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Grand Rounds

RCT Results: Oteseconazole for the Treatment of Recurrent Vulvovaginal Candidiasis

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BACKGROUND AND PURPOSE:

  • Oteseconazole is an oral selective inhibitor of fungal CYP51
  • Sobel et al. (NEJM Evidence, 2022) report on two phase 3, randomized placebo-controlled clinical trials of oteseconazole oral capsules in the treatment of RVVC through 48 weeks

METHODS:

  • Two global, phase 3, multicenter, randomized, double-blind, placebo-controlled trials
    • VIOLET: CL-011 and CL-012
  • Participants
    • Women with ≥3 symptomatic acute vulvovaginal candidiasis (VVC) episodes within the previous 12-month period
    • Acceptable contraception methods required
  • Interventions
    • Oteseconazole: 150 mg of oral daily for 7 days and then once weekly for 11 weeks
    • Placebo
  • Study design
    • During the screening VVC episode, participants had their VVC cleared with fluconazole induction therapy
    • Participants were then assigned 2:1 to an intervention group at baseline (maintenance phase)
    • Time-to-first-recurrence data collected during the maintenance phase
  • Primary outcome
    • Oteseconazole efficacy through week 48
  • Secondary outcomes
    • Time to first recurrence
    • Safety
    • Patient-reported outcomes

RESULTS:

  • Oteseconazole: 435 | Placebo: 217 (across two trials)
  • There were 13 pregnancies
    • Oteseconazole: 8
    • Placebo: 5 
  • Average percentage of participants with one or more RVVC episodes through week 48 was significantly lower in the oteseconazole groups vs placebo (P<0.001)
    • CL-011
      • Oteseconazole: 6.7% (range, 6.5 to 7.4)
      • Placebo: 42.8% (range, 41.3 to 45.0)
    • CL-012
      • Oteseconazole: 3.9% (range, 3.7 to 4.6)
      • Placebo: 39.4% (range, 38.0 to 42.6)
  • Among those who experienced an RVVC episode, the mean time to recurrence was significantly longer in the oteseconazole groups (P<0.001)
    • CL-011
      • Oteseconazole: 45.7 weeks
      • Placebo: 27.8 weeks
      • Hazard ratio 0.11 (95% CI, 0.06 to 0.21)
    • CL-012
      • Oteseconazole: 47.2 weeks
      • Placebo: 33.1 weeks
      • HR 0.08 (95% CI, 0.04 to 0.17)
  • Types and frequencies of treatment related adverse events were similar between groups in both trials
    • No serious treatment related adverse events
    • No adverse effects on
      • Pregnancy outcomes | Liver function | QT interval

CONCLUSION:

  • Oral oteseconazole effectively prevented recurrent VVC through 48 weeks
  • Adverse events were mostly mild

Learn More – Primary Sources:

Efficacy and Safety of Oteseconazole in Recurrent Vulvovaginal Candidiasis

FDA: HIGHLIGHTS OF PRESCRIBING INFORMATIOn for VIVJOA

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Related ObG Topics:

Is Oral Fluconazole Use in Pregnancy Linked to Stillbirths?
Cochrane Review: Oral or Intra-Vaginal Anti-Fungal Treatment for Candidiasis?
Are Probiotics Useful for the Treatment of Vulvovaginal Candidiasis?

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