Gilead Sciences has announced the full results of a phase 3 research study evaluating the efficacy and safety of a three-day course of Veklury® (remdesivir) administered intravenously for the treatment of Covid-19 in outpatients with high risk of disease progression showing that the drug significantly reduces the risk of hospitalization in high-risk patients with the disease caused by the coronavirus.
The results have been published in the New England Journal of Medicine (NEJM) and have been presented to the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the possible use of the drug in the early stages of the disease, even before hospitalization.
The studies reveal that remdesivir, after two years and in the middle of the sixth wave, continues to offer alternatives and is a good option for the treatment of Covid-19, generating value for the health system by reducing the risk of hospitalization.
Since the positive recommendation of the Committee for Medicinal Products for Human Use (CHMP) this month, the European Commission has been agile in making a quick decision about the approval of new indications.
Dr. Roger Paredes, head of the Department of Infectious Diseases and the Institute for AIDS Research IrsiCaixa Hospital Universitari Germans Trias I Pujol de Badalona, has pointed out that “as the rates of Covid-19 increase again and new variants such as the omicron, we need effective tools like Veklury to treat the different phases of the disease ”. “We can now use this drug to help prevent high-risk patients from progressing to more serious disease, even when they do not require oxygen, as well as continue to use Veklury as a key tool in treating severe disease. This latest approval will also help alleviate part of the impact on health systems, which are already under significant pressure from the burden of Covid-19, “he indicated.
The results published in the ‘New England Journal of Medicine’ indicate that participants who received remdesivir treatment in the randomized, double-blind, placebo-controlled trial had an 87% reduction in risk from the primary endpoint composed of Covid-19-related hospitalization or death from all causes on Day 28, and an 81% reduction in risk from the composite secondary endpoint of Covid-19-related doctor visits or death from all causes on Day 28 compared to placebo.
No differences in SARS-CoV-2 nasopharyngeal viral load were observed 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 seen in either group on day 28.
The study includes new subgroup analyzes that showed consistent drug efficacy for patients, regardless of their risk factors for severe Covid-19. Patients with comorbidities such as diabetes, obesity, and hypertension had a lower risk of Covid-19-related hospitalization on day 28 with drug treatment.
Subgroup analyzes showed that, among patients with cancer, chronic lung disease, and cardiovascular disease, all Covid-19-related hospitalizations occurred in the placebo group.
In a ‘post-hoc’ analysis, of the participants who completed a baseline patient-reported flu outcome questionnaire (FLU-PRO Plus) at any time before or during the first day of treatment, those who received the drug had a 92% greater chance of symptom relief on day 14 compared to those given placebo.
“These data provide evidence that a three-day treatment with remdesivir could play a critical role in helping Covid-19 patients reduce their risk of needing a hospital admission. Although our hospitals are prepared to assist patients with patients who need it, prevention and early intervention are preferable to reduce the risk of disease progression and allow patients who do not need oxygen to recover at home when appropriate, “said Dr. Robert L. Gottlieb, a cardiologist at the Baylor University Medical Center and Baylor Scott & White Research Institute, and lead author of the NEJM paper. “
“Remdesivir is one of the tools trusted by front-line healthcare personnel to effectively treat hospitalized patients with Covid-19 and early antiviral therapy with this drug would be a natural extension of the ongoing care that begins with efforts to primary prevention focused on vaccination. Antivirals, such as remdesivir, are routinely given as a combination of therapies to help attack a virus at multiple steps in its replication process. With this in mind, as more options become available treatment, short-term intravenous therapy could be a complementary option in settings where infusions are available for outpatients or outpatients, “he added.
In Europe, the drug is indicated for the treatment of Covid-19 disease in adults and adolescents (12 years to less than 18 years and weighing at least 40 kg) with pneumonia that require hospitalization and at risk of progression of the disease. illness.
It is also indicated for adult patients who do not require supplemental oxygen and who are at risk of developing severe Covid-19. Veklury is contraindicated in patients who are allergic to Veklury or any of its components.
The safety profile was similar between remdesivir and placebo in the variety of outpatient settings in this trial, with nausea and headache the most common emergent adverse events (≥5%) in patients taking the drug.
Adverse events reported by investigators as medication related during the blinded trial occurred in 12% of patients receiving remdesivir in 9% of patients receiving placebo.
Fewer patients in the drug group experienced serious adverse events (2%) than in the placebo group (7%). Of the 279 participants who received the drug, no new safety signs were identified. One death was observed in the study on day 59 (placebo participant); there were no deaths in either study arm for the primary endpoint on day 28.
“We welcome these results, which further demonstrate the high efficacy of Veklury and support the important role it plays in helping Covid-19 patients. We are proud that Veklury continues to be the standard of antiviral care for hospitalized patients, helping to prevent disease progression and speed patient recovery, “stated Merdad Parsey, MD, PhD, Medical Director of Gilead Sciences.” Promising data from this study also further encourages us to pursue a potential best-in-class oral therapy for Covid-19 that will be based on the same antiviral mechanism of action as remdesivir. “
In the study, the authors note that, if approved for this use, intravenous remdesivir treatment in outpatients could provide another important option for treating Covid-19 in patients at high risk of disease progression. as the efficacy of a three-day course of this drug is qualitatively similar to that observed in clinical studies of single-dose neutralizing monoclonal antibody therapies.
The authors also note that combination therapies that include a direct-acting antiviral early in the disease may be synergistic in patients at higher risk.