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Early Treatment with Pegylated Interferon Lambda for Covid-19
Gilmar Reis1, Eduardo A S Moreira Silva1, Daniela C Medeiros Silva1
1From ViRx@Stanford, Stanford Biosecurity and Pandemic Preparedness Initiative (G.R., J.S.G., E.J.M.), and the Departments of Medicine (Division of Gastroenterology and Hepatology) and Microbiology and Immunology, Stanford University School of Medicine (J.S.G.), Stanford, and the Veterans Affairs Medical Center (J.S.G.) and Eiger BioPharmaceuticals (C.H., I.C.), Palo Alto - all in California; the Research Division, Cardresearch-Cardiologia Assistencial e de Pesquisa (G.R., E.A.S.M.S., D.C.M.S., V.H.S.C., T.S.F., C.V.Q.S., M.I.C.S., L.B.R., R.O.), the Department of Medicine, Pontifícia Universidade Católica de Minas Gerais (G.R., E.A.S.M.S., D.C.M.S., V.H.S.C., C.V.Q.S.), and Target Medicina de Precisão (A.C.F.D., A.M.F.J.), Belo Horizonte, the Department of Public Health and Mental and Family Medicine, Ouro Preto Federal University, Ouro Preto (L.C.M.S., C.B., A.C.M.), the Public Health Care Division, Ibirité (C.B., A.C.M.), the Department of Public Health at UNIFIPMoc and Family Medicine Fellowship Program, Montes Claros (A.M.R.N., A.P.F.G.A.), the Public Health Fellowship Program, Governador Valadares Public Health Authority, Governador Valadares (A.D.F.-N.), and the Public Health Care Division, Brumadinho (E.D.C., B.H.) - all in Brazil; the Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON (G.R., L.T., S.S., P.M., G.H.G., E.J.M.), Cytel (O.H., H.R., P.A., E.J.M.), Platform Life Sciences (L.A.W., J.I.F., C.M.G., E.J.M.), and RainCity Analytics (E.H.L.-O., S.K.), Vancouver, BC, Michael Garron Hospital (C.K.) and the Toronto Centre for Liver Disease, University Health Network (M.A.Z., J.J.F.), University of Toronto, the School of Nursing, York University (M.J.B.), and Sunnybrook Health Sciences Centre (R.K.), Toronto - all in Canada; Certara, Princeton, NJ (C.R.R.); Monash Institute of Pharmaceutical Sciences, Monash University, Melbourne, VIC, Australia (C.R.R.); and Erasmus University Rotterdam, Rotterdam, the Netherlands (B.H.).
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. (Funded by FastGrants and others; TOGETHER ClinicalTrials.gov number, NCT04727424.).
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