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A phase 2, open-label study of the safety and efficacy of intravenous anidulafungin as a treatment for azole-refractory mucosal candidiasis.

Research paper by José A JA Vazquez, Jennifer A JA Schranz, Kay K Clark, Beth P BP Goldstein, Annette A Reboli, Carl C Fichtenbaum

Indexed on: 12 Jun '08Published on: 12 Jun '08Published in: Journal of acquired immune deficiency syndromes (1999)



Abstract

Azole-refractory mucosal candidiasis is a debilitating disease frequently seen in patients who are immunosuppressed as a result of HIV, malignancy, posttransplant immunosuppressive therapy, persistent neutropenia, steroid use, or diabetes. Anidulafungin has potent activity against a broad spectrum of Candida species, including strains resistant to azoles and amphotericin B. We performed an open-label, noncomparative study to examine efficacy and safety of anidulafungin in patients with azole-refractory oropharyngeal and esophageal candidiasis.Patients enrolled met diagnostic criteria for azole-refractory mucosal candidiasis. They received intravenous anidulafungin 100 mg on day 1 followed by daily 50-mg doses on day 2 through day 14 or for a maximum of 21 days. Primary efficacy variables were clinical response (for oropharyngeal candidiasis) and endoscopic and clinical response (for esophageal candidiasis) at the end of therapy.Nineteen patients were enrolled; 89% had advanced HIV infection. Clinical success was observed in 95% of patients at end of therapy, and endoscopic success was observed in 92% of patients with esophageal candidiasis. At follow-up, clinical success was maintained in 47% of patients. The most common adverse event, experienced by 4 patients, was nausea and/or vomiting.Anidulafungin was well tolerated and efficacious in the treatment of patients with azole-refractory esophageal and oropharyngeal candidiasis.