Sotrovimab 500mg/8ml solution for infusion vials

Background: Despite widespread implementation of vaccination against coronavirus disease 2019 (COVID-19), solid organ transplant recipients (SOTRs) can remain particularly vulnerable to this disease. The present study was conducted to investigate the efficacy and safety of sotrovimab in the treatment of SOTRs with COVID-19. Methods: A search was performed of PubMed, Cochrane Library, Web of Science, medRxiv, and Google Scholar to gather relevant evidence through July 25, 2023. The quality of the included studies was assessed using the risk of bias tool. Comprehensive Meta-Analysis software (ver. 3.0, Biostat) was employed for data analysis. Results: Ten studies, involving a total of 1,569 patients, were included. The meta-analysis revealed significant differences between the patients administered sotrovimab and those treated with the standard of care. These differences were observed in mortality rate (odds ratio [OR], 0.15; 95% confidence interval [CI], 0.03-0.67), hospitalization rate (OR, 0.35; 95% CI, 0.21-0.57), intensive care unit (ICU) admission rate (OR, 0.16; 95% CI, 0.04-0.62), the need for supplemental oxygen therapy (OR, 0.22; 95% CI, 0.09-0.51), and the need for mechanical ventilation (OR, 0.09; 95% CI, 0.01-0.70). However, no significant difference was observed between sotrovimab and other treatments regarding the rates of hospitalization or ICU admission (P>0.05). Regarding safety, sotrovimab was associated with a lower rate of adverse events compared to the absence of sotrovimab (OR, 0.15; 95% CI, 0.02-0.86). Conclusions: These results suggest that sotrovimab may improve efficacy outcomes among SOTRs with COVID-19. Nevertheless, additional high-quality trials are necessary to confirm these findings.

Abstract licence: CC BY-NC 4.0

BACKGROUND AND AIM: This systematic review and meta-analysis aimed to compare the effectiveness and safety of molnupiravir and sotrovimab in the treatment of patients with coronavirus disease 2019 (COVID-19). METHODS: Cochrane Library, Web of Science, PubMed, medRxiv, and Google Scholar were systematically searched to identify relevant evidence up to December 2023. The risk of bias was assessed using the risk of bias in nonrandomized studies of interventions tool. Data were analyzed using Comprehensive Meta-Analysis (CMA). RESULTS: Our search identified and included 13 studies involving 16166 patients. The meta-analysis revealed a significant difference between the molnupiravir and sotrovimab groups in terms of the mortality rate (odds ratio [OR] = 2.07, 95% confidence interval [CI]: 1.16, 3.70). However, no significant difference was observed between the two groups in terms of hospitalization rate (OR = 0.71, 95% CI: 0.47, 1.06), death or hospitalization rate (OR = 1.51, 95% CI: 0.81, 2.83), and intensive care unit admission (OR = 0.59, 95% CI: 0.07, 4.84). In terms of safety, molnupiravir was associated with a higher incidence of adverse events (OR = 1.67, 95% CI: 1.21, 2.30). CONCLUSION: The current findings indicate that sotrovimab may be more effective than molnupiravir in reducing the mortality rate in COVID-19 patients. However, no statistical difference was observed between the two treatments for other effectiveness outcomes. The certainty of evidence for these findings was rated as low or moderate. Further research is required to provide a better comparison of these interventions in treating COVID-19 patients.

Abstract licence: CC BY 4.0

BackgroundThe aim of this meta-analysis was to ascertain whether sotrovimab was effective in reducing COVID-19 related hospitalization and mortality also in Omicron BA.2, BA.4 and BA.5 subvariants compared to other antivirals effective in index period.MethodsA systematic review and meta-analysis of Randomized Controlled Trials (RCTs) and observational studies comparing the efficacy of early treatment with sotrovimab compared to other early treatment effective in index period, antivirals or monoclonal antibodies (mAbs), in patients with COVID-19 during BA.2, BA.4, BA.5 waves, conducted in accordance with PRISMA guidelines. We searched MEDLINE, Google Scholar and the Cochrane Library. Mortality and hospitalization were defined as outcomes.ResultsFour studies were included, allowing a meta-analysis of 8,041 patients. Meta-analysis showed no statistical difference between groups in hospitalization and mortality. Precisely, the RR of mortality showed no difference in the sotrovimab group compared to treatment with other drugs (OR 0.38, 95% CI 0.10-1.49, p<0.166). As regards the rate of hospitalization, no significant difference resulted between the patients treated with sotrovimab and those with other drugs (OR 1.66, 95% CI 0.41-6.66, p=0.477).InterpretationIn conclusion, this meta-analysis showed no significant difference between sotrovimab or other antivirals in reducing COVID-19 evolution in patients with a high risk of progression, considering both hospitalization and mortality.

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BackgroundMonoclonal antibodies (mAbs) and antiviral drugs have emerged as additional tools for treatment of COVID-19.AimWe aimed to review data on susceptibility of 14 SARS-CoV-2 variants to mAbs and antiviral drugs authorised in the European Union/European Economic Area (EU/EEA) countries.MethodsWe constructed a literature review compiling 298 publications from four databases: PubMed, Science Direct, LitCovid and BioRxiv/MedRxiv preprint servers. We included publications on nirmatrelvir and ritonavir, remdesivir and tixagevimab and cilgavimab, regdanvimab, casirivimab and imdevimab, and sotrovimab approved by the European Medicines Agency (EMA) by 1 October 2024.ResultsThe mutations identified in the open reading frame (ORF)1ab, specifically nsp5:H172Y, nsp5:H172Y and Q189E, nsp5:L50F and E166V and nsp5:L50F, E166A and L167V, led to a decrease in susceptibility to nirmatrelvir and ritonavir, ranging from moderate (25-99) to high reductions (> 100). Casirivimab and imdevimab exhibited highly reduced neutralisation capacity across all Omicron sub-lineages. Sub-lineages BA.1, BA.2 and BA.5 had decreased susceptibility to regdanvimab, while sotrovimab showed decreased efficacy for BA.2, BA.4, BQ.1.1 and BA.2.86. Tixagevimab and cilgavimab exhibited highly reduced neutralisation activity against BQ.1, BQ.1.1, XBB, XBB.1.5 and BA.2.86 sub-lineages.ConclusionsThe emergence of new variants, some with altered antigenic characteristics, may lead to resistance against mAbs and/or antiviral drugs and evasion of immunity induced naturally or by vaccination. This summary of mutations, combination of mutations and SARS-CoV-2 variants linked to reduced susceptibility to mAbs and antiviral drugs, should aid the selection of appropriate treatment strategies and/or phasing out therapies that have lost their effectiveness.

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ABSTRACT Background and Aim Remdesivir and Sotrovimab have emerged as potential treatment options for patients diagnosed with coronavirus disease 2019 (COVID‐19). This systematic review and meta‐analysis sought to evaluate and compare the effectiveness and safety of these two drugs in the context of COVID‐19 management. Methods A systematic search was conducted in PubMed, Cochrane Library, Web of Science, medRxiv, and Google Scholar up to July 2024. The effectiveness outcomes examined included mortality rate, hospitalization rate, emergency department visits, ICU admission, and adverse events. The risk of bias in nonrandomized studies of interventions was evaluated using a standardized tool, and data from the identified studies were meticulously analyzed using Comprehensive Meta‐Analysis (CMA) software. Results The analysis incorporated a total of 9 studies involving 7841 patients. The meta‐analysis findings indicated no significant disparity between the Remdesivir and Sotrovimab groups concerning mortality rate (odds ratio [OR] = 3.49, 95% confidence interval [CI]: 0.50–24.11, p  = 0.20), hospitalization rate (OR = 2.11, 95% CI: 0.85–5.22, p  = 0.10), emergency department visit (OR = 0.80, 95% CI: 0.11–5.62, p  = 0.82), and intensive care unit (2.37, 95% CI: 0.18–29.90, p  = 0.50). Moreover, comparable rates of adverse events were observed across both groups (OR = 0.98, 95% CI: 0.39–2.47, p  = 0.97). The certainty of evidence for these findings was rated as low or moderate. Conclusion The study findings suggest that there is no significant difference in effectiveness between Remdesivir and Sotrovimab in the treatment of COVID‐19 patients. Further research is needed to provide a more comprehensive comparison of these interventions for COVID‐19.

Abstract licence: CC BY-NC 4.0

Antiviral drugs likely remain effective against the SARS-CoV-2 Omicron variant, while monoclonal antibody (mAb) therapies have experienced drops in neutralizing ability. This systematic review and network meta-analysis aims to estimate the comparative effectiveness of antivirals and mAb therapies for treating COVID-19 patients infected with Omicron, capturing primarily acute outcomes. We searched multiple databases from July 4 to July 19, 2022, with updates through November 4, 2022. Studies comparing the effectiveness of antivirals or mAb to either nonuser controls or other treatments were included. Risk of bias was assessed using the Cochrane RoB 2 and ROBINS-I tools. Data extraction and verification involved five independent researchers. Among 39 studies (727,893 individuals with COVID-19, including 38 nonrandomized trials), nirmatrelvir/ritonavir and sotrovimab were associated with lower risks of mortality (HR = 0.317, 95% credible intervals [CrI] = 0.144-0.678; HR = 0.176, 95%CrI = 0.052-0.527) and hospitalization (HR = 0.479, 95%CrI = 0.319-0.711; HR = 0.489, 95%CrI = 0.293-0.797) compared with nonuser controls. Remdesivir users were associated with a lower risk of hospitalization (HR = 0.367, 95%CrI = 0.147-0.868) but not mortality. Molnupiravir and bebtelovimab showed no significant benefits for these outcomes. In conclusion, among individuals infected with COVID-19 during the Omicron wave, mortality risk was lower with nirmatrelvir/ritonavir or sotrovimab use, whereas hospitalization was reduced with nirmatrelvir/ritonavir, remdesivir, or sotrovimab. Sotrovimab and nirmatrelvir/ritonavir were effective against Omicron B.1.1.529/BA.1 and BA.2/BA.4/BA.5 subvariants, respectively. A key limitation is that findings rely on data from the last search and may be impacted by potential changes in mortality risk due to immune evasion by emerging variants, highlighting the need for ongoing randomized trials across variants and populations. TRIAL REGISTRATION: The study was registered on PROSPERO, CRD42022351508.

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