Ibrexafungerp for the treatment of vulvovaginal candidiasis: A systematic review and meta-analysis of randomized placebo-controlled trials

Introduction: Vulvovaginal candidiasis (VVC) is a prevalent fungal infection affecting millions of women globally, primarily caused by Candida species, most notably Candida albicans. Ibrexafungerp emerges as a promising candidate in the treatment arsenal against VVC, presenting a novel approach to combating this prevalent fungal infection. 

Methods: A systematic literature search was conducted across major databases, including PubMed, EMBASE, and the Cochrane Library, to identify relevant randomized controlled trials (RCTs) evaluating the efficacy and safety of ibrexafungerp in the treatment of VVC. Following rigorous methodology, data extraction, risk of bias assessment using Cochrane's RoB 2 tool, and meta-analysis were conducted. 

Results: Four RCTs were included in the analyses. The ibrexafungerp regimen utilized across the studies were 300 mg administered twice daily for one day. Meta-analysis revealed that ibrexafungerp was associated with significantly higher clinical cure rates compared to placebo in patients with VVC (pooled odds ratio (OR) 2.32; 95 % confidence interval (CI) 1.80 to 2.98). Complete symptom resolution was achieved in a greater proportion of participants receiving ibrexafungerp (pooled OR 2.76; 95 % CI 1.62 to 4.71). Analysis of treatment-emergent adverse events revealed a significant higher incidence of at least one treatment-emergent adverse event with ibrexafungerp compared to placebo (pooled OR 2.83; 95 % CI 2.06 to 3.88). 

Conclusion: This study provides robust support for the efficacy of ibrexafungerp in the treatment of VVC. While the safety profile of ibrexafungerp appears favorable with mostly mild adverse events reported, decision-making in the clinical context should be guided by individual patient factors.