Table 1.
Baseline characteristics of patients on the first isavuconazole therapeutic drug monitoring
| Variable, n (%) or median (Q1–Q3) | Patients (n = 102) |
|---|---|
| Clinical features | |
| Sex, M/F | 66/36 |
| Age (y) | 60.0 (52.0–68.0) |
| Underlying liver disease | 10 (9.8) |
| Hospitalisation units | |
| Haematology | 42 (41.1) |
| ICU | 31 (30.4) |
| Infectious disease | 12 (11.8) |
| Pneumology | 5 (4.9) |
| Others | 10 (9.8) |
| Biological parameters before isavuconazole initiation | |
| Total proteins (g/L) (n = 101) | 62.0 (55.4–70.0) |
| Albumin (g/L) (n = 77) | 25.6 (21.4–29.8) |
| AST (U/L) (n = 99) | 25 (17–47.5) |
| ALT (U/L) (n = 99) | 25 (14–49.5) |
| GGT (U/L) (n = 99) | 90 (45.5–221) |
| ALP (U/L) (n = 99) | 117 (87.5–181.5) |
| Total bilirubin (µmol/L) (n = 99) | 8 (5–13) |
| Biological parameters on the day of TDM | |
| Total proteins (g/L) (n = 94) | 63.0 (54.3–69.8) |
| Albumin (g/L) (n = 74) | 27.1 (22.0–35.2) |
| AST (U/L) (n = 100) | 24 (17.8–37.0) |
| ALT (U/L) (n = 100) | 26.5 (14.0–41.3) |
| GGT (U/L) (n = 100) | 92.5 (48.5–218.75) |
| ALP (U/L) (n = 99) | 123.0 (96.5–188.0) |
| Total bilirubin (µmol/L) (n = 91) | 9 (6–13) |
| Treatments | |
| Oral route | 74 (72.5) |
| Isavuconazole dose (mg/day) | 200 (200–600) |
| Isavuconazole duration (days) (n = 81) | 88 (25-217) |
| Isavuconazole trough concentration on the first occasion (mg/L) | 2.2 (1.3–3.6) |
| Time to TDM from isavuconazole initiation (day) | 8.5 (4.0–26.8) |
| Exposure | |
| Within therapeutic range (2–4.5 mg/L) | 47 (46.1) |
| Underexposure (< 2 mg/L) | 43 (42.2) |
| Overexposure (> 4.5 mg/L) | 12 (11.7) |
| Previous exposure to azoles (< 6 months) | 63 (52.0) |
| Hepatotoxic co-medication | 41 (40.2) |
| Mycological diagnosis | |
| Aspergillosis | 48 (47.0) |
| Mucormycosis | 26 (25.6) |
| Aspergillosis and mucormycosis co-infection | 3 (2.9) |
| Empirical treatment | 19 (18.6) |
| Prophylaxis | 6 (5.9) |
| Liver safety (n = 99) | |
| Abnormal liver test during treatment | 11 (11.1) |
| GGT | 6 (6.0) |
| GGT and ALP | 5 (5.0) |
| GGT (U/L) (n = 11) | 264.0 (166.0–413.5) |
| ALP (U/L) (n = 11) | 228.0 (185.0–334.0) |
| Time to occurrence from isavuconazole initiation (days) | 20 (6–48) |
| Isavuconazole discontinuation in case of abnormal liver test | 6 (6.0) |
| Case of isavuconazole induced liver injury | 2 (2.0) |
ALP alkaline phosphatase, ALT alanine aminotransferase, AST aspartate aminotransferase, GGT gamma-glutamyl transferase, ICU intensive care unit, TDM therapeutic drug monitoring