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19:03 EDT Gilead announces findings from two studies on Veklury use in treating COVID - Gilead Sciences announced findings from two studies, which provide further insights on the use of Veklury for the treatment of hospitalized and non-hospitalized patients with COVID-19. The first study is a retrospective observational analysis of the real-world treatment data from the Premier Healthcare Database consisting of 853,219 patients hospitalized with COVID-19 across the United States. This analysis found that more than 50% of hospitalized COVID-19 patients received Veklury, predominantly in combination with other therapies. A separate study, which is a new post-hoc analysis of data from the Phase 3 PINETREE study, demonstrated that use of Veklury within five days of symptom onset or between 5 to 7 days of symptom onset reduced hospitalizations in patients at high risk for severe COVID-19 disease. The observational analysis of real-world data also found that as the pandemic progressed, initiation of Veklury within two days of hospitalization increased from 41% to 91% between May 2020 and December 2021. During this period, as new variants arose and disease severity fluctuated, median hospital length of stay decreased from seven to six days with the greatest benefit in invasive mechanical ventilation/ ECMO patients. While ICU use decreased from 34% to 27%, with the greatest benefit in high-flow oxygen/non-invasive ventilation, overall ICU LOS remained the same. Overall mortality rates remained stable at 16%, with the greatest decline over time in patients on low-flow supplemental oxygen. These results confirm Veklury's position as a foundational treatment for hospitalized patients with COVID-19 and signify the need to treat patients early before they become more severely ill with COVID-19. The new post-hoc analysis from a Phase 3 double-blind, placebo-controlled trial demonstrating that a three-day course of Veklury treatment significantly reduced the risk of hospitalization was also presented at ECCMID. The analysis assessed the variability of treatment effect with Veklury by time of symptom onset and number of baseline risk factors. The study concluded that Veklury reduced hospitalizations in patients at high risk for severe COVID-19 disease when initiated anytime within a 7-day window from symptom onset. As expected with antiviral therapy, the benefit was modestly greater the sooner Veklury was administered. Patients treated with Veklury within five days of symptom onset had a 90% reduced risk for hospitalization. Additionally, patients who received Veklury after five 5 days of symptom onset experienced an 81% reduction in risk of hospitalization. This new analysis builds on the previously presented primary endpoint analysis, in which Veklury demonstrated a statistically significant 87% reduction in risk for the composite primary endpoint of COVID-19 related hospitalization or all-cause death by Day 28 compared with placebo; no deaths occurred in either arm of the study through the primary endpoint. Gilead presented two additional studies from the company's COVID-19 clinical and real-world evidence programs at the European Congress of Clinical Microbiology & Infectious Diseases. Data from the CARAVAN study evaluated safety, pharmacokinetic, virologic, and clinical outcomes of Veklury treatment in pediatric patients who were 28 days of age and older. The interim analysis of Veklury in pediatric patients hospitalized with COVID-19 with ages ranging from 28 days to less than 18 years demonstrated that Veklury was generally well tolerated, with a high proportion of participants showing clinical improvement and recovery. Overall, no new safety findings for Veklury were noted. In the study, 75% and 85% showed clinical improvement at Day 10 and last assessment, respectively, while 60% and 83% were discharged by Day 10 and Day 30, respectively. Overall, 38 patients experienced AEs, with 11 patients experiencing serious adverse events that were determined not to be study-drug related, including 3 participant deaths which were consistent with the patients' underlying medical condition prior to study entry or with COVID-19 disease during hospitalization. A real-world evidence analysis evaluated data from 2,310 patients hospitalized with COVID-19 who had previously undergone kidney transplantation. The analysis found that in this patient population, overall mortality was comparable to the general population hospitalized with COVID-19, but markedly increased for those with diminished renal function, comorbidities, and higher oxygen requirements upon admission. Insights from this study help inform clinical decision-making in the context of management of kidney transplant patients and other solid-organ transplant recipients, alike.