Table 2.
Relationship between elevation in liver enzyme concentration and patient characteristics at baseline by treatment regimen
| Peak ALT or AST ≥3 × ULN1 |
|||
|---|---|---|---|
| Standard arm (2EHRZ/4HR) |
Isoniazid arm (2MHRZ/2MHR) |
Ethambutol arm (2EMRZ/2MR) |
|
| n (%) | 60 / 639 (9.4%) | 52 / 654 (8.0%) | 38 / 634 (6.0%) |
| Male (%) | 40 / 447 (9.0%) | 38 / 449 (8.5%) | 24 / 447 (5.4%) |
| Female (%) | 20 / 192 (10.4%) | 14 / 205 (6.8%) | 14 / 188 (7.5%) |
| Age in years2 (%) | |||
| 18–24 | 13 / 186 (7.0%) | 17 / 203 (8.4%) | 11 / 172 (6.4%) |
| 25–34 | 21 / 184 (11.4%) | 11 / 213 (5.2%) | 9 / 210 (4.3%) |
| 35–44 | 16 / 142 (11.3%) | 11 / 115 (9.6%) | 8 / 122 (6.6%) |
| 45–54 | 2 / 88 (2.3%) | 6 / 81 (7.4%) | 8 / 86 (9.3%) |
| ≥55 | 8 / 38 (21.1%) | 7 / 41 (17.1%) | 2 / 44 (4.6%) |
| Baseline weight in kg (%) | |||
| <40 | 11 /63 (17.5%) | 6 / 56 (10.7%) | 5 / 56 (8.9%) |
| 40–49 | 22 / 218 (10.1%) | 20 / 243 (8.2%) | 11 / 224 (4.9%) |
| 50–59 | 16 / 242 (6.6%) | 19 / 231 (8.2%) | 12 / 236 (5.1%) |
| 60–69 | 8 / 88 (9.1%) | 5 / 88 (5.7%) | 8 / 86 (9.3%) |
| ≥70 | 3 / 28 (10.7%) | 2 / 36 (5.6%) | 2 / 33 (6.1%) |
| Ethnicity (%) | |||
| Black | 20 / 295 (6.8%) | 21 / 277 (7.6%) | 17 / 290 (5.9%) |
| Asian | 34 / 194 (17.5%) | 23 / 201 (11.4%) | 10 / 193 (5.18%) |
| Mixed race | 6 /149 (4.0%) | 8 / 174 (4.6%) | 11 / 151 (7.3%) |
| Other | 0 / 1 (0.0%) | 0 / 2 (0.0%) | 0 / 0 (0.0%) |
| HIV positive (%) | 7 / 46 (15.2%) | 3 / 46 (6.5%) | 4 / 48 (8.3%) |
| HIV negative (%) | 53 / 593 (8.9%) | 49 / 608 (8.1%) | 34 / 586 (5.8%) |
| Smoking history (%) | |||
| Never | 31 / 298 (10.4%) | 23 / 291 (7.9%) | 16 / 279 (5.7%) |
| Previous | 11 / 155 (7.1%) | 17 / 155 (11.0%) | 9 / 166 (5.4%) |
| Current | 18 / 186 (9.7%) | 12 / 208 (5.8%) | 13 / 190 (6.8%) |
Characteristics for patients across all treatment arms are shown according to peak ALT and/or AST while taking treatment
ALT alanine aminotransferase, AST aspartate aminotransferase, ULN upper limit of normal
1 Cell percentages shown
2 Data for date of birth was not available for some patients in all three treatment arms