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All Studies   Meta Analysis       

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
May 2023  
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Mortality -1% Improvement Relative Risk Ventilation -96% ICU admission -210% Hospitalization 53% Symp. case 29% unadjusted Tixagevimab/c..  Sindu et al.  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 sig. c19early.org Sindu et al., Transplantation Direct, May 2023 Favorstixagevimab/ci.. Favorscontrol 0 0.5 1 1.5 2+
38th 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.
5,100+ studies for 112 treatments. c19early.org
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, BQ.1.11, BA.5, BA.2.75, XBB2,3, XBB.1.53, ХВВ.1.9.13, XBB.1.9.3, XBB.1.5.24, XBB.1.16, XBB.2.9, BQ.1.1.45, CL.1, and CH.1.14.
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. Contact: sofya.tokman@dignityhealth.org.
This PaperTixagev../c..All
Pre-exposure Prophylaxis with Tixagevimab-cilgavimab did not Reduce Severity of COVID-19 in Lung Transplant Recipients with Breakthrough Infection
MD Devika Sindu, MD Deepika Razia, RN, MSN Katherine Grief, MD Lauren Cherrier, MD Ashraf Omar, MD Rajat Walia, MD Sofya Tokman
Transplantation Direct, doi:10.1097/txd.0000000000001485
I nfection with the severe acute respiratory syndrome coro- navirus 2 (SARS-CoV-2) and the resulting COVID-19 have led to significant morbidity and mortality among solid organ transplant recipients since the start of the pandemic. 1 Mutations in the viral spike protein have led to the emergence of numerous variants, with the Omicron variant and its sublineages dominating since December 2021. 2, 3 Although the rates of hospitalization and in-hospital mortality fell in the general population during the Omicron surge, the morbidity and mortality among solid organ transplant recipients remained disproportionately high. 4, 5 Vaccination is the cornerstone of prevention of severe COVID-19 in the general population; however, the immune response to vaccination among solid organ transplant recipients is often inadequate, leaving them susceptible to severe illness. A study of 658 solid organ transplant recipients, including 71 lung transplant recipients (LTRs), showed that only 39% of LTRs developed an antibody response after 2 doses of a SARS-CoV-2 mRNA vaccine. 6 Furthermore, although a third vaccine dose improved the humoral response Lung Transplantation 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;
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