Voriconazole for Salvage Treatment of Invasive Aspergillosis



Background: Voriconazole is an investigational antifungal agent with a good safety profile with fungicidal activity against Aspergillus Methods: Protocol 150-604 was an open label, noncomparative, phase III trial of voriconazole for salvage treatment of invasive fungal infections including aspergillosis. The study was conducted at > 60 sites in the US and Canada from 9/9712/99. Definite (invasive) aspergillosis was confirmed by a positive culture or evidence of tissue invasion from a biopsy sample. In subjects with allo BMT or prolonged neutropenia, probable aspergillosis was supported by a positive culture or cytology from a BAL sample. Subjects were treated with intravenous and/or oral voriconazole for up to 12 weeks. Global response at end of treatment was assessed by the investigator as complete, partial, stable or failure compared to baseline. Results: As of May, 1999, 51 subjects with aspergillosis who failed treatment with other antifungals were recruited. Antifungal treatment including lipid formulations of ampho B, was given for at least 5 days prior to entry. Most subjects had hematological conditions or malignancies, often with allo BMT, GVHD, prolonged neutropenia, or relapsed malignancy. Diagnosis of aspergillosis was confirmed as definite in 73%, probable in 27%. Sites of infection were: pulmonary (51 % ), sinus (20'/0), skin/subcutaneous (12 % ), and cerebral (6%). Satisfactory response rate (complete or partial) at end of treatment was 41%. Median survival on treatment was 57 days (1-196). There were 20 deaths, with 7 occurring within the first week of treatment. Six subjects discontinued voriconazole because of AE s or lab abnormalities. AE s reported by > l0% of all subjects treated with voriconazole in protocol 604 included: abnormal vision, rash, headache, fever, sepsis, hypotension, nausea, vomiting, diarrhea, peripheral edema, respiratory disorder, and urinary tract infection. Conclusion: Based on the results of this open-label trial, voriconazole is potentially beneficial for the treatment of invasive aspergillosis in patients with hematological malignancies and conditions who have failed other treatments including lipid formulations of ampho B.

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IDSA 38th
    • IDSA 38th