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0 0.5 1 1.5 2+ Mortality -1% Improvement Relative Risk Ventilation -96% ICU admission -210% Hospitalization 53% Symptomatic case 29% unadjusted Sindu et al. Tixagevimab/c.. for COVID-19 Prophylaxis Is prophylaxis with tixagevimab/cilgavimab beneficial for COVID-19? Retrospective 546 patients in the USA (December 2021 - August 2022) Higher ventilation (p=0.58) and ICU admission (p=0.33), not stat. sig. Sindu et al., Transplantation Direct, doi:10.1097/txd.0000000000001485 Favors tixagevimab/ci.. Favors control

Pre-exposure Prophylaxis with Tixagevimab-cilgavimab did not Reduce Severity of COVID-19 in Lung Transplant Recipients with Breakthrough Infection

Sindu et al., Transplantation Direct, doi:10.1097/txd.0000000000001485
Sindu et al., Pre-exposure Prophylaxis with Tixagevimab-cilgavimab did not Reduce Severity of COVID-19 in Lung Transplant.., Transplantation Direct, doi:10.1097/txd.0000000000001485
May 2023   Source   PDF  
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Retrospective 546 lung transplant recipients, 203 receiving tixagevimab/cilgavimab, and 343 out of state or declining treatment, showing a trend towards lower incidence of cases, but no significant difference in clinical outcomes.
Efficacy is variant dependent. In Vitro research suggests a lack of efficacy for omicron BA.2.75.2, BA.4.6, and BQ.1.1 [Planas].
risk of death, 1.5% higher, HR 1.01, p = 0.99, treatment 2 of 17 (11.8%), control 2 of 17 (11.8%), propensity score matching, Cox proportional hazards.
risk of mechanical ventilation, 95.8% higher, HR 1.96, p = 0.58, propensity score matching, Cox proportional hazards.
risk of ICU admission, 209.6% higher, HR 3.10, p = 0.33, propensity score matching, Cox proportional hazards.
risk of hospitalization, 53.2% lower, HR 0.47, p = 0.17, propensity score matching, Cox proportional hazards.
risk of symptomatic case, 28.9% lower, RR 0.71, p = 0.14, treatment 24 of 203 (11.8%), control 57 of 343 (16.6%), NNT 21, unadjusted.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Sindu et al., 12 May 2023, retrospective, USA, peer-reviewed, median age 67.4, 7 authors, study period December 2021 - August 2022.
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Abstract: Lung Transplantation IHo4XMi0hCywCX1AWnYQp/IlQrHD3i3D0OdRyi7TvSFl4Cf3VC1y0abggQZXdtwnfKZBYtws= on 05/24/2023 Pre-exposure Prophylaxis with Tixagevimabcilgavimab did not Reduce Severity of COVID-19 in Lung Transplant Recipients with Breakthrough Infection Devika Sindu, MD,1 Deepika Razia, MD,2 Katherine Grief, RN, MSN,1 Lauren Cherrier, MD,1 Ashraf Omar, MD,1,2 Rajat Walia, MD,1,2 and Sofya Tokman, MD1,2 Background. Lung transplant recipients (LTRs) have an increased risk of COVID-19–related morbidity and mortality. Tixagevimab-cilgavimab (tix-cil) is a long-acting monoclonal antibody combination granted Emergency Use Authorization approval by the US Food and Drug Administration for COVID-19 pre-exposure prophylaxis (PrEP) in immunocompromised patients. We sought to determine whether tix-cil 300–300 mg reduced the incidence and disease severity of severe acute respiratory syndrome coronavirus 2 infection in LTRs during the Omicron wave. Methods. We performed a retrospective, single-center cohort study of LTRs who had received a COVID-19 diagnosis between December 2021 and August 2022. We compared baseline characteristics and clinical outcomes after COVID-19 between LTRs who received tix-cil PrEP and those who did not. We then conducted propensity-score matching based on baseline characteristics and therapeutic interventions and compared clinical outcomes between the 2 groups. Results. Of 203 LTRs who received tix-cil PrEP and 343 who did not, 24 (11.8%) and 57 (16.6%), respectively, developed symptomatic COVID-19 (hazard ratio [HR], 0.669; 95% confidence interval [CI], 0.415-1.079; P = 0.099). The hospitalization rate of LTRs with COVID-19 during the Omicron wave trended lower in the tix-cil group than in the non–tix-cil group (20.8% versus 43.1%; HR, 0.430; 95% CI, 0.165-1.118; P = 0.083). In propensity-matched analyses, 17 LTRs who received tix-cil and 17 LTRs who did not had similar rates of hospitalization (HR, 0.468; 95% CI, 0.156-1.402; P = 0.175), intensive care unit admission (HR, 3.096; 95% CI, 0.322-29.771; P = 0.328), mechanical ventilation (HR, 1.958; 95% CI, 0.177-21.596; P = 0.583), and survival (HR, 1.015; 95% CI, 0.143-7.209; P = 0.988). COVID19–related mortality was high in both propensity-score–matched groups (11.8%). Conclusions. Breakthrough COVID-19 was common among LTRs despite tix-cil PrEP, possibly due to reduced efficacy of monoclonal antibodies against the Omicron variant. Tix-cil PrEP may reduce the incidence of COVID-19 in LTRs, but it did not reduce disease severity during the Omicron wave. (Transplantation Direct 2023;9: e1485; doi: 10.1097/TXD.0000000000001485.) Received 20 January 2023. Revision received 6 March 2023. Accepted 22 March 2023. 1 Norton Thoracic Institute, St. Joseph’s Hospital and Medical Center, Phoenix, AZ. 2 Creighton University School of Medicine, Phoenix Regional Campus, Phoenix, AZ. The authors declare no funding or conflicts of interest. D.S., D.R., A.O., R.W., and S.T. made substantial contributions to the conception and design of the work, drafting the work or revising it critically for important intellectual content, and final approval of the version to be published, in accordance with ICMJE guidelines. D.S., D.R., K.G., L.C., and S.T. worked on the acquisition of the data, D.S. contributed to analysis, and S.T. and D.S. interpreted the data for the work. All authors agree to be..
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