Gilead Sciences, Inc. (Nasdaq: GILD) today announced new data from three real-world retrospective studies being presented at the 31st Conference on Retroviruses and Opportunistic Infections (CROI).
One study showed Veklury® (remdesivir) was associated with a reduced risk of certain long-COVID symptoms in people who were hospitalized for COVID-19.
In a separate study, Veklury use was associated with significantly reduced mortality among people who were immunocompromised and were hospitalized for COVID-19 during the Omicron period (Dec’21 – April’23), irrespective of oxygen requirements.
A third analysis revealed that treatment with Veklury and dexamethasone among patients hospitalized for COVID-19 was associated with reduced mortality as compared to treatment with only dexamethasone, irrespective of oxygen requirements.
“The real-world data presented at CROI continue to reinforce the strong efficacy and safety profile of Veklury, as well as the potential benefit of Veklury for people affected by COVID-19,” said Frank Duff, MD, Senior Vice President, Virology Therapeutic Area Head, Gilead Sciences. “As we enter the fourth year of COVID-19, Veklury remains the antiviral standard of care for people hospitalized for COVID-19. These latest data add to our scientific understanding about Veklury’s potential role in reducing mortality, including in immunocompromised people, and helping to reduce the risk of getting long-COVID symptoms.”
To understand Veklury’s potential impact on the risk of long-COVID, also known as post-COVID conditions (PCC), Gilead analyzed HealthVerity data from 52,006 patients. Results from the study demonstrate that Veklury use was associated with a 10% lower risk of any PCC in both age groups analyzed: HR 0.90 (95% confidence interval [CI]: 0.86–0.93) in those <65 years old and HR 0.90 (95% CI: 0.86–0.95) in those ≥65 years old. Veklury use was associated with lower risk for 6 of 16 individual symptoms/diagnoses in the ≥65 age group (including cognitive dysfunction, cerebrovascular disease, neuropsychiatric features, diarrhea, chest pain, and dysautonomia) and for 8 of 16 individual symptoms/diagnoses in the <65 age group (including the 6 symptoms in the ≥65 age group, as well as thromboembolic disease and headache). Results from this analysis build on existing evidence that support the importance of treating COVID-19 early in the disease course with an antiviral.
In a separate analysis, data from the PINC AI Healthcare database from the Omicron era (Dec’21 – Apr’23) showed an association between Veklury use and reduced mortality among immunocompromised people in the study who were hospitalized for COVID-19. The study included 10,687 immunocompromised people who received Veklury and 4,989 who were matched controls. Results at Day 28 showed that people who were immunocompromised and treated with Veklury had an overall 25% significantly lower mortality risk compared to the non-Veklury group, irrespective of supplemental oxygen requirements (HR: 0.75, 95% CI:0.68-0.83; p<0.0001). This research builds on and further reinforces previous research presented at CROI 2023.
Additional data from a real-world study showed improved outcomes among patients with COVID-19 who received treatment with Veklury in combination with dexamethasone compared to dexamethasone alone. The study matched 33,037 patients who received both Veklury and dexamethasone to 33,037 patients who received only dexamethasone. Patients who received the dual therapy had a significantly lower mortality risk compared to dexamethasone monotherapy across all supplemental oxygen requirements at both 14 and 28 days. For patients with no documented use of supplemental oxygen at baseline, treatment with Veklury was associated with a 20% (p<0.001) lower risk of mortality at Day 28. Patients on low-flow or high-flow oxygen had a 26% (p<0.001) and 29% (p<0.001) lower risk of mortality at Day 28, respectively. Patients on invasive mechanical ventilation/ECMO at baseline had a 19% (p=0.0182) reduced risk for mortality at Day 28.
