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Prophylaxis in HSCT recipients

Voriconazole is indicated for the prophylaxis of invasive fungal infections in high-risk allogeneic haematopoietic stem cell transplant (HSCT) recipients1

IMPROVEIT was a prospective, multi-centre, phase III, randomised, comparative, open-label trial to compare the efficacy and safety of voriconazole versus itraconazole as antifungal prophylaxis in allogeneic HSCT recipients*2

Key results

Superior success of prophylaxis with voriconazole on primary endpoint*1,2

  • 48.7% of patients on voriconazole versus 33.2% on itraconazole achieved success to day 180. The difference in proportions was 16.4% (95% CI:7.7-25.1%; p=0.0002)+
  • 1.3% of patients on voriconazole versus 2.1% of patients on itraconazole developed a proven or probable IFI to day 180. The difference in proportions was -0.7% (95% CI: -3.1-1.6%; p=0.54)
  • 82.1% of patients on voriconazole survived to day 180 versus 81.7% of patients on itraconazole. The difference in proportions was 0.4% (95% CI: -6.6-7.4%; p=0.91)

Significantly more voriconazole than itraconazole patients able to complete at least 100 days of prophylaxis2

Voriconazole in comparison to itraconazole could be given for significantly longer durations, with less need for other systemic antifungals2

Better patient convenience and satisfaction with voriconazole than with itraconazole2

Based on its superiority in the composite primary endpoint incorporating tolerability, invasive fungal infection prevention and survival, voriconazole was shown to be more effective than itraconazole for antifungal prophylaxis in this (allogeneic HSCT) setting2

 

*Modified intent-to-treat population: all patients who underwent allogeneic HSCT and received at least one dose of study drug. Due to a suspected breach in Good Clinical Practice at one site, data from 10 and 14 patients in the voriconazole and itraconazole groups, respectively, were excluded from the safety and efficacy analyses.
+Difference in proportions, 95% CI and p-values obtained after adjustment for randomisation.

References

  1. Vfend® Summary of Product Characteristics.
  2. Marks DI, et al. Br J Haematol. 2011; 155(3): 318-27.