“Efficacy and safety of oteseconazole in recurrent vulvovaginal candidiasis (RVVC) – A systematic review and meta-analysis"

Abstract

BackgroundRecurrent Vulvovaginal Candidiasis (RVVC) is defined as 3 or more episodes of symptomatic Vulvovaginal Candidiasis (VVC) within a year. Out of 75 % of women with VVC, this debilitating infection is experienced by 9 % of women. Although standard guidelines recommend oral and topical fluconazole as its treatment regimen, approval of another drug Oteseconazole has drawn the attention because of its better safety profile and lower recurrence rate by its use. AimThe purpose of our Meta-analysis is to evaluate the safety and efficacy of Oteseconazole (Vivjoa) (VT-1161) in the treatment of Recurrent Vulvovaginal Candidiasis (RVVC). MethodologyFour databases namely PubMed, Google Scholar, Cochrane CENTRAL and Clinical Trial.gov were used from inception till June 2023. Studies that met the predefined inclusion criteria were statistically analyzed on RevMan (Version 5.4). A random effect model was used to pool the studies. A p value of less than 0.05 was considered significant and results were presented as Odds ratio with 95 % Confidence Intervals (CIs). ResultThe pooled analysis of our selected studies showed that Oteseconazole was associated with significantly reduced incidence of Recurrent Vulvovaginal Candidiasis (OR = 0.07; 95 % CI = 0.05–0.11; p < 0.00001, I2 = 0 %) through week 48. Additionally, Vivjoa has also been shown by our analysis to reduce incidence of RVVC through week 24. (OR = 0.05; 95 % CI = 0.03–0.09; p < 0.00001, I2 = 0 %) Furthermore, Oteseconazole was non-significantly associated with developing serious adverse effects during the treatment for Recurrent Vulvovaginal Candidiasis in comparison to the placebo (OR = 0.79; 95 % CI = 0.33–1.89; p = 0.60, I2 = 0 %). ConclusionThe available evidence suggests Oteseconazole to be safer and more efficacious. However, limited patient population points towards the need of further large and dedicated trials for definitive conclusion.