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

Abstract

BACKGROUND:

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.

METHODS:

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.

RESULTS:

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.

CONCLUSIONS:

Anidulafungin was well tolerated and efficacious in the treatment of patients with azole-refractory esophageal and oropharyngeal candidiasis.

• Authors: José A Vazquez, Jennifer A Schranz, Kay Clark, Beth P Goldstein, Annette Reboli, Carl Fichtenbaum
• Journal: Journal of acquired immune deficiency syndromes (1999) (J Acquir Immune Defic Syndr) Vol. 48 Issue 3 Pg. 304-9 (Jul 01 2008) ISSN: 1525-4135 [Print] United States
• PMID: 18545153 (Publication Type: Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Antifungal Agents
• Azoles
• Echinocandins
• Anidulafungin

Topics

• AIDS-Related Opportunistic Infections (drug therapy)
• Adult
• Anidulafungin
• Antifungal Agents (therapeutic use)
• Azoles (therapeutic use)
• Candidiasis (complications, drug therapy)
• Candidiasis, Oral (drug therapy)
• Drug Resistance, Fungal
• Echinocandins (adverse effects, therapeutic use)
• Esophageal Diseases (drug therapy)
• Female
• Humans
• Male
• Middle Aged
• Mucous Membrane