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Antimicrobial Agents and Chemotherapy, January 2006, p. 126-133, Vol. 50, No. 1
0066-4804/06/$08.00+0     doi:10.1128/AAC.50.1.126-133.2006
Copyright © 2006, American Society for Microbiology. All Rights Reserved.

Posaconazole as Salvage Therapy for Zygomycosis

R. N. Greenberg,1,2* K. Mullane,3 J.-A. H. van Burik,4 I. Raad,5 M. J. Abzug,6 G. Anstead,7 R. Herbrecht,8 A. Langston,9 K. A. Marr,10 G. Schiller,11 M. Schuster,12 J. R. Wingard,13 C. E. Gonzalez,14 S. G. Revankar,15 G. Corcoran,16 R. J. Kryscio,17 and R. Hare18

Medicine Service, Department of Veterans Affairs Medical Center, Lexington, Kentucky,1 University of Kentucky, Department of Medicine, Lexington, Kentucky,2 University of Chicago Medical School, Chicago, Illinois,3 University of Minnesota School of Medicine, Minneapolis, Minnesota,4 M. D. Anderson Cancer Center, Houston, Texas,5 University of Colorado and Children's Hospital, Denver, Colorado,6 Department of Medicine, South Texas Veterans Healthcare System, San Antonio, Texas,7 Hopital de Hautepierre, Strasbourg, France,8 Emory University Hospital, Atlanta, Georgia,9 Fred Hutchinson Cancer Research Center, Seattle, Washington,10 University of California at Los Angeles, Los Angeles, California,11 Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania,12 University of Florida, Gainesville, Florida,13 Georgetown University Hospital Lombardi Cancer Center, Washington, D.C.,14 Dallas VA Medical Center, Dallas, Texas,15 Amgen, Inc., Regulatory Affairs, Thousand Oaks, California,16 University of Kentucky, Department of Statistics and Public Health, Lexington, Kentucky,17 Schering-Plough Research Institute, Kenilworth, New Jersey,18

Received 25 July 2005/ Returned for modification 9 September 2005/ Accepted 12 October 2005

Zygomycosis, an infection that is associated with significant morbidity and mortality, is becoming common in immunocompromised patients. Posaconazole is a new extended-spectrum azole antifungal that has demonstrated in vitro and in vivo activity against zygomycetes. This report provides the results from the first 24 patients with active zygomycosis who were enrolled in two open-label, nonrandomized, multicentered compassionate trials that evaluated oral posaconazole as salvage therapy for invasive fungal infections. Posaconazole was usually given as an oral suspension of 200 mg four times a day or 400 mg twice a day. Eleven (46%) of the infections were rhinocerebral. Duration of posaconazole therapy ranged from 8 to 1,004 days (mean, 292 days; median, 182 days). Rates of successful treatment (complete cure and partial response) were 79% in 19 subjects with zygomycosis refractory to standard therapy and 80% in 5 subjects with intolerance to standard therapy. Overall, 19 of 24 subjects (79%) survived infection. Survival was also associated with surgical resection of affected tissue and stabilization or improvement of the subjects' underlying illnesses. Failures either had worsening of underlying illnesses or requested all therapy withdrawn; none of the failures received more than 31 days of posaconazole. Posaconazole oral solution was well tolerated and was discontinued in only one subject due to a drug rash. Posaconazole appears promising as an oral therapy for zygomycosis in patients who receive required surgery and control their underlying illness.

* Corresponding author. Mailing address: Department of Medicine, Room MN 672, University of Kentucky School of Medicine, 800 Rose Street, Lexington, KY 40536-0084. Phone: (859) 323-6327. Fax: (859) 323-1631. E-mail: RNgree01{at}uky.edu.

Antimicrobial Agents and Chemotherapy, January 2006, p. 126-133, Vol. 50, No. 1
0066-4804/06/$08.00+0     doi:10.1128/AAC.50.1.126-133.2006
Copyright © 2006, American Society for Microbiology. All Rights Reserved.



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