The study author of the late-breaking IDWeek findings discusses what the new data mean for using the antiviral to reduce COVID-19 burden.
A 3-day regimen of intravenous (IV) antiviral therapy remdesivir (Veklury) provided an 87% reduction in risk of hospitalization or death related to COVID-19 versus placebo after 28 days, according to new late-breaking data presented at IDWeek 2021.
Presented by study author Joshua A. Hill, MD, Assistant Professor at the Fred Hutchinson Cancer Research Center, University of Washington, the findings from the Gilead-funded phase 3, randomized, double-blind, placebo-controlled provided new insights into one of the earliest investigated therapies for severe COVID-19—and the first granted full Biologics License Application (BLA) approval by the US Food and Drug Administration (FDA) earlier this year.
Hill and colleagues sought to compare a 3-day regimen of remdesivir added to standard care to placebo plus standard care in non-hospitalized patients with COVID-19 deemed to be at high risk of the virus.
A total of 562 patients were randomized 1:1 to either IV remdesivir (n = 279; 200 mg on day 1, then 100 mg on days 2-3) or placebo (n = 283). Investigators sought a primary efficacy endpoint of composite COVID-19 hospitalization or all-cause mortality by day 28 and a primary safety endpoint of proportion of patients with treatment-emergent adverse events. The team controlled for baseline stratification factors when using Cox proportional hazards models to interpret comparative therapy efficacy.
The phase 3 trial was terminated early due to “administrative reasons in light of the evolving pandemic.”
A majority (52%) of patients were male; 44% were Hispanic/Latino and 30% were ≥60 years old. Common comorbidities in the high-risk patients with COVID-19 included diabetes (62%), obesity (56%), and hypertension (48%).
Remdesivir was associated with an 87% reduction in composite COVID-19 hospitalization or all-cause death versus placebo by day 28 (HR, 0.13; 95% CI, 0.03 – 0.59; P = .008). The antiviral was also associated with an 81% risk reduction for COVID-19 associated medically attended visits or all-cause death by day 28 versus placebo (HR, 0.19; 95% CI, 0.07 – 0.56; P = .002). Investigators observed no patient deaths in either treatment arm by day 28.
Treatment-emergent adverse events were similar across the treatment arms, with nausea (11%), headache (6%), and diarrhea (4%) occurring most frequently in patients treated with remdesivir.
In an interview with Contagion® during IDWeek 2021, Hill discussed further details surrounding the findings, and how they impact the current clinical interpretation and utility of remdesivir versus COVID-19.
“We’ve seen variable results in the in-patient hospitalization remdesivir data, but really the key takeaways that I think we’ve seen emerge from data are earlier initiation with antiviral therapy is better and associated with better efficacy and outcomes, and that’s just expanded by this study,” Hill said. “Now we’re intervening the earliest—within 7 days of symptom onset and not yet hospitalized—and now we’re really seeing a strong effect.”
Hear the rest of Hill’s takeaways in the video above.