Tixagevimab/cilgavimab for prevention and treatment of COVID-19: a review

References

• Haidar G, Mellors JW. Improving the outcomes of immunocompromised patients with COVID-19. Clinl Infect Dis. 2021;73(6):e1397–e1401.
   PubMed Web of Science ®Google Scholar
• Lee A, Wong SY, Chai LYA, et al. Efficacy of COVID-19 vaccines in immunocompromised patients: systematic review and meta-analysis. BMJ. 2022;376:e068632.
   PubMedGoogle Scholar
• Bergwerk M, Gonen T, Lustig Y, et al. Covid-19 breakthrough infections in vaccinated health care workers. N Engl J Med. 2021;385(16):1474–1484.
   PubMed Web of Science ®Google Scholar
• Pantaleo G, Correia B, Fenwick C, et al. Antibodies to combat viral infections: development strategies and progress. Nat Rev Drug Discov. 2022;21(9):676–696.
   PubMed Web of Science ®Google Scholar
• Pelfrene E, Mura M, Cavaleiro Sanches A, et al. Monoclonal antibodies as anti-infective products: a promising future? Clin Microbiol Infect. 2019;25(1):60–64.
   PubMed Web of Science ®Google Scholar
• FACT SHEET FOR HEALTHCARE PROVIDERS: EMERGENCY USE AUTHORIZATION FOR EVUSHELD™ (tixagevimab co-packaged with cilgavimab) [Internet]. The U.S. Food and Drug Administration; 2021. [cited June 27 2022]. Available from: https://www.fda.gov/media/154701/download
   Google Scholar
• FACT SHEET FOR HEALTHCARE PROVIDERS: EMERGENCY USE AUTHORIZATION FOR BEBTELOVIMAB [Internet]. The U.S. Food and Drug Administration; 2022. [cited July 25 2022]. Available from: https://www.fda.gov/media/156152/download
   Google Scholar
• FACT SHEET FOR HEALTHCARE PROVIDERS: EMERGENCY USE AUTHORIZATION FOR ACTEMRA® (tocilizumab) [Internet]. The U.S. Food and Drug Administration; 2021. [cited July 25 2022]. Available from: https://www.fda.gov/media/150321/download
   Google Scholar
• FACT SHEET FOR HEALTH CARE PROVIDERS EMERGENCY USE AUTHORIZATION (EUA) OF REGEN-COV®(casirivimab and imdevimab) [Internet]. The U.S. Food and Drug Administration; 2021. [cited July 18 2022]. Available from: https://www.fda.gov/media/145611/download
   Google Scholar
• FACT SHEET FOR HEALTHCARE PROVIDERS EMERGENCY USE AUTHORIZATION (EUA) OF SOTROVIMAB [ Internet]. The U.S. Food and Drug Administration; 2022. [cited July 25]. Available from: https://www.fda.gov/media/149534/download
   Google Scholar
• FACT SHEET FOR HEALTH CARE PROVIDERS EMERGENCY USE AUTHORIZATION (EUA) OF BAMLANIVIMAB AND ETESEVIMAB [ Internet]. The U.S. Food and Drug Administration; 2022. [cited July 25]. Available from: https://www.fda.gov/media/145802/download
   Google Scholar
• Chen RE, Winkler ES, Case JB, et al. In vivo monoclonal antibody efficacy against SARS-CoV-2 variant strains. Nature. 2021;596(7870):103–108.
   PubMed Web of Science ®Google Scholar
• Chen RE, Zhang X, Case JB, et al. Resistance of SARS-CoV-2 variants to neutralization by monoclonal and serum-derived polyclonal antibodies. Nat Med. 2021;27(4):717–726.
   PubMed Web of Science ®Google Scholar
• Dejnirattisai W, Zhou D, Supasa P, et al. Antibody evasion by the P.1 strain of SARS-CoV-2. Cell. 2021;184(11):2939–2954.e2939.
   PubMed Web of Science ®Google Scholar
• Dejnirattisai W, Huo J, Zhou D, et al. SARS-CoV-2 Omicron-B.1.1.529 leads to widespread escape from neutralizing antibody responses. Cell. 2022;185(3):467–484.e415.
   PubMed Web of Science ®Google Scholar
• Zhou D, Dejnirattisai W, Supasa P, et al. Evidence of escape of SARS-CoV-2 variant B.1.351 from natural and vaccine-induced sera. Cell. 2021;184(9):2348–2361.e2346.
   PubMed Web of Science ®Google Scholar
• Zost SJ, Gilchuk P, Chen RE, et al. Rapid isolation and profiling of a diverse panel of human monoclonal antibodies targeting the SARS-CoV-2 spike protein. Nat Med. 2020;26(9):1422–1427.
   PubMed Web of Science ®Google Scholar
• Zost SJ, Gilchuk P, Case JB, et al. Potently neutralizing and protective human antibodies against SARS-CoV-2. Nature. 2020;584(7821):443–449.
   PubMed Web of Science ®Google Scholar
• Dong J, Zost SJ, Greaney AJ, et al. Genetic and structural basis for SARS-CoV-2 variant neutralization by a two-antibody cocktail. Nat Microbiol. 2021;6(10):1233–1244.
   PubMed Web of Science ®Google Scholar
• Loo YM, McTamney PM, Arends RH, et al. The SARS-CoV-2 monoclonal antibody combination, AZD7442, is protective in nonhuman primates and has an extended half-life in humans. Sci Transl Med. 2022;14(635):eabl8124.
   PubMed Web of Science ®Google Scholar
• Robbie GJ, Criste R, Dall’acqua WF, et al. A novel investigational Fc-modified humanized monoclonal antibody, motavizumab-YTE, has an extended half-life in healthy adults. Antimicrob Agents Chemother. 2013;57(12):6147–6153.
   PubMed Web of Science ®Google Scholar
• Levin MJ, Ustianowski A, De Wit S, et al., Intramuscular AZD7442 (Tixagevimab-Cilgavimab) for prevention of covid-19. N Engl J Med. 2022;386(23):2188–2200.
   PubMed Web of Science ®Google Scholar
• Oganesyan V, Gao C, Shirinian L, et al. Structural characterization of a human Fc fragment engineered for lack of effector functions. Acta Crystallogr D Biol Crystallogr. 2008;64(6):700–704.
   PubMedGoogle Scholar
• Montgomery H, Hobbs FDR, Padilla F, et al. 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. Lancet Respir Med. 2022;10(10):985–996.
   PubMedGoogle Scholar
• ACTIV-3–Therapeutics for Inpatients with COVID-19 (TICO) Study Group. Tixagevimab–cilgavimab for treatment of patients hospitalised with COVID-19: a randomised, double-blind, phase 3 trial. Lancet Respir Med. 2022. 10.1016/S2213-2600(22)00215-6.
   Google Scholar
• Kertes J, David SSB, Engel-Zohar N, et al. Association between AZD7442 (tixagevimab-cilgavimab) administration and SARS-CoV-2 infection, hospitalization and mortality. Clinl Infect Dis. 2022;ciac625. DOI:10.1093/cid/ciac625.
   PubMed Web of Science ®Google Scholar
• Kaminski H, Gigan M, Vermorel A, et al. COVID-19 morbidity decreases with tixagevimab-cilgavimab preexposure prophylaxis in kidney transplant recipient nonresponders/low-vaccine responders. Kidney Int. 2022;102(4):936–938.
   PubMed Web of Science ®Google Scholar
• Ollila TA, Masel RH, Reagan JL, et al. Seroconversion and outcomes after initial and booster COVID-19 vaccination in adults with hematologic malignancies. Cancer. 2022;128(18):3319–3329.
   PubMed Web of Science ®Google Scholar
• Al Jurdi A, Morena L, Cote M, et al. Tixagevimab/cilgavimab pre-exposure prophylaxis is associated with lower breakthrough infection risk in vaccinated solid organ transplant recipients during the omicron wave. Am J Transplant. 2022. DOI:10.1111/ajt.17128.
   Web of Science ®Google Scholar
• Benotmane I, Velay A, Gautier-Vargas G, et al. Breakthrough Covid-19 cases despite tixagevimab and cilgavimab (Evusheld™) prophylaxis in kidney transplant recipients. Am J Transplant. 2022a. DOI:10.1111/ajt.17121.
   PubMed Web of Science ®Google Scholar
• Stuver R, Shah GL, Korde NS, et al. Activity of AZD7442 (tixagevimab-cilgavimab) against Omicron SARS-CoV-2 in patients with hematologic malignancies. Cancer Cell. 2022;40(6):590–591.
   PubMed Web of Science ®Google Scholar
• Ordaya EE, Beam E, Yao JD, et al. Characterization of early-onset severe acute respiratory syndrome coronavirus 2 infection in immunocompromised patients who received tixagevimab-cilgavimab prophylaxis. Open Forum Infect Dis. 2022;9(7):ofac283.
   PubMed Web of Science ®Google Scholar
• Young-Xu Y, Epstein L, Marconi VC, et al. Tixagevimab/Cilgavimab for prevention of COVID-19 during the omicron surge: retrospective analysis of national VA electronic data. medRxiv. 2022. DOI:10.1101/2022.05.28.22275716.
   Google Scholar
• Karaba AH, Kim JD, Chiang TP, et al. Omicron BA.1 and BA.2 neutralizing activity following pre-exposure prophylaxis with tixagevimab plus cilgavimab in vaccinated solid organ transplant recipients. medRxiv. 2022. DOI:10.1101/2022.05.24.22275467.
   PubMedGoogle Scholar
• Benotmane I, Velay A, Gautier-Vargas G, et al. Pre-exposure prophylaxis with 300 mg Evusheld elicits limited neutralizing activity against the Omicron variant. Kidney Int. 2022b;102(2):442–444.
   PubMed Web of Science ®Google Scholar
• Bertrand D, Laurent C, Lemee V, et al. Efficacy of anti-SARS-CoV-2 monoclonal antibody prophylaxis and vaccination on the Omicron variant of COVID-19 in kidney transplant recipients. Kidney Int. 2022;102(2):440–442.
   PubMed Web of Science ®Google Scholar
• Conte WL, Golzarri-Arroyo L. Tixagevimab and cilgavimab (Evusheld) boosts antibody levels to SARS-CoV-2 in patients with multiple sclerosis on b-cell depleters. Mult Scler Relat Disord. 2022;63:103905.
   PubMed Web of Science ®Google Scholar
• Fitzsimmons WE. COVID-19 vaccine associated transverse myelitis-Evusheld as an option when vaccination is not recommended due to severe adverse events. Hum Vaccin Immunother. 2022;18(5):2068338.
   PubMed Web of Science ®Google Scholar
• Bruel T, Hadjadj J, Maes P, et al. Serum neutralization of SARS-CoV-2 Omicron sublineages BA.1 and BA.2 in patients receiving monoclonal antibodies. Nat Med. 2022;28(6):1297–1302.
   PubMed Web of Science ®Google Scholar
• Lafont E, Pere H, Lebeaux D, et al. Targeted SARS-CoV-2 treatment is associated with decreased mortality in immunocompromised patients with COVID-19. J Antimicrob Chemother. 2022;77(10):2688–2692.
   PubMed Web of Science ®Google Scholar
• Vellas C, Kamar N, Izopet J. Resistance mutations in SARS-CoV-2 omicron variant after tixagevimab-cilgavimab treatment. J Infect. 2022. DOI:10.1016/j.jinf.2022.07.014
   PubMed Web of Science ®Google Scholar
• Tao K, Tzou PL, Kosakovsky Pond SL, et al. Susceptibility of SARS-CoV-2 omicron variants to therapeutic monoclonal antibodies: systematic review and meta-analysis. Microbiol Spectr. 2022;10(4):e0092622.
   PubMedGoogle Scholar
• Aggarwal A, Akerman A, Milogiannakis V, et al. SARS-CoV-2 Omicron BA.5: evolving tropism and evasion of potent humoral responses and resistance to clinical immunotherapeutics relative to viral variants of concern. medRxiv. 2022. DOI:10.1101/2022.07.07.22277128.
   PubMedGoogle Scholar
• Arora P, Zhang L, Kruger N, et al. SARS-CoV-2 Omicron sublineages show comparable cell entry but differential neutralization by therapeutic antibodies. Cell Host Microbe. 2022;30(8):1103–1111.e6.
   PubMed Web of Science ®Google Scholar
• Boschi C, Colson P, Bancod A, et al. Omicron variant escapes therapeutic mAbs including recently released Evusheld®, contrary to eight prior main VOC. Clin Infect Dis. 2022;75(1):e534–e535.
   PubMed Web of Science ®Google Scholar
• Cao Y, Yisimayi A, Jian F, et al. BA.2.12.1, BA.4 and BA.5 escape antibodies elicited by Omicron infection. Nature. 2022;608(7923):593–602.
   PubMed Web of Science ®Google Scholar
• Case JB, Mackin S, Errico JM, et al. Resilience of S309 and AZD7442 monoclonal antibody treatments against infection by SARS-CoV-2 Omicron lineage strains. Nat Commun. 2022;13(1):3824.
   PubMed Web of Science ®Google Scholar
• Duty JA, Kraus T, Zhou H, et al. Discovery and intranasal administration of a SARS-CoV-2 broadly acting neutralizing antibody with activity against multiple Omicron subvariants. Med (N Y). 2022. DOI:10.1016/j.medj.2022.08.002
   PubMedGoogle Scholar
• Fenwick C, Turelli P, Ni D, et al. Patient-derived monoclonal antibody neutralizes SARS-CoV-2 Omicron variants and confers full protection in monkeys. Nat Microbiol. 2022;7(9):1376–1389.
   PubMed Web of Science ®Google Scholar
• Nutalai R, Zhou D, Tuekprakhon A, et al. Potent cross-reactive antibodies following Omicron breakthrough in vaccinees. Cell. 2022;185(12):2116–2131.e2118.
   PubMed Web of Science ®Google Scholar
• Planas D, Saunders N, Maes P, et al. Considerable escape of SARS-CoV-2 Omicron to antibody neutralization. Nature. 2022;602(7898):671–675.
   PubMed Web of Science ®Google Scholar
• Takashita E, Kinoshita N, Yamayoshi S, et al. Efficacy of antibodies and antiviral drugs against covid-19 omicron variant. N Engl J Med. 2022;386(10):995–998.
   PubMed Web of Science ®Google Scholar
• Takashita E, Kinoshita N, Yamayoshi S, et al. Efficacy of antiviral agents against the SARS-CoV-2 Omicron Subvariant BA.2. N Engl J Med. 2022;386(15):1475–1477.
   PubMed Web of Science ®Google Scholar
• Takashita E, Yamayoshi S, Simon V, et al. Efficacy of antibodies and antiviral drugs against omicron BA.2.12.1, BA.4, and BA.5 subvariants. N Engl J Med. 2022;386(15):1475–1477.
   PubMed Web of Science ®Google Scholar
• Touret F, Baronti C, Pastorino B, et al. In vitro activity of therapeutic antibodies against SARS-CoV-2 Omicron BA.1, BA.2 and BA.5. Sci Rep. 2022;12(1):12609.
   PubMed Web of Science ®Google Scholar
• Touret F, Baronti C, Bouzidi HS, et al. In vitro evaluation of therapeutic antibodies against a SARS-CoV-2 Omicron B.1.1.529 isolate. Sci Rep. 2022;12(1):4683.
   PubMed Web of Science ®Google Scholar
• VanBlargan LA, Errico JM, Halfmann PJ, et al. An infectious SARS-CoV-2 B.1.1.529 Omicron virus escapes neutralization by therapeutic monoclonal antibodies. Nat Med. 2022;28(3):490–495.
   PubMed Web of Science ®Google Scholar