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Efficacy and safety of oral ibrexafungerp for the treatment of acute vulvovaginal candidiasis: a global phase 3, randomised, placebo‐controlled superiority study (VANISH 306)
Author(s) -
Sobel R,
Nyirjesy P,
Ghannoum MA,
Delchev DA,
Azie NE,
Angulo D,
Harriott IA,
BorrotoEsoda K,
Sobel JD
Publication year - 2022
Publication title -
bjog: an international journal of obstetrics and gynaecology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.157
H-Index - 164
eISSN - 1471-0528
pISSN - 1470-0328
DOI - 10.1111/1471-0528.16972
Subject(s) - medicine , placebo , adverse effect , clinical endpoint , clinical trial , randomized controlled trial , surgery , alternative medicine , pathology
Objective To evaluate the efficacy and safety of ibrexafungerp versus placebo for acute vulvovaginal candidiasis (VVC) treatment. Design Global phase 3, randomised, placebo‐controlled superiority study. Setting Study sites in the USA ( n = 19) and Bulgaria ( n = 18). Population Female patients aged ≥12 years with acute VVC and a vulvovaginal signs and symptoms (VSS) score ≥4 at baseline. Methods Patients were randomly assigned 2:1 to ibrexafungerp (300 mg twice for 1 day) or placebo. Main outcome measures The primary endpoint was the percentage of patients with a clinical cure (VSS = 0) at the test‐of‐cure visit (day 11 ± 3). Secondary endpoints included percentages of patients with mycological eradication, clinical cure and mycological eradication (overall success), clinical improvement (VSS ≤1) at test‐of‐cure visit, and complete resolution of symptoms at follow‐up visit (day 25 ± 4). Results At the test‐of‐cure visit, patients receiving ibrexafungerp had significantly higher rates of clinical cure (63.3% [119/188] versus 44.0% [37/84]; P = 0.007), mycological eradication (58.5% [110/188] versus 29.8% [25/84]; P < 0.001), overall success (46.1% [82/188] versus 28.4% [23/84]; P = 0.022) and clinical improvement (72.3% [136/188] versus 54.8% [46/84]; P = 0.01) versus those receiving placebo. Symptom resolution was sustained and further increased with ibrexafungerp (73.9%) versus placebo (52.4%) at follow‐up ( P = 0.001). Ibrexafungerp was generally well tolerated. Adverse events were primarily gastrointestinal and were mild to moderate in severity. Conclusions Ibrexafungerp demonstrated statistical superiority over placebo for the primary and secondary endpoints. Ibrexafungerp is a promising novel, well‐tolerated and effective oral 1‐day treatment for acute VVC. Tweetable abstract Ibrexafungerp is statistically superior to placebo for the treatment of vulvovaginal candidiasis.