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. 2025 May 1;44(5):442-448.
doi: 10.1097/INF.0000000000004657. Epub 2024 Dec 27.

Safety of Nirmatrelvir-Ritonavir Administration in Children With Immunodeficiency and/or Comorbidities With SARS-CoV-2 Infection: A Retrospective Clinical Report

Stefania Bernardi  1 , Marco Roversi  2   3 , Antonio Torelli  4 , Antonio Musolino  4 , Emanuele Nicastri  5 , Paolo Palma  6   7 , Paolo Rossi  3   7 , Leonardo Vallesi  8 , Tiziana Corsetti  8 , Laura Lancella  1 , Barbarella Lucarelli  9 , Federica Galaverna  9 , Alberto Villani  7   10 , Carlo Federico Perno  11 , Massimiliano Raponi  12 ; KIDS Study Group
Collaborators, Affiliations

Safety of Nirmatrelvir-Ritonavir Administration in Children With Immunodeficiency and/or Comorbidities With SARS-CoV-2 Infection: A Retrospective Clinical Report

Stefania Bernardi et al. Pediatr Infect Dis J. .

Abstract

Introduction: Despite the generally mild course of COVID-19 in children, immunocompromised patients may experience complications or severe infection. This study reports the clinical outcomes of pediatric patients treated with nirmatrelvir and ritonavir (N/R) for SARS-CoV-2 infection.

Methods: We retrospectively reported the data of children with any immunodeficiency with COVID-19 who received N/R treatment between March 2022 and June 2023 at the Bambino Gesù Children's Hospital. Patients were treated with N/R for 5 days. We compared liver and kidney function before and after treatment with N/R and looked for a relationship between the duration of COVID-19 infection and the time from positivity to administration of N/R administration.

Results: A total of 85 pediatric immunocompromised patients with COVID-19 were included in the study, with a mean age of 10.7 years (SD 4.8), mostly males (60%). We found a significant difference in the viral load before and after N/R administration. Four patients (4.7%) experienced adverse events related to N/R therapy. One of these had to discontinue N/R administration. Three patients (3.5%) experienced negative effects of drug interactions during N/R therapy, namely an increase of sirolimus and ciclosporin serum levels. A significant positive correlation was found between the time from SARS-CoV-2 positivity to N/R administration and the duration of SARS-CoV-2 swab positivity (R = 0.78, P < 0.001), suggesting that the earlier N/R is administered, the shorter the duration of COVID-19 in the study sample.

Conclusion: Our experience shows that N/R is reasonably safe in the pediatric population and could favor viral clearance, thus reducing the duration of infection.

Keywords: COVID-19; antivirals; immunodeficiency; nirmatrelvir-ritonavir; pediatrics.

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Conflict of interest statement

The authors have no conflict of interest to disclose.

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