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Final Results of National Institute of Allergy and Infectious Diseases’ ACTT-1 Trial Published in New England Journal of Medicine Expand Clinical Benefits of Veklury® (remdesivir) for the Treatment of COVID-19

Published: 2020-10-08 21:05:00 ET
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-- Final Day 29 Data Show Superior Efficacy of Veklury Compared with Placebo in Hospitalized Patients Receiving Standard of Care --

-- Overall, Treatment with Veklury Resulted in Five Days Faster Recovery and Reduced Disease Progression Compared with Placebo --

-- Veklury Reduced Mortality by 70 Percent at Day 29 in Patients on Low-Flow Oxygen at Baseline in Post-Hoc Analysis --

FOSTER CITY, Calif.--(BUSINESS WIRE)-- The New England Journal of Medicine (NEJM) today published the final results from the National Institute of Allergy and Infectious Diseases’ (NIAID) double-blind, placebo-controlled, Phase 3 ACTT-1 trial of Gilead’s (Nasdaq: GILD) investigational antiviral Veklury® (remdesivir) for the treatment of adults hospitalized with mild-moderate or severe COVID-19. The final ACTT-1 study results build on the preliminary results published in NEJM in May 2020, showing that treatment with Veklury resulted in consistent, clinically meaningful improvements across multiple outcome assessments compared with placebo in COVID-19 patients. The final results demonstrate that treatment with Veklury resulted in a faster time to recovery than previously reported.

In the preliminary Day 15 results, Veklury plus standard of care shortened the time to recovery by four days, compared with placebo plus standard of care (11 vs. 15 days). The primary endpoint of the study was time to clinical recovery through Day 29. The study met its primary endpoint, demonstrating Veklury plus standard of care was superior in shortening the time to recovery through Day 29 compared with placebo plus standard of care. In the final Day 29 results, patients receiving Veklury (n=541) achieved clinical recovery five days faster than those receiving placebo, with a median time to recovery of 10 days with Veklury and 15 days with placebo and an increased recovery rate by 29 percent compared with placebo (rate ratio for recovery, 1.29; 95% confidence interval [CI], 1.12 to 1.49; p