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. 2024 Aug 1;12(8):871.
doi: 10.3390/vaccines12080871.

Tixagevimab/Cilgavimab for COVID-19 Pre-Exposure Prophylaxis in Hematologic Patients-A Tailored Approach Based on SARS-CoV-2 Vaccine Response

Krischan Braitsch  1 , Samuel D Jeske  2 , Jacob Stroh  1 , Maike Hefter  1 , Louise Platen  3 , Quirin Bachmann  3 , Lutz Renders  3 , Ulrike Protzer  2 , Katharina S Götze  1 , Peter Herhaus  1 , Mareike Verbeek  1 , Christoph D Spinner  4 , Florian Bassermann  1   5   6   7 , Marion Högner  1 , Bernhard Haller  8 , Jochen Schneider  4 , Michael Heider  1   5
Affiliations

Tixagevimab/Cilgavimab for COVID-19 Pre-Exposure Prophylaxis in Hematologic Patients-A Tailored Approach Based on SARS-CoV-2 Vaccine Response

Krischan Braitsch et al. Vaccines (Basel). .

Abstract

Patients with hematologic malignancies still face a significant risk of severe coronavirus disease 2019 (COVID-19). The severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2)-neutralizing monoclonal antibody combination tixagevimab/cilgavimab (TIX/CGB) could be administered to immunocompromised patients for pre-exposure prophylaxis (PrEP) before the emergence of TIX/CGB-resistant COVID-19 Omicron variants. TIX/CGB application could be carried out regardless of the host's immune response to previous active SARS-CoV-2 vaccinations or infections. Because the efficacy of COVID-19 PrEP remains unclear, especially in SARS-CoV-2-seropositive patients, German national guidelines recommended TIX/CGB PrEP only for SARS-CoV-2-seronegative patients in addition to an intensified active vaccination schedule. Having followed these guidelines, we now report the characteristics and outcomes of 54 recipients of TIX/CGB PrEP in SARS-CoV-2-seronegative patients with hematological disease from a German tertiary medical center and compare them to 125 seropositive patients who did not receive any PrEP. While the number of patients with B-cell lymphomas was significantly higher in the seronegative cohort (33 (61%) vs. 18 (14%) cases, p < 0.01), patients with myeloid diseases were significantly more frequent in the seropositive cohort (51 (41%) vs. 5 (9%) cases, p < 0.01). Strikingly, patients who had undergone allogeneic hematopoietic stem cell transplantation were significantly more likely (forty-nine (39%) vs. six (11%) cases, p < 0.01) to be SARS-CoV-2 seropositive. We observed that prophylactic application of TIX/CGB PrEP to a highly vulnerable group of SARS-CoV-2-seronegative patients resulted in a similar number of COVID-19 breakthrough infections compared to the untreated seropositive control group (16 (32%) vs. 39 (36%), p = 0.62) and comparable COVID-19-related outcomes like hospitalization and oxygen requirement throughout an extended follow-up period of 12 months. In conclusion, our results support the tailored approach of administering TIX/CGB PrEP only to SARS-CoV-2-seronegative patients during the COVID-19 pandemic and might provide a rationale for similar strategies during future outbreaks/diseases, especially in times of initial limited availability and/or financial constraints.

Keywords: COVID-19; PrEP; hematologic malignancy; neutralizing antibodies; tixagevimab/cilgavimab.

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Conflict of interest statement

C.D.S. reports grants and personal fees from AstraZeneca, personal fees and non-financial support from Braun Melsungen, personal fees from BioNtech, grants, personal fees and non-financial support from Gilead Sciences, grants and personal fees from Janssen-Cilag, personal fees from Eli Lilly, personal fees from Formycon, personal fees from Pfizer, personal fees from Roche, other grants from Apeiron, grants and personal fees from MSD, grants from Cepheid, personal fees from GSK, personal fees from Molecular Partners, personal fees from Pfizer, other grants from Eli Lilly, personal fees from SOBI during this study, personal fees from AbbVie, personal fees from MSD, personal fees from Synairgen, personal fees from Shionogi, and grants and personal fees from ViiV Healthcare outside the submitted work. FB reports personal fees from BMS and Janssen.

Figures

Figure A1
Figure A1
SARS-CoV-2 breakthrough infection rates in the matched groups. Kaplan–Meier curve showing infections over time during the 1-year follow-up period for each group. PrEP = pre-exposure prophylaxis.
Figure 1
Figure 1
Flow diagram of study design and patient screening process.
Figure 2
Figure 2
SARS-CoV-2 breakthrough infection rates 1 year after nAB measurement. Kaplan–Meier curve showing infections over time during the 1-year follow-up period for each group. PrEP = pre-exposure prophylaxis.
Figure 3
Figure 3
Multivariate analysis for 1-year SARS-CoV-2 breakthrough infections for all patients. Forest plot of multivariate analysis showing hazard ratios (HR) and 95% confidence intervals (CI) between breakthrough infections and indicated variables on the left. * p < 0.05.
See this image and copyright information in PMC

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