Remdesivir Safety Profile in Children on Par With Adults

NEW YORK (Reuters Health) – Remdesivir appears to have a similar safety profile in children with COVID-19 as in adults, according to the largest cohort to date of children with severe COVID-19 who received the drug through a compassionate-use program.

Remdesivir, from Gilead Sciences, shortens time to recovery in adults with COVID-19, but its efficacy and safety in children are unknown. The antiviral is not yet approved for patients younger than 12 years.

In late March of 2020, Gilead Sciences began accepting requests from clinicians for compassionate use of remdesivir in hospitalized children with confirmed SARS-CoV-2 and severe manifestations of COVID-19.

In a paper in Pediatrics, clinicians from the U.S., U.K., Italy and Spain describe outcomes in 77 children (median age, 14 years) hospitalized with severe COVID-19 who received intravenous remdesivir through the compassionate-use program.

The intended course of remdesivir was 10 days (200 mg on day one and 100 mg daily subsequently for children weighing at least 40 kg and 5 mg/kg on day one and 2.5 mg/kg daily subsequently for children weighing less than 40 kg).

More than three-quarters (79%) had one or more comorbid conditions, including asthma, obesity and congenital or neurological disorders.

“Remdesivir was well tolerated, with a low incidence of serious adverse events (16%). Most adverse events were related to COVID-19 or comorbid conditions. Laboratory abnormalities, including elevations in transaminase levels, were common; 61% were grades 1 or 2,” Dr. David Goldman of Children’s Hospital at Montefiore in New York and colleagues report in Pediatrics.

At baseline, 90% of children required supplemental oxygen and 51% required invasive ventilation. By day 28 of follow-up, 88% of children had a decreased need for oxygen support, 83% recovered and 73% were discharged.

Among children requiring invasive ventilation at baseline, 90% were extubated, 80% recovered, and 67% were discharged. Four children died, three due to COVID-19.

The authors caution that “without comparative data from a randomly assigned control group, it is not possible to say if the high level of recovery observed in these patients was due to the effects of remdesivir, the natural course of the disease, or other therapeutic interventions. Another limitation is the relatively short duration of follow-up (28 days), at which point four patients remained on invasive respiratory support.”

A phase-2/3 study is underway to assess the safety, tolerability, pharmacokinetics and efficacy of remdesivir in children.

“Although morbidity and mortality rates differ, children hospitalized with acute COVID-19 often have a similar disease course as adults. Children are also likely to have a similar response to remdesivir as adults,” note the authors of an accompanying editorial.

“Safety data such as that presented by Goldman et al are critical to support labeling of remdesivir in children,” write Dr. Danny Benjamin and colleagues with Duke Clinical Research Institute, in Durham, North Carolina.

“We will need additional such data, including exposure (dosing) and safety from well-conducted pharmacokinetic and safety trials. Ideally, we will eventually have outcome data relating dosing to both safety and clinical outcomes. In the meantime, we will inform families that the therapeutic benefit of remdesivir in our youngest patients is unknown as we continue research that increases our knowledge of the molecule,” they write.

Funding for this research was provided by Gilead Sciences. Several authors have disclosed financial relationships with the company.

SOURCE: https://bit.ly/3eeoGRy and https://bit.ly/3enAnoW Pediatrics, online April 21, 2021.

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