Dados do Trabalho

Título

Treatment outcomes with rezafungin and caspofungin in adults with invasive candidiasis and/or candidaemia who had received no prior antifungal therapy: ReSTORE trial subgroup analysis

Objetivo

ReSTORE (NCT03667690) comprised a global, Phase 3, randomised, double-blind, double-dummy, non-inferiority trial, to evaluate the efficacy and safety of rezafungin and caspofungin in the treatment of candidaemia and/or invasive candidiasis (1).

Métodos

Adults with candidaemia and/or invasive candidiasis, diagnosed by clinical manifestations and mycological confirmation, received intravenous rezafungin once-weekly (Week 1: 400 mg; Weeks 2–4: 200 mg) or caspofungin once-daily (Day 1: 70 mg; Days 2–28: 50 mg) for ≥14 days. Subgroup analysis examined data review committee-assessed treatment outcomes for the ReSTORE study modified intention-to-treat population in participants who had received no antifungal therapy (within 2 days) prior to the first dose of rezafungin or caspofungin. Endpoints included global cure and mycological eradication at Days 5 and 14, Day 30 all-cause mortality (ACM) and adverse event reporting. For efficacy outcomes, two-sided 95% confidence intervals (CIs) were calculated for the observed difference between treatment groups using unadjusted Miettinen-Nurminen methodology.

Resultados

The subgroup analysis included 19 ReSTORE study participants treated with rezafungin and 29 given caspofungin. Global cure rate was 68.4% (rezafungin group) and 58.6% (caspofungin group) at Day 5 (treatment-group difference 9.8 and 73.7% ( rezafungin) and 65.5% (caspofungin) at Day 14 (treatment-group difference 8.2 ; Respective mycological eradication rates with rezafungin and caspofungin were 77.8% and 58.6% at Day 5 (treatment-group difference 19.2 and 83.3% and 65.5% at Day 14 (treatment-group difference 17.8. Day 30 ACM was 15.8% with rezafungin and 17.2% with caspofungin.

Conclusão

ACM rates were similar and both treatments were well tolerated.