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Prolonged intermittent use of efinaconazole provides sustained prophylaxis against onychomycosis and shows a favorable safety profile in all age groups.
In an innovative long-term study, researchers have presented the first-ever data supporting the extended use of 10% efinaconazole solution for up to 48 months, showing encouraging results in maintaining and improving cure rates in patients with onychomycosis (fungal nail infection).
The study followed patients who had previously undergone an 18- to 24-month treatment phase using once-daily efinaconazole. At the 24-month mark, the enrolled subjects were evaluated and classified as either having achieved a ‘Clinical Cure’—defined as 10% or less of the target great toenail being affected—or ‘No Clinical Cure,’ indicating more than 10% involvement. To assess the long-term safety and efficacy of the drug, 35 patients who completed the initial phase continued with an intermittent maintenance regimen, applying efinaconazole two to three times weekly from month 24 to month 48.
Outcomes were monitored every 4 months throughout the maintenance phase. Among the 6 patients who had attained clinical cure by month 24, all maintained their status through month 48. Of the 29 patients who had not attained clinical cure by month 24, 3 went on to attain it by month 48 with the extended intermittent use. Additional improvements in both effective cure and complete cure rates were noted over time in this subgroup. Age-related trends were also examined. While younger volunteers tended to have higher cure rates, the differences across age groups were not prominent.
Importantly, 49% of patients aged 70 and older experienced at least a 20% reduction in affected nail area during the maintenance phase, underscoring the potential benefit of extended therapy even in older populations. Safety remained a critical focus throughout the study. Only 1 patient experienced a potential application site reaction during the 24-month maintenance phase, suggesting that long-term use of efinaconazole remains well-tolerated.
Furthermore, researchers observed consistently low rates of positive fungal cultures, including a reduction in common contaminant organisms, which points to a possible prophylactic effect from the continued presence of efinaconazole in the nail plate. Thus, intermittent maintenance use of efinaconazole not only helps sustain earlier treatment gains but may also prevent the recurrence of onychomycosis over the long term. Prolonged use to 48 months appears safe across all age groups and may provide a viable strategy for preventing relapse in chronic cases.
Infectious Disease Reports
Safety and Efficacy of a 48-Month Efinaconazole 10% Solution Treatment/Maintenance Regimen: 24-Month Daily Use Followed by 24-Month Intermittent Use
Aditya K. Gupta et al.
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