FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced new data from an interim analysis of its ongoing, Phase 2/3 single arm, open-label study to evaluate the safety, tolerability and pharmacokinetics of Veklury® (remdesivir) in pediatric patients hospitalized with COVID-19 with ages ranging from 28 days to less than 18 years. This data will be presented at the 29th Conference on Retroviruses and Opportunistic Infections (virtual CROI 2022) taking place from February 12-16.

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).

“More children are being hospitalized with COVID-19 than ever before, and up to a third of them require admission to intensive care units. We need antiviral options that can help children recover faster and leave the hospital sooner,” said Amina Ahmed, MD, FAPP, epidemiologist and professor of infectious disease at Atrium Health’s Levine Children’s Hospital, North Carolina, U.S. “These interim findings from the CARAVAN study are encouraging, showing that remdesivir was generally well tolerated among children under the age of 18. Remdesivir can potentially provide meaningful clinical improvement, by reducing disease severity and returning children home to their families more quickly.”

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 [2,12]) 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).

“This interim data highlights the possible benefits of Veklury for children with COVID-19, showing that Veklury was generally well-tolerated, may help to prevent disease progression and has the potential to help children to recover faster,” said Anu Osinusi, Vice President, Clinical Research, Hepatitis, Respiratory and Emerging Viruses at Gilead Sciences. “Gilead remains committed to supporting the most vulnerable patients and continues to pursue multiple approaches to address the evolving unmet needs of patients with COVID-19.”

On January 21, 2022, the U.S. Food and Drug Administration (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.

About the CARAVAN Study (GS-US-540-5823)

Study GS-US-540-5823 (CARAVAN) is a Phase 2/3 single arm, open-label study evaluating the safety, tolerability and pharmacokinetics of remdesivir in participants from birth to 10x ULN. Discontinue Veklury if ALT elevation is accompanied by signs or symptoms of liver inflammation.

Adverse reactions

• The most common adverse reaction (≥5% all grades) was nausea.
• The most common lab abnormalities (≥5% all grades) were increases in ALT and AST.

Drug interactions

• Drug interaction trials of Veklury and other concomitant medications have not been conducted in humans.

Dosage and administration

• Dosage: For adults and pediatric patients ≥12 years old and weighing ≥40 kg: 200 mg on Day 1, followed by once-daily maintenance doses of 100 mg from Day 2 administered only via intravenous infusion. Veklury should be initiated as soon as possible after diagnosis of symptomatic COVID-19.
• Treatment duration:
  • For hospitalized patients requiring invasive mechanical ventilation and/or ECMO, the recommended total treatment duration is 10 days.
  • For hospitalized patients not requiring invasive mechanical ventilation and/or ECMO, the recommended treatment duration is 5 days. If a patient does not demonstrate clinical improvement, treatment may be extended for up to 5 additional days for a total treatment duration of up to 10 days.
  • For non-hospitalized patients diagnosed with mild-to-moderate COVID-19 who are at high risk for progression to severe COVID-19, including hospitalization or death, the recommended total treatment duration is 3 days.
• Testing prior to and during treatment: Perform eGFR, hepatic laboratory, and prothrombin time testing prior to initiating Veklury and during use as clinically appropriate.
• Renal impairment: Veklury is not recommended in individuals with eGFR