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Hedskog, C.* ; Spinner, C.D.* ; Protzer, U. ; Hoffmann, D.* ; Ko, C. ; Gottlieb, R.L.* ; Askar, M.* ; Roestenberg, M.* ; de Vries, J.J.C.* ; Carbo, E.C.* ; Martin, R.* ; Li, J.* ; Han, D.* ; Rodriguez, L.* ; Parvangada, A.* ; Perry, J.K.* ; Ferrer, R.* ; Anton, A.* ; Andres, C.* ; Casares, V.* ; Günthard, H.F.* ; Huber, M.* ; McComsey, G.A.* ; Sadri, N.* ; Aberg, J.A.* ; van Bakel, H.* ; Porter, D.P.*

No remdesivir resistance observed in the phase 3 severe and moderate COVID-19 SIMPLE trials.

Viruses 16:546 (2024)

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Remdesivir (RDV) is a broad-spectrum nucleotide analog prodrug approved for the treatment of COVID-19 in hospitalized and non-hospitalized patients with clinical benefit demonstrated in multiple Phase 3 trials. Here we present SARS-CoV-2 resistance analyses from the Phase 3 SIMPLE clinical studies evaluating RDV in hospitalized participants with severe or moderate COVID-19 disease. The severe and moderate studies enrolled participants with radiologic evidence of pneumonia and a room-air oxygen saturation of ≤94% or >94%, respectively. Virology sample collection was optional in the study protocols. Sequencing and related viral load data were obtained retrospectively from participants at a subset of study sites with local sequencing capabilities (10 of 183 sites) at timepoints with detectable viral load. Among participants with both baseline and post-baseline sequencing data treated with RDV, emergent Nsp12 substitutions were observed in 4 of 19 (21%) participants in the severe study and none of the 2 participants in the moderate study. The following 5 substitutions emerged: T76I, A526V, A554V, E665K, and C697F. The substitutions T76I, A526V, A554V, and C697F had an EC₅₀ fold change of ≤1.5 relative to the wildtype reference using a SARS-CoV-2 subgenomic replicon system, indicating no significant change in the susceptibility to RDV. The phenotyping of E665K could not be determined due to a lack of replication. These data reveal no evidence of relevant resistance emergence and further confirm the established efficacy profile of RDV with a high resistance barrier in COVID-19 patients.

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