Prolonged-release pirfenidone in patients with pulmonary fibrosis as a phenotype of post-acute sequelae of COVID-19 pneumonia. Safety and efficacy.

Autor: Sansores RH; Respiratory Department, Hospital Médica Sur, Mexico City, Mexico., Ramírez-Venegas A; Centro Respiratorio de México, Mexico City, Mexico; Tobacco and COPD Research Department, Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas, Mexico City, Mexico., Montiel-Lopez F; Centro Respiratorio de México, Mexico City, Mexico; Tobacco and COPD Research Department, Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas, Mexico City, Mexico., Domínguez-Arellano S; Centro Respiratorio de México, Mexico City, Mexico., Alva-Lopez LF; Radiology and Image Departament Hospital Médica Sur, Mexico City, Mexico., Falfán-Valencia R; HLA Laboratory, Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas, Mexico City, Mexico., Pérez-Rubio G; HLA Laboratory, Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas, Mexico City, Mexico., Olaya-López E; Pneumology Department, Hospital Español de México, Mexico City, Mexico., Zavaleta-Martínez EO; Centro Médico Naval, Secretaria de Marina, Mexico City, Mexico., Aguilar-Medina S; Respiratory Medicine Department, Hospital San Angel Inn Universidad, Mexico City, Mexico., Escobar-Alvarado JC; Sleep Laboratory, Instituto Nacional de Cardiología Ignacio Chávez, Mexico City, Mexico., Poo JL; Centro Respiratorio de México, Mexico City, Mexico., Matera MG; Department of Experimental Medicine, Chair of Pharmacology, University of Campania 'L. Vanvitelli', Naples, Italy., Cazzola M; Department of Experimental Medicine, Chair of Respiratory Medicine, University of Rome 'Tor Vergata', Rome, Italy. Electronic address: mario.cazzola@uniroma2.it.
Jazyk: angličtina
Zdroj: Respiratory medicine [Respir Med] 2023 Oct; Vol. 217, pp. 107362. Date of Electronic Publication: 2023 Jul 13.
DOI: 10.1016/j.rmed.2023.107362
Abstrakt: Introduction: One of the major concerns with post-acute sequelae of COVID-19 (PASC) is the development of pulmonary fibrosis, for which no approved pharmacological treatment exists. Therefore, the primary aim of this open-label study was to evaluate the safety and the potential clinical efficacy of a prolonged-release pirfenidone formulation (PR-PFD) in patients having PASC-pulmonary fibrosis.
Methods: Patients with PASC-pulmonary fibrosis received PR-PFD 1800 mg/day (1200 mg in the morning after breakfast and 600 mg in the evening after dinner) for three months. Blood samples were taken to confirm the pharmacokinetics of PR-PFD, and adverse events (AEs) were evaluated monthly using a short questionnaire. Symptoms, dyspnea, and pulmonary function tests (spirometry, diffusing capacity for carbon monoxide, plethysmography, and 6-min walk test [6MWT]) were evaluated at baseline, and one and three months after having started the PR-PFD treatment.
Results: Seventy subjects with mild to moderate lung restriction were included. The most common AEs were diarrhea (23%), heartburn (23%), and headache (16%), for which no modifications in the drug study were needed. Two patients died within the first 30 days of enrolment, and three opted not to continue the study, events which were not associate with PR-PFD. Pulmonary function testing, 6MWT, dyspnea, symptoms, and CT scan significantly improved after three months of treatment with PR-PFD.
Conclusion: In patients with PASC pulmonary fibrosis, three months' treatment with PR-PFD was safe and showed therapeutic efficacy. Still, it remains to be seen whether the pulmonary fibrotic process remains stable, becomes progressive or will improve.
Competing Interests: Declaration of competing interest Nothing to declare. This was an independent study. The Drug Company that markets the study drug only participated in it by providing PR-PFD free of charge without having any involvement in the study design and data collection and analysis.
(Copyright © 2023 Elsevier Ltd. All rights reserved.)
Databáze: MEDLINE
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