OBJECTIVES: Candidemia and invasive candidiasis (IC) remain significant causes of morbidity and mortality, with significant economic burden largely due to prolonged length of stay (LoS) in hospital and the intensive care unit (ICU). Rezafungin is a next-generation, once-weekly IV echinocandin antifungal that demonstrates a prolonged half-life and high front-loaded plasma exposures. This post-hoc analysis of integrated outcomes from the STRIVE (Phase 2; NCT02734862) and ReSTORE (Phase 3; NCT03667690) clinical trials aimed to examine treatment efficacy and duration of ICU stay.

METHODS: The STRIVE and ReSTORE trials were global, double-blind, controlled studies in which adults with candidemia and/or IC were randomized to receive rezafungin once weekly or caspofungin once daily for ≤4 weeks. Integrated analysis evaluated mortality and early treatment outcomes in the mITT population. ICU LoS analysis employed a generalized linear model (log-link, gamma distribution) adjusting for baseline patient characteristics.

RESULTS: The analysis integrated data for 139 rezafungin and 155 caspofungin patients. At baseline groups were well balanced, except for the proportion receiving mechanical ventilation (rezafungin: 12.2%; caspofungin: 21.9%). Distribution of APACHE II scores and absolute neutrophil count were not significantly different between groups. All-cause mortality at Day 30 was 18.7% and 19.4% for the rezafungin and caspofungin groups, respectively (difference (95% CI): -1.5 (-10.7, 7.7)). Mycological eradication at day 5 (in patients diagnosed with candidemia only) was 80% for rezafungin and 67.8% for caspofungin (difference (95% CI): 12.9 (1.5, 24.3)). Total of 126/294 patients (43%) required ICU admission. Mean LoS in the ICU after adjustment for mechanical ventilation was 17.3 days in the rezafungin group and 21.4 days in the caspofungin group (difference (95% CI): 24% (-11%, 72%)).

CONCLUSIONS: The results indicate rezafungin is efficacious for the treatment of candidemia and IC with high mycological efficacy rates early in treatment. The shorter ICU LoS for rezafungin requires further analyses.