The following is a summary of “Phase 3 study evaluating the safety and efficacy of oteseconazole in the treatment of recurrent vulvovaginal candidiasis and acute vulvovaginal candidiasis infections” published in the December 2022 issue of Obstetrics & Gynecology by Martens et al.
Nearly 138 million women worldwide suffer from recurrent vulvovaginal candidiasis each year. Fluconazole is the therapy of choice for acute vulvovaginal candidiasis in the US, but up until recently, there was no medication licensed by the US Food and Drug Administration for the management of recurring vulvovaginal candidiasis. It has been licensed to treat recurrent vulvovaginal candidiasis using oteseconazole, a new oral selective inhibitor of fungal lanosterol demethylase (sterol 14α-demethylase cytochrome P450, an enzyme necessary for fungal development). For a study, researchers compared the effectiveness of oteseconazole and fluconazole in treating the acute vulvovaginal candidiasis episode in order to assess the efficacy and safety of oral oteseconazole (VT-1161) in the prevention of recurrent acute vulvovaginal candidiasis episodes through 50 weeks in participants with recurrent vulvovaginal candidiasis.
At 38 US locations, women and postmenopausal girls (aged ≥12) with a history of recurrent vulvovaginal candidiasis (N=219) were recruited. Participants who met the criteria and had an active vulvovaginal candidiasis infection were randomly allocated 2:1 to receive either 3 successive 150-mg oral doses of fluconazole (once every 72 hours) or 3 consecutive 600-mg oral doses of oteseconazole (on days 1 and 2 of the induction phase). The 185 individuals who had a resolved acute vulvovaginal candidiasis infection (a clinical signs and symptoms score of <3) after the 2-week induction phase started the maintenance phase and received 150 mg of oteseconazole or a placebo once a week for 11 weeks.
For a further 37 weeks, participants were monitored. At the week 2 (day 14) test-of-cure visit, 93.2% of participants on oteseconazole and 95.8% of individuals taking fluconazole had successfully cleared their acute vulvovaginal candidiasis infection, making oteseconazole noninferior to fluconazole in the induction phase. Oteseconazole was superior to placebo in the maintenance phase when it came to the percentage of participants in the intended-to-treat population who had ≥1 episode of acute vulvovaginal candidiasis that had been confirmed by culture over the course of 50 weeks—5.1% versus 42.2%, respectively (P<.001). Overall, both groups experienced similar rates of treatment-emergent adverse events: 64% for individuals who got fluconazole in the induction phase and placebo in the maintenance phase compared to 54% for people who received oteseconazole in the induction and maintenance phases. The majority of treatment-related adverse events in both groups were mild or moderate; 3.4% of treatment-related adverse events in the OTESECONAZOLE/oteseconazole group and 4.2% in the FLUCONAZOLE/placebo group were categorized as severe or higher.
Oteseconazole was non-inferior to vulvovaginal candidiasis standard-of-care fluconazole in the treatment of the presenting acute vulvovaginal candidiasis infection in participants with recurrent vulvovaginal candidiasis and was safe and effective in the treatment and prevention of recurrent acute vulvovaginal candidiasis episodes.
Reference: ajog.org/article/S0002-9378(22)00577-4/fulltext
