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Micafungin noninferior to standard prophylaxis after liver transplantation
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Data from the Liver Transplant European Study into the Prevention of Fungal Infection, or TENPIN, suggest that micafungin is noninferior to standard treatments as prophylaxis in liver transplant recipients at high risk for invasive fungal infection.
In addition, micafungin (Mycamine, Astellas), an echinocandin drug, was associated with better renal function compared with standard regimens, TENPIN investigators wrote in Clinical Infectious Diseases.
“Fluconazole and liposomal amphotericin B are US guideline-recommended options for antifungal prophylaxis in liver transplant recipients with multiple invasive fungal infection risk factors,” the researchers wrote. “However, some strains of Candida have shown resistance to fluconazole and amphotericin B nephrotoxicity causes concern in renally impaired patients. The echinocandins have demonstrated broad efficacy against Candida species, have low toxicity, few drug-drug interactions and are established first-line treatments for invasive candidiasis.”
The researchers conducted an open-label, noninferiority study in which post-transplant patients were randomly assigned to IV micafungin 100 mg daily, or standard of care for a particular center, either fluconazole, liposomal amphotericin B or caspofungin (Cancidas, Merck). They compared the clinical success of micafungin with other regimens, measured by the absence of an invasive fungal infection and no need for antifungal treatment at the end of 21 days of prophylaxis.
The study included 344 patients treated at 37 centers in Europe from Dec. 15, 2009 to May 3, 2012. The clinical success rate of micafungin was noninferior to standard care: 98.6% vs. 99.3%. The two groups were similar in the incidence of invasive fungal infection and initiation of systemic antifungal treatment. There were no differences in hepatic function tests between the two regimens, but lower serum creatinine and urea levels in the micafungin group suggested better renal function in these patients. There also were fewer adverse events resulting in drug discontinuation in the micafungin group.
“In our study, more graft rejection episodes were reported in micafungin patients than standard care,” the researchers wrote. “However, further investigation found similar rates of biopsy-confirmed treated acute rejection — an objective measure of rejection — and there was no evidence that micafungin was different to standard care in this regard.”
Disclosure: The researchers report financial relationships with Astellas, Gambro, Genzyme, Gilead Sciences, Merck Sharp & Dohme, Novartis, Nycomed, Pfizer, Roche, TEVA and Vital Therapies.
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