Phase 2 Randomized Study of Oral Ibrexafungerp Versus Fluconazole in Vulvovaginal Candidiasis
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| Title: | Phase 2 Randomized Study of Oral Ibrexafungerp Versus Fluconazole in Vulvovaginal Candidiasis |
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| Authors: | Itzel A Harriott, Nkechi Azie, Paul Nyirjesy, Jane R. Schwebke, David Angulo, Jack D. Sobel |
| Source: | Clin Infect Dis |
| Publisher Information: | Oxford University Press (OUP), 2021. |
| Publication Year: | 2021 |
| Subject Terms: | 0301 basic medicine, Major Articles and Commentaries, 03 medical and health sciences, Antifungal Agents, Administration, Oral, Humans, Female, Glycosides, Fluconazole, Candidiasis, Vulvovaginal, Triterpenes, 3. Good health |
| Description: | 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 |
| Document Type: | Article Other literature type |
| Language: | English |
| ISSN: | 1537-6591 1058-4838 |
| DOI: | 10.1093/cid/ciab841 |
| Access URL: | https://academic.oup.com/cid/advance-article-pdf/doi/10.1093/cid/ciab841/41189634/ciab841.pdf https://pubmed.ncbi.nlm.nih.gov/34555149 https://academic.oup.com/cid/advance-article-pdf/doi/10.1093/cid/ciab841/40433544/ciab841.pdf https://pubmed.ncbi.nlm.nih.gov/34555149/ |
| Rights: | CC BY NC ND |
| Accession Number: | edsair.doi.dedup.....1b86a184809473dd054aac6de64457cf |
| Database: | OpenAIRE |
Nájsť tento článok vo Web of Science | Abstract: | 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 |
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| ISSN: | 15376591 10584838 |
| DOI: | 10.1093/cid/ciab841 |