This is the first scientific presentation of data assessing the clinical efficacy of VFEND in candidemia. VFEND is not currently approved by the U.S. Food and Drug Administration for the treatment of disseminated Candida infections. In Europe, VFEND is approved for the treatment of fluconazole-resistant strains of serious invasive Candida infections, including those caused by C. krusei.
The study included 370 patients who had at least one positive blood culture for Candida within 96 hours of entering the study.
Patients were randomized to receive either VFEND or amphotericin B followed by fluconazole.
In the primary analysis, VFEND was demonstrated to be as effective as amphotericin B followed by fluconazole for the treatment of candidemia, including infections caused by Candida species other than albicans. In both treatment groups, 41 percent of patients reported a successful response when assessed at 12 weeks after the end of treatment. In a secondary analysis, which incorporated response assessments at any point in the study, the response rate in both arms was comparable to that reported in previous candidemia trials. Treatment with VFEND was able to clear Candida from the blood as effectively as amphotericin B. The mean time to negative blood culture was four days in both groups.
"These results demonstrate that VFEND is effective in the treatment of candidemia," said Dr. Bart-Jan Kullberg, Professor of Medicine at Nijmegen University Center for Infectious Diseases in The Netherlands. Dr. Kullberg is the chairman of the Data Review Committee for this clinical trial. "The broad spectrum of activity with VFEND makes it especially attractive for infections caused by albicans and non-albicans species of Candida, which are becoming an increasingly common source of candidemia."
Candidemia is a systemic fungal infection that occurs when a Candida organism is present in the blood. Candidemia can lead to body organ infection and/or serious bloodstream infections . A yeast called Candida albicans is the most common cause of candidemia. However, non-albicans species such as C. glabrata and C. krusei, which are more challenging to treat effectively, have become increasingly prevalent in recent years. Surgical patients and patients with compromised immune systems are at high risk for candidemia.
Baseline characteristics were similar in the two treatment groups. The proportion of patients with non-albicans Candida was 60.5 percent for VFEND compared to 50.0 percent for amphotericin B/fluconazole. The median duration of study treatment was 15 days in both groups; median duration of amphotericin B therapy was 4 days. The adverse event profiles were comparable for both treatment groups. However, more renal events were reported in the amphotericin B/fluconazole arm.
Discovered and developed by Pfizer, VFEND is indicated for the treatment of serious fungal infections. In the United States, VFEND is approved for the treatment of acute invasive aspergillosis and salvage therapy for rare but serious fungal infections caused by the pathogens Scedosporium apospermum and Fusarium species. In 2003, VFEND received an additional U.S. indication for use in esophageal candidiasis infections.
In Europe, VFEND is approved for treatment of invasive aspergillosis, fluconazole-resistant strains of serious invasive Candida infections (including C. krusei), and serious fungal infections caused by Scedosporium and Fusarium species.
VFEND can be administered both orally and intravenously and has a broad spectrum of activity against both C. albicans and non-albicans species. Pfizer is continuing to study VFEND for the treatment of other serious fungal infections.
In clinical trials, the most common adverse events (all causalities) were visual disturbances, fever, rash, vomiting, nausea, diarrhea, headache, sepsis, peripheral edema, abdominal pain and respiratory disorders. The treatment-related adverse events that most often led to discontinuation in clinical trials were elevated liver function tests and rash.