Rezafungin versus Caspofungin in a phase 2, randomized, double-blind study for the treatment of candidemia and invasive candidiasis - the STRIVE trial

Thompson, George R.; Soriano, Alex; Skoutelis, Athanasios; Vazquez, Jose A.; Honore, Patrick M.; Horcajada Gallego, Juan Pablo; Spapen, Herbert; Bassetti, Matteo; Ostrosky-Zeichner, Luis; Das, Anita F.; Viani, Rolando M.; Sandison, Taylor; Pappas, Peter G.

doi:http://dx.doi.org/10.1093/cid/ciaa1380

Rezafungin versus Caspofungin in a phase 2, randomized, double-blind study for the treatment of candidemia and invasive candidiasis - the STRIVE trial

Citation

Thompson GR, Soriano A, Skoutelis A, Vazquez JA, Honore PM, Horcajada JP, et al. Rezafungin versus Caspofungin in a phase 2, randomized, double-blind study for the treatment of candidemia and invasive candidiasis - the STRIVE trial. Clin Infect Dis. 2021 Dec 6;73(11):e3647-55. DOI: 10.1093/cid/ciaa1380

Abstract

Background: Rezafungin (RZF) is a novel echinocandin exhibiting distinctive pharmacokinetics/pharmacodynamics. STRIVE was a phase 2, double-blind, randomized trial designed to compare the safety and efficacy of RZF once weekly (QWk) to caspofungin (CAS) once daily for treatment of candidemia and/or invasive candidiasis (IC). Methods: Adults with systemic signs and mycological confirmation of candidemia and/or IC were randomized to RZF 400 mg QWk (400 mg), RZF 400 mg on week 1 then 200 mg QWk (400/200 mg), or CAS 70 mg as a loading dose followed by 50 mg daily for ≤ 4 weeks. Efficacy assessments included overall cure (resolution of signs of candidemia/IC + mycological eradication) at day 14 (primary endpoint), investigator-assessed clinical response at day 14, and 30-day all-cause mortality (ACM) (secondary endpoints), and time to negative blood culture. Safety was evaluated by adverse events and ACM through follow-up. Results: Of 207 patients enrolled, 183 were in the microbiological intent-to-treat population (~21% IC). Overall cure rates were 60.5% (46/76) for RZF 400 mg, 76.1% (35/46) for RZF 400/200 mg, and 67.2% (41/61) for CAS; investigator-assessed clinical cure rates were 69.7% (53/76), 80.4% (37/46), and 70.5% (43/61), respectively. 30-day ACM was 15.8% for RZF 400 mg, 4.4% for RZF 400/200 mg, and 13.1% for CAS. Candidemia was cleared in 19.5 and 22.8 hours in RZF and CAS patients, respectively. No concerning safety trends were observed; ACM through follow-up was 15.2% (21/138) for RZF and 18.8% (13/69) for CAS. Conclusions: RZF was safe and efficacious in the treatment of candidemia and/or IC.