982. Effect of Hepatic Impairment on the Safety and Pharmacokinetics of Rezafungin

ABSTRACT: Abstract

Background

Rezafungin (RZF) is a novel echinocandin antifungal being developed for treatment of candidemia and invasive candidiasis, and for prevention of invasive fungal diseases among immunosuppressed patients. In the Phase 2 and Phase 3 treatment trials of rezafungin compared with caspofungin (STRIVE [NCT02734862] and ReSTORE [NCT03667690], respectively), patients with severe hepatic impairment (HI) were not included due to lack of caspofungin data in this population. Rezafungin was previously evaluated in patients with moderate hepatic impairment. Here we report an open-label, single-dose study on rezafungin in patients with HI (Child-Pugh class C).

Methods

To investigate the safety, tolerability, and pharmacokinetics (PK) of RZF in subjects with HI and healt

SUBMITTER: Huguet J 

PROVIDER: S-EPMC8643917 | biostudies-literature | 2021 Nov

REPOSITORIES: biostudies-literature