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All Studies   Meta Analysis    Recent:   

Rapid Selection of Sotrovimab Escape Variants in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Omicron-Infected Immunocompromised Patients

Gliga et al., Clinical Infectious Diseases, doi:10.1093/cid/ciac802
Oct 2022  
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Sotrovimab for COVID-19
39th treatment shown to reduce risk in May 2023
 
*, now known with p = 0.0017 from 22 studies, recognized in 37 countries. Efficacy is variant dependent.
Lower risk for hospitalization.
No treatment is 100% effective. Protocols combine complementary and synergistic treatments. * >10% efficacy in meta analysis with ≥3 clinical studies.
4,200+ studies for 70+ treatments. c19early.org
Prospective analysis of 57 COVID-19 patients receiving sotrovimab, showing rapid creation of escape mutations within immunodeficient patients. Combined treatment with remdesivir reduced the creation of escape variants.
Efficacy is variant dependent. In Vitro studies predict lower efficacy for BA.1 Liu, Sheward, VanBlargan, BA.4, BA.5 Haars, XBB.1.9.3, XBB.1.5.24, XBB.2.9, CH.1.1 Pochtovyi, and no efficacy for BA.2 Zhou, ХВВ.1.9.1, XBB.1.16, BQ.1.1.45, and CL.1 Pochtovyi. US EUA has been revoked.
Gliga et al., 3 Oct 2022, prospective, Germany, peer-reviewed, 21 authors, study period 20 January, 2022 - 25 February, 2022. Contact: nadine.luebke@med.uniduesseldorf.de.
This PaperSotrovimabAll
Rapid Selection of Sotrovimab Escape Variants in Severe Acute Respiratory Syndrome Coronavirus 2 Omicron-Infected Immunocompromised Patients
Smaranda Gliga, Nadine Lübke, Alexander Killer, Henning Gruell, Andreas Walker, Alexander T Dilthey, Alexander Thielen, Carolin Lohr, Charlotte Flaßhove, Sarah Krieg, Joanna Ventura Pereira, Tobias Paul Seraphin, Alex Zaufel, Martin Däumer, Hans-Martin Orth, Torsten Feldt, Johannes G Bode, Florian Klein, Jörg Timm, Tom Luedde, Björn-Erik Ole Jensen
Clinical Infectious Diseases, doi:10.1093/cid/ciac802
Background. Monoclonal antibodies (mAbs) that target severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are predominantly less effective against Omicron variants. Immunocompromised patients often experience prolonged viral shedding, resulting in an increased risk of viral escape. Methods. In an observational, prospective cohort, 57 patients infected with Omicron variants who received sotrovimab alone or in combination with remdesivir were followed. The study end points were a decrease in SARS-CoV-2 RNA <10 6 copies/mL in nasopharyngeal swabs at day 21 and the emergence of escape mutations at days 7, 14, and 21 after sotrovimab administration. All SARS-CoV-2 samples were analyzed using whole-genome sequencing. Individual variants within the quasispecies were subsequently quantified and further characterized using a pseudovirus neutralization assay. Results. The majority of patients (43 of 57, 75.4%) were immunodeficient, predominantly due to immunosuppression after organ transplantation or hematologic malignancies. Infections by Omicron/BA.1 comprised 82.5%, while 17.5% were infected by Omicron/ BA.2. Twenty-one days after sotrovimab administration, 12 of 43 (27.9%) immunodeficient patients had prolonged viral shedding compared with 1 of 14 (7.1%) immunocompetent patients (P = .011). Viral spike protein mutations, some specific for Omicron (e.g., P337S and/or E340D/V), emerged in 14 of 43 (32.6%) immunodeficient patients, substantially reducing sensitivity to sotrovimab in a pseudovirus neutralization assay. Combination therapy with remdesivir significantly reduced emergence of escape variants. Conclusions. Immunocompromised patients face a considerable risk of prolonged viral shedding and emergence of escape mutations after early therapy with sotrovimab. These findings underscore the importance of careful monitoring and the need for dedicated clinical trials in this patient population.
Supplementary Data Supplementary materials are available at Clinical Infectious Diseases online. Consisting of data provided by the authors to benefit the reader, the posted materials are not copyedited and are the sole responsibility of the authors, so questions or comments should be addressed to the corresponding author. Notes
References
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Author Contributions, for conceptualization and supervised the study
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All SARS-CoV-2 samples were analyzed using whole-genome ' 'sequencing. Individual variants within the quasispecies were subsequently quantified and ' 'further characterized using a pseudovirus neutralization assay.</jats:p>\n' ' </jats:sec>\n' ' <jats:sec>\n' ' <jats:title>Results</jats:title>\n' ' <jats:p>The majority of patients (43 of 57, 75.4%) were immunodeficient, ' 'predominantly due to immunosuppression after organ transplantation or hematologic ' 'malignancies. Infections by Omicron/BA.1 comprised 82.5%, while 17.5% were infected by ' 'Omicron/BA.2. Twenty-one days after sotrovimab administration, 12 of 43 (27.9%) ' 'immunodeficient patients had prolonged viral shedding compared with 1 of 14 (7.1%) ' 'immunocompetent patients (P = .011). Viral spike protein mutations, some specific for Omicron ' '(e.g., P337S and/or E340D/V), emerged in 14 of 43 (32.6%) immunodeficient patients, ' 'substantially reducing sensitivity to sotrovimab in a pseudovirus neutralization assay. ' 'Combination therapy with remdesivir significantly reduced emergence of escape ' 'variants.</jats:p>\n' ' </jats:sec>\n' ' <jats:sec>\n' ' <jats:title>Conclusions</jats:title>\n' ' <jats:p>Immunocompromised patients face a considerable risk of prolonged ' 'viral shedding and emergence of escape mutations after early therapy with sotrovimab. 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'2022110217382301200_ciac802-B25', 'volume': '386', 'year': '2022'}, { 'DOI': '10.3389/fcimb.2022.839170', 'article-title': 'SARS-CoV-2: recent variants and clinical efficacy of antibody-based ' 'therapy', 'author': 'Singh', 'doi-asserted-by': 'publisher', 'first-page': '839170', 'journal-title': 'Front Cell Infect Microbiol', 'key': '2022110217382301200_ciac802-B26', 'volume': '12', 'year': '2022'}, { 'DOI': '10.3390/v13081642', 'article-title': 'Emergence of E484K mutation following bamlanivimab monotherapy among ' 'high-risk patients infected with the Alpha variant of SARS-CoV-2', 'author': 'Peiffer-Smadja', 'doi-asserted-by': 'publisher', 'first-page': '1642', 'journal-title': 'Viruses', 'key': '2022110217382301200_ciac802-B27', 'volume': '13', 'year': '2021'}, { 'DOI': '10.1016/B978-0-12-809633-8.20958-8', 'article-title': 'Genetic diversity and evolution of viral populations', 'author': 'Sanjuán', 'doi-asserted-by': 'publisher', 'first-page': '53', 'journal-title': 'Encyclopedia 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Please send us corrections, updates, or comments. c19early involves the extraction of 100,000+ datapoints from thousands of papers. Community updates help ensure high accuracy. Treatments and other interventions are complementary. All practical, effective, and safe means should be used based on risk/benefit analysis. No treatment or intervention is 100% available and effective for all current and future variants. We do not provide medical advice. Before taking any medication, consult a qualified physician who can provide personalized advice and details of risks and benefits based on your medical history and situation. FLCCC and WCH provide treatment protocols.
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