Oral bemnifosbuvir (AT-527) vs placebo in patients with mild-to-moderate COVID-19 in an outpatient setting (MORNINGSKY).

Autor:	Horga A; Atea Pharmaceuticals, Inc, Boston, MA 02110, USA., Saenz R; Genentech, Inc, San Francisco, CA 94080, USA., Yilmaz G; Karadeniz Technical University, Trabzon, 61080, Turkey., Simón-Campos A; Köhler & Milstein Research, Anahuac-Mayab University, Mérida, 97308, Mexico., Pietropaolo K; Atea Pharmaceuticals, Inc, Boston, MA 02110, USA., Stubbings WJ; F. Hoffmann-La Roche Ltd, Basel, 4070, Switzerland., Collinson N; Roche Products Limited, Welwyn Garden City, AL7 1TW, Hertfordshire, UK., Ishak L; Atea Pharmaceuticals, Inc, Boston, MA 02110, USA., Zrinscak B; Roche Pharma Canada, Mississauga, ON, L5N 5M8, Ontario, Canada., Belanger B; Atea Pharmaceuticals, Inc, Boston, MA 02110, USA., Granier C; Roche Products Limited, Welwyn Garden City, AL7 1TW, Hertfordshire, UK., Lin K; Atea Pharmaceuticals, Inc, Boston, MA 02110, USA., C Hurt A; F. Hoffmann-La Roche Ltd, Basel, 4070, Switzerland., Zhou XJ; Atea Pharmaceuticals, Inc, Boston, MA 02110, USA., Wildum S; F. Hoffmann-La Roche Ltd, Basel, 4070, Switzerland., Hammond J; Atea Pharmaceuticals, Inc, Boston, MA 02110, USA.
Jazyk:	angličtina
Zdroj:	Future virology [Future Virol] 2023 Oct. Date of Electronic Publication: 2023 Nov 01.
DOI:	10.2217/fvl-2023-0115
Abstrakt:	Aim: This phase III study assessed the efficacy/safety/antiviral activity/pharmacokinetics of bemnifosbuvir, a novel, oral nucleotide analog to treat COVID-19. Patients & methods: Outpatient adults/adolescents with mild-to-moderate COVID-19 were randomized 2:1 to bemnifosbuvir/placebo. Time to symptom alleviation/improvement (primary outcome), risk of hospitalization/death, viral load and safety were evaluated. Results: Although the study was discontinued prematurely and did not meet its primary end point, bemnifosbuvir treatment resulted in fewer hospitalizations (71% relative risk reduction), COVID-19-related medically attended hospital visits, and COVID-19-related complications compared with placebo. No reduction in viral load was observed. The proportion of patients with adverse events was similar; no deaths occurred. Conclusion: Bemnifosbuvir showed hospitalization reduction in patients with variable disease progression risk and was well tolerated. Clinical Trial Registration : NCT04889040 (ClinicalTrials.gov). Competing Interests: Competing interests disclosure A Horga, K Pietropaolo, L Ishak and B Belanger are employees of Atea. R Saenz is an employee and owns stock for Genentech (a member of the Roche group). A Simón-Campos is a speaker and advisory board member for Pfizer, AstraZeneca, Roche and Regeneron. WJ Stubbings, N Collinson, C Granier, AC Hurt and S Wildum are employees and shareholders of F. Hoffman-La-Roche Ltd. B Zrinscak is an employee of F. Hoffman-La-Roche Ltd. K Lin is a former employee of Atea. X-J Zhou and J Hammond are employees and shareholders of Atea. The authors have no other competing interests or relevant affiliations with any organization or entity with the subject matter or materials discussed in the manuscript apart from those disclosed. (© 2023 The Authors.)
Databáze:	MEDLINE
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