International Journal of Infectious Diseases (Oct 2023)

Outcomes and clinical characteristics of the compassionate use of plitidepsin for immunocompromised adult patients with COVID-19

  • José Aguareles,
  • Paula Villares Fernández,
  • María Maravillas Carralón-González,
  • Carles Forné Izquierdo,
  • Eva María Martí-Ballesteros,
  • Virginia Pradillo Fernández,
  • Gabriel Sotres-Fernandez,
  • Teresa García-Delangue,
  • Rocío García de Viedma LaPetra,
  • María Dolores Sánchez-Manzano,
  • Carolina Gutiérrez,
  • Marta García-Coca,
  • Daniel Carnevali-Ruiz,
  • Ruth Barrena-Puertas,
  • José Manuel Luque-Pinilla,
  • Raquel Lloris,
  • Xavier Erik Luepke-Estefan,
  • José Antonio López-Martín,
  • José María Jimeno,
  • Pablo Guisado-Vasco

Journal volume & issue
Vol. 135
pp. 12 – 17

Abstract

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Objectives: To evaluate the compassionate use of plitidepsin as an antiviral treatment in hospitalized immunocompromised adult patients with moderate-to-severe COVID-19. Design: Retrospective observational study of data —collected from January 01, 2021 to April 30, 2022— from 35 immunocompromised adult patients with COVID-19 non-eligible for other available antiviral treatments. Main outcome measures were time to respiratory recovery (SpFi ≥ 315); COVID-19-related 30-day-cumulative mortality after first plitidepsin infusion; and time to undetectable levels of viral RNA. Results: Thirty-three patients receiving a full course of plitidepsin (2.5 mg [n = 29] or 1.5 mg [n = 4]) were included. Most (69.7%) had a malignant hematologic disease and 27.3% had solid tumors. A total of 111 infusions were administered with lack of relevant safety events. Median time from plitidepsin initiation to SpFi ≥315 was 8 days (95% confidence interval [CI], 7-19). Median time to first negative reverse transcription-polymerase chain reaction for SARS-CoV-2 (cycle threshold >36) was 17 days (95% CI 13-25). Mortality rate was 16.3% (95% CI 3-37.3). Conclusion: These data support plitidepsin as a well-tolerated treatment that might have potential clinical and antiviral efficacy in COVID-19 immunocompromised patients.

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