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Pre-exposure prophylaxis with tixagevimab/cilgavimab for coronavirus disease 2019 (COVID-19) during the Omicron BA.5 wave at a single institution in Japan

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Abstract

Pre-exposure prophylaxis with tixagevimab/cilgavimab was considered a useful strategy to protect immunocompromised patients from COVID-19 based on the phase 3 PROVENT trial conducted between November 2020 and March 2021. However, after late 2021, the dominant substrains of COVID-19 changed to Omicron substrains, which showed resistance to tixagevimab/cilgavimab. Therefore, it is important to re-evaluate the real-world efficacy of tixagevimab/cilgavimab for the prevention of COVID-19 in the Omicron era. To this end, we retrospectively evaluated the efficacy and safety of tixagevimab/cilgavimab prophylaxis for COVID-19 during the Omicron BA.5 wave in Japan. A total of 240 consecutive patients with hematologic malignancies received tixagevimab/cilgavimab at our institution from October 18, 2022, to January 31, 2023. Among them, the cumulative incidence of COVID-19 at 90 days was 6.4%. A total of 10/14 (71.4%) had mild infection, and 4/14 (28.5%) had severe infection. No patient died due to COVID-19. Adverse events consisted of deep vein thrombosis in 2 patients. Our analysis indicated that pre-exposure prophylaxis with tixagevimab/cilgavimab might have clinical effectiveness in reducing the severity of COVID-19 in Japanese HM patients, even in the Omicron BA.5 surge. It also suggested that tixagevimab/cilgavimab may be associated with cardiovascular complications.

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Acknowledgements

The authors are grateful to the contributions of all internal medicine outpatient nurses, seventh west floor nurses, and the Pharmaceutical Department at the University of Yamanashi Hospital.

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Authors and Affiliations

  1. Department of Hematology and Oncology, University of Yamanashi, 1110, Shimokato, Chuo-City, Yamanashi-Ken, 409-3898, Japan

    Ichiro Kawashima, Hideto Hyuga, Ayato Nakadate, Minori Matsuura, Yuma Sakamoto, Jun Suzuki, Takuma Kumagai, Megumi Suzuki, Megumi Koshiishi, Takeo Yamamoto, Kei Nakajima, Masaru Tanaka & Keita Kirito

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  1. Ichiro Kawashima
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  2. Hideto Hyuga
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  3. Ayato Nakadate
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  4. Minori Matsuura
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  6. Jun Suzuki
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  7. Takuma Kumagai
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  8. Megumi Suzuki
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  11. Kei Nakajima
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  12. Masaru Tanaka
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  13. Keita Kirito
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Contributions

IK and KK designed the study, collected data, analyzed data, and wrote the manuscript. HH, AN, MM, YS, TK, MS, MK, TY, and MT performed patient care and collected data.

Corresponding author

Correspondence to Keita Kirito.

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Conflict of interest

KK received lecture fees from Takeda Pharmaceutical Company.

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Kawashima, I., Hyuga, H., Nakadate, A. et al. Pre-exposure prophylaxis with tixagevimab/cilgavimab for coronavirus disease 2019 (COVID-19) during the Omicron BA.5 wave at a single institution in Japan. Int J Hematol 118, 731–736 (2023). https://doi.org/10.1007/s12185-023-03663-2

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  • DOI: https://doi.org/10.1007/s12185-023-03663-2

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