Søgeord (tixagevimab) valgt.
18 emner vises.
1
Spike protein genetic evolution in patients at high-risk of severe COVID-19 treated by monoclonal antibodies
Journal of Infectious Diseases, 25.11.2023
Tilføjet 25.11.2023
AbstractBackgroundHigh-risk patients, often immunocompromised and not responding to vaccine, continue to experience severe COVID-19 and death. Monoclonal antibodies (mAbs) were shown effective to prevent severe COVID-19 for these patients. Nevertheless, concerns about the emergence of resistance mutations were raised.MethodsWe conducted a multicentric prospective cohort study, including 264 patients with mild-to moderate COVID-19 at high risk for progression to severe COVID-19 and treated early with Casirivimab/Imdevimab, Sotrovimab or Tixagevimab/Cilgavimab. We sequenced the SARS-CoV-2 genome during follow-up and searched for emerging Spike mutations.ResultsImmunocompromised patients have a 6-fold increased risk of developing mutations, which are associated with a prolonged duration of viral clearance but no clinical worsening. Emerging P337S/R/L/H, E340D/K/A/Q/V/G and K356T/R substitutions in patients treated with Sotrovimab are associated with higher viral RNA loads for up to 14 days post-treatment initiation. Tixagevimab/Cilgavimab is associated with a 5-fold increased risk of developing mutations. R346K/I/T/S and K444R/N/M substitutions associated with Tixagevimab/Cilgavimab have been identified in multiple SARS-CoV-2 lineages, including BQ.1 and XBB.ConclusionsIn conclusion, the probability of emerging mutations arising in response to mAbs is significant, emphasizing the crucial need to investigate these mutations thoroughly and assess their impact on patients and the evolutionary trajectory of the SARS-CoV-2.
Læs mere
Tjek på PubMed
2
Role of tixagevimab‐cilgavimab in preventing SARS‐CoV‐2 in hematopoietic stem cell transplant and chimeric antigen receptor T‐cell therapy recipients
Aswani Thurlapati, Mary McGann, James A. Davis, Katelynn Granger, Kiera Roubal, Deidra Smith, Kelly J. Gaffney, Alyssa Cendagorta, Amanda Herbst, Lindsey Hendrickson, Brian T. Hess, Hamza Hashmi
Journal of Medical Virology, 8.08.2023
Tilføjet 8.08.2023
3
Breakthrough SARS-CoV-2 Infections in the PROVENT Prevention Trial Were Not Associated with AZD7442 (Tixagevimab/Cilgavimab) Resistant Variants
Journal of Infectious Diseases, 7.06.2023
Tilføjet 7.06.2023
AbstractBackgroundWe report spike protein-based lineage and AZD7442 (tixagevimab/cilgavimab) neutralizing activity of SARS-CoV-2 variants identified from breakthrough infections in the PROVENT pre-exposure prophylaxis trial (NCT04625725).MethodsVariants identified from PROVENT participants with reverse-transcription polymerase chain reaction–positive symptomatic illness were phenotypically assessed to determine neutralization susceptibility of variant-specific pseudotyped virus-like particles.ResultsAt completion of 6 months’ follow-up, no AZD7442-resistant variants were observed in breakthrough COVID-19 cases. SARS-CoV-2 neutralizing antibody titers were similar in breakthrough and non-breakthrough cases.ConclusionSymptomatic COVID-19 breakthrough cases in PROVENT were not due to resistance-associated substitutions in AZD7442 binding sites or lack of AZD7442 exposure.
Læs mere
Tjek på PubMed
4
Efficacy and safety of tixagevimab‐cilgavimab as pre‐exposure prophylaxis for COVID‐19: A systematic review and meta‐analysis
Arto Yuwono Soeroto; Theo Audi Yanto; Andree Kurniawan; Timotius Ivan Hariyanto;
Reviews in Medical Virology, 24.04.2023
Tilføjet 24.04.2023
Some proportions of populations, such as immunocompromised patients and organ transplant recipients might have inadequate immune responses to the vaccine for coronavirus disease 2019 (COVID‐19). For these groups of populations, administering monoclonal antibodies might offer some additional protection. This review sought to analyze the effectiveness and safety of tixagevimab‐cilgavimab (Evusheld) as pre‐exposure prophylaxis against COVID‐19. We used specific keywords to comprehensively search for potential studies on PubMed, Scopus, Europe PMC, and sources until 3 September 2022. We collected all published articles that analyzed tixagevimab‐cilgavimab on the course of COVID‐19. Review Manager 5.4 was utilized for statistical analysis. Six studies were included. Our pooled analysis revealed that tixagevimab‐cilgavimab prophylaxis may decrease the rate of SARS‐CoV‐2 infection (OR: 0.24; 95% CI: 0.15–0.40,
Læs mere
Tjek på PubMed
5
Efficacy of pre-exposure prophylaxis to prevent SARS-CoV-2 infection after lung transplantation: a two center cohort study during the omicron era
Infection, 17.03.2023
Tilføjet 17.03.2023
Abstract Purpose Lung transplant (LTx) recipients are at risk for poor outcomes from coronavirus disease 2019 (COVID-19). The aim of the study was to assess the outcome of patients receiving pre-exposure prophylaxis (PrEP) with tixagevimab and cilgavimab after LTx. Methods All LTx recipients with outpatient visits from February 28th to October 31st, 2022 at two German centers were included. Baseline characteristics were recorded and patients followed until November 30rd, 2022. Infections with SARS-CoV-2, disease severity, and COVID-19-associated death were compared between patients with and without PrEP. Results In total, 1438 patients were included in the analysis, and 419 (29%) received PrEP. Patients receiving PrEP were older and earlier after transplantation, had lower glomerular filtration rates, and lower levels of SARS-CoV-2-S antibodies. In total, 535 patients (37%) developed SARS-CoV-2 infection during a follow-up of median of 209 days. Fewer infections occurred in patients with PrEP during the study period (31% vs. 40%, p = 0.004). Breakthrough SARS-CoV-2 infections after PrEP occurred in 77 patients (19%). In total, 37 infections (8%) were severe or critical. No difference in severity of COVID-19 was observed between patients with and without PrEP. There were 15 COVID-19-associated deaths (n = 1 after PrEP). Compared to matched controls, there was a non-significant difference towards a lower risk for moderate to critical COVID-19 (p 0.184). Conclusion The number of SARS-CoV-2 infections was lower in LTx recipients with PrEP. Despite being at higher risk for worse outcome severity of COVID-19 and associated mortality were similar in patients with and without PrEP.
Læs mere
Tjek på PubMed
6
Updated COVID-19 Guidance for People Who Are Immunocompromised
Journal of the American Medical Association, 1.03.2023
Tilføjet 1.03.2023
In late January, the US Food and Drug Administration announced that Evusheld (the combined monoclonal antibodies tixagevimab and cilgavimab) is not currently authorized for emergency use because it’s likely ineffective against more than 90% of SARS-CoV-2 variants now circulating in the US. Evusheld had been used as COVID-19 preexposure prophylaxis among certain patients who are immunocompromised.
Læs mere
Tjek på PubMed
7
Tixagevimab/Cilgavimab Treatment and Cardiovascular Events: Immortal time bias
Clinical Infectious Diseases, 18.02.2023
Tilføjet 18.02.2023
8
Safety, Tolerability and Pharmacokinetics of Half-Life Extended SARS-CoV-2 Neutralizing Monoclonal Antibodies AZD7442 (Tixagevimab/Cilgavimab) in Healthy Adults
Journal of Infectious Diseases, 23.01.2023
Tilføjet 23.01.2023
AbstractBackgroundAZD7442 is a combination of extended half-life, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)−specific neutralizing monoclonal antibodies (tixagevimab/cilgavimab).MethodsThis phase 1, first-in-human, randomized, double-blind, placebo-controlled, dose-escalation study evaluated AZD7442 administered intramuscularly (300 mg) or intravenously (300, 1000, 3000 mg) in healthy adults (aged 18–55 years). The primary endpoint was safety and tolerability. Secondary endpoints included pharmacokinetics and anti-drug antibodies.ResultsBetween August 18–October 16, 2020, 60 participants enrolled; 50 received AZD7442 and 10 received placebo. Adverse events (all of mild/moderate intensity) occurred in 26 (52.0%) and 8 (80.0%) participants (AZD7442 and placebo groups, respectively). No infusion- or injection-site, or hypersensitivity reactions occurred. Tixagevimab and cilgavimab had mean half-lives of approximately 90 days (range: 87.0–95.3 [tixagevimab], 79.8–91.1 [cilgavimab]) and similar pharmacokinetic profiles over the 361-day study period. SARS-CoV-2–specific neutralizing antibody titers provided by AZD7442 were maintained above those in plasma from convalescent coronavirus disease-19 (COVID-19) patients.ConclusionsAZD7442 was well tolerated in healthy adults, showing a favorable safety profile across all doses. Depending on the SARS-CoV-2 variant, pharmacokinetic analyses suggest AZD7442 could offer protection for at least 6 months against symptomatic COVID-19 following a single 300 mg intramuscular administration.Clinical trials registrationNCT04507256 (https://clinicaltrials.gov/ct2/show/NCT04507256).
Læs mere
Tjek på PubMed
9
Increased Reporting of Venous and Arterial Thromboembolic events reported with Tixagevimab–Cilgavimab for COVID-19
Clinical Microbiology and Infection, 1.12.2022
Tilføjet 2.12.2022
Since in two phase 3 clinical trials, there were a disproportion of number of thromboembolic events in the tixagevimab/cilgavimab group than in placebo group, there is a cardiovascular safety concerns with the use of this Anti-SARS-COV-2 Monoclonal Antibody. Whether tixagevimab/cilgavimab use in real life context increases the risk for of thromboembolic events is unclear.
Læs mere
Tjek på PubMed
10
AZD7442 (Tixagevimab/Cilgavimab) for Post-exposure Prophylaxis of Symptomatic COVID-19
Clinical Infectious Diseases, 22.11.2022
Tilføjet 22.11.2022
AbstractBackgroundWe report primary results of a phase 3 trial of AZD7442 (tixagevimab/cilgavimab) for post-exposure prophylaxis to prevent symptomatic coronavirus disease 2019 (COVID-19)MethodsAdults without prior SARS-CoV-2 infection or COVID-19 vaccination were enrolled within 8 days of exposure to a SARS-CoV-2–infected individual and randomized 2:1 to a single 300-mg AZD7442 dose (one 1.5-mL intramuscular injection each of tixagevimab and cilgavimab consecutively) or placebo. Primary endpoints were safety and first post-dose SARS-CoV-2 reverse-transcription–polymerase-chain-reaction (RT-PCR)–positive symptomatic COVID-19 event before day 183.Results1121 participants were randomized and dosed (mean age 46 years; 49% females; AZD7442, n=749; placebo, n=372). Median (range) follow-up was 49 (5–115) and 48 (20–113) days for AZD7442 and placebo, respectively. Adverse events occurred in 162/749 (21.6%) and 111/372 (29.8%) participants with AZD7442 and placebo, respectively, mostly mild/moderate. RT-PCR–positive symptomatic COVID-19 occurred in 23/749 (3.1%) and 17/372 (4.6%) AZD7442- and placebo-treated participants, respectively (relative risk reduction 33.3%; 95% confidence interval [CI] –25.9 to 64.7; P=.21). In predefined subgroup analyses of 1073 (96%) participants who were SARS-CoV-2 RT-PCR–negative (n=974 [87%]) or missing an RT-PCR result (n=99 [9%]) at baseline, AZD7442 reduced RT-PCR–positive symptomatic COVID-19 by 73.2% (95% CI 27.1 to 90.1) versus placebo.ConclusionsThis study did not meet the primary efficacy endpoint of post-exposure prevention of symptomatic COVID-19 with AZD7442 versus placebo. However, predefined analysis of participants who were SARS-CoV-2 RT-PCR–negative or missing an RT-PCR result at baseline support a role for AZD7442 in preventing symptomatic COVID-19.
Læs mere
Tjek på PubMed
11
Cardiovascular outcomes after tixagevimab and cilgavimab use for pre-exposure prophylaxis against COVID-19: a population-based propensity-matched cohort study
Clinical Infectious Diseases, 17.11.2022
Tilføjet 17.11.2022
AbstractTixagevimab and cilgavimab treatment was associated with higher rates of cardiovascular events in a post-hoc analysis of a phase 3 trial. In this large population-based propensity-matched study, we found no increased risk of cardiovascular events up to 90 days after tixagevimab and cilgavimab administration, including in patients with pre-existing cardiovascular disease.
Læs mere
Tjek på PubMed
12
Monoclonals for patients hospitalised with COVID-19
Jason M Pogue, Erin K McCreary
Lancet Respiratory Medicine, 9.07.2022
Tilføjet 28.09.2022
Monoclonal antibodies that neutralise SARS-CoV-2 have consistently reduced hospitalisation or death in outpatients with mild to moderate COVID-19.1–3 Conversely, results of randomised trials in patients who are hospitalised are mixed.4–8 In The Lancet Respiratory Medicine, Thomas L Holland and colleagues present results of the ACTIV-3 trial comparing intravenous tixagevimab−cilgavimab with placebo for patients hospitalised with COVID-19.8 Although tixagevimab−cilgavimab did not improve the primary outcome of time to sustained recovery (rate ratio [RR] 1·08 [95% CI 0·97–1·20]; p=0·21), it was associated with improved 28-day (6% vs 9%; p=0·02) and 90-day (9% vs 12%; p=0·03) mortality.
Læs mere
Tjek på PubMed
13
Tixagevimab–cilgavimab for treatment of patients hospitalised with COVID-19: a randomised, double-blind, phase 3 trial
ACTIV-3–Therapeutics for Inpatients with COVID-19 (TICO) Study Group
Lancet Respiratory Medicine, 9.07.2022
Tilføjet 28.09.2022
Among patients hospitalised with COVID-19 receiving remdesivir and other standard care, tixagevimab–cilgavimab did not improve the primary outcome of time to sustained recovery but was safe and mortality was lower.
Læs mere
Tjek på PubMed
14
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
Hugh Montgomery, F D Richard Hobbs, Francisco Padilla, Douglas Arbetter, Alison Templeton, Seth Seegobin, Kenneth Kim, Jesus Abraham Simón Campos, Rosalinda H Arends, Bryan H Brodek, Dennis Brooks, Pedro Garbes, Julieta Jimenez, Gavin C K W Koh, Kelly W Padilla, Katie Streicher, Rolando M Viani, Vijay Alagappan, Menelas N Pangalos, Mark T Esser, TACKLE study group
Lancet Respiratory Medicine, 8.06.2022
Tilføjet 28.09.2022
A single intramuscular tixagevimab–cilgavimab dose provided statistically and clinically significant protection against progression to severe COVID-19 or death versus placebo in unvaccinated individuals and safety was favourable. Treating mild to moderate COVID-19 earlier in the disease course with tixagevimab–cilgavimab might lead to more favourable outcomes.
Læs mere
Tjek på PubMed
15
Patient Information: Preventive Medication for COVID-19 Infection
Journal of the American Medical Association, 20.09.2022
Tilføjet 20.09.2022
This JAMA Patient Page describes the combination medication tixagevimab-cilgavimab, which is used to help prevent COVID-19 infection in people with immunosuppression or who have had a COVID-19 vaccine reaction.
Læs mere
Tjek på PubMed
16
Evusheld Treatment Timing Set
Journal of the American Medical Association, 16.08.2022
Tilføjet 16.08.2022
People eligible for COVID-19 preexposure prophylaxis (PrEP) with the monoclonal antibody combination of tixagevimab and cilgavimab (Evusheld) should be treated every 6 months to maintain protection against infection, according to the recently revised Fact Sheet for Healthcare Providers.
Læs mere
Tjek på PubMed
17
Pre-exposure prophylaxis with tixagevimab and cilgavimab (Evusheld©) for COVID-19 among 1112 severely immunocompromised patients
Yann Nguyen, Adrien Flahault, Nathalie Chavarot, Cléa Melenotte, Morgane Cheminant, Paul Deschamps, Nicolas Carlier, Emmanuel Lafont, Marion Thomas, Edouard Flamarion, David Lebeaux, Caroline Charlier, Anne Rachline, Corinne Guérin, Robert Ratiney, Justine Touchard, Hélène Péré, Flore Rozenberg, Fanny Lanternier, Jean-Benoît Arlet, Jérôme Avouac, Véronique Boussaud, Romain Guillemain, Marguerite Vignon, Eric Thervet, Anne Scemla, Laurence Weiss, Luc Mouthon, AP-HP-Centre Monoclonal Antibodies Working Group
Clinical Microbiology and Infection, 31.07.2022
Tilføjet 1.08.2022
Immunocompromised patients have an increased risk of severe form of COVID-19. The clinical efficacy of the tixagevimab/cilgavimab monoclonal antibody combination as pre-exposure prophylaxis against BA.1 and BA.2 SARS-CoV-2 Omicron sublineages is unknown. We aimed to describe the incidence and outcomes of COVID-19 among immunocompromised patients receiving tixagevimab/cilgavimab as preexposure prophylaxis, during the Omicron wave in France.
Læs mere
Tjek på PubMed
18
Evusheld Reduces COVID-19 Disease Severity Among Unvaccinated Adults
Journal of the American Medical Association, 26.07.2022
Tilføjet 26.07.2022
Tixagevimab plus cilgavimab, a SARS-CoV-2–neutralizing monoclonal antibody combination marketed as Evusheld, protected nonhospitalized individuals with mild to moderate COVID-19 symptoms from progressing to severe COVID-19 or death in a clinical trial. The study, published in The Lancet Respiratory Medicine, is the first to evaluate the intramuscular injection for outpatient treatment; other anti–SARS-CoV-2 monoclonal antibodies must be administered intravenously or subcutaneously.
Læs mere
Tjek på PubMed