Department of Medicine, University of Alabama at Birmingham.
Department of Medicine, University of Washington, Seattle.
Clin Infect Dis. 2019 Feb 15;68(5):803-809. doi: 10.1093/cid/ciy554.
Bacterial vaginosis (BV) and vulvovaginal candidiasis (VVC) present serious reproductive health risks and management challenges, with poor control attributed to survival of treatment-resistant biofilm communities. Boric acid is used in various regimens for non-albicans VVC and recurrent BV. We investigated safety and efficacy of a novel boric acid-based vaginal anti-infective with enhanced antibiofilm activity (TOL-463) in treating BV and VVC.
In this phase 2 randomized, investigator-blinded trial conducted at 2 sexual health clinics, women with BV or VVC were randomly assigned (1:1) to 7 nights of TOL-463 vaginal gel or insert. The primary test of cure (TOC) was clinical cure at day 9-12; safety was assessed at TOC and day 21-30.
One hundred six participants (53 with BV, 36 VVC, 17 both) were enrolled; most were African American (69%). Clinical cure rate of BV at TOC was 59% (95% confidence interval [CI], 41%-75%) for TOL-463 insert and 50% (95% CI, 31%-69%) for TOL-463 gel, and for VVC, 92% (95% CI, 67%-99%) for TOL-463 insert and 81% (95% CI, 57%-93%) for TOL-463 gel. Both products were safe and well tolerated with no secondary cases of VVC; vulvovaginal burning was the most common adverse event (9.6%).
TOL-463, especially in vaginal insert form, is effective and safe in treating BV and VVC. Future studies should assess the potential role of TOL-463 as a biofilm disrupter in enhancing likelihood of cure relative to approved therapies, reducing recurrence rates, and combined with traditional antimicrobials.
NCT02866227.
细菌性阴道病（BV）和外阴阴道念珠菌病（VVC）对生殖健康构成严重威胁，且由于治疗耐药生物膜群落的存在，导致治疗效果不佳。硼酸被用于各种非白色念珠菌 VVC 和复发性 BV 治疗方案中。我们研究了一种新型硼酸阴道抗感染药物（TOL-463）在治疗 BV 和 VVC 方面的安全性和疗效，该药物具有增强的抗生物膜活性。
在 2 家性健康诊所进行的这项 2 期随机、研究者设盲试验中，患有 BV 或 VVC 的女性被随机（1:1）分配接受 7 晚 TOL-463 阴道凝胶或阴道栓剂治疗。主要疗效评估（TOC）为第 9-12 天的临床治愈；安全性评估在 TOC 和第 21-30 天进行。
共有 106 名参与者（53 名 BV，36 名 VVC，17 名 BV 和 VVC 均有）入组，大多数为非裔美国人（69%）。TOC 时 BV 的临床治愈率为 TOL-463 阴道栓剂 59%（95%置信区间[CI]，41%-75%），TOL-463 阴道凝胶 50%（95% CI，31%-69%），TOC 时 VVC 的治愈率为 TOL-463 阴道栓剂 92%（95% CI，67%-99%），TOL-463 阴道凝胶 81%（95% CI，57%-93%）。两种产品均安全且耐受良好，无 VVC 继发病例；最常见的不良事件是外阴阴道烧灼感（9.6%）。
TOL-463 尤其是阴道栓剂形式，在治疗 BV 和 VVC 方面有效且安全。未来的研究应评估 TOL-463 作为生物膜破坏剂的潜在作用，以提高相对于批准疗法的治愈可能性、降低复发率，并与传统的抗菌药物联合使用。
NCT02866227。
