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

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, F. MaggioloL. Calza, E. Focà, G. Cenderello, S. Rusconi, C. Mussini, A. Antinori, R. Gagliardini, S. Bonora, M. Ferrara, M. Santoro, A. Galli, E. Carini, A. Bigoloni, M. Tavio, L. Butini, A. Giacometti, E. Vaccher, F. Martellotta, V. Da Ros, A. Saracino, F. Balena, L. Comi, E. DI Filippo, D. Valenti, C. Suardi, B. Mazzola, P. Viale, E.R. Del Turco, M.V. Ramirez, F. Castelli, A. Celotti, F. Brognoli, G. Bonoldi, B. Menzaghi, C. Abeli, M. Farinazzo, F. Ortu, M. Campus, B. Cacopardo, M. Celesia, A. Pan, A. Bartoloni, F. Rinaldi, S. Giachè, B. Pierluigi, F. Vichi, T. Santantonio, S. Ferrara, S.R. Bruno, G. Cassola, F. Marcello, F. Calautti, M. Bassetti, B. Bruzzone, S. Artioli, A. Lazzarin, 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, 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. 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, C. Carcieri, M. Malena, B. Padovani, R. Luzzati, S. Centonze, R. Valentinotti

Research output: Contribution to journalArticlepeer-review

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. © 2020 The Author(s) 2020. Published by Oxford University Press on behalf of Infectious Diseases Society of America.
Original languageEnglish
JournalOpen Forum Infect. Dis.
Volume7
Issue number11
DOIs
Publication statusPublished - 2020

Keywords

  • 4-class drug resistance
  • AIDS-defining event
  • cancer
  • death
  • non-AIDS-defining event
  • nonnucleoside reverse transcriptase inhibitor
  • acute lymphoblastic leukemia
  • adult
  • antiretroviral therapy
  • Article
  • bacterial pneumonia
  • CD4 lymphocyte count
  • chronic kidney failure
  • cohort analysis
  • disease burden
  • disease registry
  • female
  • follow up
  • Hepatitis C virus
  • human
  • Human immunodeficiency virus infected patient
  • incidence
  • male
  • middle aged
  • multidrug resistance
  • observational study
  • Pneumocystis jiroveci
  • prospective study
  • virus load
  • virus resistance

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