Abstract
Objective and Methods: The aim of this study was to determine the efficacy and safety of fosravuconazole L-lysine ethanolate (NAILIN® Capsules, fosravuconazole) in patients with onychomycosis in real-world clinical practice. The medical records of patients who were treated with fosravuconazole for onychomycosis in our clinic between August 2018 and February 2020 were collected.
Results: Three hundred and sixty patients with onychomycosis were enrolled (toenails, 340 cases; fingernails, 28 cases; both fingernails and toenails, 8 cases). The highest number of patients, both male and female, was in the 70’s group. The treatment outcomes of 84 patients with onychomycosis of toenails, who had completed the 12-week fosravuconazole treatment, at ≥1 years after treatment initiation were as follows: complete cure, 59 patients (70.2%); unknown outcomes, 22 (26.2%); and no efficacy, 3 (3.6%). Most of the patients were completely cured at 3 months and between 6 and 12 months after treatment initiation. Most of the patients with unknown outcomes tended to show improvement at the time of dropout (the last visit to the clinic). Two hundred forty-nine (69.2%) of the 360 patients completed the 12-week fosravuconazole treatment. The efficacy of this drug was high in elderly, young patients, fingernail onychomycosis and refractory onychomycosis who were excluded from the phase 3 clinical trial. Laboratory tests performed in 260 patients during treatment showed abnormal alanine aminotransferase/aspartate aminotransferase (ALT/AST) values in 18 (6.9%) and gamma-glutamyl transpeptidase (γ-GTP) level in 61 (23.5%) patients. There were no serious adverse reactions, including cutaneous symptoms.
Conclusion: Fosravuconazole treated for onychomycosis resulted in high cure and adherence rates in real-world clinical practice. In addition, serious adverse reactions can be prevented by liver function testing. Thus, fosravuconazole can be used as a first-line drug for patients with onychomycosis, except for those who have difficulties in taking the drug owing to complications and other reasons.
