Phase 2 Randomized Study of Oral Ibrexafungerp Versus Fluconazole in Vulvovaginal Candidiasis
| Autor: | Paul Nyirjesy, Nkechi Azie, Itzel A Harriott, Jack D. Sobel, David Angulo, Jane R. Schwebke |
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| Rok vydání: | 2021 |
| Předmět: |
Microbiology (medical)
medicine.medical_specialty Antifungal Agents Population Administration Oral Gastroenterology law.invention Randomized controlled trial law Internal medicine medicine Clinical endpoint Humans Glycosides Adverse effect education Candida albicans Fluconazole Candidiasis Vulvovaginal Vaginitis education.field_of_study biology business.industry medicine.disease biology.organism_classification Triterpenes Infectious Diseases Tolerability Female business medicine.drug |
| Zdroj: | Clinical infectious diseases : an official publication of the Infectious Diseases Society of America. 74(12) |
| ISSN: | 1537-6591 |
| Popis: | Background Vulvovaginal candidiasis affects approximately 75% of women in their lifetime. Approved treatment options are limited to oral or topical azoles. Ibrexafungerp, a novel, first-in-class oral triterpenoid glucan synthase inhibitor, has demonstrated broad fungicidal Candida activity and a favorable tolerability profile. The primary objective of this dose-finding study was to identify the optimal dose of oral ibrexafungerp in patients with acute vulvovaginal candidiasis. Methods Patients with vulvovaginal signs and symptoms score ≥7 were randomized equally to 6 treatments groups: 5 treatment doses of oral ibrexafungerp or oral fluconazole 150 mg. The primary endpoint was the percentage of patients with a clinical cure (complete resolution of vulvovaginal signs and symptoms) at the test-of-cure visit (day 10). Results Overall, 186 patients were randomized into the 6 treatment groups. Results, using the modified intent-to-treat population (baseline positive culture), are reported for ibrexafungerp 300 mg twice daily (BID) for 1 day (n = 27), which was the dose selected for phase 3 studies, and fluconazole 150 mg for 1 day (n = 24). At day 10, the clinical cure rates for ibrexafungerp and fluconazole were 51.9% and 58.3%, respectively; at day 25, patients with no signs or symptoms were 70.4% and 50.0%, respectively. During the study ibrexafungerp patients required less antifungal rescue medications compared with fluconazole (3.7% vs 29.2%, respectively). Ibrexafungerp was well tolerated, with the most common treatment-related adverse events being mild gastrointestinal events. Conclusions Ibrexafungerp is a well-tolerated novel antifungal with comparable efficacy to fluconazole in the treatment of acute vulvovaginal candidiasis. Clinical Trials Registration NCT03253094 |
| Databáze: | OpenAIRE |
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