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

Author:

Schwebke Jane R1,Sobel Ryan2,Gersten Janet K3,Sussman Steven A4,Lederman Samuel N5,Jacobs Mark A6,Chappell B Todd7,Weinstein David L8,Moffett Alfred H9,Azie Nkechi E10,Angulo David A10,Harriott Itzel A10,Borroto-Esoda Katyna11,Ghannoum Mahmoud A12,Nyirjesy Paul2,Sobel Jack D13

Affiliation:

1. University of Alabama at Birmingham, Birmingham, Alabama, USA

2. Jefferson Vulvovaginal Health Center, Department of Obstetrics and Gynecology Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, Pennsylvania, USA

3. New Age Medical Research Corp, Miami, Florida, USA

4. Lawrence OB/GYN Clinical Research, Lawrenceville, New Jersey, USA

5. Altus Research  Inc, Lake Worth, Florida, USA

6. Life Research, Inc, Houston, Texas, USA

7. WR-Medical Research Center of Memphis, LLC, Memphis, Tennessee, USA

8. Consultants in Women’s Healthcare, Inc, St. Louis, Missouri, USA

9. OB-GYN Associates of Mid-Florida, PA, Leesburg, Florida, USA

10. SCYNEXIS, Inc, Jersey City, New Jersey, USA

11. KBE Consulting, Raleigh, North Carolina, USA

12. Case Western Reserve University and University Hospitals Cleveland Medical Center, Cleveland, Ohio, USA

13. Wayne State University, Detroit, Michigan, USA

Abstract

Abstract 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.

Publisher

Oxford University Press (OUP)

Subject

Infectious Diseases,Microbiology (medical)

Reference26 articles.

1. An update on the doles of non-albicans Candida species in vulvovaginitis;Makanjuola;J Fungi,2018

2. Candidiasis (vulvovaginal);Martin Lopez;BMJ Clin Evid,2015

3. Guideline: vulvovaginal candidosis (AWMF 015/072), S2k (excluding chronic mucocutaneous candidosis);Mendling;Mycoses,2015

4. Recurrent vulvovaginal candidiasis;Sobel;Am J Obstet Gynecol,2016

Cited by 46 articles. 订阅此论文施引文献 订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献

同舟云学术

1.学者识别学者识别

2.学术分析学术分析

3.人才评估人才评估

"同舟云学术"是以全球学者为主线,采集、加工和组织学术论文而形成的新型学术文献查询和分析系统,可以对全球学者进行文献检索和人才价值评估。用户可以通过关注某些学科领域的顶尖人物而持续追踪该领域的学科进展和研究前沿。经过近期的数据扩容,当前同舟云学术共收录了国内外主流学术期刊6万余种,收集的期刊论文及会议论文总量共计约1.5亿篇,并以每天添加12000余篇中外论文的速度递增。我们也可以为用户提供个性化、定制化的学者数据。欢迎来电咨询!咨询电话:010-8811{复制后删除}0370

www.globalauthorid.com

TOP

Copyright © 2019-2024 北京同舟云网络信息技术有限公司
京公网安备11010802033243号  京ICP备18003416号-3