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Gilead' Veklury Reduces Risk Of Hospitalization In High-risk Patients With COVID-19 In Phase 3 Study

Gilead Sciences Inc.'s (GILD) veklury or remdesivir significantly reduced risk of hospitalization in high-risk patients with COVID-19, as per results from a phase 3 investigational study.

The results have been published in the New England Journal of Medicine and have been submitted to the Food and Drug Administration for the potential use of Veklury in earlier stages of disease, including prior to hospitalization, Gilead said in a statement on Wednesday.

The study evaluated the efficacy and safety of a three-day course of Veklury for intravenous (IV) use for the treatment of COVID-19 in non-hospitalized patients at high risk for disease progression.

According to the company, participants 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.

The 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.

In the U.S., Veklury is indicated for adults and pediatric patients (12 years of age and older and weighing at least 40 kg) for the treatment of COVID-19 requiring hospitalization. Veklury is contraindicated in patients who are allergic to Veklury or any of its components.

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