The P-III (ultraVIOLET) study evaluating Vivjoa vs fluconazole in a ratio (2:1) to prevent acute VVC episodes in 219 women with RVVC at 38 US sites. 185 patients who had recovered from acute VVC inf. started the maintenance phase after 2wk. induction phase & received Vivjoa (150mg) for 11wks.
The results showed that Vivjoa was superior to PBO for RVVC @50wks. and noninferior to fluconazole for acute VVC in women with RVVC, 94.9% vs 57.8% did not have a VVC episode in the induction phase, followed by PBO in the maintenance phase. The results were published in AJOG
In the ITT population, 93.2% vs 95.8% had a resolved VVC episode by Day 14. In the modified ITT population, patients cleared their initial VVC episode by Day 14 (98.5% vs 94.1%), TEAEs (54% vs 64%)
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