Risk of SARS-CoV-2 infection in patients with hematologic diseases receiving tixagevimab/cilgavimab as pre-exposure prophylaxis in most recent Omicron sublineages era.

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  • Additional Information
    • Source:
      Publisher: Elsevier Country of Publication: Canada NLM ID: 9610933 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1878-3511 (Electronic) Linking ISSN: 12019712 NLM ISO Abbreviation: Int J Infect Dis Subsets: MEDLINE
    • Publication Information:
      Publication: Hamilton, ON : Elsevier
      Original Publication: Hamilton, ON : Decker, c1996-
    • Subject Terms:
      COVID-19*/prevention & control ; COVID-19*/epidemiology ; COVID-19*/mortality ; SARS-CoV-2* ; Pre-Exposure Prophylaxis*/methods ; Hematologic Diseases*/complications; Humans ; Male ; Female ; Middle Aged ; Aged ; Adult ; Incidence ; Antibodies, Monoclonal, Humanized/therapeutic use ; Antibodies, Monoclonal, Humanized/administration & dosage ; Hospitalization ; Antiviral Agents/therapeutic use ; Antiviral Agents/administration & dosage ; Breakthrough Infections
    • Abstract:
      Objectives: Whether pre-exposure prophylaxis (PrEP) with tixagevimab/cilgavimab 150 mg/150 mg (T/C) in individuals with hematologic disease (HD) may lead to a reduced risk of SARS-CoV-2 breakthrough infection (BTI)/hospitalization, or death in the Omicron era remains to be established.
      Methods: An observational study included participants with HD who received PrEP. BTIs were defined as SARS-CoV-2 positivity by reverse transcription-polymerase chain reaction. The incidence of BTIs (95% CI) and of BTIs/hospitalization/death was calculated using the Kaplan-Meier method and as the number of BTIs per 100 person-years of follow-up according to the circulating variant of concern (VoC). A Poisson regression model was used to evaluate the association between the rate of incidence and circulating VoCs after controlling for demographics and clinical factors.
      Results: We included 550 HD patients: 71% initiated T/C PrEP when BA.5 was the most prevalent, followed by XBB/EG, BA.2, and BA.1 (19%, 7%, and 3%, respectively). Overall, the 1-year incidence estimate of BTIs/hospitalization/death was 24% (18.7-29.4%). A greater risk of incident infections was observed when BA.5 and XBB/EG sub-lineages circulated (aRR 5.05 [2.17, 11.77]; P < .001 and 3.82 [1.50, 9.7]; P = 0.005, compared to BA.1, respectively).
      Conclusions: The 1-year incidence of SARS-CoV-2 BTIs/hospitalization/death was 24% which is in line with what was observed in other similar studies. The risk appeared to be higher when more recent Omicron sub-lineages were circulating suggesting a reduction of in vitro neutralization.
      Competing Interests: Declaration of competing interest All authors report no conflicts of interest relevant to this article.
      (Copyright © 2024 The Author(s). Published by Elsevier Ltd.. All rights reserved.)
    • Contributed Indexing:
      Keywords: COVID-19; Hematologic disease; Pre-exposure prophylaxis; SARS-CoV-2; Tixagevimab/cilgavimab
    • Accession Number:
      0 (Antibodies, Monoclonal, Humanized)
      0 (Antiviral Agents)
    • Subject Terms:
      COVID-19 breakthrough infections
    • Subject Terms:
      SARS-CoV-2 variants
    • Publication Date:
      Date Created: 20240413 Date Completed: 20240530 Latest Revision: 20240606
    • Publication Date:
      20240607
    • Accession Number:
      10.1016/j.ijid.2024.107042
    • Accession Number:
      38614231