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Gilead Announces New England Journal of Medicine Publication of Data Demonstrating Veklury® (Remdesivir) Significantly Reduced Risk of Hospitalization in High-Risk Patients With COVID-19
-- Subgroup Analyses Show Consistently High Efficacy for Patients Regardless of Underlying Medical Conditions Associated with Higher Risk for Severe COVID-19
About this update from Gilead Sciences, Inc.
[{"type":"text","content":"\n-- Subgroup Analyses Show Consistently High Efficacy for Patients Regardless of Underlying Medical Conditions Associated with Higher Risk for Severe COVID-19 Compared to Placebo --\n\n FOSTER CITY, Calif.--(BUSINESS WIRE)--\nGilead Sciences, Inc. (Nasdaq: GILD) today announced full results from a Phase 3 investigational study evaluating the efficacy and safety of a three-day course of Veklury® (remdesivir) for intravenous (IV) use for the treatment of COVID-19 in non-hospitalized patients at high risk for disease progression. The results have been published today in the New England Journal of Medicine (NEJM) and have been submitted to the Food and Drug Administration (FDA) for the potential use of Veklury in earlier stages of disease, including prior to hospitalization.\n\nParticipants receiving Veklury treatment in the randomized, double-blind, placebo-controlled trial had an 87% reduction in risk for the composite primary endpoint of COVID-19-related hospitalization or all-cause death by Day 28 and an 81% reduction in the risk for the composite secondary endpoint of COVID-19-related medical visits due to COVID-19 or all-cause death by Day 28 compared to placebo. There was no difference observed in nasopharyngeal SARS-CoV-2 viral load up to Day 7 between groups, indicating that upper respiratory viral loads do not reliably predict treatment outcomes in COVID-19. In the study, no deaths were observed in either arm by Day 28.\n\nThe study includes new subgroup analyses which showed consistent efficacy of Veklury for patients irrespective of their key risk factors for severe COVID-19. Participants with comorbidities such as diabetes, obesity, and hypertension had reduced risk of COVID-19-related hospitalization by Day 28 with Veklury treatment. Additional subgroup analyses showed among participants with cancer, chronic lung disease, and cardiovascular disease all instances of COVID-19-related hospitalization occurred in the placebo group. In a post-hoc analysis of participants who completed a baseline influenza patient reported outcome (FLU-PRO Plus) questionnaire any time prior to or on the first day of treatment, those receiving Veklury had a 92% greater probability of symptom alleviation by Day 14 compared to those receiving placebo.\n\n“These data provide evidence that a three-day course of remdesivir could play a critical r...