Abstract
Posaconazole is used for prophylaxis for invasive fungal infections (IFIs) among patients with hematologic malignancies. We compared the incidence of breakthrough IFIs and early discontinuation between patients receiving delayed-release tablet and oral suspension formulations of posaconazole. This was a retrospective cohort study of patients receiving posaconazole between 1 January 2010 and 30 June 2016. We defined probable or proven breakthrough IFIs using the European Organization for Research and Treatment of Cancer (EORTC) criteria. Overall, 547 patients received 860 courses of posaconazole (53% received the oral suspension and 48% received the tablet); primary indications for prophylaxis were acute myeloid leukemia (69%), graft-versus-host disease (18%), and myelodysplastic syndrome (3%). There were no significant differences in demographics or indications between patients receiving the different formulations. The incidence and incidence rate of probable or proven IFIs were 1.6% and 3.2 per 10,000 posaconazole days, respectively. There was no significant difference in the rate of IFIs between suspension courses (2.8 per 10,000 posaconazole days) and tablet courses (3.7 per 10,000 posaconazole days) (rate ratio = 0.8, 95% confidence interval [CI] = 0.3 to 2.3). Of the 14 proven or probable cases of IFI, 8/14 had posaconazole serum concentrations measured, and the concentrations in 7/8 were above 0.7 μg/ml. Posaconazole was discontinued early in 15.5% of courses; however, the frequency of discontinuation was also not significantly different between the tablet (16.5%) and oral suspension (14.6%) formulations (95% CI for difference = -0.13 to 0.06). In conclusion, the incidence of breakthrough IFIs was low among patients receiving posaconazole prophylaxis and not significantly different between patients receiving the tablet formulation and those receiving the oral suspension formulation.
Highlights
Invasive fungal infections (IFIs) are associated with considerable excess morbidity, mortality, and costs among infected patients
There was no significant difference in the rate of IFIs between suspension courses (2.8 per 10,000 posaconazole days) and tablet courses (3.7 per 10,000 posaconazole days)
Posaconazole prophylaxis was discontinued while still indicated in 17% of courses; the frequency of discontinuation was not significantly different between the two formulations
Summary
Invasive fungal infections (IFIs) are associated with considerable excess morbidity, mortality, and costs among infected patients. Posaconazole prophylaxis has been recommended to prevent IFIs and improve patient outcomes in these high-risk patients [4, 5]. The suboptimal absorption of the oral suspension formulation of posaconazole and the requirements of the dosing regimen may have limited its effectiveness. Improved clinical outcomes with the tablet formulation compared to the outcomes with the oral suspension have not been clearly demonstrated. We expand upon prior work performed at Oregon Health & Science University Hospitals and Clinics (OHSU) to assess the clinical outcomes between the oral suspension and tablet formulations of posaconazole for prophylaxis for IFIs. We identified and compared the frequency and rationale for discontinuation of posaconazole and postdiscontinuation outcomes between patients receiving the different formulations of posaconazole prophylaxis. (These data were presented in part at ASM Microbe 2017, June 2017, New Orleans, LA, and IDWeek 2017, October 2017, San Diego, CA.)
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