Gilead’s Remdesivir Cuts COVID-19 Recovery Time by Five Days and Death Risk by 70% in “Gold Standard” Trial

Gilead Sciences (Foster City, CA, USA) has published final results from the double-blind, placebo-controlled, Phase 3 ACTT-1 trial of Veklury (remdesivir) that demonstrates treatment with its investigational antiviral resulted in a faster time to recovery than previously reported in adults hospitalized with mild-moderate or severe COVID-19.

The results of the final ACTT-1 study conducted by the National Institute of Allergy and Infectious Diseases’ (NIAID) build on the preliminary results published in NEJM in May 2020, showing that treatment with Veklury resulted in consistent, clinically meaningful improvements across multiple outcome assessments compared with placebo in COVID-19 patients. The final results demonstrate that treatment with Veklury resulted in a faster time to recovery than previously reported.

In the preliminary Day 15 results, Veklury plus standard of care shortened the time to recovery by four days, compared with placebo plus standard of care (11 vs. 15 days). The primary endpoint of the study was time to clinical recovery through Day 29. The study met its primary endpoint, demonstrating Veklury plus standard of care was superior in shortening the time to recovery through Day 29 compared with placebo plus standard of care. In the final Day 29 results, patients receiving Veklury achieved clinical recovery five days faster than those receiving placebo, with a median time to recovery of 10 days with Veklury and 15 days with placebo and an increased recovery rate by 29 percent compared with placebo. This result was most pronounced in patients who required oxygen support at baseline; in this group, patients receiving Veklury achieved clinical recovery seven days faster than those receiving placebo, with a median time to recovery of 11 days with Veklury and 18 days with placebo.

The key secondary study endpoint of clinical status at Day 15 was also met. Patients receiving Veklury were 50% more likely to have improved by Day 15 compared with those receiving placebo, and the effect was maintained through Day 29. The benefit of Veklury was greater when given within 10 days of symptom onset, though benefit was observed across most ranges of symptom duration. In the overall study population, there was a trend toward reduced mortality, a secondary study endpoint, at Day 15 in Veklury-treated patients compared with placebo. Given the range of disease severity in the overall study population, a post-hoc analysis with no adjustment for multiple testing was conducted to determine whether there were differences in mortality based on patients’ baseline clinical status and to better understand where Veklury may have the most benefit. In this analysis, patients requiring low-flow oxygen at baseline who received Veklury achieved a statistically significant 72% reduction in mortality at Day 15.

“The ACTT-1 trial results demonstrate that in hospitalized patients with COVID-19 pneumonia, remdesivir is the first antiviral medication significantly associated with a shorter time to recovery—five days shorter for all patients and seven days shorter for the more severely ill patients—in combination with a lower progression to mechanical ventilation,” said Andre Kalil, MD, MPH, Professor of Internal Medicine, Division of Infectious Diseases, Director, Transplant Infectious Diseases Program at the University of Nebraska Medical Center, and principal ACTT-1 trial investigator. “Based on clinical experience, we have seen that patient response and mortality risk differ across the disease spectrum. With this mortality subgroup post-hoc analysis, we now have data suggesting that giving remdesivir to patients on oxygen may significantly reduce their chances of death as compared to other subgroups. These data provide clinicians with important information to help optimize patient care.”

Separately, Gilead and the European Commission (EC) have signed a joint procurement agreement (JPA) that will enable rapid and equitable access to Veklury in the European Union (EU). The JPA enables participating countries in the EU and the European Economic Area (EEA) and the UK to purchase Veklury for both real-time demand and stockpiling needs, coordinated by the EC. The agreement covers purchases of Veklury over the next six months and has the option to be extended. In the EU, EEA and UK, Veklury is indicated for the treatment of COVID-19 in adult and adolescent patients with pneumonia requiring supplemental oxygen. The increased supply of Veklury will expand access to the medicine to additional appropriate patients with COVID-19, offering the potential for patients to recover faster, thereby reducing hospital stays and healthcare resource utilization.

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