Veklury® (Remdesivir) Efficacy and Safety Profile Further Demonstrated in Vulnerable Patient Populations
Gilead Sciences, Inc. (Nasdaq: GILD) today announced positive results from several COVID-19 clinical and real-world evidence studies being presented at the 33rd European Congress of Clinical Microbiology & Infectious Diseases (ECCMID). A Phase 3 clinical study demonstrated that Veklury® (remdesivir) was generally well tolerated in people with moderate to severe renal impairment. Additional data includes a retrospective real-world study which demonstrated that Veklury treatment is associated with a lower risk of death from COVID-19 for people living with cancer. A separate real-world analysis demonstrated that use of Veklury is also associated with reduced hospital readmission risk in immunocompromised patients hospitalized with COVID-19. Results from a Phase 1 study evaluating the safety, tolerability, and pharmacokinetics (PK) of obeldesivir, previously known as GS-5245, a novel investigational oral compound being developed by Gilead for the treatment of SARS-CoV-2 infection, showed obeldesivir reaches expected therapeutic plasma concentrations for the treatment of COVID-19.
“The breadth of clinical and real-world evidence data presented at ECCMID further support the strong efficacy and safety profile of Veklury,” said Frank Duff, MD, Senior Vice President, Virology Therapeutic Area Head, Gilead Sciences. “Since the beginning of the pandemic, Veklury has played a critical role in the treatment of hospitalized patients with COVID-19. The real-world data further demonstrates its role in reducing mortality and hospital readmission rates in vulnerable patient populations, including people living with cancer and other immunosuppressed conditions.”
Results from a Phase 3, randomized, double-blind, placebo-controlled, parallel-group, multicenter study (REDPINE) evaluated the safety of Veklury in patients with moderately and severely reduced kidney function who were hospitalized for COVID-19, a population with increased COVID-19-related mortality. The trial included 243 hospitalized adult participants with confirmed COVID-19 and renal impairment, including 90 participants (37%) with acute kidney injury (AKI), 64 participants (26%) with chronic kidney disease (CKD) and 89 participants (37%) with end stage kidney disease (ESKD) requiring hemodialysis. Patients were randomized 2:1 to receive Veklury (n=163) or placebo (n=80), in addition to standard of care. No new safety signals were observed in the study and no additional adverse reactions to Veklury were identified in 163 hospitalized patients with AKI (n=60), CKD (n=44) or ESKD (n=59) on hemodialysis receiving Veklury for up to 5 days.
Two real-world studies of clinical practice presented at ECCMID examined Veklury’s effectiveness in reducing COVID-19-associated mortality for those living with cancer, as well as the role Veklury plays in reducing hospital readmission for immunocompromised patients infected with dominant variants of concern (VOC): pre-Delta, Delta and Omicron. In the first analysis, 7,482 people with cancer and hospitalized for COVID-19 who were treated with Veklury in the first two days of admission were evaluated. Results at Day 28 showed that people with cancer treated with Veklury had a significantly lower risk for mortality compared to people with cancer that were not treated with Veklury (HR:0.67, 95% CI:0.59-0.75; p<0.0001). This finding was seen across all VOC at Day 28: pre-Delta, 25% (HR:0.75, 95% CI:0.61-0.92; p=0.006); Delta, 32% (HR:0.68, 95% CI:0.55-0.85; p=0.0005); and Omicron, 40% (HR:0.60. 95% CI:0.50-0.72; p<0.0001).
In the second analysis, 4,664 immunocompromised patients were evaluated and those who received treatment with Veklury (n=2,332) had lower risk for hospital readmission at both 30- and 60-day time periods. Results demonstrated that 60-day readmission rates were 16% lower for patients treated with Veklury during the Delta wave (HR:0.84, 95% CI:0.71-0.96; p<0.01) and 13% lower during the Omicron wave (HR:0.87, 95% CI:0.81-0.93; p<0.01) compared to matched controls (n=2,332). These data further confirm RWE presented at CROI earlier this year which demonstrated that use of Veklury was associated with a reduced risk of 30-day all-cause readmission.
“Antivirals play a key role in halting the replication of the SARS-CoV-2 virus. Remdesivir is also an important treatment option for vulnerable patient populations such as the immunocompromised, because it has a well-established safety and tolerability profile and it maintains activity across variants of concern,” said Michele Bartoletti, MD, PhD, Head of Infectious Disease Unit at Humanitas Research Hospital in Milan and Associate Professor of Humanitas University, Milan, Italy.
Gilead also announced positive data at ECCMID from its Phase 1 randomized, double-blind, placebo-controlled, dose escalation study of obeldesivir in healthy adult participants. Results demonstrated that obeldesivir reaches expected therapeutic plasma concentrations for the treatment of COVID-19. Obeldesivir is an investigational novel oral antiviral being developed for the treatment of COVID-19, which once metabolized, works in the same way as Veklury by targeting SARS-CoV-2 virus replication through inhibition of the viral RNA polymerase. Gilead has advanced obeldesivir into two Phase 3 studies – BIRCH and OAKTREE – in broad populations and geographies to assess the efficacy and safety of obeldesivir for the treatment of non-hospitalized participants with COVID-19.
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