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Treatment Outcome with Fosravuconazole for Onychomycosis

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Abstract

Fosravuconazole L-lysine ethanolate (F-RVCZ), a ravuconazole prodrug, is a newly available agent with high expectations for efficacy in the treatment of onychomycosis. However, clinical data regarding the efficacy of F-RVCZ are limited because the drug was launched only in Japan in 2018. Therefore, we analyzed the outcome of F-RVCZ therapy in the treatment of onychomycosis at outpatient dermatology clinics in Japan. We examined data for 109 patients (68 male, 41 female) with varying clinical type, including total dystrophic onychomycosis and dermatophytoma, and a wide range of age groups, including the elderly. The complete cure rate at 12 weeks was 6.4% (7/109) and 67.9% (74/109) at the last visit (mean time to last visit: 32 ± 14.2 weeks). Mean rate of improvement in the affected nail area was 49.1 ± 23.3% at 12 weeks and 86.8 ± 22.4% at the last visit. Efficacy at 12 weeks and the last visit, respectively, was as follows: none, 4 cases and 1 case; slight, 35 cases and 4 cases; moderate, 51 cases and 21 cases; significant, 12 cases and 9 cases; complete cure, 7 cases and 74 cases. There were no serious adverse events. This retrospective survey was the first large-scale analysis of actual clinical practice outcomes and had minimal exclusions. Compared to previous reports, our results demonstrated excellent efficacy of F-RVCZ therapy in a variety of patients. Considering our results and the ease of oral administration (1 capsule/day for 12 weeks) and few adverse events, F-RVCZ therapy appears to be a useful option for the treatment of onychomycosis.

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Data Availability

The data that support the findings of this study are available from the corresponding author upon reasonable request.

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Acknowledgements

The authors thank Koichi Makimura of Teikyo University for contributions based on expertise in mycology. The authors thank Kazuo Satoh of Teikyo University for contributions to the statistical analyses and manuscript revisions.

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Authors

Contributions

HS designed the study, carried out the diagnosis, treatment, and data analysis, and drafted the manuscript. YS, AY, and YK participated in the diagnosis and treatment of onychomycosis and revision of the manuscript. All authors read and approved the final manuscript.

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Correspondence to Harunari Shimoyama.

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The author declare that they have no conflict of interest.

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Informed consent was obtained from all individual participants included in the study.

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Consent for publication was obtained from the study participant presented in Fig. 1.

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All procedures performed in the study involving human participants were in accordance with the ethical standards of the institutional and/or national research committees (Research Ethics Committee of Teikyo University; Tei-rin 18–235-2) and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.

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Shimoyama, H., Yo, A., Sei, Y. et al. Treatment Outcome with Fosravuconazole for Onychomycosis. Mycopathologia 186, 259–267 (2021). https://doi.org/10.1007/s11046-021-00540-6

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