Real-world Effectiveness of Sotrovimab for the Early Treatment of COVID-19 During SARS-CoV-2 Delta and Omicron Waves in the United States
PhD Mindy M Cheng, PhD Carolina Reyes, PhD Sacha Satram, PhD Helen Birch, MB Daniel C Gibbons, MPH Myriam Drysdale, Christopher F Bell, PhD Anvar Suyundikov, PhD Xiao Ding, M Cyrus Maher, MD Wendy Yeh, MD, PhD Amalio Telenti, MD Lawrence Corey
doi:10.1101/2022.09.07.22279497
Background Sotrovimab, a recombinant human monoclonal antibody (mAb) against SARS-CoV-2 had US FDA Emergency Use Authorization (EUA) for the treatment of high-risk outpatients with mildto-moderate COVID-19 from May 26, 2021 to April 5, 2022. The study objective was to evaluate the real-world effectiveness of sotrovimab in reducing the risk of 30-day all-cause hospitalization and/or mortality during the time period when the prevalence of circulating SARS-CoV-2 variants was changing between Delta and Omicron sub-lineages in the US.
Methods A retrospective analysis was conducted on de-identified claims data for 1,530,501 patients diagnosed with COVID-19 (ICD-10: U07.1) from September 1, 2021, to April 30, 2022, in the FAIR Health National Private Insurance Claims (FH NPIC ® ) database. Patients meeting EUA high-risk criteria were identified via pre-specified ICD-10-CM diagnoses in records ≤24 months prior to their first COVID-19 diagnosis and divided into two cohorts based on claimed procedural codes: treated with sotrovimab ("sotrovimab") and not treated with a mAb ("no mAb"). All-cause hospitalizations and facility-reported all-cause mortality within 30 days of diagnosis ("30-day hospitalization or mortality") were identified. Multivariable and propensity score-matched Poisson and logistic regressions were conducted to estimate the adjusted relative risk (RR) and odds of 30-day hospitalization or mortality among those treated with sotrovimab compared with those not treated with a mAb.
Results Of the high-risk COVID-19 patients identified, 15,633 were treated with sotrovimab and 1,514,868 were not treated with a mAb. Compared with the no mAb cohort, the sotrovimab All rights reserved. No reuse allowed without permission. preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.
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doi:10.1101/2022.04.21.22274060{ 'institution': [{'name': 'medRxiv'}],
'indexed': {'date-parts': [[2022, 9, 11]], 'date-time': '2022-09-11T15:41:40Z', 'timestamp': 1662910900586},
'posted': {'date-parts': [[2022, 9, 11]]},
'group-title': 'Health Economics',
'reference-count': 0,
'publisher': 'Cold Spring Harbor Laboratory',
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'abstract': '<jats:p>Background \n'
'Sotrovimab, a recombinant human monoclonal antibody (mAb) against SARS-CoV-2 had US FDA '
'Emergency Use Authorization (EUA) for the treatment of high-risk outpatients with '
'mild-to-moderate COVID-19 from May 26, 2021, to April 5, 2022. The study objective was to '
'evaluate the real-world effectiveness of sotrovimab in reducing the risk of 30-day all-cause '
'hospitalization and/or mortality during the time period when the prevalence of circulating '
'SARS-CoV-2 variants was changing between Delta and Omicron sub-lineages in the US.\n'
'Methods \n'
'A retrospective analysis was conducted on de-identified claims data for 1,530,501 patients '
'diagnosed with COVID-19 (ICD-10: U07.1) from September 1, 2021, to April 30, 2022, in the '
'FAIR Health National Private Insurance Claims (FH NPIC®) database. Patients meeting EUA '
'high-risk criteria were identified via pre-specified ICD-10-CM diagnoses in records ≤24 '
'months prior to their first COVID-19 diagnosis and divided into two cohorts based on claimed '
'procedural codes: treated with sotrovimab (″sotrovimab″) and not treated with a mAb (″no '
'mAb″). All-cause hospitalizations and facility-reported all-cause mortality within 30 days of '
'diagnosis (″30-day hospitalization or mortality″) were identified. Multivariable and '
'propensity score-matched Poisson and logistic regressions were conducted to estimate the '
'adjusted relative risk (RR) and odds of 30-day hospitalization or mortality among those '
'treated with sotrovimab compared with those not treated with a mAb.\n'
'Results \n'
'Of the high-risk COVID-19 patients identified, 15,633 were treated with sotrovimab and '
'1,514,868 were not treated with a mAb. Compared with the no mAb cohort, the sotrovimab cohort '
'was older and had a higher proportion of patients across the majority of high-risk '
'conditions. In the no mAb cohort, 84,307 (5.57%) patients were hospitalized and 8,167 (0.54%) '
'deaths were identified, while in the sotrovimab cohort, 418 (2.67%) patients were '
'hospitalized and 13 (0.08%) deaths were identified. After adjusting for potential '
'confounders, high-risk COVID-19 patients treated with sotrovimab had a 55% relative risk '
'reduction of 30-day hospitalization or mortality (RR: 0.45, 95% CI: 0.41,0.49) and an 85% '
'relative risk reduction of 30-day mortality (RR: 0.15, 95% CI: 0.08, 0.29) compared with '
'high-risk patients not treated with a mAb. From September 2021 to April 2022, sotrovimab '
'maintained clinical effectiveness with relative risk reductions of 30-day hospitalization or '
'mortality ranging from 46% to 71%. Stratifying by high-risk condition, sotrovimab-treated '
'patients exhibited statistically significant relative risk reductions of 30-day '
'hospitalization or mortality compared with the no mAb cohort across all high-risk conditions '
'(P<0.0001), ranging from 44% among pregnant women to 70% among patients 65 years and '
'older. \n'
'Conclusion \n'
'In this large, US real-world, observational study of high-risk COVID-19 patients with '
'reported diagnosis between September 2021 and April 2022 during the Delta and early Omicron '
'variant waves, treatment with sotrovimab was associated with reduced risk of 30-day all-cause '
'hospitalization and facility-reported mortality compared with no mAb treatment. Sotrovimab '
'clinical effectiveness persisted throughout the months when Delta and early Omicron '
'sub-lineages were the predominant circulating variants in the US, though there was an '
'uncertain RR estimate in April 2022 with wide confidence intervals due to the small sample '
'size. Sotrovimab clinical effectiveness also persisted among all high-risk subgroups '
'assessed.</jats:p>',
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'title': 'Real-world Effectiveness of Sotrovimab for the Early Treatment of COVID-19 During SARS-CoV-2 '
'Delta and Omicron Waves in the United States',
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