瑞德西韦最新数据公布！可显著降低COVID-19高危患者的住院风险

On December 22, 2021, Gilead announced the full results of a Phase 3 investigational trial evaluating the effectiveness and safety of intravenous Veklury® (remdesivir) (a three-day course) for the treatment of non-hospitalized patients with COVID-19 who are at high risk of disease progression. The findings have been published in the New England Journal of Medicine and submitted to the U.S. Food and Drug Administration (FDA) to determine the potential use of Veklury to treat early-stage disease, including before hospitalization.

The study included new subgroup analyzes showing Veklury's efficacy in COVID-19 patients was consistent regardless of key risk factors for severe COVID-19. A reduction in the risk of COVID-19-related hospitalization was observed on day 28 after treatment with Veklury in subjects with comorbidities such as diabetes, obesity and hypertension. Additional subgroup analyzes showed that among participants with cancer, chronic lung disease, and cardiovascular disease, all COVID-19-related hospitalizations occurred in the placebo group. In a post hoc analysis of subjects who completed a baseline Flu Patient-Reported Outcomes (FLU-PRO Plus) questionnaire before treatment or on the first day of treatment, patients who received Veklury were 92% more likely to be symptom-free on Day 14 compared with placebo.

In the United States, the use of Veklury in 3-day doses to treat non-hospitalized patients is experimental, and the FDA has not determined or approved the safety and effectiveness of the therapy and the timing of its administration. In the United States, Veklury is indicated for adult and pediatric patients (12 years and older and weighing at least 40 kilograms) with COVID-19 who require hospitalization.

In this trial, the safety profiles of Veklury and placebo were similar across outpatient settings, with the most common treatment-emergent adverse events (≥5%) in the Veklury group being nausea and headache. In the blinded trial, the incidence of investigator-specified adverse events related to the study drug was 12% in the Veklury group and 9% in the placebo group.

Gilead's Chief Medical Officer Merdad Dr. Parsey said: "We are pleased to see these study results, which further demonstrate the high efficacy of Veklury and confirm the important role it plays in the treatment of COVID-19. Veklury remains the standard of antiviral treatment for the treatment of hospitalized patients, helping to prevent disease progression and accelerate patient recovery. These promising treatment data also give us greater encouragement to pursue the best oral therapy for the treatment of COVID-19 (based on the same antiviral mechanism of action as remdesivir)."

Veklury is a direct-acting antiviral drug that can be transported and stored at room temperature and does not require extended infusion times. Veklury targets the highly conserved viral RNA-dependent RNA polymerase, thereby maintaining effectiveness against existing SARS-CoV-2 variants of concern discovered to date.

Gilead will continue to study the effectiveness and safety of Veklury in hospitalized patient populations with unmet treatment needs, such as patients with renal impairment, children and pregnant women, supported by several externally sponsored trials. Gilead is also developing a new oral treatment option for non-hospitalized patients with COVID-19 and submitted an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration (FDA) earlier in December.

References:

https://investors.gilead.com/news-releases/news-release-details/gilead-announces-new-england-journal-medicine-publication-data