TY - JOUR
T1 - Rezafungin Versus Caspofungin in a Phase 2, Randomized, Double-blind Study for the Treatment of Candidemia and Invasive Candidiasis
T2 - The STRIVE Trial
AU - Thompson, George R.
AU - Soriano, Alex
AU - Skoutelis, Athanasios
AU - Vazquez, Jose A.
AU - Honore, Patrick M.
AU - Horcajada, Juan P.
AU - Spapen, Herbert
AU - Bassetti, Matteo
AU - Ostrosky-Zeichner, Luis
AU - Das, Anita F.
AU - Viani, Rolando M.
AU - Sandison, Taylor
AU - Pappas, Peter G.
N1 - Publisher Copyright:
© 2020 The Author(s). Published by Oxford University Press for the Infectious Diseases Society of America.
PY - 2021/12/1
Y1 - 2021/12/1
N2 - 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. In total, 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.
AB - 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. In total, 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.
KW - candidemia
KW - echinocandins
KW - rezafungin
KW - systemic antifungal therapy
UR - http://www.scopus.com/inward/record.url?scp=85101763045&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85101763045&partnerID=8YFLogxK
U2 - 10.1093/cid/ciaa1380
DO - 10.1093/cid/ciaa1380
M3 - Article
C2 - 32955088
AN - SCOPUS:85101763045
SN - 1058-4838
VL - 73
SP - E3647-E3655
JO - Clinical Infectious Diseases
JF - Clinical Infectious Diseases
IS - 11
ER -