Efficacy is variant dependent. In Vitro research suggests a lack of efficacy for omicron BQ.1.11, BA.5, BA.2.75, XBB, XBB.1.5, XMM.1.9.12,3. mAb use may create new variants that spread globally4,5, and may be associated with prolonged viral loads, clinical deterioration, and immune escape5-8.
Bebtelovimab was adopted
in 2 countries.
May 4 |
Bebtelovimab for COVID-19: real-time meta analysis of 6 studies | |
| Meta analysis using the most serious outcome reported shows 34% [-24‑65%] lower risk, without reaching statistical significance. Results are similar for peer-reviewed studies and worse for Randomized Controlled Trials. 2 studie.. | ||
Dec 25 2024 |
et al., Pulmonary Therapy, doi:10.1007/s41030-024-00284-w | Real-World Effectiveness of Bebtelovimab Versus Nirmatrelvir/Ritonavir in Outpatients with COVID-19 |
| Retrospective 5,827 matched pairs of non-hospitalized COVID-19 patients showing no significant differences between bebtelovimab and paxlovid treatment. Authors do not exclude patients with contraindications for paxlovid. | ||
Nov 12 2024 |
et al., Pharmacoepidemiology and Drug Safety, doi:10.1002/pds.70043 | Investigating the Safety Profile of Fast‐Track COVID‐19 Drugs Using the FDA Adverse Event Reporting System Database: A Comparative Observational Study |
| FAERS adverse event analysis for remdesivir, bebtelovimab, molnupiravir, and paxlovid. Top 10 signals for serious adverse drug reactions for remdesivir included death and acute kidney injury, for paxlovid: disease recurrence and rebound, .. | ||
Sep 19 2024 |
et al., Antiviral Research, doi:10.1016/j.antiviral.2024.106006 | Identification of antibody-resistant SARS-CoV-2 mutants via N4-Hydroxycytidine mutagenesis |
| In Vitro selection study identifying SARS-CoV-2 spike mutations that confer resistance to therapeutic antibodies. Using a Wuhan-like strain and omicron B.1.1.529, the authors used sequential mutagenesis with the molnupiravir active compou.. | ||
Aug 11 2024 |
, D., Current Topics in Microbiology and Immunology, doi:10.1007/82_2024_268 | Monoclonal Antibody Therapies Against SARS-CoV-2: Promises and Realities |
| Review of monoclonal antibodies for SARS-CoV-2. Author notes that the omicron variant has reset achievements to date. | ||
Aug 8 2024 |
et al., Clinical Infectious Diseases, doi:10.1093/cid/ciae408 | Single monoclonal antibodies should not be used for COVID-19 therapy: a call for antiviral stewardship |
| Review arguing against use of single monoclonal antibodies for COVID-19 treatment, particularly in immunosuppressed patients, due to the risk of rapidly selecting for resistant viral variants. Authors suggest that while monoclonal antibod.. | ||
Aug 5 2024 |
et al., Viral Immunology, doi:10.1089/vim.2024.0034 | Effective Treatment of COVID-19 Infection with Repurposed Drugs: Case Reports |
| Review of the successful treatment of COVID-19 using existing medications including HCQ, AZ, ivermectin, famotidine, monoclonal antibodies, and others. Authors note that the typical treatment of severe viral infections with multiple thera.. | ||
Mar 30 2024 |
et al., Infection, doi:10.1007/s15010-024-02223-y | SARS-CoV-2 journey: from alpha variant to omicron and its sub-variants |
| Review of SARS-CoV-2 variants showing increased transmissibility, disease severity, and immune escape with mutations in the spike protein receptor binding domain. Authors cover variants from the initial D614G mutation through omicron sub-.. | ||
Jan 26 2024 |
et al., JAMA Health Forum, doi:10.1001/jamahealthforum.2023.5044 | Clinical Risk and Outpatient Therapy Utilization for COVID-19 in the Medicare Population |
| Analysis of Medicare beneficiaries in 2022 showing that outpatient COVID-19 treatments like antivirals and monoclonal antibodies were disproportionately used by patients at lower risk of severe infection and outcomes. Retrospective studie.. | ||
Nov 30 2023 |
et al., iScience, doi:10.1016/j.isci.2023.108147 | Antiviral efficacy against and replicative fitness of an XBB.1.9.1 clinical isolate |
| In Vitro and animal study showing that the SARS-CoV-2 omicron subvariant XBB.1.9.1 has similar antigenicity, antiviral susceptibility, and replicative ability compared to XBB.1.5. Casirivimab, imdevimab, tixagevimab, cilgavimab, sotrovima.. | ||
Sep 27 2023 |
et al., Microorganisms, doi:10.3390/microorganisms11102417 | Prevalence of SARS-CoV-2 Omicron Sublineages and Spike Protein Mutations Conferring Resistance against Monoclonal Antibodies in a Swedish Cohort during 2022–2023 |
| Analysis of 7,950 SARS-CoV-2 samples from central Sweden collected between March 2022 and May 2023 tracking the prevalence of omicron sublineages and mutations in the spike protein conferring resistance to monoclonal antibodies over time... | ||
Aug 10 2023 |
et al., Drug Resistance Updates, doi:10.1016/j.drup.2023.100991 | Analysis of SARS-CoV-2 mutations associated with resistance to therapeutic monoclonal antibodies that emerge after treatment |
| Review of reports of treatment-emergent resistance to COVID-19 monoclonal antibodies (mAbs), showing that some post-mAb treatment mutations appeared to spread globally soon after the mAb was introduced, raising concerns about transmission.. | ||
Apr 28 2023 |
et al., PLOS ONE, doi:10.1371/journal.pone.0279326 | Lack of effectiveness of Bebtelovimab monoclonal antibody among high-risk patients with SARS-Cov-2 Omicron during BA.2, BA.2.12.1 and BA.5 subvariants dominated era |
| 86% lower mortality (p=0.25), 25% lower combined mortality/hospitalization (p=0.31), and 11% lower hospitalization (p=0.78). PSM retrospective 19,778 high-risk outpatients in the USA, showing no significant difference in outcomes with bebtelovimab treatment. | ||
Apr 16 2023 |
et al., International Journal of Infectious Diseases, doi:10.1016/j.ijid.2023.04.396 | Real-World Evaluation of Bebtelovimab Effectiveness During the Period of COVID-19 Omicron Variants including BA.4/BA.5 |
| 57% lower mortality (p=0.14), 59% lower ICU admission (p=0.05), 56% lower hospitalization (p<0.0001), and 33% higher progression (p=0.001). Retrospective 3,739 patients treated with bebteloviman in the USA and matched controls, showing lower mortality and hospitalization with treatment, but higher emergency department visits. | ||
Apr 4 2023 |
et al., Annals of Internal Medicine, doi:10.7326/M22-1286 | Evolving Real-World Effectiveness of Monoclonal Antibodies for Treatment of COVID-19 |
| 20% lower combined mortality/hospitalization (p=0.65). Retrospective 2,571 patients treated with mAbs in the USA, and 5,135 control patients, showing lower combined mortality/hospitalization for bamlanivimab, bamlanivimab/etesevimab, casirivimab/imdevimab, sotrovimab, and bebtelovimab, with s.. | ||
Nov 17 2022 |
et al., bioRxiv, doi:10.1101/2022.11.17.516888 | Resistance of Omicron subvariants BA.2.75.2, BA.4.6 and BQ.1.1 to neutralizing antibodies |
| In Vitro study suggesting a lack of efficacy for bebtelovimab with BQ.1.1. | ||
Oct 27 2022 |
et al., Open Forum Infectious Diseases, doi:10.1093/ofid/ofac565 | Bebtelovimab for high-risk outpatients with early COVID-19 in a large US health system |
| 86% lower mortality (p=0.25), 43% lower combined mortality/hospitalization (p=0.14), and 29% lower hospitalization (p=0.53). Retrospective 377 outpatients in the USA and matched controls, showing lower hospitalization/mortality with bebtelovimab treatment, without statistical significance. Notably, none of the patients that died in the control group were hospit.. | ||
Mar 12 2022 |
et al., medRxiv, doi:10.1101/2022.03.10.22272100 | Bebtelovimab, alone or together with bamlanivimab and etesevimab, as a broadly neutralizing monoclonal antibody treatment for mild to moderate, ambulatory COVID-19 |
| 25% faster recovery and 4% improved viral clearance (p<0.0001). RCT showing improved viral clearance with bebtelovimab. Results refer to the placebo controlled portion of the trial. | ||
Feb 12 2022 |
A Study of Immune System Proteins in Participants With Mild to Moderate COVID-19 Illness | |
| 36% improved viral clearance (p=0.07). RCT with 127 bamlanivimab, etesevimab, and bebtelovimab patients, 125 bebtelovimab patients, and 128 control patients, showing no significant differences in hospitalization and mortality. Viral clearance was improved although not statisti.. | ||
References
Planas et al., Resistance of Omicron subvariants BA.2.75.2, BA.4.6 and BQ.1.1 to neutralizing antibodies, bioRxiv, doi:10.1101/2022.11.17.516888.
Haars et al., Prevalence of SARS-CoV-2 Omicron Sublineages and Spike Protein Mutations Conferring Resistance against Monoclonal Antibodies in a Swedish Cohort during 2022–2023, Microorganisms, doi:10.3390/microorganisms11102417.
Uraki et al., Antiviral efficacy against and replicative fitness of an XBB.1.9.1 clinical isolate, iScience, doi:10.1016/j.isci.2023.108147.
Focosi et al., Analysis of SARS-CoV-2 mutations associated with resistance to therapeutic monoclonal antibodies that emerge after treatment, Drug Resistance Updates, doi:10.1016/j.drup.2023.100991.
Leducq et al., Spike protein genetic evolution in patients at high-risk of severe COVID-19 treated by monoclonal antibodies, The Journal of Infectious Diseases, doi:10.1093/infdis/jiad523.
Choudhary et al., Emergence of SARS-CoV-2 Resistance with Monoclonal Antibody Therapy, medRxiv, doi:10.1101/2021.09.03.21263105.
Günther et al., Variant-specific humoral immune response to SARS-CoV-2 escape mutants arising in clinically severe, prolonged infection, medRxiv, doi:10.1101/2024.01.06.24300890.
Casadevall et al., Single monoclonal antibodies should not be used for COVID-19 therapy: a call for antiviral stewardship, Clinical Infectious Diseases, doi:10.1093/cid/ciae408.
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