Remdesivir demonstrated a statistically significant 87% reduction in risk for the composite primary endpoint of COVID-19-related hospitalization or all-cause death by day 28.
Intravenous (IV) treatment with remdesivir (Veklury; Gilead) significantly reduced the risk of hospitalization in high-risk patients who were diagnosed with COVID-19 but were not hospitalized, according to the results of a double-blind, placebo-controlled study.
Remdesivir is a nucleotide analog currently used as the antiviral standard of care for hospitalized patients with COVID-19. According to a Gilead press release, more than half of patients hospitalized with COVID-19 in the United States are treated with remdesivir because it directly inhibits viral replication of SARS-CoV-2.
“As the pandemic continues to evolve and new viral variants emerge, Veklury is playing a critical role as the antiviral standard of care for hospitalized patients, helping prevent disease progression and speed patients’ recovery,” said Merdad Parsey, MD, PhD, chief medical officer at Gilead Sciences, in the press release.
Researchers analyzed 562 participants who were randomly assigned 1:1 to receive either remdesivir or placebo. According to the press release, remdesivir demonstrated a statistically significant 87% reduction in risk for the composite primary endpoint of COVID-19-related hospitalization or all-cause death by day 28 compared with placebo.
Furthermore, the investigators found an 81% reduction in risk for the composite secondary endpoint of medical visits due to COVID-19 or all-cause death by day 28 for participants treated with remdesivir compared with placebo. No deaths were observed in either arm by day 28, according to the press release.
“Antiviral medications provide maximal benefit when used early in the disease course,” said Robert L. Gottlieb, MD, PhD, cardiologist and principal investigator at the Baylor University Medical Center, in the press release. “Last summer, data from clinical trials demonstrated the benefit of remdesivir in patients hospitalized with COVID-19, even when not yet requiring oxygen. These latest data show remdesivir’s potential to help high-risk patients recover before they get sicker and stay out of the hospital altogether.”
The researchers noted that enrollment for the trial was halted prior to fulfilling the enrollment targets in April 2021, due to changing epidemiology and adoption of new treatment options at the time. However, the researchers continued to collect data on enrolled participants and both the investigators and participants remained blinded.
In the trial, the safety profile was similar between remdesivir and placebo. The most common treatment-emergent adverse events in patients taking remdesivir were nausea and headache, and no new safety signals were identified among the 279 patients in the remdesivir arm. One death was observed in the study at day 59.
The use of a 3-day treatment cycle of remdesivir for the treatment of non-hospitalized patients with COVID-19 is investigational. The safety and efficacy for this use has not been established or approved by any regulatory agency globally. In the United States, remdesivir is FDA-approved for hospitalized adults and pediatric patients 12 years of age and older for the treatment of COVID-19.
“We are seeing very high numbers of hospitalized patients as new COVID-19 infections surge, placing increased demands on already overburdened health care systems,” Gottlieb said in the press release. “Remdesivir, also known as Veklury, is an effective antiviral for the treatment of hospitalized patients with COVID-19 and an essential tool to help reduce disease progression.”
Veklury (Remdesivir) Significantly Reduced Risk of Hospitalization in High-Risk Patients with COVID-19. News release. Gilead; September 22, 2021. Accessed September 22, 2021. https://www.gilead.com/news-and-press/press-room/press-releases/2021/9/veklury-remdesivir-significantly-reduced-risk-of-hospitalization-in-highrisk-patients-with-covid19