Posaconazole (POS) Long-Term Safety in Patients with Invasive Fungal Infections (IFIs)

J. R. GRAYBILL 1, I. RAAD 2, R. NEGRONI 3, G. CORCORAN 4, L. PEDICONE 4

Author address: 

1 Univ. of Texas Hlth. Sci. Ctr., San Antonio, TX, 2 Univ. of Texas M. D. Anderson Cancer Ctr., Houston, TX, 3 Hosp. F. J. Muñiz, Buenos Aires, Argentina, 4 Schering-Plough Res. Inst., Kenilworth, NJ.

Abstract: 

Background: The long-term safety of antifungal agents for IFIs is important because extended therapy is often required. The safety (>6 months) of IFI treatment with POS, an oral, extended-spectrum triazole antifungal agent, is reviewed here. Methods: Safety and efficacy were evaluated in a large open-label, multicenter clinical trial of POS 800 mg/day in divided doses, given to patients intolerant of, or with disease refractory to, other antifungal therapy. In all, 102/330 patients were treated for >6 months, of whom 27 were treated for >1 year. Results: The most common treatment-related adverse events (TRAEs) reported in the long-term population at any time during therapy were headache (10%), nausea (8%), abdominal pain (5%), increased SGPT (5%), diarrhea (4%), and vomiting (4%). These events were reported more often during the first 6 months of treatment than after 6 months of treatment. During the first 6 months, 43% reported TRAEs; only 20% reported TRAEs after 6 months. Of the 27 subjects treated for >1 year, 5 had mild to moderate elevated hepatic enzymes that were recorded as a TRAE. For 4/5, the increase occurred early in treatment (1 year were aspergillosis, coccidioidomycosis, and chromoblastomycosis/mycetoma. Conclusions: In this salvage therapy trial, POS appeared to be well tolerated during long-term use. The AE profile of long-term POS treatment was similar to that reported in the overall population. Therefore, POS therapy appears to be a clinically useful oral alternative for long-term treatment of serious IFIs.
2004

abstract No: 

M-1025-200

Full conference title: 

44th Interscience Conference on Antimicrobial Agents and Chemotherapy
    • ICAAC 44th