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All Studies   Meta Analysis    Recent:   

Tixagevimab/cilgavimab pre-exposure prophylaxis is associated with lower breakthrough infection risk in vaccinated solid organ transplant recipients during the omicron wave

Al Jurdi et al., American Journal of Transplantation, doi:10.1111/ajt.17128
Dec 2022  
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Mortality 86% Improvement Relative Risk Hospitalization 83% Case 66% Tixagevimab/c..  Al Jurdi et al.  Prophylaxis Is prophylaxis with tixagevimab/cilgavimab beneficial for COVID-19? Retrospective 444 patients in the USA Fewer cases with tixagevimab/cilgavimab (p=0.0011) c19early.org Al Jurdi et al., American J. Transplan.., Dec 2022 Favorstixagevimab/ci.. Favorscontrol 0 0.5 1 1.5 2+
39th treatment shown to reduce risk in May 2022
 
*, now with p = 0.000029 from 17 studies, recognized in 31 countries. Efficacy is variant dependent.
Lower risk for mortality, hospitalization, and cases.
No treatment is 100% effective. Protocols combine treatments. * >10% efficacy, ≥3 studies.
4,400+ studies for 79 treatments. c19early.org
Retrospective cohort study of 444 solid organ transplant recipients showing significantly lower risk of SARS-CoV-2 breakthrough infections with tixagevimab/cilgavimab pre-exposure prophylaxis compared to controls during the omicron period.
Confounding by treatment propensity. This study analyzes a population where only a fraction of eligible patients received the treatment. Patients receiving treatment may be more likely to follow other recommendations, more likely to receive additional care, and more likely to use additional treatments that are not tracked in the data (e.g., nasal/oral hygiene1,2, vitamin D3, etc.) — either because the physician recommending tixagevimab/cilgavimab also recommended them, or because the patient seeking out tixagevimab/cilgavimab is more likely to be familiar with the efficacy of additional treatments and more likely to take the time to use them. Therefore, these kind of studies may overestimate the efficacy of treatments.
Efficacy is variant dependent. In Vitro research suggests a lack of efficacy for omicron BA.2.75.2, BA.4.6, BQ.1.14, BA.5, BA.2.75, XBB5, ХВВ.1.9.1, XBB.1.9.3, XBB.1.5.24, XBB.1.16, XBB.2.9, BQ.1.1.45, CL.1, and CH.1.16.
risk of death, 85.7% lower, RR 0.14, p = 0.25, treatment 0 of 222 (0.0%), control 3 of 222 (1.4%), NNT 74, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm).
risk of hospitalization, 83.3% lower, RR 0.17, p = 0.12, treatment 1 of 222 (0.5%), control 6 of 222 (2.7%), NNT 44.
risk of case, 65.6% lower, RR 0.34, p = 0.001, treatment 11 of 222 (5.0%), control 32 of 222 (14.4%), NNT 11.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Al Jurdi et al., 31 Dec 2022, retrospective, USA, peer-reviewed, 6 authors. Contact: lriella@mgh.harvard.edu.
This PaperTixagev../c..All
Tixagevimab/cilgavimab pre-exposure prophylaxis is associated with lower breakthrough infection risk in vaccinated solid organ transplant recipients during the omicron wave
Ayman Al Jurdi, Leela Morena, Mariesa Cote, Emily Bethea, Jamil Azzi, Leonardo V Riella
American Journal of Transplantation, doi:10.1111/ajt.17128
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in solid organ transplant recipients (SOTRs) is associated with higher mortality compared to immunocompetent individuals. 1 Since antiviral responses to SARS-CoV-2 vaccines in SOTRs are attenuated, 2 additional strategies such as monoclonal antibody pre-exposure prophylaxis have been developed. 3 Tixagevimab and cilgavimab are neutralizing monoclonal antibodies directed against different epitopes of the receptor-binding domain of SARS-CoV-2 spike protein that have been associated with a lower risk of SARS-CoV-2 infection when used for pre-exposure prophylaxis in unvaccinated individuals. 4 Based on that, tixagevimab/cilgavimab received emergency use authorization from the US Food and Drug
| 3135 AJT AL JURDI et AL. We also found that tixagevimab/cilgavimab use was associated with a lower incidence of breakthrough infection regardless of whether SOTRs had received 0-3 or 4-5 vaccines doses. Separate analysis of SOTRs who received 0-2 or 5 vaccine doses was not performed due to the small number of SOTRs in these groups. In addition, we found that tixagevimab/cilgavimab use was associated with a lower risk of breakthrough infection in kidney and lung transplant recipients. There was no statistically significant difference in the risk of breakthrough infection between liver or liver/kidney transplant recipients who did and did not receive tixagevimab/cilgavimab. However, given the small number of liver and liver/kidney transplant recipients in our cohort, our study was underpowered to find differences in this subgroup of SOTRs. Importantly, we also found a higher incidence of breakthrough infections in the low-dose (150-150 mg) compared to the high-dose (300-300 mg) tixagevimab/cilgavimab cohort, suggesting a lower risk of breakthrough infections in the high-dose group, which supports the FDA's revised recommendation to use the higher dose for preexposure prophylaxis in SOTRs. 14 A randomized controlled trial comparing the two doses would provide further evidence supporting the difference in breakthrough infection between the two doses in SOTRs. We also found that tixagevimab/cilgavimab was safe with a low rate of adverse events and no evidence of allograft..
References
Altarawneh, Chemaitelly, Hasan, Protection against the omicron variant from previous SARS-CoV-2 infection, N Engl J Med, doi:10.1056/NEJMc2200133
Andrews, Stowe, Kirsebom, Covid-19 vaccine effectiveness against the omicron (B.1.1.529) variant, N Engl J Med, doi:10.1056/NEJMoa2119451
Bertrand, Laurent, Lemée, Efficacy of anti SARS-CoV-2 monoclonal antibodies prophylaxis and vaccination on omicron COVID-19 in kidney transplant recipients, Kidney Int, doi:10.1016/j.kint.2022.05.007
Caillard, Chavarot, Francois, Is COVID-19 infection more severe in kidney transplant recipients?, Am J Transplant, doi:10.1111/ajt.16424
Goldberg, Mandel, Bar-On, Protection and waning of natural and hybrid immunity to SARS-CoV-2, N Engl J Med, doi:10.1056/NEJMoa2118946
Hall, Foulkes, Charlett, SARS-CoV-2 infection rates of antibody-positive compared with antibody-negative health-care workers in England: a large, multicentre, prospective cohort study (SIREN), Lancet, doi:10.1016/S0140-6736(21)00675-9
Hansen, Michlmayr, Gubbels, Mølbak, Ethelberg, Assessment of protection against reinfection with SARS-CoV-2 among 4 million PCR-tested individuals in Denmark in 2020: a population-level observational study, Lancet, doi:10.1016/S0140-6736(21)00575-4
Jurdi, Gassen, Borges, Non-invasive monitoring for rejection in kidney transplant recipients after SARS-CoV-2 mRNA vaccination, Front Immunol, doi:10.3389/fimmu.2022.838985
Levin, Ustianowski, Wit, Intramuscular AZD7442 (Tixagevimab-Cilgavimab) for prevention of Covid-19, N Engl J Med, doi:10.1056/NEJMoa2116620
Loo, Mctamney, Arends, The SARS-CoV-2 monoclonal antibody combination, AZD7442, is protective in nonhuman primates and has an extended half-life in humans, Sci Transl Med, doi:10.1126/scitranslmed.abl8124
Magen, Waxman, Makov-Assif, Fourth dose of BNT162b2 mRNA Covid-19 vaccine in a Nationwide setting, N Engl J Med, doi:10.1056/NEJMoa2201688
Sheehan, Reddy, Rothberg, Reinfection rates among patients who previously tested positive for coronavirus disease 2019: a retrospective cohort study, Clin Infect Dis, doi:10.1093/cid/ciab234
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