Author: M. J. G. T. Vehreschild

Author address:

University Hospital Cologne, Cologne, Germany

Full conference title:

8th Trends in Medical Mycology, Organised under the auspices of EORTC-IDG and ECMM, 6-9 October 2017, Belgrade, Serbia

Date: 16 October 2017


Isavuconazole has high oral bioavailability, linear pharmacokinetics, and is active against a broad range of clinically important fungi, including Aspergillus spp. And moulds of the order Mucorales. Isavuconazole inhibits ergosterol biosynthesis, which results in accumulation of toxic sterols and cell death. It was recently registered for the treatment of invasive aspergillosis and mucormycosis. The underlying phase III program included both, the traditional approach of large randomized, controlled trials and an orphan disease program. A direct randomized comparison of voriconazole vs standard care (the SECURE study) was applied to obatin data on isavuconaole’s clinical efficacy in the treatment of invasive aspergillosis. This study showed that ssfully proved that isavuconazole provided non-inferior efficacy and a lower rate of adverse events. In the case of candidaemia and invasive candidiasis, a study comparing isavuconazole vs caspofungin failed to fulfill the criteria for meeting the noninferiority target. Since isavuconazole has in vitro and in vivo activity against Candida, these results came as a surprise. At the same time, they underline the important role of echinocandins in the treatment of candidemia. Finally, the non-comparative VITAL study enrolled patients with rare invasive fungal diseases, including mucormycosis. While it would be consideredstandard to compare a new drug with the present first-line treatment for the indication under study, that such a study is difficult to complete in orphan diseases. In the case of isavuconazole treatment for mucormycosis, the investigators chose a matched control design using the FungiScopeTM registry (NCT01731353) of the European Confederation of Medical Mycology. This innovative approach, facilitated the first ever licence for an anti-infective in the treatment of an extremely rare disease. 

Abstract Number: S19.2

Conference Year: 2017

Link Conference abstract: 

TIMM 8th (2017)

Conference abstracts, posters & presentations

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