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Efficacy and safety of isavuconazole against deep-seated mycoses: A phase 3, randomized, open-label study in Japan
Shigeru Kohno1, Koichi Izumikawa2, Takahiro Takazono3
1Nagasaki University, Nagasaki, 852-8521, Japan.
Objectives:
Isavuconazole is a convenient triazole antifungal agent with a broad antifungal spectrum. A randomized, open-label study (ClinicalTrials.gov, NCT03471988) was conducted to evaluate the efficacy and safety of isavuconazole in Japanese patients with deep-seated mycoses.
Patients And Methods:
In Cohort A, patients with aspergillosis (chronic pulmonary aspergillosis and invasive aspergillosis) were randomized in a 2:1 ratio to isavuconazole or voriconazole, and in Cohort B, patients with cryptococcosis and mucormycosis were assigned to isavuconazole for up to 84 days of treatment. The overall outcome was evaluated according to the clinical, radiological, and mycological responses at Days 42 and 84 and at the end of treatment (EOT).
Results:
A total of 103 participants were enrolled and received the study drug. The overall response rate of patients with chronic pulmonary aspergillosis in the isavuconazole (52 patients) and voriconazole (27 patients) groups was 82.7% and 77.8% at EOT, respectively. The response rate in patients with cryptococcosis (10 patients, isavuconazole group only) was 90.0%. One of three participants with invasive aspergillosis and one of three participants with mucormycosis responded in the isavuconazole group. In the safety evaluation, the incidence of adverse events in participants with chronic pulmonary aspergillosis was similar in both groups. Adverse drug reactions were reported in 32 (61.5%) patients receiving isavuconazole and 23 (85.2%) patients receiving voriconazole.
Conclusions:
Isavuconazole showed efficacy and safety in Japanese patients with chronic pulmonary aspergillosis and cryptococcosis, for which the drug is not currently indicated.
Insights
Isavuconazole demonstrated efficacy and safety in Japanese patients with chronic pulmonary aspergillosis and cryptococcosis. This study highlights its potential for treating deep-seated mycoses in this population.
Area of Science:
- Mycology
- Infectious Diseases
- Clinical Pharmacology
Background:
- Isavuconazole is a broad-spectrum triazole antifungal agent.
- Deep-seated mycoses pose significant health challenges, particularly in immunocompromised individuals.
- Current treatment options may have limitations in efficacy or safety profiles.
Purpose of the Study:
- To evaluate the efficacy and safety of isavuconazole in Japanese patients with deep-seated mycoses.
- To compare isavuconazole with voriconazole in the treatment of chronic pulmonary aspergillosis.
- To assess isavuconazole's effectiveness in cryptococcosis and mucormycosis.
Main Methods:
- A randomized, open-label study (NCT03471988) involving 103 Japanese patients.
- Cohort A: Aspergillosis patients randomized (2:1) to isavuconazole or voriconazole.
- Cohort B: Cryptococcosis and mucormycosis patients treated with isavuconazole for up to 84 days.
Main Results:
- Overall response rates at end of treatment (EOT) were 82.7% for isavuconazole and 77.8% for voriconazole in chronic pulmonary aspergillosis.
- Isavuconazole showed a 90.0% response rate in cryptococcosis patients.
- Similar adverse event incidence between groups for aspergillosis; fewer adverse drug reactions with isavuconazole.
Conclusions:
- Isavuconazole is effective and safe for Japanese patients with chronic pulmonary aspergillosis and cryptococcosis.
- The findings suggest isavuconazole's potential utility in treating these specific deep-seated mycoses.
- Further investigation may be warranted for invasive aspergillosis and mucormycosis.
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