Veklury demonstrates reduced risk of hospitalisation in high-risk patients with COVID-19
pharmafile | December 23, 2021 | News story | Business Services |
Gilead Sciences have announced full results from a Phase III 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-hospitalised patients at high risk of severe disease.
The results were published in the New England Journal of Medicine (NEJM), and have been submitted to the FDA to evaluate the use of Veklury in earlier stages of disease.
The Phase III trial was a randomised, double-blind, placebo-controlled study, and participants had an 87% reduction in risk of COVID-19 related hospitalisation, They also demonstrated a lower risk of 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, suggesting 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.
Robert L Gottlieb, MD, PhD, Cardiologist at Baylor University Medical Center and Baylor Scott & White Research Institute, and primary author of the NEJM article, commented: “These data provide evidence that a three-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.
Remdesivir is one of the tools frontline healthcare workers rely on to effectively treat hospitalised patients with COVID-19, and early antiviral therapy with remdesivir would be a natural extension of the continuum of care that begins with primary prevention efforts centred on vaccination.
“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.”
Lina Adams
