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

Jose Antonio Vazquez, Jennifer A. Schranz, Kay Clark, Beth P. Goldstein, Annette Reboli, Carl Fichtenbaum

Research output: Contribution to journalArticle

34 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)304-309
Number of pages6
JournalJournal of Acquired Immune Deficiency Syndromes
Volume48
Issue number3
DOIs
StatePublished - Jul 1 2008
Externally publishedYes

Fingerprint

anidulafungin
Azoles
Candidiasis
Safety
Therapeutics
Amphotericin B
Immunosuppressive Agents
Neutropenia
Candida
Nausea
HIV Infections
Vomiting

Keywords

  • Anidulafungin
  • Azole-refractory candidiasis
  • Mucosal candidiasis

ASJC Scopus subject areas

  • Infectious Diseases
  • Pharmacology (medical)

Cite this

A phase 2, open-label study of the safety and efficacy of intravenous anidulafungin as a treatment for azole-refractory mucosal candidiasis. / Vazquez, Jose Antonio; Schranz, Jennifer A.; Clark, Kay; Goldstein, Beth P.; Reboli, Annette; Fichtenbaum, Carl.

In: Journal of Acquired Immune Deficiency Syndromes, Vol. 48, No. 3, 01.07.2008, p. 304-309.

Research output: Contribution to journalArticle

Vazquez, Jose Antonio ; Schranz, Jennifer A. ; Clark, Kay ; Goldstein, Beth P. ; Reboli, Annette ; Fichtenbaum, Carl. / A phase 2, open-label study of the safety and efficacy of intravenous anidulafungin as a treatment for azole-refractory mucosal candidiasis. In: Journal of Acquired Immune Deficiency Syndromes. 2008 ; Vol. 48, No. 3. pp. 304-309.
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N2 - 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.

AB - 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.

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