Sotrovimab: A Review of Its Efficacy against SARS-CoV-2 Variants

Viruses, Journal Year: 2024, Volume and Issue: 16(2), P. 217 - 217

Published: Jan. 31, 2024

Among the anti-Spike monoclonal antibodies (mAbs), S-309 derivative sotrovimab was most successful in having longest temporal window of clinical use, showing a high degree resiliency to SARS-CoV-2 evolution interrupted only by appearance BA.2.86* variant interest (VOI). This success undoubtedly reflects rational selection target highly conserved epitope coronavirus Spike proteins. We review here efficacy against different variants outpatients and inpatients, discussing both randomized controlled trials real-world evidence. Although it could not be anticipated at time its development introduction, sotrovimab's use immunocompromised individuals who harbor large populations viruses created conditions for eventual demise, as antibody viral led withdrawal due inefficacy later lineages. Despite this, based on observational data, some authorities have continued promote sotrovimab, but lack binding newer strongly argues futility use. The story highlights power modern biomedical science generate novel therapeutics while also providing cautionary tale need devise strategies minimize emergence resistance antibody-based therapeutics.

Language: Английский

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Characteristics and outcomes of COVID-19 patients presumed to be treated with sotrovimab in NHS hospitals in England

BMC Infectious Diseases, Journal Year: 2024, Volume and Issue: 24(1)

Published: April 22, 2024

Abstract Background The impact of the constantly evolving severe acute respiratory syndrome coronavirus 2 on effectiveness early disease 2019 (COVID-19) treatments is unclear. Here, we report characteristics and clinical outcomes patients with COVID-19 treated a monoclonal antibody (mAb; presumed to be sotrovimab) across six distinct periods covering emergence predominance Omicron subvariants (BA.1, BA.2, BA.5) in England. Methods Retrospective cohort study using data from Hospital Episode Statistics database January 1–July 31, 2022. Included received mAb delivered by National Health Service (NHS) hospital as day-case, for which primary diagnosis was COVID-19. Patients were have sotrovimab based NHS showing that 99.98% COVID-19-mAb-treated individuals during period. COVID-19-attributable hospitalizations reported overall subvariant prevalence. Subgroup analyses conducted renal active cancer. Results Among total 10,096 patients, 1.0% ( n = 96) had hospitalization, 4.6% 465) visit due any cause, 0.3% 27) died cause hospitalization rates consistent among subgroups, no significant differences observed predominance. Conclusions Levels deaths low mAb-treated subgroups. Similar whilst BA.1, BA.5 predominant, despite reductions vitro neutralization activity against BA.2 BA.5.

Language: Английский

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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

Infection, Journal Year: 2024, Volume and Issue: 52(5), P. 1839 - 1861

Published: April 11, 2024

To evaluate clinical outcomes associated with sotrovimab use during Omicron BA.2 and BA.5 predominance.

Language: Английский

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Effectiveness of Nirmatrelvir-Ritonavir for the Prevention of COVID-19–Related Hospitalization and Mortality: A Systematic Literature Review

American Journal of Therapeutics, Journal Year: 2024, Volume and Issue: 31(3), P. e246 - e257

Published: April 29, 2024

Background: Nirmatrelvir/ritonavir (NMV/r) is an oral antiviral drug used to treat mild-to-moderate coronavirus disease 2019 (COVID-19) in patients aged 12 years or older at high risk of progression severe (eg, hospitalization and death). Despite being the preferred option for outpatient treatment majority countries worldwide, NMV/r currently underutilized real-world clinical practice. Areas Uncertainty: As numerous studies have described patient outcomes following with NMV/r, this systematic literature review provides a comprehensive summary evidence on effectiveness against mortality further organized by clinically meaningful categories, such as acute versus longer-term follow-up, age, underlying health conditions, vaccination status, help inform care decision making. Data Sources: We searched Embase PubMed (December 22, 2021–March 31, 2023) congress abstracts 1, 2021–December 2022) reports describing effectiveness. Therapeutic Advances: In total, 18 met final selection criteria. The showed that significantly reduced postinfection all-cause COVID-19-related both (≤30 days) (21%–92%) (>30 (1%–61%) follow-up. reduction was higher when received within 5 days symptom onset. Real-world observed regardless high-risk status. Conclusion: findings demonstrated during Omicron period among individuals COVID-19 disease.

Language: Английский

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Intramuscular vs Intravenous SARS-CoV-2 Neutralizing Antibody Sotrovimab for Treatment of COVID-19 (COMET-TAIL): A Randomized Noninferiority Clinical Trial

Open Forum Infectious Diseases, Journal Year: 2023, Volume and Issue: 10(8)

Published: July 12, 2023

Convenient administration of coronavirus disease 2019 (COVID-19) treatment in community settings is desirable. Sotrovimab a pan-sarbecovirus dual-action monoclonal antibody formulated for intravenous (IV) or intramuscular (IM) early mild/moderate COVID-19.

Language: Английский

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Real‐World Effectiveness of Sotrovimab in Patients Infected With SARS‐CoV‐2 Omicron Subvariant BA.2 in Western Sydney, Australia

Journal of Medical Virology, Journal Year: 2025, Volume and Issue: 97(2)

Published: Feb. 1, 2025

ABSTRACT Laboratory‐based findings suggest that Sotrovimab is significantly less effective against emerging CARS‐CoV‐2 variants, however, clinical data lacking. Here we examined the effectiveness of sotrovimab, in preventing emergency department (ED) presentation and subsequent hospitalization high‐risk subgroups patients during SARS‐CoV‐2 Delta Omicron waves Western Sydney, Australia ( n = 515). Risk for ED attendance was comparable patients, whether BA.1 or BA.2, compared to (hazard ratio 0.97 [0.36–2.64]). These highlight need caution when using vitro drive practice, especially consequence withhold potentially lifesaving treatment.

Language: Английский

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Cost-effectiveness Analysis of Nirmatrelvir/Ritonavir Compared with Molnupiravir in Patients at High Risk for Progression to Severe COVID-19 in Japan

Journal of health economics and outcomes research, Journal Year: 2025, Volume and Issue: unknown, P. 75 - 85

Published: Jan. 1, 2025

Background: Nirmatrelvir/ritonavir (NMV/r) and molnupiravir are oral antiviral drugs approved for the treatment of early symptomatic patients with mild to moderate COVID-19 at high risk progression severe disease in Japan. Objective: This study evaluated, from a Japanese payer perspective, cost-effectiveness NMV/r compared among COVID-19. Methods: model describes history impact on short-term long-term outcomes. was molnupiravir, scenario analysis standard care over lifetime horizon. Results: When showed higher quality-adjusted life years (QALYs) (15.752 vs 15.739) total cost (¥6 248 014 ¥6 245 829 [US $44 136.86 121.42]). The incremental ratio ¥164 934 (US $1165.12) per QALY gained, which lower than willingness-to-pay (WTP) threshold Japan (¥5 000 000/QALY $35 320.71/QALY]). In analysis, ¥3 646 821 $25 761.66) gained. One-way sensitivity probabilistic that cost-effective consistently. All results one-way ratios were below WTP result acceptability curve probability ¥5 320.71/QALY) 100.00%. Conclusion: is perspective. provides evidence

Language: Английский

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Cost-effectiveness Analysis of Nirmatrelvir/Ritonavir Compared with Molnupiravir in Patients at High Risk for Progression to Severe COVID-19 in Japan

Journal of health economics and outcomes research, Journal Year: 2025, Volume and Issue: 12(1)

Published: Feb. 24, 2025

Background: Nirmatrelvir/ritonavir (NMV/r) and molnupiravir are oral antiviral drugs approved for the treatment of early symptomatic patients with mild to moderate COVID-19 at high risk progression severe disease in Japan. Objective: This study evaluated, from a Japanese payer perspective, cost-effectiveness NMV/r compared among COVID-19. Methods: model describes history impact on short-term long-term outcomes. was molnupiravir, scenario analysis standard care over lifetime horizon. Results: When showed higher quality-adjusted life years (QALYs) (15.752 vs 15.739) total cost (¥6 248 014 ¥6 245 829 [US $44 136.86 121.42]). The incremental ratio ¥164 934 (US $1165.12) per QALY gained, which lower than willingness-to-pay (WTP) threshold Japan (¥5 000 000/QALY $35 320.71/QALY]). In analysis, ¥3 646 821 $25 761.66) gained. One-way sensitivity probabilistic that cost-effective consistently. All results one-way ratios were below WTP result acceptability curve probability ¥5 320.71/QALY) 100.00%. Conclusion: is perspective. provides evidence

Language: Английский

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Comparative effectiveness of sotrovimab versus no treatment in non-hospitalised high-risk COVID-19 patients in north west London: a retrospective cohort study

BMJ Open Respiratory Research, Journal Year: 2024, Volume and Issue: 11(1), P. e002238 - e002238

Published: April 1, 2024

Background We assessed the effectiveness of sotrovimab vs no early COVID-19 treatment in highest-risk patients during Omicron predominance. Methods Retrospective cohort study using Discover dataset North West London. Included were non-hospitalised, aged ≥12 years and met ≥1 National Health Service criterion for treatment. used Cox proportional hazards models to compare HRs 28-day COVID-19-related hospitalisation/death between sotrovimab-treated untreated patients. Age, renal disease subvariant subgroup analyses performed. Results included 599 5191 Compared with patients, risk (HR 0.50, 95% CI 0.24, 1.06; p=0.07) hospitalisation 0.43, 0.18, 1.00; p=0.051) both lower group; however, statistical significance was not reached. In ≥65 subgroups, associated a significantly reduced hospitalisation, by 89% 0.11, 0.02, 0.82; p=0.03) 82% 0.05, 0.62; p=0.007), respectively. Conclusions Risk compared Overall, also but

Language: Английский

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Safety, Virology, Pharmacokinetics, and Clinical Experience of High-Dose Intravenous Sotrovimab for the Treatment of Mild to Moderate COVID-19: An Open-Label Clinical Trial

Open Forum Infectious Diseases, Journal Year: 2023, Volume and Issue: 10(7)

Published: July 1, 2023

Abstract Background Five hundred milligrams of intravenous (IV) sotrovimab has been shown to be well tolerated and efficacious against pre-Omicron strains in treating patients with mild moderate coronavirus disease 2019 (COVID-19) at high risk for progression. Methods This was an open-label, single-arm substudy phase 3 COMET-TAIL (NCT04913675) assessing the safety tolerability a 2000 mg IV dose sotrovimab. Symptomatic (aged ≥18 years) COVID-19 progression were enrolled from June 30 through July 11, 2022, when Omicron BA.5, BA.2.12.1, BA.4 predominant circulating variants United States. The primary end point occurrence adverse events (AEs), serious AEs (SAEs), special interest, disease-related (DREs) day 8. Safety, pharmacokinetics, viral load, hospitalization >24 hours acute management illness or death 29 assessed. Results All participants (n = 81) Hispanic, 58% female, 51% aged ≥55 years. Through 8, no AEs, including infusion-related reactions hypersensitivity, reported; 2 reported DREs (mild cough, n 2). One SAE (acute myocardial infarction), which considered unrelated by investigator, occurred on 27 only reported. Maximum serum concentration (geometric mean) 745.9 µg/mL. Viral load decreased baseline 29; (3%) had persistently (≥4.1 log10 copies/mL) Conclusions Two thousand tolerated, signals observed. Trial registration ClinicalTrials.gov Identifier: NCT04913675.

Language: Английский

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