Several new studies presented at ECCMIC 2022 confirm Veklury activity in treating COVID-19.

The company said that analysis of real world data confirmed 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

Gilead added the first study consisted of analysis of the real-world treatment data from the Premier Healthcare Database of 853,219 patients hospitalized with COVID-19 in the U.S.

Gilead said the analysis found that more than 50% of hospitalized patients with COVID-19 received Veklury, predominantly in combination with other therapies. The company said that as 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 (LOS) decreased to 6 days from 7 with the greatest benefit in invasive mechanical ventilation/ECMO patients (15 days to 11 days). While ICU use decreased from 34% to 27%, with the greatest benefit was in high-flow oxygen/non-invasive ventilation (66% to 52%), overall ICU length of stay remained the same. Gilead added that overall mortality rates remained stable at 16%, with the greatest decline over time in patients on low-flow supplemental oxygen (15% to 12%).

In addition, the company said post-hoc analysis from a phase III trial, dubbed PINETREE, showed that a three-day course of Veklury significantly reduced the risk of hospitalization. Gilead said 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, while patients who received Veklury after five 5 days of symptom onset experienced an 81% reduction in risk of hospitalization.

The company noted the new analysis data builds on the previously presented main goal data, in which Veklury showed a statistically significant 87% reduction in risk for the composite primary endpoint of COVID-19 related hospitalization or all-cause death by Day 28..

The company presented these two analysis and data from other studies at the European Congress of Clinical Microbiology & Infectious Diseases (ECCMID 2022). Last week (April 22), the World Health Organization (WHO) recommended the use of Gilead's (GILD) remdesivir in patients with mild or moderate COVID-19 who are at high risk of hospitalization, following publication of new data.

Gilead presented two additional studies from the company’s COVID-19 clinical and real-world evidence programs at the conference: 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 (2 point increase on the ordinal scale) at Day 10 and last assessment, respectively, while 60% and 83% were discharged by Day 10 and Day 30, respectively. Overall, 38 patients (72%) experienced AEs, with 11 patients (21%) experiencing serious adverse events (SAEs) 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.