Evusheld (cilgavimab/tixagevimab) / AstraZeneca - LARVOL DELTA

Clinical outcomes of immunocompromised patients administered tixagevimab-cilgavimab as pre-exposure prophylaxis for COVID-19: real-world experience in Taiwan. (PubMed, Int J Infect Dis) - "Tixagevimab/cilgavimab -treated immunocompromised patients had a low rate of subsequent severe or critical COVID-19. Our study provides insights into the role of future monoclonal antibodies as COVID-19 pre-exposure prophylaxis among immunocompromised patients and emphasizes the need for ongoing research."

Clinical data • Journal • Real-world evidence • Hematological Disorders • Hematological Malignancies • Immunology • Infectious Disease • Novel Coronavirus Disease • Oncology • Respiratory Diseases • Solid Organ Transplantation • Solid Tumor • Transplantation

Stochastic Gates for Covariate Selection in Population Pharmacokinetics Modeling. (PubMed, CPT Pharmacometrics Syst Pharmacol) - "In real clinical data from a monalizumab study, the method successfully identified covariates that matched those found by experts. However, for tixagevimab/cilgavimab, it identified a superset of covariates, indicating a potential need for further pruning. This machine learning-based method enhances the covariate preselection process in population pharmacokinetics model development, offering significant time savings and improving efficiency even under challenging scenarios."

Journal • PK/PD data

Value of Emerging and Existing Pre-prophylaxis and Therapeutic Options for COVID-19 in Transplant Recipients: A Systematic Review of Economic Evaluations. (PubMed, Pharmacoecon Open) - "Cost effectiveness varied widely across studies due to differences in variant periods, population risk profiles, model assumptions, and healthcare systems. Future research should integrate variant-specific effectiveness, real-world vaccine responsiveness, long-term COVID-19 outcomes, and adverse events to better inform resource allocation for transplant and other high-risk populations."

HEOR • Journal • Review • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • Transplantation

Safety and Pharmacokinetics of Repeat Dosing of Long-Acting SARS-CoV-2 Antibodies Tixagevimab/Cilgavimab (AZD7442): Results from the PROVENT Sub-study. (PubMed, Clin Drug Investig) - P3 | "AZD7442 safety, pharmacokinetic, and ADA response profiles were similar regardless of repeat dosing schedule, and consistent with single-dose study data. These results may support future use of long-acting antibodies."

Journal • PK/PD data • Cardiovascular • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Viral clearance and escape during therapy of COVID-19 outpatients: A prospective cohort study. (PubMed, iScience) - "The emergence of mutations within Spike was observed in 21.9% of patients, all being immunocompromised treated by Sotrovimab or Tixagevimab/Cilgavimab after Omicron emergence, and was independently associated with higher viral load and serum neutralization at day 7. Our data show that suboptimal neutralizing antibodies should be avoided in immunocompromised individuals, given the risk of emergence of viral escape mutations."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Efficacy, safety, pharmacokinetics, immunogenicity, and serum neutralizing activity of AZD7442 (tixagevimab-cilgavimab) in hospitalized COVID-19 patients: long-term results from the DisCoVeRy trial. (PubMed, Clin Microbiol Infect) - "AZD7442 did not demonstrate any clinical benefit and was safe up to 15 months. This study also provides valuable data on the pharmacokinetics, immunogenicity, and neutralizing activity of AZD7442 in hospitalized COVID-19 patients."

Journal • PK/PD data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Prophylactic role of tixagevimab/cilgavimab for COVID-19 in newly transplanted kidney recipients: Single-center experience and review of literature. (PubMed, World J Transplant) - "Tixagevimab/cilgavimab has a favorable safety profile when administered in newly transplanted kidney recipients. Although breakthrough infections were not uncommon, there was a low rate of hospitalization and no deaths. This study highlights the need to examine the efficacy of novel monoclonal antibodies administered for COVID-19 prophylaxis in newly transplanted recipients."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • Solid Organ Transplantation • Transplantation

Real World Evaluation of Evusheld in Prevention of COVID-19 in Immunocompromised Patients: An Observational Cohort Study. (PubMed, Am J Med Sci) - "Within six months of Evusheld administration, immunocompromised patients showed no episodes of rehospitalization, mechanical ventilation, or death, and experienced low rates of severe COVID-19."

HEOR • Journal • Observational data • Real-world evidence • Hematological Disorders • Hematological Malignancies • Infectious Disease • Novel Coronavirus Disease • Oncology • Respiratory Diseases • Solid Tumor

Impact of COVID-19 in Patients with Chronic Lymphocytic Leukemia Treated with Venetoclax: A Possible Role of the Association to Anti-CD20 Antibody? a Multicentre Seifem Study (ASH 2023) - "The retrospective multicenter study included CLL patients treated since 2017 with venetoclax single agent until progression or toxicity or venetoclax plus anti-CD20 antibody (mainly rituximab as part of VR protocol for 24 months in relapsed/refractory patients or obinutuzumab as part of VO protocol for 12 months in untreated patients)...Prophylaxis with tixagevimab/cilgavimab was administered in less than 20% of the patients...Remdesivir was chosen as treatment in 48.9%, nirmatrelvir/ritonavir in 21.3%...The analysis found over a third of patients infected by SARS-CoV-2, in 57% of the cases the infection was grade 1-2 with a mortality rate of almost 10%, but higher if COVID-19 was of grade 3-4 (18.2%). We confirmed the association of anti-CD20 antibody to venetoclax as a risk factor for SARS-CoV-2 infection and mortality rate in patients with CLL and severe COVID-19."

Clinical • Chronic Lymphocytic Leukemia • Hematological Malignancies • Infectious Disease • Leukemia • Novel Coronavirus Disease • Oncology • Respiratory Diseases

Severe COVID-19 Infection in Patients with Chronic Lymphocytic Leukemia or Indolent B-Cell Non-Hodgkin Lymphoma Who Received Pre-Exposure Prophylaxis with Tixagevimab and Cilgavimab in Italy: Preliminary Results of the Observational Study By the Gimema Working Party on Chronic Lymphoproliferative Disorders and By the Fondazione Italiana Linfomi (ASH 2024) - P | "These patients respond poorly to vaccination, especially those receiving anti-CD20 monoclonal antibodies, Bruton tyrosine kinase inhibitors (BTKi) or the BCL2 inhibitor venetoclax...At 6 months from PrEP, 159/513 patients (31%) had a COVID-19 infection and 39% of these patients received an anti-viral treatment with nirmatrelvir/ritonavir or remdesivir...Noteworthy, 17/18 cases of severe COVID infection occurred in a period (August 2022-January 2023) in which the Omicron sub-variants BA.5 and BQ.1 were prevalent in Italy. In conclusion, in this population of CLL and iB-NHL at high risk for poor response to vaccination, the modern management strategy that included PrEP with tixagevimab and cilgavimab and treatment with antiviral drugs resulted in low rates of severe COVID infection and death."

Clinical • Observational data • Chronic Lymphocytic Leukemia • Follicular Lymphoma • Hematological Malignancies • Indolent Lymphoma • Infectious Disease • Leukemia • Lymphoma • Lymphoplasmacytic Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Respiratory Diseases • Waldenstrom Macroglobulinemia

Incidence and Management of COVID-19 Infections in Vaccinated Patients with CLL (ASH 2023) - P | "The incidence of COVID-19 was comparable amongst men and women in the initial cohort (4%, 2%) and booster cohort (25%, 24%) as well as those who received mRNA-1273 and BNT162b2 vaccines (2%, 4%) and (24%, 26%). There were no infections in the 6 pts who received Ad26.COV2.S in the initial cohort nor 4 in booster cohort. Infections by treatment in initial cohort: 1% of treatment-native, 4% BTKi, 7% CD20 mAb + venetoclax, 9% BTKi + venetoclax...All infections (8/8) occurred in the initial cohort prior to the receipt of tixagevimab/cilgavimab or in those who did not receive prophylaxis; 84% (27/32) in the booster cohort... There were 243 pts enrolled in the initial vaccine cohort from 03/21-09/21 and 129 in the booster cohort from 08/21-02/22; 73 pts from initial cohort enrolled into the booster cohort. Patient characteristics are in Table 1. Eight pts (3.3%) reported COVID-19 in the initial cohort within 1 year of receiving the initial vaccine or prior to receipt of a..."

Clinical • Chronic Lymphocytic Leukemia • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • CD20

The Efficacy and Safety of Tixagevimab/Cilgavimab (AZD7442) Against Sars-Cov-2 Omicron BA.5 for Patients with Hematologic Malignancies (ASH 2023) - "6%) received Rituximab-based therapy. Figure. Anti-SARS-CoV-2 spike protein antibody (Anti-S) titers after admistration of tixagevimab/cilgavimab (AZD7442/Evusheld)"

Clinical • Hematological Malignancies • Infectious Disease • Leukemia • Lymphoma • Multiple Myeloma • Oncology • Respiratory Diseases

Efficacy and Safety of Tixagevimab-Cilgavimab (Evusheld or AZD7442) As Pre-Exposure Prophylaxis for COVID-19 Among Allogeneic Hematopoietic Stem Cell Transplant Recipients (ASH 2023) - "Our study found no evidence of efficacy of Evusheld against COVID-19 after Allo-HSCT transplant. This lack of efficacy may be attributed to the emergence of the XBB. 1."

Clinical • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Cardiovascular • Chronic Myeloid Leukemia • Cytomegalovirus Infection • Diabetes • Dyslipidemia • Epstein-Barr Virus Infections • Graft versus Host Disease • Hematological Malignancies • Hypertension • Immunology • Infectious Disease • Leukemia • Metabolic Disorders • Myelodysplastic Syndrome • Novel Coronavirus Disease • Oncology • Transplantation

Efficacy of Monoclonal Antibody Tixagevimab/Cilgavimab for Prevention of Sars-Cov-2 Infection Among Cancer Patients: Double Blined Randomized Placebo Controlled Trail (ProvMAB trial) (ASH 2023) - "DiscussionIn this study, we present our findings comparing Tixagevimab/Cilgavimab in immunocompromised patients who received over three doses of vaccination for the prevention of SARS-CoV-2 infection in patients with hematologic malignancies and Oncologic malignancies undergoing chemotherapy during the SARS-CoV-2 omicron surge. Our results suggest that booster vaccinations, beyond the standard three doses, were sufficient to protect against SARS-CoV-2 infection in this particular patient population, considering their ongoing standard of care during the pandemic variant in the future."

Clinical • Hematological Malignancies • Infectious Disease • Oncology • Respiratory Diseases

Pre-Graft Vaccination or Infection Do Not Provide More Protection Against COVID-19 Infections in Post-Graft Vaccinated Recipients of Allogeneic Stem Cell Transplantation (ASH 2023) - "Some pts also received tixagevimab and cilgavimab (Tix/cil) as preventive treatment after Allo-HSCT during the Delta wave...Conclusion : In this study, post-Allo-SCT vaccination appears to be of crucial importance to protect recipients against COVID-19 infections. Pre-graft vaccine or infection are not associated with less COVID-19 infections nor severe forms of the disease in pts vaccinated after transplant, suggesting that post-graft vaccination is sufficient to ensure good protection in these pts."

Bone Marrow Transplantation • Hematological Disorders • Hematological Malignancies • Infectious Disease • Novel Coronavirus Disease • Transplantation

Toward a Brighter Future for Preventing COVID-19 in Patients With Hematologic Malignancies: Leveraging the Power of Current Strategies and Next-Generation Agents (ASH 2023) - "Tixagevimab/cilgavimab lost its emergency use authorization as prevention for immunocompromised patients because of its lack of efficacy against newer variants. However, next-generation prevention agents are in development, including a new monoclonal antibody, AZD3152...PeerView's expert faculty will discuss strategies to engage patients with elevated risk of serious COVID-19 infection in the development of customized prevention plans. In addition, they will explore approaches to overcoming real-time barriers to access and use of available options for prevention of serious COVID-19 illness."

Clinical • Hematological Malignancies • Infectious Disease • Novel Coronavirus Disease • Oncology

Waning Long Term Efficacy of COVID-19 Post-Transplant Vaccination for Prevention of COVID-19 Adverse Events in Transplant and Cellular Therapy (TCT) Patients (ASH 2024) - "Per guideline recommendations and institutional policy, all patients post-TCT were offered COVID-19 vaccination and bivalent booster, as well as tixagevimab-cilgavimab (Evusheld) during the period it was available under FDA emergency authorization...These findings highlight the impact of COVID-19 re-vaccination to reduce COVID-19 related AEs and serious COVID-19 infections in the first year post-TCT, but also demonstrate waning long term efficacy beyond 1-year post-TCT. Further research is needed to confirm these observations and to further elucidate the potential mechanisms for diminished long-term efficacy of COVID-19 vaccination in the post-TCT population."

Adverse events • Clinical • Post-transplantation • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • Transplantation

Retrospective Study Assessing Acceptance of Tixagevimab and Cilgavimab (Evusheld) Among Immunocompromised Patients (ACG 2025) - "Inclusion criteria were the following: received a solid-organ transplant within 1 year, used biologic agents, immunosuppressive medications, or high-dose corticosteroids (i.e., ≥20 mg prednisone or equivalent per day when administered for ≥2 weeks). 98 patients satisfied the inclusion criteria. There were 34 female and 64 male patients in the study (Table 1). 23 patients had underlying alcoholic cirrhosis, 23 patients had autoimmune hepatitis, 24 patients had ulcerative colitis, 4 patients had Crohn's disease, 2 patients had alcoholic hepatitis, 7 patients had a history of liver transplant, 4 patients had combined liver and kidney transplantation, 5 patients had human immunodeficiency virus, 3 patients had primary sclerosing cholangitis, 2 patients had primary biliary cirrhosis, and 1 patient had neuroendocrine tumor of the pancreas."

Retrospective data • Autoimmune Hepatitis • Crohn's disease • Fibrosis • Gastroenterology • Gastrointestinal Disorder • Hepatology • Human Immunodeficiency Virus • Immunology • Infectious Disease • Inflammatory Bowel Disease • Neuroendocrine Tumor • Novel Coronavirus Disease • Pancreatic Cancer • Primary Biliary Cholangitis • Solid Organ Transplantation • Solid Tumor • Ulcerative Colitis

RISK FACTORS AND OUTCOMES OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA WHO EXPERIENCED A SUBSEQUENT COVID-19 EVENT: A RETROSPECTIVE OBSERVATIONAL STUDY (SIE 2025) - "No differences were found in terms of Tixagevimab/cilgavimab prophylaxis (p=0.167) or additional vaccine doses (p=0.638)...Our "real word" study reveals a 33.8% rate of new COVID-19 events in CLL patients, with high comorbidity and active treatment as significant risk factors for reinfection. Moreover, our data show that SARS-CoV-2 vaccination delays reinfection, supporting booster doses to extend infection-free intervals."

Observational data • Retrospective data • Chronic Lymphocytic Leukemia • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases • IGH • TP53

Safety and pharmacokinetics of SARS-CoV-2 DNA-encoded monoclonal antibodies in healthy adults: a phase 1 trial. (PubMed, Nat Med) - P1 | "In this phase 1 dose-escalation study, we evaluated the safety, tolerability and pharmacokinetics of a pDNA cocktail encoding AZD5396 and AZD8076, modified versions of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) neutralizing mAb cocktail tixagevimab/cilgavimab in healthy adults...DMAb delivery may represent a long-acting, scalable, cold-chain-independent platform against a wide range of diseases that can be targeted with mAbs and their derivatives. ClinicalTrials.gov registration: NCT05293249."

Journal • P1 data • PK/PD data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A SARS-CoV-2 variant‑adjusted threshold of protection model for monoclonal antibody pre-exposure prophylaxis against COVID-19. (PubMed, Nat Commun) - P2/3, P3 | "Using efficacy data from the phase 3 PROVENT pre-exposure prophylaxis trial of tixagevimab-cilgavimab (NCT04625725), individual nAb ID50 titres were predicted by dividing serum mAb concentration by prevalence-adjusted tixagevimab-cilgavimab potency (from in vitro IC50 values combined with viral surveillance data) and related to efficacy with a Cox model. The Threshold of Protection (ToP) Cox model was externally validated using data from the phase 3 SUPERNOVA trial (NCT05648110), which assessed sipavibart efficacy against symptomatic COVID-19 in immunocompromised participants. The PROVENT ToP model estimated the variant-specific observed efficacies from SUPERNOVA for 3 and 6 months post any dose with Lin's concordance of 0.86 and 0.75, respectively. This approach integrates predicted nAb ID50 titres against multiple SARS-CoV-2 variants into a ToP model that can be applied across different variants and could serve as a surrogate endpoint in immunobridging..."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Safety, tolerability and efficacy of the use of tixagevimab/cilgavimab as pre-exposure COVID-19 prophylaxis in kidney and simultaneous pancreas kidney transplant recipients. (PubMed, Intern Med J) - "Less than 0.5% experienced adverse events from Evusheld®. Prophylactic monoclonal antibody therapy may be considered an important adjunct to vaccination among immunocompromised patients to prevent severe infection during future viral outbreaks."

Journal • Infectious Disease • Inflammation • Novel Coronavirus Disease • Pneumonia • Solid Organ Transplantation • Transplantation

Tixagevimab-Cilgavimab Effectively Prevents COVID-19 Infection in Patients with End-Stage Kidney Disease. (PubMed, Viruses) - "CK levels remained unchanged after administration. Tixagevimab-Cilgavimab was effective in reducing the risk of COVID-19 infection among ESKD patients, without evidence of adverse effects, supporting its use as a prophylactic agent in this high-risk population."

Journal • Retrospective data • Chronic Kidney Disease • Diabetes • Dyslipidemia • Infectious Disease • Metabolic Disorders • Nephrology • Novel Coronavirus Disease • Renal Disease • Transplantation • Type 2 Diabetes Mellitus

Rapid Elimination of Culturable SARS-CoV-2 With Intramuscular or Intravenous Administration of Antiviral Monoclonal Antibody Therapy. (PubMed, Open Forum Infect Dis) - "We evaluated intramuscular (IM) versus intravenous (IV) administration of tixagevimab/cilgavimab in early COVID-19. Both routes achieved rapid elimination of culturable virus and minimal emergence of resistance. These results support IM delivery as a viable alternative to IV, with important implications for scalable deployment in future viral pandemics."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

COVID-19 Outcomes in Kidney Transplant Recipients Receiving Tixagevimab/Cilgavimab for Pre-exposure Prophylaxis: A Single-center Retrospective Study. (PubMed, Transplant Proc) - "These real-world data show that pre-exposure prophylaxis with tixagevimab/cilgavimab was a feasible alternative for patients without sufficient serological response to vaccination during a period of Omicron dominance. Novel therapeutics are necessary for variants resistant to tixagevimab/cilgavimab."

Journal • Retrospective data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • Transplantation