Effects of isavuconazonium: A Synthesis of Findings from 26 Studies

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Original Abstract of the Article

Major Research Findings

Isavuconazole is a novel triazole antifungal agent with broad-spectrum activity against various pathogenic fungi, including Aspergillus spp. and other filamentous fungi. 21 It is effective in treating invasive fungal infections, including aspergillosis and mucormycosis. 22 15 The drug's effectiveness can vary depending on the type of fungus and its susceptibility to the drug. 5 It has been shown to shorten the QT interval in some patients. 1 Isavuconazole is a mild inducer of CYP2B6 and may interact with drugs metabolized by this enzyme. 19

Benefits and Risks

Benefit Summary

Isavuconazole is an effective antifungal agent for treating severe fungal infections such as aspergillosis and mucormycosis. 22 15 It is available in both oral and intravenous formulations and has a favorable safety profile. 14 Compared to other antifungal drugs, it may have fewer side effects on the liver and skin. 15

Risk Summary

Isavuconazole can shorten the QT interval in some patients. 1 Since it is a mild inducer of CYP2B6, caution is needed when using it with drugs metabolized by this enzyme. 19 Isavuconazole can cause gastrointestinal side effects and liver dysfunction. 15

Comparison Across Studies

Commonalities Across Studies

Multiple studies have demonstrated the effectiveness of isavuconazole in treating severe fungal infections like aspergillosis and mucormycosis. 22 15 14 Research indicates that isavuconazole is available in both oral and intravenous formulations, and its safety profile is generally good. 14 2

Differences Across Studies

The methods and results of the assessment of isavuconazole's effectiveness and safety varied among the studies. 22 15 14 The patient populations and fungal species targeted in the research also differed. 22 21

Consistency and Discrepancies in Findings

Several studies have shown that isavuconazole is effective in treating severe fungal infections like aspergillosis and mucormycosis. 22 15 14 However, the effectiveness of isavuconazole can vary depending on the type of fungus and its susceptibility to the drug; strains with MIC values exceeding 1 mg/L might exhibit reduced susceptibility. 5 Additionally, isavuconazole has been shown to shorten the QT interval in some patients. 1 Further research is needed to fully understand the effectiveness and safety of isavuconazole.

Considerations for Real-World Application

Isavuconazole is an effective antifungal agent for treating severe fungal infections like aspergillosis and mucormycosis, but it can cause side effects. 22 15 When taking isavuconazole, it is important to follow your doctor's instructions and monitor for potential side effects.

Limitations of Current Research

Research on isavuconazole is still ongoing and not comprehensive. 22 15 Specifically, research on the long-term effectiveness and safety of isavuconazole is limited. 14 Furthermore, since isavuconazole is a mild inducer of CYP2B6, caution is needed when using it with drugs metabolized by this enzyme. 19 More research is needed on the drug interactions of isavuconazole.

Future Research Directions

Further research is needed on the long-term effectiveness and safety of isavuconazole, as well as on its use in combination with other drugs. 14 Development of new treatment approaches for fungal strains exhibiting reduced susceptibility to isavuconazole is also crucial. 5 Further investigation into the mechanism by which isavuconazole shortens the QT interval is essential. 1

Conclusion

Isavuconazole is a promising antifungal agent for treating severe fungal infections like aspergillosis and mucormycosis, but it can cause side effects. 22 15 It is essential to follow your doctor's instructions and monitor for potential side effects when taking isavuconazole. 14 Further research is needed to fully understand the effectiveness and safety of isavuconazole. 5 1

Literature analysis of 26 papers
Positive Content
24
Neutral Content
0
Negative Content
2
Article Type
4
0
1
6
26
1.

QT Interval Shortening With Isavuconazole: In Vitro and In Vivo Effects on Cardiac Repolarization.

Author: KeirnsJ, DesaiA, KowalskiD, LademacherC, MujaisS, ParkerB, SchneidkrautM J, TownsendR, WojtkowskiT, YamazakiT, YenM, KoweyP R

Cardiac safety
Isavuconazole efficacy
QT interval shortening

This phase I study evaluated the effects of isavuconazole on cardiac ion channels in vitro and cardiac repolarization clinically. Isavuconazole shortened the QT interval in a dose-dependent manner but was generally well tolerated. No cardiac safety signals were detected in a phase III study.

Clinical Trial, Phase IThe first stage of clinical trials in humans. Evaluates the safety, tolerability, and pharmacokinetics of a new drug/treatment.
Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

2.

Pharmacokinetics, Safety, and Tolerability of Single and Multiple Doses of Isavuconazonium Sulfate in Healthy Adult Japanese Subjects.

Author: ShiraeShinichiro, OseAtsushi, KumagaiYuji

Safety and tolerability

Isavuconazonium sulfate, a prodrug of the antifungal agent isavuconazole, was found to be safe and well-tolerated in healthy adult Japanese subjects.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

4.

Pharmacodynamics of isavuconazole in experimental invasive pulmonary aspergillosis: implications for clinical breakpoints.

Author: KovandaLaura L, PetraitieneRuta, PetraitisVidmantas, WalshThomas J, DesaiAmit, BonatePeter, HopeWilliam W

Aspergillosis treatment

Isavuconazole, a novel antifungal agent, has broad-spectrum activity against Aspergillus spp. and other fungi. This study investigated its exposure-response relationship in experimental invasive pulmonary aspergillosis using galactomannan index (GMI) suppression as a marker of disease clearance.

Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

5.

Outcomes by MIC Values for Patients Treated with Isavuconazole or Voriconazole for Invasive Aspergillosis in the Phase 3 SECURE and VITAL Trials.

Author: AndesDavid R, GhannoumMahmoud A, MukherjeePranab K, KovandaLaura L, LuQiaoyang, JonesMark E, Santerre HenriksenAnne, LademacherChristopher, HopeWilliam W

Aspergillus infection treatment
Reduced efficacy

This pooled analysis evaluated the relationship between isavuconazole and voriconazole MICs and clinical outcomes in patients with Aspergillus infections. The results suggest that these drugs may have reduced efficacy against pathogens with MICs of ≥16 μg/mL, but there was no relationship with clinical outcomes in cases where the MIC was <16 μg/mL.

Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

6.

Pharmacokinetic Interaction Between Isavuconazole and a Fixed-Dose Combination of Lopinavir 400 mg/Ritonavir 100 mg in Healthy Subjects.

Author: YamazakiTakao, DesaiAmit, HanDavid, KatoKota, KowalskiDonna, AkhtarShahzad, LademacherChristopher, KovandaLaura, TownsendRobert

This phase 1 study evaluated the pharmacokinetic effects of coadministering isavuconazole with lopinavir/ritonavir. The study found that coadministration increased isavuconazole exposure by 113% in part 1 and 96% in part 2, while decreasing lopinavir/ritonavir exposure by 27%/23% and 31%/33%, respectively. Mild to moderate gastrointestinal disorders were the most common adverse events.

Clinical Trial, Phase IThe first stage of clinical trials in humans. Evaluates the safety, tolerability, and pharmacokinetics of a new drug/treatment.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

8.

Safety of Isavuconazonium Sulfate in Pediatrics Patients With Hematologic Malignancies and Hematopoietic Cell Transplantation With Invasive Fungal Infections: A Real World Experience.

Author: RossJustine A, KarrasNicole A, TegtmeierBernard, YamadaChris, ChenJason, SunWeili, PawlowskaAnna, RosenthalJoseph, ZaiaJohn, DadwalSanjeet

Treatment of IFI
Elevated liver enzymes
Mortality

This retrospective review evaluated the safety of isavuconazonium sulfate (ISA) in pediatric patients with possible, probable, or proven invasive fungal infection (IFI). The study found that ISA was safe, with elevated alanine aminotransferase being the most common adverse event.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, N.I.H., ExtramuralResearch funding provided by the NIH to external research institutions and researchers.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

9.

Safety, Tolerability, and Population Pharmacokinetics of Intravenous and Oral Isavuconazonium Sulfate in Pediatric Patients.

Author: ArrietaAntonio C, NeelyMichael, DayJ Christopher, RheingoldSusan R, SuePaul K, MullerWilliam J, Danziger-IsakovLara A, ChuJulie, YildirimInci, McComseyGrace A, FrangoulHaydar A, ChenTempe K, StatlerVictoria A, SteinbachWilliam J, YinDwight E, HamedKamal, JonesMark E, LademacherChristopher, DesaiAmit, MicklusKelley, PhillipsDesiree Leiva, KovandaLaura L, WalshThomas J

Fungal infection treatment

Isavuconazole, a new antifungal agent, was safe and well-tolerated in pediatric patients with a similar exposure to adults at a dose of 10 mg/kg. This phase 1 study evaluated the pharmacokinetics, safety, and tolerability of isavuconazole in children with fungal infections.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

10.

Pharmacodynamics of Isavuconazole in a Rabbit Model of Cryptococcal Meningoencephalitis.

Author: KovandaLaura L, GiamberardinoCharles, McEnteeLaura, ToffalettiDena L, FrankeKelly S, BartuskaAndrew, SmilnakGordon, de CastroGeorge C, RippleKatelyn, HopeWilliam W, PerfectJohn R

Effective against cryptococcal meningoencephalitis

Isavuconazonium sulfate is a new drug for cryptococcal meningoencephalitis, a serious fungal infection. Early studies suggest it may be as effective as fluconazole.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, N.I.H., ExtramuralResearch funding provided by the NIH to external research institutions and researchers.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

11.

Pharmacokinetic and Pharmacodynamic Evaluation of the Drug-Drug Interaction Between Isavuconazole and Warfarin in Healthy Subjects.

Author: DesaiAmit, YamazakiTakao, DietzAlbert J, KowalskiDonna, LademacherChristopher, PearlmanHelene, AkhtarShahzad, TownsendRobert

This phase 1 trial evaluated pharmacokinetic and pharmacodynamic interactions between isavuconazole and warfarin in healthy adults. The study found that coadministration with isavuconazole had no clinically relevant effects on warfarin pharmacokinetics or pharmacodynamics.

Clinical Trial, Phase IThe first stage of clinical trials in humans. Evaluates the safety, tolerability, and pharmacokinetics of a new drug/treatment.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

12.

Isavuconazonium sulfate: a new agent for the treatment of invasive aspergillosis and invasive mucormycosis.

Author: KovandaLaura L, MaherRochelle, HopeWilliam W

Invasive fungal infection treatment

This review discusses isavuconazonium sulfate, a novel antifungal drug with potential benefits for treating invasive fungal infections. It addresses the challenges faced with existing antifungal therapies and highlights the promise of isavuconazonium sulfate for overcoming these limitations.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

13.

Variability and exposure-response relationships of isavuconazole plasma concentrations in the Phase 3 SECURE trial of patients with invasive mould diseases.

Author: KaindlThomas, AndesDavid, EngelhardtMarc, SaulayMikael, LargerPatrice, GrollAndreas H

Outcome consistency
Plasma consistency

This analysis evaluated the variability of isavuconazole plasma concentrations between subjects and between sampling times, and assessed their relationship to outcomes for subjects with invasive fungal disease (IFD). Plasma concentrations of isavuconazole were reasonably consistent between subjects and sampling times, and were not associated with differences in outcomes.

Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

14.

Isavuconazole: A New Broad-Spectrum Triazole Antifungal Agent.

Author: MiceliMarisa H, KauffmanCarol A

Fewer drug interactions
Good bioavailability
Invasive fungal infection treatment
Few serious adverse effects

Isavuconazole is a new triazole antifungal drug that is effective against yeasts, molds, and dimorphic fungi. It has a good safety profile and few drug-drug interactions.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

15.

Isavuconazole: A new broad-spectrum azole. Part 2: pharmacokinetics and clinical activity.

Author: LedouxM-P, DenisJ, NivoixY, HerbrechtR

Invasive aspergillosis treatment
Invasive mucormycosis treatment
Candidemia

Isavuconazole is a new extended-spectrum triazole antifungal drug for invasive aspergillosis and mucormycosis, showing non-inferiority to voriconazole with improved safety and tolerability.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

16.

Mucormycosis.

Author: ReidGail, LynchJoseph P, FishbeinMichael C, ClarkNina M

High mortality
Limited diagnostic value
Rapid progression

Mucormycosis is a serious fungal infection that can be fatal, particularly in immunocompromised individuals. The infection can affect multiple organs, most commonly the sinuses and lungs. Treatment involves antifungal medications and surgery.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

19.

Pharmacokinetic Effects of Isavuconazole Coadministration With the Cytochrome P450 Enzyme Substrates Bupropion, Repaglinide, Caffeine, Dextromethorphan, and Methadone in Healthy Subjects.

Author: YamazakiTakao, DesaiAmit, GoldwaterRonald, HanDavid, HowiesonCorrie, AkhtarShahzad, KowalskiDonna, LademacherChristopher, PearlmanHelene, RammelsbergDiane, TownsendRobert

Drug interactions

This phase 1 study assessed interactions of oral isavuconazole with single oral doses of cytochrome P450 (CYP) substrates. The study found that isavuconazole is a mild inducer of CYP2B6 but does not appear to affect CYP1A2-, CYP2C8-, or CYP2D6-mediated metabolism.

Clinical Trial, Phase IThe first stage of clinical trials in humans. Evaluates the safety, tolerability, and pharmacokinetics of a new drug/treatment.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

20.

What Can Be Learned from Recent New Drug Applications? A Systematic Review of Drug Interaction Data for Drugs Approved by the US FDA in 2015.

Author: YuJingjing, ZhouZhu, OwensKatie H, RitchieTasha K, Ragueneau-MajlessiIsabelle

Drug interactions

This analysis systematically examines all drug metabolism, transport, pharmacokinetics (PK), and drug-drug interaction (DDI) data available in the 33 new drug applications (NDAs) approved by the Food and Drug Administration (FDA) in 2015. The findings highlight significant interactions between new molecular entities (NMEs) and drug metabolizing enzymes or transporters.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.
Systematic ReviewA review that systematically collects, evaluates, and integrates relevant research to answer a specific research question.

Language : English

21.

Population Pharmacokinetics of Isavuconazole from Phase 1 and Phase 3 (SECURE) Trials in Adults and Target Attainment in Patients with Invasive Infections Due to Aspergillus and Other Filamentous Fungi.

Author: DesaiAmit, KovandaLaura, KowalskiDonna, LuQiaoyang, TownsendRobert, BonatePeter L

Invasive fungal infection treatment

Isavuconazole is a triazole antifungal agent used to treat invasive fungal infections. This study developed a population pharmacokinetic model to identify covariates that affect isavuconazole pharmacokinetics and to determine the probability of target attainment (PTA) for invasive aspergillosis patients. The model showed that isavuconazole clearance was approximately 36% lower in Asians than in Caucasians. The PTA indicated that adequate exposures were achieved in most simulated patients to treat infections with MICs up to 1 mg/liter according to EUCAST methodology and 0.5 mg/liter according to CLSI methodology.

Clinical Trial, Phase IThe first stage of clinical trials in humans. Evaluates the safety, tolerability, and pharmacokinetics of a new drug/treatment.
Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

22.

Isavuconazole versus voriconazole for primary treatment of invasive mould disease caused by Aspergillus and other filamentous fungi (SECURE): a phase 3, randomised-controlled, non-inferiority trial.

Author: MaertensJohan A, RaadIssam I, MarrKieren A, PattersonThomas F, KontoyiannisDimitrios P, CornelyOliver A, BowEric J, RahavGalia, NeofytosDionysios, AounMickael, BaddleyJohn W, GiladiMichael, HeinzWerner J, HerbrechtRaoul, HopeWilliam, KarthausMeinolf, LeeDong-Gun, LortholaryOlivier, MorrisonVicki A, OrenIlana, SelleslagDominik, ShohamShmuel, ThompsonGeorge R, LeeMisun, MaherRochelle M, Schmitt-HoffmannAnne-Hortense, ZeiherBernhardt, UllmannAndrew J

Invasive mould treatment
Eye
Gastrointestinal
Hepatobiliary

Isavuconazole was found to be non-inferior to voriconazole for the primary treatment of suspected invasive mould disease, and was well tolerated.

Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

23.

Systemic antifungal therapy with isavuconazonium sulfate or other agents in adults with invasive mucormycosis or invasive aspergillosis (non-fumigatus): A multicentre, non-interventional registry study.

Author: ThompsonGeorge R, Garcia-DiazJulia, MiceliMarisa H, NguyenM Hong, Ostrosky-ZeichnerLuis, YoungJo-Anne H, FisherCynthia E, ClarkNina M, GreenbergRichard N, SpecAndrej, KovandaLaura, Croos-DabreraRodney, KontoyiannisDimitrios P

Invasive fungal disease treatment

Isavuconazole, a drug for fungal infections, is as effective as other common treatments for invasive aspergillosis and mucormycosis.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.

Language : English

24.

Isavuconazonium sulfate for the treatment of fungal infection.

Author: WalkerR C, ZeuliJ D, TemesgenZ

Invasive aspergillosis treatment
Invasive mucormycosis treatment

This review describes isavuconazole, a new antifungal medication with a broad spectrum of activity against various fungi. The drug is currently approved for treating invasive aspergillosis and invasive mucormycosis, two serious fungal infections.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

26.

Pharmacokinetics and Concentration-Dependent Efficacy of Isavuconazole for Treatment of Experimental Invasive Pulmonary Aspergillosis.

Author: PetraitisVidmantas, PetraitieneRuta, MoradiPatriss W, StraussGittel E, KatragkouAspasia, KovandaLaura L, HopeWilliam W, WalshThomas J

Decreased pulmonary injury
Prolonged survival
Reduced fungal burden

Isavuconazole, a broad-spectrum triazole, demonstrates dose-dependent efficacy in treating invasive pulmonary aspergillosis in rabbits. It reduces fungal burden, decreases pulmonary injury, and prolongs survival.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

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