Early Treatment with Fluvoxamine among Patients with COVID-19: A Cost-Consequence Model
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Abstract
To date, two published randomized trials have indicated a clinical benefit of early treatment with fluvoxamine versus placebo for adults with symptomatic COVID-19. Using the results of the largest of these trials, the TOGETHER trial, we conducted a cost–consequence analysis to assess the health system benefits of preventing progression to severe COVID-19 in outpatient populations in the United States. A decision-analytic model in the form of a decision tree was constructed to evaluate two treatment strategies for high-risk patients with confirmed, symptomatic COVID-19 in the primary analysis: treatment with a 10-day course of fluvoxamine (100 mg twice daily) and current standard-of-care. A secondary analysis comparing a 5-day course of nirmatrelvir–ritonavir was also conducted. We used a time horizon of 28 days. Reported outcomes included cost-savings and hospitalization days avoided. The results of our analysis indicated that administration of fluvoxamine to symptomatic outpatients at high risk of progressing to severe COVID-19 was substantially cost-saving, in the amount of $232 per eligible patient and prevented an average of 0.15 hospital days per patient treated, compared with standard of care. Nirmatrelvir–ritonavir was also shown to be cost-saving despite its higher acquisition cost and provided savings to the healthcare system of $625 per patient treated. These findings suggest that fluvoxamine is likely to be a cost-effective addition to frontline COVID-19 mitigation strategies in many settings, particularly where access to nirmaltrevir–ritonavir or monoclonal antibodies is limited.
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SciScore for 10.1101/2021.12.23.21268352: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
NIH rigor criteria are not applicable to paper type.Table 2: Resources
Software and Algorithms Sentences Resources Given the limited time horizon of the trial data, and the fundamentally financial objectives of the analysis, we applied a decision-tree model, and a simple arithmetic model was constructed in MS Excel using the TreePlan add-in,(TreePlan Software, San Francisco, CA). MS Excelsuggested: NoneResults from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:There are strengths and …
SciScore for 10.1101/2021.12.23.21268352: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
NIH rigor criteria are not applicable to paper type.Table 2: Resources
Software and Algorithms Sentences Resources Given the limited time horizon of the trial data, and the fundamentally financial objectives of the analysis, we applied a decision-tree model, and a simple arithmetic model was constructed in MS Excel using the TreePlan add-in,(TreePlan Software, San Francisco, CA). MS Excelsuggested: NoneResults from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:There are strengths and limitations to our analysis. Strengths include that we obtained results from each of the trials to inform both the meta-analysis and the decision-analysis. As with all trials, the demographic and disease characteristics of the population enrolled may differ from those seen in other health systems, particularly in vaccination status. However, subgroup analyses uniformly demonstrate favorable results for fluvoxamine.[2] This suggests that heterogeneity of patient characteristics is unlikely to undermine the validity of the conclusions of this analysis. Nonetheless, two sources of uncertainty affect the selection of appropriate patients. First, the TOGETHER study, which dominated the meta-analysis, was conducted among predominantly unvaccinated patients, and further evidence is therefore needed to inform the clinical value of fluvoxamine among vaccinated populations. Among vaccinated persons with breakthrough infections aged >50 years, they may have 2-3.5 fold lower risk of hospitalization than unvaccinated populations.[16] Even with this reduction in risk of severe disease, fluvoxamine would be cost beneficial. However, a naïve scenario analysis based on reduced treatment escalation rates suggested that the primary findings remain robust. Second, enrolled patients were not already receiving treatment with fluvoxamine or medications within the SSRI class. Further research is therefore needed to determine whether patients already receiving such therapies s...
Results from TrialIdentifier: We found the following clinical trial numbers in your paper:
Identifier Status Title NCT04668950 Completed Fluvoxamine for Early Treatment of Covid-19 (Stop Covid 2) NCT04727424 Recruiting Repurposed Approved and Under Development Therapies for Pati… NCT04342663 Completed A Double-blind, Placebo-controlled Clinical Trial of Fluvoxa… Results from Barzooka: We did not find any issues relating to the usage of bar graphs.
Results from JetFighter: We did not find any issues relating to colormaps.
Results from rtransparent:- Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
- Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
- No protocol registration statement was detected.
Results from scite Reference Check: We found no unreliable references.
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