Remdesivir reduces risk for COVID-19 hospitalization in high-risk patients
A 3-day course of IV remdesivir was safe, well tolerated and prevented COVID-19-related hospitalizations among high-risk COVID-19 patients, according to data presented at IDWeek.
“There is an urgent need for antiviral treatments that can be offered to people with COVID-19 who are at increased risk for progression to hospitalization and other complications,” Joshua A. Hill, MD, a researcher and assistant professor in the vaccine and infectious disease division at the Fred Hutchinson Cancer Research Center in Seattle, told Healio.
Hill noted there are no currently 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 monoclonal antibodies available under emergency use authorization are the only other option.
“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.”
For the study, Hill and colleagues randomly assigned participants in a 1:1 ratio to receive IV remdesivir over 3 days — 200 mg on day 1 and 100 mg on days 2 to 3 — or placebo. The primary endpoints were composite COVID-19 hospitalization or all-cause death by day 28 and proportion of participants with treatment-emergent adverse events, they said.
Gilead said in a press release before the conference 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 the participants who were already enrolled. Overall, 562 patients started their assigned treatment, with 279 receiving remdesivir and 283 receiving placebo.
The study demonstrated that treatment with remdesivir significantly reduced COVID-19 hospitalization or all-cause death by day 28 (HR = 0.13; 95% CI, 0.03-0.59) compared with placebo, Hill and colleagues reported. They also found that participants receiving remdesivir had a significantly lower risk for COVID-19-related medically attended visits or all-cause death through day 28 compared with placebo (HR = 0.19; 95% CI, 0.07-0.56).
Additionally, the proportion of patients who experienced adverse events was similar between the groups, with the most commonly reported events in the remdesivir group being nausea (11%), headache (6%) and diarrhea (4%).
The Infectious Diseases Society of America suggests using remdesivir for some hospitalized patients with COVID-19 — but not others — based on a randomized clinical trial that showed it shortens recovery time, but it does not have recommendations for non-hospitalized patients. WHO recommends against using remdesivir in hospitalized patients, arguing it has not shown a benefit.
“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 said. “If there are shortages of monoclonal antibody therapies or lack of access, remdesivir could provide an alternative and/or additional treatment option.”
Collapse
Hill JA, et al. Abstract LB1. Presented at: IDWeek; Sept. 29-Oct.3, 2021 (virtual meeting).
Read more about