Key clinical-trial evidence for posaconazole

Author: Anoma Ranaweera B.V.Sc; PhD (Clinical Biochemistry, University of Liverpool, UK). Chief Editor: Dr Amanda Oakley, Dermatologist, Hamilton, New Zealand, April 2015.

Posaconazole (NOXAFIL®) is indicated for use in the treatment of the following invasive fungal infections in patients 18 years of age or older:

Posaconazole is also indicated for the:

Clinical studies

Prophylaxis of aspergillus and candida infections with posaconazole oral suspension

Table 1
Study Posaconazole Controla P value
Proportion (%) of patients with proven/probable IFIs – no./total no. patients (%)
On treatment period*
Study 1 7/291 (2) 22/288 (8) 0.0038
Study 2 7/304 (2); 25/298 (8) 0.0009
Fixed time period**
Study 1 7/301 (2) 21/299 (7) < 0.0059
Study 2 4 /304 (1); 26 /298 (9) < 0.0001

* In study 2 this was the period from randomization to last dose of study medication plus 7 days; in study 1 it was the period from first dose to last dose of study medication plus 7 days.

**In study 2, this was the period from randomization to 100 days post-randomization; in study 1 it was the period from the Baseline day to 111 days post-baseline. a ); fluconazole (study1); Fluconazole/itraconazole (study 2)

Treatment of azole-susceptible oropharyngeal candidiasis

Table 2
End point Posaconazole Fluconazole
Clinical success rate at Day 14 91.7 % (155/169) 92.5 % (148/160)
Clinical success ratea 4 weeks after end of treatment 68.5 % (98/143) 61.8 % (84/136)
Mycological response rateb 4 weeks after end of treatment** 40.6 % (41/101) 26.4 % (24/91)

a Clinical success rate was defined as the number of cases assessed as having a clinical response (cure or improvement) divided by the total number of cases eligible for analysis.

b Mycological response rate was defined as mycological success (≤ 20 CFU/ml) divided by the total number of cases eligible for analysis.

** p = 0.04

Treatment of azole-refractory oropharyngeal candidiasis

Treatment of invasive aspergillosis

Table 3
End point Posaconazole External control group
Overall response 45/107 (42%) 22/86 (26%)
Survival at day 365 38% 22% [P= 0.006]
Success by species
Aspergillus fumigatus 12/29 (41 %) 12/34 (35 %)
Aspergillus flavus 10/19 (53 %) 3/16 (19 %)
Aspergillus tereus 4/14 (29 %) 2/13 (15 %)
Aspergillus niger 3/5 (60 %) 2/7 (29 %)

Treatment of coccidioidomycosis

Place of posaconazole in fungal infections

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