Phase II/III interim data evaluating the safety, tolerability and clinical outcomes of Veklury in pediatric patients with COVID-19 presented at CROI 2022.- Gilead Sciences.

These latest data demonstrate that Veklury was generally well tolerated among pediatric patients hospitalized with COVID-19 with a high proportion of participants showing clinical improvement and recovery. Overall, no new safety findings for Veklury were noted, and 85% of patients showed clinical improvement based on the clinical ordinal scale and the recovery rate was 83% at last assessment (N=53).

The primary objective of this study was to evaluate the safety, tolerability, and pharmacokinetics of Veklury in pediatric patients, as assessed by the proportion of participants experiencing treatment-emergent adverse events; proportion of participants experiencing treatment-emergent graded laboratory abnormalities; and plasma concentrations of Veklury and metabolites, respectively. Safety was assessed by adverse events (AEs) and lab tests (hematology, chemistry, urine, inflammatory, coagulation). Clinical outcomes included improvement on a 7-point ordinal scale, time to discharge, and oxygenation modality. Virologic outcomes included days to confirmed negative SARS-CoV-2 PCR (defined as 2 consecutive negative results).

In this study of 53 pediatric patients across five cohorts grouped by age (median age 7 years ) with more than half (57%) being on high-flow oxygen, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO) at baseline. Of the 53 pediatric patients enrolled in the study, no new safety signals were apparent for Veklury. 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 conditions prior to study entry or with COVID-19 disease during hospitalization.

Children weighing at least 40kg were in cohorts 1 and 8 and received 200mg on Day 1 followed by 100mg daily. Infants and children weighing 3kg to less than 40kg were in cohorts 2-4 and received weight-based dosing of 5mg/kg on Day 1 followed by 2.5mg/kg daily. In the analysis, the most common adverse event in patients taking Veklury was constipation (17%), followed by acute kidney injury (11%), hyperglycemia (9%) and pyrexia (9%). Additionally, 8% of participants had an increase in alanine transaminase (ALT).

On January 21, 2022, the FDA expanded the pediatric Emergency Use Authorization (EUA) of Veklury to include non-hospitalized pediatric patients weighing at least 3.5 kg who are younger than 12 years of age or weighing less than 40 kg who are at high risk of disease progression, in addition to those with COVID-19 requiring hospitalization. Gilead has submitted this interim data to the FDA, EMA and other regulatory agencies. The use of Veklury in pediatric patients younger than 12 years of age or weighing less than 40 kg is investigational and Veklury is not approved by the FDA for this use. Please see below for more information on the approved use of Veklury and the EUA for pediatric patients.