Early treatment with pegylated interferon lambda for Covid-19.
Nenhuma Miniatura disponível
Data
2023
Título da Revista
ISSN da Revista
Título de Volume
Editor
Resumo
BACKGROUND
The efficacy of a single dose of pegylated interferon lambda in preventing clinical
events among outpatients with acute symptomatic coronavirus disease 2019 (Covid-19) is unclear.
METHODS
We conducted a randomized, controlled, adaptive platform trial involving predominantly vaccinated adults with severe acute respiratory syndrome coronavirus 2
(SARS-CoV-2) infection in Brazil and Canada. Outpatients who presented with an
acute clinical condition consistent with Covid-19 within 7 days after the onset of
symptoms received either pegylated interferon lambda (single subcutaneous injection, 180 μg) or placebo (single injection or oral). The primary composite outcome
was hospitalization (or transfer to a tertiary hospital) or an emergency department
visit (observation for >6 hours) due to Covid-19 within 28 days after randomization.
RESULTS
A total of 933 patients were assigned to receive pegylated interferon lambda (2
were subsequently excluded owing to protocol deviations) and 1018 were assigned
to receive placebo. Overall, 83% of the patients had been vaccinated, and during
the trial, multiple SARS-CoV-2 variants had emerged. A total of 25 of 931 patients
(2.7%) in the interferon group had a primary-outcome event, as compared with 57
of 1018 (5.6%) in the placebo group, a difference of 51% (relative risk, 0.49; 95%
Bayesian credible interval, 0.30 to 0.76; posterior probability of superiority to placebo, >99.9%). Results were generally consistent in analyses of secondary outcomes, including time to hospitalization for Covid-19 (hazard ratio, 0.57; 95%
Bayesian credible interval, 0.33 to 0.95) and Covid-19–related hospitalization or
death (hazard ratio, 0.59; 95% Bayesian credible interval, 0.35 to 0.97). The effects
were consistent across dominant variants and independent of vaccination status.
Among patients with a high viral load at baseline, those who received pegylated
interferon lambda had lower viral loads by day 7 than those who received placebo.
The incidence of adverse events was similar in the two groups.
CONCLUSIONS
Among predominantly vaccinated outpatients with Covid-19, the incidence of hospitalization or an emergency department visit (observation for >6 hours) was significantly lower among those who received a single dose of pegylated interferon
lambda than among those who received placebo.
Descrição
Palavras-chave
Citação
REIS, G. et al. Early treatment with pegylated interferon lambda for Covid-19. The New England Journal of Medicine, v. 388, p. 518-528, 2023. Disponível em: <https://www.nejm.org/doi/full/10.1056/NEJMoa2209760>. Acesso em: 01 ago. 2023.