Gilead announces publication of data demonstrating Veklury significantly reduced risk of hospitalization in high-risk patients with COVID-19.

The results have been published in the New England Journal of Medicine (NEJM) and have been submitted to the FDA for the potential use of Veklury in earlier stages of disease, including prior to hospitalization.

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.

The use of Veklury for the treatment of non-hospitalized patients in the United States with three days of dosing is investigational, and the safety and efficacy for this use and dosing duration have not been established or approved by the FDA. 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.; The safety profile was similar between Veklury and placebo across the variety of outpatient settings in this trial, with the most common treatment emergent adverse events ( greater than 5%) in patients taking Veklury being nausea and headache.

About the IV Outpatient Study (GS-US-540-9012): Study GS-US-540-9012 (PINETREE) was a Phase III, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of a three-day course of Veklury IV in reducing the rate of hospitalization or all-cause death among non-hospitalized COVID-19 patients at high risk for disease progression. The primary study endpoint was the composite of COVID-19 hospitalization or all-cause death by Day 28. The composite endpoint of medical visits due to COVID-19 or all-cause death by Day 28 was a secondary outcome measure. The study was designed to enroll 1,264 participants, randomized in a double-blind fashion so that half of enrolled participants would receive Veklury and the other half would receive a matched placebo. Gilead stopped the study in April 2021 for administrative reasons associated with the reduction of COVID-19 prevalence and patient enrollment. At the time that enrollment was terminated, 584 participants were enrolled. The study remained blinded and participants already enrolled in the study were followed according to the protocol until the last patient visit occurred, and at that point the study was closed.

This trial was designed to evaluate the potential role of Veklury in helping patients diagnosed with COVID-19 who were considered high-risk for disease progression based on comorbidities and age but had not recently been hospitalized due to the infection. Common comorbidities in study participants included obesity, hypertension and diabetes. A third of the participants were aged 60 or older. Participants in the study must have received a positive diagnosis within four days of initiating treatment and experienced symptoms for seven days or fewer.

See-"Early Remdesivir to Prevent Progression to Severe Covid-19 in Outpatients"-Robert L. Gottlieb, M.D., Ph.D., Carlos E. Vaca, M.D., Roger Paredes, M.D., Ph.D., et al., for the GS-US-540-9012 (PINETREE) Investigators.