P30 Efficacy and safety of rezafungin in critically ill patients with candidaemia and/or IC: Outcomes of patients treated in the ICU from an integrated analysis of Phase 2 and Phase 3 trials

Critically ill patients are susceptible to invasive candidiasis (IC), approximately one-third of all candidaemia (C) cases occur in the ICU. This post hoc, integrated analysis of STRIVE (NCT02734862) and ReSTORE (NCT03667690) investigated the efficacy and safety of rezafungin (RZF), a novel, once-weekly (QW) echinocandin, in a subgroup of patients with C and/or IC in the ICU.

Patients received RZF QW (400 mg in Week 1, then 200 mg) or caspofungin (CAS) once daily (70 mg on Day [D] 1, then 50 mg with optional oral fluconazole stepdown) for 2–4 weeks. The primary endpoint (FDA) was all-cause mortality (ACM) at D30. Other endpoints included mycological eradication at D5 and D14 (secondary) and time to negative blood culture (TTNBC; exploratory). Safety was evaluated by adverse events (AEs).

Baseline patient characteristics were generally similar between the RZF (n=55) and CAS (n=71) arms; 32.1% (17) and 29.6% (21) of patients receiving RZF and CAS, respectively had an APACHEII score ≥20. ACM at D30 was 36.4% (20/55) with RZF and 26.8% (19/71) with CAS. Through D30, 4 (7.3%) deaths were attributable to C/IC in the RZF arm and 6 (8.5%) in the CAS arm. Mycological eradication at D5 was 72.7% RZF and 57.7% CAS, D14 67.3% vs 63.4%. The proportion of patients with negative blood culture at 24 h was 61.0% RZF vs 42.3% CAS and 48 h was 75.0% vs 55.8%. Median TTNBC was 18 h with RZF vs 38 h with CAS (stratified log-rank P=0.003; not adjusted for multiplicity). Safety profiles were similar between treatment arms; the incidence of treatment-emergent AEs was 90.9% (50/55) with RZF and 81.7% (58/71) with CAS.

RZF is efficacious and well tolerated in critically ill patients with C and/or IC, with high rates of mycological eradication observed early in treatment.