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April 23, 2020
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Panel suggests remdesivir as preferred antiviral for pediatric COVID-19 patients

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Kathleen Chiotos
Mari M. Nakamura

In new guidance, a panel of pediatric infectious diseases physicians and pharmacists suggested that supportive care alone is sufficient to treat most children with COVID-19. Among children who develop severe or critical cases — a rare occurrence — the panel suggested the use of remdesivir as the preferred antiviral.

In the guidance, Kathleen Chiotos, MD, MSCE, attending physician in the PICU at the Children’s Hospital of Philadelphia, Mari M. Nakamura, MD, MPH, associate physician in pediatrics at Boston Children’s Hospital, and colleagues said antiviral use should be considered on a case-by-case basis. If antiviral therapy is considered, the medications “should preferably be used as part of a clinical trial” as they become available for pediatric patients, they wrote.

“We hope that this guidance will provide clinicians a framework to approach treatment decisions in a time of uncertainty,” Chiotos and Nakamura told Healio. “One thing that we hope was clear from the guidance is that the literature around therapy is changing rapidly — so clinicians should continue to critically review the literature as therapeutic decisions are being considered.”

The panel considered pediatric cases of COVID-19 as “severe” when a patient needed supplemental oxygen. Although it is rare for children to become severely ill with COVID-19, the authors of the guidance approximately 6% of 2,143 pediatric COVID-19 cases were categorized as severe and critical.

“The most important thing to remember is that most pediatric patients will recover with supportive care, meaning no antiviral therapy,” Chiotos and Nakamura said. “Therefore, use of these medications outside of a clinical trial should really be the exception, not the rule.”

The authors noted that as of now, there are no antivirals with proven efficacy for treating COVID-19. Therefore, all antiviral use should be considered experimental. Out of all antivirals, the panel concluded that remdesivir (Gilead Sciences) would work most efficiently.

“We have generated a ‘guidance document,’ which unlike recent publications by the Infectious Diseases Society of America and NIH is not a guideline,” Chiotos and Nakamura said. “Providers should therefore regard the guidance as ‘evidence-based expert opinion,’ as of the time of publication, and as always, use best clinical judgement in making therapeutic decisions.”

The authors reference limited published data regarding remdesivir as a treatment COVID-19. In one case series, which was not peer-reviewed, three U.S. patients were treated with remdesivir. All recovered, but developed transaminase elevations.

Another case series, which was published by Gilead, included 53 adults who required respiratory support and received remdesivir. Overall, 68% showed respiratory improvement, whereas 13% died. Also, 23% developed transaminase elevations.

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Currently, there are three randomized controlled trials evaluating remdesivir use in the country, according to the authors. Two of them include adolescents aged 12 years or older; none include children or infants aged younger than 12 years. Presently, remdesivir is available to patients aged younger than 18 years through Single Patient Expanded Access requests to Gilead.

“We strongly agree with enrolling kids in trials when possible, but there are not many trials that are enrolling kids as of April 21,” Chiotos and Nakamura said. “There are some trials that include adolescents, but there are not as many of these trials as there are for adults. While we hope that more trials will become available to children in the future, we recognize that trial enrollment may not be feasible for most kids, and this was part of the motivation for writing this guidance document.”

The panel said hydroxychloroquine could be considered when waiting for delivery of remdesivir, or if remdesivir is not available. The panel recommended against combining hydroxychloroquine with azithromycin.

“We also want to highlight the emerging literature suggesting the cardiac toxicity from the combination of hydroxychloroquine and azithromycin — we do not recommend this combination be prescribed to any child with COVID-19,” Chiotos and Nakamura said. – by Ken Downey Jr.

Disclosures: The authors report no relevant financial disclosures.