Effectiveness of the neutralizing antibody sotrovimab among high-risk patients with mild to moderate SARS-CoV-2 in Qatar

Zaqout, Ahmed; Almaslamani, Muna; Chemaitelly, Hiam; Hashim, Samar; Ittaman, Ajithkumar; Alimam, Abeir; Rustom, Fatma; Daghfal, Joanne; Abukhattab, Mohammed; AlMukdad, Sawsan; Kaleeckal, Anvar Hassan; Latif, Ali Nizar; Butt, Adeel A.; Bertollini, Roberto; Al‐Khal, Abdullatif; Omrani, Ali S.; Abu‐Raddad, Laith J.

doi:10.1101/2022.04.21.22274060

Cited by 6 publications

(17 citation statements)

References 17 publications

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Section: Discussionsupporting

confidence: 85%

“…Despite evaluating a cohort predominantly infected with Omicron BA.1 sublineages, our findings do not fully support observed sotrovimab neutralization of BA.1 variants in vitro ,[23] though perhaps a lower sotrovimab neutralization potency against Omicron/BA.1 and Omicron/BA.1.1 as compared to ancestral strains and prior variants of concern made our findings more predictable. [13, 14] Further, with ineffective in vitro sotrovimab neutralization against Omicron BA.2 [13, 14] and among newer Omicron subvariants,[24] as well as a clinical observation that sotrovimab did not mitigate disease progression during a BA.2 Omicron dominant phase, [15] our findings do support the statements by the NIH guidelines committee [25] and FDA [26] that sotrovimab should not be recommended as a current outpatient treatment against COVID-19 among the general population of outpatients that meet EUA criteria. However, with a signal towards potential sotrovimab benefit in patients ≥ 65 years old, immunosuppressed, or with multiple comorbid conditions, some consideration should be given towards continued treatment in highest risk individuals depending on the availability of alternate treatments options, particularly if these observations continue to be made in other studies.…”

Section: Discussionmentioning

confidence: 99%

“…In support of this determination, a report of real-world clinical data suggested sotrovimab ineffectiveness in reducing rates of COVID-19 progression during BA.2 Omicron subvariant dominant phase in Qatar. [15] However, a recent report in immunocompromised solid organ transplant recipients suggested a benefit of sotrovimab in reducing severity of illness following early administration after SARS-CoV-2 infection during the Omicron BA.1 phase, [16] yet sotrovimab evaluation of effectiveness against Omicron BA.1 or BA.1.1 in a broader population of high-risk outpatients is lacking.…”

Section: Introductionmentioning

confidence: 99%

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Change in Effectiveness of Sotrovimab for Preventing Hospitalization and Mortality in COVID-19 Outpatients During the Omicron Phase

Aggarwal

Beaty

Bennett

et al. 2022

Preprint

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Background: Sotrovimab, a neutralizing monoclonal antibody (mAb) treatment authorized for early symptomatic COVID-19 patients, was effective in preventing the progression of severe disease and mortality following SARS-CoV-2 Delta variant infection. It is not known whether sotrovimab is similarly effective for SARS-CoV-2 Omicron variant infection. Methods: Observational cohort study of non-hospitalized adult patients with SARS-CoV-2 infection from December 26, 2021 to March 10, 2022 (>96% Omicron BA.1 variant), using electronic health records from a statewide health system linked to state-level vaccine and mortality data. We used propensity matching to select up to 3 patients not receiving mAbs or other authorized antivirals for each patient who received outpatient sotrovimab treatment. The primary outcome was 28-day hospitalization; secondary outcomes included mortality. To evaluate change in sotrovimab effectiveness during the Omicron phase, we propensity matched sotrovimab-treated patients from Omicron to Delta (October 1-December 11, 2021) phases to each other and then to untreated controls with a treatment-variant interaction added to the logistic regression model. Results: Of 30,247 patients with SARS-CoV-2 infection, we matched 1,542 receiving sotrovimab to 3,663 not receiving treatment. Compared to untreated patients, sotrovimab treatment was not associated with reduced odds of all-cause 28-day hospitalization (raw rate 2.5% versus 3.2%; adjusted OR 0.82, 95% CI 0.55, 1.19) or mortality (raw rate 0.1% versus 0.2%; adjusted OR 0.62, 95% CI 0.07, 2.78). In the combined analysis across Omicron and Delta phases, the observed treatment OR was higher during Omicron than during Delta (OR 0.85 vs. 0.39, respectively; interaction p=0.053) Conclusion: Real-world evidence demonstrated sotrovimab was not associated with reduced hospitalization and all-cause 28-day mortality among COVID-19 outpatients during the Omicron BA.1 phase and attenuated compared to the Delta phase

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Section: Discussionsupporting

confidence: 85%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Change in Effectiveness of Sotrovimab for Preventing Hospitalization and Mortality in COVID-19 Outpatients During the Omicron Phase

Aggarwal

Beaty

Bennett

et al. 2022

Preprint

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“…A small study in Qatar conducted during the reported Omicron BA.2 wave found nonsignificant higher odds (OR 2.67, 95% CI 0.60–11.91) of progression to severe, critical, or fatal COVID-19 in sotrovimab-treated patients compared with those untreated [ 17 ]. However, patients were excluded from the control group if they showed signs or symptoms of severe COVID-19 within 7 days of diagnosis.…”

Section: Discussionmentioning

confidence: 99%

Real-World Effectiveness of Sotrovimab for the Early Treatment of COVID-19 During SARS-CoV-2 Delta and Omicron Waves in the USA

et al. 2023

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Introduction Sotrovimab, a recombinant human monoclonal antibody (mAb) against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) had US Food and Drug Administration Emergency Use Authorization for the treatment of high-risk outpatients with mild-to-moderate coronavirus disease 2019 (COVID-19) from 26 May 2021 to 5 April 2022. Real-world clinical effectiveness of sotrovimab in reducing the risk of 30-day all-cause hospitalization and/or mortality was evaluated for the period when the prevalence of circulating SARS-CoV-2 variants changed between Delta and Omicron in the USA. Methods A retrospective analysis was conducted of de-identified patients diagnosed with COVID-19 between 1 September 2021 to 30 April 2022 in the FAIR Health National Private Insurance Claims database. Patients meeting high-risk criteria were divided into two cohorts: sotrovimab and not treated with a mAb (“no mAb”). All-cause hospitalizations and facility-reported mortality ≤ 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 in each cohort. Results Compared with the no mAb cohort ( n = 1,514,868), the sotrovimab cohort ( n = 15,633) was older and had a higher proportion of patients with high-risk conditions. In the no mAb cohort, 84,307 (5.57%) patients were hospitalized and 8167 (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, the sotrovimab cohort had a 55% lower risk of 30-day hospitalization or mortality (RR 0.45, 95% CI 0.41–0.49) and an 85% lower risk of 30-day mortality (RR 0.15, 95% CI 0.08–0.29). Monthly, from September 2021 to April 2022, the RR reduction for 30-day hospitalization or mortality in the sotrovimab cohort was maintained, ranging from 46% to 71% compared with the no mAb cohort; the RR estimate in April 2022 was uncertain, with wide confidence intervals due to the small sample size. Conclusion Sotrovimab was associated with reduced risk of 30-day all-cause hospitalization and mortality versus no mAb treatment. Clinical effectiveness persisted during Delta and early Omicron variant waves and among all high-risk subgroups assessed. Supplementary Information The online version contains supplementary material available at 10.1007/s40121-022-00755-0.

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“…Up to February 27, 2023, seven of the 14 studies were published in an international peer-reviewed journal, [26][27][28][29][30][31][32] and seven were published as pre-prints. [33][34][35][36][37][38][39] Three of the preprints have since been published in a peer-reviewed journal .…”

Section: Study Characteristicsmentioning

confidence: 99%

Real-world effectiveness of sotrovimab for the treatment of SARS-CoV-2 infection during Omicron BA.2 and BA.5 subvariant predominance: a systematic literature review

Drysdale,

Berktas,

Gibbons

et al. 2023

Preprint

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BackgroundEmerging SARS-CoV-2 variants have impacted the in vitro activity of sotrovimab, with variable fold changes in neutralization potency reported for Omicron BA.2 and subsequent variants. We performed a systematic literature review (SLR) to evaluate clinical outcomes associated with sotrovimab use during Omicron BA.2 and BA.5 predominance.MethodsElectronic databases were searched for observational studies published in peer-reviewed journals, preprint articles and conference abstracts from January 1, 2022–February 27, 2023.ResultsThe 14 studies identified were heterogeneous in terms of study design, population, endpoints and definitions, and comprised >1.7 million high-risk patients with COVID-19, of whom approximately 41,000 received sotrovimab (range n=20– 5979 during BA.2 and n=76–1383 during BA.5 predominance). Studies were from the US, UK, Italy, Denmark, France, Qatar, and Japan. Four studies compared the effectiveness of sotrovimab with untreated or no monoclonal antibody treatment controls, two compared sotrovimab with other treatments, and three single-arm studies compared outcomes during BA.2 and/or BA.5 versus BA.1. The remaining five studies descriptively reported rates of clinical outcomes in patients treated with sotrovimab. Rates of COVID-19-related hospitalization or mortality among sotrovimab-treated patients were consistently low (0.95% to 4.0% during BA.2; 0.5% to 2.0% during BA.5). All-cause hospitalization or mortality was also low (1.7% to 2.0% during BA.2; 3.4% during combined BA.2 and BA.5 periods). During BA.2, a lower risk of all-cause hospitalization or mortality was reported across studies with sotrovimab versus untreated cohorts. Compared with other treatments, sotrovimab was associated with a lower (molnupiravir) or similar (nirmatrelvir/ritonavir) risk of COVID-19-related hospitalization or mortality during BA.2 and BA.5. There was no significant difference in outcomes between the BA.1, BA.2 and BA.5 periods.ConclusionsThe studies included in this SLR suggest continued effectiveness of sotrovimab in preventing severe clinical outcomes during BA.2 and BA.5 predominance, both against an active/untreated comparator and compared with BA.1 predominance.

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Effectiveness of the neutralizing antibody sotrovimab among high-risk patients with mild to moderate SARS-CoV-2 in Qatar

Cited by 6 publications

References 17 publications

Change in Effectiveness of Sotrovimab for Preventing Hospitalization and Mortality in COVID-19 Outpatients During the Omicron Phase

Change in Effectiveness of Sotrovimab for Preventing Hospitalization and Mortality in COVID-19 Outpatients During the Omicron Phase

Real-World Effectiveness of Sotrovimab for the Early Treatment of COVID-19 During SARS-CoV-2 Delta and Omicron Waves in the USA

Real-world effectiveness of sotrovimab for the treatment of SARS-CoV-2 infection during Omicron BA.2 and BA.5 subvariant predominance: a systematic literature review

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