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Onychomycosis
Published in Robert Baran, Dimitris Rigopoulos, Chander Grover, Eckart Haneke, Nail Therapies, 2021
Dimitris Rigopoulos, Robert Baran
Tavaborole is a benzoxaborole, and its mechanism of action is inhibition of protein synthesis through fungal aminoacyl transfer RNA synthetase. It exhibits a broad spectrum of activity against dermatophytes, NDMs, and yeasts. Tavaborole 5% solution was FDA approved in 2014 for the treatment of toenail onychomycosis due to T. rubrum and T. mentagrophytes. It is applied daily for 48 weeks with no need for removal, trimming, or filing. Mycological cure rates were 31.1% and 35.9% and complete cure rates were 6.5% and 9.1%, respectively.
Onychomycosis
Published in Nilton Di Chiacchio, Antonella Tosti, Therapies for Nail Disorders, 2020
Roberto Arenas-Guzmán, Sabrina Escandón-Pérez, Eder R. Juárez-Durán
Two clinical trials uncovered the efficacy and safety of tavaborole topical solution in the treatment of onychomycosis after 52 weeks of treatment. It was found that 31.1%–35.9% had a negative mycological test, 6.5%–9.1% a complete cure, and 26.1%–27.5% a clear nail presentation.17
Dermatophytosis
Published in Mahmoud A. Ghannoum, John R. Perfect, Antifungal Therapy, 2019
Mahmoud A. Ghannoum, Iman Salem, Nancy Isham
Topical treatment with ciclopirox 8% nail lacquer may be effective in mild-to-moderate (early) T. rubrum onychomycosis infections without lunula involvement when used every day, 8 hours before washing hands, with removal once a week with alcohol. Treatment may take 6 months to 1 year to be effective with a clinical cure rate of 5%–8% and a mycological cure rate of 29%–36% [42]. Two new topical agents have been approved by the FDA for the treatment of onychomycosis. Efinaconazole 10% solution achieved a complete cure rate (defined as KOH and culture negative and normal nail appearance) of 15%–18% in pivotal randomized clinical trials [43]. Tavaborole 5% solution, a novel, boron-based antifungal with low molecular weight, which allows a high amount of penetration through the human nail plate, achieved a complete cure rate of 6.5%–9.1% [44]. Both of these new topical agents are applied once daily for 48 weeks.
Safety of current therapies for onychomycosis
Published in Expert Opinion on Drug Safety, 2020
Jose W. Ricardo, Shari R. Lipner
Tavaborole has an excellent safety profile for the treatment of onychomycosis. In a recent systematic review and network meta-analysis assessing monotherapy, including oral drugs (terbinafine continuous and pulse regimens, itraconazole continuous and pulse regimens, and fluconazole) and topicals (tavaborole and ciclopirox) for toenail onychomycosis, tavaborole was least likely to cause adverse reactions[24]. Side effects are localized, and include application site exfoliation (2.7%), ingrown toenail (2.5%), application site erythema (1.6%) and dermatitis (1.3%)[107]. It is labeled as pregnancy category C. In pregnant rats exposed to tavaborole during organogenesis, oral doses 570 times the maximum recommended human dose resulted in maternal toxicity, increased embryo-fetal resorption and/or death, skeletal malformations and variations suggesting delayed ossification[79]. In rabbits, there was maternal toxicity and embryo-fetal mortality due to post-implantation loss at oral dosing 150 times the maximum recommended human dose[79]. Studies assessing safety during human pregnancy are lacking. It is unknown whether the drug is excreted into breast milk. Thus, tavaborole should be avoided during pregnancy and breastfeeding.
Emerging drugs for the treatment of onychomycosis
Published in Expert Opinion on Emerging Drugs, 2019
Currently available topical treatments in North America are efinaconazole, tavaborole, and ciclopirox. Efinaconazole is a triazole that inhibits the synthesis of ergosterol in the fungal cell wall. Two phase III studies of infected patients with 20–50% nail involvement had patients treated once daily for 48 weeks and evaluated at 52 weeks. Complete cure rates were 17.8% and 15.2% and mycological cure rates were 55.2% and 53.4% [58]. Tavaborole is another option that relies on an oxaborole compound to penetrate the nail and inhibit the fungus at the point of the cytosolic leucyl-transfer RNA synthetase [25]. The mycological and complete cure rates come from two studies: mycological cure rates have been reported as 31.1% and 35.9%, whereas clinical cure was 6.5% and 9.1%. Both topical formulas were FDA-approved in 2014 for the treatment of onychomycosis [59,60]. Lastly, ciclopirox is an older topical option, approved in 1999 in the USA. Ciclopirox is a hydroxypyridone that chelates trivalent cations, inhibiting metal-dependent enzyme of the fungus cell membrane. Ultimately, it disrupts cellular respiration processes [61–63]. The mycological cure rates for toes are 29–36%, and complete cure is lower at 5.5–8.5%. The side effects of topical treatments are localized to the site of application and are milder, ranging from exfoliation, erythema, and dermatitis at the application site [64].
Update on current approaches to diagnosis and treatment of onychomycosis
Published in Expert Review of Anti-infective Therapy, 2018
Aditya K. Gupta, Rachel R. Mays, Sarah G. Versteeg, Neil H. Shear, Vincent Piguet
Tavaborole 5% is a boron based solution that inhibits the protein synthesis of the nail plate and arrests fungal cell growth [51]. This treatment is of particular interest if an infection appears unresponsive or poorly responsive to other antifungals. Tavaborole should be applied daily for 48 weeks for the treatment of toenail onychomycosis caused by T. rubrum and T. interdigitale [51]. Efficacy against NDM and yeasts has not yet been shown; however, activity against these species has been observed in vitro [60]. The long-term benefit of tavaborole can be extended, with reported complete cure rates at week 60 of 29% in tavaborole patients who had achieved complete or almost clear nail at week 52 [61]. Penetration of efinaconazole 10% and tavaborole 5% into the nail is not significantly influenced by application of cosmetic nail polish, thus the presence of onychomycosis can be concealed during treatment [62,63].