P-1958. Efficacy and Safety of Rezafungin, A Long-Acting Echinocandin

TL;DR

A new long-acting antifungal drug called Rezafungin was found to be safe and effective for treating fungal infections in patients.

Contribution

Rezafungin is the first long-acting echinocandin with once-weekly dosing approved for outpatient treatment of candidemia and invasive candidiasis.

Findings

Rezafungin achieved clinical success in 91% of treatment courses.

The drug was well-tolerated with only 7% of treatments experiencing non-serious adverse events.

Candida glabrata was the most common pathogen treated with Rezafungin.

Abstract

Rezafungin (RZF), a novel long-acting intravenous echinocandin, was approved by the FDA in March 2023 for adult patients (pts) with candidemia and invasive candidiasis and safety data for up to 4 weekly doses. The once weekly dosing regimen is advantageous in outpatient settings, eliminating the requirement for central venous catheters and daily medication administration.Table 1.Demographics and Baseline CharacteristicsFigure 1.Pathogens in RZF Treatment Courses

Demographics and Baseline Characteristics

Pathogens in RZF Treatment Courses

Rezafungin (RZF), a novel long-acting intravenous echinocandin, was approved by the FDA in March 2023 for adult patients (pts) with candidemia and invasive candidiasis and safety data for up to 4 weekly doses. The once weekly dosing regimen is advantageous in outpatient settings, eliminating the requirement for central venous catheters and daily medication administration.Figure 2.Clinical Outcomes in RZF Treatment Courses

Clinical Outcomes in RZF Treatment Courses

50 pts received 55 treatment courses from 9/2023 to 3/2025, with characteristics in Table 1. Median age was 62 years (IQR 53-74). 20 pts (40%) received RZF following hospitalization. Median Charlson Comorbidity Index was 4 (IQR 2-6). 36 pts (72%) had risk factors for fungal infections and 48 (96%) had prior anti-fungal therapy, including all those with mucosal candidiasis. Initial dose was 400 mg and the median number of weekly doses received was 2 (IQR 2-4). RZF was used to treat candidemia (n=11), invasive candidiasis (n=15), or mucosal candidiasis (n=29). Pathogens are noted in Figure 1. Candida glabrata was the predominant organism. Out of 55 treatment courses, clinical success overall was achieved in 50 patient treatment courses (91%), with non-success in 3 (5%) and 2 (4%) non-evaluable. Outcomes are displayed in Figure 2, including those by diagnostic group. Non-serious adverse events occurred in 4 (7%) treatments, none requiring discontinuation.

RZF was a safe, tolerable, and effective treatment for candidemia and candidiasis in this treatment experienced comorbid population. This real-world data establishes the successful use of a long-acting weekly echinocandin in the outpatient treatment of patients with fungal infections.

Richard L. Hengel, MD, FIDSA, Gilead: Grant/Research Support Brian S. Metzger, MD, MPH, Abbvie: Advisor/Consultant|Cumberland Pharmaceuticals: Advisor/Consultant|Ferring Pharmaceuticals: Advisor/Consultant Lucinda J. Van Anglen, PharmD, FIDSA, Cumberland Pharmaceuticals: Grant/Research Support|Ferring Pharmaceuticals: Grant/Research Support|Melinta Therapeutics: Grant/Research Support|Novartis: Grant/Research Support|Takeda Pharmaceuticals: Grant/Research Support

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