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

作者全名："Wang, Xiaoqian; Wang, Wenying; Li, Jingjing; An, Ruifang; Chen, Lihong; Lin, Jiajing; Xu, Dabao; Qiu, Jin; Song, Weihua; Patiman, Mijiti; Ruan, Hongjie; Wang, Gang; Xue, Fengxia; Wang, Xu; Luo, Xiaowan; Ruan, Qi; Shi, Ling; Zhang, Chun; Hu, Lina; Wang, Shijin; Shi, Hong; Wang, Xiaoli; Zhang, Songling; Li, Yingxiong; Lu, Jing; Wang, Baojin; Xu, Hongyan; Ye, Hong; Zhang, Bei; Zhang, Chunlian; Qian, Sumin; Wu, Qiong; Jia, Wen; Li, Chuan; Liao, Qinping"

作者地址："[Wang, Xiaoqian; Liao, Qinping] Tsinghua Univ, Beijing Tsinghua Changgung Hosp, Sch Clin Med, Dept Gynecol, Beijing, Peoples R China; [Wang, Wenying] Xian Med Coll, Dept Gynecol, Affiliated Hosp 1, Xian, Shaanxi, Peoples R China; [Li, Jingjing] Liuzhou Matern & Child Healthcare Hosp, Dept Gynecol, Liuzhou, Guangxi, Peoples R China; [Li, Jingjing] Liuzhou Hosp, Guangzhou Women & Childrens Med Ctr, Dept Gynecol, Liuzhou, Guangxi, Peoples R China; [An, Ruifang] Xi An Jiao Tong Univ, Dept Obstet & Gynecol, Affiliated Hosp 1, Xian, Shaanxi, Peoples R China; [Chen, Lihong] Shaanxi Prov Peoples Hosp, Dept Gynecol, Xian, Shaanxi, Peoples R China; [Lin, Jiajing] Liuzhou Workers Hosp, Dept Gynecol, Liuzhou, Guangxi, Peoples R China; [Xu, Dabao] Cent South Univ, Dept Gynecol, Xiangya Hosp 3, Changsha 410013, Hunan, Peoples R China; [Qiu, Jin] Shanghai Tongren Hosp, Dept Gynecol, Shanghai, Peoples R China; [Song, Weihua] Women & Childrens Hlth Care Hosp Linyi, Dept Gynecol, Linyi, Shandong, Peoples R China; [Patiman, Mijiti] Univ Chinese Acad Sci, Dept Gynecol, Dept Pathol, Shenzhen Hosp, Beijing, Guangdong, Peoples R China; [Ruan, Hongjie] Nanjing Matern & Child Hlth Care Hosp, Gynecol Dept, Nanjing, Jiangsu, Peoples R China; [Wang, Gang] Sichuan Maternal & Child Hlth Hosp, Dept Gynecol, Chengdu, Sichuan, Peoples R China; [Xue, Fengxia] Tianjin Med Univ, Gen Hosp, Dept Gynecol, Tianjin, Peoples R China; [Wang, Xu] Tonghua Cent Hosp, Dept Gynecol, Jilin, Peoples R China; [Luo, Xiaowan] Zhongshan Women & Childrens Hosp, Dept Gynecol, Zhongshan, Guangdong, Peoples R China; [Ruan, Qi] Guangdong Med Univ, Dept Gynecol, Shunde Women & Childrens Hosp, Zhanjiang, Guangdong, Peoples R China; [Shi, Ling] Liaoning Univ Tradit Chinese Med, Dept Gynecol, Affiliated Hosp 2, Shenyang, Liaoning, Peoples R China; [Zhang, Chun] Cent Hosp Wuhan, Dept Gynecol, Wuhan, Hubei, Peoples R China; [Hu, Lina] Chongqing Med Univ, Dept Gynecol, Affiliated Hosp 2, Chongqing, Peoples R China; [Wang, Shijin] Xinxiang Med Univ, Dept Gynecol, Affiliated Hosp 1, Xinxiang, Henan, Peoples R China; [Shi, Hong] Dalian Med Univ, Dept Plast Surg, Affiliated Hosp 1, Dalian, Liaoning, Peoples R China; [Wang, Xiaoli] Hainan Women & Childrens Med Ctr, Dept Gynecol, Haikou, Hainan, Peoples R China; [Zhang, Songling] First Hosp Jilin Univ, Dept Gynecol, Changchun, Jilin, Peoples R China; [Li, Yingxiong] Guangzhou Panyu Cent Hosp, Dept Gynecol, Guangzhou, Guangdong, Peoples R China; [Lu, Jing] Urumqi Maternal & Child Hlth Hosp, Dept Obstet & Gynecol, Urumqi, Xinjiang, Peoples R China; [Wang, Baojin] Zhengzhou Univ, Dept Gynecol, Affiliated Hosp 3, Zhengzhou, Henan, Peoples R China; [Xu, Hongyan] Yuebei Peoples Hosp, Dept Gynecol, Shaoguan, Guangdong, Peoples R China; [Ye, Hong] Yichang Cent Peoples Hosp, Dept Gynecol, Yichang, Hubei, Peoples R China; [Zhang, Bei] Xuzhou Cent Hosp, Dept Gynecol, Xuzhou, Jiangsu, Peoples R China; [Zhang, Chunlian] Hubei Univ Med, Taihe Hosp, Dept Gynecol, Affiliated Hosp, Shiyan, Hubei, Peoples R China; [Qian, Sumin] Cangzhou Cent Hosp, Dept Gynecol, Cangzhou, Hebei, Peoples R China; [Wu, Qiong; Jia, Wen; Li, Chuan] Jiangsu Hansoh Pharmaceut Grp Co Ltd, Lianyungang, Jiangsu, Peoples R China"

通信作者："Liao, QP (通讯作者)，Tsinghua Univ, Beijing Tsinghua Changgung Hosp, Sch Clin Med, Dept Gynecol, Beijing, Peoples R China."

来源：INFECTION

ESI学科分类：IMMUNOLOGY

WOS号：WOS:001196958400001

JCR分区：Q1

影响因子：5.4

年份：2024

卷号：　

期号：　

开始页：　

结束页：　

文献类型：Article; Early Access

关键词：Vulvovaginal candidiasis; Ibrexafungerp; Candida; Antifungal; Randomized clinical trial

摘要："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."

基金机构："Jiangsu Hansoh Pharmaceutical Group Co. Ltd; Jiangsu Hansoh Pharmaceutical Group Co., Ltd."

基金资助正文："We appreciate all the patients and their families, the investigators and investigational staff who participated in this study. We thank Jiayang Song and Peng Zhang for carefully analyzing and reviewing the data and also thank Kaimeng Kong and Wensu Yu for medical writing assistance during manuscript preparation. This study was funded by the Jiangsu Hansoh Pharmaceutical Group Co., Ltd."