Clinical experience with isavuconazole in healthy volunteers and patients with invasive aspergillosis in China, and the results from an exposure-response analysis.
Mycoses
; 64(4): 445-456, 2021 Apr.
Article
en En
| MEDLINE
| ID: mdl-33355949
ABSTRACT
BACKGROUND:
Isavuconazole is a broad-spectrum triazole for the treatment of invasive fungal disease (IFD).OBJECTIVE:
To investigate the clinical experience with isavuconazole in Chinese individuals. PATIENTS/METHODS:
Participants were Chinese healthy volunteers from a Phase I pharmacokinetics (PK) and safety study of single/multiple doses of isavuconazole (n = 36) and Chinese patients from the global Phase III SECURE study that assessed safety and efficacy of isavuconazole vs voriconazole for IFD treatment (n = 26).RESULTS:
No clinically relevant differences in PK were found between Chinese and Western participants, although exposure was increased in Chinese volunteers. Treatment-emergent adverse events (TEAEs) were reported in 75.0% of healthy volunteers, many of which were infusion-related. No serious AEs were reported. In SECURE, findings in Chinese patients (n = 26) were similar to the global population. For patients who received ≥1 dose of study drug, allcause mortality from first dose to Day 42 was 10.0% (1/10) with isavuconazole and 25.0% (4/16) with voriconazole (treatment difference [95% confidence interval, CI] -15.0% [-43.2%, 13.2%]). Overall response at the end of treatment for patients with proven/probable IFD was 25.0% and 16.7% with isavuconazole and voriconazole, respectively (treatment difference [95% CI] -8.3% [-60.2%, 43.5%]). Isavuconazole was associated with lower incidence of hepatobiliary, eye, skin, subcutaneous tissue and psychiatric disorders compared with voriconazole and lower incidence of treatment-related TEAEs, serious TEAES or death overall.CONCLUSIONS:
Although further research is required, this study demonstrated a favourable risk-benefit profile of isavuconazole in Chinese patients.Palabras clave
Texto completo:
1
Ejes tematicos:
Pesquisa_clinica
Banco de datos:
MEDLINE
Asunto principal:
Piridinas
/
Aspergilosis
/
Triazoles
/
Voluntarios Sanos
/
Antifúngicos
/
Nitrilos
Tipo de estudio:
Clinical_trials
Límite:
Humans
País como asunto:
Asia
Idioma:
En
Año:
2021
Tipo del documento:
Article