Gilead's Veklury (Remdesivir) Shows 83% Recovery Rate in Hospitalized Pediatric COVID-19 Patients Amid Global Surge to Over 419 Million Cases
Feb 18, 2022 03:34
CST Updated
03:34
Gilead Sciences
Antiviral Drug Developer
News on February 17, 2022 /BioValleyBIOON/ -- According to Baidu's "Real-time Updates on the COVID-19 Pandemic"Big DataReport》，as of February 18, 2022, 00:00, globallyCumulative confirmed cases exceed 410 million (419.12 million), with more than 5,870,000 deaths.
Recently, Gilead Sciences participated in the 29th Annual Conference on Retroviruses and Opportunistic Infections in 2022.MeetingNew data from the interim analysis of the ongoing single-arm, open-label Phase 2/3 CARAVAN (GS-US-540-5823, NCT04431453) study of the antiviral drug Veklury (remdesivir) were presented at CRIO 2022.
The study is being conducted in hospitalized pediatric patients with COVID-19 (age range: from birth to under 18 years) to evaluate the safety, tolerability, and pharmacokinetics of Veklury. The data presented come from 53 pediatric patients (age range: from 28 days to under 18 years; median: 7 years [2,12]), who were divided into five cohorts based on age. More than half of the patients (57%) were receiving high-flow oxygen, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO) at baseline.
These latest data show,Veklury was well-tolerated in hospitalized pediatric patients with COVID-19, with a high proportion of patients showing clinical improvement and recovery. According to the clinical ordinal scale, 85% of patients demonstrated clinical improvement, and the recovery rate was 83% at the time of the last assessment (N=53).
Overall, no new safety signals for Veklury were identified. Adverse events (AEs) occurred in 38 patients (72%), and serious adverse events (SAEs) occurred in 11 patients (21%). These SAEs were determined to be unrelated to the study drug, including three deaths. The causes of death were consistent with the patients' underlying medical conditions prior to hospitalization or with COVID-19 disease during hospitalization. In this analysis, the most common adverse events reported in patients receiving Veklury were constipation (17%), followed by acute kidney injury (11%), hyperglycemia (9%), and fever (9%). Additionally, 8% of patients experienced elevated alanine aminotransferase (ALT).
"More children are hospitalized with COVID-19 now than ever before, with up to one-third admitted to the intensive care unit (ICU)," said Amina Ahmed, Professor of Epidemiology and Infectious Diseases at Levine Children's Hospital, Atrium Health, North Carolina, USA. "We need antiviral options to help kids recover faster and get out of the hospital sooner. These interim results from the CARAVAN study are encouraging, indicating that Veklury is generally well-tolerated in children under 18. Veklury can provide meaningful clinical improvement by halting disease progression and reducing disease severity, helping children recover and be discharged more quickly."
Veklury (Remdesivir) is an antiviral drug developed by Gilead Sciences, Inc. that inhibits the replication of the novel coronavirus (SARS-CoV-2), which causes COVID-19. Veklury, a prodrug of a nucleotide analog, directly suppresses SARS-CoV-2 viral replication within host cells by targeting the viral RNA polymerase. Once inside the body, Veklury is metabolized into its active form, Remdesivir triphosphate, which then incorporates into the viral RNA, halting the virus's replication in the infected cells.
In the United States, the FDA approved Veklury in October 2020: for the treatment of COVID-19 in adults and pediatric patients aged 12 years and older, weighing at least 40 kg, who require hospitalization. In January 2022,FDAApproval of Veklury's Supplemental New Drug Application (sNDA): For the treatment of non-hospitalized adult and adolescent patients at high risk of progressing to severe COVID-19 (including hospitalization or death). This expanded indication allows Veklury to be used in eligible outpatient settings, administered as a 3-day course of intravenous therapy.
January 2022,FDAThe pediatric Emergency Use Authorization (EUA) for Veklury has also been expanded: in addition to pediatric patients with COVID-19 who require hospitalization, outpatient pediatric patients who weigh at least 3.5 kg, are less than 12 years old or weigh less than 40 kg, and are at high risk for disease progression are now included.
As new SARS-CoV-2 variants emerge around the world, Gilead Sciences continues to evaluate the effectiveness of Veklury against viral variants. In vitro laboratory tests conducted in multiple independent studies have shown that Veklury retains activity against the Omicron variant. To date, no significant genetic changes that would substantially alter the viral RNA polymerase targeted by Veklury have been identified in any known variants. Gilead will continue to experimentally assess the activity of Veklury against SARS-CoV-2 variants through in vitro antiviral testing.The antiviral activity of Veklury has been confirmed in vitro against all previously identified major variants of SARS-CoV-2, including Alpha (α), Beta (β), Gamma (γ), Delta (δ), and Omicron (o). (Bioon.com)