Table 2.
Infection Characteristics in Patients who Received Mold-Active Triazole Prophylaxis at Index/Enrollment and Had a Breakthrough Infection (Full Analysis Set)
| Isavuconazole (n = 256) | Posaconazole (n = 397) | Voriconazole (n = 272) | Multiple/Sequenced MATsa (n = 252) | Total (N = 1177) | |
|---|---|---|---|---|---|
| Prophylaxis patients with assessment, No.b | 221 | 374 | 226 | 209 | 1030 |
| Breakthrough IFD | 11 (5.0) | 20 (5.3) | 9 (4.0) | 33 (15.8) | 73 (7.1) |
| Not applicable,c No. | 35 | 22 | 46 | 42 | 145 |
| Missing, No. | 0 | 1 | 0 | 1 | 2 |
| Highest level of diagnosis during study, No. | 9 | 16 | 3 | 30 | 58 |
| Proven | 7 (77.8) | 10 (62.5) | 3 (100.0) | 15 (50.0) | 35 (60.3) |
| Probable | 2 (22.2) | 5 (31.3) | 0 | 9 (30.0) | 16 (27.6) |
| Possible | 0 | 1 (6.3) | 0 | 6 (20.0) | 7 (12.1) |
| Missing, No. | 2 | 4 | 6 | 3 | 15 |
| Pathogen recovered,d No. | 10 | 18 | 4 | 29 | 61 |
| Aspergillus spp. | 4 (40.0) | 3 (16.7) | 0 | 11 (37.9) | 18 (29.5) |
| fumigatus | 3 (30.0) | 1 (5.6) | 0 | 3 (10.3) | 7 (11.5) |
| niger | 1 (10.0) | 1 (5.6) | 0 | 2 (6.9) | 4 (6.6) |
| Not specified | 1 (10.0) | 1 (5.6) | 0 | 5 (17.2) | 7 (11.5) |
| Missing, No. | 0 | 0 | 0 | 2 | 2 |
| Candida spp. | 3 (30.0) | 10 (55.6) | 1 (25.0) | 8 (27.6) | 22 (36.1) |
| albicans | 0 | 3 (16.7) | 0 | 1 (3.4) | 4 (6.6) |
| glabrata | 3 (30.0) | 5 (27.8) | 1 (25.0) | 1 (3.4) | 10 (16.4) |
| krusei | 0 | 1 (5.6) | 0 | 1 (3.4) | 2 (3.3) |
| parapsilosis | 1 (10.0) | 1 (5.6) | 0 | 0 | 2 (3.3) |
| tropicalis | 0 | 1 (5.6) | 0 | 2 (6.9) | 3 (4.9) |
| Not specified | 0 | 1 (5.6) | 0 | 2 (6.9) | 3 (4.9) |
| Missing, No. | 0 | 0 | 0 | 2 | 2 |
| Fusarium spp. | 0 | 2 (11.1) | 1 (25.0) | 2 (6.9) | 5 (8.2) |
| Mucoralese.e | 0 | 0 | 0 | 3 (10.3) | 3 (4.9) |
| Penicillium spp. | 1 (10.0) | 1 (5.6) | 0 | 0 | 2 (3.3) |
| Coccidioides spp. | 1 (10.0) | 0 | 0 | 0 | 1 (1.6) |
| Histoplasma spp. | 0 | 0 | 1 (25.0) | 0 | 1 (1.6) |
| Otherf | 1 (10.0) | 2 (11.1) | 1 (25.0) | 5 (17.2) | 9 (14.8) |
| Infection site, No. | 11 | 18 | 4 | 32 | 65 |
| Abdominal cavity | 1 (9.1) | 0 | 0 | 0 | 1 (1.5) |
| Chest | 0 | 1 (5.6) | 0 | 6 (18.8) | 7 (10.8) |
| Lung | 7 (63.6) | 6 (33.3) | 0 | 11 (34.4) | 24 (36.9) |
| Maxillary sinus | 0 | 1 (5.6) | 0 | 1 (3.1) | 2 (3.1) |
| Oropharynx | 0 | 3 (16.7) | 0 | 3 (9.4) | 6 (9.2) |
| Otherg | 4 (36.4) | 8 (44.4) | 4 (100.0) | 13 (40.6) | 29 (44.6) |
| Skin | 0 | 0 | 1 (25.0) | 1 (3.1) | 2 (3.1) |
| Missing, No. | 0 | 2 | 5 | 1 | 8 |
Data are reported as No. (%), except where indicated. No. represents the number of applicable patients who received the prophylactic assessment. FAS included patients meeting study entry criteria for the relevant enrollment protocol. Prophylaxis groups were not randomized, and prophylactic assessment results were not adjusted; it is possible that any differences between prophylaxis groups could be due to other confounders rather than effects of MAT prophylaxis. Patients in the prophylaxis subgroup may have transitioned to treatment during the course of the study. Patients who initiated prophylaxis at index/enrollment and subsequently developed IFDs were determined to have bIFDs, which were classified at the end of the MAT course(s) as proven, probable, or possible bIFDs [16].
Abbreviations: bIFD, breakthrough invasive fungal infection; FAS, full analysis set; IFD, invasive fungal infection; MAT, mold-active triazole; spp., multiple species.
Multiple/sequenced MATs describe patients receiving >1 MAT throughout the study since index/enrollment.
Only patients receiving prophylaxis at index/enrollment were included in the prophylactic response assessment.
Patients deemed not applicable by the investigator, including those who transitioned to treatment for a non-bIFD at the time of assessment by an investigator.
Pathogen subgroups were determined by considering all recorded fungal infections, including those that started before the start date of the MAT at index/enrollment. More than 1 pathogen species could be recovered from a single patient.
Mucorales includes the genera Mucor, Rhizomucor, and Rhizopus.
“Other” pathogens include (but are not limited to) Zygomycetes (most frequently reported) and Simplicillium subtropicum.
“Other” sites include (but are not limited to) blood (most frequently reported), sputum, bladder, eye, esophagus, abdomen, urine, and sinus.