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Real world use of Tixagevimab/Cilgavimab pre-exposure prophylaxis of COVID-19 in immunocompromised individuals: data from the OCTOPUS study.
  • +30
  • Alessandra Vergori,
  • Giulia Matusali,
  • Eleonora Cimini,
  • Licia Bordi,
  • Paola Borrelli,
  • Simone Lanini,
  • Roberta Palazzi,
  • Jessica Paulicelli,
  • Davide Mariotti,
  • Valentina Mazzotta,
  • Stefania Notari,
  • R. Casetti,
  • Massimo Francalancia,
  • Silvia Rosati,
  • Alessandra D’Abramo,
  • Cosmina Mija,
  • Paola Mencarini,
  • Eugenia Milozzi,
  • Caraffa E,
  • Simona Sica,
  • Elisabetta Metafuni,
  • Federica Sorà,
  • Angela Rago,
  • Agostina Siniscalchi,
  • Elisabetta Abruzzese,
  • Mariagrazia Garzia,
  • Giovanni Luzi,
  • Roberta Battistini,
  • Luca Prosperini,
  • Antonella Cingolani,
  • Enrico Girardi,
  • Fabrizio Maggi,
  • Andrea Antinori
Alessandra Vergori
Istituto Nazionale Malattie Infettive Lazzaro Spallanzani

Corresponding Author:alessandra.vergori@inmi.it

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Giulia Matusali
Istituto Nazionale Malattie Infettive Lazzaro Spallanzani
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Eleonora Cimini
Istituto Nazionale Malattie Infettive Lazzaro Spallanzani
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Licia Bordi
Istituto Nazionale Malattie Infettive Lazzaro Spallanzani
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Paola Borrelli
Universita degli Studi Gabriele d'Annunzio Chieti Pescara Dipartimento di Scienze Mediche Orali e Biotecnologiche
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Simone Lanini
Istituto Nazionale Malattie Infettive Lazzaro Spallanzani
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Roberta Palazzi
Istituto Nazionale Malattie Infettive Lazzaro Spallanzani
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Jessica Paulicelli
Istituto Nazionale Malattie Infettive Lazzaro Spallanzani
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Davide Mariotti
Istituto Nazionale Malattie Infettive Lazzaro Spallanzani
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Valentina Mazzotta
Istituto Nazionale Malattie Infettive Lazzaro Spallanzani
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Stefania Notari
Istituto Nazionale Malattie Infettive Lazzaro Spallanzani
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R. Casetti
Istituto Nazionale Malattie Infettive Lazzaro Spallanzani
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Massimo Francalancia
Istituto Nazionale Malattie Infettive Lazzaro Spallanzani
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Silvia Rosati
Istituto Nazionale Malattie Infettive Lazzaro Spallanzani
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Alessandra D’Abramo
Istituto Nazionale Malattie Infettive Lazzaro Spallanzani
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Cosmina Mija
Istituto Nazionale Malattie Infettive Lazzaro Spallanzani
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Paola Mencarini
Istituto Nazionale Malattie Infettive Lazzaro Spallanzani
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Eugenia Milozzi
Istituto Nazionale Malattie Infettive Lazzaro Spallanzani
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Caraffa E
Istituto Nazionale Malattie Infettive Lazzaro Spallanzani
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Simona Sica
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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Elisabetta Metafuni
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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Federica Sorà
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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Angela Rago
Presidio Ospedaliero San Filippo Neri
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Agostina Siniscalchi
Presidio Ospedaliero San Filippo Neri
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Elisabetta Abruzzese
Ospedale Sant'Eugenio
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Mariagrazia Garzia
Azienda Ospedaliera San Camillo Forlanini
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Giovanni Luzi
Azienda Ospedaliera San Camillo Forlanini
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Roberta Battistini
Azienda Ospedaliera San Camillo Forlanini
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Luca Prosperini
Azienda Ospedaliera San Camillo Forlanini
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Antonella Cingolani
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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Enrico Girardi
Istituto Nazionale Malattie Infettive Lazzaro Spallanzani
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Fabrizio Maggi
Istituto Nazionale Malattie Infettive Lazzaro Spallanzani
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Andrea Antinori
Istituto Nazionale Malattie Infettive Lazzaro Spallanzani
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Abstract

We report real world use over time in immunocompromised subjects receiving tixagevimab/cilgavimab (T/C) pre-exposure prophylaxis (PrEP). Observational study on participants receiving T/C PrEP stratified: never had COVID-19 (NoC), hybrids (H) and breakthrough infections (BTIs) if COVID-19 before or after PrEP, respectively. Anti-RBD IgG and BA.5 neutralizing antibodies (nAbs), mucosal IgG, T-cell immunity at the administration of T/C (T0), 3 (T1), 6 (T2), and 9 (T3) months after, were measured. Comparison of markers in each group across timepoints, Poisson regression model for BTIs incidence rate ratios were performed. N=231 participants: median age 63 years (IQR 54.0-73.0), 84% hematological disease, median vaccine dose of three. N=72 NoC, 103 H and 56 (24%) BTIs, mostly mild/moderate, IR 4.2 (95%CI 3.2-5.4) BTIs/100 patients-months, no factors associated with. A significant increase of anti-RBD IgG at T1 was observed in all the groups, with a decline at T2. GMTs of anti-BA.5 nAbs were low at T1 for all the groups and around/below the cut off. No changes of IFN-γ. Overall, a mucosal response was observed at T1. An incidence of 24% of mild/moderate BTIs was observed. Anti-RBD IgG levels persistence was ensured, BA.5 nAbs were low/undetectable, cellular T immunity remained stable.