Materials and Methods
HIV infection, diabetes mellitus
HIV INFECTION, DIABETES MELLITUS, MIXED INFECTION, VAGINAL CANCER, VULVOVAGINAL SIGNS AND SYMPTOMS
This analysis pooled data from VANISH 303 (NCT03734991) and VANISH 306 (NCT03987620). Methods, overall efficacy, and tolerability and safety results for these two studies have been published previously.Exclusion criteria included patients pregnant, lactating, or likely to become pregnant; any condition that may have interfered with the diagnosis or evaluation of response to therapy, including mixed infections; the use of systemic and/or topical (vaginal) antifungal treatment products within 28 days of baseline; patients with known HIV infection and/or receiving treatment that could compromise their immune response; and patients with history of or active cervical or vaginal cancer. The only difference between the two studies was that VANISH 303 included only sites in the United States, whereas VANISH 306 included sites in both the United States and Bulgaria.Both studies were conducted in accordance with the principles of the Declaration of Helsinki. Before study initiation, each study site obtained institutional review board approval. All patients provided written consent for study participation. Patients were randomized at a 2:1 ratio to receive either ibrexafungerp 300 mg BID for 1 day or matching placebo. Randomization was stratified according to diabetes mellitus diagnosis (yes or no). All site and sponsor personnel were blinded to treatment assignments except for a team member who was responsible for drug distribution logistics. To maintain blinding, appearance was similar between active and placebo dose forms, both of which were provided by SCYNEXIS, Inc. (Jersey City, NJ, USA).The objective of these pooled analyses was to evaluate the efficacy of oral ibrexafungerp compared with placebo in patients with acute VVC, with efficacy based on the clinical cure rate at the test-of-cure visit using the pooled data from VANISH 303 and VANISH 306.Efficacy End Point DefinitionsVSS, vulvovaginal signs and symptoms.Statistical analysis for overall efficacy outcomes was performed using SAS software version 9.4 (SAS Institute Inc., Cary, NC, USA). The Cochran–Mantel–Haenszel method was used to adjust for country and diabetes mellitus diagnosis and to assess the statistical significance of a difference between treatment groups. The SCYNEXIS, Inc. sponsored this study and was responsible for working with authors in the development of the protocols; in the collection, analysis, and interpretation of study data; in writing of the clinical study report; and in the decision to submit the article for publication. The authors' personal interests, financial or nonfinancial, relating to this research and its publication have been disclosed.