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.

Burden of Disease in PWH Harboring a Multidrug-Resistant Virus: Data from the PRESTIGIO Registry / L. Galli, M.R. Parisi, A. Poli, M. Menozzi, M. Fiscon, E. Garlassi, D. Francisci, A. DI Biagio, G. Sterrantino, C. Fornabaio, A. Degli Antoni, G. Angarano, F.M. Fusco, A. D'Arminio Monforte, G.M. Corbelli, M.M. Santoro, M. Zazzi, A. Castagna, N. Gianotti, L. Galli, F. Maggiolo, L. Calza, E. Foca, G. Sterrantino, G. Cenderello, S. Rusconi, C. Mussini, M. Menozzi, A. Antinori, R. Gagliardini, S. Bonora, M. Ferrara, M. Zazzi, M. Santoro, G.M. Corbelli, M. Zazzi, M.M. Santoro, A. Galli, E. Carini, M.R. Parisi, L. Galli, A. Poli, A. Bigoloni, M. Tavio, L. Butini, A. Giacometti, E. Vaccher, F. Martellotta, V. Da Ros, G. Angarano, A. Saracino, F. Balena, F. Maggiolo, L. Comi, E. DI Filippo, D. Valenti, C. Suardi, B. Mazzola, P. Viale, L. Calza, E.R. Del Turco, M.V. Ramirez, F. Castelli, E. Foca, A. Celotti, F. Brognoli, G. Bonoldi, B. Menzaghi, C. Abeli, M. Farinazzo, F. Ortu, M. Campus, B. Cacopardo, M. Celesia, A. Pan, C. Fornabaio, A. Bartoloni, G. Sterrantino, F. Rinaldi, S. Giache, B. Pierluigi, F. Vichi, F.M. Fusco, T. Santantonio, S. Ferrara, S.R. Bruno, G. Cassola, G. Cenderello, F. Marcello, F. Calautti, M. Bassetti, B. Bruzzone, S. Artioli, A. Lazzarin, A. Castagna, E. Carini, M.R. Parisi, L. Galli, A. Poli, A. Galli, D. Canetti, M. Galli, T. Formenti, V. Morena, A. Gabrieli, L. Gazzola, E. Merlini, V. Minieri, A. Gori, A. Bandera, V. Pastore, V. Ferroni, M. Puoti, C. Moioli, S. Vassalli, M. Menozzi, R. Enrica, N. Giulia, B. Beghetto, E. Manzillo, A. Franco, A.M. Cattelan, S. Marinello, S. Cavinato, A. MacArio, A. Cascio, G. Mazzola, A.M.D. Antoni, C. Ferrari, D. Laccabue, G. Filice, R. Gulminetti, L. Pagnucco, A. Asti, E. Frsdi, E. Schiaroli, C. Papalini, F. Italiani, M. DI Pietro, G. Magnani, G. Elisa, E. Barchi, R. Corsini, A. Vergori, S. Cicalini, G. Onnelli, A. Giannetti, R. Cauda, A. Ciccullo, S. La Monica, V. Vullo, G. Dettorre, E.N. Cavallari, M. Andreoni, V. Malagnino, L. Ceccarelli, F. Viviani, L. Sasset, C. Dentone, B. Rossetti, S. Modica, V. Borgo, G. DI Perri, S. Bonora, M. Ferrara, C. Carcieri, M. Malena, M. Fiscon, B. Padovani, R. Luzzati, S. Centonze, R. Valentinotti. - In: OPEN FORUM INFECTIOUS DISEASES. - ISSN 2328-8957. - 7:11(2020 Nov), pp. ofaa456.1-ofaa456.8. [10.1093/ofid/ofaa456]

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

A. D'Arminio Monforte
Membro del Collaboration Group
;
S. Rusconi;S. Bonora
Membro del Collaboration Group
;
E. Carini
Membro del Collaboration Group
;
V. Da Ros
Membro del Collaboration Group
;
C. Suardi
Membro del Collaboration Group
;
B. Menzaghi
Membro del Collaboration Group
;
A. Lazzarin
Membro del Collaboration Group
;
E. Carini
Membro del Collaboration Group
;
L. Gazzola
Membro del Collaboration Group
;
A. Gori
Membro del Collaboration Group
;
A. Bandera
Membro del Collaboration Group
;
G. Mazzola
Membro del Collaboration Group
;
S. Centonze
Membro del Collaboration Group
;
2020

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.
4-class drug resistance; AIDS-defining event; cancer; death; non-AIDS-defining event;
Settore MED/17 - Malattie Infettive
nov-2020
Article (author)
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2434/898576
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