Effectiveness of Tixagevimab/cilgavimab for SARS-CoV-2 Pre‑exposure Prophylaxis in Hemodialysis Patients: A Retrospective Cohort Study from a Tertiary Hospital in Thailand
Abstract
Objectives: To evaluate the effectiveness and safety of Tixagevimab/cilgavimab as pre-exposure prophylaxis against coronavirus disease 2019 (COVID-19) in patients with end-stage kidney disease (ESKD) undergoing hemodialysis during the Omicron surge.
Material and Methods: This retrospective cohort study was conducted at Trang Hospital, Thailand, from September 2022 to March 2024. Adult ESKD patients receiving maintenance hemodialysis were included. Patients who received Tixagevimab/cilgavimab were compared with those who did not. The primary outcomes included asymptomatic and symptomatic COVID-19 infection, COVID-19-related hospitalization, and mortality over 18 months. Kaplan-Meier curves and Cox proportional hazards models were used to assess outcomes. The secondary outcome was adverse events after administration.
Results: Among 207 patients (40 intervention, 167 controls), incidence rates of symptomatic infection (0.261 vs. 1.432 per 1,000 person-days) and COVID-19-related hospitalization (0.047 vs. 0.236 per 1,000 person-days) were lower in the intervention group. No COVID–19–related deaths occurred. Tixagevimab/cilgavimab significantly reduced the risk of symptomatic infection (adjusted hazard ratio 0.22; 95% CI, 0.087–0.545). Adverse events were infrequent and mild.
Conclusion: Tixagevimab/cilgavimab was associated with a significant reduction in symptomatic COVID-19 infection among hemodialysis patients during the Omicron wave. Although hospitalization rates were lower in the intervention group, the difference was not statistically significant. The treatment was well tolerated and may provide preventive benefits for high-risk ESKD populations.
Keywords
Full Text:
PDFReferences
Grasselli G, Zangrillo A, Zanella A, Antonelli M, Cabrini L, Castelli A, et al. Baseline characteristics and outcomes of 1591 patients infected with SARS-CoV-2 admitted to ICUs of the Lombardy Region, Italy. JAMA 2020;323:1574-81.
Yi Y, Lagniton PNP, Ye S, Li E, Xu RH. COVID-19: what has been learned and to be learned about the novel coronavirus disease. Int J Biol Sci 2020;16:1753-66.
World Health Organization. COVID-19 epidemiological update 2024 [homepage on the Internet]. Geneva: WHO; 2024 [cited 2025 Jan 2]. Available from: https://www.who.int/publications/m/item/covid-19-epidemiological-update---24-december-2024
Nasreen S, Chung H, He S, Brown KA, Gubbay JB, Buchan SA, et al. Effectiveness of COVID-19 vaccines against symptomatic SARS-CoV-2 infection and severe outcomes with variants of concern in Ontario. Nat Microbiol 2022;7:379-85.
Liu H, Chen S, Liu M, Nie H, Lu H. Comorbid chronic diseases are strongly correlated with disease severity among COVID-19 patients: a systematic review and meta-analysis. Aging Dis 2020;11:668-78.
Dessie ZG, Zewotir T. Mortality-related risk factors of COVID-19: a systematic review and meta-analysis of 42 studies and 423,117 patients. BMC Infect Dis 2021;21:855.
Valeri AM, Robbins-Juarez SY, Stevens JS, Ahn W, Rao MK, Radhakrishnan J, et al. Presentation and outcomes of patients with ESKD and COVID-19. J Am Soc Nephrol 2020;31:1409-15.
Clarke CL, Prendecki M, Dhutia A, Gan J, Edwards C, Prout V, et al. Longevity of SARS-CoV-2 immune responses in hemodialysis patients and protection against reinfection. Kidney Int 2021;99:1470-7.
Boongird S, Setthaudom C, Kitpermkiat R, Prasongtanakij S, Srisala S, Chuengsaman P, et al. Durability of humoral and cellular immunity after an extended primary series with heterologous inactivated SARS-CoV-2 Prime-Boost and ChAdOx1 nCoV-19 in Dialysis Patients (ICON3). Vaccines (Basel) 2022;10:1064.
Angel-Korman A, Peres E, Bryk G, Lustig Y, Indenbaum V, Amit S, et al. Diminished and waning immunity to COVID-19 vaccination among hemodialysis patients in Israel: the case for a third vaccine dose. Clin Kidney J 2022;15:226-34.
Speer C, Schaier M, Nusshag C, Töllner M, Buylaert M, Kälble F, et al. Longitudinal humoral responses after COVID-19 vaccination in Peritoneal and Hemodialysis patients over twelve weeks. Vaccines (Basel) 2021;9:1130.
Loo YM, McTamney PM, Arends RH, Abram ME, Aksyuk AA, Diallo S, et al. The SARS-CoV-2 monoclonal antibody combination, AZD7442, is protective in nonhuman primates and has an extended half-life in humans. Sci Transl Med 2022;14:eabl8124.
U.S. Food and Drug Administration. Fact sheet for healthcare provider: emergency use of authorization for EVUSHELD™ (tixagevimab co-packaged with cilgavimab) [homepage on the Internet]. Geneva: WHO; 2023 [cited 2023 Dec 6]. Available from: https://www.fda.gov/media/154701/download
Montgomery H, Hobbs FDR, Padilla F, Arbetter D, Templeton A, Seegobin S, et al. Efficacy and safety of intramuscular administration of tixagevimab-cilgavimab for early outpatient treatment of COVID-19 (TACKLE): a phase 3, randomised, double-blind, placebo-controlled trial. Lancet Respir Med 2022;10:985-96.
Al Jurdi A, Morena L, Cote M, Bethea E, Azzi J, Riella LV. Tixagevimab/cilgavimab pre-exposure prophylaxis is associated with lower breakthrough infection risk in vaccinated solid organ transplant recipients during the omicron wave. Am J Transplant 2022;22:3130-6.
Nassar MK, Sabry A, Elgamal M, Zeid Z, Abdellateif Abdelghany D, Tharwat S. Tixagevimab and Cilgavimab (Evusheld) Boosts antibody levels to SARS-CoV-2 in end-stage renal disease patients on chronic Hemodialysis: a single-center study. Medicina (Kaunas) 2023;59:2109.
Department of Medical Sciences, Ministry of Public Health, Thailand. Guidelines for the administration of Long-Acting Antibody (LAAB) in Thailand [homepage on the Internet]. Nonthaburi: Ministry of Public Health; 2022 [cited 2025 June 1]. Available from: https://dmsic.moph.go.th/index/detail/9036
StataCorp. STATA Index: Release 17 [homepage on the Internet]. Texas: StataCorp LLC; 2021 [cited 2025 Jun 2]. Available from: https://www.stata.com/manuals17/i.pdf
Fu MS, Ling CJ, Sugurmar ANK, P’ng HS, Ng SM, Ee LW, et al. POS-941 the effectiveness of COVID-19 vaccine in reducing the severity and mortality rate among the end stage kidney disease with COVID-19. Kidney Int Rep 2022;7:S410–1.
Tylicki L, Biedunkiewicz B, Puchalska-Reglińska E, Gellert R, Burnier M, Wolf J, et al. COVID-19 vaccination reduces mortality in patients on maintenance hemodialysis. Front Med (Lausanne) 2022;9:937167.
Khan BA, Pagsinohin M, Lu LM, Tan P, Teo R. Tixagevimab and Cilgavimab administration for hemodialysis patients at community-based dialysis centers in Singapore as Pre-Exposure Prophylaxis for SARS-CoV-2 infection. Cureus 2023;15:e41297.
Puenpa J, Chansaenroj J, Suwannakarn K, Poovorawan Y. Genomic epidemiology and evolutionary analysis during XBB.1.16-predominant periods of SARS-CoV-2 omicron variant in Bangkok, Thailand: December 2022-August 2023. Sci Rep 2024;14:645.
Yan VKC, Yang Y, Wan EYF, Lai FTT, Chui CSL, Li X, et al. Real-World effectiveness and safety of Tixagevimab–cilgavimab: a target trial emulation study. Drug Saf 2024;47:10-25
Hou Y, Chen M, Bian Y, Hu Y, Chuan J, Zhong L, et al. Insights into vaccines for elderly individuals: from the impacts of immunosenescence to delivery strategies. NPJ Vaccines 2024;9:77.
Chen DT-H, Copland E, Hirst JA, Mi E, Dixon S, Coupland C, et al. Uptake, effectiveness and safety of COVID-19 vaccines in individuals at clinical risk due to immunosuppressive drug therapy or transplantation procedures: a population-based cohort study in England. BMC Medicine 2024;22:237.
McMenamin ME, Nealon J, Lin Y, Wong JY, Cheung JK, Lau EHY, et al. Vaccine effectiveness of one, two, and three doses of BNT162b2 and CoronaVac against COVID-19 in Hong Kong: a population-based observational study. Lancet Infect Dis 2022;22:1435-43.
Marra AR, Kobayashi T, Callado GY, Pardo I, Gutfreund MC, Hsieh MK, et al. The effectiveness of COVID-19 vaccine in the prevention of post-COVID conditions: a systematic literature review and meta-analysis of the latest research. Antimicrob Steward Healthc Epidemiol 2023;3:e168.
Levin MJ, Ustianowski A, De Wit S, Launay O, Avila M, Templeton A, et al. Intramuscular AZD7442 (Tixagevimab-Cilgavimab) for Prevention of Covid-19. N Engl J Med 2022;386:2188-200.
Simone S, Pronzo V, Pesce F, Bavaro DF, Infante B, Mercuri S, et al. Safety and efficacy of tixagevimab/cilgavimab for pre-exposure prophylaxis in kidney transplant recipients: a multicenter retrospective cohort study. J Nephrol 2024;37:1539-50.
Refbacks
- There are currently no refbacks.
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.