Gilead Sciences Announces Results of Phase 3 Study of Remdesivir for COVID-19 Treatment
Individuals receiving the therapy had an 87% reduction in risk for the composite primary endpoint of virus-related hospitalization or all-cause death by day 28.
Gilead Sciences has announced full results from a phase 3 investigational study evaluating the efficacy and safety of a 3-day course of remdesivir (Veklury) for intravenous (IV) use for the treatment of COVID-19 for individuals who are at high risk for disease progression and are not hospitalized, the company said in a statement.
Individuals received the remdesivir treatment in the double-blind, placebo-controlled, randomized trial and of those individuals and had an 87% reduction in risk for the composite primary endpoint of COVID-19-related hospitalization or all-cause death by day 28.
Individuals also experienced 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 when compared with the 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 are not a reliable predictor of treatment outcomes in COVID-19.
There were no deaths observed in either arm by day 28.
The study included new subgroup analyses which showed consistent efficacy for individuals irrespective of their key risk factors for severe COVID-19. Individuals with comorbidities such as diabetes, hypertension, and obesity, had reduced risk of COVID-19 hospitalization by day 28.
Additional subgroup analyses showed that among individuals with cancer, cardiovascular disease, and chronic lung disease, all instances of COVID-19-related hospitalization occurred in the placebo group.
In a post-hoc analysis of individuals who completed a baseline influenza patient reported outcome questionnaire any time prior to or on the first day of treatment, individuals receiving remdesivir had a 92% greater probability of symptom alleviation by day 14 compared with those receiving the placebo.
“These data provide evidence that a 3-day course of remdesivir could play a critical role in helping COVID-19 patients stay out of the hospital. While our hospitals are ready to assist patients in need, prevention and early intervention are preferable to reduce the risk of disease progression and allow patients not requiring oxygen to recover from home when appropriate,” Robert Gottlieb, MD, PhD, cardiologist at Baylor University Medical Center and Baylor Scott & White Research Institute, said in the statement.
“Antivirals, like remdesivir, are routinely administered as a combination of therapies to help target a virus at multiple steps in its replication process. With this in mind, as additional treatment options become available, short-course IV therapy could potentially be a complementary option in settings where outpatient infusions are available,” Gottlieb said in the statement.
The safety profile was similar between the placebo and remdesivir across the variety of outpatient settings in the trial. The most common adverse events (AEs)for individuals taking remdesivir were headache and nausea.
AEs were assigned by investigators to be related to the study drug during the blinded trial occurred in 12% of individuals receiving remdesivir and 9% of individuals receiving the placebo.
Additionally, 2% of individuals in the remdesivir group experienced serious AEs compared with 7% in the placebo group. No new safety profiles were identified.
At day 59, there was 1 death observed in the study from the placebo group.
The full results are published in the New England Journal of Medicine.
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. Gilead. News release. December 22, 2021. Accessed January 3, 2022. https://www.gilead.com/news-and-press/press-room/press-releases/2021/12/gilead-announces-new-england-journal-of-medicine-publication-of-data-demonstrating-veklury-remdesivir-significantly-reduced-risk-of-hospitalization