Remdesivir lowers the likelihood of COVID-19 hospitalization in high-risk patients
According to data presented at IDWeek, a 3-day course of IV remdesivir was safe, well tolerated, and prevented COVID-19-related hospitalizations in high-risk COVID-19 patients.
“There is an urgent need for antiviral treatments that can be offered to people with COVID-19 who are at increased risk of progression to hospitalization and other complications,” said Joshua A. Hill, MD, a researcher and assistant professor in the vaccine and infectious disease division at Seattle’s Fred Hutchinson Cancer Research Center.
Hill noted that there are currently no FDA-approved treatments for nonhospitalized people with COVID-19 — remdesivir is FDA-approved for hospitalized patients but not yet available for outpatient use — and that the only other option is monoclonal antibodies available under emergency use authorization.
“These treatments continue to be limited in supply in some places, and mutations in the virus raise the possibility that they may not be universally effective as the virus evolves,” Hill said. “Having additional tools to tackle this viral infection early will be key to reducing complications for high-risk individuals who contract SARS-CoV-2 and could also help to curb transmission.”
Hill and colleagues assigned participants in a 1:1 ratio to receive IV remdesivir over three days — 200 mg on day one and 100 mg on days two and three — or placebo. According to the researchers, the primary endpoints were composite COVID-19 hospitalization or all-cause death by day 28 and the proportion of participants who experienced treatment-emergent adverse events.
In a press release issued prior to the conference, Gilead stated that it stopped enrolling participants in the trial in April, “reflecting the changing epidemiology and adoption of additional treatment options at the time,” but that it continued to collect data on those who were already enrolled. Overall, 562 patients began their treatment, with 279 receiving remdesivir and 283 receiving a placebo.
Hill and colleagues reported that remdesivir treatment significantly reduced COVID-19 hospitalization or all-cause death by day 28 (HR = 0.13; 95 percent CI, 0.03-0.59) compared to placebo. They also discovered that when compared to placebo, participants receiving remdesivir had a significantly lower risk of COVID-19-related medically attended visits or all-cause death through day 28 (HR = 0.19; 95% CI, 0.07-0.56).
Furthermore, the proportion of patients who experienced adverse events was comparable across groups, with nausea (11%) being the most commonly reported event in the remdesivir group, followed by headache (6%) and diarrhea (6%). (4 percent ).
The Infectious Diseases Society of America recommends remdesivir for some hospitalized COVID-19 patients — but not others — based on a randomized clinical trial that found it shortens recovery time, but it makes no recommendations for non-hospitalized patients. The World Health Organization advises against using remdesivir in hospitalized patients, claiming that no benefit has been demonstrated.
“This study provides support for using remdesivir early in the course of infection with SARS-CoV-2 in high-risk individuals who are not hospitalized. If available, it would add to our therapeutic options, which are currently limited to monoclonal antibody infusions as there are no other outpatient therapies available,” Hill explained. “If monoclonal antibody therapies are in short supply or are inaccessible, remdesivir may provide an alternative and/or additional treatment option.”