A phase 3 clinical trial promoted by the National Institute of Allergy and Infectious Diseases (Niaid) of United States has shown that the antiviral Veklury (remdesivir) accelerates patient recovery with Covid-19.
Magazine The New England Journal of Medicine (NEJM) has published this Friday the final results of the ACTT-1 trial, a phase 3 study, double blind and placebo driven by the Iniaid of the United States, which analyzes the investigational antiviral Veklury (remdesivir), a Gilead drug, for the treatment of hospitalized adults with mild-moderate or severe Covid-19.
These conclusions from ACTT-1 are based on preliminary data published in the NEJM last May, which showed that remdesivir treatment resulted in consistent and clinically significant improvements across multiple assessments of results compared to placebo in patients with Covid-19. Final data released this Friday shows that Veklury treatment offers a recovery timefaster than previously reported.
Recovery in four days
Preliminary results on day 15 showed that Veklury treatment, along with standard care, shortened recovery time in four days, compared to placebo-based treatment plus standard care (11 vs. 15 days). The primary endpoint of the study was clinical recovery time to day 29.
The study met its primary endpoint, showing that Veklury plus standard of care was superior in shortening recovery time to day 29 compared to placebo plus standard of care. In the final results of the 29th, patients who received Veklury achieved a clinical recovery five days faster than those who received placebo, with a median recovery time of 10 days with Veklury and 15 days with placebo and a 29% higher recovery rate compared to placebo.
This result was more pronounced in those patients who required oxygen support at the start of the study; In this group, the patients who received Veklury achieved clinical recovery seven days faster than those given placebo, with a median recovery time of 11 days with Veklury and 18 days with placebo.
The criterion of key secondary assessment of clinical status on day 15. Patients who received Veklury were 50% more likely to have improved on day 15 compared to those who received placebo, and the effect was sustained until day 29. The benefit of Veklury was greatest when given within 10 days after symptoms started, although a benefit was observed in most ranges of symptom duration.
In the general study population there was a trend towards a reduction in mortality. Given the range of disease severity in the general study population, a post-hoc analysis without adjustment was performed for multiple tests to determine if there were differences in mortality based on the initial clinical status of patients and to better understand where it may be Veklury provide a higher profit.
In this analysis, patients who required low-flow oxygen at baseline and who received Veklury achieved a statistically significant reduction of 72% in mortality on day 15 and a statistically significant 70% reduction in mortality on day 29 (4% vs. 13%). The difference in mortality in other subgroups based on baseline clinical status was not statistically significant.
“Results from the ACTT-1 trial demonstrate that in hospitalized Covid-19 patients with pneumonia, remdesivir is the first antiviral drug associated with significantly shorter recovery time – five days shorter for all patients and seven days shorter for patients with severe disease- and lower progression to mechanical ventilation“Said Andre Kalil, Professor of Internal Medicine in the Area of Infectious Diseases, director of the Transplant Infectious Diseases Program at the University of Nebraska Medical Center and principal investigator of the ACTT-1 trial.
To this he added that “based on clinical experience, we have seen that patient response and risk of mortality differ across the spectrum of the disease. With this post-hoc analysis of mortality subgroups, we now have data suggesting that administering remdesivir to patients receiving oxygen can significantly reduce their chances of death compared to other subgroups. This data provides clinicians with important information to help optimize the care they offer to their patients. “
Other secondary endpoints were also met, including time to discharge, oxygen use, and incidence and duration of reuse of oxygen or other respiratory support. Patients in the Veklury treatment group had shorter time to discharge. Veklury reduced disease progression among those receiving remdesivir, resulting in a shorter median days on oxygen support (13 days vs. 21 days) and a significantly lower incidence of re-ventilation.
In general, the incidence of associated adverse events a Veklury was similar to those recorded with placebo, with no new safety signals being identified compared to the interim analysis. The rates of serious adverse events (SAEs) were numerically higher in the placebo group compared to Veklury’s. Treatment discontinuation, all grade 3 and 4 adverse events, and laboratory abnormalities were similar in all groups.