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Isavuconazol

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https://www.readbyqxmd.com/read/28864232/development-and-validation-of-a-liquid-chromatography-tandem-mass-spectrometry-assay-for-the-simultaneous-quantitation-of-5-azole-antifungals-and-1-active-metabolite
#1
Adam J McShane, Sihe Wang
BACKGROUND: Azole antifungal medications are often administered to prevent or treat invasive fungal infections. These infections are deadly in the immunocompromised population. Therapeutic drug monitoring of the azole antifungal medications may potentially decrease morbidity and mortality in patients undergoing azole treatment. METHODS: To assist with azole therapeutic drug monitoring, a liquid chromatography tandem mass spectrometry (LC-MS/MS) method was developed and validated for 6 azole analytes: fluconazole, voriconazole, posaconazole, isavuconazole, itraconazole, and its active metabolite hydroxyitraconazole...
August 31, 2017: Clinica Chimica Acta; International Journal of Clinical Chemistry
https://www.readbyqxmd.com/read/28830945/pharmacodynamics-of-the-orotomides-against-aspergillus-fumigatus-new-opportunities-for-treatment-of-multidrug-resistant-fungal-disease
#2
William W Hope, Laura McEntee, Joanne Livermore, Sarah Whalley, Adam Johnson, Nicola Farrington, Ruwanthi Kolamunnage-Dona, Julie Schwartz, Anthony Kennedy, Derek Law, Michael Birch, John H Rex
F901318 is an antifungal agent with a novel mechanism of action and potent activity against Aspergillus spp. An understanding of the pharmacodynamics (PD) of F901318 is required for selection of effective regimens for study in phase II and III clinical trials. Neutropenic murine and rabbit models of invasive pulmonary aspergillosis were used. The primary PD endpoint was serum galactomannan. The relationships between drug exposure and the impacts of dose fractionation on galactomannan, survival, and histopathology were determined...
August 22, 2017: MBio
https://www.readbyqxmd.com/read/28806568/a-simple-high-performance-liquid-chromatography-mass-spectrometry-method-for-therapeutic-drug-monitoring-of-isavuconazole-and-four-other-antifungal-drugs-in-human-plasma-samples
#3
Giovanna Fatiguso, Fabio Favata, Ilaria Zedda, Amedeo De Nicolò, Jessica Cusato, Valeria Avataneo, Giovanni Di Perri, Antonio D'Avolio
Triazoles chanced the prevention and treatment of invasive fungal infections, but their pharmacokinetic properties are still unclear. In particular, isavuconazole (ISC) is a new broad-spectrum antifungal triazole approved in 2015 as first-line treatment for intravenous and oral use against invasive aspergillosis and for mucormycosis. Nowadays, the optimal management of the treatments with triazoles requires the use of Therapeutic Drug Monitoring (TDM), in order to prevent sub-therapeutic or toxic concentrations...
October 25, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28802855/antifungal-resistance-in-mucorales
#4
E Dannaoui
The order Mucorales, which includes the agents of mucormycosis, comprises a large number of species. These fungi are characterized by high-level resistance to most currently available antifungal drugs. Standardized antifungal susceptibility testing methods are now available, allowing a better understanding of the in vitro activity of antifungal drugs against members of Mucorales. Such tests have made apparent that antifungal susceptibility within this group may be species-specific. Experimental animal models of mucormycosis have also been developed and are of great importance in bridging the gap between in vitro results and clinical trials...
August 9, 2017: International Journal of Antimicrobial Agents
https://www.readbyqxmd.com/read/28750160/two-phase-1-open-label-mass-balance-studies-to-determine-the-pharmacokinetics-of-14-c-labeled-isavuconazonium-sulfate-in-healthy-male-volunteers
#5
Robert Townsend, Kota Kato, Christine Hale, Donna Kowalski, Christopher Lademacher, Takao Yamazaki, Shahzad Akhtar, Amit Desai
Isavuconazonium sulfate is the water-soluble prodrug of the active triazole isavuconazole. Two phase 1 studies were conducted to identify the metabolic profile and mass balance of isavuconazole and BAL8728 (inactive cleavage product). Seven subjects in study 1 (isavuconazole mass balance) received a single oral dose of [cyano-(14) C]isavuconazonium sulfate corresponding to 200 mg isavuconazole. Six subjects in study 2 (BAL8728 mass balance) received a single intravenous dose of [pyridinylmethyl-(14) C]isavuconazonium sulfate corresponding to 75 mg BAL8728...
July 27, 2017: Clinical Pharmacology in Drug Development
https://www.readbyqxmd.com/read/28742650/reliable-and-easy-to-use-liquid-chromatography-tandem-mass-spectrometry-method-for-simultaneous-analysis-of-fluconazole-isavuconazole-itraconazole-hydroxy-itraconazole-posaconazole-and-voriconazole-in-human-plasma-and-serum
#6
Carsten Müller, David Gehlen, Cornelia Blaich, Domenik Prozeller, Blasius Liss, Thomas Streichert, Martin H J Wiesen
BACKGROUND: A fast and easy-to-use liquid chromatography-tandem mass spectrometry method for the determination and quantification of 6 triazoles [fluconazole (FLZ), isavuconazole (ISZ), itraconazole (ITZ), hydroxy-itraconazole (OH-ITZ), posaconazole (PSZ), and voriconazole (VRZ)] in human plasma and serum was developed and validated for therapeutic drug monitoring. METHODS: Sample preparation was based on protein precipitation with acetonitrile and subsequent centrifugation...
October 2017: Therapeutic Drug Monitoring
https://www.readbyqxmd.com/read/28722255/drug-drug-interactions-between-triazole-antifungal-agents-used-to-treat-invasive-aspergillosis-and-immunosuppressants-metabolized-by-cytochrome-p450-3a4
#7
REVIEW
Andreas H Groll, Robert Townsend, Amit Desai, Nkechi Azie, Mark Jones, Marc Engelhardt, Anne-Hortense Schmitt-Hoffman, Roger J Brüggemann
Patients undergoing treatment with immunosuppressant drugs following solid organ or hematopoietic stem cell transplantation are at particular risk for development of serious infections such as invasive aspergillosis. Four triazole antifungal drugs, voriconazole, posaconazole, itraconazole, and isavuconazole, are approved to treat invasive aspergillosis either as first- or second-line therapy. All of these agents are inhibitors of cytochrome P450 3A4, which plays a key role in metabolizing immunosuppressant drugs such as cyclosporine, tacrolimus, and sirolimus...
July 19, 2017: Transplant Infectious Disease: An Official Journal of the Transplantation Society
https://www.readbyqxmd.com/read/28702763/pharmacokinetics-of-antifungal-drugs-practical-implications-for-optimized-treatment-of-patients
#8
REVIEW
Romuald Bellmann, Piotr Smuszkiewicz
INTRODUCTION: Because of the high mortality of invasive fungal infections (IFIs), appropriate exposure to antifungals appears to be crucial for therapeutic efficacy and safety. MATERIALS AND METHODS: This review summarises published pharmacokinetic data on systemically administered antifungals focusing on co-morbidities, target-site penetration, and combination antifungal therapy. CONCLUSIONS AND DISCUSSION: Amphotericin B is eliminated unchanged via urine and faeces...
July 12, 2017: Infection
https://www.readbyqxmd.com/read/28696236/combination-therapy-with-isavuconazole-and-micafungin-for-treatment-of-experimental-invasive-pulmonary-aspergillosis
#9
Vidmantas Petraitis, Ruta Petraitiene, Matthew W McCarthy, Laura L Kovanda, Myo H Zaw, Kaiser Hussain, Naima Shaikh, Bo Bo W Maung, Navjot K Sekhon, William W Hope, Thomas J Walsh
Invasive pulmonary aspergillosis (IPA) is an important cause of morbidity and mortality in immunocompromised patients. We hypothesized that simultaneous inhibition of biosynthesis of ergosterol in the fungal cell membrane and (1→3)-β-d-glucan in the cell wall, respectively, by the antifungal triazole isavuconazole (ISA) and the echinocandin micafungin (MFG) may result in improved outcomes in experimental IPA in persistently neutropenic rabbits. Treatments included ISA at 20 mg/kg of body weight/day (ISA20), 40 mg/kg/day (ISA40), and 60 mg/kg/day (ISA60); MFG at 2 mg/kg/day (MFG2); combinations of ISA20 and MFG2, ISA40 and MFG2, and ISA60 and MFG2; and no treatment (untreated controls [UC])...
September 2017: Antimicrobial Agents and Chemotherapy
https://www.readbyqxmd.com/read/28674051/effects-of-isavuconazole-on-the-plasma-concentrations-of-tacrolimus-among-solid-organ-transplant-patients
#10
Ryan M Rivosecchi, Cornelius J Clancy, Ryan K Shields, Christopher R Ensor, Michael A Shullo, Bonnie A Falcione, Raman Venkataramanan, M Hong Nguyen
We evaluated the interaction between isavuconazole and tacrolimus among 55 organ transplant recipients. After isavuconazole discontinuation, the tacrolimus concentration/dose ratio normalized by weight (C/D) was reduced by 16%. Liver transplant recipients experienced the largest C/D reduction. A 1.3-fold decrease in tacrolimus daily dose was required to maintain desired tacrolimus levels. There was considerable interpatient variability in the magnitude of the drug interaction. Tacrolimus doses should not be adjusted uniformly but, rather, be guided by therapeutic drug monitoring...
September 2017: Antimicrobial Agents and Chemotherapy
https://www.readbyqxmd.com/read/28636889/complications-of-hematopoietic-stem-transplantation-fungal-infections
#11
REVIEW
Ali S Omrani, Reem S Almaghrabi
Patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT) are at increased risk of invasive fungal infections, especially during the early neutropenic phase and severe graft-versus-host disease. Mold-active prophylaxis should be limited to the highest risk groups. Empiric antifungal therapy for HSCT with persistent febrile neutropenia is associated with unacceptable response rates, unnecessary antifungal therapy, increased risk of toxicity, and inflated costs. Empiric therapy should not be a substitute for detailed work up to identify the cause of fever in such patients...
June 13, 2017: Hematology/oncology and Stem Cell Therapy
https://www.readbyqxmd.com/read/28605488/in-vitro-activity-of-the-novel-antifungal-compound-f901318-against-difficult-to-treat-aspergillus-isolates
#12
J B Buil, A J M M Rijs, J F Meis, M Birch, D Law, W J G Melchers, P E Verweij
Background: F901318 is a new antifungal agent with a novel mechanism of action with activity against Aspergillus species. We investigated the in vitro activity of F901318 against a collection of Aspergillus isolates. Methods: A total of 213 Aspergillus isolates were used in this study. A total of 143 Aspergillus fumigatus sensu stricto isolates were used, of which 133 were azole resistant [25 TR34/L98H; 25 TR46/Y121F/T289A; 33 A. fumigatus with cyp51A-associated point mutations (25 G54, 1 G432 and 7 M220); and 50 azole-resistant A...
September 1, 2017: Journal of Antimicrobial Chemotherapy
https://www.readbyqxmd.com/read/28595486/special-considerations-for-the-diagnosis-and-treatment-of-invasive-pulmonary-aspergillosis
#13
Matthew William McCarthy, Thomas J Walsh
The diagnosis and treatment of invasive pulmonary aspergillosis (IPA) are ongoing challenges in clinical practice. While important advances have recently been made, including enhanced diagnostic modalities as well as novel therapeutic and prophylactic options, more effective options are urgently needed as the population of immunocompromised patients continues to expand. Areas covered: In this paper, we review novel approaches to diagnosis of IPA, including multiplex PCR, Matrix Assisted Laser Desorption/Ionization-Time of Flight Mass Spectrometry and provide a detailed review of the extended-spectrum triazole isavuconazole, which was approved in 2015 to treat IPA...
September 2017: Expert Review of Respiratory Medicine
https://www.readbyqxmd.com/read/28497121/implementation-of-isavuconazole-in-a-fluorescence-based-high-performance-liquid-chromatography-kit-allowing-simultaneous-detection-of-all-four-currently-licensed-mold-active-triazoles
#14
René Jørgensen, Siri Rytcher Andersen, Karen Marie Thyssen Astvad, Maiken Cavling Arendrup
Isavuconazole (ISZ) is a newly available broad-spectrum triazole agent recently approved for the treatment of both invasive aspergillosis and mucormycosis. The aim of this study was to develop a simple and reliable method for therapeutic drug monitoring (TDM) of ISZ in human plasma samples. The method involves using a kit from ChromSystems intended for TDM of itraconazole (ITZ), posaconazole (PSZ), and voriconazole (VRZ) in serum/plasma for sample preparation and high-performance liquid chromatography, using fluorescence detection with emission and excitation wavelengths set to 261 and 366 nm, respectively...
May 2017: MSphere
https://www.readbyqxmd.com/read/28491888/successful-treatment-of-allergic-bronchopulmonary-aspergillosis-with-isavuconazole-case-report-and-review-of-the-literature
#15
Samantha E Jacobs, Deborah Saez-Lacy, Walter Wynkoop, Thomas J Walsh
Isavuconazole is a new triazole that is approved for primary therapy of invasive aspergillosis. We provide the first report of a patient with allergic bronchopulmonary aspergillosis (ABPA) who was successfully treated with isavuconazole with marked improvement and minimal adverse effects. We further review the literature on antifungal management of ABPA.
2017: Open Forum Infectious Diseases
https://www.readbyqxmd.com/read/28472247/pharmacodynamics-of-isavuconazole-for-invasive-mold-disease-role-of-galactomannan-for-real-time-monitoring-of-therapeutic-response
#16
Laura L Kovanda, Ruwanthi Kolamunnage-Dona, Michael Neely, Johan Maertens, Misun Lee, William W Hope
Background.: The ability to make early therapeutic decisions when treating invasive aspergillosis using changes in biomarkers as a surrogate for therapeutic response could significantly improve patient outcome. Methods.: Cox proportional hazards model and logistic regression were used to correlate early changes in galactomannan index (GMI) to mortality and overall response, respectively, from patients with positive baseline GMI (≥0.5) and serial GMI during treatment from a phase 3 clinical trial for the treatment of invasive mold disease...
June 1, 2017: Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America
https://www.readbyqxmd.com/read/28434195/use-of-isavuconazole-in-a-patient-with-voriconazole-induced-qtc-prolongation
#17
Tracy P Trang, Alexandra M Hanretty, Charles Langelier, Katherine Yang
A 22-year-old woman with cystic fibrosis developed QTc interval prolongation following lung transplantation in the setting of voriconazole therapy. After the discontinuation of voriconazole and initiation of isavuconazole, her QTc interval normalized. This case highlights the unique property of QTc interval shortening by isavuconazole among the triazole antifungals.
August 2017: Transplant Infectious Disease: An Official Journal of the Transplantation Society
https://www.readbyqxmd.com/read/28416539/comparison-of-eucast-and-clsi-reference-microdilution-mics-of-eight-antifungal-compounds-for-candida-auris-and-associated-tentative-epidemiological-cutoff-values
#18
M C Arendrup, Anupam Prakash, Joseph Meletiadis, Cheshta Sharma, Anuradha Chowdhary
Candida auris is an emerging multidrug-resistant yeast. So far, all but two susceptibility testing studies have examined ≤50 isolates, mostly with the CLSI method. We investigated CLSI and EUCAST MICs for 123 C. auris isolates and eight antifungals and evaluated various methods for epidemiological cutoff (ECOFF) determinations. MICs (in milligrams per liter) were determined using CLSI method M27-A3, and the EUCAST E.Def 7.3. ANOVA analysis of variance with Bonferroni's multiple-comparison test and Pearson analysis were used on log2 MICs (significance at P values of <0...
June 2017: Antimicrobial Agents and Chemotherapy
https://www.readbyqxmd.com/read/28373148/evaluation-of-the-in-vitro-activity-of-isavuconazole-and-comparator-voriconazole-against-2635-contemporary-clinical-candida-and-aspergillus-isolates
#19
K M T Astvad, R K Hare, M C Arendrup
OBJECTIVE: The in vitro activity of isavuconazole was determined for 1677 Candida and 958 Aspergillus isolates from 2012-2014 with voriconazole as comparator. METHODS: Aspergillus isolates were screened for resistance using azole-agar. Screening positive Aspergillus and all Candida isolates underwent EUCAST broth-microdilution testing. Isolates were categorised as wild-type (wt) or non-wt, adopting EUCAST ECOFFs (where available) or wt upper limits (wtULs; two 2-fold dilutions above the MIC50)...
March 31, 2017: Clinical Microbiology and Infection
https://www.readbyqxmd.com/read/28372907/design-synthesis-and-in-vitro-evaluation-of-novel-antifungal-triazoles
#20
Fei Xie, Tingjunhong Ni, Jing Zhao, Lei Pang, Ran Li, Zhan Cai, Zichao Ding, Ting Wang, Shichong Yu, Yongsheng Jin, Dazhi Zhang, Yuanying Jiang
Twenty-nine novel triazole analogues of ravuconazole and isavuconazole were designed and synthesized. Most of the compounds exhibited potent in vitro antifungal activities against 8 fungal isolates. Especially, compounds a10, a13, and a14 exhibited superior or comparable antifungal activity to ravuconazole against all the tested fungi. Structure-activity relationship study indicated that replacing 4-cyanophenylthioazole moiety of ravuconazole with fluorophenylisoxazole resulted in novel antifungal triazoles with more effectiveness and a broader-spectrum...
May 15, 2017: Bioorganic & Medicinal Chemistry Letters
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