, Marta Montero-Alsonso, Antonio Ocampo Hermida, Juan Pasquau Liaño, Joaquin Portilla Sogorb, Federico Pulido Ortega, Antonio Rivera Roman, Jose Ramon Santos Fernandez, Rafael Torres Perea, Jesus Troya Garcia, Pompeyo Viciana Fernandez, Alexandra Calmy, Christoph Hauser, Jan Fehr, Shu-Hsing Cheng, Wen-Chien Ko, Hsi-Hsun Lin, Po-Liang Lu, Yu-Ting Tseng, Ning-Chi Wang, Wing-Wai Wong, Chia-Jui Yang, Roberto Arduino, Paul Benson, Mezgebe Berhe, Fritz Bredeek, Cynthia Brinson, Thomas Campbell, Gordon Crofoot, Douglas Cunningham, Edwin DeJesus, Robin Dretler, Joseph Eron, Kenneth Fife, Carl Fichtenbaum, Jason Flamm, Deborah Goldstein, Samir Gupta, Debbie Hagins, Margaret Hoffman-Terry, Dushyantha Jayaweera, Clifford Kinder, Daniel Klein, Cheryl McDonald, Anthony Mills, Ronald Nahass, Olayemi Osiyemi, Edgar Overton, David Parks, David Prelutsky, Moti Ramgopal, Shannon Schrader, Beverly Sha, Gary Simon, James Sims, Daniel Skiest, Jihad Slim, Karen Tashima, Blair Thedinger, Brian Gazzard, Julie Fox, Margaret Johnson, Stephen Kegg, Saye Khoo, Charles Mazhude, Chloe Orkin, Gabriel Schembri, Andrew Ustianowski, Clinical sciences, Microbiology and Infection Control, Internal Medicine, Cahn, P, Madero, J, Arribas, J, Antinori, A, Ortiz, R, Clarke, A, Hung, C, Rockstroh, J, Girard, P, Sievers, J, Man, C, Currie, A, Underwood, M, Tenorio, A, Pappa, K, Wynne, B, Fettiplace, A, Gartland, M, Aboud, M, Smith, K, Cassetti, L, David, D, Figueras, L, Losso, M, Lopardo, G, Lupo, S, Porteiro, N, Sanchez, M, Bloch, M, Cooper, D, Finlayson, R, Kelleher, A, Koh, K, Lewis, D, Mcmahon, J, Moore, R, Roth, N, Shields, M, De Wit, S, Florence, E, Goffard, J, Demeester, R, Lacor, P, Vandercam, B, Vandekerckhove, L, Angel, J, Baril, J, Conway, B, De Pokomandy, A, Szabo, J, Walmsley, S, Bouchaud, O, Chidiac, C, Delobel, P, Goujard, C, Katlama, C, Molina, J, Pialoux, G, Philibert, P, Bogner, J, Esser, S, Krznaric, I, Lehmann, C, Spinner, C, Stellbrink, H, Stephan, C, Stoehr, A, Barchi, E, Caramello, P, Castelli, F, Cattelan, A, D'Arminio Monforte, A, Di Biagio, A, Di Perri, G, Gori, A, Maggiolo, F, Menzaghi, B, Migliorino, G, Mussini, C, Penco, G, Puoti, M, Rizzardini, G, Gulminetti, R, Lazzarin, A, Quirino, T, Sighinolfi, L, Viale, P, Amaya Tapia, G, Andrade Villanueva, J, Granados Reyes, E, Perez Rios, A, Santoscoy Gomez, M, Den Hollander, J, Rijnders, B, Hidalgo, J, Hercilla Vasquez, L, Illescas, L, Olczak, A, Mansinho, K, Correia Pacheco, P, Teofilo, E, Saraiva da Cunha, J, Sarmento e Castro, R, Serrao, R, Arbune, M, Jianu, C, Oprea, A, Preotescu, L, Prisacariu, L, Belonosova, E, Borodkina, O, Chernova, O, Gankina, N, Kizhlo, S, Kulagin, V, Kurina, N, Nagimova, F, Pokrovsky, V, Ryamova, E, Voronin, E, Yakovlev, A, Kaplan, R, Lee, S, Kim, S, Kim, W, Antela Lopez, A, Casado Osorio, J, Castano Carracedo, M, De Los Santos Gil, I, Estrada Perez, V, Falco Ferrer, V, Force, L, Galinda Puerto, M, Garcia Deltoro, M, Gatell, J, Goenaga Sanchez, M, Gonzalez Cordon, A, Knobel, H, Lopez Bernaldo de Quiros, J, Losa Garcia, J, Masia, M, Montero-Alsonso, M, Ocampo Hermida, A, Pasquau Liano, J, Portilla Sogorb, J, Pulido Ortega, F, Rivera Roman, A, Santos Fernandez, J, Torres Perea, R, Troya Garcia, J, Viciana Fernandez, P, Calmy, A, Hauser, C, Fehr, J, Cheng, S, Ko, W, Lin, H, Lu, P, Tseng, Y, Wang, N, Wong, W, Yang, C, Arduino, R, Benson, P, Berhe, M, Bredeek, F, Brinson, C, Campbell, T, Crofoot, G, Cunningham, D, Dejesus, E, Dretler, R, Eron, J, Fife, K, Fichtenbaum, C, Flamm, J, Goldstein, D, Gupta, S, Hagins, D, Hoffman-Terry, M, Jayaweera, D, Kinder, C, Klein, D, Mcdonald, C, Mills, A, Nahass, R, Osiyemi, O, Overton, E, Parks, D, Prelutsky, D, Ramgopal, M, Schrader, S, Sha, B, Simon, G, Sims, J, Skiest, D, Slim, J, Tashima, K, Thedinger, B, Gazzard, B, Fox, J, Johnson, M, Kegg, S, Khoo, S, Mazhude, C, Orkin, C, Schembri, G, and Ustianowski, A

Subjects
Male, HIV Dolutegravir, HIV Infections, 030204 cardiovascular system & hematology, Piperazines, chemistry.chemical_compound, 0302 clinical medicine, Abacavir, Heterocyclic Compounds, Emtricitabine, 030212 general & internal medicine, Viral, Tenofovir/adverse effects, Lamivudine/adverse effects, Medicine(all), education.field_of_study, Adult, Anti-HIV Agents, Anti-Retroviral Agents, Double-Blind Method, Drug Therapy, Combination, Female, HIV-1, Heterocyclic Compounds, 3-Ring, Humans, Lamivudine, Middle Aged, RNA, Viral, Tenofovir, Viral Load, Heterocyclic Compounds, 3-Ring/adverse effects, General Medicine, Emtricitabine/adverse effects, Tolerability, Dolutegravir, Combination, medicine.drug, medicine.medical_specialty, Pyridones, Population, HIV Infections/drug therapy, Anti-Retroviral Agents/adverse effects, 3-Ring, 03 medical and health sciences, Drug Therapy, SDG 3 - Good Health and Well-being, Internal medicine, Oxazines, medicine, HIV-1/isolation & purification, RNA, Viral/blood, education, business.industry, Viral Load/drug effects, Regimen, chemistry, RNA, Anti-HIV Agents/adverse effects, Ritonavir, business
Abstract

Summary Background Effective two-drug regimens could decrease long-term drug exposure and toxicity with HIV-1 antiretroviral therapy (ART). We therefore aimed to evaluate the efficacy and safety of a two-drug regimen compared with a three-drug regimen for the treatment of HIV-1 infection in ART-naive adults. Methods We conducted two identically designed, multicentre, double-blind, randomised, non-inferiority, phase 3 trials: GEMINI-1 and GEMINI-2. Both studies were done at 192 centres in 21 countries. We included participants (≥18 years) with HIV-1 infection and a screening HIV-1 RNA of 500 000 copies per mL or less, and who were naive to ART. We randomly assigned participants (1:1) to receive a once-daily two-drug regimen of dolutegravir (50 mg) plus lamivudine (300 mg) or a once-daily three-drug regimen of dolutegravir (50 mg) plus tenofovir disoproxil fumarate (300 mg) and emtricitabine (200 mg). Both drug regimens were administered orally. We masked participants and investigators to treatment assignment: dolutegravir was administered as single-entity tablets (similar to its commercial formulation, except with a different film colour), and lamivudine tablets and tenofovir disoproxil fumarate and emtricitabine tablets were over-encapsulated to visually match each other. Primary endpoint was the proportion of participants with HIV-1 RNA of less than 50 copies per mL at week 48 in the intention-to-treat-exposed population, using the Snapshot algorithm and a non-inferiority margin of −10%. Safety analyses were done on the safety population. GEMINI-1 and GEMINI-2 are registered with ClinicalTrials.gov, numbers NCT02831673 and NCT02831764, respectively. Findings Between July 18, 2016, and March 31, 2017, 1441 participants across both studies were randomly assigned to receive either the two-drug regimen (n=719) or three-drug regimen (n=722). At week 48 in the GEMINI-1 intention-to-treat-exposed population, 320 (90%) of 356 participants receiving the two-drug regimen and 332 (93%) of 358 receiving the three-drug regimen achieved plasma HIV-1 RNA of less than 50 copies per mL (adjusted treatment difference −2·6%, 95% CI −6·7 to 1·5); in GEMINI-2, 335 (93%) of 360 in the two-drug regimen and 337 (94%) of 359 in the three-drug regimen achieved HIV-1 RNA of less than 50 copies per mL (adjusted treatment difference −0·7%, 95% CI −4·3 to 2·9), showing non-inferiority at a −10% margin in both studies (pooled analysis: 655 [91%] of 716 in the two-drug regimen vs 669 [93%] of 717 in the three-drug regimen; adjusted treatment difference −1·7%, 95% CI −4·4 to 1·1). Numerically, more drug-related adverse events occurred with the three-drug regimen than with the two-drug regimen (169 [24%] of 717 vs 126 [18%] of 716); few participants discontinued because of adverse events (16 [2%] in the three-drug regimen and 15 [2%] in the two-drug regimen). Two deaths were reported in the two-drug regimen group of GEMINI-2, but neither was considered to be related to the study medication. Interpretation The non-inferior efficacy and similar tolerability profile of dolutegravir plus lamivudine to a guideline-recommended three-drug regimen at 48 weeks in ART-naive adults supports its use as initial therapy for patients with HIV-1 infection. Funding ViiV Healthcare.

Published
2019

10. Chemical inhibition of the integrated stress response impairs the ubiquitin-proteasome system.

Author

Xu S, Gierisch ME, Barchi E, Poser I, Alberti S, Salomons FA, and Dantuma NP

Subjects
Humans, Ribosomes metabolism, Ribosomes drug effects, Proteasome Inhibitors pharmacology, Proteolysis drug effects, Puromycin pharmacology, Cytosol metabolism, HeLa Cells, Acetamides, Cyclohexylamines, Proteasome Endopeptidase Complex metabolism, Ubiquitin metabolism, Stress, Physiological drug effects
Abstract

Inhibitors of the integrated stress response (ISR) have been used to explore the potential beneficial effects of reducing the activation of this pathway in diseases. As the ISR is in essence a protective response, there is, however, a risk that inhibition may compromise the cell's ability to restore protein homeostasis. Here, we show that the experimental compound ISRIB impairs degradation of proteins by the ubiquitin-proteasome system (UPS) during proteotoxic stress in the cytosolic, but not nuclear, compartment. Accumulation of a UPS reporter substrate that is intercepted by ribosome quality control was comparable to the level observed after blocking the UPS with a proteasome inhibitor. Consistent with impairment of the cytosolic UPS, ISRIB treatment caused an accumulation of polyubiquitylated and detergent insoluble defective ribosome products (DRiPs) in the presence of puromycin. Our data suggest that the persistent protein translation during proteotoxic stress in the absence of a functional ISR increases the pool of DRiPs, thereby hindering the efficient clearance of cytosolic substrates by the UPS., (© 2024. The Author(s).)

Published
2024
Full Text
View/download PDF

11. "The Spirit Thickened": Making the Case for Dance in the Medical Humanities.

Author

Shevzov-Zebrun N, Barchi E, and Grogan K

Subjects
Curriculum, Humanities, Humans, Philosophy, Education, Medical, Education, Medical, Undergraduate, Medicine
Abstract

In comparison to other art forms, dance remains underrepresented in the medical humanities, especially within the academic medical setting. Several factors, including perceived lack of applicability to patient care, contribute to this pattern. This paper contends that, to the contrary, learners across the medical education spectrum stand to gain much from engaging with the movement arts, including improvement of clinically-relevant skills such as physical self-awareness, observation, communication, and mindfulness. This paper makes the case for the nascent subdiscipline of Movement and Medicine, developed by the authors and piloted for inclusion in medical humanities curricula within a medical education context. Movement and Medicine employs a dance-inspired pedagogy to a) promote awareness of personal movement and embodiment tendencies and b) harness that awareness to gain more profound, sensory insight into the embodied experiences of others-experiences of health, illness, or otherwise. This work outlines the research, rationale, and philosophy behind Movement and Medicine; concretely defines the subdiscipline and situates it within the medical humanities landscape; proposes practical approaches to engaging with and applying this material; and describes a Movement and Medicine course developed for one American medical school.

Published
2020
Full Text
View/download PDF

12. Unlikely SuspectPeroneus Tertius Tear in a Professional Ballet Dancer.

Author

Barchi E and Rose D

Subjects
Adult, Female, Humans, Treatment Outcome, Ankle Injuries diagnosis, Ankle Injuries physiopathology, Ankle Injuries surgery, Ankle Joint diagnostic imaging, Ankle Joint physiopathology, Conservative Treatment methods, Dancing injuries, Debridement methods, Range of Motion, Articular, Tendinopathy diagnosis, Tendinopathy etiology, Tendinopathy therapy
Abstract

Peroneus tertius tendon tears are uncommon and patients typically recover with conservative management. The objec-tive of this case report is to highlight this usual injury and provide an alternative treatment option when conserva-tive management fails. A 24-year-old female professional ballet dancer presented with acute right lateral foot pain after hyperflexing over her pointe shoe. She completed a full course of physical therapy and non-steroidal anti-inflammatory drugs. However, upon returning to dance, she developed worsening pain and swelling over the lateral ankle. Magnetic resonance imaging revealed a complete peroneus tertius tear with retraction. She underwent surgi-cal debridement of this tendon and was able to return to dancing en pointe in 9 weeks.

Published
2020

13. A prospective randomized trial on abacavir/lamivudine plus darunavir/ritonavir or raltegravir in HIV-positive drug-naïve patients with CD4<200 cells/uL (the PRADAR study).

Author

Mussini C, Roncaglia E, Borghi V, Rusconi S, Nozza S, Cattelan AM, Segala D, Bonfanti P, Di Biagio A, Barchi E, Focà E, Degli Antoni A, Bonora S, Francisci D, Limonta S, Antinori A, D'Ettorre G, and Maggiolo F

Subjects
Adult, Anti-HIV Agents administration & dosage, CD4 Lymphocyte Count, Darunavir administration & dosage, Delayed Diagnosis, Dideoxynucleosides administration & dosage, Female, Humans, Lamivudine administration & dosage, Male, Middle Aged, Raltegravir Potassium administration & dosage, Ritonavir administration & dosage, Anti-HIV Agents therapeutic use, Darunavir therapeutic use, Dideoxynucleosides therapeutic use, HIV Infections drug therapy, Lamivudine therapeutic use, Raltegravir Potassium therapeutic use, Ritonavir therapeutic use
Abstract

Background: Very few data are available on treatment in HIV Late presenter population that still represents a clinical challenge., Methods: Prospective, multicenter, randomized open-label, 2 arm, phase-3 trial comparing the 48-week virological response of two different regimens: abacavir/lamivudine + darunavir/r vs abacavir/lamivudine + raltegravir in antiretroviral naive with CD4+ counts < 200/mm3 and a viral load (VL)<500,000 copies/mL. The primary Endpoint was the proportion of patients with undetectable viremia (VL<50 copies/mL) after 48 weeks. The planned sample size for this trial was 350 patients., Results: In 3 years, 53 patients were screened and 46 enrolled: 22 randomized to raltegravir and 24 to darunavir/r; 7 patients were excluded, 4 because of a VL >500,000 copies/mL and 3 for HLAB5701 positivity. The snapshot analysis at 48 weeks showed a virologic success of 77.3% in raltegravir and 66.7% in darunavir/r. Time to starting treatment was 34.5 days in raltegravir and 53 days in darunavir/r. At the as treated analysis, the median CD4 counts at 48 weeks was 297 cells/μL in raltegravir and 239 cells/μL in darunavir/r. No difference in total cholesterol, while triglycerides were higher in the darunavir/r arm. No statistical analyses were performed due to the low number of patients enrolled., Conclusions: Late presenter patients are frequent but very difficult to enroll in clinical trials, especially in western countries. These regimens and the conditions of many patients could not allow the test and treat strategy. The rate of virologic success was higher than 65% in both arms with a median CD4 cell count >200/μL at week 48., Trial Registration: EUDRACT number: 2011-005973-21., Competing Interests: We received unrestricted financial support for the study from the Companies: ViiV Healthcare, Merck Sharp and Dohme Corp and Janssen, but this does not alter our adherence to PLOS ONE policies on sharing data and materials.

Published
2019
Full Text
View/download PDF

14. Simplification to dual-therapy containing lamivudine and darunavir/ritonavir or atazanavir/ritonavir in HIV-infected patients on virologically suppressive antiretroviral therapy.

Author

Calza L, Cafaggi M, Colangeli V, Borderi M, Barchi E, Lanzafame M, Nicole' S, Degli Antoni AM, Bon I, Re MC, and Viale P

Subjects
Adult, Anti-HIV Agents administration & dosage, Atazanavir Sulfate administration & dosage, Atazanavir Sulfate therapeutic use, CD4 Lymphocyte Count, Cohort Studies, Darunavir administration & dosage, Darunavir therapeutic use, Female, HIV Infections virology, HIV-1 drug effects, Humans, Lamivudine administration & dosage, Lamivudine therapeutic use, Male, Middle Aged, Retrospective Studies, Reverse Transcriptase Inhibitors administration & dosage, Ritonavir administration & dosage, Ritonavir therapeutic use, Anti-HIV Agents therapeutic use, Antiretroviral Therapy, Highly Active methods, Drug Therapy, Combination methods, HIV Infections drug therapy, Reverse Transcriptase Inhibitors therapeutic use, Viral Load drug effects
Abstract

Background: The ritonavir-boosted protease inhibitor (PI/r)-based dual regimens are warranted in order to optimize the combination antiretroviral therapy (cART), prevent the long-term toxicity and reduce the cost of treatments., Methods: We performed an observational, retrospective study of HIV-infected patients on suppressive antiretroviral therapy who switched to a dual regimen containing lamivudine (3TC) plus darunavir/ritonavir (DRV/r) 800/100 mg qd or atazanavir/ritonavir (ATV/r) 300/100 mg qd., Results: As a whole, 122 well-treated patients (mean age, 45.2 years; mean CD4 T + lymphocyte count, 589 cells/mm 3 ; mean duration of current cART, 3.1 years) were enrolled. Current antiretroviral regimen included tenofovir/emtricitabine in 91 subjects, abacavir/lamivudine in 25, lopinavir/r in 41, DRV/r in 38 and ATV/r in 33. Baseline mean estimated glomerular filtration rate (eGFR) was 94.2 mL/min/1.73 m 2 , and proteinuria was detected in 46 subjects (38%). Overall 70 subjects switched to 3TC + DRV/r (group A) and 52 to 3TC + ATV/r (group B). After 12 months, 65 patients (92.8%) in group A and 46 (88.4%) in group B showed HIV RNA <20 copies/mL. A significant and comparable increase in eGFR was observed in group A and B (+3.8 and +3.1 mL/min/1.73 m 2 , respectively), such as a significant decrease in prevalence of proteinuria. A significantly greater increase in total bilirubin concentration was reported in group B than in group A., Conclusion: In our study, simplification to a dual therapy containing 3TC + DRV/r or ATV/r in virologically suppressed patients was effective and showed a good tolerability profile.

Published
2018
Full Text
View/download PDF

15. STAM protocol in dementia: a multicenter, single-blind, randomized, and controlled trial.

Author

Ceccato E, Vigato G, Bonetto C, Bevilacqua A, Pizziolo P, Crociani S, Zanfretta E, Pollini L, Caneva PA, Baldin L, Frongillo C, Signorini A, Demoro S, and Barchi E

Subjects
Activities of Daily Living, Aged, Aged, 80 and over, Attention, Dementia complications, Female, Humans, Male, Memory Disorders etiology, Memory Disorders rehabilitation, Neuropsychological Tests, Single-Blind Method, Treatment Outcome, Dementia rehabilitation, Music Therapy methods
Abstract

Background: The Sound Training for Attention and Memory in Dementia (STAM-Dem) is a manualized music-based protocol designed to be used in the rehabilitation of cognitive functions in elderly patients with dementia (PWD)., Method: This was a multicenter, single-blind, randomized, and controlled trial that involved 51 PWD. The objective was to test the STAM-Dem efficacy. Patients in the experimental group followed the STAM-Dem for 2 weekly sessions of 45 minutes for 12 weeks (in addition to standard care). Those in the control group continued with the normal "standard care" provided., Results: In the experimental group, the instruments immediate prose memory test (MPI), deferred prose memory test (MPD), attentional matrices, activities of daily living, Music Therapy Activity Scale (SVAM) and Geriatric Music Therapy Profile (GMP) increase significantly from pre to post-test (P < .05)., Conclusion: The protocol is feasible and data suggest that there was an effect on attentino (matrices) and prose memory skills (MPI and MPD). The effect size reveals a general improvement in the results of the experimental group.

Published
2012
Full Text
View/download PDF

16. Pandemic (H1N1) 2009 and HIV co-infection.

Author

Barchi E, Prati F, Parmeggiani M, and Tanzi ML

Subjects
HIV Infections diagnosis, HIV Infections virology, Humans, Influenza, Human diagnosis, Influenza, Human virology, Male, Middle Aged, Pandemics, RNA, Viral analysis, Reverse Transcriptase Polymerase Chain Reaction, HIV Infections complications, HIV-1 genetics, Influenza A Virus, H1N1 Subtype genetics, Influenza, Human complications
Published
2010
Full Text
View/download PDF

17. CD4 cell-monitored treatment interruption in patients with a CD4 cell count > 500 x 106 cells/l.

Author

Mussini C, Bedini A, Borghi V, Guaraldi G, Esposito R, Barchi E, Enilia R, Cozzi-Lepri A, Philips AN, Ortolani P, Bratt G, Eriksson LE, Sighinolfi L, Cossarizza A, d'Arminio Monforte A, De Luca A, Di Giambenedetto S, and Antinori A

Subjects
Adult, Antiretroviral Therapy, Highly Active, Cholesterol blood, Disease Progression, Drug Administration Schedule, Female, HIV Infections blood, Humans, Male, Middle Aged, Prospective Studies, Risk Assessment, Triglycerides blood, Viral Load, Anti-HIV Agents administration & dosage, CD4 Lymphocyte Count, HIV Infections drug therapy, HIV Infections immunology, HIV-1
Abstract

Background: Little is known about CD4 cell count changes in patients with high CD4 cell counts who interrupt antiretroviral therapy, especially in those with a nadir of 250-350 x 10 cells/l., Methods: Data derived from 139 patients from seven prospective cohorts who had > 12 months highly active antiretroviral therapy (HAART), CD4 cell count nadir of > 250 x 10 cells/l and at pre-interruption of > 500 x 10 cells/l. Endpoint was time to CD4 cell count < 350 x 10 cells/l or reinitiation of treatment., Results: At interruption, the median CD4 cell count was 800 x 10 cells/l, median viral load was 1.7 log10 copies/ml. At the time of analysis, 63 (45.3%) had resumed therapy or experienced < 350 x 10 cells/l CD4 cells over a median interruption of 75 weeks. Of these, 33 (52.4%) experienced a decline to < 350 x 10 cells/l and 30 (47.6%) restarted therapy before their CD4 cell count had fallen below this level. In 43 patients with CD4 cell nadir of 251-350 x 10 cells/l, median time to therapy resumption or CD4 cell count < 350 x 10 cells/l was 61 weeks. Higher CD4 cell count nadir, longer duration of viral load suppression on therapy, and higher viral load level at interruption were independently associated with longer time to restart therapy. The risk of clinical events was 5 per 1000 person-years of follow-up., Conclusions: Patients who started therapy with CD4 cell count of 250-350 x 10 cells/l and who later interrupted therapy appear able to remain off therapy with a CD4 cell count > 350 x 10 cells/l for a substantial period of time.

Published
2005

18. Nonnucleoside reverse transcriptase inhibitor-containing regimens are associated with increased satisfaction with sexual life.

Author

Murri R, Fantoni M, Del Borgo C, Longo B, Deiana G, Visonà R, Zambelli A, Barchi E, Orchi N, Bosco O, and Wu AW

Subjects
Follow-Up Studies, HIV Infections psychology, Humans, Italy, Quality of Life, Reverse Transcriptase Inhibitors chemistry, Substance Abuse, Intravenous epidemiology, HIV Infections drug therapy, Patient Satisfaction, Reverse Transcriptase Inhibitors therapeutic use, Sexual Behavior
Published
2003
Full Text
View/download PDF

19. Intravenous drug use, relationship with providers, and stage of HIV disease influence the prescription rates of protease inhibitors.

Author

Murri R, Fantoni M, Del Borgo C, Izzi I, Visonà R, Suter F, Banfi MC, Barchi E, Orchi N, Bosco O, and Wu AW

Subjects
Adult, Cohort Studies, Cross-Sectional Studies, Female, Humans, Male, Anti-HIV Agents therapeutic use, Drug Prescriptions, HIV Infections drug therapy, HIV Protease Inhibitors therapeutic use, Physician-Patient Relations, Substance Abuse, Intravenous
Abstract

Objective: To assess rates of prescriptions of protease inhibitors (PI) and determinants of not being prescribed PIs in a cohort of HIV-infected people eligible (according to published guidelines) for highly active antiretroviral therapy (HAART)., Design: Cross-sectional survey., Methods: A total of 684 patients with CD4+ counts <500 cells/microl were enrolled from seven Italian HIV treatment centers from October 1997 to April 1998. A questionnaire on health-related quality of life (MOS-HIV) and patient ratings of the quality of care was administered. Sociodemographic variables, HIV disease-related factors, and prescribed antiretroviral therapy were also recorded., Results: 61% of those enrolled were prescribed PI (median, 7.5 months). In addition, 75% of patients had previously received antiretroviral therapy. Fewer than 1% were prescribed nonnucleoside reverse transcriptase inhibitors (NNRTIs). Using multivariable logistic regression considering those with CD4+ counts <500 cells/microl, patients reporting the least information received (odds ratio [OR], 1.78; 95% confidence interval [CI], 1.23-2.58), injecting drug users (IDUs; OR, 1.73; 95% CI, 1.18-2.54), people with CD4+ counts >200 cells/microl (OR, 1.76; 95% CI, 1.19-2.61), and patients with early stage disease (OR, 2.24; 95% CI, 1.73-2.90) were less likely to have be prescribed PIs., Conclusions: Of patients eligible for HAART, only 61% were prescribed PIs. People who wanted more information, IDUs, and patients in earlier disease stages are significantly less likely to be prescribed PIs. Access to HAART remains a critical issue in the management of HIV disease.

Published
1999
Full Text
View/download PDF

20. Combination of a drug targeting the cell with a drug targeting the virus controls human immunodeficiency virus type 1 resistance.

Author

Lori F, Malykh AG, Foli A, Maserati R, De Antoni A, Minoli L, Padrini D, Degli Antoni A, Barchi E, Jessen H, Wainberg MA, Gallo RC, and Lisziewicz J

Subjects
Acquired Immunodeficiency Syndrome blood, Anti-HIV Agents therapeutic use, CD4 Lymphocyte Count, Didanosine therapeutic use, Dose-Response Relationship, Drug, Evaluation Studies as Topic, HIV-1 genetics, Humans, Hydroxyurea administration & dosage, Hydroxyurea therapeutic use, Leukocytes, Mononuclear drug effects, Leukocytes, Mononuclear virology, Time Factors, Viremia drug therapy, Viremia metabolism, Virus Replication drug effects, Acquired Immunodeficiency Syndrome drug therapy, Cells drug effects, Cells virology, Drug Therapy, Combination, HIV-1 drug effects
Abstract

Combinations of drugs targeting viral proteins have been used to limit or control drug resistance, which is the most important cause of treatment failure in HIV-1-infected individuals. We suggest an alternative approach, namely to target cellular proteins, which are less prone to mutations than viral proteins. Here we show that simultaneous inhibition of a cellular protein (by hydroxyurea) and a viral protein (by ddI) produces a consistent and sustained suppression of HIV-1 for as long as 40 weeks in the absence of virus rebound. We identified the mechanism to explain this lack of rebound: although the combination of the two drugs did not prevent the emergence of mutant viral strains resistant to didanosine (ddI) in these patients, the mutants were still sensitive to standard doses of ddI in the presence of hydroxyurea. These in vivo results were consistent with our in vitro observations: HIV-1 molecular clones resistant to ddI were rendered sensitive to this drug (at concentrations routinely achievable in vivo) after addition of hydroxyurea. This phenomenon can be explained by the observation that hydroxyurea decreases the level of dATP, the cellular competitor of ddI. A low level of dATP favors the incorporation of ddI, even if the viral reverse transcriptase is resistant to this nucleoside analog. This is a novel mechanism of control of resistance and it explains the efficacy of a treatment that is well tolerated, simple, and inexpensive.

Published
1997
Full Text
View/download PDF

21. Pulmonary deposition of aerosolised pentamidine using a new nebuliser: efficiency measurements in vitro and in vivo.

Author

Ferretti PP, Versari A, Gafà SI, Becquemin MH, Barchi E, Serafini D, Roy M, Salvo D, and Bouchikhi A

Subjects
Administration, Inhalation, Adult, Female, Humans, In Vitro Techniques, Lung diagnostic imaging, Male, Models, Structural, Pentamidine pharmacokinetics, Pneumonia, Pneumocystis prevention & control, Radionuclide Imaging, Technetium Tc 99m Aggregated Albumin, Lung metabolism, Nebulizers and Vaporizers, Pentamidine administration & dosage
Abstract

The therapeutic efficacy of nebulised pentamidine in the prophylaxis of Pneumocystis carinii pneumonia (PCP) depends on the absolute pulmonary deposition of the drug. We studied the performance of a new nebuliser (Pentasave) by comparison both in vitro and in vivo with a standard nebuliser (Respirgard II). In vitro, deposition of pentamidine labelled with technetium-99m human serum albumin was measured indirectly by capturing inhaled particles on an absolute filter and measuring radioactivity with a gamma camera. The nebulisers were initially assessed with a pentamidine dose of 100 mg in 5 ml at 44 psi and an air flow of 10 l/min for Respirgard II and 16 l/min for Pentasave. Nebuliser output, expressed as the percentage of the initial nebuliser radioactivity captured by the inhalation filter, was 15% +/- 2% (mean +/- SD) for Respirgard II, and significantly increased to 23% +/- 3% for an initial version and to 33% +/- 2% for the final version of Pentasave. Measurements with a gamma camera in a group of ten patients with human immunodeficiency virus infection were made in vivo. The results revealed that pulmonary drug distributions are good using both Respirgard II and Pentasave. The literature reports that once-monthly pulmonary deposition of 9 mg pentamidine seems enough to produce prophylactic effects against Pneumocystis carinii. We measured pulmonary pentamidine deposition of 20.22 +/- 4.31 mg (mean +/- SD) using Respirgard II (with 300 mg in 5 ml) and of 16.00 +/- 7.18 mg using Pentasave (with 150 mg in 6 ml). These findings show that the therapeutic dose of pentamidine (9 mg) was widely exceeded with both nebulisers. Further investigations might demonstrate that about 200 mg and 125 mg pentamidine for Respirgard II and Pentasave, respectively, will achieve a pulmonary deposition of therapeutic dose, allowing significant savings in terms of drug and expense.

Published
1994
Full Text
View/download PDF

22. Enhancement of erythrocytic adenosine deaminase following treatment of AIDS-related complex/AIDS patients with zidovudine.

Author

Casoli C, Magnani G, Schianchi C, Barchi E, and Bertazzoni U

Subjects
AIDS-Related Complex enzymology, Acquired Immunodeficiency Syndrome enzymology, Adult, Anemia chemically induced, Erythrocytes drug effects, Humans, Zidovudine adverse effects, AIDS-Related Complex drug therapy, Acquired Immunodeficiency Syndrome drug therapy, Adenosine Deaminase blood, Erythrocytes enzymology, HIV-1 drug effects, Zidovudine therapeutic use
Abstract

The levels of adenosine deaminase (ADA) were determined in the erythrocytes of 10 patients with sexually transmitted HIV-1 infection [five cases with AIDS-related complex (ARC) and five with AIDS] before and after therapy with zidovudine (azidothymidine; AZT). A linear increase in ADA activity was observed during the second and third months of zidovudine treatment, with a final increase of about threefold after 3 months of drug administration. The concentration of adenosine triphosphate (ATP) was significantly lower in the erythrocytes of the same group of patients with respect to healthy controls, and a further decrease was noted after 3 months of zidovudine treatment. The results obtained indicate that treatment of ARC/AIDS subjects with zidovudine induces metabolic changes which could be responsible for the development of anaemia, an adverse effect frequently associated with zidovudine therapy.

Published
1990
Full Text
View/download PDF

Catalog

Books, media, physical & digital resources
See catalog results