Ibrexafungerp Versus Placebo for Vulvovaginal Candidiasis Treatment: A Phase 3, Randomized, Controlled Superiority Trial (VANISH 303).

Autor:	Schwebke JR; University of Alabama at Birmingham, Birmingham, Alabama, USA., Sobel R; Jefferson Vulvovaginal Health Center, Department of Obstetrics and Gynecology Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, Pennsylvania, USA., Gersten JK; New Age Medical Research Corp, Miami, Florida, USA., Sussman SA; Lawrence OB/GYN Clinical Research, Lawrenceville, New Jersey, USA., Lederman SN; Altus Research Inc, Lake Worth, Florida, USA., Jacobs MA; Life Research, Inc, Houston, Texas, USA., Chappell BT; WR-Medical Research Center of Memphis, LLC, Memphis, Tennessee, USA., Weinstein DL; Consultants in Women's Healthcare, Inc, St. Louis, Missouri, USA., Moffett AH; OB-GYN Associates of Mid-Florida, PA, Leesburg, Florida, USA., Azie NE; SCYNEXIS, Inc, Jersey City, New Jersey, USA., Angulo DA; SCYNEXIS, Inc, Jersey City, New Jersey, USA., Harriott IA; SCYNEXIS, Inc, Jersey City, New Jersey, USA., Borroto-Esoda K; KBE Consulting, Raleigh, North Carolina, USA., Ghannoum MA; Case Western Reserve University and University Hospitals Cleveland Medical Center, Cleveland, Ohio, USA., Nyirjesy P; Jefferson Vulvovaginal Health Center, Department of Obstetrics and Gynecology Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, Pennsylvania, USA., Sobel JD; Wayne State University, Detroit, Michigan, USA.
Jazyk:	angličtina
Zdroj:	Clinical infectious diseases : an official publication of the Infectious Diseases Society of America [Clin Infect Dis] 2022 Jun 10; Vol. 74 (11), pp. 1979-1985.
DOI:	10.1093/cid/ciab750
Abstrakt:	Background: Current treatment of vulvovaginal candidiasis (VVC) is largely limited to azole therapy. Ibrexafungerp is a first-in-class triterpenoid antifungal with broad-spectrum anti-Candida fungicidal activity. The objective of this study was to evaluate the efficacy and safety of ibrexafungerp compared with placebo in patients with acute VVC. Methods: Patients were randomly assigned 2:1 to receive ibrexafungerp (300 mg twice for 1 day) or placebo. The primary endpoint was the percentage of patients with a clinical cure (complete resolution of vulvovaginal signs and symptoms [VSS] = 0) at test-of-cure (day 11 ± 3). Secondary endpoints included the percentage of patients with mycological eradication, overall success (clinical cure and mycological eradication), clinical improvement (VSS ≤ 1) at test-of-cure, and symptom resolution at follow-up (day 25 ± 4). Results: Patients receiving ibrexafungerp had significantly higher rates of clinical cure (50.5% [95/188] vs 28.6% [28/98]; P = .001), mycological eradication (49.5% [93/188] vs 19.4% [19/98]; P < .001), and overall success (36.0% [64/178] vs 12.6% [12/95]; P < .001) compared with placebo. Symptom resolution was sustained and further increased with ibrexafungerp compared with placebo (59.6% [112/188] vs 44.9% [44/98]; P = .009) at follow-up. Post hoc analysis showed similar rates of clinical cure and clinical improvement at test-of-cure for Black patients (54.8% [40/73] and 63.4% [47/73], respectively) and patients with a body mass index >35 (54.5% [24/44] and 68.2% [30/44], respectively) compared with overall rates. Ibrexafungerp was well tolerated. Adverse events were primarily gastrointestinal and mild in severity. Conclusions: Ibrexafungerp provides a promising safe and efficacious oral treatment that mechanistically differs from current azole treatment options for acute VVC. (© The Author(s) 2021. Published by Oxford University Press for the Infectious Diseases Society of America.)
Databáze:	MEDLINE
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