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Whole Genome Sequencing of Candida glabrata for Detection of Markers of Antifungal Drug Resistance
Published on: December 28, 2017
Exploring Early Antifungal Activity of Rezafungin as a Stepping-Stone for Shorter Treatment Duration for Candidemia:
Luis Ostrosky-Zeichner1, Jalal A Aram2, Mark Redell2
1Division of Infectious Diseases, McGovern Medical School, Houston, Texas, USA.
Background:
Guidelines recommend ≥2 weeks of antifungal therapy after candidemia clearance and for invasive candidiasis (IC). This post-hoc analysis evaluates Day 7 pooled data from the phase 2 STRIVE and phase 3 ReSTORE trials to explore early antifungal activity.
Methods:
Adults with candidemia and/or IC received weekly rezafungin 400/200 mg or daily caspofungin 70/50 mg for ≤4 weeks. Efficacy was evaluated in the modified intent-to-treat population via all-cause mortality (ACM; primary endpoint; 20% noninferiority margin), mycological eradication, and time to negative blood culture (TTNBC) at days 7, 14, and 30 (TTNBC assessed only in patients with candidemia). Day 7 safety was evaluated in the safety population.
Results:
Rezafungin was noninferior to caspofungin at each timepoint. Day 7 ACM rates were 7.9% (11/139) for rezafungin and 5.2% (8/155) for caspofungin (weighted difference [95% CI]: 3.0% [-3.7, 9.7]). Mycological eradication was similar between groups at all timepoints. Day 7 rates were 71.2% (99/139) and 65.2% (101/155), respectively (weighted difference [95% CI]: 6.6% [-4.0, 17.1]). Median (interquartile range) TTNBC was numerically shorter for rezafungin (22.3 [14.3-47.0] hours; caspofungin 26.3 [17.8-112.6] hours). Subgroup analyses suggested potential Day 7 benefits for rezafungin in patients with candidemia or C. albicans. Day 7 safety for rezafungin was consistent with previous reports.
Conclusions:
Rezafungin was noninferior to caspofungin in candidemia and/or IC from Day 7, with shorter TTNBC in patients with candidemia. Subgroup analysis suggested a potential early benefit with rezafungin in some patients. Trials exploring shorter treatment durations for some patients are warranted.
Clinical Trials Registrations:
NCT02734862 (STRIVE); NCT03667690 (ReSTORE).
Insights
Rezafungin demonstrated noninferiority to caspofungin for invasive fungal infections by Day 7. Early data suggests potential benefits for rezafungin, prompting further investigation into shorter treatment durations.
Area of Science:
- Mycology
- Infectious Diseases
- Clinical Pharmacology
Background:
- Current guidelines recommend at least two weeks of antifungal therapy for invasive candidiasis (IC) and candidemia.
- Early antifungal activity is crucial for patient outcomes.
- This analysis focuses on Day 7 pooled data from the STRIVE and ReSTORE trials.
Purpose of the Study:
- To evaluate the early efficacy of rezafungin compared to caspofungin at Day 7.
- To assess all-cause mortality (ACM), mycological eradication, and time to negative blood culture (TTNBC).
- To explore potential benefits of rezafungin in specific patient subgroups.
Main Methods:
- Adult patients with candidemia and/or IC received weekly rezafungin or daily caspofungin.
- Efficacy endpoints included ACM, mycological eradication, and TTNBC at Days 7, 14, and 30.
- Safety was assessed on Day 7.
Main Results:
- Rezafungin was noninferior to caspofungin across all timepoints.
- Day 7 ACM rates were 7.9% for rezafungin vs. 5.2% for caspofungin.
- Mycological eradication rates were similar; median TTNBC was shorter with rezafungin.
Conclusions:
- Rezafungin showed noninferiority to caspofungin by Day 7 for candidemia and/or IC.
- Subgroup analyses indicated potential early advantages for rezafungin in certain patients.
- Further trials investigating shorter treatment durations are warranted.
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