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Nine months later, results from the randomized, controlled trials of Veklury involving thousands of patients have been published in peer-reviewed journals, conclusively demonstrating the clinical benefits of treatment with Veklury. In clinical research, the gold standard for demonstrating the efficacy and safety of a drug is the randomized, double-blind, placebo-controlled trial. This type of study reduces the potential for bias and provides the highest quality scientific evidence. The National Institute of Allergy and Infectious Diseases’ ACTT-1 trial of Veklury in hospitalized adult patients with moderate to severe COVID-19 is one such trial. We know from the ACTT-1 trial that Veklury leads to a five-day faster recovery in hospitalized patients overall, and a seven-day faster recovery in people who required oxygen support at baseline.[i] We also know that Veklury reduces the likelihood of patients requiring new or more intensive oxygen support.[i] And, we have seen evidence that Veklury may reduce the likelihood of death, with a numerical trend toward reduced mortality in the overall ACTT-1 population[i] and, in a post-hoc analysis, a reduction in mortality in patients on low-flow oxygen at baseline.[ii] There was no difference in mortality in other subgroups.[ii] The ACTT-1 study sets a high bar for clinical evidence that must be considered as new data emerge.
Based on the ACTT-1 trial results and the data from two Gilead-sponsored global, randomized, open-label Phase 3 trials, the FDA approved Veklury for adults and adolescents (at least 12 years of age and weighing at least 40 kg) for the treatment of COVID-19 requiring hospitalization. Veklury is contraindicated in patients who are hypersensitive to remdesivir or any of its components; please see below for additional important safety information.