Аннотация
Неуклонный рост частоты инвазивных грибковых инфекций, на что в определенной степении оказала влияния пандемия COVID-19, вызыванных как дрожжевыми, так и мицелиальными микромицетами, делает необходимым совершенствование применяемых для терапии противогрибковых препаратов. Исторически азолы занимают ключевую позицию применительно к целому ряду клинических форм и групп пациентов. Изавуконазол – новейший из клинически доступных в текущее время триазов нового поколения, одобренный в 2015 г. для терапии инвазивного аспергиллеза и инвазивного мукормикоза. Изавуконазол активен в отношении различных дрожжевых, мицелиальных и диморфных грибов. Значительные преимущества изавуконазола, в первую очередь перед вориконазолом, а в отдельных случаях и позаконазолом, делают его привлекательным вариантом для терапии сложных пациентов с инвазивными микозами. Эти потенциальные преимущества включают более предсказуемую фармакокинетику, значимо менее сложный профиль лекарственных взаимодействий, отсутствие удлинения интервала QTc и хорошую переносимость, особенно в сравнении с вориконазолом, доступность в форме для перорального и внутривенного введения. В этом обзоре будут обсуждены ключевые аспекты клинической фармакологии изавуконазола с акцентом на инвазивный аспергиллез и мукормикоз, включая активность соединения in vitro против различных микромицетов, характеристики фармакокинетики и фармакодинамики, отличающие изавуконазол от других новых триазолов. В обзоре также будет представлено текущее позиционировании препарата в клинической практике, прежде всего на основании текущих версий международных практических рекомендаций.
НИИ антимикробной химиотерапии ФГБОУ ВО СГМУ Минздрава России, Смоленск, Россия
-
1.
Ananda-Rajah M.R., Kontoyiannis D. Isavuconazole: a new extended spectrum triazole for invasive mold diseases. Future Microbiol. 2015;10:693-708.
DOI: 10.2217/fmb.15.34
-
2.
Van Matre E.T., Evans S.L., Mueller S.W., Maclaren R., Fish D.N., Kiser T.H. Comparative evaluation of isavuconazonium sulfate, voriconazole, and posaconazole for the management of invasive fungal infections in an academic medical center. Ann Clin Microbiol Antimicrob. 2019;18:13.
DOI: 10.1186/s12941-019-0311-3
-
3.
Jenks J.D., Mehta S.R., Hoenigl M. Broad spectrum triazoles for invasive mould infections in adults: which drug and when? Med Mycol. 2019;57:S168-S178.
DOI: 10.1093/mmy/myy052
-
4.
Gavalda J., Meije Y., Fortun J., Roilides E., Saliba F., Lortholary O., et al. Invasive fungal infections in solid organ transplant recipients. Clin Microbiol Infect. 2014;20:27-48.
DOI: 10.1111/1469-0691.12660
-
5.
Brown G.D., Denning D.W., Gow N.A.R., Levitz S.M., Netea M.G., White T.C. Hidden killers: human fungal infections. Sci Transl Med. 2012;4:1-10.
DOI: 10.1126/scitranslmed.3004404
-
6.
Peng J., Wang Q., Mei H., Zheng H., Liang G., She X., Liu W. Fungal co-infection in COVID-19 patients: evidence from a systematic review and meta-analysis. Aging (Albany NY). 2021;13(6):7745-7757.
DOI: 10.18632/aging.202742
-
7.
Formanek P.E., Dilling D.F. Advances in the diagnosis and management of the invasive fungal disease. Chest. 2019;156:834-842.
DOI: 10.1016/j.chest.2019.06.032
-
8.
Lanternier F., Lortholary O. Liposomal amphotericin B: what is its role in 2008? Clin Microbiol Infect. 2008;14:71-83.
DOI: 10.1111/j.1469-0691.2008.01984.x
-
9.
Al-Nakeeb Z., Petraitis V., Goodwin J., Petraitiene R., Walsh T.J., Hope W.W. Pharmacodynamics of amphotericin B deoxycholate, amphotericin B lipid complex, and liposomal amphotericin B against Aspergillus fumigatus. Antimicrob Agents Chemother. 2015;59(5):2735-2745.
DOI: 10.1128/AAC.04723-14
-
10.
Patterson T.F., Thompson G.R. III, Denning D.W., Fishman J.A., Hadley S., Herbrecht R., et al. Practice guidelines for the diagnosis and management of aspergillosis: 2016 update by the Infectious Diseases Society of America. Clin Infect Dis. 2106;63:e1-e60.
DOI: 10.1093/cid/ciw326
-
11.
Enoch D.A., Idris S.F., Aliyu S.H., Micallef C., Sule O., Karas J.A. Micafungin for the treatment of invasive aspergillosis. J Infect. 2014;68:507-526.
DOI: 10.1016/j.jinf.2014.01.007
-
12.
Dodds Ashley E., Lewis R., Lewis J.S., Martin С., Andes D. Pharmacology of systemic antifungal agents. Clin Infect Dis. 2006;43:S28-39.
DOI: 10.1086/504492
-
13.
Mikulska M., Novelli A., Aversa F., Cesaro S., de Rosa F.G., Girmenia C., et al. Voriconazole in clinical practice. J Chemother. 2012;24:311-327.
DOI: 10.1179/1973947812Y.0000000051
-
14.
Levine M.T., Chandrasekar P.H. Adverse effects of voriconazole: over a decade of use. Clin Transplant. 2016;30(11):1377-1386.
DOI: 10.1111/ctr.12834
-
15.
Chen L., Krekels E.H.J., Verweij P.E., Buil J.B., Knibbe C.A.J., Brüggemann R.J.M. Pharmacokinetics and pharmacodynamics of posaconazole. Drugs. 2020;80(7):671-695.
DOI: 10.1007/s40265-020-01306-y
-
16.
Maertens J.A., Rahav G., Lee D.G., Ponce-de-León A., Ramírez Sánchez I.C., Klimko N., et al. Posaconazole versus voriconazole for primary treatment of invasive aspergillosis: a phase 3, randomised, controlled, noninferiority trial. Lancet. 2021;397:499-509.
DOI: 10.1016/S0140-6736(21)00219-1
-
17.
Prescribing information for Noxafil. Available at: https://www.msdmed.ru/instruction/instrukcziya-pomediczinskomu-primeneniyu-lekarstvennogo-preparatanoksafil/. Accessed November 2023. Russian. (Инструкция по применению лекарственного препарата Ноксафил. Доступно по адресу: https://www.msdmed.ru/instruction/instrukcziya-po-mediczinskomuprimeneniyu-lekarstvennogo-preparata-noksafil/. Ссылка активна на ноябрь 2023 г.)
-
18.
Miceli M.H., Kauffman C.A. Isavuconazole: a new broad-spectrum triazole antifungal agent. Clin Infect Dis. 2015;61:1558-1565.
DOI: 10.1093/cid/civ571
-
19.
Prescribing information for Cresemba. Available at: https://www.pfizer.ru/products/allproducts/cresemba. Accessed November 2023. Russian. (Инструкция по применению лекарственного препарата Креземба. Доступно по адресу: https://www.pfizer.ru/products/allproducts/cresemba. Ссылка активна на ноябрь 2023 г.)
-
20.
Schmitt-Hoffmann A., Roos B., Maares J., Heep M., Spickerman J., Weidekamm E., et al. Multiple-dose pharmacokinetics and safety of the new antifungal triazole BAL4815 after intravenous infusion and oral administration of its prodrug, BAL8557, in healthy volunteers. Antimicrob Agents Chemother. 2006;50(1):286-293.
DOI: 10.1128/AAC.50.1.286-293.2006
-
21.
Schmitt-Hoffmann A., Roos B., Heep M., Schleimer M., Weidekamm E., Brown T., et al. Single-ascending-dose pharmacokinetics and safety of the novel broad-spectrum antifungal triazole BAL4815 after intravenous infusions (50, 100, and 200 milligrams) and oral administrations (100, 200, and 400 milligrams) of its prodrug, BAL8557, in healthy volunteers. Antimicrob Agents Chemother. 2006; 50(1):279-285.
DOI: 10.1128/AAC.50.1.279-285.2006
-
22.
Cornely O.A., Bohme A., Schmitt-Hoffmann A., Ullmann A.J. Safety and pharmacokinetics of isavuconazole as antifungal prophylaxis in acute myeloid leukemia patients with neutropenia: results of a phase 2, dose escalation study. Antimicrob Agents Chemother. 2015;59:2078-2085.
DOI: 10.1128/AAC.04569-14
-
23.
Desai A., Schmitt-Hoffmann A.H., Mujais S., Townsend R. Population pharmacokinetics of isavuconazole in subjects with mild or moderate hepatic impairment. Antimicrob Agents Chemother. 2016;60:3025-3031.
DOI: 10.1128/AAC.02942-15
-
24.
Lamoth F., Mercier T., Andre P., Pagani J.L., Pantet O., Maduri R., et al. Isavuconazole brain penetration in cerebral aspergillosis. J Antimicrob Chemother. 2019;74:1751-1753.
DOI: 10.1093/jac/dkz050
-
25.
Schwartz S., Cornely O.A., Hamed K., Marty F.M., Maertens J., Rahav G., et al. Isavuconazole for the treatment of patients with invasive fungal diseases involving the central nervous system. Med Mycol. 2020;58:417-424.
DOI: 10.1093/mmy/myz103
-
26.
Schmitt-Hoffmann A., Desai A., Kowalski D., Pearlman H., Yamazaki T., Townsend R. Isavuconazole absorption following oral administration in healthy subjects is comparable to intravenous dosing, and is not affected by food, or drugs that alter stomach pH. Int J Clin Pharmacol Ther. 2016;54:572-580.
DOI: 10.5414/CP202434
-
27.
Townsend R., Kato K., Hale C., Kowalski D., Lademacher C., Yamazaki T., et al. Two phase 1, open-label, mass balance studies to determine the pharmacokinetics of (14) c-labeled isavuconazonium sulfate in healthy male volunteers. Clin Pharmacol Drug Dev. 2018;7:207-216.
DOI: 10.1002/cpdd.376
-
28.
Gomez-Lopez A. Antifungal therapeutic drug monitoring: focus on drugs without a clear recommendation. Clin Microbiol Infect. 2020;26:1481-1487.
DOI: 10.1016/j.cmi.2020.05.037
-
29.
Furfaro E., Signori A., Di Grazia C., Dominietto A., Raiola A.M., Aquino S., et al. Serial monitoring of isavuconazole blood levels during prolonged antifungal therapy. J Antimicrob Chemother. 2019;74:2341-2346.
DOI: 10.1093/jac/dkz188
-
30.
Zurl C., Waller M., Schwameis F., Muhr T., Bauer N., Zollner-Schwetz I., et al. Isavuconazole treatment in a mixed patient cohort with ninvasive fungal infections: outcome, tolerability and clinical implications of isavuconazole plasma concentrations. J Fungi (Basel). 2020;6:90.
DOI: 10.3390/jof6020090
-
31.
Höhl R., Bertram R., Kinzig M., Haarmeyer G.S., Baumgärtel M., Geise A., et al. Isavuconazole therapeutic drug monitoring in critically ill ICU patients: a monocentric retrospective analysis. Mycoses. 2022;65(7):747-752.
DOI: 10.1111/myc.13469
-
32.
Borman A.M., Hughes J.M., Oliver D., Fraser M., Sunderland J., Noel A.R., Johnson E.M. Lessons from isavuconazole therapeutic drug monitoring at a United Kingdom reference center. Med Mycol. 2020;58:996-999.
DOI: 10.1093/mmy/myaa022
-
33.
Lepak A.J., Marchillo K., VanHecker J., Diekema D., Andes D.R. Isavuconazole pharmacodynamic target determination for Candida species in an in vivo murine disseminated candidiasis model. Antimicrob Agents Chemother. 2013;57:5642-5648.
DOI: 10.1128/AAC.01354-13
-
34.
Lepak A.J., Marchillo K., Vanhecker J., Andes D.R. Isavuconazole (BAL4815) pharmacodynamic target determination in an in vivo murine model of invasive pulmonary aspergillosis against wild-type and cyp51 mutant isolates of Aspergillus fumigatus. Antimicrob Agents Chemother. 2013;57:6284-6289.
DOI: 10.1128/AAC.01355-13
-
35.
Kovanda L.L., Petraitiene R., Petraitis V., Walsh T.J., Desai A., Bonate P., Hope W.W. Pharmacodynamics of isavuconazole in experimental invasive pulmonary aspergillosis: implications for clinical breakpoints. J Antimicrob Chemother. 2016;71:1885-1891.
DOI: 10.1093/jac/dkw098
-
36.
Schmitt-Hoffmann A., Roos B., Spickermann J., Heep M., Peterfaí E., Edwards D.J., Stoeckel K. Effect of mild and moderate liver disease on the pharmacokinetics of isavuconazole after intravenous and oral administration of a single dose of the prodrug BAL8557. Antimicrob Agents Chemother. 2009;53:4885-4890.
DOI: 10.1128/AAC.00319-09
-
37.
Seyedmousavi S., Mouton J.W., Verweij P.E., Brüggemann R.J. Therapeutic drug monitoring of voriconazole and posaconazole for invasive aspergillosis. Expert Rev Anti Infect Ther. 2013;11(9):931-941.
DOI: 10.1586/14787210.2013.826989
-
38.
Perez L., Corne P., Pasquier G., Konecki C., Sadek M., Le Bihan C., et al. Population pharmacokinetics of isavuconazole in critical care patients with COVID-19-associated pulmonary aspergillosis and Monte Carlo simulations of high off-label doses. J Fungi. 2023;9:211.
DOI: 10.3390/jof9020211
-
39.
Thompson G.R., 3rd, Wiederhold N.P. Isavuconazole: a comprehensive review of spectrum of activity of a new triazole. Mycopathologia. 2010;170:291-313.
DOI: 10.1007/s11046-010-9324-3
-
40.
Pfaller M.A., Messer S.A, Rhomberg P.R., Jones R.N., Castanheira M. In vitro activities of isavuconazole and comparator antifungal agents tested against a global collection of opportunistic yeasts and molds. J Clin Microbiol. 2013;51(8):2608-2616.
DOI: 10.1128/JCM.00863-13
-
41.
Desnos-Ollivier M., Bretagne S., Boullie A., Gautier C., Dromer F., Lortholary O., French Mycoses Study Group. Isavuconazole MIC distribution of 29 yeast species responsible for invasive infections (2015-2017). Clin Microbiol Infect. 2019;25:634.e1-634.e4.
DOI: 10.1016/j.cmi.2019.02.007
-
42.
Borman A.M., Muller J., Walsh-Quantick J., Szekely A., Patterson Z., Palmer M.D., et al. MIC distributions for amphotericin B, fluconazole, itraconazole, voriconazole, flucytosine and anidulafungin and 35 uncommon pathogenic yeast species from the UK determined using the CLSI broth microdilution method. J Antimicrob Chemother. 2020;75:1194-1205.
DOI: 10.1093/jac/dkz568
-
43.
O'Brien B., Chaturvedi S., Chaturvedi V. In vitro evaluation of antifungal drug combinations against multidrugresistant Candida auris isolates from New York outbreak. Antimicrob Agents Chemother. 2020;64(4):e02195-19.
DOI: 10.1128/AAC.02195-19
-
44.
Thompson G.R., 3rd, Wiederhold N.P., Sutton D.A., Fothergill A., Patterson T.F. In vitro activity of isavuconazole against Trichosporon, Rhodotorula, Geotrichum, Saccharomyces and Pichia species. J Antimicrob Chemother. 2009;64:79-83.
DOI: 10.1093/jac/dkp138
-
45.
Guinea J., Recio S., Escribano P., Peláez T., Gama B., Bouza E. In vitro antifungal activities of isavuconazole and comparators against rare yeast pathogens. Antimicrob Agents Chemother. 2010;54:4012-4015.
DOI: 10.1128/AAC.00685-10
-
46.
Pfaller M.A., Rhomberg P.R., Wiederhold N.P., Gibas C., Sanders C., Fan H., et al. In vitro activity of isavuconazole against opportunistic fungal pathogens from two mycology reference laboratories. Antimicrob Agents Chemother. 2018;62:e01230-18.
DOI: 10.1128/AAC.01230-18
-
47.
Badali H., Canete-Gibas C., McCarthy D., Patterson H., Sanders C., David M.P., et al. Species distribution and antifungal susceptibilities of Aspergillus section Fumigati isolates in clinical samples from the United States. J Clin Microbiol. 2022;60:e0028022.
DOI: 10.1128/jcm.00280-22
-
48.
Wiederhold N.P., Gil V.G., Gutierrez F., Lindner J.R., Albataineh M.T., McCarthy D.I., et al. First detection of TR34 L98H and TR46 Y121F T289A Cyp51 mutations in Aspergillus fumigatus isolates in the United States. J Clin Microbiol 2016;54:168-171.
DOI: 10.1128/JCM.02478-15
-
49.
Chowdhary A., Sharma C., Kathuria S., Hagen F., Meis J.F. Azole-resistant Aspergillus fumigatus with the environmental TR46/Y121F/T289A mutation in India. J Antimicrob Chemother. 2014;69:555-557.
DOI: 10.1093/jac/dkt397
-
50.
CLSI. 2020. Performance standards for antifungal susceptibility testing of filamentous fungi, 2nd ed. (CLSI supplement M61). Clinical and Laboratory Standards Institute, Wayne, PA.
-
51.
EUCAST. 2020. The European Committee on Antimicrobial Susceptibility Testing: breakpoint tables for interpretation of MICs for antifungal agents, version 10.0. EUCAST, Copenhagen, Denmark. Available at: https://www.eucast.org/ast_of_fungi. Accessed November, 2023.
-
52.
Seyedmousavi S., Mouton J.W., Melchers W.J., Bruggemann R.J., Verweij P.E. The role of azoles in the management of azole-resistant aspergillosis: from the bench to the bedside. Drug Resist Update. 2014;17:37-50.
DOI: 10.1016/j.drup.2014.06.001
-
53.
Howard S.J., Webster I., Moore C.B., Gardiner R.E., Park S., Perlin D.S., Denning D.W. Multi-azole resistance in Aspergillus fumigatus. Int J Antimicrob Agents. 2006;28:450-453.
DOI: 10.1016/j.ijantimicag.2006.08.017
-
54.
Baddley J.W., Marr K.A., Andes D.R., Walsh T.J., Kauffman C.A., Kontoyiannis D.P., et al. Patterns of susceptibility of Aspergillus isolates recovered from patients enrolled in the Transplant-Associated Infection Surveillance Network. J Clin Microbiol. 2009;47:3271-3275.
DOI: 10.1128/JCM.00854-09
-
55.
Alastruey-Izquierdo A., Mellado E., Pelaez T., Peman J., Zapico S., Alvarez M., et al. Population-based survey of filamentous fungi and antifungal resistance in Spain (FILPOP Study). Antimicrob Agents Chemother. 201;357:3380-3387.
DOI: 10.1128/AAC.00383-13
-
56.
Andes D.R., Ghannoum M.A., Mukherjee P.K., Kovanda L.L., Lu Q., Jones M.E., et al. Outcomes by MIC values for patients treated with isavuconazole or voriconazole for invasive aspergillosis in the phase 3 SECURE and VITAL Trials. Antimicrob Agents Chemother. 2019;63: e01634-18.
DOI: 10.1128/AAC.01634-18
-
57.
Guinea J., Peláez T., Recio S., Torres-Narbona M., Bouza E. In vitro antifungal activities of isavuconazole (BAL4815), voriconazole, and fluconazole against 1,007 isolates of Zygomycete, Candida, Aspergillus, Fusarium, and Scedosporium species. Antimicrob Agents Chemother. 2008;52:1396-1400.
DOI: 10.1128/AAC.01512-07
-
58.
Jorgensen K.M., Astvad K.M.T., Hare R.K., Arendrup M.C. EUCAST susceptibility testing of isavuconazole: MIC data for contemporary clinical mold and yeast isolates. Antimicrob Agents Chemother. 2019;63:e00073-19.
DOI: 10.1128/AAC.00073-19
-
59.
Lackner M., de Hoog G.S., Verweij P.E., Najafzadeh M.J., Curfs-Breuker I., Klaassen C.H., Meis J.F. Species-specific antifungal susceptibility patterns of Scedosporium and Pseudallescheria species. Antimicrob Agents Chemother. 2012;56:2635-2642.
DOI: 10.1128/AAC.05910-11
-
60.
Rivero-Menendez O., Cuenca-Estrella M., AlastrueyIzquierdo A. In vitro activity of olorofim against clinical isolates of Scedosporium species and Lomentospora prolificans using EUCAST and CLSI methodologies. J Antimicrob Chemother. 2020;75:3582-3585.
DOI: 10.1093/jac/dkaa351
-
61.
Alvarez E., Sutton D.A., Cano J., Fothergill A.W., Stchigel A., Rinaldi M.G., Guarro J. Spectrum of zygomycete species identified in clinically significant specimens in the United States. J Clin Microbiol. 2009;47:1650-1656.
DOI: 10.1128/JCM.00036-09
-
62.
Badali H., Canete-Gibas C., McCarthy D., Patterson H., Sanders C., David M.P., et al. Epidemiology and antifungal susceptibilities of mucoralean fungi in clinical samples from the United States. J Clin Microbiol. 2021;59:e0123021.
DOI: 10.1128/JCM.01230-21
-
63.
Jeong W., Keighley C., Wolfe R., Lee W.L., Slavin M.A., Kong D.C.M., Chen S.C. The epidemiology and clinical manifestations of mucormycosis: a systematic review and meta-analysis of case reports. Clin Microbiol Infect. 2019;25:26-34.
DOI: 10.1016/j.cmi.2018.07.011
-
64.
Arendrup M.C., Jensen R.H., Meletiadis J. In vitro activity of isavuconazole and comparators against clinical isolates of the Mucorales order. Antimicrob Agents Chemother. 2015;59:7735-7742.
DOI: 10.1128/AAC.01919-15
-
65.
Wagner L., de Hoog S., Alastruey-Izquierdo A., Voigt K., Kurzai O., Walther G. A revised species concept for opportunistic Mucor species reveals species-specific antifungal susceptibility profiles. Antimicrob Agents Chemother. 2019;63:e00653-19.
DOI: 10.1128/AAC.00653-19
-
66.
Borman A.M., Fraser M., Patterson Z., Palmer M.D., Johnson E.M. In vitro antifungal drug resistance profiles of clinically relevant members of the Mucorales (Mucoromycota) especially with the newer triazoles. J Fungi (Basel). 2021;7:271.
DOI: 10.3390/jof7040271
-
67.
Nagy G., Kiss S., Varghese R., Bauer K., Szebenyi C., Kocsube S., et al. Characterization of three pleiotropic drug resistance transporter genes and their participation in the azole resistance of Mucor circinelloides. Front Cell Infect Microbiol. 2021;11:660347.
DOI: 10.3389/fcimb.2021.660347
-
68.
Gonzalez G.M. In vitro activities of isavuconazole against opportunistic filamentous and dimorphic fungi. Med Mycol. 2009;47:71-76.
DOI: 10.1080/13693780802562969
-
69.
The European Committee on Antimicrobial Susceptibility Testing. AST of fungi. Available at: https://www.eucast.org/ast_of_fungi. Accessed November 2023.
-
70.
De Pauw B., Walsh T.J., Donnelly J.P., Stevens D.A., Edwards J.E., Calandra T., et al. Revised definitions of invasive fungal disease from the European Organization for Research and Treatment of Cancer/Invasive Fungal Infections Cooperative Group and the National Institute of Allergy and Infectious Diseases Mycoses Study Group (EORTC/MSG) Consensus Group. Clin Infect Dis. 2008;46(12):1813-1821.
DOI: 10.1086/588660
-
71.
Maertens J.A., Raad I.I., Marr K.A., Patterson T.F., Kontoyiannis D.P., Cornely O.A., et al. Isavuconazole versus voriconazole for primary treatment of invasive mould disease caused by Aspergillus and other filamentous fungi (SECURE): a phase 3, randomized, controlled, noninferiority trial. Lancet. 2016;387(10020):760-769.
DOI: 10.1016/S0140-6736(15)01159-9
-
72.
Marty F.M., Perfect J.R., Cornely O.A., Mullane K.M., Rahav G., Lee M., et al. An open-label Phase 3 study of isavuconazole (VITAL): focus on mucormycosis. Presented at: ID Week ASM. PA, USA, 8-12 October 2014 (Abstract no. 824).
-
73.
Perfect J.R., Cornely O.A., Heep M., Ostrosky-Zeichner L., Mullane K.M., Maher R., et al. Isavuconazole treatment for rare fungal diseases and for invasive aspergillosis in patients with renal impairment: challenges and lessons of the VITAL trial. Mycoses. 2018;61(7):420-429.
DOI: 10.1111/myc.12769
-
74.
Peixoto D., Gagne L.S., Hammond S.P., Gilmore E.T., Joyce A.C., Soiffer R.J., Marty F.M. Isavuconazole treatment of a patient with disseminated mucormycosis. J Clin Microbiol. 2014;52(3):1016-1019.
DOI: 10.1128/JCM.03176-13
-
75.
Ervens J., Ghannoum M., Graf B., Schwartz S. Successful isavuconazole salvage therapy in a patient with invasive mucormycosis. Infection. 2014;42(2):429-432.
DOI: 10.1007/s15010-013-0552-6
-
76.
Pomorska A., Malecka A., Jaworski R., Radon-Proskura J., Hare R.K., Nielsen H.V., et al. Isavuconazole in a successful combination treatment of disseminated mucormycosis in a child with acute lymphoblastic leukaemia and generalized haemochromatosis: a case report and review of the literature. Mycopathologia. 2019;184(1):81-88.
DOI: 10.1007/s11046-018-0287-0
-
77.
Thompson G., Rendon A., Santos R. Outcomes in patients with invasive fungal disease caused by dimorphic fungi treated with isavuconazole: experience from the VITAL trial. Presented at: 54th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) ASM. Washington, DC, USA, 5-9 September 2014 (Abstract no. M-1775).
-
78.
Hamed K., Engelhardt M., Kovanda L.L., Huang J.J., Yan J., Aram J.A. Post-hoc analysis of the safety and efficacy of isavuconazole in older patients with invasive fungal disease from the VITAL and SECURE studies. Sci Rep. 2023;13(1):6730.
DOI: 10.1038/s41598-023-31788-1
-
79.
Durand M.L., Kitt T.M., Song Y., Marty F.M. Isavuconazole Treatment of invasive fungal sinusitis: a post hoc analysis of the SECURE and VITAL trials. Clin Infect Dis. 2021;73(6):e1380-e1383.
DOI: 10.1093/cid/ciab386
-
80.
Kullberg B.J., Viscoli C., Pappas P.G., Vazquez J., Ostrosky-Zeichner L., Rotstein C., et al. Isavuconazole versus caspofungin in the treatment of candidemia and other invasive candida infections: the ACTIVE trial. Clin Infect Dis. 2019;68(12):1981-1989.
DOI: 10.1093/cid/ciy827
-
81.
Dagher H., Hachem R., Chaftari A.M., Jiang Y., Ali S., Deeba R., et al. Real-world use of isavuconazole as primary therapy for invasive fungal infections in high-risk patients with hematologic malignancy or stem cell transplant. J Fungi (Basel). 2022;8:74-80.
DOI: 10.3390/jof8010074
-
82.
Cattaneo C., Busca A., Gramegna D., Farina F., Candoni A., Piedimonte M., et al. Isavuconazole in hematological patients: results of a real-life multicentre observational SEIFEM study. Hemasphere. 2019;3:e320.
DOI: 10.1097/01.HS9.0000563348.29099.4a
-
83.
Nwankwo L., Gilmartin D., Matharu S., Nuh A., Donovan J., Armstrong-James D., et al. Experience of isavuconazole as a salvage therapy in chronic pulmonary fungal disease. J Fungi (Basel). 2022;8(4):362.
DOI: 10.3390/jof8040362
-
84.
Monforte A., Los-Arcos I., Martı́n-Gó mez M.T., CampanyHerrero D., Sacanell J., Berastegui C., et al. Safety and effectiveness of isavuconazole treatment for fungal infections in solid organ transplant recipients (ISASOT study). Microbiol Spectr. 2022;10:e0178421.
DOI: 10.1128/spectrum.01784-21
-
85.
Fernández-Ruiz M., Bodro M., Gutiérrez Martín I., Rodriguez-Álvarez R., Ruiz-Ruigómez M., Sabé N., et al.; SOTIS Study Group. Isavuconazole for the treatment of invasive mold disease in solid organ transplant recipients: a multicenter study on efficacy and safety in real-life clinical practice. Transplantation. 2023;107(3):762-773.
DOI: 10.1097/TP.0000000000004312
-
86.
Thompson G.R., Garcia-Diaz J., Miceli M.H., Nguyen M.H., Ostrosky-Zeichner L., Young J.H., et al. Systemic antifungal therapy with isavuconazonium sulfate or other agents in adults with invasive mucormycosis or invasive aspergillosis (non-fumigatus): a multicentre, noninterventional registry study. Mycoses. 2022;65(2):186-198.
DOI: 10.1111/myc.13412
-
87.
Miller M.A., Molina K.C., Gutman J.A., Scherger S., Lum J.M., Mossad S.B., et al. Mucormycosis in hematopoietic cell transplant recipients and in patients with hematological malignancies in the era of new antifungal agents. Open Forum Infect Dis. 2021;8:ofaa646.
DOI: 10.1093/ofid/ofaa646
-
88.
Cornely O.A., Alastruey-Izquierdo A., Arenz D., Chen S.C.A., Dannaoui E., Hochhegger B., et al. Global guideline for the diagnosis and management of mucormycosis: an initiative of the European confederation of medical mycology in cooperation with the mycoses study group education and research consortium. Lancet Infect Dis. 2019;19:e405-e421.
DOI: 10.1016/S1473-3099(19)30312-3
-
89.
Kohno S., Izumikawa K., Takazono T., Miyazaki T., Yoshida M., Kamei K., et al. Efficacy and safety of isavuconazole against deep-seated mycoses: a phase 3, randomized, open-label study in Japan. J Infect Chemother. 2023;29:163-170.
DOI: 10.1016/j.jiac.2022.10.010
-
90.
Mellinghoff S.C., Bassetti M., Dörfel D., Hagel S., Lehners N., Plis A., et al. Isavuconazole shortens the QTc interval. Mycoses. 2018;61(4):256-260.
DOI: 10.1111/myc.12731
-
91.
Keirns J., Desai A., Kowalski D., Lademacher C., Mujais S., Parker B., et al. QT interval shortening with isavuconazole: in vitro and in vivo effects on cardiac repolarization. Clin Pharmacol Ther. 2017;101(6):782-790.
DOI: 10.1002/cpt.620
-
92.
Bruggemann R.J., Verheggen R., Boerrigter E., Stanzani M., Verweij P.E., Blijlevens N.M.A., Lewis R.E. Management of drug-drug interactions of targeted therapies for haematological malignancies and triazole antifungal drugs. Lancet Haematol. 2021;9:E58-E72.
DOI: 10.1016/S2352-3026(21)00232-5
-
93.
Saad A.H., DePestel D.D., Carver P.L. Factors influencing the magnitude and clinical significance of drug interactions between azole antifungals and select immunosuppressants. Pharmacotherapy. 2006;26:1730-1744.
DOI: 10.1592/phco.26.12.1730
-
94.
Fructuoso-González L., Najera-Perez M.D., ManresaRamón N., Torrano-Belmonte P., Caracena-López S., Pacheco-López P. Isavuconazole-tacrolimus drugdrug interactions in HSCT patients. J Antimicrob Chemother. 2023;78(10):2559-2562.
DOI: 10.1093/jac/dkad271
-
95.
Tissot F., Agrawal S., Pagano L., Petrikkos G., Groll A.H., Skiada A., et al. ECIL-6 guidelines for the treatment of invasive candidiasis, aspergillosis and mucormycosis in leukemia and hematopoietic stem cell transplant patients. Haematologica. 2017;102(3):433-444.
DOI: 10.3324/haematol.2016.152900
-
96.
Ullmann A.J., Aguado J.M., Arikan-Akdagli S., Denning D.W., Groll A.H., Lagrou K., et al. Diagnosis and management of Aspergillus diseases: executive summary of the 2017 ESCMID-ECMM-ERS guideline. Clin Microbiol Infect. 2018;24(Suppl. 1):e1-e38.
DOI: 10.1016/j.cmi.2018.01.002
-
97.
Husain S., Camargo J.F. Invasive aspergillosis in solidorgan transplant recipients: guidelines from the American Society of Transplantation Infectious Diseases Community of Practice. Clin Transplant. 2019;33(9):e13544.
DOI: 10.1111/ctr.13544