The following is a summary of “Prolonged-release pirfenidone in patients with pulmonary fibrosis as a phenotype of post-acute sequelae of COVID-19 pneumonia. Safety and efficacy,” published in the July 2023 issue of Pulmonology by Sansores, et al.

One of the major concerns arising from post-acute sequelae of COVID-19 (PASC) is the development of pulmonary fibrosis, a condition currently lacking approved pharmacological treatments. For an open-label study, researchers sought to assess the safety and potential clinical efficacy of a prolonged-release pirfenidone formulation (PR-PFD) in patients with PASC-related pulmonary fibrosis.

Patients diagnosed with PASC-pulmonary fibrosis received PR-PFD at a dosage of 1,800 mg/day (1,200 mg in the morning after breakfast and 600 mg in the evening after dinner) for a period of three months. Blood samples were collected to confirm the pharmacokinetics of PR-PFD, and adverse events (AEs) were monitored monthly using a brief questionnaire. Symptom severity, dyspnea, and pulmonary function tests (spirometry, diffusing capacity for carbon monoxide, plethysmography, and 6-minute walk test [6MWT]) were assessed at baseline, one month, and three months after initiating PR-PFD treatment.

Seventy subjects with mild to moderate lung restriction were enrolled in the study. The most common AEs reported were diarrhea (23%), heartburn (23%), and headache (16%), none of which necessitated modifications to the drug study. Two patients died within the first 30 days of enrollment, and three others chose not to continue the study, but these events were not associated with PR-PFD. After three months of PR-PFD treatment, pulmonary function testing, 6MWT, dyspnea, symptoms, and CT scan results showed significant improvement.

In patients with PASC pulmonary fibrosis, three months of PR-PFD treatment was safe and demonstrated therapeutic efficacy. However, further research was required to ascertain whether the pulmonary fibrotic process remains stable, progresses, or improves over time.

Source: resmedjournal.com/article/S0954-6111(23)00250-0/fulltext