Background: POS is an oral azole antifungal with potent in vitro activity against a wide array of fungal organisms. Methods: 330 patients intolerant of, or with IFI refractory to, other antifungal therapy were treated with POS 800 mg/day in divided doses for up to 12 months in a large, multicenter, open-label study. A contemporaneous external control (CON) of 279 patients was developed for comparison. An external, blinded data review committee reviewed all data and confirmed study eligibility and treatment outcome. Global response (clinical, mycologic, and radiographic data) at the end of therapy (EOT) was the primary end point. Successes were complete or partial responses; non-successes were stable disease, failures, or undetermined. Results: 238/330 patients from the POS group and 218/279 from the CON group were included in the MITT group (proven/probable and refractory/intolerant). Most (86%) were refractory to previous therapy (primarily AMB). Successful outcomes at EOT in POS and CON groups, respectively, were as follows: Aspergillus, 107 (42%) vs 86 (26%) (P = .006); Fusarium, 18 (39%) vs 4 (50%); Zygomycetes, 11 (56%) vs 8 (50%); Coccidioides, 16 (69%) vs 7 (43%); Candida, 23 (52%) vs 30 (53%); Cryptococcus, 31 (48%) vs 64 (58%); chromoblastomycosis/mycetoma, 11 (81%) vs 2 (0); other fungi, 30 (64%) vs 20 (60%). Conclusions: POS therapy was successful in treating a wide variety of refractory fungal infections. These results support preclinical data showing an extended spectrum of activity and suggest that POS may have broad clinical utility for the treatment of infections when other therapy has failed.
Full conference title:
44th Interscience Conference on Antimicrobial Agents and Chemotherapy
- ICAAC 44th