Efficacy and safety of oral ibrexafungerp in Chinese patients with vulvovaginal candidiasis: a phase III, randomized, double-blind study

安慰剂 医学 内科学 氟康唑 临床终点 不利影响 外阴阴道念珠菌病 白色念珠菌 临床试验 随机对照试验 胃肠病学 皮肤病科 抗真菌 替代医学 病理 生物 遗传学
作者
Xiaoqian Wang,Wenying Wang,Jing Wang,Ruifang An,Lihong Chen,Jiajing Lin,Dabao Xu,Jin Qiu,Weihua Song,Mijiti Patiman,Hongjie Ruan,Gang Wang,Fengxia Xue,Sheng Wang,Xiaowan Luo,Qiuqi Ruan,Ling Shi,Chun Zhang,Lina Hu,Shijin Wang,S-H Hong,Zhenjun Li,Songling Zhang,Yingxiong Li,Jing Lu,Bao-jin Wang,Hongyan Xu,Ye Hong,Bei Zhang,Chunlian Zhang,Sumin Qian,Qiong Wu,Jia Wen,Chuan Li,Qinping Liao
出处
期刊:Infection [Springer Science+Business Media]
标识
DOI:10.1007/s15010-024-02233-w
摘要

Abstract Purpose To evaluate the efficacy and safety of oral ibrexafungerp (HS-10366) versus placebo in Chinese patients with vulvovaginal candidiasis (VVC). Methods A double-blind, placebo-controlled, randomized, multicenter phase III study was conducted in symptomatic VVC patients. Patients received (2:1) twice-daily oral ibrexafungerp 300 mg or matching placebo for 1 day. The primary endpoint was clinical cure (vulvovaginal signs and symptoms [VSS] score = 0) at test-of-cure (TOC) on day 11 ± 3. The secondary endpoints included mycological eradication, overall response, and clinical improvement (VSS score ≤ 1) at TOC, and vulvovaginal symptom resolution at follow-up on day 25 ± 4. Results In total, 360 patients were included in the modified intention-to-treat set (defined as positive Candida cultured and receiving at least one study drug; 239 for ibrexafungerp, 121 for placebo). Compared with placebo, patients receiving ibrexafungerp had a significantly higher proportion of clinical cure (51.0% vs. 25.6%), mycological eradication (55.6% vs. 18.2%), overall response (33.9%, vs. 8.3%) at TOC and complete symptom resolution (74.5% vs. 39.7%, all P < 0.001) at follow-up. Subgroup analysis of clinical cure indicated that patients with C. albicans could benefit from ibrexafungerp over placebo. A similar benefit trend was also observed in those with non- albicans Candida by post-hoc analysis. Further analyses revealed similar efficacy of ibrexafungerp between patients with fluconazole non-susceptible C. albicans and fluconazole susceptible C. albicans regarding clinical cure and mycological eradication. Ibrexafungerp was generally well tolerated. Adverse events were primarily gastrointestinal and were mainly mild in severity. Conclusions As a first-in-class antifungal agent, ibrexafungerp demonstrated promising efficacy and favorable safety for VVC treatment in Chinese patients. Chinadrugtrials.org.cn registry number CTR20220918.
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