Evaluation of Hepatic and Renal Function Algorithms for Fosravuconazole in Real-World Clinical Practice
Harunari Shimoyama1,2,3, Yoshihiro Sei2
1Mizonokuchi Dermatology and Medical Mycology Clinic.
Background:
Oral antifungal therapy is the standard treatment for onychomycosis. However, many physicians still prefer topical agents because of concerns about adverse effects.
Objectives:
This study evaluated changes in hepatic and renal function parameters during fosravuconazole therapy and assessed the utility of an algorithmic approach for interpreting these abnormalities.
Methods:
Laboratory parameters including aspartate aminotransferase (AST), alanine aminotransferase (ALT), γ glutamyltransferase (γ-GTP), serum creatinine (sCr), and estimated glomerular filtration rate (eGFR) were compared between baseline and follow-up. Fold changes were calculated, and γ-GTP was classified according to the LiverTox database. Each parameter was assessed using an algorithm for managing hepatic and renal side effects.
Results:
A total of 128 cases were analyzed. Median baseline values were AST 22 U/L, ALT 19 U/L, γ-GTP 25 U/L, sCr 0.75 mg/dL, and eGFR 74.9 mL/min/1.73 m². At follow-up, values were AST 22 U/L, ALT 22 U/L, γ-GTP 51.5 U/L, sCr 0.86 mg/dL, and eGFR 67.1 mL/min/1.73 m². γ-GTP showed significantly greater fold changes than other parameters (p < 0.001). Thresholds for discontinuation were met in 3 hepatic (2.3%) and 5 renal (3.9%) cases. No patient developed clinical symptoms, and only one discontinued treatment.
Conclusions:
Algorithm-based monitoring enabled safe fosravuconazole administration. This practical approach may help clinicians adopt oral antifungal therapy more confidently as first-line treatment for onychomycosis.
Insights
This study shows that an algorithm-based monitoring approach allows for safe oral antifungal (fosravuconazole) treatment for onychomycosis. This method helps clinicians confidently use oral antifungals as a first-line therapy.
Area of Science:
- Medical Research
- Pharmacology
- Dermatology
Background:
- Onychomycosis (fungal nail infection) is typically treated with oral antifungal medications.
- Physicians often hesitate to prescribe oral antifungals due to concerns regarding potential adverse effects.
Purpose of the Study:
- To evaluate hepatic and renal function during fosravuconazole therapy for onychomycosis.
- To assess the effectiveness of an algorithmic approach in managing potential liver and kidney function abnormalities.
Main Methods:
- Compared baseline and follow-up laboratory values for liver enzymes (AST, ALT, γ-GTP) and kidney function (sCr, eGFR) in 128 patients.
- Calculated fold changes and classified γ-GTP using LiverTox criteria.
- Applied an algorithm to manage potential hepatic and renal side effects.
Main Results:
- Fosravuconazole treatment showed minimal changes in most parameters, except for a significant increase in γ-GTP (p < 0.001).
- Discontinuation thresholds were met in only 2.3% of hepatic and 3.9% of renal cases.
- No patients experienced clinical symptoms, and only one discontinued treatment due to adverse events.
Conclusions:
- Algorithm-based monitoring facilitates the safe administration of fosravuconazole.
- This practical monitoring strategy can increase clinician confidence in using oral antifungals as a primary treatment for onychomycosis.
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