Utilisation, efficacy and safety of voriconazole: prospective, non-interventional study on treatment of IFIs in clinical practice

Abstract

Objective:

Invasive fungal infections (IFIs) are an important cause of morbidity and mortality, particularly in patients with cancer. The triazole voriconazole, given as oral or intravenous formulation, has a high bioavailability and proven efficacy against invasive aspergillosis, candidiasis and other fungi. We aimed to assess the utilisation, efficacy and safety of voriconazole with emphasis on the route of administration under standard clinical conditions.

Methods:

Prospective, observational study performed by 17 hospitals and office-based physicians in Germany.

Results:

A total of 264 patients received oral (53%) or intravenous (22%) voriconazole or both formulations sequentially (25%). Of 228 patients with specified fungal diagnosis, 95 (36.0%) had aspergillosis, 73 (27.7%) candidiasis. Sixty (22.7%) received voriconazole for other fungal indications (OFI). In 195 of 226 patients (86.2%), treatment was successful (39.8% cured and 46.5% partial response). In terms of primary diagnoses, favourable responses were noted in 90% for pulmonary aspergillosis, 85% for candidiasis and 87% for OFI. Microbiological success was documented in 138 patients, of whom 105 (76.1%) had complete eradication of fungi. Response rates by initial route were similar for oral and intravenous administration (86 and 87%). Twenty-six of 264 patients died during the study, 53 patients experienced a serious adverse event (five treatment related), and 10 withdrew due to all-causality adverse events (AEs). Tolerability was assessed as very good in 55%, and good in 40% of patients.

Conclusions:

Voriconazole as oral or intravenous formulation was well tolerated and equally effective in critically ill patients with IFIs. This study in daily care confirms the outcomes of controlled clinical trials.

Key words::

• Fungal infections
• Intensive care
• Study
• Voriconazole

Transparency

Declaration of funding

The study was funded by Pfizer Pharma GmbH.

Declaration of financial/other relationships

W.J.H received speakers honoraria from Pfizer Pharma GmbH; A.B. has disclosed that she has no significant relationships with or financial interests in a commercial companies related to this study or article. G.S. received speakers honoraria and research grands from Pfizer Pharma GmbH.

Acknowledgement

The database was retained by Pfizer Pharma GmbH, and the investigators had full access. The authors thank Dr Ulrike Brunnmüller for her continued efforts in coordinating this project. The input of Prof. Dr D. Pittrow, Institute for Clinical Pharmacology, TU Dresden, for the interpretation of data and a first manuscript is acknowledged. Dr Pittrow has disclosed that he received a consultancy fee from Pfizer Pharma GmbH. The manuscript was reviewed and approved by the academic authors, and they assume full responsibility for the completeness and accuracy of its content.