Implementation of AZD7442 (Tixagevimab/Cilgavimab) COVID-19 Pre-exposure Prophylaxis (PrEP) in the Largest Health Maintenance Organization in Israel: Real-world Uptake and Sociodemographic and Clinical Characteristics Across Immunocompromised Patient Groups.

AZD7442 COVID-19 Immunocompromised Israel Pre-exposure prophylaxis Real-world evidence SARS-CoV-2 Tixagevimab/cilgavimab

Journal

Infectious diseases and therapy
ISSN: 2193-8229
Titre abrégé: Infect Dis Ther
Pays: New Zealand
ID NLM: 101634499

Informations de publication

Date de publication:
10 May 2024
Historique:
received: 06 02 2024
accepted: 15 04 2024
medline: 10 5 2024
pubmed: 10 5 2024
entrez: 10 5 2024
Statut: aheadofprint

Résumé

AZD7442 is a combination of two neutralizing antibodies (tixagevimab/cilgavimab) with demonstrated efficacy in reducing the risk of symptomatic coronavirus disease 2019 (COVID-19) among individuals at high risk of severe COVID-19 ≤ 6 months after administration. On February 15, 2022, the Israeli Ministry of Health (IMoH) authorized the administration of 300 mg AZD7442 as pre-exposure prophylaxis (PrEP) against severe acute respiratory syndrome coronavirus 2 infection among immunocompromised individuals aged ≥ 12 years. This study describes the real-world uptake of AZD7442 in Israel. This descriptive, observational study analyzed data from Israel's largest health maintenance organization, Clalit Health Services (CHS). Individuals were assessed for AZD7442 eligibility between February 13 and December 11, 2022, and were included if they were aged ≥ 12 years, had ≥ 1 year of continuous CHS membership, had ≥ 1 moderate or severe immunocompromising condition, and were eligible for AZD7442 per IMoH recommendations during this time frame. Overall, 19,161 AZD7442-eligible individuals with immunocompromising conditions were identified during the study period; 2829 (14.8%) received AZD7442. A higher proportion of individuals receiving AZD7442 were older (aged ≥ 65 years), male, not current smokers and residents in large cities; required more physician visits (> 50 visits); and had ≥ 1 COVID-19 hospitalization over 12 months, while uptake was lowest among ultra-orthodox Jewish individuals. AZD7442 uptake was also higher among individuals with multiple comorbidities (Charlson Comorbidity Index ≥ 5), including hypertension, diabetes and chronic kidney disease. In specific immunocompromised types, AZD7442 uptake was highest among individuals with lung transplantation (41%), primary immunodeficiency (32%), bone marrow transplantation (29%) and multiple myeloma (25%) or those receiving anti-CD20 therapy (26%) and was lowest in individuals with lymphoma (8%). These results show AZD7442 uptake among the eligible population of Israel in 2022 was relatively low, at 14.8%. Uptake was generally higher among immunocompromised individuals who may be perceived to be frail or at highest risk of COVID-19 infection and complications, although at 25-41%, further improvements in uptake would be more impactful. These results also indicate there is opportunity to expand AZD7442 uptake across immunocompromised groups and ensure more equitable uptake among some other sociodemographic groups. Overall, this study will help inform and reassess future implementation strategies for vulnerable populations.

Identifiants

pubmed: 38728006
doi: 10.1007/s40121-024-00981-8
pii: 10.1007/s40121-024-00981-8
doi:

Types de publication

Journal Article

Langues

eng

Informations de copyright

© 2024. The Author(s).

Références

Johns Hopkins University & Medicine. COVID-19 DashBoard [Internet]. 2022. [cited January 12, 2022]. https://gisanddata.maps.arcgis.com/apps/dashboards/bda7594740fd40299423467b48e9ecf6 . Accessed 12 Apr 2024.
Worldometer. COVID-19 coronavirus pandemic. [Internet]. 2022. [cited April 25, 2022]. https://www.worldometers.info/coronavirus/ . Accessed 25 Apr 2022.
Zhu N, Zhang D, Wang W, Li X, Yang B, Song J, et al. A novel coronavirus from patients with pneumonia in China, 2019. N Engl J Med. 2020;382(8):727–33.
doi: 10.1056/NEJMoa2001017 pubmed: 31978945 pmcid: 7092803
Watson OJ, Barnsley G, Toor J, Hogan AB, Winskill P, Ghani AC. Global impact of the first year of COVID-19 vaccination: a mathematical modelling study. Lancet Infect Dis. 2022;22(9):1293–302.
doi: 10.1016/S1473-3099(22)00320-6 pubmed: 35753318 pmcid: 9225255
World Health Organization. Statement on the fifteenth meeting of the IHR (2005) Emergency Committee on the COVID-19 pandemic. [Internet]. 2023. [cited December 28, 2023]. https://www.who.int/news/item/05-05-2023-statement-on-the-fifteenth-meeting-of-the-international-health-regulations-(2005)-emergency-committee-regarding-the-coronavirus-disease-(covid-19)-pandemic . Accessed 12 Apr 2024.
World Health Organization. WHO COVID-19 dashboard. [Internet]. 2023 [cited June 1, 2023]. https://covid19.who.int/ . Accessed 12 Apr 2024.
Bahremand T, Yao JA, Mill C, Piszczek J, Grant JM, Smolina K. COVID-19 hospitalisations in immunocompromised individuals in the Omicron era: a population-based observational study using surveillance data in British Columbia, Canada. Lancet Reg Health Am. 2023;20: 100461.
pubmed: 36890850 pmcid: 9987330
Williamson EJ, Walker AJ, Bhaskaran K, Bacon S, Bates C, Morton CE, et al. Factors associated with COVID-19-related death using OpenSAFELY. Nature. 2020;584(7821):430–6.
doi: 10.1038/s41586-020-2521-4 pubmed: 32640463 pmcid: 7611074
Shoham S, Batista C, Amor YB, Ergonul O, Hassanain M, Hotez P, et al. Vaccines and therapeutics for immunocompromised patients with COVID-19. EClinicalMedicine. 2023;59: 101965.
doi: 10.1016/j.eclinm.2023.101965 pubmed: 37070102 pmcid: 10091856
Lee ARYB, Wong SY, Chai LYA, Lee SC, Lee MX, Muthiah MD, et al. Efficacy of covid-19 vaccines in immunocompromised patients: systematic review and meta-analysis. BMJ. 2022;376: e068632.
doi: 10.1136/bmj-2021-068632 pubmed: 35236664
US Food and Drug Administration. Coronavirus (COVID-19) update: FDA authorizes new long-acting monoclonal antibodies for pre-exposure prevention of COVID-19 in certain individuals. [Internet]. 2021. [cited December 28, 2023]. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-new-long-acting-monoclonal-antibodies-pre-exposure . Accessed 12 Apr 2024.
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(23):2188–200.
doi: 10.1056/NEJMoa2116620 pubmed: 35443106
AstraZeneca. Evusheld (formerly AZD7442) long-acting antibody combination authorised for emergency use in the US for pre-exposure prophylaxis (prevention) of COVID-19. [Internet]. 2021. [cited December 28, 2023]. https://www.astrazeneca.com/media-centre/press-releases/2021/evusheld-long-acting-antibody-combination-authorised-for-emergency-use-in-the-us-for-pre-exposure-prophylaxis-prevention-of-covid-19.html# . Accessed 12 Apr 2024.
Kmietowicz Z. Covid-19: monoclonal antibodies authorised in US as alternative to vaccines for certain groups. BMJ. 2021;375: n3064.
doi: 10.1136/bmj.n3064 pubmed: 34893506
Israeli Ministry of Health. The Ministry of Health has instructed the HMOs to vaccinated immunosuppressed individuals with AstraZeneca's Evusheld vaccine. [Internet]. 2022. [cited December 28, 2023]. https://www.gov.il/en/departments/news/15022022-02 . Accessed 12 Apr 2024.
Bar-On YM, Goldberg Y, Mandel M, Bodenheimer O, Amir O, Freedman L, et al. Protection by a fourth dose of BNT162b2 against Omicron in Israel. N Engl J Med. 2022;386(18):1712–20.
doi: 10.1056/NEJMoa2201570 pubmed: 35381126
US Food and Drug Administration. FDA announces Evusheld is not currently authorized for emergency use in the U.S. [Internet]. 2023 [cited June 1, 2023]. https://www.fda.gov/drugs/drug-safety-and-availability/fda-announces-evusheld-not-currently-authorized-emergency-use-us . Accessed 12 Apr 2024.
Barda N, Dagan N, Ben-Shlomo Y, Kepten E, Waxman J, Ohana R, et al. Safety of the BNT162b2 mRNA Covid-19 vaccine in a nationwide setting. N Engl J Med. 2021;385(12):1078–90.
doi: 10.1056/NEJMoa2110475 pubmed: 34432976
Dagan N, Barda N, Kepten E, Miron O, Perchik S, Katz MA, et al. BNT162b2 mRNA Covid-19 vaccine in a nationwide mass vaccination setting. N Engl J Med. 2021;384(15):1412–23.
doi: 10.1056/NEJMoa2101765 pubmed: 33626250
Najjar-Debbiny R, Gronich N, Weber G, Stein N, Saliba W. Effectiveness of Evusheld in immunocompromised patients: propensity score–matched analysis. Clin Infect Dis. 2023;76(6):1067–73.
doi: 10.1093/cid/ciac855 pubmed: 36310534
Kertes J, Shapiro Ben David S, Engel-Zohar N, Rosen K, Hemo B, Kantor A, et al. Association between AZD7442 (tixagevimab-cilgavimab) administration and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, hospitalization, and mortality. Clin Infect Dis. 2023;76(3):e126–e32.
Muhsen K, Cohen D. Rotavirus vaccines in Israel: uptake and impact. Hum Vaccin Immunother. 2017;13(7):1722–7.
doi: 10.1080/21645515.2017.1297908 pubmed: 28281866 pmcid: 5512754
Gorelik Y, Anis E, Edelstein M. Inequalities in initiation of COVID19 vaccination by age and population group in Israel-December 2020-July 2021. Lancet Reg Health Eur. 2022;12: 100234.
doi: 10.1016/j.lanepe.2021.100234 pubmed: 34746908
Muhsen K, Na’aminh W, Lapidot Y, Goren S, Amir Y, Perlman S, et al. A nationwide analysis of population group differences in the COVID-19 epidemic in Israel, February 2020–February 2021. Lancet Reg Health Eur. 2021;7: 100130.
doi: 10.1016/j.lanepe.2021.100130 pubmed: 34109321 pmcid: 8177966

Auteurs

Samah Hayek (S)

Department of Epidemiology and Preventive Medicine, School of Public Health, Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel. samahha@clalit.org.il.
Innovation Division, Clalit Research Institute, Clalit Health Services, Tel Aviv, Israel. samahha@clalit.org.il.

Joseph Levy (J)

Innovation Division, Clalit Research Institute, Clalit Health Services, Tel Aviv, Israel.

Galit Shaham (G)

Innovation Division, Clalit Research Institute, Clalit Health Services, Tel Aviv, Israel.

Noa Dagan (N)

Innovation Division, Clalit Research Institute, Clalit Health Services, Tel Aviv, Israel.
Software and Information Systems Engineering, Ben Gurion University, Be'er Sheva, Israel.
Department of Biomedical Informatics, Harvard Medical School, Boston, MA, USA.
The Ivan and Francesca Berkowitz Family Living Laboratory Collaboration, Harvard Medical School and Clalit Research Institute, Boston, MA, USA.

Danielle Serby (D)

Clalit Community Division, Clalit Health Services, Tel Aviv, Israel.

Hadar Duskin-Bitan (H)

Clalit Community Division, Clalit Health Services, Tel Aviv, Israel.

Adva Yarden (A)

Medical Affairs, BioPharmaceuticals Medical, AstraZeneca, Kfar-Saba, Israel.

Cátia Ferreira (C)

Vaccines and Immune Therapies Unit, BioPharmaceuticals Medical, AstraZeneca, Wilmington, DE, USA.

Idit Livnat (I)

Medical Affairs, BioPharmaceuticals Medical, AstraZeneca, Kfar-Saba, Israel.

Sabada Dube (S)

Epidemiology, Vaccines and Immune Therapies Unit, AstraZeneca, Cambridge, UK.

Sylvia Taylor (S)

Medical Evidence, Vaccines and Immune Therapies Unit, AstraZeneca, Cambridge, UK.

Sudhir Venkatesan (S)

Medical and Payer Evidence, BioPharmaceuticals Medical, AstraZeneca, Cambridge, UK.

Ran D Balicer (RD)

Innovation Division, Clalit Research Institute, Clalit Health Services, Tel Aviv, Israel.
The Ivan and Francesca Berkowitz Family Living Laboratory Collaboration, Harvard Medical School and Clalit Research Institute, Boston, MA, USA.
School of Public Health, Faculty of Health Sciences, Ben Gurion University of the Negev, Be'er Sheva, Israel.

Doron Netzer (D)

Medical Affairs, BioPharmaceuticals Medical, AstraZeneca, Kfar-Saba, Israel.

Alon Peretz (A)

Medical Affairs, BioPharmaceuticals Medical, AstraZeneca, Kfar-Saba, Israel.

Classifications MeSH