Peginterferon lambda was consistent in the direction of effect on all secondary outcomes. The treatment effect for peginterferon lambda was more pronounced in patients who were treated within 3 days of symptom onset. Primary events in the study happened a median of 5 days (interquartile range 3 to 7 days) after randomization. The incidence of adverse events was similar in the two groups. Among individuals with a high viral level at baseline, peginterferon lambda resulted in lower viral loads and a higher percentage of patients clearing SARS-COV-2 RNA by Day 7, compared to placebo. The effects were consistent across dominant variants and vaccination status. This effect was maintained in subgroup analyses including COVID-19-related hospitalization alone (relative risk 0.57, 95% Bayesian credible intervals 0.33-0.95) and COVID-19-related hospitalization or death (hazard ratio 0.59, 95% Bayesian credible interval 0.35-0.97). placebo, with 2.7% (25 of 931) of participants randomized to peginterferon lambda experiencing a primary outcome event, compared with 5.6% (57 of 1018) (relative risk 0.49, 95% Bayesian credible interval 0.30-0.76, posterior probability >99.9%) among patients randomized to placebo. The publication detailed results, highlighting a 51% reduction in COVID-19-related hospitalizations or emergency room visits greater than six hours (the primary outcome) for participants receiving peginterferon lambda vs. The study period included emergence of multiple COVID-19 variants of concern. This was among the first trials to include a predominantly vaccinated population with 84% of the population having received vaccination prior to study entry. In the study, 931 patients received peginterferon lambda and 1018 received placebo. Secondary endpoints included SARS-CoV-2 viral clearance, all-cause hospitalization, mortality due to COVID-19, days in hospital and on ventilator, and adverse events. The primary endpoint was a composite endpoint of COVID-19-related hospitalization or emergency room visits greater than six hours. "Resistance due to variants or new strains of the virus could be an issue with some therapies, but this may not be a concern with peginterferon lambda due to its mechanism of action that involves activation of multiple virus-killing pathways." "Peginterferon lambda has tremendous therapeutic potential, and we continue to see the emergence of aggressive variants of the virus spreading around the globe which are less sensitive to both vaccines and treatment with antibodies," said Jordan Feld, MD, MPH, Associate Professor of Medicine at University of Toronto and Senior Scientist at Toronto Centre for Liver Disease and Toronto General Hospital Research Institute and co-Lead Investigator for TOGETHER. The manuscript titled "Effect of Early Treatment with Pegylated Interferon Lambda among COVID-19 Patients" will be published in the Februissue of NEJM and follows the topline safety and efficacy data announced March 17 2022. The study, which evaluated newly diagnosed outpatients with mild-to-moderate COVID-19, found that among predominantly vaccinated participants with COVID-19, a single-dose treatment with Eiger's investigational agent, peginterferon lambda, resulted in significantly decreased clinical events.
(Nasdaq: EIGR), a commercial-stage biopharmaceutical company focused on the development of innovative therapies for hepatitis delta virus (HDV) and other serious diseases, today announced the publication of data from the investigator-sponsored Phase 3 TOGETHER study in patients with COVID-19 in the New England Journal of Medicine (NEJM). 8, 2023 /PRNewswire/ - Eiger BioPharmaceuticals Inc. Effects consistent across multiple dominant SARS-CoV-2 variants in a largely vaccinated population Lambda reduced risk of hospitalization by 42% and COVID-19 related death by 50% Lambda reduced risk of hospitalization or emergency room visits by 51% (primary endpoint) Phase 3 TOGETHER data showed early treatment with a single dose of peginterferon lambda (Lambda) in patients with mild-to-moderate COVID-19 infections resulted in significantly decreased clinical events
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